InfoCons Consumer Protection informs you – EDURANT – Package Leaflet

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 pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is i n this leaflet 1. What EDURANT is and what it is used for 2. What you need to know before you take EDURANT 3. How to take EDURANT 4. Possible side effects 5. How to store EDURANT 6. Contents of the pack and other information 1. What EDURANT is and what it is used for EDURANT contains r ilpivirine thatis used for the treatment of Human Immunodeficiency Virus (HIV) infection. It belongs to a group of HIV medicines called non -nucleoside rev erse transcriptase inhibitors (NNRTIs). EDURANT works by reducing the amount of HIV in your body.

EDURANT is used in combination with other HIV medicines to treat adults, adolescents and children weighing at least 25kgwho are infected with HIV.

Your doctor will discuss with you which combination of medicines is best for you.

2. What you need to know before you take EDURANT Do not take EDURANT if you are allergic to rilpivirine or any of the other ingredients of this medicine (listed in section 6).

Do not take EDURANT in combination with any of the following medicines as they may affect the way EDURANT or the other medicine works:

• carbamazepine, oxcarbazepine, phenobarbital, phenytoin (medicines to treat epilepsy and prevent seizures)
• rifampicin, rifapentine (medicines to treat some bacterial infections such as tubercu losis)
• omeprazole, esomeprazole, lansoprazole, pantoprazole, rabeprazole, (proton pump inhibitors that are medicines to prevent and treat stomach ulcers, heartburn or acid reflux disease)
• dexamethasone (a corticosteroid used in a variety of conditions such as inflammation and allergic reactions )when taken by mouth or injected, except as a single dose treatment
• products that contain St John’s wort ( Hypericum perforatum ) (a herbal product used for depression) .

If you are taking any of the above, ask your do ctor about alternatives .

Warnings and precautions

Talk to your doctor or pharmacist before taking EDURANT .

60EDURANT is not a cure for HIV infection. It is part of a treatment reducing the amount of virus in the blood.

EDURANT has only been used in a limi ted number of patients of 65years or older. If you belong to this age group, please discuss the use of EDURANT with your doctor.

Tell your doctor about your situation Make sure that you check the following points and tell your doctor if any of these apply to you.

• Tell your doctor if you have or have had problems with your liver, including hepatitis Band/or C, and/or problems with your kidneys . Your doctor may evaluate how severe your liver or kidney disease is before deciding if you can take EDURANT .
• Tell your doctor immediately if you notice any symptoms of infections (for example ,fever , chills, sweats ). In some patients with advanced HIV infection and a history of opportunistic infection, signs and symptoms of inflammation from previous infections may occur soon after HIV treatment is started. It is believed that these symptoms are due to an improvement in the body’s immune response, enabling the body to fight infections that may have been present with no obvious symptoms.
• In addition to the opportunistic infections, autoimmune disorders (a condition that occurs when the immune system attacks healthy body tissue) may also occur after you start taking medicines for the treatment of your HIV infection. Autoimmune disorders may occur many months after the start of treatment. If you notice any symptoms of infection or other symptoms such as muscle weakness, weakness beginning in the hands and feet and moving up towards the trunk of the body, palpitations, tremor or hyperactivity, please inform your doctor immediatel yto seek necessary treatment.
• Tell your doctor if you are taking any medicines that may cause a life -threatening irregular heartbeat (Torsade de Pointes) .

Children

EDURANT is not for use in children less than 2 years of age or weighing less than 14kg, because it has not been evaluated inthese patients.

Other medicines and EDURANT

You must take EDURANT together with other HIV medicines. Y our doctor will advise on which HIV medicines can be combined with EDURANT and together you will decide which combination fits your needs best . Follow your doctor’s instruction carefully.

Some medicines may affect the levels of EDURANT in the blood when they are taken at the same time as EDURANT .

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

It is not recommended to combine EDURANT with other non -nucleoside reverse transcriptase inhibitors (NNRTIs) such as delavirdine, efavirenz, etravirine, and nevirapine .

