InfoCons Consumer Protection informs you – Zebinix – Package Leaflet

Before anything else

Read all of this leaflet carefully before you or your child 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 Zebinix is and what it is used for

Zebinix contains the active substance eslicarbazepine acetate.

Zebinix belongs to a group of medicines called antiepileptics used to treat epilepsy, a condition where someone has repeated seizures or fits.

Zebinix is used:

• on its own (monotherapy) in adult patients with newly diagnosed epilepsy
• with other antiepileptic medicines (adjunctive therapy), in adult , adolescents and children patients above 6 years of age, who are experiencing seizures that affect one part of the brain (partial seizure). These seizures may or may not be followed by a seizure affecting all of the brain (secondary generalisation).

Zebinix has been given to you by your doctor to reduce your number of seizures.

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

Do not take Zebinix

• if you are allergic to eslicarbazepine acetate, to other carboxamide derivatives (e.g. carbamazepine or oxcarbazepine, medicines used to treat epilepsy) or to any of the other ingredients of this medicine (listed in section 6);
• if you suffer from a certain type of heart rhythm disorder (second or third degree atrioventricular (AV) block).

Warnings and precautions

Talk to your doctor or pharmacist before taking Zebinix.

Contact your doctor immediately:

• if you have blistering or peeling of the skin and/or mucous membranes, rash, swallowing or breathing problems, swelling of your lips, face, eyelids, throat or tongue. These could be signs of an allergic reaction.

158 • if you suffer from confusion, worsening of seizures or decreased consciousness which can be signs of low blood salt levels.

Please tell your doctor:

• if you have kidney problems. Your doctor may need to adjust the dose. Zebinix is not recommended in patients with severe renal disease.
• if you have liver problems. Zebinix is not recommended in patients with severe liver problems.
• if you are taking any medicine which can cause an abnormality on the ECG (electrocardiogram) called increased PR interval. If you are not sure if the medicines you are taking could have this effect, discuss with your doctor.
• if you suffer from a heart disease such as heart failure or heart attack , or have any heart rhytm disorder .
• if you suffer from seizures that begin with a widespread electric discharge that involves both sides of the brain.

A small number of people being treated with antiepileptics have had thoughts of harming or killing themselves. If at any time you have these thoughts, when taking Zebinix, contact your doctor immediately.

Zebinix may make you feel dizzy and/or drowsy, particularly at the beginning of treatment. Take special care when taking Zebinix to avoid accidental injury, such as fall.

Take special care with Zebinix:

Serious and potentially life -threatening skin reactions including Stevens -Johnson syndrome/toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported in post -marketing experience in patients treated with Ze binix.

If you develop a serious rash or another skin symptoms (see section 4), stop taking Zebinix and contact your doctor or seek medical attention immediately.

In patients of Han Chinese or Thai origin t he risk of serious skin reactions associated with carbamazepine or chemically -related compounds may be predicted by testing a blood sample of these patients. Your doctor should be able to advise if a blood test is necessary before taking Zebinix.

Children

Zebinix is not to be given to children aged 6 years and below .

Other medicines and Zebinix

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is just in case any of them interfere with how Zebinix works or how Zebinix interferes with their effect.

Tell your doctor if you are taking :

• phenytoin (a medicine used to treat epilepsy) since your dose may need to be adjusted ;
• carbamazepine (a medicine used to treat epilepsy) since your dose may have to be adjusted and the following side effects of Zebinix may occur in higher frequency: seeing double, abnormal coordination and dizziness ;
• hormonal contraceptives (such as the contraceptive pill ) since Zebinix may make these less effective ;
• simvastatin (a medicine used to lower cholesterol levels) since your dose may have to be adjusted ;
• rosuvastatin, a medicine used to lower cholesterol level ;
• the blood thinner – warfarin ;
• monoamino oxidase inhibitors (MAOIs) antidepressants;
• do not take oxcarbazepine (a medicine used to treat epilepsy) with Zebinix, as it is not known whether it is safe to take these medicines together.

