Package Leaflet:Information for the User

Efavirenz/Emtricitabina/Tenofovir disoproxilo Macleods

600 mg/200 mg/245 mg Film-Coated Tablets EFG

Efavirenz/Emtricitabina/Tenofovir disoproxilo

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

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

-If you have any questions, ask your doctor or pharmacist.

-This medicine has been prescribed for you only. Do not pass it on to others even if their symptoms are the same as yours. It may harm them.

-If you experience any side effects, talk to your doctor or pharmacist. See section 4.

1.What is Efavirenz/Emtricitabina/Tenofovir disoproxilo Macleods and what is it used for

2.What you need to know before you start taking Efavirenz/Emtricitabina/Tenofovir disoproxilo Macleods

3.How to take Efavirenz/Emtricitabina/Tenofovir disoproxilo Macleods

4.Possible side effects

5Storage of Efavirenz/Emtricitabina/Tenofovir disoproxilo Macleods

6.Contents of the pack and additional information

Efavirenz/Emtricitabina/Tenofovir disoproxilo Macleodscontains three active ingredientsthat are used to treat human immunodeficiency virus (HIV) infection.

-Efavirenz is a non-nucleoside reverse transcriptase inhibitor (NNRTI)

-Emtricitabine is a nucleoside reverse transcriptase inhibitor (NRTI)

-Tenofovir is a nucleotide reverse transcriptase inhibitor

Each of these active ingredients is also known as an antiretroviral medication, acting by interfering with the normal working of an enzyme (reverse transcriptase) that is essential for the virus to multiply.

Efavirenz/Emtricitabina/Tenofovir disoproxilo Macleodsis a treatment for human immunodeficiency virus (HIV) infection(HIV)in adults aged 18 years orolderwho have been treated previously with other antiretroviral medications and have HIV-1 infection under control for at least three months. Patients should not have experienced failure of a previous HIV treatment.

Do not takeEfavirenz/Emtricitabina/Tenofovir disoproxil Macleods:

-if you are allergicto efavirenz, emtricitabine, tenofovir, tenofovir disoproxil, or any of the other ingredients of this medicine (listed in section 6).

-if you have severe liver disease.

-if you have a heart condition, such as an abnormal heart rhythm called QT interval prolongation that puts you at high risk of serious heart rhythm problems (Torsade de Pointes).

-if any of your family members (parents, grandparents, siblings, or children) have died suddenly from a heart problem or were 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 takingany of the following medicines (see also “Other medicines and Efavirenz/Emtricitabina/Tenofovir disoproxil Macleods”):

-astemizole or terfenadine(used to treat hay fever or other allergies)

-bepridil(used to treat heart disease)

-cisaprida(used to treat heartburn)

-elbasvir/grazoprevir(used to treat hepatitis C)

-alkaloids of ergot(such as ergotamine, dihydroergotamine, ergonovine, and methylergonovine) (used to treat migraines and histamine headaches)

-midazolam or triazolam(used to help with sleep)

-pimozida, imipramina, amitriptilina, or clomipramina(used to treat certain mental health problems)

-St. John's Wort (Hypericum perforatum)(a herbal medicine used to treat depression and anxiety)

-voriconazol(used to treat fungal infections)

-flecainida, metoprolol(used to treat irregular heartbeats)

-certain antibiotics(macrolides, fluoroquinolones, imidazoles)

-triazole antifungals

-certain antimalarials

-metadona(used to treat opioid addiction).

?If you are taking any of these medicines, tell your doctor immediately.Taking these medicines withEfavirenz/Emtricitabina/Tenofovir disoproxil Macleodsmay cause serious and/or potentially life-threatening side effects or may cause these medicines to stop working properly.

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medicine.

*This medicine is not a cure for HIV infection. While you are taking this medicine, you may still experience infections or other diseases associated with HIV infection.

*While taking this medicine, you must remain under the supervision of your doctor.

*Inform your doctor:

-If you are taking other medicinesthat contain efavirenz, emtricitabine, tenofovir disoproxil, tenofovir alafenamide, lamivudine, or adefovir dipivoxil. Do not take this medicine with any of these medicines.

-If you have or have had kidney disease, or if your blood tests have shown problems with your kidneys. This medicine is not recommended if you have moderate to severe kidney disease.