The effects of EDURANT or other medicines might be influenced if you take EDURANT together with any of the following medicines. Tell your doctor if you take:

• rifabutin ( a medicine to treat some bacterial infections ). If you take this medicine while taking EDURANT , please carefu lly read how to take EDURANT in section 3 “Instructions for proper use in adults and adole scents (12 to less than 18years of age )”.
• clarithromycin, erythromycin (antibiotics)
• cimetidine, famotidine , nizatidine, ranitid ine(H2-receptor antagonists used to treat stomach or intestinal ulcers or used to relieve heartburn due to acid reflux) . If you take these medicines, please carefully read how to take them in section 3 “Instructions for proper use in adults and adolescents (12 to less than 18years of age )”.
• antacids ( used to treat diseases related to the acid in the stomach; for example , aluminium/magnesium hydroxide , calcium carbonate ). If you take these medicines, please 61carefully read how to take them in section 3 “Instructions for proper use inadults and adolescents (12 to less than 18years of age )”.
• methadone (used to treat narcotic withdrawal and dependence)
• dabigatran etexilate (anticoagulant) .

Tell your doctor if you take any of the medicines listed above.

Pregnancy and breast -feeding Tell your doctor immediately if you are pregnant or if you plan to become pregnant. Pregnant women should discuss the use of EDURANT with their doctor.

Breast -feeding is not recommended in women living with HIV because HIV infection can be passed on to the baby in breast milk.

If you are breast -feeding, or thinking about breast -feeding, you should discuss it with your doctor as soon as possible.

Ask you rdoctor or pharmacist for advice before taking any medicine.

Driving and using machines

Some patients may experience tiredness, dizziness or drowsiness during treatment with EDURANT .

Do not drive or operate machinery if you feel tired, dizzy or drowsy while taking EDURANT .

EDURANT contains lactose

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

EDURANT contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium -free’.

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

Instructions for proper use inadults ,adolescents and children (weighing at least 25kg) EDURANT is also available as dispersible tablets for paediatric patients 2 to less than 18years of age weighing at least 14kg and less than 25 kg (see the separate instructions for use ). Film -coated tablets and dispersible tablets are not the same. Do not replace the 25 mg film -coated tablet with ten 2.5mg dispersible tablets.

The recommended dose of EDURANT is onetablet once a day .

EDURANT must be taken with a meal .A meal is important to get the right levels of active substance in your body. A nutritional drink (e.g.,protein -rich) alone does not replace a meal.

There are four situations that require special attention:

1. If you take rifabutin (a medicine to treat some bacterial infections), take two tablets of EDURANT once a day. When you stop taking rifabutin, take one tablet of EDURANT once a day. Talk to your doctor or pharmacist if you are not sure.

2. If you take an antacid (a medicine to treat diseases related to the acid in the stomach such as aluminium /magnesium hydroxide, calcium carbonate). Take the antacid either at least 2 hours before or at least 4 hours after EDURANT (see section 2 “Other medicines and EDURANT”).

3. If you take an H 2-receptor antagonist (medicines used to treat stomach or intestinal ulcers or used to relieve heartburn due to acid reflux (such as cimetidine, famotidine, nizatidine or ranitidine). Take the H 2-receptor antagonist at least 12 hours before or at least 4hours after 62EDURANT (see section 2 “Other medicines and EDURANT”). H 2-receptor antagonists should not be taken in a twice a day regimen. Talk to your doctor about an alternative regimen.

4. If you take didanosine (a medicine to treat HIV infection), no dose adjustment is required.

Didanosine should be administered on an empty stomach at least two hours before or at least four hours after EDURANT (which must be taken with a meal).

Removing the child resistant cap The bottle comes with a child resistan t cap .It can be opened by pushing the screw cap down while turning it anti-clockwise.

If you take more EDURANT than you should

Contact your doctor or pharmacist immediately. In case of overdose, you may have a headache, nausea, dizziness, and/or abnormal dreams.

If you forget to take EDURANT

If you notice within 12hours of the time you usually take EDURANT ,you must take the tablet as soon as possible. The EDURANT tablet must be taken with a meal. Then take the next dose as usual.

If you notice after 12hours , then skip that dose and take the next doses as usual.

Do not take a double dose to make up for a forgotten dose.

