Patient Information Leaflet

Efavirenz/Emtricitabina/Tenofovir disoproxilo Glenmark 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, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet.See section 4.

Efavirenz/emtricitabina/tenofovir disoproxilo contains three active ingredientsthat are used to treat human immunodeficiency virus (HIV) infection.

• Efavirenz is a non-nucleoside reverse transcriptase inhibitor (NNRTI)
• Emtricitabina is a nucleoside reverse transcriptase inhibitor (NRTI)
• Tenofovir is a nucleotide reverse transcriptase inhibitor

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

Efavirenz/emtricitabina/tenofovir disoproxilo is a treatment for human immunodeficiency virus (HIV) infectionin adults 18 years of age or older who 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.

No take efavirenz/emtricitabina/tenofovir disoproxil if:

• You are allergic to: efavirenz, emtricitabina, 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 a prolonged QT interval that puts you at high risk of serious heart rhythm problems (Torsade de Pointes).

• If a family member (parents, grandparents, siblings, or children) 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 taking: any of the following medications (see also "Other medications and efavirenz/emtricitabina/tenofovir disoproxil"):
• astemizol or terfenadine: (used to treat hay fever or other allergies),
• bepridil: (used to treat heart diseases),
• cisaprida: (used to treat heartburn),
• alcaloides del cornezuelo: (such as ergotamine, dihidroergotamina, ergonovina, and metilergonovina) (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),
• hierba de San Juan (Hipérico): (Hypericum perforatum) (herbal medicine used to treat depression and anxiety),
• voriconazol: (used to treat fungal infections).
• flecainida, metoprolol: (used to treat irregular heartbeats)
• Certain antibiotics: (macrólidos, fluoroquinolonas, imidazol)
• Triazol antifungals:
• Certain antimalarials:
• metadona: (used to treat opioid addiction)

? If you are taking any of these medications, inform your doctor immediately. Taking these medications with efavirenz/emtricitabina/tenofovir disoproxil may produce severe and/or potentially fatal side effects or may cause these medications to stop working correctly.

Warnings and precautions:

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

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

• While taking this medication, you must remain under your doctor's supervision.

• Inform your doctor:
• If you are taking other medications, including those that contain efavirenz, emtricitabina, tenofovir disoproxil, tenofovir alafenamida, lamivudina, or adefovir dipivoxil. Do not take efavirenz/emtricitabina/tenofovir disoproxil with any of these medications.

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

This medication is usually not taken with other medications that can damage your kidneys (see also "Other medications and efavirenz/emtricitabina/tenofovir disoproxil"): If this is unavoidable, your doctor will monitor your kidney function once a week.

• If you have a heart condition, such as a prolonged QT interval.

• 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, "Possible side effects").

• If you have a history of seizures (convulsions or fits) or if you are being treated with anticonvulsant therapy, such as carbamazepina, fenobarbital, and fenitoína. If you are taking any of these medications, your doctor may need to check the level of anticonvulsant medication in your blood to ensure it is not affected while taking efavirenz/emtricitabina/tenofovir disoproxil. Your doctor may prescribe a different anticonvulsant medication.

• If you have a history of liver disease, including active chronic hepatitis. Patients with liver disease, including chronic hepatitis B or C, treated with combined antiretrovirals, have a higher risk of severe and potentially fatal liver complications. Your doctor may perform blood tests to monitor your liver function or switch you to a different medication. If you have severe liver disease, do not take efavirenz/emtricitabina/tenofovir disoproxil (see before, in section 2, "Do not take Efavirenz/Emtricitabina/Tenofovir disoproxil Glenmark").

If you have hepatitis B infection, your doctor will carefully consider the best treatment regimen for you. Tenofovir disoproxil and emtricitabina, two of the active ingredients in efavirenz/emtricitabina/tenofovir disoproxil, have some activity against the hepatitis B virus, although emtricitabina is not authorized for the treatment of hepatitis B infection. Your liver symptoms may worsen after stopping efavirenz/emtricitabina/tenofovir disoproxil. 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 Glenmark").

• 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 medication, your doctor will monitor you closely.

• Once you start taking efavirenz/emtricitabina/tenofovir disoproxil, be aware 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.

