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

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

Do not take Efavirenz/Emtricitabine/Tenofovir disoproxil Teva

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

• if any of your relatives (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.

• any of the following medicines (see also "Taking Efavirenz/Emtricitabine/Tenofovir disoproxil Teva with other medicines":

• astemizole or terfenadine(used to treat hay fever or other allergies)
• bepridil(used to treat heart diseases)
• 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 facilitate sleep)
• pimozide,imipramine, amitriptyline, or clomipramine(used to treat certain mental problems)
• St. John's Wort(Hypericum perforatum) (herbal preparation 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 medicines, inform your doctor immediately.Taking these medicines with Efavirenz/Emtricitabine/Tenofovir disoproxil Teva could produce serious or potentially fatal side effects or could cause these medicines to stop working properly.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Efavirenz/Emtricitabine/Tenofovir disoproxil Teva.

• While you are taking this medicine you can still transmit HIV to others,although effective antiretroviral treatment reduces the risk. Consult your doctor about what precautions are necessary to avoid infecting others. This medicine is not a cure for HIV infection. While you are taking efavirenz/emtricitabine/tenofovir disoproxil, you may still suffer from infections or other diseases associated with HIV infection.
• While you are taking efavirenz/emtricitabine/tenofovir disoproxil, you must remain under the supervision of your doctor.

• Consultyour doctor:

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

• If you have or have had kidney disease,or if tests have shown problems with your kidneys. Efavirenz/emtricitabine/tenofovir disoproxil is not recommended if you have moderate to severe kidney disease.

Efavirenz/emtricitabine/tenofovir disoproxil 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.

Efavirenz/emtricitabine/tenofovir disoproxil is not normally taken with other medicines that can damage your kidneys (see Taking Efavirenz/Emtricitabine/Tenofovir disoproxil Teva with other medicines). If this is unavoidable, your doctor will monitor your kidney function once a week.

• If you have a heart condition, such as an abnormal 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 medicines, your doctor may need to check the level of anticonvulsant medicine in your blood to ensure that it is not affected while you are taking 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 combined antiretrovirals, have a higher risk of severe and potentially fatal liver complications. Your doctor may perform blood tests to monitor the condition of your liver or change you to another medicine. 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 Teva).

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

• Regardless of whether you have a history of liver disease, your doctor will consider performing regular blood tests to monitor the condition of 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 efavirenz/emtricitabine/tenofovir disoproxil, your doctor will monitor you carefully.

• Once you start taking Efavirenz/Emtricitabine/Tenofovir disoproxil Teva, 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.Efavirenz/emtricitabine/tenofovir disoproxil may cause skin rashes. If you notice any sign of a severe skin rash with blisters or fever, stop taking efavirenz/emtricitabine/tenofovir disoproxil 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 efavirenz/emtricitabine/tenofovir disoproxil.

• 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 antiretroviral 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 medicines 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 towards the body, palpitations, tremors, or hyperactivity, inform your doctor immediately to receive the necessary treatment.

• Bone problems.Some patients who receive combined antiretroviral treatment 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 combined antiretroviral treatment, 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) 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 can 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 risk of future fractures in adult and pediatric patients are uncertain.

Inform your doctor if you know you have osteoporosis.

Patients with osteoporosis have a higher risk of suffering from 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.

Taking Efavirenz/Emtricitabine/Tenofovir disoproxil Tevawithother medicines

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

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

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

Inform your doctorif you are taking other medicines that can damage your kidneys. Some examples include:

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

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

• Medicines that contain didanosine (for HIV infection):taking efavirenz/emtricitabine/tenofovir disoproxil with other antiviral medicines that contain didanosine may increase the levels of didanosine in your blood and may reduce the CD4 cell count. When medicines that contain tenofovir disoproxil and didanosine are taken together, rare cases of pancreatitis and lactic acidosis (excess of lactic acid in the blood) have been reported, sometimes fatally. Your doctor will carefully consider whether to treat you with medicines that contain tenofovir and didanosine.
• Other medicines 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 medicine or changing the dose of the protease inhibitors. Also, inform your doctor if you are taking maraviroc.
• Medicines used for the treatment of hepatitis C virus infection:Glecaprevir/pibrentasvir, elbasvir/grazoprevir, sofosbuvir/velpatasvir, sofosbuvir/velpatasvir/voxilaprevir.
• Medicines used to lower the fat in the blood (also called statins):Atorvastatin, pravastatin, simvastatin. Efavirenz/emtricitabine/tenofovir disoproxil 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.
• Medicines 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 efavirenz/emtricitabine/tenofovir disoproxil, in the blood. Your doctor may need to consider prescribing a different anticonvulsant.
• Medicines 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.
• Medicines 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 prescribing a different antimycotic.
• Medicines used to treat malaria:Atovaquone/proguanil or artemether/lumefantrine. Efavirenz/emtricitabine/tenofovir disoproxil may reduce the amount of atovaquone/proguanil or artemether/lumefantrine in the blood.
• Hormonal contraceptive, such as birth control pills, an injectable contraceptive (e.g., Depo-Provera), or a contraceptive implant (e.g., Implanon):You should also use a reliable barrier method of contraception (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 efavirenz/emtricitabine/tenofovir disoproxil, while using a contraceptive implant, although it has not been established that treatment with efavirenz was the cause of the contraceptive failure.
• Sertraline, a medicine used to treat depression, as your doctor may need to change the dose of sertraline.
• Bupropion, a medicine used to treat depression or to help you stop smoking, as your doctor may need to change the dose of bupropion.
• Diltiazem or similar medicines (called calcium channel blockers):when you start treatment with efavirenz/emtricitabine/tenofovir disoproxil, your doctor will need to adjust the dose of the calcium channel blocker.
• Medicines used to prevent organ rejection after transplantation (also called immunosuppressants)such as cyclosporin, sirolimus, or tacrolimus. Both when you start treatment with efavirenz/emtricitabine/tenofovir disoproxil and when you stop it, your doctor will carefully monitor your blood levels of the immunosuppressant and may need to adjust the dose you receive.
• Warfarin or acenocoumarol(medicines used to reduce blood clotting): Your doctor may need to adjust your dose of warfarin or acenocoumarol.
• Ginkgo biloba extracts(herbal medicine).
• Metamizole, a medicine used to treat pain and fever.
• Praziquantel, a medicine used to treat parasitic infections.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, 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 or in the 12 weeks after.

Your doctor may request a pregnancy test to ensure that you are not pregnant before starting treatment with efavirenz/emtricitabine/tenofovir disoproxil.

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

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/emtricitabine/tenofovir disoproxil should be taken on an empty stomach (usually defined as one hour before or two hours after a meal) and preferably at bedtime. This may make some of the adverse effects (e.g., dizziness, drowsiness) less problematic. Swallow efavirenz/emtricitabine/tenofovir disoproxil 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 Teva 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 it is advised that you go to the nearest emergency service. Bring the package of tablets with you so that you can easily describe what you have taken.

If you forget to take Efavirenz/Emtricitabine/Tenofovir disoproxil Teva

It is essential 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 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/emtricitabine/tenofovir disoproxil),you should take another tablet. Do not wait until the time of your next dose. You do not need to take another tablet if you vomit more than one hour after taking efavirenz/emtricitabine/tenofovir disoproxil.

If you interrupt treatment with Efavirenz/Emtricitabine/Tenofovir disoproxil Teva

Do not interrupt treatment with Efavirenz/Emtricitabine/Tenofovir disoproxil Teva without speaking to your doctor first.Stopping treatment with efavirenz/emtricitabine/tenofovir disoproxil may severely affect your response to future treatments. If you stop treatment with efavirenz/emtricitabine/tenofovir disoproxil, consult your doctor before restarting the tablets. Your doctor may consider giving you the components of efavirenz/emtricitabine/tenofovir disoproxil separately if you have problems or if your dose needs to be adjusted.