If you vomit less than 4 hours after taking EDURANT , take another tablet with a meal. If you vomit more than 4 hours after taking EDURANT you do not need to take another tablet until your next regularly scheduled tablet.

Contact your doctor if uncertain about what to do if you miss a dose or vomit.

Do not stop using EDURANT HIV treatment does not cure HIV infection! Do not stop using EDURANT without talking to your doctor first. Even if you feel better, do not stop taking EDURANT or your other HIV medicines.

Doing so could increase the risk of the vi rus developing resistance. Talk to your doctor first.

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

4. Possible side effect s Like allmedicine s, this medicine can cause side effects, although not everybod y gets them.

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

• headache
• nausea
• difficulty falling asleep (insomnia)
• feeling dizzy
• changes in one of your routine liver tests (transaminase)
• increase in cholesterol and/or pancreatic amylase in your blood

Common (may affect up to 1 in 10 people)

• abnormal dreams
• rash
• stomach pain
• depression
• feeling very tired
• vomiting 63- feeling sleepy
• decreased appetite
• sleep disorders
• stomach discomfort
• feeling depressed
• dry mouth
• low white blood cell and/or platelet count, decrease in haemoglobin in your blood, increase in triglycerides, lipase and/or bilirubin in your blood

Uncommon (may affect up to 1 in 100 people)

• signs or symptoms of inflammation or infection , for example fever, chills, sweats (immune reactivation syndrome)

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 EDURANT 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 on the bottle after EXP. The expiry date refers to the last day of that month.

Store in the original bottle in order to protect from light .This medicinal product does not require any special temper ature storage conditions.

Donot 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 informati on

What EDURANT contains

• The active substance is rilpivirine in the form of rilpivirine hydrochloride . Each tablet of

EDURANT contains rilpivirine hydrochloride equivalent to 25mg rilpivirine .

• The other ingredients of the film -coated tablet core are lactose monohydrate, croscarmellose sodium (E468) , povidone K30 (E1201) , polysorbate 20, silicified microcrystalline cellulose

(E460) andmagnesium stearate (E470b) . The film -coating contains lactose monohydrate, hypromellose 2910 6mPa.s (E464) , titanium dioxide (E171 ), macrogol 3000 and triac etin (E1518) .

What EDURANT looks like and contents of the pack

White to off -white , film -coated, round, biconvex tablet, with “TMC” on one side and “25” on the other side.

A bottle with child resistant closure containing 30film-coated tablets.

Marketing Authorisation Holder

Janssen -Cilag International NV Turnhoutseweg 30 B-2340 Beerse Belgium 64Manufacturer Janssen -Cilag SpA Via C. Janssen Borgo San Michele 04100 Latina Italy For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Janssen -Cilag NV Tel/Tél: +32 14 64 94 11 [email protected] UAB “JOHNSON & JOHNSON ” Tel: +370 5 278 68 88 [email protected] България „Джонсън & Джонсън България” ЕООД Тел.: +359 2 489 94 00 [email protected]/Luxemburg Janssen -Cilag NV Tél/Tel: +32 14 64 94 11 [email protected] Česká republika Janssen -Cilag s.r.o.

Tel: +420 227 012 227Magyarország Janssen -Cilag Kft.

Tel.: +36 1 884 2858 [email protected] Danmark Janssen -Cilag A/S Tlf.: +45 4594 8282 [email protected] AM MANGION LTD Tel: +356 2397 6000 Deutschland Janssen -Cilag GmbH Tel: 0800 086 9247 / +49 2137 955 6955 [email protected] Janssen -Cilag B.V.

Tel: +31 76 711 1111 [email protected] Eesti UAB “JOHNSON & JOHNSON “Eesti filiaal Tel: +372 617 7410 [email protected] Janssen -Cilag AS Tlf: +47 24 12 65 00 [email protected] Ελλάδα Janssen -Cilag Φαρμακευτική Μονοπρόσωπη Α.Ε.Β.Ε.

Tηλ: +30 210 80 90 000Österreich Janssen -Cilag Pharma GmbH Tel: +43 1 610 300 España Janssen -Cilag, S.A.

Tel: +34 91 722 81 00 [email protected] Janssen -Cilag Polska Sp. zo.o.