This medicine may affect your kidneys. Before starting treatment, your doctor may ask you to have blood tests to check how well your kidneys are working. Your doctor may also ask you to have blood tests during treatment to monitor your kidneys.

This medicine is usually not taken with other medicines that can damage your kidneys (seeTaking Efavirenz/Emtricitabina/Tenofovir disoproxil Macleodswith other medicines). If this is unavoidable, your doctor will monitor your kidney function once a week.

-If you have a heart condition, such as an abnormal heart rhythm called QT interval prolongation.

-If you have a history of mental illness, including depression, or substance abuse. Inform your doctor immediately if you feel depressed, have suicidal thoughts, or have abnormal thoughts (see section 4,Undesirable effects).

-If you have a history of seizures (convulsions or fits)or if you are being treated with anticonvulsant therapy 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 takingEfavirenz/Emtricitabina/Tenofovir disoproxil Macleods. Your doctor may prescribe a different anticonvulsant.

-If you have a history of liver disease, including active chronic hepatitis.Patients with liver disease, including chronic hepatitis B or C, treated with combination antiretrovirals, have a higher risk of severe and potentially life-threatening liver complications. Your doctor may perform blood tests to monitor your liver function or switch you to a different medicine.If you have severe liver disease, do not takeEfavirenz/Emtricitabina/Tenofovir disoproxil Macleods(see before, in section 2,Do not take Efavirenz/Emtricitabina/Tenofovir disoproxil Macleods).

If you have hepatitis B infection, your doctor will carefully consider the best treatment plan for you. Tenofovir disoproxil and emtricitabine, two of the active ingredients in this medicine, have some activity against the hepatitis B virus, although emtricitabine is not authorized for the treatment of hepatitis B infection. Your symptoms of hepatitis may worsen after stopping this medicine. Your doctor may perform blood tests at regular intervals to monitor your liver function (see section 3,If you interrupt treatment with Efavirenz/Emtricitabina/Tenofovir disoproxil Macleods).

- Regardless of the presence of a history of liver disease, your doctor will consider regular blood tests to monitor your liver function.

-If you are over 65 years old.The number of patients over 65 years old who have been studied is insufficient. If you are over 65 years old and have been prescribed this medicine, your doctor will monitor you closely.

-Once you start takingEfavirenz/Emtricitabina/Tenofovir disoproxil Macleods, be aware of:

-Signs of dizziness, difficulty sleeping, somnolence, difficulty concentrating, or abnormal dreams.These side effects may begin in the first 1 or 2 days of treatment and usually disappear after the first 2 to 4 weeks.

-Any sign of skin rash.This medicine may cause skin rashes. If you observe any sign of a severe skin rash with blisters or fever, stop takingEfavirenz/Emtricitabina/Tenofovir disoproxil Macleodsand inform your doctor immediately. If you have had a skin rash while taking another ITINN, you may be at higher risk of having a skin rash with this medicine.

-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, allowing it to fight off infections that were present without apparent symptoms. If you observe any symptoms of infection, please inform your doctor immediately.

Additionally, autoimmune disorders (a condition that occurs when the immune system attacks healthy body tissue) may appear after you start taking medicines to treat your 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 starting in the hands and feet and ascending to the trunk of the body, palpitations, tremors, or hyperactivity, inform your doctor immediately to receive 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 numerous risk factors for developing this disease are the duration of combination antiretroviral therapy, the use of corticosteroids, alcohol consumption, severe immunosuppression, and high body mass index. 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.

Bone problems (which manifest as persistent bone pain or worsening and sometimes ending in fractures) may also occur due to damage to renal tubular cells (see section 4,Undesirable effects).Inform your doctor if you have bone pain or fractures.

Tenofovir disoproxil may also cause bone loss. The most pronounced bone loss was observed in clinical studies when patients were treated with tenofovir disoproxil in combination with a protease inhibitor booster.

In general, the effects of tenofovir disoproxil on long-term bone health and the future risk of fractures in adult and pediatric patients are imprecise.

Inform your doctor if you know you have osteoporosis. Patients with osteoporosis have a higher risk of fractures.

Children and adolescents

-Do not administerEfavirenz/Emtricitabina/Tenofovir disoproxil Macleodsto children and adolescentsunder 18 years old. This medicine has not been studied in children and adolescents.

