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

Introduction

Package Leaflet: Information for the Patient

Efavirenz/Emtricitabine/Tenofovir Disoproxil Glenmark 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 Efavirenz/Emtricitabine/Tenofovir Disoproxil Glenmark is and what it is used for
2. What you need to know before you take Efavirenz/Emtricitabine/Tenofovir Disoproxil Glenmark
3. How to take Efavirenz/Emtricitabine/Tenofovir Disoproxil Glenmark
4. Possible side effects
5. Storing Efavirenz/Emtricitabine/Tenofovir Disoproxil Glenmark
6. Package contents and further information

1. What Efavirenz/Emtricitabine/Tenofovir Disoproxil Glenmark is and what it is used for

Efavirenz/emtricitabine/tenofovir disoproxil contains three active substancesused 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 is a treatment for Human Immunodeficiency Virus(HIV) infection in adults aged 18 years or older who have been previously treated with other antiretroviral medicines and have controlled HIV-1 infection for at least three months. Patients must not have experienced failure of a previous HIV treatment.

2. What you need to know before you take Efavirenz/Emtricitabine/Tenofovir Disoproxil Glenmark

Do not take efavirenz/emtricitabine/tenofovir disoproxil if:

• you are allergicto efavirenz, emtricitabine, tenofovir, tenofovir disoproxil, or any of the other components of this medication (listed in section 6).

• you have severe liver disease

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

• if any 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.

• you are currently takingany of the following medications (see also "Other medications and efavirenz/emtricitabine/tenofovir disoproxil"):
• • astemizole or terfenadine(used to treat hay fever or other allergies),
  • bepridil(used to treat heart disease),
  • cisapride(used to treat stomach upset),
  • ergot alkaloids(e.g., ergotamine, dihydroergotamine, ergonovine, and methylergonovine) (used to treat migraines and histamine headaches),
  • midazolam or triazolam(used to facilitate 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)
  • antifungal triazoles
  • certain antimalarial agents
  • 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 may cause serious and/or potentially life-threatening side effects or may cause these medications to stop working properly.

Warnings and precautions

Consult your doctor or pharmacist before starting to take efavirenz/emtricitabine/tenofovir disoproxil.

• While taking this medication you can still transmit HIV to others,even if effective antiretroviral therapy reduces the risk. Consult your doctor about what precautions are necessary to avoid infecting others. This medication is not a cure for HIV infection. While you are taking this medication, you may still suffer from infections or other diseases associated with HIV infection.

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

• Tell your doctor:
• • If you are taking other medicationsthat contain efavirenz, emtricitabine, tenofovir disoproxil, tenofovir alafenamide, lamivudine, or adefovir dipivoxil. You must not take efavirenz/emtricitabine/tenofovir disoproxil with any of these medications.

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

This medication may affect your kidneys. Before starting treatment, your doctor may ask you for blood tests to check your kidney function. Your doctor may also ask you for blood tests during treatment to monitor your kidneys.

This medication is not normally taken with other medications that can harm your kidneys (see also "Other medications and efavirenz/emtricitabine/tenofovir disoproxil"):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 suicidal thoughts, or 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 medication in your blood to ensure that it is not affected while you take efavirenz/emtricitabine/tenofovir disoproxil. 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 medication. If you have severe liver disease, do not take efavirenz/emtricitabine/tenofovir disoproxil(see above, in section 2, Do not take Efavirenz/Emtricitabine/Tenofovir disoproxil Glenmark).

If you have a hepatitis B infection, your doctor will carefully consider the best treatment regimen for you. Tenofovir disoproxil and emtricitabine, two of the active ingredients in efavirenz/emtricitabine/tenofovir disoproxil, 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 efavirenz/emtricitabine/tenofovir disoproxil. 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 Glenmark).

• 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 of age who have been studied is insufficient. If you are over 65 years of age and have been prescribed this medication, your doctor will monitor you closely.

• Once you start taking efavirenz/emtricitabine/tenofovir disoproxil, 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 medication may cause skin rashes. If you notice any sign of a severe skin rash with blisters or fever, stop taking this medication and inform your doctor immediately. If you have had a skin rash while taking another NNRTI, you may be at higher risk of having a rash with this medication or with other medications that contain 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 may appear due to previous infections shortly 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 start taking medications for 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 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 immunosuppression, 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) may also occur due to damage to the renal tubular cells (see section 4, Possible side effects). Inform your doctor if you have bone pain or fractures.

Tenofovir disoproxil (a component of efavirenz/emtricitabine/tenofovir disoproxil) may also cause bone mass loss. The most pronounced bone loss was observed in clinical studies when patients received HIV treatment with tenofovir disoproxil in combination with a boosted protease inhibitor.

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

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

Children and adolescents

• Do not give efavirenz/emtricitabine/tenofovir disoproxil to children and adolescentsunder 18 years of age. The use of efavirenz/emtricitabine/tenofovir disoproxil in children and adolescents has not been studied.