See ‘ Pregnancy and breast -feeding ’ section for advice about contraception.

Pregnancy and breast -feeding It is not recommended to take Zebinix if you are pregnant, as the effects of Zebinix on pregnancy and the unborn baby are not known. If you are planning a pregnancy, talk to your doctor before you stop contraception and before you become pregnant. Your doctor may decide to change your treatment.

There are limited data from the use of eslicarbazepine acetate in pregnant women. Research has shown an increased risk of birth defects and problems with neurodevelopment (development of the brain) in children of women taking antiepileptic medicines particularly when more than one antiepileptic medicine is taken at the same time.

If you are or think you might be pregnant, tell your doctor straight away. You should not stop taking your medicine until you have discussed this with your doctor. Stopping your medication without consulting your doctor could cause seizures, which could be dangerous to you and your unborn child.

Your doctor may decide to change your treatment .

If you are a woman of childbearing age and are not planning a pregnancy; you should use effective contraception during treatment with Zebinix. Zebinix may affect how hormonal contraceptives, such as the contraceptive (birth control) pill, work and make the m less effective at preventing pregnancy.

Therefore, it is recommended that you use other forms of safe and effective contraception, when taking Zebinix. Talk to your doctor, who will discuss with you the most suitable type of contraception to use while yo u are taking Zebinix. If treatment with Zebinix is discontinued you should continue using effective contraception up to the end of the current menstrual cycle.

If you take Zebinix during pregnancy, your baby is also at risk for bleeding problems right after birth.

Your doctor may give you and your baby a medicine to prevent this.

Do not breast -feed while you are taking Zebinix. It is not known whether it passes into breast milk.

Driving and using machines

Zebinix may make you feel dizzy, drowsy and affect your vision, particularly at the beginning of treatment. If this happens to you, do not drive or use any tools or machines.

Zebinix contains methyl parahydroxybenzoate (E218) and sulphites

Zebinix oral suspension contains methyl parahydroxybenzoate (E218) which may cause allergic reactions (possibly delayed) and sulphites which may rarely cause severe hypersensitivity reactions and bronchospasm .

💊 3. How to take Zebinix

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

Adults Dose when you start treatment 400 mg once daily for one or two weeks, before increasing to the maintenance dose. Your doctor will decide whether you will be given this dose for one or two weeks.

Maintenance dose The usual maintenance dose is 800 mg once daily.

160 Depending on how you respond to Zebinix, your dose may be increased to 1,200 mg once daily. If you are taking Zebinix on its own your doctor may consider you can benefit of a dose of 1,600 mg once daily.

Patients with kidney problems If you have kidney problems you will usually be given a lower dose of Zebinix. Your doctor will work out the correct dose for you. Zebinix is not recommended if you have severe kidney problems.

Elderly (over 65 years of age) If you are elderly and taking Zebinix on its own the dose of 1,600 mg is not a suitable dose for you.

Children above 6 years of age Dose when you start treatment The starting dose is 10 mg per kg body weight taken once a day for one or two weeks, before increasing to the maintenance dose.

Maintenance dose Depending on the response to Zebinix, the dose may be increased by 10 mg per kg body weight, at intervals of one or two weeks, up to 30 mg per kg body weight. The maximum dose is 1,200 mg once daily.

Children with ≥60 kg Children with 60 kg or more body weight should take the same dose as adults.

Other form of this medicine, like oral suspension, maybe more suitable for children. Ask your doctor or pharmacist.

Method and route of administration Zebinix is for oral use.

Zebinix oral suspension may be taken with or without food.

Shake well before use.

Always use the oral syringe provided to take your medicine .

Instructions for use:

Step 1. Remove the bottle, the oral syringe and the bottle adapter from the box Step 2. Shake the bottle for at least 10 seconds and remove the child resistant closure by pushing it down and turning it counter -clockwise (to the left).

