EFAVIRENZ/EMTRICITABINE/TENOFOVIR DISOPROXIL MACLEODS 600 mg/200 mg/245 mg FILM-COATED TABLETS

Introduction

Package Leaflet:information for the user

Efavirenz/Emtricitabine/Tenofovir disoproxil Macleods

600 mg/200 mg/245 mg film-coated tablets EFG

Efavirenz/Emtricitabine/Tenofovir disoproxil

Read all of 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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Efavirenz/Emtricitabine/Tenofovir disoproxil Macleods and what is it used for
2. What you need to know before you take Efavirenz/Emtricitabine/Tenofovir disoproxil Macleods
3. How to take Efavirenz/Emtricitabine/Tenofovir disoproxil Macleods
4. Possible side effects

5 Storage of Efavirenz/Emtricitabine/Tenofovir disoproxil Macleods

1. Package contents and additional information

1. What is Efavirenz/Emtricitabine/Tenofovir disoproxil Macleods and what is it used for

Efavirenz/Emtricitabine/Tenofovir disoproxil Macleodscontains three active substancesthat 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 substances is also known as antiretroviral medicines, they work by interfering with the normal working of an enzyme (reverse transcriptase) that is essential for the virus to multiply.

Efavirenz/Emtricitabine/Tenofovir disoproxil Macleodsis a treatment for human immunodeficiency virus (HIV) infectionin adults aged 18 years or older who have been previously treated with other antiretroviral medicines and have a controlled HIV-1 infection for at least three months. Patients should not have experienced failure of a previous HIV infection treatment.

2. What you need to know before starting to take Efavirenz/Emtricitabine/Tenofovir disoproxil Macleods

Do not takeEfavirenz/Emtricitabine/Tenofovir disoproxil Macleods:

• if you are allergic to efavirenz, emtricitabine, tenofovir, tenofovir disoproxil, or any of the other components of this medicine (listed in section 6).

• if you have severe liver disease.

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

• if any of your family members (parents, grandparents, brothers, or sisters) have died suddenly due to 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 taking any of the following medications (see also "Other medications and Efavirenz/Emtricitabine/Tenofovir disoproxil Macleods"):

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

• bepridil (used to treat heart disease)
• cisapride (used to treat heartburn)
• elbasvir/grazoprevir (used to treat hepatitis C)
• ergot alkaloids (e.g., ergotamine, dihydroergotamine, ergonovine, and methylergonovine) (used to treat migraines and histamine headaches)
• midazolam or triazolam (used to help you sleep)
• pimozide, imipramine, amitriptyline, or clomipramine (used to treat certain mental problems)
• St. John's Wort (Hypericum perforatum) (a herbal medicine used to treat depression and anxiety)
• voriconazole (used to treat fungal infections)
• flecainide, metoprolol (used to treat irregular heartbeats)
• certain antibiotics (macrolides, fluoroquinolones, imidazoles)
• triazole antifungals
• certain antimalarials
• methadone (used to treat opioid addiction).

If you are taking any of these medications, inform your doctor immediately.Taking these medications with Efavirenz/Emtricitabine/Tenofovir disoproxil Macleods could cause serious and/or potentially life-threatening side effects or could cause these medications 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 have infections or other illnesses associated with HIV infection.

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

• Tell your doctor:

• If you are taking other medications that contain efavirenz, emtricitabine, tenofovir disoproxil, tenofovir alafenamide, lamivudine, or adefovir dipivoxil. You must not take this medicine with any of these medications.

• If you have or have had kidney disease, or if 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 your kidney function. Your doctor may also ask you to have blood tests during treatment to monitor your kidneys.

This medicine is not normally taken with other medications that can harm your kidneys (see Taking Efavirenz/Emtricitabine/Tenofovir disoproxil Macleods with other medications). If this is unavoidable, your doctor will monitor your kidney function once a week.

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

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

• If you have a history of seizures (fits or attacks) or if you are being treated with anticonvulsant therapy such as carbamazepine, phenobarbital, 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 you take Efavirenz/Emtricitabine/Tenofovir disoproxil Macleods. Your doctor may prescribe a different anticonvulsant.

• If you have a history of liver disease, including chronic active 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 or change you to another medicine. If you have severe liver disease, do not take Efavirenz/Emtricitabine/Tenofovir disoproxil Macleods (see above, in section 2, Do not take Efavirenz/Emtricitabine/Tenofovir disoproxil Macleods).