Tel.: +48 22 237 60 00 France Janssen -Cilag Tél: 0 800 25 50 75 / +33 1 55 00 40 03 [email protected] Janssen -Cilag Farmacêutica, Lda.

Tel: +351 214 368 600 65Hrvatska Johnson & Johnson S.E. d.o.o.

Tel: +385 1 6610 700 [email protected]ânia Johnson & Johnson R omânia SRL Tel: +40 21 207 1800 Ireland Janssen Sciences Ireland UC Tel: 1 800 709 122 [email protected] Johnson & Johnson d.o.o.

Tel: +386 1 401 18 00 [email protected] Ísland Janssen -Cilag AB c/o Vistor hf .

Sími: +354 535 7000 [email protected]á republika Johnson & Johnson ,s.r.o.

Tel: +421 232 408 400 Italia Janssen -Cilag SpA Tel: 800.688.777 / +39 02 2510 1 [email protected]/Finland Janssen -Cilag Oy Puh/Tel: +358 207 531 300 [email protected] Κύπρος Βαρνάβας Χατζηπαναγής Λτδ Τηλ: +357 22 207 700Sverige Janssen -Cilag AB Tfn: +46 8 626 50 00 [email protected] Latvija UAB “JOHNSON & JOHNSON “filiāle Latvijā Tel: +371 678 93561 [email protected] Kingdom (Northern Ireland) Janssen Sciences Ireland UC Tel: +44 1 494 567 444 [email protected]

This leaflet was last revised in

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

66Package leaflet: Information for the user EDURANT 2.5 mg dispers ible tablets rilpivirine 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 (or your child )only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours (or your child) .
• If you (or your child )get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
• The information in this leaflet is for you or your child –but in this leaflet we usually just say ‘you’ .

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

EDURANT contains ‘rilpiv irine’that is used for the treatment of Human Immunodeficiency Virus (HIV) infection. It belongs to a group of HIV medicines called non -nucleoside rev erse transcriptase inhibitors (NNRTIs). EDURANT works by reducing the amount of HIV in thebody.

EDURANT is used in combination with other HIV medicines to treat children and adolescent s2 to less than 18 years of age weighing at least 14kgand less than 25 kg who are infected with HIV .

Your doctor will talk toyou about which combination of medicines is best for you.

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

Do not take EDURANT if you are allergic to rilpivirine or any of the other ingredients of this medicine (listed in section 6).

Do not take EDURANT in combination with any of the following medicines as they may affect the way EDURANT or the other medicine works:

• carbamazepine, oxcarbazepine, phenobarbital, phenytoin (medici nes to treat epilepsy and prevent seizures)
• rifampicin, rifapentine (medicines to treat some bacterial infections such as tuberculosis)
• omeprazole, esomeprazole, lansoprazole, pantoprazole, rabeprazole, (proton pump inhibitors that are medicines to prevent and treat stomach ulcers, heartburn or acid reflux disease)
• dexamethasone (a corticosteroid used in a variety of conditions such as inflammation and allergic reactions) when taken by mouth or injected, except as a single dose treatment
• products that conta in St John’s wort (a herbal product used for depression).

Do not take EDURANT if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking EDURANT. Ask your doctor about alternatives to the medicines listed above.

67Warnings and precautions Talk to your doctor or pharmacist before you start taking EDURANT.

EDURANT is not a cure for HIV infection. It is part of a treatment reducing the amount of virus in the blood.

Tell your doctor about your situation Make sure that you check the following points and tell your doctor if any of these apply to you.

• Tell your doctor if you have or have had problems with your liver, including hepatitis Band/or C, and/or problems with your kidneys . Your doctor may evaluate how severe your liver or kidney disease is before deciding if you can take EDURANT.
• Tell your doctor immediately if you notice any symptoms of infections (for example, fever, chills, sweats) . In some patients with advanced HIV infection and a history of opportunisti c infection, signs and symptoms of inflammation from previous infections may occur soon after HIV treatment is started. It is believed that these symptoms are due to an improvement in the body’s immune response, enabling the body to fight infections that m ay have been present with no obvious symptoms.
• In addition to the opportunistic infections, autoimmune disorders (a condition that occurs when the immune system attacks healthy body tissue) may also occur after you start taking medicines for the treatment of your HIV infection. Autoimmune disorders may occur many months after the start of treatment. If you notice any symptoms of infection or other symptoms such as muscle weakness, weakness beginning in the hands and feet and moving up towards the trunk of the body, palpitations, tremor or hyperactivity, please inform your doctor immediately to seek necessary treatment.
• Tell your doctor if you are taking any medicines that may cause a life -threatening irregular heartbeat (Torsade de Pointes).