161 Step 3. Insert the bottle adapter in the bottle neck opening. You may need to apply some pressure to insert it securely. Once inserted, the bottle adapter must not be removed from the bottle. The bottle can be closed with the closure with the bottle adapter still in place.

Step 4. To ease the process you should mark the desired volume in the syringe by moving the plunger.

Insert the tip of the oral syringe into the bottle adapter opening, keeping the bottle upright . Push the plunger all the way down. This will create pressure inside the bottle that will help the dosing of the suspension, forcing it to leave from the bottle to the oral syringe.

Step 5: Hold the oral syringe in place and turn the bottle upside down.

Gently p ull the plunger of the oral syringe to the desired volume .

Step 6: If you see any air bubbles in the oral syringe, push the plunger upwards just far enough to completely push out any large air bubbles . Gently pull the plunger back downwards to the dose prescribed by your doctor.

Step 7. Turn the bottle upright and remove the entire oral syringe from the bottle. Be careful, do not push the plunger down when removing the oral syringe from the bottle.

Step 8. Replace the closure on the bottle by turning it clock- wise (to the right).

Step 9. Place the oral syringe into the mouth against the inside of the cheek. Press the plugger down slowly to release Zebinix into the mouth.

Step 10: Rinse the empty oral syringe after each use into a glass of clean water . Repeat this cleaning process 3 times.

Store the bottle and the oral syringe together in the carton until next use .

If you take more Zebinix than you should

If you accidently take more Zebinix than you should, you are potentially at risk of having more seizures; or you may feel like your heart beat is irregular or faster. Contact a doctor or go to a hospital immediately if you experience any of the above symptoms . Take the medicine pack with you. This is so the doctor knows what you have taken.

163 If you forget to take Zebinix If you forget to take a dose, take it as soon as you remember and carry on as usual. Do not take a double dose to make up for a forgotten dose .

If you stop taking Zebinix

Do not stop taking your oral suspension suddenly. If you do, you are at risk of having more seizures.

Your doctor will decide how long you should take Zebinix. Should your doctor decide to stop your treatment with Zebinix your dose will usually be reduced gradually. It is important that your tr eatment is completed as advised by your doctor or your symptoms may get worse.

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.

The following side effects can be very serious. If they happen to you stop taking Zebinix and tell a doctor or go to a hospital immediately, as you may need urgent medical treatment :

• blistering or peeling of the skin and/or mucous membranes, rash, swallowing or breathing problems, swelling of your lips, face, eyelids, throat or tongue. These could be signs of an allergic reaction .

Very common (may affect more than 1 in 10 people ) side effects are

• Feeling dizzy or sleepy.

Common (may affect up to 1 in 10 people ) side effects are

• Feeling unsteady or having a sensation of spinning or floating;
• Feeling sick or vomiting;
• Headache;
• Diarrhoea;
• Seeing double or blurred vision;
• Difficulty in concentration;
• Feeling low in energy or tired;
• Shaking;
• Skin rash;
• Blood tests showing that you have low levels of sodium in your blood;
• Decrease of appetite ;
• Difficulty in sleeping;
• Difficulty in coordinating movements (ataxia) ;
• Weight increase.

Uncommon (may affect up to 1 in 100 people ) side effects are

• Clumsiness;
• Allergy ;
• Constipation ;
• Seizures;
• Underactive thyroid gland. Symptoms include decreased level of thyroid hormone levels (seen in blood tests) , cold intolerance, large tongue, thin and brittle fingernails or hair and low body temperature;
• Liver problems (such as increased liver enzymes) ;
• High blood pressure or severe increase in blood pressure;
• Low blood pressure or a fall in blood pressure on standing up;
• Blood tests showing that you have low levels of salts (including chloride) in your blood or a reduction in red blood cells;

164 • Dehydration;

