Prospect: information for the user

Efavirenz Aurovitas 600 mg film-coated tablets EFG

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

-Keep this prospect, as you may need to read it again.

-If you have any doubts, consult your doctor or pharmacist.

-This medicine has been prescribed only to you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.

-If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

1.What is Efavirenz Aurovitas and how it is used

2.What you need to know before starting to take Efavirenz Aurovitas

3.How to take Efavirenz Aurovitas

4.Adverse effects

5.Storage of Efavirenz Aurovitas

6.Contents of the package and additional information

Efavirenz Aurovitas, which contains the active ingredient efavirenz, is part of a class of antiretroviral medications called non-nucleoside reverse transcriptase inhibitors (NNRTIs). It is amedication that acts against the 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 over 3 months old and weighing at least 3.5 kg.

Your doctor has prescribed efavirenz because you have an HIV infection. Efavirenz taken in combination with other antiretroviral medications reduces the amount of virus in the blood. This may strengthen your immune system and reduce the risk of developing diseases associated with HIV infection.

Do not take Efavirenz Aurovitas

•If you are allergic to efavirenz or any of the other components of this medication (listed in section 6). Contact your doctor or pharmacist for any questions you may have about this.

•If you have severe liver disease.

•If you have any heart problems, such as changes in heart rhythm or frequency of heartbeats, or a serious heart disease.

•If a family member (parents, grandparents, brothers, or sisters) 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 medications (see also “Other medications and Efavirenz Aurovitas”):

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

-Bepridil(used to treat heart diseases).

-Cisaprida(used to treat heartburn).

-Alcaloides del cornezuelo(for example, ergotamina, dihidroergotamina, ergonovina, and metilergonovina) (used to treat migraines and cluster headaches).

-Midazolam or triazolam(used to help sleep).

-Pimozida, imipramina, amitriptilina, or clomipramina(used to treat certain mental illnesses).

-Elbasvir or grazoprevir(used to treat hepatitis C).

-Hierba de San Juan(Hypericum perforatum) (medicinal plant used to treat depression and anxiety).

-Flecainida, metoprolol(used to treat irregular heartbeat).

-Certainantibiotics(macrólidos, fluoroquinolonas, imidazol).

-Triazolicantifungal agents.

-Certainantimalarial treatments.

-Metadona(used to treat opioid addiction).

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Efavirenz Aurovitas:

•Efavirenz should be taken with other medications that act against HIV.If you are prescribed efavirenz, it is because your current treatment has not prevented the virus from multiplying, you will need to receive another medication that you have not taken before at the same time.

•This medication 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 the supervision of your doctor 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 thoughts or strange dreams (see section 4, “Possible side effects”).

-If you have a history of seizures (attacks or seizures) or if you are being treated with anticonvulsants such as carbamazepina, fenobarbital, and phenytoin. If you are taking any of these medications, your doctor may need to check the level of anticonvulsant in your blood to ensure that it is not affected while taking efavirenz. Your doctor may give you a different anticonvulsant.

-If you have a history of liver disease, including chronic hepatitis.Patients with chronic hepatitis B or C and treated with a combination of antiretroviral medications have a higher risk of developing severe and potentially fatal liver damage. Your doctor may perform blood tests to monitor your liver function or may switch you to another medication.If you have severe liver disease, do not take efavirenz(see section 2, “Do not take Efavirenz Aurovitas”).

-If you have a heart problem, such as an abnormal electrical signal known as prolonged QT interval.

