Etravirine 200 mg Tablets

• 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.

1. What Etravirine Tablets are and what it is used for
2. What you need to know before you take Etravirine Tablets
3. How to take Etravirine Tablets
4. Possible side effects
5. How to store Etravirine Tablets
6. Contents of the pack and other information

• if you are allergic to etravirine or any of the other ingredients of this medicine (listed in section 6)
• if you are taking elbasvir/grazoprevir (a medicine to treat hepatitis C infection).

Talk to your doctor or pharmacist before taking Etravirine.

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

Elderly

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

Weight and increased blood lipids and glucose

During HIV therapy there may be an increase in weight and in levels of blood lipids and glucose. This is partly linked to restored health and lifestyle, and in the case of blood lipids sometimes to the HIV medicines themselves. Your doctor will test for these changes.

Bone problems

Some patients taking combination antiretroviral therapy may develop a bone disease called osteonecrosis (death of bone tissue caused by loss of blood supply to the bone). The length of combination antiretroviral therapy, corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index, among others, may be some of the many risk factors for developing this disease. Signs of osteonecrosis are joint stiffness, aches and pains (especially of the hip, knee and shoulder) and difficulty in movement. If you notice any of these symptoms, please inform 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 develop a rash. If a rash occurs, it usually appears soon after anti- HIV treatment with Etravirine is started and often disappears within 1 to 2 weeks, even with continued use of the medicine. Rarely, during Etravirine treatment, you can experience severe skin rash with blisters or peeling skin, particularly around the mouth or eyes or hypersensitivity reaction (allergic reaction including rash and fever but also swelling of the face, tongue or throat, difficulty in breathing or swallowing) which could be potentially life-threatening. Please contact your doctor immediately if you experience these symptoms. Your doctor will advise you how to deal with your symptoms and whether Etravirine must be stopped. If you have stopped treatment due to a hypersensitivity reaction, you should not restart therapy with Etravirine.
• Tell your doctor if you have or have had problems with your liver, including hepatitis B and/or C. Your doctor may evaluate how severe your liver disease is before deciding if you can take Etravirine.
• Tell your doctor immediately if you notice any symptoms of infections. 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 anti-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 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.

Do not give this medicine to children less than 2 years of age and weighing less than 10 kg because the potential benefits and risks have not been established.

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

In most cases, Etravirine can be combined with anti-HIV medicines belonging to another class. However, some combinations are not recommended. In other cases, increased monitoring and/or a change in the dose of the medicine may be needed. Therefore, always tell your doctor which other anti-HIV medicines you take. Furthermore, it is important that you carefully read the package leaflets that are provided with these medicines. Follow your doctor’s instruction carefully on which medicines can be combined.

It is not recommended to combine Etravirine with any of the following medicines:

• tipranavir/ritonavir, efavirenz, nevirapine, rilpivirine, indinavir, atazanavir/cobicistat, darunavir/cobicistat (anti-HIV medicine)
• carbamazepine, phenobarbital, phenytoin (medicines to prevent seizures)
• rifampicin, because it is contraindicated with boosted protease inhibitors, and rifapentine (medicines to treat some infections such as tuberculosis)
• products that contain St John’s wort (Hypericum perforatum) (a herbal product used for depression)
• daclatasvir (a medicine to treat hepatitis C infection).

If you are taking any of these, ask your doctor for advice.

The effects of Etravirine or other medicines might be influenced if you take Etravirine together with any of the following medicines. The dosages of some medicines might need to be changed since their therapeutic effect or side effects may be influenced when combined with Etravirine. Tell your doctor if you take:

• dolutegravir, maraviroc, amprevanir/ritonavir and fosamprenavir/ritonavir (anti-HIV medicine)
• amiodarone, bepridil, digoxin, disopyramide, flecainide, lidocaine, mexiletine, propafenone and quinidine (medicines to treat certain heart disorders, e.g., abnormal heartbeat)
• warfarin (a medicine used to reduce clotting of the blood). Your doctor will have to check your blood
• fluconazole, itraconazole, ketoconazole, posaconazole, voriconazole (medicines to treat fungal infections)
• clarithromycin, rifabutin (antibiotics)
• artemether/lumefantrine (a medicine to treat malaria)
• diazepam (medicines to treat trouble with sleeping and/or anxiety)
• dexamethasone (a corticosteroid used in a variety of conditions such as inflammation and allergic reactions)
• atorvastatin, fluvastatin, lovastatin, rosuvastatin, simvastatin (cholesterol-lowering medicines)
• ciclosporin, sirolimus, tacrolimus (immunosuppressants – medicines used to dampen down your immune system)
• sildenafil, vardenafil, tadalafil (medicines to treat erectile dysfunction and/or pulmonary arterial hypertension)
• clopidogrel (a medicine to prevent blood clots).