If you have a 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, show some activity against the hepatitis B virus, although emtricitabine is not authorized for the treatment of hepatitis B infection. Your hepatitis symptoms may worsen after stopping this medicine. Your doctor may perform blood tests at regular intervals to monitor your liver (see section 3, If you stop treatment with Efavirenz/Emtricitabine/Tenofovir disoproxil Macleods).

• Regardless of whether you have a history of liver disease, your doctor will consider regular blood tests to monitor your liver.

• 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 taking Efavirenz/Emtricitabine/Tenofovir disoproxil Macleods, be aware of:

• Signs of dizziness, difficulty sleeping, drowsiness, difficulty concentrating, or abnormal dreams. These side effects may start 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 notice any sign of a severe skin rash with blisters or fever, stop taking Efavirenz/Emtricitabine/Tenofovir disoproxil Macleods and inform your doctor immediately. If you have had a skin rash while taking another NNRTI, you may have a 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, signs and symptoms of inflammation of previous infections may appear soon after starting anti-HIV treatment. It is believed that these symptoms are due to an improvement in the body's immune response, allowing it to fight infections that were present without any apparent symptoms. If you notice any symptoms of infection, please 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 for the treatment of your 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 that starts in the hands and feet and moves up towards the trunk of the body, palpitations, tremors, or hyperactivity, inform your doctor immediately to receive the necessary treatment.

• Bone problems. Some patients who receive 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.

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

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

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

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

Children and adolescents

• Do not administer Efavirenz/Emtricitabine/Tenofovir disoproxil Macleods to children and adolescents under 18 years of age. The use of this medicine in children and adolescents has not been studied.

Other medications and Efavirenz/Emtricitabine/Tenofovir disoproxil Macleods

Do not take Efavirenz/Emtricitabine/Tenofovir disoproxil Macleods with certain medications.These are listed under Do not take Efavirenz/Emtricitabine/Tenofovir disoproxil Macleods, at the beginning of section 2. These include some common medications and some herbal medicines (including St. John's Wort) that can cause serious interactions.

Tell your doctoror pharmacist if you are taking, have recently taken, or might take any other medication.

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

Tell your doctorif you are taking other medications that may harm your kidneys. Some examples include:

• aminoglycosides, vancomycin (medications for bacterial infections)
• foscarnet, ganciclovir, cidofovir (medications for viral infections)
• amphotericin B, pentamidine (medications for fungal infections)
• interleukin-2 (for cancer treatment)
• non-steroidal anti-inflammatory drugs (NSAIDs, for bone or muscle pain relief).

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

• Medications that contain didanosine (for HIV infection): taking this medicine with other antiviral medications that contain didanosine may increase the levels of didanosine in your blood and may reduce the CD4 cell count. When medications that contain tenofovir disoproxil and didanosine are taken together, rare cases of pancreatitis and lactic acidosis (excess lactic acid in the blood) have been reported, sometimes fatally. Your doctor will carefully consider whether to treat you with medications that contain tenofovir and didanosine.
• Other medications used for HIV infection: the following protease inhibitors: darunavir, indinavir, lopinavir/ritonavir, ritonavir, or atazanavir boosted by ritonavir or saquinavir. Your doctor may consider prescribing a different medication or changing the dose of the protease inhibitors. Also, inform your doctor if you are taking maraviroc.
• Medications used for the treatment of hepatitis C virus infection: elbasvir/grazoprevir, glecaprevir/pibrentasvir, sofosbuvir/velpatasvir, sofosbuvir/velpatasvir/voxilaprevir.
• Medications used to lower fat in the blood (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 changing the dose of the statin if necessary.
• Medications used for the treatment of seizures/attacks (anticonvulsants): carbamazepine, phenytoin, phenobarbital. Efavirenz/Emtricitabine/Tenofovir disoproxil Macleods may 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.
• Medications used for the treatment of bacterial infections, including tuberculosis and Mycobacterium avium complex related to AIDS: clarithromycin, rifabutin, rifampicin. Your doctor may need to consider changing the dose or prescribing an alternative antibiotic. Additionally, your doctor may consider prescribing an additional dose of efavirenz to treat your HIV infection.
• Medications 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.
• Medications used to treat malaria: atovaquone/proguanil or artemether/lumefantrine. This medicine may reduce the amount of atovaquone/proguanil or artemether/lumefantrine in your blood.
• Hormonal contraceptives, such as birth control pills, an injectable contraceptive (e.g., Depo-Provera), or a contraceptive implant (e.g., Implanon): you must also use a reliable barrier contraceptive method (see Pregnancy and breastfeeding). Efavirenz/Emtricitabine/Tenofovir disoproxil Macleods may affect the functioning of hormonal contraceptives. Cases of pregnancy have been reported in women taking efavirenz, one of the components of this medicine, while using a contraceptive implant, although it has not been established that treatment with efavirenz was the cause of the contraceptive failure.
• Sertraline, a medication used to treat depression, as your doctor may need to change the dose of sertraline.
• Bupropion, a medication used to treat depression or to help you stop smoking, as your doctor may need to change the dose of bupropion.
• Diltiazem or similar medications (called calcium antagonists): when you start treatment with this medicine, your doctor will need to adjust the dose of the calcium antagonist.
• Medications used to prevent organ rejection after transplantation (also called immunosuppressants) such as cyclosporine, sirolimus, or tacrolimus. Both when you start treatment with this medicine and when you stop it, your doctor will closely monitor your immunosuppressant levels and may need to adjust the dose you receive.
• Warfarin or acenocoumarol (medications used to reduce blood clotting): your doctor may need to adjust your dose of warfarin or acenocoumarol.
• Ginkgo biloba extracts (a herbal medicine).
• Metamizole, a medication used to treat pain and fever.
• Praziquantel, a medication used to treat parasitic infections.