Other medicines andEfavirenz/Emtricitabina/Tenofovir disoproxil Macleods

Do not takeEfavirenz/Emtricitabina/Tenofovir disoproxil Macleodswith certain medicines.These are listed underDo not take Efavirenz/Emtricitabina/Tenofovir disoproxil Macleods, at the beginning of section 2. Among these are some common medicines and some herbal medicines (including St. John's Wort) that may cause serious interactions.

Inform your doctoror pharmacist if you are taking, have taken recently, or may need to take any other medicine.

Additionally, do not take this medicine with any other medicine that contains efavirenz (unless your doctor recommends it), emtricitabine, tenofovir disoproxil, tenofovir alafenamide, lamivudine, or adefovir dipivoxil.

Inform your doctorif you are taking other medicines that may damage your kidneys. Examples include:

- aminoglycosides, vancomycin (medicines for bacterial infections)

- foscarnet, ganciclovir, cidofovir (medicines for viral infections)

- amphotericin B, pentamidine (medicines for fungal infections)

- interleukin-2 (to treat cancer)

- nonsteroidal anti-inflammatory drugs (NSAIDs, to relieve bone or muscle pain).

Efavirenz/Emtricitabina/Tenofovir disoproxil Macleodsmay interact with other medicines, including herbal medicines such as Ginkgo biloba extract. This may result in the levels of this medicine or other medicines in your blood being affected. And this may prevent the medicines from working properly, or may worsen some side effects. In some cases, your doctor may need to adjust your dose or check blood levels.It is essential to inform your doctor or pharmacist if you are taking some of the following:

-Medicines that contain didanosine (for HIV infection):Taking this medicine with other antiviral medicines that contain didanosine may increase didanosine levels in your blood and reduce CD4 cell counts. When taken together, medicines that contain tenofovir disoproxil and didanosine have been associated with rare cases of pancreatitis and lactic acidosis (excess lactic acid in the blood) in some cases, fatal. Your doctor will carefully consider whether to treat you with medicines that contain tenofovir and didanosine.

-Other medicines used to treat HIV infection:the following protease inhibitors: darunavir, indinavir, lopinavir/ritonavir, ritonavir, or atazanavir boosted with ritonavir or saquinavir. Your doctor may consider prescribing a different medicine or adjusting the dose of the protease inhibitors. Also, inform your doctor if you are taking maraviroc.

-Medicines used to treat hepatitis C infection:elbasvir/grazoprevir, glecaprevir/pibrentasvir, sofosbuvir/velpatasvir, sofosbuvir/velpatasvir/voxilaprevir.

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

-Medicines used to treat seizures/convulsions (anticonvulsants):carbamazepine, phenytoin, phenobarbital.Efavirenz/Emtricitabina/Tenofovir disoproxil Macleodsmay reduce the amount of anticonvulsant in your blood. Carbamazepine may reduce the amount of efavirenz, one of the components of this medicine, in your blood. Your doctor may need to consider prescribing a different anticonvulsant.

-Medicines used to treat bacterial infections,including tuberculosis and Mycobacterium avium complex (MAC) related to AIDS: clarithromycin, rifabutin, rifampicin. Your doctor may need to consider adjusting the dose or prescribing an alternative antibiotic. Additionally, your doctor may consider prescribing an additional dose of efavirenz to treat your HIV infection.

-Medicines used to treat fungal infections (antimycotics):itraconazole or posaconazole. This medicine may reduce the amount of itraconazole or posaconazole in your blood. Your doctor may need to consider prescribing a different antimycotic.

-Medicines used to treat malaria:atovaquone/proguanil or artemether/lumefantrine. This medicine may reduce the amount of atovaquone/proguanil or artemether/lumefantrine in your blood.

-Contraceptive hormones, such as birth control pills, an injectable contraceptive (e.g., Depo-Provera), or an implantable contraceptive (e.g., Implanon):You should also use a reliable barrier contraceptive method (seePregnancy and breastfeeding).Efavirenz/Emtricitabina/Tenofovir disoproxil Macleodsmay affect the functioning of hormonal contraceptives. Cases of pregnancy have been reported in women taking efavirenz, a component of this medicine, while using an implantable contraceptive, although it has not been established that treatment with efavirenz was the cause of contraceptive failure.

