Intelence 200 mg tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

INTELENCE 200 mg tablets

etravirine

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

1. What INTELENCE is and what it is used for

INTELENCE contains the active substance etravirine. INTELENCE belongs to a group of anti-HIV medicines called non-nucleoside reverse transcriptase inhibitors (NNRTIs).

INTELENCE is a medicine used to treat infection with the Human Immunodeficiency Virus (HIV). INTELENCE works by reducing the amount of HIV in the body. This way, your immune system will improve and the risk of developing HIV-related illnesses will decrease.

INTELENCE is used in combination with other anti-HIV medicines to treat adults and children aged 6 years and older who are infected with HIV and who have previously used other anti-HIV medicines.

Your doctor will explain the most appropriate combination of medicines for you.

2. What you need to know before taking INTELENCE

Do not take INTELENCE

• 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 used to treat hepatitis C infection).

Warnings and precautions

Talk to your doctor or pharmacist before starting INTELENCE.

INTELENCE does not cure HIV infection. It is part of a treatment that reduces the amount of virus in the blood. While taking this medicine, you may still transmit HIV to others, although effective antiviral treatment reduces this risk. Ask your doctor what precautions you should take to avoid infecting other people.

Elderly patients

INTELENCE has only been used in a limited number of patients aged 65 years or older.

If you belong to this age group, discuss the use of INTELENCE with your doctor.

Weight gain and increased levels of lipids and glucose in the blood

During HIV treatment, weight gain and increases in blood glucose and lipid levels may occur. This may be partly related to improved health and lifestyle, and, in the case of blood lipids, sometimes to the HIV medicines themselves. Your doctor will monitor these changes.

Bone problems

Some patients receiving combination antiretroviral therapy may develop a bone disease called osteonecrosis (death of bone tissue caused by reduced blood supply to the bone). Factors that may increase the risk of developing this condition include long-term combination antiretroviral therapy, use of corticosteroids, alcohol consumption, severe immunosuppression, and increased body mass index, among others. Signs of osteonecrosis include joint stiffness, pain, and difficulty moving (especially in the hip, knee, or shoulder). If you experience any of these symptoms, please consult your doctor.

Inform your doctor about your condition

Check the following points and inform your doctor if any of these apply to you.

• Inform your doctor if you develop a rash. Rashes usually appear shortly after starting HIV treatment with INTELENCE and typically resolve within one or two weeks, even if you continue taking the medicine. Occasionally, during treatment with INTELENCE, you may experience a hypersensitivity reaction (an allergic reaction including rash and fever, but also swelling of the face, tongue, or throat, difficulty breathing or swallowing) that could be life-threatening. Please contact your doctor immediately if you experience a hypersensitivity reaction. Your doctor will advise you on managing symptoms and whether to discontinue INTELENCE treatment. If you have stopped treatment due to a hypersensitivity reaction, you must not restart treatment with INTELENCE.
• Inform your doctor if you have or have had liver problems, including hepatitis B and/or C. Your doctor may assess the severity of your liver disorder before deciding whether you can use INTELENCE.
• Inform your doctor immediately if you notice any signs of infections. In some patients with advanced HIV infection and a history of opportunistic infections, signs and symptoms of inflammation from previous infections may appear shortly after starting HIV treatment. These symptoms are believed to result from improved immune response, enabling the body to fight infections that may have been present but asymptomatic.
• In addition to opportunistic infections, autoimmune disorders (a condition in which the immune system attacks healthy body tissue) may also occur after you start taking medicines for HIV infection. Autoimmune disorders may appear many months after starting treatment. If you notice any signs of infection or other symptoms such as muscle weakness, ascending weakness starting in the hands and feet moving toward the trunk, palpitations, tremors, or hyperactivity, inform your doctor immediately to receive necessary treatment.

Children and adolescents

Do not give this medicine to children under 6 years of age and weighing less than 16 kg, as the benefit or risk has not yet been established.

