Efavirenz Teva 600 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Efavirenz Teva 600 mg film-coated tablets EFG

efavirenz

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 further questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any side effects, talk to your doctor, pharmacist or nurse, even if they are side effects not listed in this leaflet. See section 4.

What this leaflet contains:

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

1. What Efavirenz Teva is and what it is used for

Efavirenz Teva, which contains the active substance efavirenz, belongs to a class of antiretroviral medicines known as non-nucleoside reverse transcriptase inhibitors (NNRTIs). It is an antiretroviral medicine that acts against infection caused by the human immunodeficiency virus (HIV-1) by reducing the amount of virus in the blood. It is used in adults, adolescents, and children aged 3 years and older.

Your doctor has prescribed Efavirenz Teva because you have an HIV infection. When taken in combination with other antiretroviral medicines, Efavirenz Teva reduces the amount of virus in the blood.

This may strengthen your immune system and reduce the risk of developing HIV-related illnesses.

2. What you need to know before starting Efavirenz Teva

Do not take Efavirenz Teva

• if you are allergic to efavirenz or to any of the other ingredients of this medicine (listed in section 6). Contact your doctor or pharmacist for any questions you may have;
• if you have severe liver disease;
• if you have any heart problems, such as changes in heart rhythm or heartbeat frequency, or serious heart disease;
• if any member of your family (parents, grandparents, siblings) has died suddenly due to a heart problem or was born with heart problems;
• if your doctor has told you that you have high or low levels of electrolytes, such as potassium or magnesium, in your blood;
• if you are currently taking any of the following medicines (see also ‘Other medicines and Efavirenz Teva’):
• astemizole or terfenadine (used to treat allergic symptoms)
• bepridil (used to treat heart disease)
• cisapride (used to treat heartburn)
• ergot alkaloids (e.g. ergotamine, dihydroergotamine, ergonovine and methylergonovine) (used to treat migraine and cluster headaches)
• midazolam or triazolam (used to help sleep)
• pimozide, imipramine, amitriptyline or clomipramine (used to treat certain mental illnesses)
• elbasvir or grazoprevir (used to treat hepatitis C)
• St. John’s wort (Hypericum perforatum) (herbal remedy used for depression and anxiety)
• flecainide, metoprolol (used to treat irregular heartbeat)
• certain antibiotics (macrolides, fluoroquinolones, imidazoles)
• triazole antifungal agents
• certain antimalarial treatments
• methadone (used to treat opioid addiction)

If you are taking any of these medicines, inform your doctor immediately. Taking these medicines with Efavirenz Teva could cause serious and/or potentially fatal adverse reactions or prevent Efavirenz Teva from working properly.

Warnings and precautions

Talk to your doctor before starting Efavirenz Teva.

• Efavirenz Teva must be taken with other medicines that act against HIV virus. If Efavirenz Teva is prescribed because your current treatment has not prevented virus multiplication, you must also receive another medicine you have not taken before.

• This medicine is not a cure for HIV infection, and you may continue to develop infections or other diseases associated with HIV disease.

• You must remain under your doctor’s supervision while taking Efavirenz Teva.

• Tell your doctor:

• if you have a history of mental illness, including depression, or alcohol or drug abuse. Inform your doctor immediately if you feel depressed, have suicidal thoughts or unusual thoughts (see section 4, Possible side effects).

• if you have a history of seizures (fits or convulsions) or if you are being treated with anticonvulsants such as carbamazepine, phenobarbital and phenytoin. If you are taking any of these medicines, your doctor may need to check the level of anticonvulsant in your blood to ensure it is not affected while taking Efavirenz Teva. Your doctor may prescribe a different anticonvulsant.

• if you have a history of liver disease, including active chronic hepatitis. Patients with chronic hepatitis B or C receiving combination antiretroviral therapy have an increased risk of developing severe and potentially fatal hepatic adverse effects. Your doctor may perform blood tests to monitor your liver function or may switch you to another medicine. If you have severe liver disease, do not take Efavirenz Teva (see section 2, Do not take Efavirenz Teva).

