InfoCons Consumer Protection informs you – Nemdatine – Package Leaflet

Nemdatine – Package Leaflet: InfoCons – Consumer Protection presents, in an accessible format, the official package leaflet of the medicine Nemdatine, as authorised in the European Union and published in the Union Register of medicinal products.

📋 Nemdatine – at a glance

Active substance	Memantine
ATC code	N06DX01
EU authorisation number	EU/1/13/824
Marketing Authorisation Holder	Actavis Group PTC ehf.
Therapeutic indication	Treatment of patients with moderate to severe Alzheimer’s disease.
Last Commission decision	2024-03-21

Before anything else

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you .

Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
If you get any side effects, talk to your doctor or pharmacis t. This includes any possible side effects not listed in this leaflet. See section 4.

What is i n this leaflet 1. What Nemdatine is and what it is used for 2. What you need to know before you take Nemdatine 3. How to take Nemdatine 4. Possible side effects 5. How to store Nemdatine 6. Contents of the pack and other information 1. What Nemdatine is and what it is used for How does Nemdatine work Nemdatine contains the active substance memantine hydrochloride. Nemdatine belongs to a group of medicines known as anti -dementia medicines.

Memory loss in Alzheimer’s disease is due to a disturbance of message signals in the brain. The brain contains so -called N- methyl -D-aspartate (NMDA) -receptors that are involved in transmitt ing nerve signals important in learning and memory. Nemdatine belongs to a group of medicines called NMDA- receptor antagonists. Nemdatine acts on these NMDA-receptors improving the transmission of nerve signals and the memory.

What is Nemdatine used for Nemdatine is used for the treatment of adult patients with moderate to severe Alzheimer’s disease.

2. What you need to know before you take Nemdatine

Do not take Nemdatine

if you are allergic to memantine hydrochloride or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor or pharmacist before taking Nemdatine

if you have a history of epileptic seizures
if you have recently experienced a myocardial infarction (heart attack), or if you are suffering from congestive heart failure or from an uncontrolled hypertension (high blood pressure).

In these situations the treatment should be carefully supervised, and the clinical benefit of Nemdatine reassessed by your doctor on a regular basis.

If you suffer from renal impairment (kidney problems), your doctor should closely monitor your kidney function and if necessary adapt the memantine doses accordingly.

The use of medicinal products called amantadine (for the treatment of Parkinson’s disease), ketamine (a substance generally used as an anaesthetic), dextromethorphan (generally used to treat cough) and 72 other NMDA -antagonists at the same time should be avoided.

Children and adoles cents Nemdatine is not recommended for children and adolescents under the age of 18 years.

Other medicines and Nemdatine

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

In particular, Nemdatine may change the effects of the following medicines and their dose ma y need to be adjusted by your doctor:

amantad ine, ketamine, dextromethorphan
dantrolene, baclofen
cimetidine, ranitidine, procainamid e, quinidine, quinine, nicotine
hydrochlorothiazide (or any combination with hydrochlorothiazide)
anticholinergics (substances generally used to treat movement disorders or intestinal cramps)
anticonvulsants (substances used t o prevent and relieve seizures)
barbiturates (substances generally used to induce sleep)
dopaminergic agonists (substances such as L -dopa, bromocriptine)
neuroleptics (substances used in the treatment of mental disorders)
oral anticoagulants If you go into hospital, let your doctor know that you are taking Nemdatine.

Nemdatine with food and drink You should inform your doctor if you have recently changed or intend to change your diet substantially (e.g. from normal diet to strict vegetarian diet) or if you are suffering from states of renal tubulary acidosis (RTA, an excess of acid -forming substances in the blood due to renal dysfunction (poor kidney function)) or severe infections of the urinary tract (structure that carries urine), as your doctor may need to adjust the dose of your medicine.

Pregnancy and breast -feeding If you are pregnant or breast -feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

The use of memantine in pregnant women is not recommended.

Breast -feeding Women taking Nemdatine should not breast -feed.

Driving and using machines

Your doctor will tell you whether your illness allows you to drive and to use machines safely. Also, Nemdatine may change your reactivity, making driving or operating machinery inappropriate.

Nemdatine contains lactose monohydra te

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3. How to take N emdatine Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Dosage The recommended dose of Nemdatine for adults and older people is 20 mg once a day.

73 In order to reduce the risk of side effects this dose is achieved gradually by the following daily treatment scheme:

Week 1 One 5 mg tablet Week 2 Two 5 mg tablet s Week 3 Three 5 mg tablets Week 4 and beyond Four 5 mg tablets once a day The usual starting dose is one tablet once a day ( 1x 5 mg) for the first week. This is increased to two tablet s once a day ( 1x 10 mg) in the second week and to three tablets once a day (1x 15 mg) in the third week. From the fourth week on, the usual dose is 4 tablets once a day ( 1x 20 mg).

Dosage in patients with impaired kidney function If you have impaired kidney function, your doctor will decide upon a dose that suits your condition. In this case, monitoring of your kidney function should be performed by your doctor at specified intervals.

Administration Nemdatine should be administered orally once a day. To benefit from your medicine you should take it regularly every day at the same time of the day. The tablets should be swallowed with some water. The tablets can be taken with or without food.

Duration of treatm ent Continue to take Nemdatine as long as it is of benefit to you. Your doctor should assess your treatment on a regular basis.

If you take more Nemdatine than you should

In general, taking too much Nemdatine should not result in any harm to you. You m ay experience increased symptoms as described in sect ion 4 ‘Possible side effects’ .
If you take a large overdose of Nemdatine, contact your doctor or get medical advice, as you may need medical attention.

If you forget to take Nemdatine

If you find yo u have forgotten to take your dose of Nemdatine, wait and take your next dose at the usual time.
Do not take a double dose to make up for a forgotten dose.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects Like all medicines, this medicine can cause side effects, although not everybody gets them.

In general, the observed side effects are mild to moderate.