Children

Do not use EDURANT for children less than 2 years old or weighing less than 14kgbecause it has not been evaluated in these patients .

Other medicines and EDURANT

You must take EDURANT together with other HIV medicines. Y our doctor will tell you which HIV medicines can be taken with EDURANT and together you will decide which combination fits your needs best . You must f ollow your doctor’s instruction carefully.

Some medicines may affect the levels of EDURANT in the blood when they are taken at the same time as EDURANT.

Tell your doctor or pharmacist if you aretaking, ha ve recently taken or might take any other medicines.

It is not recommended to combine EDURANT with other non -nucleoside reverse transcriptase inhibitors (NNRTIs) such as delavirdine, efavirenz, etravirine, and nevirapine .

The effects of EDURANT or other medicines might be influenced if you take EDURANT together with any of the following medicines. Tell your doctor if you take:

• antibiotics such as clarithromycin, erythromycin
• cimetidine, famotidine, nizatidine, ranitidine (H 2-receptor antagonists used to treat stomach or intestinal ulcers or used to relieve heartburn due to acid reflux). I f you take these medicines, please carefully read how to take them in section 3.
• antacids (used to treat diseases related to the acid in the stomach; for example, aluminium/magnesium hydroxide, calcium carbonate). I f you take these medicines, please carefully read how to take them in section 3.
• methadone (used to treat narcotic withdrawal and d ependence)
• dabigatran etexilate (anticoagulant).

Tell your doctor if you take any of the medicines listed above.

68Pregnancy and breast -feeding Tell your doctor immediately if you are pregnant or if you plan to become pregnant. Pregnant women should discuss the use of EDURANT with their doctor.

Breast -feeding is not recommended in women living with HIV because HIV infection can be passed on to the baby in breast milk.

If you are breast -feeding, or thinking about breast -feeding, you should discuss it with your doctor as soon as possible.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving , cycling, andusing tools or machines Some patients may feeltired, dizz yor drowsy during treatment with EDURANT.

• Do not drive , cycle or use tools or machines if you feel tired, dizzy or drowsy while taking EDURANT.

EDURANT contains lactose and sodium

This medicine contains lactose. If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before ta king this medicine.

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium -free’.

💊 3. How to take EDURANT

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Your doctor or pharmacis twill tell you how many EDURANT dispers ible tablets you should take. EDURANT dispers ible tablets must be dispersed in water and must be taken with a meal .

• EDURANT is also available as film -coated tablets for paediatric and adult patients weighing at least 25 kg (see the separate instructions for use). Film -coated tablets and dispersible tablets are not the same. Do not replace the 25 mg film -coated tablet wi th ten 2.5 mg dispersible tablets.

Instructions for use EDURANT dispersible tablets must be taken with a meal . A meal is important to get the right levels of medicine in your body. A nutritional drink (such as a protein shake ) or yogurt alone does not replace a meal.

Prepare and take EDURANT dispers ible tablets every day exactly as your doctor tells you. Read these instructions carefully before you take EDURANT dispers ible tablets . Your doctor will tell you how many EDURANT dispers ible tablets you need to take, based on your weight. EDURANT dispers ible tablets must be dispersed in water. You must not chew or swallow the tablets whole.

69Step 1: Prepare the medicine Count the number of tablets you need and tear each unit from the blister pack along th e dotted line. Do not push the tablets out of the foil as they may break. For each unit, peel back the foil gently in the direction of the arrow .

Step 2:Place the tablets in a cup Gently place the tablets in a cup. Do not crush the tablets. Add 5 ml(1teaspoon) of water at room temperature to the cup. Swirl the cup carefully to disperse the tablets. The mixture will start to look cloudy.

