RIFATER Coated Tablets

Contents of the pack and other information

1. What Rifater coated tablets are and what they are used for
2. What you need to know before you take Rifater coated tablets
3. How to take Rifater coated tablets
4. Possible side effects
5. Storing Rifater coated tablets

Contents of the pack and additional information

1. What Rifater coated tablets are and what they are used for

Rifater is presented in blisters with 100 coated tablets and is an antibiotic belonging to the group of antitubercular associations. Antibiotics stop the growth of bacteria that cause infections.

Antibiotics are used to treat bacterial infections and are not effective againstviral infections such as flu or the common cold.

It is essential that you follow the instructions regarding the dose, administration interval, and treatment duration indicated by your doctor.

Do not store or reuse this medication. If you have any leftover antibiotic after completing treatment, return it to the pharmacy for proper disposal.Do not throw away medicines via wastewater or household waste.

Rifater is indicated in the intensive phase of short or ultra-short treatment of pulmonary tuberculosis.

During this phase, which usually lasts 2 months, Rifater is generally administered daily along with another antitubercular medication.

Once this phase is completed, it is appropriate to switch to a treatment that contains rifampicin and isoniazid.

2. What you need to know before you take Rifater coated tablets

Do not takeRifater

• If you are allergic to rifamycins, isoniazid, pyrazinamide, or any of the other components of this medication (see section 6).
• If you have liver disease or suffer from jaundice (yellowing of the skin and/or eye conjunctiva).
• If you are pregnant or breastfeeding.
• If you are under 12 years old.
• If you are taking medications that contain:

• Combinations of saquinavir/ritonavir or elvitegravir/cobicistat (antiretroviral medications).
• Atazanavir, darunavir, fosamprenavir, tipranavir, rilpivirine, or dolutegravir/rilpivirine (antiviral medications).
• Nifedipine, nimodipine, nisoldipine, or nitrendipine (antihypertensive medications).
• Glecaprevir/pibrentasvir or elbasvir/grazoprevir (medications for hepatitis C).
• Voriconazole (antifungal medication).
• Artemether/lumefantrine (antimalarial medication).
• BCG live attenuated vaccine (interferon).

Warnings and Precautions

Consult your doctor or pharmacist before starting to take Rifater:

• If the symptoms of tuberculosis return or worsen (see 4. Possible side effects).
• If you are diabetic. Treatment with rifampicin may make it difficult to manage diabetic patients.

• Since this medication is an association of three medications (rifampicin, isoniazid, and pyrazinamide), each of which has been associated with liver function alteration. Therefore, your doctor will periodically monitor your liver by performing blood tests before and every 2-4 weeks during treatment. If any liver cell damage appears, your doctor will suspend treatment.

• If you experience itching, weakness, loss of appetite, nausea, vomiting, abdominal pain, yellowing of the eyes or skin, or dark urine, inform your doctor immediately. These symptoms may be related to severe liver damage.
• During treatment, severe skin reactions such as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), Stevens-Johnson Syndrome (SSJ), and Toxic Epidermal Necrolysis (NET) may occur, some of which can be fatal (see section 4. Possible side effects). If you present symptoms of hypersensitivity to Rifater such as fever, lymphadenopathy (swelling of the lymph nodes), biological alterations (eosinophilia - increase of a certain group of white blood cells -, liver disorders), with or without skin rash, blisters, and mucosal lesions, contact your doctor immediately.

Rifater should be discontinued if a different origin for these symptoms cannot be established.

• If you present a severe, generalized, blistering skin rash with blister formation or skin peeling, as well as flu-like symptoms and fever (Stevens-Johnson Syndrome), general discomfort, fever, chills, and muscle pain (Toxic Epidermal Necrolysis) or a red, scaly rash with bumps under the skin and blisters (Acute Generalized Exanthematous Pustulosis), consult your doctor as soon as possible, as treatment with rifampicin should be suspended immediately.
• If you are elderly, an adolescent, malnourished, or have a predisposition to neuropathy (e.g., if you are diabetic), you may need to take a supplementary intake of vitamin B6.
• If you have a history of gout and present an acute attack of gouty arthritis, your doctor will change the treatment to a medication that does not contain pyrazinamide.
• Due to rifampicin, discoloration (yellow, orange, red, brown) may appear in your teeth, urine, sweat, sputum, tears, and feces without clinical significance. Similarly, it can cause permanent discoloration of soft contact lenses.

• Rifampicin may compete with several medications at the level of absorption, biochemical change, and metabolism and, therefore, could decrease or increase the exposure, safety, and efficacy of these medications (see "Use of Rifater with other medications").