Common (affects 1 to 1 0 users in 100)

Headache, sleepiness, constipation, elevated liver function test, dizziness, balance disorders, shortness of breath, high blood pressure and drug hypersensitivity

Uncommon ( affects 1 to 1 0 users in 1,000)

Tiredness, fungal infections, confusion, hallucinations, vomiting, abnormal gait, heart failure and venous blood clotting (thrombosis/thromboembolism)

Very Rare (affects less than 1 user in 10,000)

Seizures

Not known (frequency cannot be est imated from the available data)

Inflammation of the pancreas , inflammation of the liver (he patitis) and psychotic reactions Alzheimer’s disease has been associated with depression, suicidal ideation and suicide. These events have been reported in patients treated with meman tine.

Reporting of side effects

If you get any side effects, talk to yo ur doctor, pharmacist or nurse . This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V . By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Nemdatine Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and blister after ‘EXP ’.

The expiry date refers to the last day of that month.

Do not store above 25°C.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Nemdatine contains

The active substance is memantine hydrochloride. Each film -coated tablet contains 5 mg memantine hydrochloride equivalent to 4.15 mg memantine.
The other ingredients are: Tablet core: Microcrystalline cellulose, crospovidone Type A , talc and magnesium stearate. Tablet coat ( Opadry II White 33G28435): Hypromellose 6cP, titanium dioxide (E171) , lactose monoh ydrate, macrogol 3350 and triacetin.

What Nemdatine looks like and contents of the pack

Nemdatine 5 mg film-coated tablets (tablets) are white, oval shaped, biconvex, 8 mm x 4.5 mm in size, with the marking “M5” engraved on one side.

Pack sizes Blister packs: 42 and 98 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Actavis Group PTC ehf .

Dalshraun 1 220 Hafnarfjörður Iceland

Manufacturer

Actavis Ltd.

BLB 015 -016 Bulebel Industrial Estate Zejtun ZTN 3000 Malta TEVA Gyógyszergyár Zrt.

Pallagi út 13 Debrecen 4042 Hungary For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Teva Pharma Belgium N.V./S.A./AG Tél/Tel: + 32 38207373 Lietuva UAB Teva Baltics Tel: +370 5 2660203 България Тева Фарма ЕАД Тел: +359 24899585 Luxembourg/Luxemburg ratiopharm GmbH Allemagne/Deutschland Tél/Tel: + 49 73140202 Česká republika Teva Pharmaceuticals CR, s.r.o.

Tel: +420 251007111 Magyarország Teva Gyógyszergyár Zrt.

Tel: +36 12886400 Danmark Teva Denmark A/S Tlf: +45 44985511 Malta Teva Pharmaceuticals Ireland L-Irlanda Tel: +44 2075407117 Deutschland ratiopharm GmbH Tel: + 49 73140202 Nederland Teva Nederland B.V.

Tel: + 31 8000228400 Eesti UAB Teva Baltics Eesti filiaal Tel: +372 6610801 Norge Teva Norway AS Tlf: +47 66775590 Ελλάδα TEVA HELLAS A.E.

Τηλ: +30 2118805000 Österreich ratiopharm Arzneimittel Vertriebs -GmbH Tel: +43 1970070 España Teva Pharma, S.L.U.

Tel: + 34 913873280 Polska Teva Pharmaceuticals Polska Sp. z o.o.

Tel: +48 223459300 France Teva Santé Tél: + 33 155917800 Portugal Teva Pharma – Produtos Farmacêuticos, Lda.

Tel: +351 214767550 Hrvatska Pliva Hrvatska d.o.o.

Tel: +385 13720000 România Teva Pharmaceuticals S.R.L .

Tel: + 40 212306524 Ireland Teva Pharmaceuticals Ireland Tel: +44 2075407117 Slovenija Pliva Ljubljana d.o.o.

Tel: +386 15890390 76 Ísland Teva Pharma Iceland ehf.

Sími: +354 5503300 Slovenská republika TEVA Pharmaceuticals Slovakia s.r.o .

Tel: +421 2 57267911 Italia Teva Italia S.r.l.

Tel: +39 028917981 Suomi/Finland Teva Finland Oy Puh/Tel: +358 201805900 Κύπρος TEVA HELLAS A.E.

Ελλάδα Τηλ: +30 2118805000 Sverige Teva Sweden AB Tel: +46 42121100 Latvija UAB Teva Baltics filiāle Latvijā Tel: +371 67323666 United Kingdom (Northern Ireland) Accord Healthcare Ireland Ltd.

Ireland Tel: +353 214619040

This leaflet was last revised in {MM/YYYY}

Other sources of information Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu /.

77 Package leaflet: Information for the patient Nemdatine 10 mg film -coated tablets memantine hydrochloride Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is i n this leaflet 1. What Nemdatine is and what it is used for 2. What you need to know before you take Nemdat ine 3. How to take Nemdatine 4. Possible side effects 5. How to store Nemdatine 6. Contents of the pack and other information 1. What Nemdatine is and what it is used for How does Nemdatine work Nemdatine contains the active substance memantine hydrochloride. Nemdatine belongs to a group of medicines known as anti -dementia medicines.

Memory loss in Alzheimer’s disease is due to a disturbance of message signals in the brain. The brain contains so -called N- methyl -D-aspartate (NMDA) -receptors that are involved in transmitting nerve signals important in learning and memory. Nemdatine belongs to a group of medicines called NMDA- receptor antagonists. Nemdatine acts on these NMDA-receptors improving the transmission of nerve signals and the memory.

What is Nemdatine used for Nemdatine is used for the treatment of adult patients with moderate to severe Alzheimer’s disease.

2. What you need to know before you take Nemdatine

Do not take Nemdatine

if you are allergic to memantine hydrochloride or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor or pharmacist before taking Nemdatine

if you have a history of epileptic seizures
if you have recently experienced a myocardial infarction (heart attack), or if you are suffering from congestive heart failure or from an uncontrolled hypertension (high blood pressure).

