Efavirenz Aurovitas 600 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Efavirenz Aurovitas 600 mg film-coated tablets EFG

Read the entire 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may 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.

Contents of the leaflet

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

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

Efavirenz Aurovitas, 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 older than 3 months who weigh at least 3.5 kg.

Your doctor has prescribed efavirenz because you have an HIV infection. Efavirenz, when taken in combination with other antiretroviral medicines, reduces the amount of virus in the blood. This can strengthen your immune system and reduce the risk of developing HIV-related illnesses.

2. What you need to know before taking Efavirenz Aurovitas

Do not take Efavirenz Aurovitas

• If you are allergic to efavirenz or any of the other components of this medicine (listed in section 6). Contact your doctor or pharmacist if you have any questions about this.
• If you have severe liver disease.
• If you have any heart problems, such as changes in heart rhythm or heartbeat frequency, or a serious heart condition.
• If a family member (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 Aurovitas”):

- Astemizole or terfenadine (used to treat allergic symptoms).

- Bepridil (used to treat heart conditions).

- Cisapride (used to treat heartburn).

- Ergot alkaloids (e.g., ergotamine, dihydroergotamine, ergonovine, and methylergonovine) (used to treat migraines 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) (a 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 in the treatment of opioid addiction).

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

Warnings and precautions

Talk to your doctor or pharmacist before starting Efavirenz Aurovitas:

• Efavirenz must be taken with other medicines that act against HIV. If efavirenz is prescribed for you because your current treatment has failed to prevent viral replication, you will need to receive another medicine at the same time that 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 infection.
• You must remain under your doctor’s supervision while taking efavirenz.
• Inform 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 or have suicidal 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, or 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 you are taking efavirenz. 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 serious 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 (see section 2, Do not take Efavirenz Aurovitas).

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

• Once you have started taking efavirenz, be cautious of:

- 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 notice any sign of severe rash, with blisters or fever, stop taking efavirenz 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 when taking efavirenz.

- Any sign of inflammation or infection. In some patients with advanced HIV infection (AIDS) and a history of opportunistic infections, signs and symptoms of inflammation from prior infections may appear shortly after starting anti-HIV treatment. These symptoms are believed to result from improved immune response, enabling the body to fight infections that were previously present without apparent symptoms. If you notice any symptoms of infection, inform your doctor immediately. 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 symptoms 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 condition 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 is not recommended for children under 3 months of age or weighing less than 3.5 kg, as it has not been adequately studied in these patients.

Other medicines and Efavirenz Aurovitas

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

Inform your doctor, pharmacist, or nurse if you are using, have recently used, or might need to use any other medicine.

Efavirenz may interact with other medicines, including herbal preparations such as Ginkgo biloba extracts. As a result, the levels of efavirenz 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 medicines:

• 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 combination tablet of efavirenz, emtricitabine, and tenofovir should not be taken with efavirenz unless recommended by your doctor, as it contains efavirenz, the active substance in Efavirenz Aurovitas.
• 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 tuberculosis and Mycobacterium avium complex infection associated with AIDS: clarithromycin, rifabutin, rifampicin. Your doctor may consider changing the dose or prescribing an alternative antibiotic. Additionally, your doctor may prescribe a higher dose of efavirenz.
• Medicines used to treat fungal infections (antifungals):
  • Voriconazole. Efavirenz 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 may decrease the amount of itraconazole in your blood.
  • Posaconazole. Efavirenz may decrease the amount of posaconazole in your blood.
• Medicines used to treat parasitic worm infections:
  • Praziquantel: efavirenz may reduce the amount of praziquantel in your blood. If you take these two medicines together, your doctor may recommend increasing the praziquantel dose if necessary.
• Medicines used to treat malaria:
  • Artemether/lumefantrine: efavirenz may reduce the amount of artemether/lumefantrine in your blood.
  • Atovaquone/proguanil: efavirenz may reduce the amount of atovaquone/proguanil in your blood.
• Medicines used to treat seizures (anticonvulsants): carbamazepine, phenytoin, phenobarbital. Efavirenz may decrease or increase the amount of anticonvulsant in your blood. Carbamazepine may reduce the likelihood of efavirenz working. Your doctor may consider prescribing a different anticonvulsant.
• Medicines used to lower blood fat (also called statins): atorvastatin, pravastatin, simvastatin. Efavirenz may reduce the amount of statins in your blood. Your doctor will check your cholesterol levels and consider adjusting the statin dose if necessary.
• Methadone (a medicine used to treat opioid addiction): your doctor may recommend an alternative treatment.
• 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 for high blood pressure or heart problems): when starting efavirenz 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, 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 and breastfeeding”). Efavirenz may reduce the effectiveness of hormonal contraceptives. Pregnancies have occurred in women taking efavirenz while using a contraceptive implant, although it has not been established that efavirenz treatment caused contraceptive failure.
• Warfarin or acenocoumarol (medicines used to reduce blood clots): your doctor may need to adjust your warfarin or acenocoumarol dose.
• Ginkgo biloba extracts (a herbal preparation).
• Metamizole, a medicine used to treat pain and fever.
• 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.