Taking INTELENCE with other medicines

INTELENCE may interact with other medicines. Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

In most cases, INTELENCE can be combined with HIV medicines from another drug class. However, some combinations are not recommended. In other cases, increased monitoring and/or dose adjustments may be necessary. Therefore, always inform your doctor if you are taking other HIV medicines. It is also important to read carefully the package leaflets of these medicines. Always follow your doctor's instructions regarding which medicines can be combined.

Combining INTELENCE with any of the following medicines is not recommended:

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

If you are taking any of the medicines listed above, consult your doctor.

The effects of INTELENCE or other medicines may be affected if you take INTELENCE together with any of the following medicines. It may be necessary to adjust the doses of some medicines, as their therapeutic effect or adverse effects may be altered when combined with INTELENCE. Inform your doctor if you are taking:

• dolutegravir, maraviroc, amprenavir/ritonavir, and fosamprenavir/ritonavir (HIV medicines)
• amiodarone, bepridil, digoxin, disopyramide, flecainide, lidocaine, mexiletine, propafenone, and quinidine (medicines used to treat certain heart conditions, e.g., irregular heartbeats)
• warfarin (a medicine used to reduce blood clotting). Your doctor will perform blood tests
• fluconazole, itraconazole, ketoconazole, posaconazole, voriconazole (medicines used to treat fungal infections)
• clarithromycin, rifabutin (antibiotics)
• artemether/lumefantrine (a medicine used to treat malaria)
• diazepam (a medicine used to treat sleep problems and/or anxiety)
• dexamethasone (a corticosteroid used to treat various disorders such as inflammation and allergic reactions)
• boceprevir (a medicine used to treat hepatitis C infection)
• atorvastatin, fluvastatin, lovastatin, rosuvastatin, simvastatin (medicines used to lower cholesterol)
• cyclosporine, sirolimus, tacrolimus (immunosuppressants – medicines that reduce the activity of your immune system)
• sildenafil, vardenafil, tadalafil (medicines used to treat erectile dysfunction and/or pulmonary arterial hypertension)
• clopidogrel (a medicine used to prevent blood clots).

Pregnancy and breastfeeding

If you are pregnant, inform your doctor immediately. Pregnant women should not take INTELENCE unless specifically instructed by their doctor.

Mothers infected with HIV must not breastfeed, as there is a risk that the baby may become infected with HIV.

Driving and using machines

Do not operate machinery or drive if you experience drowsiness or dizziness after taking your medicines.

3. How to take INTELENCE

Follow exactly the administration instructions for this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Use in adults

The recommended dose of INTELENCE is one tablet twice daily.

Take one 200 mg tablet of INTELENCE in the morning after a meal.

Take one 200 mg tablet of INTELENCE in the evening after a meal.

Use in children and adolescents from 6 years of age and weighing at least 16 kg

Your doctor will determine the correct dose based on the child's weight.

Your doctor will inform you exactly how much INTELENCE the child should take.

Instructions for taking INTELENCE for all patients

It is important that you take INTELENCE after meals. If you take INTELENCE on an empty stomach, only half the amount of INTELENCE is absorbed. Follow your doctor's instructions regarding the type of food you should take with INTELENCE.

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

• If you cannot swallow the INTELENCE 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,
• shake well until the water appears milky,
• if desired, you may add more water, or orange juice, or milk (do not place the tablets directly into orange juice or milk),
• drink it immediately,
• rinse the glass several times with water, orange juice, or milk, and drink all the contents each time to ensure you take the full dose.
• Do not use hot water (40°C or higher) or carbonated beverages when taking the INTELENCE tablet(s).

Removing the child-resistant cap

If you take more INTELENCE than you should

Contact your doctor or pharmacist immediately. The most common adverse effects of INTELENCE are rash, diarrhea, nausea, and headache (see section “4. Possible side effects”).