In these situations the treatment should be carefully supervised, and the clinical benefit of Nemdatine reassessed by your doctor on a regular basis.

If you suffer from renal impairment (kidney problems), your doctor should closely monitor your kidney function and if necessary adapt the memantine doses accordingly.

The use of medicinal products called amantadine (for the treatment of Parkinson’s disease), ketamine (a substance generally used as an anaesthetic), dextromethorphan (generally used to treat cough) and 78 other NMDA -antagonists at the same time should be avoi ded.

Children and adoles cents Nemdatine is not recommended for children and adolescents under the age of 18 years.

Other medicines and Nemdatine

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

In particular, Nemdatine may change the effects of the following medicines and their dose may need to be adjusted by your doctor:

amantadine, ketamine, dextromethorphan
dantrolene, baclofen
cimetidine, ranitidine, procainamide, quinidine, quinine, nicotine
hydrochlorothiazide (or any combination with hydrochlorothiazide)
anticholinergics (substances generally used to treat movement disorders or intestinal cramps)
anticonvulsants (substances used to prevent and relieve seizures)
barbiturates (substances generally used to induce sleep)
dopaminergic agonists (substances such as L -dopa, bromocriptine)
neuroleptics (substances used in the treatment of mental disorders)
oral anticoagulants If you go into hospital, let your doctor know that you are taking Nemdatine.

Nemdatine with food and drink You should inform your doctor if you have recently changed or intend to change your diet substantially (e.g. from normal diet to strict vegetarian d iet) or if you are suffering from states of renal tubulary acidosis (RTA, an excess of acid -forming substances in the blood due to renal dysfunction (poor kidney function)) or severe infections of the urinary tract (structure that carries urine), as your doctor may need to adjust the dose of your medicine.

Pregnancy and breast -feeding If you are pregnant or breast -feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

The use of memantine in pregnant women is not recommended.

Breast -feeding Women taking Nemdatine should not breast -feed.

Driving and using machines

Your doctor will tell you whether your illness allows you to drive and to use machines safely. A lso, Nemdatine may change your reactivity, making driving or operating machinery inappropriate.

Nemdatine contains lactose monohydrate

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3. How to take N emdatine Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Dosage The recommended dose of Nemdatine for adults and older people is 20 mg once a day.

79 In order to reduce the risk of side effects this dose is achieved gradually by the following daily treatment scheme:

Week 1 Half a 10 mg tablet Week 2 One 10 mg tablet Week 3 One and a half 10 mg tablets Week 4 and beyond Two 10 mg tablets once a day The usual starting dose is half a tablet once a day (1x 5 mg) for the first week. This is increased to one tablet once a day (1x 10 mg) in the second week and to 1 and a half tablets once a day (1x 15 mg) in the third week. From the fourth week on, the usual dose is 2 tablets once a day (1x 20 mg).

The tablets can be taken with or without food.

Duration of treatment Continue to take Nemdatine as long as it is of benefit to you. Your doctor should assess your treatment on a regular basis.

If you take more Nemdatine than you should

In general, taking too much Nemdatine should not result in any harm to you. You may experience increased symptoms as described in section 4 ‘Possible side effects’.
If you take a large overdose of Nemdatine, contact your doctor or get medical advice, as you may need medical attention.

If you forget to take Nemdatine

If you find you have forgotten to take your dose of Nemdatine, wait and take your next dose at the usual time.
Do not take a double dose to make up for a forgotten dose .

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects Like all medicines, this medicine can cause side effects, although not everybody gets them.

In general, the observed side effects are mild to moderate.

Common (affects 1 to 10 users in 100)

Headache, sleepiness, constipation, elevated liver function test, dizziness, balance disorders, shortness of breath, high blood pressure and drug hypersensitivity

Uncommon (affects 1 to 10 users in 1,000)

Tiredness, fungal infections, confusion, hallucinations, vomiting, abnormal gait, heart failure and venous blood clotting (thrombosis/thromboembolism)

Very Rare (affects less than 1 user in 10,000)

Seizures

Not known (frequency can not be estimated from the available data)

Inflammation of the pancreas , inflammation of the liver (hepatitis) and psychotic reactions Alzheimer’s disease has been associated with depression, suicidal ideation and suicide. These events have been reported in patients treated with memantine .

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse . This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V . By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Nemdatine Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton, blister and bottle label after ‘EXP’. The expiry date refers to the last day of that month.

Do not store above 25°C. <[For HDPE bottle only:]> Use within 100 days after opening.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help p rotect the environment.

6. Contents of the pack and other information

What Nemdatine contains

The active substance is memantine hydrochloride. Each film -coated tablet contains 10 mg memantine hydrochloride equivalent to 8.31 mg memantine.
The other ingredients are: Tablet core: Microcrystalline cellulose, crospovidone Type A, talc and magnesium stearate. Tablet coat (Opadry II White 33G28435): Hypromellose 6cP, titanium dioxide (E171), lactose monohydrate, macrogol 3350 and triacetin.

What Nemdatine looks like and contents of the pack

Nemdatine 10 mg film -coated tablets (tablets) are white, capsule-shaped, biconvex, 9.8 mm x 4.9 mm in size, with score line and the marking “M 10” engraved on the scored side Pack sizes Blister packs: 28, 30, 42, 50, 56, 60, 98 and 112 film-coated tablets.

Bottle : 100, 130 *, 250 * and 500 * film-coated tablets .

intended for dose dispensing centres only Not all pack sizes may be marketed.

Marketing Authorisation Holder

Actavis Group PTC ehf.

Dalshraun 1 220 Hafnarfjörður Iceland 81 Manufacturer Actavis Ltd.

BLB 015 -016 Bulebel Industrial Estate Zejtun ZTN 3000 Malta TEVA Gyógyszergyár Zrt.

Pallagi út 13 Debrecen 4042 Hungary For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Tel: +420 251007111 Magyarország Teva Gyógyszergyár Zrt.