Taking Efavirenz Aurovitas with food, drinks, and alcohol

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

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

If you could become pregnant while on efavirenz treatment, 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 treatment.

Inform your doctor immediately if you are pregnant or plan to become pregnant. If you are, you should only take efavirenz if both you and your doctor decide it is clearly necessary. Consult 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 a medicine containing a combination of efavirenz, emtricitabine, and tenofovir during pregnancy. If you have taken efavirenz 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 child’s development.

You must not breastfeed while taking efavirenz.

It is not recommended that women living with HIV breastfeed, as 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 use of machines

Efavirenz may cause dizziness, difficulty concentrating, and drowsiness. If you experience these symptoms, do not drive or operate tools or machinery.

Excipients

Efavirenz Aurovitas contains lactose

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with your doctor before taking this medicine.

Efavirenz Aurovitas contains sodium

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

3. How to take Efavirenz Aurovitas

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 provide instructions on how to take the appropriate dose.

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

Use in children and adolescents

• Efavirenz film-coated tablets are not suitable for children weighing less than 40 kg.
• The recommended dose in children weighing 40 kg or more is 600 mg once daily.

If you take more Efavirenz Aurovitas than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Efavirenz Aurovitas

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 to take the medicine, consult your doctor or pharmacist.

If you stop taking Efavirenz Aurovitas

When you start running out of your efavirenz supply, request a refill from your doctor or pharmacist. This is extremely important because the amount of virus could begin to increase if you stop taking the medicine, even for a short period of time. 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 experiences them. When treating HIV infection, it is not always possible to determine whether adverse effects are due to efavirenz, to other medications taken simultaneously, or to the HIV infection itself.

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

The most significant adverse effects reported with efavirenz, when used together with other anti-HIV medicines, are skin rash and nervous system symptoms.

If you develop a skin rash, you should consult your doctor, as some rashes may be serious. However, in most cases, the rash resolves without needing to change the efavirenz treatment. Cases of rash have been more frequent in children than in adults treated with efavirenz.

Nervous system symptoms usually occur at the beginning of treatment but generally decrease within 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 taking efavirenz at bedtime and on an empty stomach. Some patients experience more severe symptoms that may affect mood or the ability to think clearly. Indeed, some patients have died by suicide. These problems tend to occur more frequently in patients with a history of mental illness. Inform your doctor immediately if you experience these symptoms or any adverse effects while taking efavirenz.

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

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

• Skin rash

Common (may affect up to 1 in 10 people)

• Abnormal dreams, difficulty concentrating, dizziness, headaches, difficulty sleeping, drowsiness, problems with coordination or balance.
• Stomach pain, diarrhea, nausea, and 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 (may affect up to 1 in 100 people)

• Nervousness, amnesia, confusion, seizures, and abnormal thoughts.
• Blurred vision.
• Sensation of movement or tilting (dizziness).
• Abdominal pain caused by inflammation of the pancreas.
• Allergic reaction (hypersensitivity) that may cause severe skin reactions (erythema multiforme, Stevens-Johnson syndrome).
• Yellowing of the skin and eyes or abdominal pain caused by liver inflammation.
• Breast enlargement in men.
• Irritability, mood disturbances, seeing or hearing things that are not real (hallucinations), mania (a mental illness characterized by episodes of overactivity, euphoria, or irritability), paranoia, suicidal thoughts, catatonia (a disorder in which the patient remains immobile and mute for a period of time).
• Ringing, buzzing, or other continuous noise in the ears.
• Tremor (shaking).
• Flushing.

Blood tests may show:

• Increased cholesterol in the blood.

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

• Itchy skin rash caused by a reaction to sunlight.
• Liver failure, which in some cases may lead to death or require a liver transplant. 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 it may be difficult to think clearly and rationally.
• Suicide.

Frequency not known (cannot be estimated from available data)

• A group of conditions causing brain dysfunction (encephalopathy).

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Efavirenz Aurovitas

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

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

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Efavirenz Aurovitas

• The active substance is efavirenz. Each film-coated tablet contains 600 mg of efavirenz.
• The other components are:

Tablet core: microcrystalline cellulose (Grade 101) (E460), hydroxypropyl cellulose (low-substituted (LH-21)), lactose monohydrate, hydroxypropyl cellul游戏副本

Date of the most recent review of this leaflet: January 2025

Other sources of information

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).