• If you have a bleeding problem or tend to bruise easily. Rifampicin can cause vitamin K-dependent coagulopathy (this means it can decrease the blood's ability to clot) and severe bleeding (see section "Possible side effects").

• If you are taking other antibiotics at the same time.
• If you have a history of pulmonary inflammation (interstitial lung disease/pneumonitis).
• If you present a new or sudden worsening of difficulty breathing, possibly with dry cough or fever that does not respond to antibiotic treatment. These may be symptoms of pulmonary inflammation (interstitial lung disease/pneumonitis) and can cause serious respiratory problems and interfere with normal breathing due to fluid accumulation in the lungs, which can lead to life-threatening conditions.
• If you notice any of the symptoms related to cerebellar syndrome described in section 4 - Possible side effects. This syndrome has been reported mainly in patients with chronic kidney disease. Your healthcare professional may reduce the dose or ask you to suspend treatment.

Use of Rifater with other medications

Rifater may modify the effects of many medications, so it is very important that you inform your doctor or pharmacist if you are using, have recently used, or may need to use any other medication, including those purchased without a prescription.

The interactions of Rifater when taken with other medications can be due to rifampicin, isoniazid, and pyrazinamide, which are the active principles of this medication.

Rifampicin increases the elimination of many medications from the body, which can produce a decrease in their activity. Among these medications are:

• medications for the treatment of epilepsy: phenytoin, phenobarbital
• medications for treating heart arrhythmias: disopyramide, mexiletine, quinidine, propafenone, tocainide
• medications for other heart problems: beta-blockers and losartan (for the treatment of high blood pressure), medications called calcium channel blockers such as diltiazem, nifedipine, or verapamil, cardiac glycosides such as digoxin (for the treatment of heart failure)

medications for the treatment of blood coagulation problems: warfarin

• medications for the treatment of mental disorders: haloperidol
• medications for the treatment of fungal infections: caspofungina, fluconazole, itraconazole, ketoconazole
• medications for HIV infection: zidovudine, saquinavir, indinavir, efavirenz
• medications used as anesthetics: thiopental

• certain antibiotics: chloramphenicol, clarithromycin, doxycycline, fluoroquinolones, telithromycin
• corticosteroids (e.g., prednisolone)
• medications to prevent transplant rejection: cyclosporine, tacrolimus, sirolimus
• systemic hormonal contraceptives (including estrogens and progestogens)
• other medications for the treatment of infections: dapsone (for the treatment of leprosy and/or malaria) and quinine (for the treatment of malaria)
• medications for the treatment of diabetes: sulfonylureas (glipizide, gliburide), rosiglitazone
• medications for the treatment of depression: nortriptyline
• medications for the treatment of anxiety and/or insomnia: diazepam, zopiclone, zolpidem
• medications for the treatment of pain: opioid analgesics (oxycodone, morphine)
• medications for treating high cholesterol: clofibrate, statins (e.g., simvastatin)
• medications for the treatment of nausea and vomiting: ondansetron
• medications for the treatment of cancer: irinotecan
• medications for the treatment of degenerative nervous diseases such as amyotrophic lateral sclerosis: riluzole
• medications with estrogenic and antiestrogenic activity (tamoxifen, toremifene)
• antiviral medications for the treatment of hepatitis C (daclatasvir, simeprevir, sofosbuvir, telaprevir, velpatasvir, voxilaprevir)
• other medications: hexobarbital (barbiturate), levothyroxine (for the treatment of hypothyroidism), methadone, theophylline (for the treatment of asthma), praziquantel (for the treatment of helminthic parasites)
• certain medications used to thin the blood, such as clopidogrel
• dapsone: if you are taking dapsone (an antibiotic) with rifampicin, hematologic toxicity, including a decrease in blood cells and bone marrow, and methemoglobinemia (decrease in blood oxygen caused by changes in red blood cells) may occur.

• lurasidone for schizophrenia and bipolar disorders, since rifampicin can reduce lurasidone blood levels.

In case you are taking any of these medications, it may be necessary for your doctor to modify the dose.

If you are taking paracetamol and rifampicin, the risk of liver damage may increase.

When atovaquone and Rifater are used simultaneously, a decrease in atovaquone concentrations and an increase in rifampicin concentrations are observed.

The simultaneous use of ketoconazole and rifampicin decreases the serum levels of both drugs.

If you are taking enalapril (a medication for the treatment of arterial hypertension) at the same time as Rifater, your doctor will adjust the dose of enalapril since rifampicin decreases its concentration in the blood and, therefore, its activity.

If you are taking systemic hormonal contraceptives, your doctor will indicate that you should replace them with a non-hormonal contraceptive method during treatment with Rifater, since it decreases their contraceptive effect.