Tel: + 36 12886400 Danmark Teva Denmark A/S Tlf: +45 44985511 Malta Teva Pharmaceuticals Ireland L-Irlanda Tel: +44 2075407117 Deutschland ratiopharm GmbH Tel: + 49 73140202 Nederland Teva Nederland B.V.

Tel: + 31 8000228400 Eesti UAB Teva Baltics Eesti filiaal Tel: +372 6610801 Norge Teva Norway AS Tlf: +47 66775590 Ελλάδα TEVA HELLAS A.E.

Τηλ: +30 2118805000 Österreich ratiopharm Arzneimittel Vertriebs -GmbH Tel: +43 1970070 España Teva Pharma, S.L.U.

Tel: + 34 913873280 Polska Teva Pharmaceuticals Polska Sp. z o.o.

Tel: +48 223459300 France Teva Santé Tél: + 33 155917800 Portugal Teva Pharma – Produtos Farmacêuticos, Lda.

Tel: +351 214767550 Hrvatska Pliva Hrvatska d.o.o.

Tel: +385 13720000 România Teva Pharmaceuticals S.R.L.

Tel: + 40 212306524 82 Ireland Teva Pharmaceuticals Ireland Tel: +44 2075407117 Slovenija Pliva Ljubljana d.o.o.

Tel: +386 15890390 Ísland Teva Pharma Iceland ehf.

Sími: +354 5503300 Slovenská republika TEVA Pharmaceuticals Slovakia s.r.o.

Tel: +421 2 57267911 Italia Teva Italia S.r.l.

Tel: +39 028917981 Suomi/Finland Teva Finland Oy Puh/Tel: +358 201805900 Κύπρος TEVA HELLAS A.E. Ελλάδα Τηλ: +30 2118805000 Sverige Teva Sweden AB Tel: +46 42121100 Latvija UAB Teva Baltics filiāle Latvijā Tel: +371 67323666 United Kingdom (Northern Ireland) Accord Healthcare Ireland Ltd.

Ireland Tel: +353 214619040

This leaflet was last revised in {MM/YYYY}

Other sources of information Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu /.

83 Package leaflet: Information for the patient Nemdatine 15 mg film -coated tablets memantine hydrochloride Read all of this leaflet carefully before you start taking this medicine because it contains important information for you .

Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Memory loss in Alzheimer’s disease is due to a disturbance of message signals in the brain. The brain contains so -called N- methyl -D-aspartate (NMDA) -receptors that are involved in transmitting nerve signals important in learning and memory. Nemdatine belongs to a group of medicines called NMDA- receptor antagonists. Nemdatine acts on these NMDA-receptors improving the transmission of nerve signals and the memory.

What is Nemdatine used for Nemdatine is used for the treatment of adult patients with moderate to severe Alzheimer’s disease.

2. What you need to know before you take Nemdatine

Do not take Nemdatine

if you are allergic to memantine hydrochloride or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor or pharmacist before taking Nemdatine

if you have a history of epileptic seizures
if you have recently experienced a myocardial infarction (heart attack), or if you are suffering from congestive heart failure or from an uncontrolled hypertension (high blood pressure).

In these situations the treatment should be carefully supervised, and t he clinical benefit of Nemdatine reassessed by your doctor on a regular basis.

If you suffer from renal impairment (kidney problems), your doctor should closely monitor your kidney function and if necessary adapt the memantine doses accordingly.

The use o f medicinal products called amantadine (for the treatment of Parkinson’s disease), ketamine (a substance generally used as an anaesthetic), dextromethorphan (generally used to treat cough) and 84 other NMDA -antagonists at the same time should be avoided.

Children and adoles cents Nemdatine is not recommended for children and adolescents under the age of 18 years.

Other medicines and Nemdatine

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

In particular, Nemdatine may change the effects of the following medicines and their dose may need to be adjusted by your doctor:

amantadine, ketamine, dextromethorphan
dantrolene, baclofen
cimetidine, ranitidine, procainamide, quinidine, quinine, nicotine
hydrochlorothiazide (or any combination with hydrochlorothiazide)
anticholinergics (substances generally used to treat movement disorders or intestinal cramps)
anticonvulsants (substances used to prevent and relieve seizures)
barbiturates (substances generally used to induce sleep)
dopaminergic agonists (substances such as L -dopa, bromocriptine)
neuroleptics (substances used in the treatment of mental disorders)
oral anticoagulants If you go into hospital, let your doctor know that you are taking Nemdatine.

Pregnancy and breast -feeding If you are pregnant or breast -feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

The use of memantine in pregnant women is not recommended.

Breast -feeding Women taking Nemdatine should not breast -feed.

Driving and using machines

Your doctor will tell you whether your illness allows you to drive and to use machines safely. Also, Nemdatine may change your reactivity, making driving or operating machinery inappropriate.

Nemdatine contains lactose monohydrate

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3. How to take N emdatine Always t ake this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Dosage The recommended dose of Nemdatine for adults and older people is 20 mg once a day.

85 In order to reduce the risk of side effects this dose is achieved gradually by the following daily treatment scheme:

Week 1 One 5 mg tablet Week 2 One 10 mg tablet Week 3 One 15 mg tablet Week 4 and beyond One 20 mg tablet once a day The usual starting dose is 5 mg memantine once a day for the first week. This is increased to 10 mg memantine in the second week and to 15 mg memantine once a day in the third week. From the fourth week on, the usual dose is 20 mg memantine once a day.

Administration Nemdatine should be administered oral ly once a day. To benefit from your medicine you should take it regularly every day at the same time of the day. The tablets should be swallowed with some water. The tablets can be taken with or without food.

Duration of treatment Continue to take Nemdati ne as long as it is of benefit to you. Your doctor should assess your treatment on a regular basis.

If you take more Nemdatine than you should

In general, taking too much Nemdatine should not result in any harm to you. You may experience increased sympt oms as described in section 4 ‘Possible side effects’.
If you take a large overdose of Nemdatine, contact your doctor or get medical advice, as you may need medical attention.