• if you have a heart condition, such as an abnormal electrical signal known as QT interval prolongation.

• Once you have started taking Efavirenz Teva, be careful about:

• signs of dizziness, difficulty sleeping, drowsiness, difficulty concentrating, or abnormal dreams. These adverse effects may begin on the first or second day of treatment and usually disappear within the first 2 to 4 weeks.

• any sign of skin rash. If you develop any sign of severe rash, with blisters or fever, stop taking Efavirenz Teva and inform your doctor immediately. If you previously had a rash while taking any other NNRTI, you may be at higher risk of developing a rash with Efavirenz Teva.

• any sign of inflammation or infection. In some patients with advanced HIV (AIDS) and a history of opportunistic infections, signs and symptoms of inflammation from previous infections may appear shortly after starting anti-HIV treatment. These symptoms are believed to result from an improved immune response, enabling the body to fight infections that were previously present without apparent symptoms. If you notice any signs of infection, please inform your doctor immediately. In addition to opportunistic infections, autoimmune disorders (a condition occurring when the immune system attacks healthy body tissue) may also occur after starting HIV treatment. Autoimmune disorders may appear many months after treatment initiation. If you notice any signs of infection or other symptoms such as muscle weakness, weakness starting in the hands and feet and moving upward toward the trunk, palpitations, tremors or hyperactivity, inform your doctor immediately for appropriate treatment.

• bone problems. Some patients receiving combination antiretroviral therapy may develop a bone disease called osteonecrosis (bone tissue death caused by loss of blood supply to the bone). Numerous risk factors for developing this disease include duration of combination antiretroviral therapy, corticosteroid use, alcohol consumption, severe immunosuppression and high body mass index. Symptoms of osteonecrosis include joint stiffness, pain and discomfort, especially in the hip, knee and shoulder, and difficulty moving. If you notice any of these symptoms, inform your doctor.

Children and adolescents

Efavirenz Teva film-coated tablets are not recommended for children under 3 years of age or weighing less than 40 kg.

Other medicines and Efavirenz Teva

You must not take Efavirenz Teva with certain medicines. These are listed under the heading “Do not take Efavirenz Teva” at the beginning of Section 2. This includes some common medicines and an herbal remedy (St. John’s wort) that may cause serious interactions.

Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might need to take any other medicine.

Efavirenz Teva may interact with other medicines, including herbal preparations such as Ginkgo biloba extracts. As a result, the amount of Efavirenz Teva or other medicines in your blood may be affected. This could prevent the medicines from working properly or worsen any of their adverse effects. In some cases, your doctor may need to adjust your dose or monitor your blood levels. It is important to inform your doctor or pharmacist if you are taking any of the following:

• Other medicines used for HIV infection:

• protease inhibitors: darunavir, indinavir, lopinavir/ritonavir, ritonavir, atazanavir boosted with ritonavir, saquinavir or fosamprenavir/saquinavir. Your doctor may consider giving you an alternative medicine or adjusting the dose of protease inhibitors.

• maraviroc

• the tablet containing efavirenz, emtricitabine and tenofovir should not be taken with Efavirenz Teva unless recommended by your doctor, as it contains efavirenz, the active substance in Efavirenz Teva.

• Medicines used to treat hepatitis C virus infection: boceprevir, telaprevir, elbasvir/grazoprevir, simeprevir, sofosbuvir/velpatasvir, sofosbuvir/velpatasvir/voxilaprevir, glecaprevir/pibrentasvir.

• Medicines used to treat bacterial infections, including regimens to treat tuberculosis and Mycobacterium avium infection associated with AIDS: clarithromycin, rifabutin, rifampicin. Your doctor may consider changing the dose or giving you an alternative antibiotic. Additionally, your doctor may prescribe a higher dose of Efavirenz Teva.