•Once you have started taking efavirenz, be careful with:

-Dizziness, difficulty sleeping, drowsiness, difficulty concentrating, or abnormal dreams.These side effects may start 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 observe any sign of severe rash, blisters, or fever, stop taking efavirenz and inform your doctor immediately. If you 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, symptoms and signs of previous infections may appear shortly after starting antiretroviral treatment. It is believed that these symptoms are due to an improvement in the body's immune response, which allows it to fight off infections that were present without any apparent symptoms. If you observe any symptoms of infection, inform your doctor immediately. In addition to opportunistic infections, autoimmune disorders (a condition that occurs when the immune system attacks healthy body tissue) may also appear after you have started taking medications to treat HIV infection. Autoimmune disorders may appear many months after starting treatment. If you observe any symptoms of infection or other symptoms such as muscle weakness, weakness that begins in the hands and feet and ascends to the body trunk, palpitations, tremors, or hyperactivity, inform your doctor immediately to receive necessary treatment.

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

Children and adolescents

Efavirenzis not recommended for children under 3 months or weighing less than 3.5 kg as it has not been adequately studied in these patients.

Other medications and Efavirenz Aurovitas

Do not take efavirenz with certain medications.These are listed under the title “Do not take Efavirenz Aurovitas” at the beginning of section 2. This includes some common medications and a medicinal plant (St. John's Wort) that may cause severe interactions.

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

Efavirenz may interact with other medications, even with herbal preparations such asextracts ofGinkgo biloba. As a result, the amount of efavirenz or other medications in your blood may be affected. This may prevent the medications from working properly or make one of their side effects worse. In some cases, your doctor may need to adjust your dose or check your blood levels.It is essential to inform your doctor or pharmacist if you are taking any of the following medications:

•Other medications used to treat 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 medication or changing the dose of protease inhibitors.

-Maraviroc.

-The combination tablet of efavirenz, emtricitabina, and tenofovir should not be taken with efavirenz unless your doctor recommends it, as it contains efavirenz, the active ingredient ofEfavirenz Aurovitas.

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

•Medications used to treat bacterial infections, including tuberculosis and Mycobacterium avium complex (MAC) infection associated with AIDS: clarithromycin, rifabutina, rifampicina. Your doctor may consider changing your dose or giving you an alternative antibiotic. Additionally, your doctor may prescribe a higher dose of efavirenz.

•Medications used to treat fungal infections (antifungals):

-Voriconazol. Efavirenz may decrease the amount of voriconazol in your blood, and voriconazol may increase the amount of efavirenz in your blood. If you take these two medications together, your doctor may need to increase the dose of voriconazol and reduce the dose of efavirenz. You should check with your doctor first.

-Itraconazol. Efavirenz may decrease the amount of itraconazol in your blood.

-Posaconazol. Efavirenz may decrease the amount of posaconazol in your blood.

•Medications used to treat parasitic worm infections:

-Praziquantel: efavirenz may reduce the amount of praziquantel in your blood. If you take these two medications together, your doctor may recommend increasing the dose of praziquantel, if necessary.

•Medications used to treat malaria:

-Arteméter/lumefantrina: efavirenz may reduce the amount of arteméter/lumefantrina in your blood.

-Atovacuona/proguanil: efavirenz may reduce the amount of atovacuona/proguanil in your blood.

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

•Medications used to lower cholesterol (also called statins):atorvastatina, pravastatina, simvastatina. Efavirenz may decrease the amount of statins in your blood. Your doctor will check your cholesterol levels and may consider changing the dose of statin if necessary.

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

•Sertralina(a medication used to treat depression): your doctor may need to change your dose of sertralina.

•Bupropión(a medication used to treat depression or to help quit smoking): your doctor may need to change your dose of bupropión.

•Diltiazem or similar medications (called calcium channel blockers, which are medications that are usually used to treat high blood pressure or heart problems): when you start taking efavirenz, your doctor may need to adjust your dose of calcium channel blocker.

•Immunosuppressants such as ciclosporina, sirolimus, or tacrolimus(medications used to prevent rejection in organ transplants): when you start or stop taking efavirenz, your doctor will closely monitor your plasma levels of immunosuppressants and may need to adjust your dose.