Antacids reduce the absorption of rifampicin, so you should take your daily dose of Rifater at least one hour before taking antacids.

Concomitant use with a group of antiretroviral medications, non-nucleoside reverse transcriptase inhibitors such as etravirine, nevirapine, or any protease inhibitor (alone or combined with an antiviral called ritonavir), is not recommended.

Concomitant use with maraviroc, another antiretroviral medication, is also not recommended; if clinically justified, a dose adjustment is required.

Concomitant use of rifampicin with other antibiotics that cause vitamin K-dependent coagulopathy (decrease in blood clotting ability), such as cefazolin (or other cephalosporins of the same group), should be avoided, as it can cause severe coagulation disorders (when blood loses its liquidity and becomes a gel to form a clot) that can lead to a fatal outcome (especially with high doses).

When Rifater is taken with the combination saquinavir/ritonavir, the possibility of hepatotoxicity increases. Therefore, concomitant use of Rifater with the combination saquinavir/ritonavir is contraindicated.

Isoniazid inhibits the metabolism of carbamazepine and phenytoin (medications for the treatment of epilepsy).

Para-aminosalicylic acid (a medication used for the treatment of tuberculosis) increases blood levels of isoniazid.

Interference with laboratory tests

Rifater modifies the results of some laboratory tests, such as:

• the determination of folates and vitamin B12 in blood,
• the bromosulfthalein test,
• bilirubin levels in blood,
• it can interfere with the elimination of contrast media used to examine your gallbladder.

Therefore, if necessary, these tests will be performed in the morning and before taking your dose of Rifater.

In patients treated with rifampicin, cases of false-positive results for the presence of opiates in urine have been reported when the analysis was performed with a test called ICMS (Kinetic Interaction of Microparticles in Solution). For this reason, it is recommended to use other techniques in these patients, such as gas chromatography and mass spectrometry.

Inform your doctor or pharmacist if you are pregnant and if you are planning or need to undergo abortion with mifepristone.

Taking Rifater with food, drinks, and alcohol

Isoniazid interacts with foods that contain a substance called tyramine, which is present in foods such as cheese and red wine. Similarly, if taken with foods that contain a substance called histamine (e.g., tuna or other tropical fish), an exaggerated response with headache, sweating, palpitations, flushing, and decreased blood pressure may occur. Due to this, your doctor will indicate that you should not take foods that contain tyramine or histamine during your treatment with Rifater.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.

This medication should not be taken during pregnancy.

Rifampicin, isoniazid, and pyrazinamide are excreted in breast milk, so you should not breastfeed your child during treatment.

Ask your doctor or pharmacist for advice before taking any medicine.

There are no human data on the long-term ability of Rifater to alter fertility.

Driving and using machines

Rifampicin can produce certain side effects that can interfere with the ability to drive and use machines. If you experience these side effects (difficulty breathing, nausea, vomiting, muscle weakness), you should not drive or use machines.

Rifater contains sucrose

This medication contains sucrose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication. Patients with diabetes mellitus should be aware that this medication contains 105 mg of sucrose per coated tablet.

Rifater contains sodium

This medication contains less than 23 mg of sodium (1 mmol) per coated tablet, which is essentially "sodium-free".

3. How to take Rifater coated tablets

Follow the administration instructions for Rifater exactly as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Remember to take your medication.

Your doctor will indicate your daily dose and the duration of your treatment. Do not suspend your treatment beforehand. The dosage is individual for you and may be modified by your doctor based on your response to treatment.

Take the tablets with a sufficient amount of liquid (a glass of water).

The absorption of Rifater is affected by food, so to ensure adequate absorption, you should take Rifater on an empty stomach, that is:

• at least 30 minutes before meals, or
• at least 2 hours after meals.

If you think the action of Rifater is too strong or too weak, inform your doctor or pharmacist.

The recommended dose in adults varies depending on weight and is:

Patients weighing less than 40 kg: 3 coated tablets/day

Patients weighing 40-49 kg: 4 coated tablets/day

Patients weighing 50-64 kg: 5 coated tablets/day

Patients weighing 65 kg or more: 6 coated tablets/day

This medication is not recommended for use in children due to different dosage needs.

If you take more Rifater than you should

Consult your doctor immediately or go to the emergency department of the nearest hospital accompanied by this prospectus.

After a massive intake of this medication, nausea, vomiting, stomach pain, itching, headache, and progressive drowsiness may be expected; in case of having a severe liver disease, loss of consciousness may occur. Dizziness, difficulty speaking, blurred vision, and visual hallucinations (bright colors and strange shapes) may also occur, as well as serious breathing difficulties and severe convulsions.