When Efavirenz/Emtricitabine/Tenofovir disoproxil Teva runs out, ask your doctor or pharmacist for more. This is extremely important because the amount of virus can start to increase 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 both an HIV infection and hepatitis B,it is especially important not to stop your treatment with efavirenz/emtricitabine/tenofovir disoproxil without first talking to your doctor. Some patients have had blood tests or symptoms indicating that their hepatitis worsened after stopping emtricitabine or tenofovir disoproxil (two of the three components of this medication). If you stop treatment with efavirenz/emtricitabine/tenofovir disoproxil, your doctor may recommend that you resume hepatitis B treatment. You may need blood tests to check liver function for 4 months after stopping treatment. 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 your treatment, particularly symptoms you associate with hepatitis B virus infection.

If you have any other questions about using this medication, ask your doctor or pharmacist.

4. Possible adverse effects

During HIV treatment, there may be an increase in weight and lipid and glucose 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 antiretroviral 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

The following adverse effects are 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
• aggressive behavior, 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 unable to speak 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 (stomach) 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 often 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(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.
• bone weakening (with bone pain and sometimes resulting in fractures) that can occur due to damage to 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

The following adverse effects are 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

Lab 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(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

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

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

Lab 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 sometimes resulting in fractures), muscle pain, muscle weakness, and decreased potassium or phosphate levels in the blood may occur.

The following adverse effects are 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 is not listed in this leaflet.You can also report them directly through the Spanish Medication Surveillance System for Human Use: 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/Emtricitabine/Tenofovir disoproxil Teva

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date that appears on the blister, box, or bottle after EXP. The expiration date is the last day of the month indicated.

Blister: Store in the original packaging to protect it from moisture. This medication does not require any special storage temperature.

Bottle: Store in the original packaging to protect it from moisture. Keep the bottle tightly closed. This medication does not require any special storage temperature.

Medications should not be thrown down the drain or into the trash. Deposit the packaging and medications you no longer need at the SIGRE collection 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 Teva

• The active ingredients are efavirenz, emtricitabine, and tenofovir disoproxil. Each film-coated tablet of Efavirenz/Emtricitabine/Tenofovir disoproxil Teva contains 600 mg of efavirenz, 200 mg of emtricitabine, and 245 mg of tenofovir disoproxil (equivalent to 291.22 mg of tenofovir disoproxil phosphate or 136 mg of tenofovir).
• The other ingredients are microcrystalline cellulose, sodium croscarmellose, mannitol (E421), hydroxypropylcellulose, low-substituted hydroxypropylcellulose, poloxamer 407, crospovidone, hypromellose, hydrogenated vegetable oil, sodium stearyl fumarate.
• The other ingredients of the coating (Opadry II 85F240144 PINK) are polyvinyl alcohol - partially hydrolyzed, titanium dioxide (E171), macrogol 3350, talc, carmine (E120).

Appearance of the product and package contents

The film-coated tablets of Efavirenz/Emtricitabine/Tenofovir disoproxil Teva are pink, oval, marked with "TEE" on one side of the tablet, and smooth on the other side. The bottles may contain an HDPE container with silica gel that should be kept in the bottle to help protect the tablets. The silica gel container should not be swallowed.

The following package sizes are available:

Blister: 10, 30, 90 film-coated tablets and a unit dose of 30x1 film-coated tablets.

Bottle: 30 and a multi-pack containing 90 (3 bottles of 30) film-coated tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder

Teva Pharma, S.L.U.

Anabel Segura Street, 11. Albatros B Building, 1st floor.

28108 Alcobendas, Madrid

Spain

Manufacturer

Teva Operations Poland Sp. z.o.o

Mogilska Street, 80

31-546 Krakow

Poland

or

Merckle GmbH

Ludwig-Merckle-Strasse 3,

89143 Blaubeuren, Baden-Wuerttemberg

Germany

or

PLIVA Croatia Ltd.

Prilaz baruna Filipovica 25,

10000 Zagreb

Croatia

Date of the last revision of this leaflet:July 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/)