If you forget to take Nemdatine

If you find you have forgotten to take your dose of Nemdatine, wait and take your next dose at the usual time.
Do not take a double dose to make up for a forgotten dose.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects Like all medicines, this medicine can cause side effects, although not everybody gets them.

In general, the observed side effects are mild to moderate.

Common (affects 1 to 10 users in 100)

Headache, sleepiness, constipation, elevated liver function test, dizziness, balance disorders, shortness of breath, high blood pressure and drug hypersensitivity

Uncommon (affects 1 to 10 users in 1,000)

Tiredness, fungal infections, confusion, halluci nations, vomiting, abnormal gait, heart failure and venous blood clotting (thrombosis/thromboembolism)

Very Rare (affects less than 1 user in 10,000)

Seizures

Not known (frequency cannot be estimated from the available data)

Inflammation of the pancr eas, inflammation of the liver (hepatitis) and psychotic reactions Alzheimer’s disease has been associated with depression, suicidal ideation and suicide. These events have been reported in patients treated with memantine .

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse . This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V . By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Nemdatine Keep this m edicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and blister after ‘EXP’.

The expiry date refers to the last day of that month.

Do not store above 25°C.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the pack and other information

What Nemdatine contains

The active substance is memantine hydrochloride. Each film -coated tablet contains 15 mg memantine hydrochloride equivalent to 12.46 mg memantine.
The other ingredients are: Tablet core: Microcrystalline cellulose, crospovidone Type A, talc and magnesium stearate. Tablet coat (Opadry II Orange 33G230001): Hypromellose 6cP, titanium dioxide (E171), lactos e monohydrate, macrogol 3350, triacetin and iron oxide yellow, red and black (E172) .

What Nemdatine looks like and contents of the pack

Nemdatine 15 mg film -coated tablets (tablets) are orange, oval shaped, biconvex, 11.4 mm x 6.4 mm in size, with the marking “M15” engraved on one side.

Pack sizes Blister packs: 7, 42 and 98 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Actavis Group PTC ehf.

Dalshraun 1 220 Hafnarfjörður Iceland 87 Manufacturer Actavis Ltd.

BLB 015 -016 Bulebel Industrial Estate Zejtun ZTN 3000 Malta TEVA Gyógyszergyár Zrt.

Pallagi út 13 Debrecen 4042 Hungary For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Tel: +420 251007111 Magyarország Teva Gyógyszergyár Zrt.

Tel: + 36 12886400 Danmark Teva Denmark A/S Tlf: +45 44985511 Malta Teva Pharmaceuticals Ireland L-Irlanda Tel: +44 2075407117 Deutschland ratiopharm GmbH Tel: + 49 73140202 Nederland Teva Nederland B.V.

Tel: + 31 8000228400 Eesti UAB Teva Baltics Eesti filiaal Tel: +372 6610801 Norge Teva Norway AS Tlf: +47 66775590 Ελλάδα TEVA HELLAS A.E.

Τηλ: +30 2118805000 Österreich ratiopharm Arzneimittel Vertriebs -GmbH Tel: +43 1970070 España Teva Pharma, S.L.U.

Tel: + 34 913873280 Polska Teva Pharmaceuticals Polska Sp. z o.o.

Tel: +48 223459300 France Teva Santé Tél: + 33 155917800 Portugal Teva Pharma – Produtos Farmacêuticos, Lda.

Tel: +351 214767550 Hrvatska Pliva Hrvatska d.o.o.

Tel: +385 13720000 România Teva Pharmaceuticals S.R.L.

Tel: + 40 212306524 88 Ireland Teva Pharmaceuticals Ireland Tel: +44 2075407117 Slovenija Pliva Ljubljana d.o.o.

Tel: +386 15890390 Ísland Teva Pharma Iceland ehf.

Sími: +354 5503300 Slovenská republika TEVA Pharmaceuticals Slovakia s.r.o.

Tel: +421 2 57267911 Italia Teva Italia S.r.l.

Ireland Tel: +353 214619040

This leaflet was last revised in {MM/YYYY}

Other sources of information Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu /.

89 Package leaflet: Information for the patient Nemdatine 5 mg film -coated tablets Nemdatine 10 mg film -coated tablets Nemdatine 15 mg film -coated tablets Nemdatine 20 mg film -coated tablet s memantine hydrochloride Read all of this leaflet carefully before you start taking this medicine because it contains important information for you .

Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Memory loss in Alzheimer’s disease is due to a disturbance of message signals in the brain. The brain contains so -called N- methyl -D-aspartate (NMDA) -receptors that are involved in transmitting nerve signals important in learning and memory. Nemdatine belongs to a group of medicines called NMDA- receptor antagonists. Nemdatine acts on these NMDA-receptors improving the transmission of nerve signals and the memory.

What is Nemdatine used for Nemdatine is used for the treatment of adult patients with moderate to severe Alzheimer’s disease.

2. What you need to know before you take Nemdatine

Do not take Nemdatine

if you are allergic to memantine hydrochloride or any of the other ingredients of this medicine (listed in section 6).

Warnings and preca utions Talk to your doctor or pharmacist before taking Nemdatine

if you have a history of epileptic seizures
if you have recently experienced a myocardial infarction (heart attack), or if you are suffering from congestive heart failure or from an uncontrolled hypertension (high blood pressure).

In these situations the treatment should be carefully supervised, and the clinical benefit of Nemdatine reassessed by your doctor on a regular basis.

If you suffer from renal impairment (kidney problems), your doctor should closely monitor your kidney function and if necessary adapt the memantine doses accordingly.

The use of medicinal products called amantadine (for the treatment of Parkinson’s disease), ketamine (a substance generally used as an anaesthetic), dextromethorphan (generally used to treat cough) and other NMDA -antagonists at the same time should be avoided.

Children and adoles cents Nemdatine is not recommended for children and adolescents under the age of 18 years.