• Eye movement changes, fuzzy vision or red eye;
• Having falls;
• Thermal burn;
• Poor memory or forgetfulness;
• Crying, feeling depressed, nervous or confused, lack of interest or emotion;
• Inability to speak or write or understand spoken or written language;
• Agitation ;
• Attention deficit/ hyperactivity disorder ;
• Irritability;
• Mood changes or hallucinations;
• Difficulty in speaking;
• Nosebleed;
• Chest pain;
• Tingling and/or f eeling numb in any part of your body;
• Migraine;
• Burning sensation;
• Abnormal sense of touch;
• Disturbances in the sense of smell;
• Ringing in the ears;
• Hearing difficulty;
• Swelling in your legs and arms;
• Heart burn, stomach upset, abdominal pain, abdominal bloating and discomfort or dry mouth;
• Charcoal (dark) stool ;
• Inflamed gums or toothache;
• Sweating or having dry skin;
• Itching ;
• Skin changes (e.g. red skin);
• Hair loss;
• Urinary tract infection;
• Feeling generally weak, unwell or having chills;
• Weight loss;
• Muscle pain , pain in limbs, muscular weakness ;
• Bone metabolism disorder ;
• Increased bone proteins;
• Flushing, cold limbs;
• Slower or irregular heart beat;
• Feeling extremely sleepy;
• Sedation;
• Neurological movement disorder where your muscles contract causing twisting and repetitive movements or abnormal postures. Symptoms include tremors, pain, cramping;
• Medicine toxicity;
• Anxiety.

Not known (frequency cannot be estimated from available data) side effects are

• Reduction in blood platelets which increases risk of bleeding or bruising;
• Severe pain in the back and stomach (caused by inflamation of the pancreas) ;
• Reduction in white blood cells which makes infections more likely ;
• Reddish target -like macules or circular patches often with central blisters on the trunk, skin peeling, ulcers of mouth, throat, nose, genitals and eyes, red and swollen eyes and can be preceded by fever and/or flu- like symptoms (Stevens -Johnson syndrome/t oxic epidermal necrolysis);
• Initially flu -like symptoms, rash on the face then widespread rash, high body temperature, liver enzyme elevations, blood abnormalities (eosinophilia), enlarged lymph nodes and other body 165 organs involvement (Drug Reaction with Eosinophilia and Systemic Symptoms which is also known as DRESS or drug hypersensitivity syndrome);
• Serious allergic reaction which causes swelling of the face, throat, hand, feet, ankles, or lower legs;
• Urticaria (skin rash with itching).
• Lethargy, confusion, muscle twitching or significant worsening of convulsions (possible symptoms of low sodium levels in the blood due to inappropriate ADH secretion) The use of Zebinix is associated with an abnormality in ECG (electrocardiogram) called increase in PR interval. Side effects associated with this ECG abnormality (e.g. fainting and slowing of heart beat) may occur.

There have been reports of bone disorders including osteopenia and osteoporosis (thinning of the bone) and fractures with structurally related antiepileptics medicines like carbamazepine and oxcarbazepine. Check with your doctor or pharmacist, if you are on long- term antiepileptic treatment , have a history of osteoporosis, or take steroids.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. 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 Zebinix

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 bottle and the carton after EXP.

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

Once you have opened the bottle, you must not use it longer than 2 months This medicine does not require any special storage conditions.

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 Zebinix contains

• The active substance is eslicarbazepine acetate. Each ml of oral suspension contains 50 mg of eslicarbazepine acetate.

The other ingredients are xanthan gum (E415) , macrogol -100 stearate, methyl parahydroxybenzoate (E218), s accharin sodium (E954), f lavour tutti -frutti artificial (contains maltodextrin, propylene glycol, natural and artificial flavouring, and gum acacia (E414), masking flavour (contains propylene glycol, water and natural and artificial flavouring) and purified water .

What Zebinix looks like and contents of the pack

Zebinix 50 mg/ml is an off -white to white oral suspension.

The oral suspension is packaged in amber glass bottles with HDPE child resistant closures containing 200 ml oral suspension, inside a cardboard box. Each cardboard box contains a 10 ml polypropylene graduated syringe and a copolymer push- in bottle adapter.