If you forget to take INTELENCE

If you remember within 6 hours of your usual INTELENCE dose time, take the tablet as soon as possible. Always take the tablet after a meal.

Then take your next dose at the usual time. If you remember after 6 hours, skip the missed dose and take the next dose at the usual time. Do not take a double dose to make up for the missed dose.

If you vomit within 4 hours after taking INTELENCE, take another tablet after a meal. If you vomit more than 4 hours after taking INTELENCE, you do not need to take another tablet until your next scheduled dose.

Contact your doctor if you have any doubts about what to do if you miss a dose or vomit.

Do not stop taking INTELENCE without first talking to your doctor

HIV treatment may improve your sense of well-being. However, even if you feel better, do not stop taking INTELENCE or other HIV medications. Doing so may increase the risk of the virus becoming resistant. Always consult your doctor first.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

The frequency rate of adverse effects associated with INTELENCE is shown below.

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

• rash. The rash is usually mild to moderate. In rare cases, a very severe type of rash has been reported, which may become life-threatening. Therefore, it is important that you contact your doctor immediately if you develop a rash.

Your doctor will advise you on how to manage your symptoms and whether you should stop taking INTELENCE;

• headache;
• diarrhoea, nausea.

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

• allergic reactions (hypersensitivity);
• diabetes, reduced appetite;
• anxiety, drowsiness, insomnia, sleep disorders;
• tingling or pain in hands or feet, numbness, loss of skin sensitivity, memory loss, fatigue;
• blurred vision;
• renal failure, high blood pressure, heart attack, difficulty breathing during exercise;
• vomiting, heartburn, abdominal pain, abdominal distension, stomach inflammation, flatulence, constipation, mouth inflammation; dry mouth;
• night sweats, itching, dry skin;
• changes in certain blood cell counts or blood biochemistry that can be seen in blood and/or urine test results. Your doctor will explain these to you. For example, low red blood cells.

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

• decrease in white blood cell count;
• signs of infection (e.g., swollen lymph nodes and fever);
• abnormal dreams, confusion, disorientation, restlessness, nightmares;
• stupor, tremor, fainting, seizures, attention disorders;
• dizziness, slowness;
• angina, irregular heartbeat;
• difficulty breathing;
• retching, pancreatitis, vomiting blood;
• liver problems such as hepatitis, enlarged liver;
• excessive sweating, swelling of the face and/or throat;
• breast enlargement in men.

Rare adverse effects (may affect up to 1 in 1,000 people)

• stroke.

Adverse effects with unknown frequency (frequency cannot be estimated from available data)

• severe hypersensitivity reactions characterised by rash accompanied by fever and organ inflammation such as hepatitis.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of INTELENCE

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the outer carton and on the bottle after EXP. The expiry date refers to the last day of the month indicated.

Do not use more than 6 weeks after first opening the bottle.

INTELENCE tablets must be stored in the original bottle and the bottle must be kept tightly closed to protect from moisture. The bottle contains 3 sachets (desiccants) to keep the tablets dry. These sachets must always remain in the bottle and must not be swallowed.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of containers and medicines no longer required. This will help protect the environment.

6. Package contents and other information

Composition of INTELENCE

• The active substance is etravirine. Each INTELENCE tablet contains 100 mg of etravirine.
• The other components are silicified microcrystalline hypromellose, microcrystalline cellulose, anhydrous colloidal silica, sodium croscarmellose, and magnesium stearate.

Appearance of the medicine and contents of the pack

This medicine is available as a white to off-white, biconvex, oblong tablet, marked with "T200" on one side.

Plastic bottle containing 60 tablets and 3 desiccant bags to keep the tablets dry.

Marketing Authorization Holder

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

Manufacturer

Janssen-Cilag SpA, Via C. Janssen, 04100 Borgo San Michele, Latina, Italy

For more information about this medicine, please contact the local representative of the Marketing Authorization Holder:

Date of the last review of this leaflet: {MM/YYYY}

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.