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 HIV treatment. 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 (manifesting as persistent bone pain or worsening, which sometimes end in fractures) may also occur due to damage to 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/emtricitabina/tenofovir) may also cause bone loss. The most pronounced bone loss was observed in clinical studies when patients received HIV treatment with tenofovir disoproxil in combination with a protease inhibitor booster.

The long-term effects of tenofovir disoproxil on 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 are at higher risk of fractures.

Children and adolescents:

• Do not give efavirenz/emtricitabina/tenofovir disoproxil to children and adolescents under 18 years old. The use of efavirenz/emtricitabina/tenofovir disoproxil in children and adolescents has not yet been studied.

Other medications and efavirenz/emtricitabina/tenofovir disoproxil:

Do not take efavirenz/emtricitabina/tenofovir disoproxil with certain medications. These are listed under "Do not take efavirenz/emtricitabina/tenofovir disoproxil" at the beginning of section 2. Among these are some common medications and some herbal medicines (including St. John's Wort) that may cause serious interactions.

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

Additionally, do not take efavirenz/emtricitabina/tenofovir disoproxil with any other medication that contains efavirenz (unless your doctor recommends it), emtricitabina, tenofovir disoproxil, tenofovir alafenamida, lamivudina, or adefovir dipivoxil.

Inform your doctor if you are taking other medications that may damage your kidneys. Examples include:

• aminoglucósidos, vancomicina (medications for bacterial infections),
• foscarnet, ganciclovir, cidofovir (medications for viral infections),
• amfotericina B, pentamidina (medications for fungal infections),
• interleucina-2 (for cancer treatment),
• antiinflamatorios no esteroideos (AINE, for relieving bone or muscle pain).

This medication may interact with other medications, including herbal medicines such as Ginkgo biloba extracts. This may result in the affected levels of efavirenz/emtricitabina/tenofovir disoproxil or other medications in the blood. This may prevent medications 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:

• Medications that contain didanosina (for HIV infection): Taking this medication with other antiviral medications that contain didanosina may increase didanosina levels in your blood and reduce CD4 cell counts. When taken concomitantly with medications that contain tenofovir disoproxil and didanosina, rare cases of pancreatitis and lactic acidosis (excess lactic acid in the blood) have been reported in some cases. Your doctor will consider whether to treat you with medications that contain tenofovir and didanosina.

• Other medications used for 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 medication or adjusting the dose of protease inhibitors. Also, inform your doctor if you are taking maraviroc.

• Medications used for the treatment of hepatitis C infection: boceprevir, elbasvir/grazoprevir, simeprevir, sofosbuvir/velpatasvir, sofosbuvir/velpatasvir/voxilaprevir.

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

• Medications used for seizure/attack (anticonvulsants): carbamazepina, fenitoína, fenobarbital. Efavirenz/emtricitabina/tenofovir disoproxil may reduce the amount of anticonvulsant medication in the blood. Carbamazepina 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 medication.

• Medications used for bacterial infections, including tuberculosis and Mycobacterium avium complex related to AIDS: claritromicina, rifabutina, rifampicina. 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.

• Medications used to treat fungal infections (antimicotics): itraconazol or posaconazol. Efavirenz/emtricitabina/tenofovir disoproxil may reduce the amount of itraconazol or posaconazol in the blood. Your doctor may need to consider administering a different antimicotic medication.

• Medications used to treat malaria: atovacuona/proguanil or arteméter/lumefantrina. This medication may reduce the amount of atovacuona/proguanil or arteméter/lumefantrina in the blood.

• Anticonceptivo hormonal, como píldoras de control de natalidad, un anticonceptivo inyectable (por ejemplo, Depo-Provera), o un implante anticonceptivo (por ejemplo, Implanon): Deberá también utilizar un método anticonceptivo de barrera fiable (ver Embarazo y lactancia). Efavirenz/emtricitabina/tenofovir disoproxilo puede alterar el funcionamiento de los anticonceptivos hormonales. Se han dado casos de embarazos en mujeres que toman efavirenz, un componente de este medicamento, mientras utilizaban un implante anticonceptivo, aunque no se ha establecido que el tratamiento con efavirenz fuese la causa del fallo anticonceptivo.

• Sertralina: un medicamento utilizado para el tratamiento de la depresión, puesto que su médico podría necesitar cambiar la dosis de sertralina.

• Bupropión: un medicamento utilizado para el tratamiento de la depresión o para ayudarle a dejar de fumar, puesto que su médico podría necesitar cambiar la dosis de bupropión.