-Sertraline, a medicine used to treat depression, as your doctor may need to adjust the dose of sertraline.

-Bupropion, a medicine used to treat depression or to help you quit smoking, as your doctor may need to adjust the dose of bupropion.

-Diltiazem or similar medicines (called calcium channel blockers):When you start treatment with this medicine, your doctor will need to adjust the dose of the calcium channel blocker.

-Medicines used to prevent organ rejection after transplantation (also called immunosuppressants)such as ciclosporin, sirolimus, or tacrolimus. Both when you startyour treatment with this medicine and when you stop it, your doctor will closely monitor your plasma levels of the immunosuppressant, possibly adjusting the dose you receive.

-Warfarin or acenocoumarol(medicines used to reduce blood clotting): your doctor may need to adjust your dose of warfarin or acenocoumarol.

- Ginkgo biloba extract(herbal medicine).

-Metamizol, a medicine used to treat pain and fever

- Praziquantel,a medicine used to treat parasitic infections.

Pregnancy and breastfeeding

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

Women should not become pregnant during treatment withEfavirenz/Emtricitabina/Tenofovir disoproxil Macleodsor in the 12 weeks following. Your doctor may ask you to have a pregnancy test to ensure that you are not pregnant before starting treatment with this medicine.

If you may become pregnant while receivingEfavirenz/Emtricitabina/Tenofovir disoproxil Macleods, you should use a reliable barrier contraceptive method (e.g., a condom) together with other methods of contraception, including oral contraceptives or other hormonal contraceptives (e.g., implants, injections). Efavirenz, one of the active ingredients in this medicine, may remain in your blood for a time after stopping treatment. Therefore, you should continue using contraceptive methods, as indicated above, for 12 weeks after stopping this medicine.

Inform your doctor immediately if you are pregnant or intend to become pregnant. If you are pregnant, you should only takeEfavirenz/Emtricitabina/Tenofovir disoproxil Macleodsif both you and your doctor decide that it is clearly necessary.

Severe birth defects have been observed in animal fetuses and human newborns of women treated with efavirenz during pregnancy.

Consult your doctor or pharmacist before using any medicine.

If you have takenEfavirenz/Emtricitabina/Tenofovir disoproxil Macleodsduring your pregnancy, your doctor may ask you to have periodic blood tests and other diagnostic tests to monitor your child's development. In children whose mothers took ITINNs during pregnancy, the benefit of HIV protection was greater than the risk of adverse effects.

Do not breastfeed your child during treatment withEfavirenz/Emtricitabina/Tenofovir disoproxil Macleods.Both HIV and the ingredients in this medicine may pass into breast milk and cause severe harm to the baby.

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

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

Driving and operating machinery

Efavirenz/Emtricitabina/Tenofovir disoproxil Macleodsmay cause dizziness, concentration problems, and somnolence.If you are affected, do not drive and do not operate tools or machinery.

Efavirenz/Emtricitabina/Tenofovir disoproxilcontains sodium

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

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is:

One tablet per day, taken orally. Efavirenz/Emtricitabina/Tenofovir disoproxilo Macleods should be taken with an empty stomach (usually defined as one hour before or two hours after a meal) preferably at bedtime. This may make some of the adverse effects (e.g., dizziness, drowsiness) less problematic. Swallow this medication whole with a glass of water.

Efavirenz/Emtricitabina/Tenofovir disoproxilo Macleods should be taken daily.

If your doctor decides to discontinue one of the components of this medication, they may give you efavirenz, emtricitabina, and/or tenofovir disoproxilo separately or with other medications for the treatment of HIV infection.

If you take more Efavirenz/Emtricitabina/Tenofovir disoproxilo Macleods than you should

If you accidentally take too many tablets of Efavirenz/Emtricitabina/Tenofovir disoproxilo Macleods, you may be at a higher risk of experiencing possible adverse effects with this medication (see section 4, Possible Adverse Effects). If you have taken more Efavirenz/Emtricitabina/Tenofovir disoproxilo Macleods than you should, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount used.

If you forgot to take Efavirenz/Emtricitabina/Tenofovir disoproxilo Macleods

It is essential that you do not forget a dose of Efavirenz/Emtricitabina/Tenofovir disoproxilo Macleods.