Other medications and efavirenz/emtricitabine/tenofovir disoproxil

You must not take efavirenz/emtricitabine/tenofovir disoproxil with certain medications.These are listed under Do not take efavirenz/emtricitabine/tenofovir disoproxil, 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, you must not take efavirenz/emtricitabine/tenofovir disoproxil 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 can 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).

This medication may interact with other medications, including herbal medicines such as Ginkgo bilobaextracts. This may result in the amounts of efavirenz/emtricitabine/tenofovir disoproxil or other medications in the 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 medication 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 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:boceprevir, elbasvir/grazoprevir, simeprevir, sofosbuvir/velpatasvir, sofosbuvir/velpatasvir/voxilaprevir.

• Medications used to lower fat in the blood (also called statins):atorvastatin, pravastatin, simvastatin. This medication may reduce the amount of statins in the 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 may reduce the amount of anticonvulsant in the blood. Carbamazepine may reduce the amount of efavirenz, one of the components of this medication, in the blood. Your doctor may need to consider prescribing a different anticonvulsant.

• Medications used for the treatment of bacterial infections,including tuberculosis and Mycobacterium aviumcomplex 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. Efavirenz/emtricitabine/tenofovir disoproxil may reduce the amount of itraconazole or posaconazole in the blood. Your doctor may need to consider administering a different antimycotic.

• Medications used to treat malaria:atovaquone/proguanil or artemether/lumefantrine. This medication may reduce the amount of atovaquone/proguanil or artemether/lumefantrine in the 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 may affect the functioning of hormonal contraceptives. There have been cases of pregnancy in women taking efavirenz, a component of this medication, 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 channel blockers):when you start treatment with this medication, your doctor will need to adjust the dose of the calcium channel blocker.

• Medications used to prevent organ rejection after transplantation (also called immunosuppressants)such as cyclosporine, sirolimus, or tacrolimus. Both when you start treatment with this medication and when you stop it, your doctor will closely monitor your blood levels of the immunosuppressant 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 worm 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 medication.

Women must not become pregnant during treatment with efavirenz/emtricitabine/tenofovir disoproxil or in the 12 weeks following.Your doctor may request a pregnancy test to ensure that you are not pregnant before starting treatment with this medication.

If you could become pregnant while taking efavirenz/emtricitabine/tenofovir disoproxil, 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., an implant).

3. How to take Efavirenz/Emtricitabine/Tenofovir disoproxil Glenmark

Follow the administration instructions for this medication exactly as 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/emtricitabine/tenofovir disoproxil should be taken on an empty stomach (usually defined as one hour before or two hours after a meal) preferably when lying down. This can make some of the adverse effects (such as dizziness, drowsiness) less problematic. Swallow this medication whole with a glass of water.

Efavirenz/emtricitabine/tenofovir disoproxil should be taken daily.

If your doctor decides to suspend one of the components of efavirenz/emtricitabine/tenofovir disoproxil, 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/emtricitabine/tenofovir disoproxil than you should

If you accidentally take too many tablets of efavirenz/emtricitabine/tenofovir disoproxil, you may be at a higher risk of experiencing possible adverse effects with this medication (see section 4, Possible adverse effects). Consult your doctor or go to the nearest emergency service. Bring the tablet bottle with you so that you can easily describe what you have taken. Or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take efavirenz/emtricitabine/tenofovir disoproxil

It is important that you do not forget a dose of efavirenz/emtricitabine/tenofovir disoproxil.

If you forget a dose of efavirenz/emtricitabine/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 the 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 the 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/emtricitabine/tenofovir disoproxil),you should take another tablet. Do not wait until the time of the next dose. You do not need to take another tablet if you vomit more than 1 hour after taking this medication.

If you interrupt treatment with efavirenz/emtricitabine/tenofovir disoproxil

Do not interrupt treatment with efavirenz/emtricitabine/tenofovir disoproxil without talking to your doctor first.Stopping treatment with this medication can seriously affect your response to future treatments. If you stop treatment with this medication, consult with your doctor before resuming taking tablets of this medication. 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/emtricitabine/tenofovir disoproxil is running 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 just for a short time. In this case, the virus may become more difficult to treat.

If you have HIV and hepatitis B at the same time,it is especially important not to stop treatment with efavirenz/emtricitabine/tenofovir disoproxil without talking to your doctor first. 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 suspension. In some patients with advanced liver disease or cirrhosis, it is not recommended to stop treatment, as this can cause worsening of hepatitis, which can be life-threatening.

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

If you have any other questions about the use of this medication, consult 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.

Severe possible adverse effects: inform your doctor immediately

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

• deep and rapid breathing,
• drowsiness,
• feeling sick (nausea), being sick (vomiting), and stomach pain.