Other medicines and Nemdatine

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

In particular, Nemdatine may change the effects of the following medicines and their dose may need to be adjusted by your doctor:

amantadine, ketamin e, dextromethorphan
dantrolene, baclofen
cimetidine, ranitidine, procainamide, quinidine, quinine, nicotine
hydrochlorothiazide (or any combination with hydrochlorothiazide)
anticholinergics (substances generally used to treat movement disorders or intestinal cramps)
anticonvulsants (substances used to prevent and relieve seizures)
barbiturates (substances generally used to induce sleep)
dopaminergic agonists (substances such as L -dopa, bromocriptine)
neuroleptics (substances used in the treatment of mental disorders)
oral anticoagulants If you go into hospital, let your doctor know that you are taking Nemdatine.

Pregnancy and breast -feeding If you are pregnant or breast -feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

The use of memantine in pregnant women is not recommended.

Breast -feeding Women taking Nemdatine should not breast -feed.

Driving and using machines

Your doctor will tell you whether your illness allows you to drive and to use machines safely. Also, Nemdatine may change your reactivity, making driving or operating machinery inappropriate.

Nemdatine contains lactose monohydrate

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product .

3. How to take N emdatine Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are n ot sure.

The Nemdatine treatment initiation pack is only to be used for the beginning of the treatment with Nemdatine.

Dosage The recommended treatment dose of 20 mg per day is achieved by a gradual increase of the Nemdatine dose during the first 3 weeks of treatment. The treatment scheme is also indicated on the treatment initiation pack. Take one tablet once a day.

Week 1 (day 1-7):

Take one 5 mg tablet once a day ( white, oval -shaped ) for 7 days.

Week 2 (day 8-14):

Take o ne 10 mg tablet once a day ( white, capsule shaped ) for 7 days.

Week 3 (day 15-21):

Take one 1 5 mg tablet once a day ( orange, oval shaped ) for 7 days.

Week 4 (day 22-28):

Take one 2 0 mg tablet per day ( dark pink, oval shaped) for 7 days.

Week 1 5 mg tablet Week 2 10 mg tablet Week 3 15 mg tablet Week 4 and beyond 20 mg tablets once a day Maintenance dose The recommended daily dose is 2 0 mg once a day.

For continuation of the treatment please consult your doctor.

The tablets can be taken with or without food.

Duration of treatm ent Continue to take Nemdatine as long as it is of benefit to you. Your doctor should assess your treatment on a regular basis.

If you take more Nemdatine than you should

In general, taking too much Nemdatine should not result in any harm to you. You ma y experience increased symptoms as described in section 4 ‘Possible side effects’.
If you take a large overdose of Nemdatine, contact your doctor or get medical advice, as you may need medical attention.

If you forget to take Nemdatine

If you find you have forgotten to take your dose of Nemdatine, wait and take your next dose at the usual time.
Do not take a double dose to make up for a forgotten dose.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects Like all medicines, this medicine can cause side effects, although not everybody gets them.

In general, the observed side effects are mild to moderate.

Common (affects 1 to 10 users in 100)

Headache, sleepiness, constipation, e levated liver function test, dizziness, balance disorders, shortness of breath, high blood pressure and drug hypersensitivity

Uncommon (affects 1 to 10 users in 1,000)

Tiredness, fungal infections, confusion, hallucinations, vomiting, abnormal gait, hea rt failure and venous blood clotting (thrombosis/thromboembolism)

Very Rare (affects less than 1 user in 10,000)

Seizures

Not known (frequency cannot be estimated from the available data)

Inflammation of the pancreas , inflammation of the liver (hepat itis) and psychotic reactions Alzheimer’s disease has been associated with depression, suicidal ideation and suicide. These events have been reported in patients treated with memantine .

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse . This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V . By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Nemdatine Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and blister after ‘EXP’.

The expiry date refers to the last day of that month.

Do not store above 25°C.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist ho w to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Nemdatine contains

The active substance is memantine hydrochloride. Each film -coated tablet contains 5 , 10, 15, or 20 mg memantine hydrochloride equivalent to 4.15, 8.31, 12.46 or 16.62 mg memantine.
The other ingredients for Nemdatine 5, 10, 15 and 20 mg film -coated tablets are: Tablet core:

Microcrystalline cellulose, crospovidone Type A, talc and magne sium stearate. Tablet coat:

Hypromellose 6cP, titanium dioxide (E171), lactose monohydrate, macrogol 3350 and triacetin.

The 15 mg tablets furthermore contain iron oxide yellow, red and black (E172). The 20 mg tablets furthermore contain iron oxide red and yellow (E172).

93 What Nemdatine looks like and contents of the pack Nemdatine 5 mg film -coated tablets (tablets) are white, oval shaped, biconvex, 8 mm x 4.5 mm in size, with the marking “M5” engraved on one side.

Nemdatine 10 mg film -coated tablets (tablets) are white, capsule-shaped, biconvex, 9.8 mm x 4.9 mm in size, with score line and the marking “M 10” engraved on the scored side.

Nemdatine 15 mg film -coated tablets (tablets) are orange, oval shaped, biconvex, 11.4 mm x 6.4 mm in size, with the marking “M15” engraved on one side.

Nemdatine 20 mg film -coated tablets (tablets) are dark pink, oval shaped, biconvex, 12. 6 mm x 7 mm in size, with the marking “M20” engraved on one side.

One treatment initiation pack contains 2 8 tablets in 4 blisters in a wallet pack or a multipack of 4 blisters in 4 separate immediate cartons and one outer carton with 7 tablets of Nemdatine 5 mg, 7 tablets of Nemdatine 10 mg, 7 tablets of Nemdatine 15 mg and 7 tablets of Nemdatine 20 mg.

Marketing Authorisation Holder

Actavis Group PTC ehf.

Dalshraun 1 220 Hafnarfjörður Iceland

Manufacturer

Actavis Ltd.