• Diltiazem o medicamentos similares (llamados antagonistas del calcio): cuando inicie su tratamiento con este medicamento, será necesario que su médico le ajuste la dosis del antagonista del calcio.

• Medicamentos utilizados para prevenir el rechazo de órganos tras su trasplante (también llamados inmunosupresores) como ciclosporina, sirolimus o tacrolimus. Tanto cuando inicie su tratamiento con este medicamento como cuando lo deje, su médico controlará cuidadosamente sus niveles plasmáticos del inmunosupresor pudiendo ser necesario ajustar la dosis que recibe,

• Warfarina o acenocumarol: (medicamentos utilizados para reducir la coagulación de la sangre): su médico puede necesitar ajustar su dosis de warfarina o acenocumarol.

• Extractos de Ginkgo biloba: (medicamento a base de plantas).

• Metamizol, un medicamento utilizado para el tratar el dolor y la fiebre.

• Praziquantel, un medicamento utilizado para tratar las infecciones por lombrices parasitarias.

Embarazo y lactancia:

Si está embarazada o en periodo de lactancia, consulte a su médico o farmacéutico antes de utilizar este medicamento.

Las mujeres no deben quedarse embarazadas durante el tratamiento con efavirenz/emtricitabina/tenofovir disoproxilo ni en las 12 semanas posteriores. Su médico puede solicitarle una prueba de embarazo para asegurarse de que no está embarazada antes de comenzar el tratamiento con este medicamento.

Si usted pudiera quedarse embarazada mientras recibe efavirenz/emtricitabina/tenofovir disoproxilo , debe utilizar un método anticonceptivo de barrera fiable (por ejemplo, un preservativo) junto con otros métodos anticonceptivos, incluidos los orales (la píldora) u otros anticonceptivos hormonales (por ejemplo, implantes, inyección). Efavirenz, uno de los principios activos de este medicamento, puede permanecer en su sangre durante un tiempo después de cesar el tratamiento. Por lo tanto, deberá continuar usando medidas anticonceptivas, como se indica más arriba, durante 12 semanas después de dejar de tomar este medicamento.

Comunique inmediatamente a su médico si está embarazada o tiene intención de estarlo . Si está embarazada, sólo deberá tomar este medicamento en el caso que tanto usted como su médico decidan que es estrictamente necesario.

Se han observado graves defectos natales en animales neonatos y en humanos recién nacidos, de mujeres que fueron tratadas con efavirenz durante su embarazo.

Consulte a su médico o farmacéutico antes de utilizar cualquier medicamento.

Si usted ha tomado efavirenz/emtricitabina/tenofovir disoproxilo durante su embarazo, su médico puede solicitarle análisis de sangre periódicos y otras pruebas diagnósticas para controlar el desarrollo de su hijo. En niños cuyas madres tomaron ITIANs durante el embarazo, el beneficio de la protección frente al VIH fue mayor que el riesgo de que se produjeran efectos adversos.

No dé el pecho a su hijo durante el tratamiento con efavirenz/emtricitabina/tenofovir disoproxilo. Tanto el VIH como los ingredientes de este medicamento pueden pasar a la leche materna y causar graves daños al bebé.

Conducción y uso de máquinas:

Efavirenz/emtricitabina/tenofovir disoproxilo puede causar mareo, trastornos de la concentración y somnolencia. Si usted resulta afectado, no conduzca y no maneje herramientas o máquinas.

Efavirenz/emtricitabina/tenofovir disoproxilo contiene sodio

Este medicamento contiene menos de 1 mmol de sodio (23 mg) por comprimido recubierto con película, esto es esencialmente “exento de sodio”.

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 disoproxiloshould 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 (e.g., dizziness, drowsiness) less problematic. Swallow this medication whole with a glass of water.

Efavirenz/emtricitabina/tenofovir disoproxiloshould be taken daily.

If your doctor decides to discontinue one of the components ofefavirenz/emtricitabina/tenofovir disoproxilo, 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 than you should

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

If you forget to take efavirenz/emtricitabina/tenofovir disoproxilo

It is essential that you do not forget a dose ofefavirenz/emtricitabina/tenofovir disoproxilo.