•Birth control medications, such as oral contraceptives, injectable contraceptives (e.g., Depo-Provera), or implantable contraceptives (e.g., Implanon):You should also use a reliable barrier method of contraception (see “Pregnancy and breastfeeding”). Efavirenz may make birth control medications less effective. There have been pregnancies in women taking efavirenz while using an implantable contraceptive, although it has not been established that efavirenz treatment caused contraceptive failure.

•Warfarina or acenocumarol(medications used to reduce blood clotting): your doctor may need to change your dose of warfarina or acenocumarol.

•Extracts ofGinkgo biloba(a herbal preparation).

•Metamizol, a medication used to treat pain and fever.

•Medications that affect heart rhythm:

-Medications used to treat heart rhythm problems,such as flecainida or metoprolol.

-Medications used to treat depression,such as imipramina, amitriptilina, or clomipramina.

-Antibiotics,including the following types: macrólidos, fluoroquinolonas, or imidazol.

Taking Efavirenz Aurovitas with food, drinks, and alcohol

Taking efavirenz on an empty stomach may reduce side effects. You should avoid grapefruit juice when taking efavirenz.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, consult your doctor or pharmacist before using this medication.

Women should not become pregnant during treatmentwith efavirenz or in the12 weeks following treatment. Your doctor may request a pregnancy test to ensure that you are not pregnant before starting treatment with efavirenz.

If you could become pregnant while taking efavirenz, you should always use a reliable barrier method of contraception (such as a condom) along with other methods of contraception, including oral contraceptives or other hormonal contraceptives (such as implants, injections). Efavirenz may remain in your blood for some time after stopping treatment. Therefore, you should continue to use methods of contraception approximately12 weeks after stopping treatment with efavirenz.

Inform your doctor immediately if you are pregnant or intend to become pregnant.If you are pregnant, you should only take efavirenz if both you and your doctor decide that it is clearly necessary. Consult your doctor or pharmacist before taking any medication.

Severe malformations have been observed in animal fetuses and newborns whose mothers were treated with efavirenz or a medication containing a combination of efavirenz, emtricitabina, and tenofovirduring pregnancy. If you have taken efavirenz or the combination tablet containing efavirenz, emtricitabina, and tenofovirduring your pregnancy, your doctor may request periodic blood tests and other diagnostic tests to monitor your child's development.

Do not breastfeed your childif you are taking efavirenz.

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

If you are breastfeeding or plan to breastfeed,you should consult your doctoras soon as possible.

Driving and operating machinery

Efavirenz may cause dizziness, concentration problems, and drowsiness.If you notice these symptoms, do not drive or operate tools or machinery.

Excipients

Efavirenz Aurovitas contains lactose

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

Efavirenz Aurovitas contains sodium

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

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again. Your doctor will give you instructions for taking the appropriate dose.

•The dose for adults is 600 mg once a day.

•You may need to increase or decrease the dose of efavirenz if you are also taking certain medications (see “Other Medications and Efavirenz Aurovitas”).

•Efavirenz is administered orally. It is recommended to take efavirenz on an empty stomach, preferably before breakfast. This may make some side effects (e.g., dizziness, drowsiness) less problematic. Normally, an empty stomach is defined as 1 hour before or 2 hours after a meal.

•It is recommended to swallow the tablet whole with water.

•Efavirenz should be taken every day.

•Efavirenz should never be used as the only medication for HIV treatment. Efavirenz should always be taken in combination with other anti-HIV medications.

Use in children and adolescents

•The film-coated tablets of efavirenz are not suitable for children weighing less than 40 kg.

•The recommended doses in children weighing 40 kg or more is 600 mg once a day.

If you take more Efavirenz Aurovitas than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Efavirenz Aurovitas

Make sure not to miss any doses.If you do, take the next dose as soon as possible, but do not take a double dose to compensate for the missed doses. If you need help to better schedule the medication hours, consult your doctor or pharmacist.