If you spill any medicine, clean up the spill. Throw away the rest of the prepared medicine and make a new dose .

You must take the dose of medicine immediately. If you do not take the medicine immediately, throw away the mixture, and prepare a new dose of medicine.

Step 3:Taking the medicine Take all the prepared medicine immediately or add another 5ml(1teaspoon) of either water or any of the following to aid in administration: milk, orange juice or applesauce which has acclimated to room temperature before use. Swirl and take all medicine immediately. A spoon can be used if needed. Make sure the entire dose is taken and no medicine is left in the cup, if required addanother 5 ml(1teaspoon) of water or same beverage (milk, orange juice )orapplesau ce, swirl and drink immediately There are three situations that require special attention . If you take :

1. An antacid (a medicine to treat diseases related to the acid in the stomach such as aluminium /magnesium hydroxide, calcium carbonate). Take the antacid either :  at least 2 hours before or,  at least 4 hours after EDURANT (see section 2 “Other medicines and EDURANT”) .

2. An H2-receptor antagonist (medicines used to treat stomach or intestinal ulcers or used to relieve heartburn due to acid reflux (such as cimetidine, famotidine, nizatidine or ranitidine).

Take the H 2-receptor antagonist either:  at least 12 hours before or,  at least 4 hours after EDURANT (see section 2 “Other medicines and EDURANT”).

H2-receptor antagonists should not be taken in a twice a day regimen. Talk to your doctor about an alternative regimen.

703. Didanosine (a medicine to treat HIV infecti on), no dose adjustment is required. Didanosine should be administered on an empty stomach  at least two hours before E DURANT or,  at least four hours after E DURANT (which must be taken with a meal).

If you take more EDURANT than you should

Contact your doctor or pharmacist immediately. In case of overdose, you may have a headache, nausea, feel dizzy, and/or have abnormal dreams.

If you forget to take EDURANT

If you notice within 12 hours of the time you usually take EDURANT, you must take the dose as soon as possible. The EDURANT tablet smust be taken with a meal. Then take the next dose as usual.

If you notice after 12 hours , then skip that dose and take the next dose as usual.

Do not take a double dose to make up for a forgotten dose.

Contact yo ur doctor if you are not sure about what to do if you miss a dose.

If you vomit after taking E DURANT If you vomit within 4hours after taking EDURANT, take another dose with a meal. If you vomit more than 4hours after taking EDURANT you do not need to take another dose until thenext regularly scheduled dose.

Contact your doctor if uncertain about what to do if you vomit after taking this medicine .

Do not stop using EDURANT HIV treatment does not cure HIV infection! Do not stop using EDURANT without t alking to your doctor first. Even if you feel better, do not stop EDURANT or other HIV medicines. Ifyou do, it could increase the risk of the virus developing resistance. Talk to your doctor before stopping taking this medicine .

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.

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

• headache
• nausea
• difficulty falling asleep (insomnia)
• feeling dizzy
• changes in one of your routine liver tests (transaminase)
• increase in cholesterol and/or pancreatic amylase in your blood

Common (may affect up to 1 in 10 people)

• abnormal dreams
• rash
• stomach pain
• depression
• feeling very tired
• vomiting
• feeling sleepy
• decreased appetite
• sleep disorders
• stomach discomfort
• feeling depressed 71- dry mouth
• low white blood cell and/or platelet count, decrease in haemoglobin in your blood, increase in triglycerides, lipase and/or bilirubin in your blood

Uncommon (may affect up to 1 in 100 people)

• signs or symptoms of inflammation or infection, for example fever, chills, sweats (immune reactivation syndrome)

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 EDURANT

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 on the blister after EXP. The expiry date refers to the last day of that month.

Store in the original package in order to protect from light and moisture. This medicinal product does not require any special temperature storage conditions.

Do not throw away any medicines via wast ewater 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 EDURANT contains

• The active substance is ‘rilpivirine ’in the form of ‘rilpivirine hydrochloride ’. Each dispersible

tablet of EDURANT contains rilpivirine hydrochloride equivalent to 2.5mg rilpivirine.