BLB 015 -016 Bulebel Industrial Estate Zejtun ZTN 3000 Malta TEVA Gyógyszergyár Zrt.

Pallagi út 13 Debrecen 4042 Hungary For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Tel: +420 251007111 Magyarország Teva Gyógyszergyár Zrt.

Tel: + 36 12886400 Danmark Teva Denmark A/S Tlf: +45 44985511 Malta Teva Pharmaceuticals Ireland L-Irlanda Tel: +44 2075407117 Deutschland ratiopharm GmbH Tel: + 49 73140202 Nederland Teva Nederland B.V.

Tel: + 31 8000228400 94 Eesti UAB Teva Baltics Eesti filiaal Tel: +372 6610801 Norge Teva Norway AS Tlf: +47 66775590 Ελλάδα TEVA HELLAS A.E.

Τηλ: +30 2118805000 Österreich ratiopharm Arzneimittel Vertriebs -GmbH Tel: +43 1970070 España Teva Pharma, S.L.U.

Tel: + 34 913873280 Polska Teva Pharmaceuticals Polska Sp. z o.o.

Tel: +48 223459300 France Teva Santé Tél: + 33 155917800 Portugal Teva Pharma – Produtos Farmacêuticos, Lda.

Tel: +351 214767550 Hrvatska Pliva Hrvatska d.o.o.

Tel: +385 13720000 România Teva Pharmaceuticals S.R.L.

Tel: + 40 212306524 Ireland Teva Pharmaceuticals Ireland Tel: +44 2075407117 Slovenija Pliva Ljubljana d.o.o.

Tel: +386 15890390 Ísland Teva Pharma Iceland ehf.

Sími: +354 5503300 Slovenská republika TEVA Pharmaceuticals Slovakia s.r.o.

Tel: +421 2 57267911 Italia Teva Italia S.r.l. Tel: +39 028917981 Suomi/Finland Teva Finland Oy Puh/Tel: +358 201805900 Κύπρος TEVA HELLAS A.E. Ελλάδα Τηλ: +30 2118805000 Sverige Teva Sweden AB Tel: +46 42121100 Latvija UAB Teva Baltics filiāle Latvijā Tel: +371 67323666 United Kingdom (Northern Ireland) Accord Healthcare Ireland Ltd.

Ireland Tel: +353 214619040

This leaflet was last revised in {MM/YYYY}

Other sources of information Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu /.

95 Package leaflet: Information for the patient Nemdatine 20 mg film -coated tablets memantine hydrochloride Read all of this leaflet carefully before you start taking this medicine because it contains important information for you .

Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

ℹ️ 1. What Nemdatine is and what it is used for

How does Nemdatine work Nemdatine contains the active substance memantine hydrochloride. Nemdatine belongs to a group of medicines known as anti -dementia medicines.

Memory loss in Alzheimer’s disease is due to a disturbance of message signals in the brain. The brain contains so -called N- methyl -D-aspartate (NMDA) -receptors that are involved in transmitting nerve signals important in learning and memory. Nemdatine belongs to a group of medicines called NMDA- receptor antagonists. Nemdatine acts on these NMDA-receptors improving the transmission of nerve signals and the memory.

What is Nemdatine used for Nemdatine is used for the treatment of adult patients with moderate to severe Alzheimer’s disease.

⚠️ 2. What you need to know before you before you take Nemdatine

Do not take Nemdatine

if you are allergic to memantine hydrochloride or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor or pharmacist before taking Nemdatine

if you have a history of epileptic seizures
if you have recently experienced a myocardial infarction (heart attack), or if you are suffering from congestive heart failure or from an uncontrolled hypertension (high blood pressure).

In these situations the treatment should be carefully sup ervised, and the clinical benefit of Nemdatine reassessed by your doctor on a regular basis.

If you suffer from renal impairment (kidney problems), your doctor should closely monitor your kidney function and if necessary adapt the memantine doses accordingly.

The use of medicinal products called amantadine (for the treatment of Parkinson’s disease), ketamine (a substance generally used as an anaesthetic), dextromethorphan (generally used to treat cough) and 96 other NMDA -antagonists at the same time should be avoided.

Children and adoles cents Nemdatine is not recommended for children and adolescents under the age of 18 years.

Other medicines and Nemdatine

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

In particular, Nemdatine may change the effects of the following medicines and their dose may need to be adjusted by your doctor:

amantadine, ketamine, dextromethorphan
dantrolene, baclofen
cimetidine, ranitidine, procainamide, quinidine, quinine, nicotine
hydrochlorothiazide (or any combination with hydrochlorothiazide)
anticholinergics (substances generally used to treat movement disorders or intestinal cramps)
anticonvulsants (substances used to prevent and relieve seizures)
barbiturates (substances generally used to induce sleep)
dopaminergic agonists (substances such as L -dopa, bromocriptine)
neuroleptics (substances used in the treatment of mental disorders)
oral anticoagulants If you go into hospital, let your doctor know that y ou are taking Nemdatine.

Pregnancy and breast -feeding If you are pregnant or breast -feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

The use of memantine in pregnant women is not recommended.

Breast -feeding Women taking Nemdatine should not breast -feed.

Driving and using machines

Your doctor will tell you whether your illness allows you to drive and to use machines safely. Also, Nemdatine may change your reactivity, making driving or operating machinery inappropriate.

Nemdatine contains lactose monohydrate

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

💊 3. How to take N emdatine

Always t ake this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Dosage The recommended dose of Nemdatine for adults and older people is 20 mg once a day.

97 In order to reduce the risk of side effects this dose is achieved gradually by the following daily treatment scheme. For up-titration other tablet strengths are available.

At the beginning of treatment you will start by using Nemdatine 5 mg film -coated tablets once a day.

This dose will be increased weekly by 5 mg until the recommended (maintenance) dose is reached.

The recommended maintenance dose is 20 mg once a day, which is reached at the beginning of the 4th week.