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

Other severe possible adverse effects

The following adverse effects are uncommon (they can affect up to 1 in 100 people):

• 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, vision or hearing things that are not really there (hallucinations), suicide attempts, personality changes (psychosis), catatonia (a condition in which the patient remains immobile and speechless for a period).
• abdominal pain (stomach) caused by pancreas inflammation,
• forgetfulness, confusion, seizures (convulsions), incoherent speech, tremors (shakes),
• yellow skin or eyes, itching, or stomach pain (abdomen) caused by liver inflammation,
• kidney tubule damage.

Psychiatric adverse effects, in addition to those listed above, include delusions (false beliefs), neurosis. Some patients have committed suicide. These problems tend to occur more frequently in those with a history of mental illness. Always inform your doctor immediately if you experience these symptoms.

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

The following adverse effects are rare (they 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 who already had liver disease, but there have been some reports in patients without previous 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,
• bone weakening (with bone pain and which sometimes ends in fractures) that can occur due to damage to kidney tubule cells,
• fatty liver.

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

More frequent adverse effects

The following adverse effects are very common (they can affect more than 1 in 10 people):

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

Tests may also show:

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

Other possible effects

The following adverse effects are common (they can affect up to 1 in 10 people):

• 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, 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 triglycerides, bilirubin, or blood sugar levels.

The following adverse effects are uncommon (they can affect up to 1 in 100 people):

• muscle rupture, muscle pain, muscle weakness,
• anemia (low red blood cell count),
• feeling of spinning or moving sideways (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:

• decreased potassium levels in the blood,
• increased creatinine levels in the blood,
• protein in the urine,
• increased cholesterol levels in the blood.

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

The following adverse effects are rare (they can affect up to 1 in 1,000 people):

• 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 is not listed in this leaflet.You can also report them directly through the Spanish Medicines and Health Products Surveillance System: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Conservation of Efavirenz/Emtricitabine/Tenofovir disoproxil Glenmark

Keep this medication out of sight and reach of children.

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

Do not store above 30°C.

Keep in the original packaging to protect it from moisture. Keep the bottle tightly closed.

Medications should not be thrown down the drain or into the trash. Deposit the packaging and medications you no longer need at the SIGRE Point in 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 of Efavirenz/Emtricitabine/Tenofovir disoproxil Glenmark

• The active ingredients are efavirenz, emtricitabine, and tenofovir disoproxil. Each film-coated tablet of this medication contains 600 mg of efavirenz, 200 mg of emtricitabine, and 245 mg of tenofovir disoproxil (as fumarate).
• The other components in the tablet are:

• Core: microcrystalline cellulose, sodium croscarmellose, hydroxypropyl cellulose, sodium lauryl sulfate, magnesium stearate, pregelatinized corn starch
• Coating: 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/Emtricitabine/Tenofovir disoproxil Glenmark are film-coated tablets, pink in color, capsule-shaped, biconvex, film-coated tablets with "CL 81" engraved on one side and smooth on the other side (approx. 20.3 mm x 10.7 mm).

Efavirenz/Emtricitabine/Tenofovir disoproxil Glenmark comes in a bottle of 30 or 90 tablets, which contains a silica gel desiccant. The silica gel should not be swallowed.

The following package sizes are available:

-Carton package containing 1 bottle of 30 film-coated tablets and 90 (3 bottles of 30 film-coated tablets and 1 bottle of 90 film-coated tablets) film-coated tablets.

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Glenmark Arzneimittel GmbH

Industriestr. 31

82194 Gröbenzell

Germany

Manufacturer:

Glenmark Pharmaceuticals s.r.o.

Fibichova, 143

56617 Vysoke Myto

Czech Republic

Mawdsley-Brooks Company Limited

Unit 22, Quest Park, Wheatley Hall Road

DN2 4LT Doncaster

United Kingdom

You can request more information about this medication from the local representative of the marketing authorization holder:

Glenmark Farmacéutica, S.L.U.

C/ Retama 7, 7th floor

28045 Madrid

Spain

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

Germany: Efavirenz/Emtricitabin/Tenofovirdisoproxil Glenmark 600 mg/200 mg/245mg Filmtabletten

Denmark: Efavirenz/Emtricitabine/Tenofovir disoproxil Glenmark 600 mg/200 mg/245mg filmovertrukne tabletter

Netherlands: Efavirenz/Emtricitabine/Tenofovir disoproxil Glenmark 600 mg/200 mg/245mg filmomhulde tabletten

United Kingdom: Efavirenz/Emtricitabine/Tenofovir disoproxil Glenmark 600 mg/200 mg/245mg film-coated tablets

Sweden: Efavirenz/Emtricitabine/Tenofovir disoproxil Glenmark 600 mg/200 mg/245mg filmdragerade tabletter

Date of the last revision of this leaflet:September 2022

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/