• Medicines used to treat fungal infections (antifungals):

• voriconazole. Efavirenz Teva may decrease the amount of voriconazole in your blood, and voriconazole may increase the amount of efavirenz in your blood. If you take these two medicines together, the voriconazole dose should be increased and the efavirenz dose reduced. Discuss this with your doctor first.

• itraconazole. Efavirenz Teva may decrease the amount of itraconazole in your blood.

• posaconazole. Efavirenz Teva may decrease the amount of posaconazole in your blood.

• Medicines used to treat malaria:

• artemether/lumefantrine: Efavirenz Teva may reduce the amount of artemether/lumefantrine in your blood.

• atovaquone/proguanil: Efavirenz Teva may reduce the amount of atovaquone/proguanil in your blood.

• Praziquantel (a medicine used to treat parasitic infections). Efavirenz Teva may reduce the amount of praziquantel in your blood.

• Medicines used to treat seizures (anticonvulsants): carbamazepine, phenytoin, phenobarbital. Efavirenz Teva may decrease or increase the amount of anticonvulsant in your blood. Carbamazepine may make it less likely for Efavirenz Teva to work. Your doctor may consider giving you another anticonvulsant.

• Medicines used to lower blood fat (also called statins): atorvastatin, pravastatin, simvastatin. Efavirenz Teva may reduce the amount of statins in your blood. Your doctor will check your cholesterol levels and consider adjusting your statin dose if necessary.

• Methadone (a medicine used to treat opioid addiction): your doctor may recommend an alternative treatment.

• Metamizole, a medicine used to treat pain and fever.

• Sertraline (a medicine used to treat depression): your doctor may need to adjust your sertraline dose.

• Bupropion (a medicine used to treat depression or to help quit smoking): your doctor may need to adjust your bupropion dose.

• Diltiazem or similar medicines (called calcium channel blockers, used typically for high blood pressure or heart problems): when starting Efavirenz Teva treatment, your doctor may need to adjust your calcium channel blocker dose.

• Immunosuppressants such as cyclosporine, sirolimus or tacrolimus (medicines used to prevent organ transplant rejection): when starting or stopping Efavirenz Teva, your doctor will closely monitor your immunosuppressant blood levels and may need to adjust your dose.

• Hormonal contraceptives, such as birth control pills, injectable contraceptives (e.g., Depo-Provera) or contraceptive implants (e.g., Implanon): you should also use a reliable barrier method of contraception (see Pregnancy, breastfeeding and fertility). Efavirenz Teva may cause hormonal contraceptives to be ineffective. Pregnancies have occurred in women taking Efavirenz Teva while using a contraceptive implant, although it has not been established that Efavirenz Teva treatment caused contraceptive failure.

• Warfarin or acenocoumarol (a medicine used to reduce blood clots): your doctor may need to adjust your warfarin or acenocoumarol dose.

• Ginkgo biloba extracts (an herbal preparation)

• Medicines affecting heart rhythm:

• Medicines used to treat heart rhythm problems: such as flecainide or metoprolol.

• Medicines used to treat depression: such as imipramine, amitriptyline or clomipramine.

• Antibiotics, including the following types: macrolides, fluoroquinolones or imidazoles.

Efavirenz Teva with food and drink

Taking Efavirenz Teva on an empty stomach may reduce adverse effects. Grapefruit juice should be avoided while taking Efavirenz Teva.

Pregnancy, breastfeeding and fertility

Women must not become pregnant during treatment with Efavirenz Teva or within 12 weeks after treatment ends. Your doctor may require a pregnancy test to confirm you are not pregnant before starting Efavirenz Teva treatment.

If you could become pregnant while being treated with Efavirenz Teva, you must always use a reliable barrier method of contraception (e.g., a condom) along with other contraceptive methods, including oral contraceptives (the pill) or other hormonal contraceptives (e.g., implants, injections). Efavirenz may remain in your blood for some time after stopping treatment. Therefore, you should continue using contraceptive methods for approximately 12 weeks after stopping Efavirenz Teva treatment.