Dosage in patien ts with impaired kidney function If you have impaired kidney function, your doctor will decide upon a dose that suits your condition. In this case, monitoring of your kidney function should be performed by your doctor at specified intervals.

Administratio n Nemdatine should be administered orally once a day. To benefit from your medicine you should take it regularly every day at the same time of the day. The tablets should be swallowed with some water.

The tablets can be taken with or without food.

Duratio n of treatment Continue to take Nemdatine as long as it is of benefit to you. Your doctor should assess your treatment on a regular basis.

If you take more Nemdatine than you should

In general, taking too much Nemdatine should not result in any harm to you. You may experience increased symptoms as described in section 4 ‘Possible side effects’.
If you take a large overdose of Nemdatine, contact your doctor or get medical advice, as you may need medical attention.

If you forget to take Nemdatine

If you find you have forgotten to take your dose of Nemdatine, wait and take your next dose at the usual time.
Do not take a double dose to make up for a forgotten dose.

If you have any further questions on the use of this medicine, ask your doctor or pharm acist.

❗ 4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

In general, the observed side effects are mild to moderate.

Common (affects 1 to 10 users in 100)

Headache, sleepiness, constipation, elevated liver function test, dizziness, balance disorders, shortness of breath, high blood pressure and drug hypersensitivity

Uncommon (affects 1 to 10 users in 1,000)

Tiredness, fungal infections, confusion, halluci nations, vomiting, abnormal gait, heart failure and venous blood clotting (thrombosis/thromboembolism)

Very Rare (affects less than 1 user in 10,000)

Seizures

Not known (frequency cannot be estimated from the available data)

Inflammation of the pancr eas, inflammation of the liver (hepatitis) and psychotic reactions Alzheimer’s disease has been associated with depression, suicidal ideation and suicide. These events 98 have been reported in patients treated with memantine .

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse . This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V . By reporting side effects you can help provide more information on the safety of this medicine.

🌡️ 5. How to store Nemdatine

Keep this m edicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton, blister and bottle label after ‘EXP’. The expiry date refers to the last day of that month.

Do not store above 25°C. <[For HDPE bottle only:]> Use within 100 days after opening.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

📦 6. Contents of the pack and other information

What Nemdatine contains

The active substance is memantine hydrochloride. Ea ch film -coated tablet contains 2 0 mg memantine hydrochloride equivalent to 16.62 mg memantine.
The other ingredients are: Tablet core: Microcrystalline cellulose, crospovidone Type A, talc and magnesium stearate. Tablet coat ( Opadry II Pink 33G240000): Hypromellose 6cP, titanium dioxide (E171), lactose monohydrate, macrogol 3350, triacetin and iron oxide red and yellow (E172) .

What Nemd atine looks like and contents of the pack

Nemdatine 20 mg film -coated tablets (tablets) are dark pink, oval shaped, biconvex, 12.6 mm x 7 mm in size, with the marking “M20” engraved on one side.

Pack sizes Blister packs: 28, 42, 56 and 98 film-coated tablets.

Bottle : 100, 130 *, 250 * and 500 * film-coated tablets .

intended for dose dispensing centres only Not all pack sizes may be marketed.

Marketing Authorisation Holder

Actavis Group PTC ehf.

Dalshraun 1 220 Hafnarfjörður Iceland

Manufacturer

Actavis Ltd.

BLB 015 -016 Bulebel Industrial Estate Zejtun ZTN 3000 99 Malta TEVA Gyógyszergyár Zrt.

Pallagi út 13 Debrecen 4042 Hungary For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Tel: +420 251007111 Magyarország Teva Gyógyszergyár Zrt.

Tel: + 36 12886400 Danmark Teva Denmark A/S Tlf: +45 44985511 Malta Teva Pharmaceuticals Ireland L-Irlanda Tel: +44 2075407117 Deutschland ratiopharm GmbH Tel: + 49 73140202 Nederland Teva Nederland B.V.

Tel: + 31 8000228400 Eesti UAB Teva Baltics Eesti filiaal Tel: +372 6610801 Norge Teva Norway AS Tlf: +47 66775590 Ελλάδα TEVA HELLAS A.E.

Τηλ: +30 2118805000 Österreich ratiopharm Arzneimittel Vertriebs -GmbH Tel: +43 1970070 España Teva Pharma, S.L.U.

Tel: + 34 913873280 Polska Teva Pharmaceuticals Polska Sp. z o.o.

Tel: +48 223459300 France Teva Santé Tél: + 33 155917800 Portugal Teva Pharma – Produtos Farmacêuticos, Lda.

Tel: +351 214767550 Hrvatska Pliva Hrvatska d.o.o.

Tel: +385 13720000 România Teva Pharmaceuticals S.R.L.

Tel: + 40 212306524 Ireland Teva Pharmaceuticals Ireland Tel: +44 2075407117 Slovenija Pliva Ljubljana d.o.o.

Tel: +386 15890390 100 Ísland Teva Pharma Iceland ehf.

Sími: +354 5503300 Slovenská republika TEVA Pharmaceuticals Slovakia s.r.o.

Tel: +421 2 57267911 Italia Teva Italia S.r.l.

Tel: +39 028917981 Suomi/Finland Teva Finland Oy Puh/Tel: +358 201805900 Κύπρος TEVA HELLAS A.E.

Ireland Tel: +353 214619040

This leaflet was last revised in {MM/YYYY}

Other sources of information Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu /.

📄 Package Leaflet – official source

This article reproduces the information in the official package leaflet, as authorised in the European Union. You can consult the original document here: Product information Nemdatine (PDF, ec.europa.eu).

You can check this medicine at any time in the Union Register of medicinal products (EU number EU/1/13/824).

⚠️ Important: This article is for information purposes only and does not replace medical advice or the package leaflet inside the medicine box. Read the leaflet carefully before use. For any questions about your treatment, talk to your doctor or pharmacist. If you experience side effects, tell your doctor or pharmacist and report them through your national reporting system.