If you forget a dose of Efavirenz/Emtricitabina/Tenofovir disoproxilo in the 12-hour period since when you normally take it, take it as soon as possible, and then take your next dose at your usual time.

If it is almost time for your next dose (less than 12 hours),do not take the missed dose. Wait and take the next dose at your usual time. Do not take a double dose to compensate for the missed doses.

If you vomit the tablet (within 1 hour after taking Efavirenz/Emtricitabina/Tenofovir disoproxilo Macleods),you should take another tablet. Do not wait until the time to take the next dose. You do not need to take another tablet if you vomited more than one hour after taking this medication.

If you interrupt the treatment with Efavirenz/Emtricitabina/Tenofovir disoproxilodisoproxiloMacleods

Do not interrupt the treatment with Efavirenz/Emtricitabina/Tenofovir disoproxilo without speaking with your doctor first.The interruption of treatment with this medication may severely affect your response to future treatments. If you interrupt the treatment with this medication, consult with your doctor before restarting the tablets of this medication. Your doctor may consider administering the components of this medication separately if you have problems or if you need to adjust your dose.

When your supplies of Efavirenz/Emtricitabina/Tenofovir disoproxilo Macleods start to run out, request more from your doctor or pharmacist. This is extremely important, because the amount of virus will start to proliferate if you stop taking the medication, even for a short period. In this case, the virus may become more difficult to treat.

If you have HIV and hepatitis B infection at the same time,it is especially important not to discontinue your treatment with Efavirenz/Emtricitabina/Tenofovir disoproxilo without speaking with your doctor first. Some patients have had blood tests or symptoms indicating that their hepatitis had worsened after discontinuing emtricitabina or tenofovir disoproxilo (two of the three components of this medication). If you discontinue treatment with this medication, your doctor may recommend that you resume hepatitis B treatment. You may need blood tests to check liver function in the four months following treatment discontinuation. In some patients with advanced liver disease or cirrhosis, it is not recommended to discontinue treatment, as this may lead to worsening of hepatitis, which may put your life at risk.

→ Talk to your doctor immediately about new or unusual symptoms after discontinuing treatment, particularly symptoms you associate with hepatitis B virus infection.

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

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

Like all medications, this medication can produce side effects, although not everyone will experience them.

Severe side effects: report to your doctor immediately

Lactic acidosis (excess lactic acid in the blood) is a rare but severe side effect (can affect up to 1 in 1,000 patients) that can be fatal. The following side effects may be signs of lactic acidosis:

- Deep and rapid breathing

- Drowsiness

- Nausea, vomiting, and stomach pain

?If you think you may have lactic acidosis, contact your doctor immediately.

Other possible severe side effects

Rare (can affect up to 1 in 100 patients):

• Allergic reaction (hypersensitivity) that can cause severe skin reactions (Stevens-Johnson syndrome, erythema multiforme, see section 2)
• Swelling of the face, lips, tongue, or throat
• Aggression, suicidal thoughts, abnormal thoughts, paranoia, inability to think clearly, mood changes, visual or auditory hallucinations, suicidal attempts, personality modification (psychosis), catatonia (a condition in which the patient becomes immobile and unable to speak for a time)
• Abdominal pain (stomach) caused by pancreatitis inflammation
• Forgetfulness, confusion, spasms (convulsions), incoherent speech, tremors
• Yellow skin or eyes, itching, or abdominal pain (stomach) caused by liver inflammation
• Kidney tubule damage

Side effects in addition to those mentioned above include delusions (false beliefs), neurosis. Some patients have committed suicide. These problems tend to occur more often in those with a history of mental illness. Always report these symptoms to your doctor immediately.

Side effects for the liver: If you are also infected with the hepatitis B virus, you may experience a worsening of hepatitis after stopping treatment (see section 3).

Rare (can affect up to 1 in 1,000 patients):

• Liver failure, which in some cases leads to death or liver transplant. Most cases occurred in patients with pre-existing liver disease, but there have been some reports in patients without previous liver disease
• Renal inflammation, increased urine volume, and sensation of thirst
• Back pain due to renal problems, including renal failure. Your doctor may perform blood tests to see if your kidneys are functioning properly.
• Weakening of the bones (with bone pain and sometimes ending in fractures) that can occur due to damage to kidney tubule cells
• Fatty liver

If you think you may have any of these severe side effects, talk to your doctor.