Inform your doctor immediately if you are pregnant or plan to become pregnant. If you are, you should only take Efavirenz Teva if both you and your doctor decide it is clearly necessary. Seek advice from your doctor or pharmacist before taking any medicine.

Severe birth defects have been observed in animal fetuses and in newborns whose mothers were treated with efavirenz or with a medicine containing a combination of efavirenz, emtricitabine and tenofovir during pregnancy. If you have taken Efavirenz Teva or the tablet containing the combination of efavirenz, emtricitabine and tenofovir during pregnancy, your doctor may request periodic blood tests and other diagnostic tests to monitor your baby’s development.

You must not breastfeed while taking Efavirenz Teva.

It is not recommended that women living with HIV breastfeed, because HIV infection can be transmitted to the baby through breast milk.

If you are breastfeeding or considering breastfeeding, you must consult your doctor as soon as possible.

Driving and using machines

Efavirenz Teva contains efavirenz and may cause dizziness, concentration disorders and drowsiness. If you experience these symptoms, do not drive or operate tools or machinery.

Efavirenz Teva contains lactose

This medicine contains 9.98 mg of lactose (as monohydrate) per tablet.

If your doctor has told you that you have an intolerance to certain sugars, consult him before taking this medicine.

Efavirenz Teva contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is essentially “sodium-free”.

3. How to take Efavirenz Teva

Follow exactly the instructions for using this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again. Your doctor will give you instructions on how to take the correct dose.

• The adult dose is 600 mg once daily.
• It may be necessary to increase or decrease the dose of Efavirenz Teva if you are also taking certain medicines (see Taking Efavirenz Teva with other medicines).
• Efavirenz Teva is administered orally. It is recommended to take it on an empty stomach and preferably before bedtime. This may reduce the impact of certain adverse effects (e.g., dizziness, somnolence). An empty stomach is typically defined as 1 hour before or 2 hours after a meal.
• It is recommended that the tablet be swallowed whole with water.
• Efavirenz Teva must be taken every day.
• Efavirenz Teva must never be used as the only medicine for the treatment of HIV. It must always be taken in combination with other anti-HIV medicines.

Use in children and adolescents

Efavirenz Teva film-coated tablets are not suitable for children weighing less than 40 kg.

• The dose for children weighing 40 kg or more is 600 mg once daily.

If you take more Efavirenz Teva than you should

If you take too much Efavirenz Teva, contact your doctor or go to the nearest hospital. Keep the medicine pack with you so you can easily describe what you have taken.

If you forget to take Efavirenz Teva

Try not to miss any doses. If you do, take the next dose as soon as possible, but do not take a double dose to make up for missed doses. If you need help scheduling the times at which you take the medicine, consult your doctor or pharmacist.

If you stop taking Efavirenz Teva

When you are running out of your Efavirenz Teva pack, request a new supply from your doctor or pharmacist. This is extremely important because the amount of virus may start to increase if you stop taking the medicine, even for a short period. If this happens, the virus may become more difficult to treat.

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.

When treating HIV infection, it is not always possible to determine whether the unwanted side effects have been caused by Efavirenz Teva, by other medicines taken at the same time, or by the HIV disease itself.

During HIV treatment, there may be an increase in body weight and in blood levels of glucose and lipids. This may be partly related to the recovery of health and lifestyle, and in the case of blood lipids, sometimes to the HIV medicines themselves. Your doctor will monitor these changes.

The most relevant adverse effects reported with the use of efavirenz in combination with other anti-HIV medicines are skin rash and nervous system symptoms.

If you develop a rash, you should consult your doctor, as some rashes can be serious; however, most cases of rash resolve without the need to change treatment with Efavirenz Teva. Cases of rash were more frequent in children than in adults treated with efavirenz.