Tell your doctor immediately if you are pregnant. Pregnant women should not take Etravirine unless specifically directed by the doctor.

Because of the potential for side effects in breast-fed infants, it is recommended that women not breast-feed if they are receiving Etravirine.

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 breastfeeding, you should discuss it with your doctor as soon as possible.

Do not drive or operate machines if you feel sleepy or dizzy after taking your medicines.

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

The recommended dose of Etravirine tablet is one tablet twice a day.

In the morning, take one 200 milligram Etravirine tablet, following a meal.

In the evening, take one 200 milligram Etravirine tablet, following a meal.

The doctor will work out the right dose based on the weight of the child.

The doctor will inform you exactly how much Etravirine the child should take.

It is important that you take Etravirine tablets following a meal. If you take Etravirine tablets on an empty stomach, only half the amount of Etravirine is absorbed. Follow your doctor’s advice on the type of meal you should be taking with Etravirine tablets.

Swallow the Etravirine tablet(s) whole with a glass of water. Do not chew the tablet(s).

If you are unable to swallow the Etravirine tablet(s) whole, you may do the following:

• place the tablet(s) in 5 ml (1 teaspoon) of water, or at least enough liquid to cover the medicine,
• stir well for about 1 minute until the water looks milky,
• if desired, add up to 30 ml (2 tablespoons) more of water or alternatively orange juice or milk (do not place the tablets directly in orange juice or milk),
• drink it immediately,
• rinse the glass several times with water, orange juice, or milk and completely swallow the rinse each time to make sure you take the entire dose.

If you mix Etravirine tablet(s) with a liquid, take this first, before other liquid anti-HIV medicines that you need to take at the same time.

Contact your doctor if you are not able to swallow the entire dose when mixed with a liquid.

If your child needs to take Etravirine tablet(s) mixed with a liquid, it is very important that he/she takes the entire dose so that the right amount of medicine enters into the body. If the full dose is not taken, the risk of the virus developing resistance is higher. Contact your doctor if your child is not able to swallow the entire dose when mixed with a liquid, as they may consider giving another medicine to treat your child.

Do not use warm (40°C and above) or carbonated beverages when taking Etravirine tablet(s).

The plastic bottle comes with a child resistant cap and should be opened as follows:

• Push the plastic screw cap down while turning it counterclockwise.
• Remove the unscrewed cap.

Contact your doctor or pharmacist immediately. The most frequent side effects of Etravirine are rash, diarrhoea, nausea, and headache (see section ‘4. Possible side effects’).

If you notice within 6 hours of the time you usually take Etravirine tablets, you must take the tablet(s) as soon as possible. Always take the tablet(s) following a meal. Then take the next dose as usual. If you notice after 6 hours, then skip the intake and take the next dose as usual. Do not take a double dose to make up for a forgotten dose.

If you vomit less than 4 hours after taking Etravirine, take another dose following a meal. If you vomit more than 4 hours after taking Etravirine, then you do not need to take another dose until your regularly scheduled dose.

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

HIV therapy may increase your sense of well-being. Even if you feel better, do not stop taking Etravirine or your other anti-HIV medicines. Doing so could increase the risk of the virus developing resistance. Talk to your doctor first.

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 Yellow Card Scheme,Website: www.mhra.gov.uk/yellowcard, or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

The active substance is etravirine.

Inactive ingredients are sodium lauryl sulfate, povidone K-30, microcrystalline cellulose, crospovidone, sodium starch glycolate, silicon dioxide, magnesium stearate.

White to off-white uncoated, oval shaped (Approx. dimensions of 22 mm × 11 mm) tablet debossed with “CP113” on one side and plain on other side

60 Tablets packed in 200 cc HDPE bottle with 38/400 CR Cap with a heat induction foil liner and 3 desiccant pouches.