Marketing Authorisation Holder and Manufacturer

166 BIAL – Portela & Cª , S.A., À Av. da Siderurgia Nacional 4745- 457 S. Mamede do Coronado Portugal tel: +351 22 986 61 00 fax: +351 22 986 61 99 e-mail: [email protected] For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.

België/Belgique/Belgien BIAL -Portela & Cª., S.A.

Tél/Tel: + 351 22 986 61 0 0 (Portugal) Luxembourg/Luxemburg BIAL -Portela & Cª., S.A.

Tél/Tel: + 351 22 986 61 00 (Portugal) България BIAL -Portela & Cª., S.A.

Teл.: + 351 22 986 61 00 (Португалия) Magyarország BIAL -Portela & Cª., S.A.

Tel.: + 351 22 986 61 00 (Portugália ) Česká republika BIAL -Portela & Cª., S.A.

Tel: + 351 22 986 61 00 (eisai ) Malta BIAL -Portela & Cª., S.A.

Tel: + 351 22 986 61 00 (Il-Portugall) Danmark Nordicinfu Care AB Tlf: +45 (0) 70 28 10 24 Nederland BIAL -Portela & Cª., S.A.

Tél/Tel: + 351 22 986 61 00 (Portugal) Deutschland BIAL -Portela & Cª., S.A.

Tel: + 351 22 986 61 00 (Portugal) Norge Nordicinfu Care AB Tlf: +47 (0) 22 20 60 00 Eesti BIAL -Portela & Cª, S.A.

Tel: +351 22 986 61 00 (Portugal) Österreich BIAL -Portela & Cª., S.A.

Tel: + 351 22 986 61 00 (Portugal) Ελλάδα ΑΡΡΙΑΝΙ ΦΑΡΜΑΚΕΥΤΙΚΗ Α.Ε.

Τηλ: + 30 210 668 3000 Polska BIAL -Portela & Cª, S.A.

Tel.: + 351 22 986 61 00 (Portugália) España Laboratorios BIAL, S.A.

Tel: + 34 91 562 41 96 Portugal BIAL -Portela & Cª., S.A.

Tel.: + 351 22 986 61 00 Franc e BIAL -Portela & Cª., S.A.

Tél: + 351 22 986 61 00 (Portugal) România BIAL -Portela & Cª, S.A.

Tel: + 351 22 986 61 00 (Portugalia) 167 Hrvatska BIAL -Portela & Cª, S.A.

Tel: + 351 22 986 61 00 (Portugal) Slovenija BIAL -Portela & Cª, S.A.

Tel: + 351 22 986 61 00 (Portugalska) Ireland BIAL -Portela & Cª., S.A.

Tel: + 351 22 986 61 00 (Portugal ) Slovenská republika BIAL -Portela & Cª., S.A.

Tel: + 351 22 986 61 00 (Portugalsko ) Ísland Nordicinfu Care AB Sími: +46 (0) 8 601 24 40 Suomi/Finland Nordicinfu Care AB Puh/Tel : +358 (0) 207 348 760 Italia BIAL -Portela & Cª., S.A.

Tel: + 351 22 986 61 00 (Portogallo) Sverige Nordicinfu Care AB Tel: +46 (0) 8 601 24 40 Κύπρος BIAL -Portela & Cª, S.A.

Τηλ: + 351 22 986 61 00 (Πορτογαλία ) United Kingdom BIAL -Portela & Cª., S.A.

Tel: + 351 22 986 61 00 (Portugal) Latvija BIAL -Portela & Cª, S.A.

Tel: + 351 22 986 61 00 (Portugāle) Lietuva BIAL -Portela & Cª, S.A.

Tel: + 351 22 986 61 00 (Portugalija)

This leaflet was last revised in MM/YYYY

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 Zebinix (PDF, ec.europa.eu).

You can check this medicine at any time in the Union Register of medicinal products (EU number EU/1/09/514).

⚠️ 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.