Nervous system symptoms usually occur at the beginning of treatment but generally decrease during the first few weeks. In one study, nervous system symptoms frequently occurred within the first 1–3 hours after taking a dose. If these symptoms affect you, your doctor may suggest that you take Efavirenz Teva at bedtime and on an empty stomach. Some patients experience more severe symptoms that may affect mood or thinking ability. Indeed, some patients have committed suicide. These problems usually occur more frequently in patients with a history of mental illness. Inform your doctor immediately if you experience these symptoms or any side effect while taking Efavirenz Teva.

Tell your doctor if you notice any of the following adverse effects:

Very common (affects more than 1 in 10 patients)

• Skin rash

Common (affects between 1 and 10 in 100 patients)

• Abnormal dreams, difficulty concentrating, dizziness, headache, difficulty sleeping, drowsiness, coordination or balance problems
• Stomach pain, diarrhoea, nausea, vomiting
• Itching
• Fatigue
• Feeling anxious, feeling depressed

Blood tests may show:

• Increased liver enzymes in the blood
• Increased triglycerides (fatty acids) in the blood

Uncommon (affects between 1 and 10 in 1,000 patients)

• Nervousness, amnesia, confusion, seizures, abnormal thoughts
• Blurred vision
• Sensation of movement or tilting (dizziness)
• Abdominal pain (stomach pain) caused by inflammation of the pancreas
• Allergic reaction (hypersensitivity) which may cause severe skin reactions (erythema multiforme, Stevens-Johnson syndrome)
• Yellowing of the skin and eyes, itching, or abdominal pain (stomach pain) caused by inflammation of the liver
• Breast enlargement in men
• Irritable behaviour, mood disturbances, seeing or hearing things that are not real (hallucinations), mania (a mental condition characterized by overactivity, euphoria, or irritability), paranoia, suicidal thoughts, catatonia (a condition in which the patient remains immobile and speechless for a period of time)
• Wheezing (a high-pitched whistling sound when breathing), ringing or other continuous noise in the ears
• Tremor (shaking)
• Flushing

Blood tests may show:

• Increased cholesterol in the blood

Rare (affects between 1 and 10 in 10,000 patients)

• Itchy rash caused by a reaction to sunlight
• Liver failure, which in some cases may lead to death or liver transplantation. Most cases occurred in patients who already had liver disease, but there have been some reports in patients without pre-existing liver disease.
• Unexplained feelings of distress not associated with hallucinations, but may make it difficult to think clearly and rationally
• Suicide

Reporting of adverse effects

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

5. Storage of Efavirenz Teva

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

Do not use this medicine after the expiry date stated on the blister and the carton after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging when they are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

Composition of Efavirenz Teva

• Each Efavirenz Teva film-coated tablet contains 600 mg of the active substance efavirenz.

• The other ingredients are microcrystalline cellulose, hydroxypropylcellulose, sodium lauryl sulfate, sodium starch glycolate (Type A), poloxamer 407 and magnesium stearate in the core. The film-coating component contains hypromellose, lactose monohydrate, titanium dioxide, macrogol/PEG 3350, triacetin and yellow iron oxide.

Appearance of the product and contents of the pack

• Film-coated tablet: yellow, capsule-shaped film-coated tablet, engraved with “Teva” on one side and “7541” on the other.
• Efavirenz Teva is available in pack sizes of 30, 90 film-coated tablets or 30x1/90x1 film-coated tablets (in perforated unit dose blisters), or a multipack or carton containing 90 film-coated tablets (3 packs of 30x1 film-coated tablets). Only certain pack sizes may be commercially available.

Marketing Authorization Holder

Teva B.V., Swensweg 5, 2031GA Haarlem, The Netherlands

Manufacturer

PLIVA Hrvatska d.o.o. (PLIVA Croatia Ltd.), Prilaz baruna Filipovica 25, 10000 Zagreb, Croatia

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

Date of the most recent review of this leaflet

Other sources of information

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