• The other ingredients of the dispers ible tablet are croscarmellose sodium (E468) , lactose monohydrate, mannitol (E421) , microcrystalline cellulose (E460) , polysorbate 20, povidone K30 (E1201) , sodium lauryl sulfate (E487) andsodium stearyl fumarate .

What EDURANT looks like and contents of the pack

White to almost white, round 6.5 mm, debossed with “TMC” o n one side and “PED” on the other side.

EDURANT 2.5 mg dispers ible tablets come in perforated Alu-Alu unit dose blister swith integrated desiccant and an alumin ium peelable lidding foil. Each child -resistant blister contains 10x1dispersible tablets. Each carton contains 90 x1dispersible tablets.

Marketing Authorisation Holder

Janssen -Cilag International NV Turnhoutseweg 30 B-2340 Beerse Belgium

Manufacturer

Janssen -Cilag SpA Via C. Janssen Borgo San Michele 04100 Latina Italy 72For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Janssen -Cilag NV Tel/Tél: +32 14 64 94 11 [email protected] UAB “JOHNSON & JOHNSON” Tel: +370 5 278 68 88 [email protected] България „Джонсън & Джонсън България” ЕООД Тел.: +359 2 489 94 00 [email protected]/Luxemburg Janssen -Cilag NV Tél/Tel: +32 14 64 94 11 [email protected] Česká republika Janssen -Cilag s.r.o.

Tel: +420 227 012 227Magyarország Janssen -Cilag Kft.

Tel.: +36 1 884 2858 [email protected] Danmark Janssen -Cilag A/S Tlf.: +45 4594 8282 [email protected] AM MANGION LTD Tel: +356 2397 6000 Deutschland Janssen -Cilag GmbH Tel: 0800 086 9247 / +49 2137 955 6955 [email protected] Janssen -Cilag B.V.

Tel: +31 76 711 1111 [email protected] Eesti UAB “JOHNSON & JOHNSON” Eesti filiaal Tel: +372 617 7410 [email protected] Janssen -Cilag AS Tlf: +47 24 12 65 00 [email protected] Ελλάδα Janssen -Cilag Φαρμακευτική Μονοπρόσωπη Α.Ε.Β.Ε.

Tηλ: +30 210 80 90 000Österreich Janssen -Cilag Pharma GmbH Tel: +43 1 610 300 España Janssen -Cilag, S.A.

Tel: +34 91 722 81 00 [email protected] Janssen -Cilag Polska Sp. zo.o.

Tel.: +48 22 237 60 00 France Janssen -Cilag Tél: 0 800 25 50 75 / +33 1 55 00 40 03 [email protected] Janssen -Cilag Farmacêutica, Lda.

Tel: +351 214 368 600 Hrvatska Johnson & Johnson S.E. d.o.o.

Tel: +385 1 6610 700 [email protected]ânia Johnson & Johnson R omânia SRL Tel: +40 21 207 1800 73Ireland Janssen Sciences Ireland UC Tel: 1 800 709 122 [email protected] Johnson & Johnson d.o.o.

Tel: +386 1 401 18 00 [email protected] Ísland Janssen -Cilag AB c/o Vistor hf .

Sími: +354 535 7000 [email protected]á republika Johnson & Johnson ,s.r.o.

Tel: +421 232 408 400 Italia Janssen -Cilag SpA Tel: 800.688.777 / +39 02 2510 1 [email protected]/Finland Janssen -Cilag Oy Puh/Tel: +358 207 531 300 [email protected] Κύπρος Βαρνάβας Χατζηπαναγής Λτδ Τηλ: +357 22 207 700Sverige Janssen -Cilag AB Tfn: +46 8 626 50 00 [email protected] Latvija UAB “JOHNSON & JOHNSON” filiāle Latvijā Tel: +371 678 93561 [email protected] Kingdom (Northern Ireland) Janssen Sciences Ireland UC Tel: +44 1 494 567 444 [email protected]

This leaflet was last revised in

Detailed information on this medicine is available on the European Medicines Agency web site: https://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 EDURANT (PDF, ec.europa.eu).

You can check this medicine at any time in the Union Register of medicinal products (EU number EU/1/11/736).

⚠️ 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.