EFAVIRENZ AUROVITAS 600 mg FILM-COATED TABLETS

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

Do not take Efavirenz Aurovitas

• If you are allergic to efavirenz or any of the other ingredients of this medicine (listed in section 6). Contact your doctor or pharmacist if you have any questions.
• If you have severe liver disease.
• If you have any heart problems, such as changes in heart rhythm or heart rate, or severe heart disease.
• If any member of your family (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 medicines (see also "Other medicines and Efavirenz Aurovitas"):
  • Astemizole or terfenadine (used to treat allergic symptoms).
  • Bepridil (used to treat heart disease).
  • Cisapride (used to treat stomach upset).
  • Alkaloids of ergot (e.g., ergotamine, dihydroergotamine, ergonovine, and methylergonovine) (used to treat migraines and cluster headaches).
  • Midazolam or triazolam (used to help you 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 medicinal product used for depression and anxiety).
  • Flecainide, metoprolol (used for irregular heartbeat treatment).
  • Certain antibiotics (macrolides, fluoroquinolones, imidazole).
  • 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 may cause serious and/or potentially fatal side effects or prevent efavirenz from working properly.

Warnings and precautions

Consult your doctor or pharmacist before starting Efavirenz Aurovitas:

• Efavirenz must be taken with other medicines that act against HIV. If you are prescribed efavirenz, it is because your current treatment has not prevented the multiplication of the virus, and you will need to take another medicine 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 the supervision of your doctor while taking efavirenz.
• 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 or have suicidal or strange thoughts (see section 4, Possible side effects).
  • If you have a history of seizures (attacks or convulsions) or 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 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 active hepatitis. Patients with chronic hepatitis B or C and treated with a combination of antiretroviral medicines have a higher risk of developing serious and potentially fatal liver side 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 problem, such as an abnormal electrical signal known as QT interval prolongation.
• Once you have started taking efavirenz, be careful with:
  • Signs of 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 notice any sign of severe rash, with blisters or fever, stop taking efavirenz and inform your doctor immediately. If you had a rash while taking any other NNRTI, you may have a 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 of previous infections may appear shortly after starting anti-HIV treatment. It is believed that these symptoms are due to an improvement in the body's immune response, which allows it to fight infections that were present without apparent symptoms. If you notice 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 start taking medicines for HIV treatment. Autoimmune disorders may appear many months after starting treatment. If you notice any symptoms of infection or other symptoms such as muscle weakness, weakness that starts in the hands and feet and moves towards the body, palpitations, tremors, or hyperactivity, inform your doctor immediately to receive the necessary treatment.
  • Bone problems. Some patients receiving combination antiretroviral therapy may develop a bone disease called osteonecrosis (death of bone tissue caused by loss of blood supply to the bone). Among the many risk factors for developing this disease are the duration of combination antiretroviral therapy, the use of corticosteroids, alcohol consumption, severe immunodepression, and high body mass index. The symptoms of osteonecrosis are stiffness in the joints, 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

Do not take efavirenz with certain medicines.These are listed under the heading "Do not take Efavirenz Aurovitas" at the beginning of section 2. They include some common medicines and a herbal medicinal product (St. John's Wort) that can cause serious interactions.

Tell your doctor, pharmacist, or nurse if you are using, have recently used, or might use any other medicines.

Efavirenz may interact with other medicines, including herbal preparations such as Ginkgo biloba extracts. As a result, the amount of efavirenz or other medicines in your blood may be affected. This may prevent the medicines from working properly or make some of their side effects worse. In some cases, your doctor may need to adjust your dose or check 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 changing the dose of the protease inhibitors.
  • Maraviroc.
  • The combination tablet of efavirenz, emtricitabine, and tenofovir should not be taken with efavirenz unless your doctor recommends it, as it contains efavirenz, the active substance of Efavirenz Aurovitas.
• Medicines used to treat hepatitis C 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 related to 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.
• 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 dose of voriconazole should be increased and the dose of efavirenz should be reduced. You should check 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 dose of praziquantel 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 make it less likely that efavirenz will work. Your doctor may consider giving you another 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 changing the dose of statin if necessary.
• Methadone (a medicine used to treat opioid addiction): your doctor may recommend alternative treatment.
• Sertraline (a medicine used to treat depression): your doctor may need to change your dose of sertraline.
• Bupropion (a medicine used to treat depression or to help you stop smoking): your doctor may need to change your dose of bupropion.
• Diltiazem or similar medicines (called calcium channel blockers, which are medicines used to treat high blood pressure or heart problems): when you start treatment with efavirenz, your doctor may need to adjust your dose of calcium channel blocker.
• Immunosuppressants such as cyclosporine, sirolimus, or tacrolimus (medicines used to prevent rejection in organ transplants): when you start or stop taking efavirenz, your doctor will carefully monitor your blood levels of immunosuppressants 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 contraceptive method (e.g., condom). Efavirenz may make hormonal contraceptives less effective. Pregnancies have occurred in women taking efavirenz while using a contraceptive implant, although it has not been established that efavirenz treatment caused the contraceptive failure.
• Warfarin or acenocoumarol (medicines used to prevent blood clots): your doctor may need to change your dose of warfarin or acenocoumarol.
• Ginkgo biloba extracts (a herbal medicinal product).
• Metamizole, a medicine used to treat pain and fever.
• Medicines that affect 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 imidazole.