More frequent side effects

Very frequent (can affect more than 1 in 10 patients):

• Dizziness, headache, diarrhea, feeling unwell (nausea), vomiting
• Rashes (including red spots or blisters sometimes with skin swelling), which can be allergic reactions
• Weakness

Tests may also show:

• Decreased phosphorus levels in the blood
• Increased creatinine kinase levels in the blood that can cause muscle pain and weakness

Other possible side effects

Frequent (can affect up to 1 in 10 patients):

• Allergic reactions
• Balance and coordination disorders
• Feeling anxious or depressed
• Difficulty sleeping, abnormal dreams, difficulty concentrating, drowsiness
• Pain, stomach pain
• Digestive problems with discomfort after meals, feeling bloated (gas), gas (flatulence)
• Loss of appetite
• Fatigue
• Itching
• Changes in skin color such as darkening of the skin in patches, often starting on the hands and feet.

Tests may also show:

• Low white blood cell count (a reduced white blood cell count can make you more prone to infections)
• Problems with the liver and pancreas
• Increased triglycerides, bilirubin, or blood sugar levels

Rare (can affect up to 1 in 100 patients):

• Muscle rupture, muscle pain, muscle weakness
• Anemia (low red blood cell count)
• Sensation of spinning or moving to the sides (vertigo), ringing, buzzing, or other persistent sounds in the ears
• Blurred vision
• Chills
• Enlargement of the breasts in men
• Loss of sexual appetite
• Flush
• Dry mouth
• Increased appetite

Tests may also show:

• Decreased potassium levels in the blood
• Increased creatinine in the blood
• Proteins in the urine
• Increased cholesterol in the blood

In the case of damage to kidney tubule cells, muscle rupture, bone weakening (with bone pain and sometimes ending in fractures), muscle pain, muscle weakness, and decreased potassium or phosphate levels in the blood may occur.

Rare (can affect up to 1 in 1,000 patients):

• Rash with itching, caused by a reaction to sunlight

Reporting 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 prospectus. You can also report them directly through the Spanish System for the Vigilance of Medicinal Products for Human Use https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

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

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

Do not store at a temperature above 30°C

After the first opening of the bottle, use within 90 days

Medicines should not be thrown into the drains or trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment

Composition ofEfavirenz/Emtricitabina/Tenofovir disoproxilo Macleods

- The active principles are efavirenz, emtricitabina, and tenofovir disoproxilo. Each film-coated tablet contains 600 mg of efavirenz, 200 mg of emtricitabina, and 245 mg of tenofovir disoproxilo (as fumarate).

- The other components in the tablet are microcrystalline cellulose, sodium croscarmellose, hydroxypropyl cellulose, sodium lauryl sulfate, magnesium stearate, pregelatinized cornstarch,isopropyl alcohol.

- The other components of the film coating of the tablet are partially hydrolyzed polyvinyl alcohol, titanium dioxide(E171), macrogol, talc(E553b), red iron oxide(E172), and black iron oxide(E172).

Appearance of the product and contents of the package

Efavirenz/Emtricitabina/Tenofovir disoproxilo Macleods are pink film-coated tablets in capsule shape, biconvex,marked on one face with “CL 81” and smooth on the other.

Efavirenz/Emtricitabina/Tenofovir disoproxilo Macleodscomes in bottles of 30 and 90 tablets with a silica gel sachet. The silica gel should not be swallowed.

This medication is available in the following sizes: bottles of 30 (1 bottle of 30 film-coated tablets) and 90 (3 bottles of 30 film-coated tablets) film-coated tablets.

This medication is also available in unit dose blister packaging.

Unit dose blister packaging: 30 and 90 film-coated tablets

Only some sizes of packaging may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Macleods Pharma España S.L.U.

Avenida Diagonal, 409, 1st Floor

08008 Barcelona

Spain

Responsible for manufacturing

Synoptis Industrial SP.Z.O.O.

ul. Rabowicka 15

62020 Swarzedz

Poland

O

Heumann Pharma GmbH & Co.Generica KG,

Suedwestpark 50

90449 Nuremberg

Germany

Last review date of this leaflet: June 2024

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