If you interrupt the treatment with Efavirenz Aurovitas

When your efavirenz package is about to run out,request more from your doctor or pharmacist. This is extremely important because the amount of virus could start to increase if you stop taking the medication, even for a short period of time. If this happens, the virus may become more difficult to treat.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them. When treating HIV infection, it is not always possible to determine which side effects have been caused by efavirenz or by other medicines being taken at the same time or by the HIV infection itself.

During HIV treatment, there may be an increase in weight and blood glucose and lipid levels. This may be partly related to 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 side effects reported from the use of efavirenz with other HIV medicines are skin rash and nervous system symptoms.

If you experience a skin rash, consult your doctor, as some rashes can be severe; however, in most cases, the skin rash disappears without the need to change treatment with efavirenz. Skin rash cases were more frequent among children than among adults treated with efavirenz.

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

Inform your doctor immediately if you experience any of the following side 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, coordination or balance problems.

•stomach pain, diarrhea, nausea, and vomiting.

•itching.

•fatigue.

•feeling anxious, feeling depressed.

Laboratory tests may show:

•increased liver enzymes in the blood.

•increased triglycerides (fats) 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 (vertigo).

•abdominal pain caused by pancreatitis.

•allergic reaction (hypersensitivity) that can cause severe skin reactions (erythema multiforme, Stevens-Johnson syndrome).

•yellowing of the skin and eyes or abdominal pain (stomach) caused by liver inflammation.

•breast enlargement in men.

•irritability, mood changes, seeing or hearing things that are not there (hallucinations), mania (mental illness characterized by episodes of overactivity, euphoria, or irritability), paranoia, and suicidal thoughts, catatonia (disorder in which the patient remains immobile and silent for a period of time).

•tinnitus, buzzing, or other continuous noise in the ears.

•tremors.

•flushing.

Laboratory tests may show:

•increased cholesterol in the blood.

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

•skin rash with itching caused by a reaction to sunlight.

•liver failure, which in some cases can cause death or require a liver transplant. In most cases, it occurred in patients who already had liver disease, but there have been some reports of cases in patients without pre-existing liver disease.

•unexplained feelings of anxiety that are not associated with hallucinations, but it may be difficult to think clearly and sensibly.

•suicide.

Frequency not known(cannot be estimated from available data)

•group of disorders that cause brain dysfunction (encephalopathy).

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the label and packaging after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or trash. Dispose of packaging and medications you no longer need at the SIGRE point of your pharmacy. Ask your pharmacist how to dispose of packaging and medications you no longer need. This will help protect the environment.

Composition of Efavirenz Aurovitas

-The active ingredient is efavirenz. Each film-coated tablet contains 600 mg of efavirenz.

-The other components are:

Core of the tablet:microcrystalline cellulose (Grado 101) (E460), low-substituted hydroxypropyl cellulose (LH-21), lactose monohydrate, low-viscosity hydroxypropyl cellulose, anhydrous colloidal silica, crospovidone (type B), sodium lauryl sulfate, microcrystalline cellulose (Grado 200) (E460), crospovidone (type A), and magnesium stearate.

Covering:hypromellose type 2910 (E464), macrogol, titanium dioxide (E171), and yellow iron oxide (E172).

Appearance of the product and contents of the package

Film-coated tablets of yellow color, biconvex, oval, with beveled edge, with the mark “L” on one face and “11” on the other. The size is 20.1 mm × 9.6 mm.

Efavirenz Aurovitas 600 mg film-coated tablets EFG are available in PVC/PVdC transparent-Aluminum blisters and in high-density polyethylene (PEAD) white opaque bottles with white opaque polypropylene caps.

Package sizes:

Blister: 30 and 90 tablets

PEAD bottle: 30, 90, and 500 tablets

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16 D

28036 Madrid

Spain

Responsible manufacturer

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

This medicinal product is authorized in the member states of the European Economic Area with the following names:

Last review date of this leaflet:January 2025

Other sources of information

The detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).