Taking Efavirenz Aurovitas with food, drinks, and alcohol

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Women must not become pregnant during treatmentwith efavirenz or in the 12 weeks following treatment. Your doctor may ask for a pregnancy test to ensure that you are not pregnant before starting treatment with efavirenz.

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

Inform your doctor immediately if you are pregnant or plan to become pregnant.If you are, you should only take efavirenz if you and your doctor decide that it is clearly necessary. Ask your doctor or pharmacist for advice before taking any medicine.

Severe birth defects have been seen in animal fetuses and in newborns whose mothers were treated with efavirenz or a medicine that contains a combination of efavirenz, emtricitabine, and tenofovir during pregnancy. If you have taken efavirenz or the combination tablet that contains efavirenz, emtricitabine, and tenofovir during your pregnancy, your doctor may ask for regular blood tests and other diagnostic tests to monitor the development of your child.

Do not breastfeed your childif you are taking efavirenz.

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

If you are breastfeeding or thinking of breastfeeding, you should consult your doctor as soon as possible.

Driving and using machines

Efavirenz may cause dizziness, difficulty concentrating, and drowsiness.If you notice these symptoms, do not drive or use tools or machines.

Excipients

Efavirenz Aurovitas contains lactose

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

Efavirenz Aurovitas 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 Aurovitas

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

• The dose for adults is 600 mg once a day.
• It may be necessary 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 bedtime. This may make some adverse effects (such as dizziness, drowsiness) cause fewer problems. 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 the treatment of HIV. 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 who weigh less than 40 kg.
• The recommended dose in children who weigh 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 Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Efavirenz Aurovitas

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

If you interrupt treatment with Efavirenz Aurovitas

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

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

4. Possible adverse effects

Like all medications, this medication can produce adverse effects, although not all people suffer from them. When treating HIV infection, it is not always possible to determine which adverse effects have been produced by efavirenz or by other medications being taken at the same time or by the HIV infection itself.

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

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

If you present a skin rash, you should consult your doctor, as some rashes can be serious; however, in most cases, the skin rash disappears without needing to change the treatment with efavirenz. Cases of rash were more frequent among children than among adults treated with efavirenz.

Nervous system symptoms usually occur at the start of treatment but generally decrease in the first few weeks. In one 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 present 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 present these symptoms or any adverse effect 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, coordination or balance problems.
• stomach pain, diarrhea, nausea, and vomiting.
• itching.
• fatigue.
• feeling of anxiety, feeling of depression.

Lab tests may show:

• increase in liver enzymes in blood.
• increase in triglycerides (fatty acids) in blood.

Uncommon(may affect up to 1 in 100 people)

• nervousness, amnesia, confusion, convulsions, and abnormal thoughts.
• blurred vision.
• feeling of movement or inclination (vertigo).
• abdominal pain caused by pancreas inflammation.
• allergic reaction (hypersensitivity) that can produce severe skin reactions (erythema multiforme, Stevens-Johnson syndrome).
• yellowing of the skin and eyes or abdominal pain (from the stomach) caused by liver inflammation.
• breast enlargement in men.
• aggressive behavior, mood affection, seeing and hearing things that really do not exist (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 speechless for a period of time).
• ringing, whistling, or other continuous noise in the ears.
• tremor (shaking).
• flushing.

Lab tests may show:

• increase in cholesterol in 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 lead to death or require a liver transplant. In most cases, this occurred in patients who already had liver disease, but there are some reports of cases in patients without existing liver disease.
• unexplained feelings of distress 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 conditions that cause brain dysfunction (encephalopathy).

Reporting adverse effects

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

5. Conservation of Efavirenz Aurovitas

Keep this medication out of 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 thrown away through the sewers or in the trash. Deposit the packaging and medications you no longer need at the SIGRE point in the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of Efavirenz Aurovitas

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

Tablet core:microcrystalline cellulose (Grade 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 (Grade 200) (E460), crospovidone (Type A), and magnesium stearate.

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

Appearance of the product and package contents

Yellow, biconvex, oval, film-coated tablets with a 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 transparent PVC/PVdC-Aluminum blister packs and in white opaque high-density polyethylene (HDPE) bottles with a white opaque polypropylene closure.

Package sizes:

Blister: 30 and 90 tablets

HDPE bottle: 30, 90, and 500 tablets

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16 D

28036 Madrid

Spain

Manufacturer

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

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

Date of the last revision of this prospectus:January 2025

Other sources of information

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