If you forget a dose of efavirenz/emtricitabina/tenofovir disoproxilo within 12 hours of 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),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 disoproxilo

Do not interrupt treatment with efavirenz/emtricitabina/tenofovir disoproxilo without first talking to your doctor.The interruption of treatment with this medication may severely affect your response to future treatments. If treatment with this medication is interrupted, consult your doctor before restarting the tablets. Your doctor may consider administering the components of this medication separately if you have problems or if you need your dose adjusted.

When your supplies of efavirenz/emtricitabina/tenofovir disoproxilo 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 at the same time,it is especially important not to discontinue treatment withefavirenz/emtricitabina/tenofovir disoproxilowithout first talking to your doctor. 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 their hepatitis, which may put their life at risk.

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

If you have any other questions about the use of this medication, consult 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 all people will experience them.

Severe side effects: inform your doctor immediately

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

• Deep and rapid breathing,
• Drowsiness,
• Feeling sick (nausea), vomiting, and stomach pain.

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

Other possible severe side effects

The following side effects areinfrequent(affecting 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, visual or auditory hallucinations, suicide attempts, personality modification (psychosis),catatonia (a condition in which the patient becomes immobile and silent for a period).
• Abdominal pain (stomach) caused by pancreatitis inflammation,
• Forgetfulness, confusion, seizures (convulsions), incoherent speech, tremors (shaking),
• Yellow skin or eyes, itching, or abdominal pain (stomach) caused by liver inflammation,
• Kidney damage.

The psychiatric 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 inform your doctor immediately if you experience these symptoms.

Side effects in 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).

Other possible severe side effects

The following side effects arerare(affecting 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 leading to fractures) that can occur due to damage to the renal tubular cells,
• Fatty liver.

If you think you may have any of these severe side effects, speak with your doctor.

More frequent side effects

The following side effects arevery frequent(affecting more than 1 in 10 people):

• Dizziness, headache, diarrhea, feeling unwell (nausea), vomiting,
• Rashes (including red patches or blisters on the skin, sometimes with 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 side effects arecommon(affecting up to 1 in 10 people):

• Allergic reactions,
• Balance and coordination problems,
• Feeling anxious or depressed,
• Difficulty sleeping, abnormal dreams, difficulty concentrating, drowsiness,
• Pain, stomach pain,
• Digestive problems with discomfort after meals, feeling bloated, gas (flatulence),
• Loss of appetite,
• Tiredness,
• 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.

The following side effects areinfrequent(affecting up to 1 in 100 people):

• 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,
• Increased breast size in men,
• Loss of sexual appetite,
• Flush,
• Dry mouth,
• Increased appetite.

Tests may also show:

• Decreased potassium levels in the blood,
• Increased creatine levels in the blood,
• Protein in the urine,
• Increased cholesterol levels in the blood.

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

The following side effects arerare(affecting up to 1 in 1,000 people):

• Skin 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 bottle and carton after “CAD”. The expiration date is the last day of the month indicated.

Do not store above 86°F (30°C).

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

Medications should not be disposed of through drains or in the trash. Deposit the containers and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

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 cornstarch
• Coating: partially hydrolyzed polyvinyl alcohol, titanium dioxide (E171), macrogol, talc (E553b), iron oxide red (E172), iron oxide black (E172).

Appearance of the product and contents of the package

Efavirenz/Emtricitabine/Tenofovir disoproxil Glenmark are pink film-coated tablets, in the form of biconvex capsules, with "CL 81" engraved on one face and smooth on the other face (approximately 20.3 mm x 10.7 mm).

Efavirenz/Emtricitabine/Tenofovir disoproxil Glenmark comes in a bottle of 30 or 90 film-coated tablets that 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:

Glenmark Arzneimittel GmbH

Industriestr. 31,

82194 Gröbenzell,

Germany

Responsible for Manufacturing:

Mawdsley-Brooks Company Limited

Unit 22, Quest Park, Wheatley Hall Road,

DN2 4LT Doncaster,

United Kingdom

Or

Glenmark Pharmaceuticals s.r.o.

Fibichova, 143,

56617 Vysoke Myto,

Czech Republic

For further information about this medication, please contact the local representative of the Marketing Authorization Holder:

Viso Farmacéutica, S.L.U.

c/ Retama 7, 7ª Planta

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/245mgFilmtabletten

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

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

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

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

Last reviewed date of this leaflet:September 2022

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