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/Emtricitabine/Tenofovir disoproxil Macleods or in the 12 weeks after stopping treatment.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 could become pregnant while taking Efavirenz/Emtricitabine/Tenofovir disoproxil Macleods, you must use a reliable barrier contraceptive method (e.g., a condom) in addition to other contraceptive methods, including oral contraceptives or other hormonal contraceptives (e.g., implants, injections). Efavirenz, one of the components of this medicine, may remain in your blood for some time after stopping treatment. Therefore, you must continue to use contraceptive measures, as described above, for 12 weeks after stopping this medicine.

Inform your doctor immediately if you are pregnant or plan to become pregnant.If you are pregnant, you should only take Efavirenz/Emtricitabine/Tenofovir disoproxil Macleods if you and your doctor decide that it is clearly necessary.

Severe birth defects have been observed in animal offspring and in human newborns of mothers who were treated with efavirenz during pregnancy.

Consult your doctor or pharmacist before using any medication.

If you have taken Efavirenz/Emtricitabine/Tenofovir disoproxil Macleods during pregnancy, your doctor may ask you to have regular blood tests and other diagnostic tests to monitor the development of your child. In children whose mothers took NNRTIs during pregnancy, the benefit of protection against HIV must be weighed against the potential risks.

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

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, orally. Efavirenz/Emtricitabina/Tenofovir disoproxil Macleods should be taken on 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 (such as dizziness, drowsiness) less problematic. Swallow this medication whole with a glass of water.

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

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

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

If you accidentally take too many tablets of Efavirenz/Emtricitabina/Tenofovir disoproxil 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 disoproxil Macleods than you should, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount used.

If you forget to take Efavirenz/Emtricitabina/Tenofovir disoproxil Macleods

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

If you forget a dose of Efavirenz/Emtricitabina/Tenofovir disoproxil within 12 hours of when you normally take it, take it as soon as you can, 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 make up for missed doses.

If you vomit the tablet (within 1 hour after taking Efavirenz/Emtricitabina/Tenofovir disoproxil 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 treatment with Efavirenz/Emtricitabina/Tenofovir disoproxil Macleods

Do not interrupt treatment with Efavirenz/Emtricitabina/Tenofovir disoproxil without speaking to your doctor first.Interrupting treatment with this medication can seriously affect your response to future treatments. If you interrupt treatment with this medication, consult your doctor before restarting the tablets. Your doctor may consider administering the components of this medication separately if you have problems or if your dose needs to be adjusted.

When your supply of Efavirenz/Emtricitabina/Tenofovir disoproxil Macleods starts to run out, request more from your doctor or pharmacist. This is extremely important because the amount of virus will start to multiply if you stop taking the medication, even if it's for a short time. In this case, the virus may become more difficult to treat.

If you have both HIV and hepatitis B infection at the same time, it is especially important not to stop your treatment with Efavirenz/Emtricitabina/Tenofovir disoproxil without first talking to your doctor. Some patients have had blood tests or symptoms indicating that their hepatitis had worsened after stopping emtricitabine or tenofovir disoproxil (two of the three components of this medication). If you stop 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 stop treatment since this can cause worsening of hepatitis, which can be life-threatening.

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

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

4. Possible adverse effects

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.

Like all medications, this medication can cause adverse effects, although not all people experience them.

Possible serious adverse effects: inform your doctor immediately

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

Uncommon(may 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 alteration, vision or hearing things that are not really there (hallucinations), suicide attempts, personality change (psychosis), catatonia (a condition in which the patient remains immobile and unable to speak for a period of time)
• abdominal pain (stomach) caused by pancreas inflammation
• forgetfulness, confusion, seizures (convulsions), incoherent speech, tremors (shaking)
• yellow skin or eyes, itching, or abdominal pain (stomach) caused by liver inflammation
• kidney tubule damage

Psychiatric adverse 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 inform your doctor immediately if you present these symptoms.

Adverse effects on the liver: if you are also infected with the hepatitis B virus, you may experience worsening of hepatitis after stopping treatment (see section 3).

Rare(may 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 who already had liver disease, but there have been some reports in patients without prior liver disease
• kidney inflammation, increased urine volume, and feeling of thirst
• back pain due to kidney problems, including kidney failure. Your doctor may perform blood tests to see if your kidneys are working properly
• weakening of the bones (with bone pain and which sometimes ends in fractures) that can occur due to damage to the kidney tubule cells
• fatty liver

If you think you may have any of these serious adverse effects, talk to your doctor.

More frequent adverse effects

Very common(may affect more than 1 in 10 patients):

• dizziness, headache, diarrhea, feeling of discomfort (nausea), vomiting
• rash (including red spots or pimples sometimes with blisters and skin swelling), which can be allergic reactions
• weakness

Tests may also show:

• decrease in blood phosphate levels
• increased creatine kinase levels in the blood, which can cause muscle pain and weakness

Other possible adverse effects

Common(may affect up to 1 in 10 patients):

• allergic reactions
• balance and coordination disorders
• feeling of worry or depression
• difficulty sleeping, abnormal dreams, difficulty concentrating, drowsiness
• pain, stomach pain
• digestive problems with discomfort after meals, feeling bloated (gases), 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 soles of the feet

Tests may also show:

• low white blood cell count (a reduced number of white blood cells can make you more prone to infections)
• liver and pancreas problems
• increased fatty acids (triglycerides), bilirubin, or blood sugar levels

Uncommon(may affect up to 1 in 100 patients):

• muscle rupture, muscle pain, muscle weakness
• anemia (low red blood cell count)
• feeling of spinning or moving to the sides (vertigo), ringing, buzzing, or other persistent noises in the ears
• blurred vision
• chills
• breast enlargement in men
• loss of sexual appetite
• flushing
• dry mouth
• increased appetite

Tests may also show:

• decrease in blood potassium levels
• increase in blood creatinine levels
• protein in the urine
• increase in blood cholesterol levels

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

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

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

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 leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Efavirenz/Emtricitabina/Tenofovir disoproxil Macleods

Keep this medication out of sight and reach of children.

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

Do not store above 30°C

After opening the bottle, use within 90 days

Medications should not be thrown away in drains or trash. Deposit the packaging and medications you no longer need in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment

6. Package contents and additional information

Composition ofEfavirenz/Emtricitabina/Tenofovir disoproxil Macleods

• The active ingredients are efavirenz, emtricitabine, and tenofovir disoproxil. Each film-coated tablet contains 600 mg of efavirenz, 200 mg of emtricitabine, and 245 mg of tenofovir disoproxil (as fumarate).

• The other ingredients in the tablet are microcrystalline cellulose, sodium croscarmellose, hydroxypropyl cellulose, sodium lauryl sulfate, magnesium stearate, pregelatinized corn starch, isopropyl alcohol.

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

Appearance of the product and package contents

Efavirenz/Emtricitabina/Tenofovir disoproxil Macleods are film-coated tablets of pink color, capsule-shaped, biconvex, marked on one side with “CL 81” and smooth on the other.

Efavirenz/Emtricitabina/Tenofovir disoproxil Macleods come in bottles of 30 and 90 film-coated tablets with a silica gel bag. The silica gel should not be swallowed.

This medication is available in the following sizes: packages 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 a unit dose blister pack.

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

Not all package sizes may be marketed

Marketing authorization holder and manufacturer

Marketing authorization holder

Macleods Pharma España S.L.U.

Avenida Diagonal, 409, 1ª Planta

08008 Barcelona

Spain

Manufacturer

Synoptis Industrial SP.Z.O.O.

ul. Rabowicka 15

62020 Swarzedz

Poland

Or

Heumann Pharma GmbH & Co. Generica KG,

Suedwestpark 50

90449 Nuremberg

Germany

Date of last revision of this leaflet: June 2024

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/)