A transient increase in liver enzymes and/or bilirubin may occur, which may lead to toxic effects on the liver and an increase in blood urate concentrations.

Also, due to rifampicin, a reddish color may appear on: skin, urine, sweat, saliva, tears, and feces; the intensity of this color will vary depending on the amount of medication taken. It can also cause permanent discoloration of soft contact lenses.

In case of overdose or accidental ingestion, consult the Toxicology Information Service. Phone: 91 5620420.

If you forgot to take Rifater

Do not take a double dose to make up for forgotten doses.

If you interrupt treatment with Rifater

It is essential that you follow your doctor's instructions, as taking the treatment intermittently (less than 2 or 3 times a week) may cause severe allergic reactions. If you interrupt treatment and restart it, you will do so with small doses that will be progressively increased.

4. Possible adverse effects

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

Due to Rifater

Adverse effects frequent(may affect up to 1 in 10 patients):

• Paradoxical reaction to the medication: during treatment, the symptoms of tuberculosis may reappear or new symptoms may appear after initial improvement. Paradoxical reactions have been reported 2 weeks to 18 months after starting antitubercular treatment. Paradoxical reactions are usually associated with fever, lymph node inflammation (lymphadenitis), difficulty breathing, and cough. Patients with a paradoxical reaction to the medication may also experience headaches, loss of appetite, and weight loss.

Due to rifampicin:

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

If any of the following serious adverse effects occur, stop taking Rifater and consult your doctor immediately (see section 2 - Warnings and precautions):

• Kidney failure (the kidneys are not able to filter toxins properly).
• Thrombocytopenia (decrease in the number of platelets in the blood).
• Hemolytic anemia (destruction of red blood cells in the blood, before normal).

Your doctor will indicate that you immediately interrupt treatment with rifampicin and do not take this medication again.

Adverse effects very frequent(may affect more than 1 in 10 patients):

• Fever, chills.

Adverse effects frequent(may affect up to 1 in 10 patients):

• Thrombocytopenia (reduction in the number of platelets), with or without the appearance of red spots on the skin formed by small subcutaneous bleeding (purpura).
• Headache, dizziness.
• Nausea, vomiting.
• Elevation of bilirubin in the blood, elevation of transaminases [aspartate aminotransferase (AST), alanine aminotransferase (ALT)].

Adverse effects infrequent(may affect up to 1 in 100 patients):

• Leukopenia (decrease in the number of white blood cells).
• Diarrhea.

Other adverse effects frequency not known(cannot be estimated from available data) that may occur with rifampicin are:

• Pseudomembranous colitis (severe inflammation of the intestine that may appear after antibiotic treatment).
• Flu.
• Disseminated intravascular coagulation (coagulation problems within blood vessels in a generalized manner).
• Eosinophilia (increase in a certain group of white blood cells).
• Agranulocytosis (decrease in a type of white blood cell, granulocytes).
• Hemolytic anemia (decrease in the number of red blood cells produced by their destruction).
• Vitamin K-dependent coagulation disorders.
• Anaphylactic reaction (severe allergic reaction that causes respiratory difficulty and even loss of consciousness).
• Adrenal insufficiency (alteration of adrenal gland function in patients with renal impairment).
• Loss of appetite.
• Psychotic disorder (mental state that consists of a loss of contact with reality).
• Cerebral hemorrhage and death, in cases where, after the appearance of purpura (purple spots on the skin), treatment with rifampicin has been continued or resumed.
• Change in tear color.
• Shock (cardiocirculatory insufficiency syndrome), flushing (redness of the skin), vasculitis (inflammation of blood vessels), severe bleeding.
• Dyspnea (shortness of breath), wheezing (sounds during breathing), change in sputum color.
• Gastrointestinal disorder, abdominal discomfort, discoloration of teeth (which can be permanent).
• Hepatitis (liver inflammation), hyperbilirubinemia (elevation of bilirubin in the blood), cholestasis (reduction of bile flow) (see section 2. Warnings and precautions).
• Erythema multiforme.
• Severe skin reactions such as acute generalized exanthematous pustulosis (red and scaly rash with bumps under the skin and blisters), Stevens-Johnson syndrome (generalized rash with blisters and skin peeling, particularly around the mouth, nose, eyes, and genitals), and toxic epidermal necrolysis [generalized rash with blisters and skin peeling, particularly around the mouth, nose, eyes, and genitals, causing generalized skin peeling (more than 30% of the body surface)], drug reaction with eosinophilia and systemic symptoms (DRESS): flu-like symptoms with skin rash, fever, gland inflammation, and abnormal blood test results such as increased white blood cells (eosinophilia) and elevated liver enzymes.
• Skin reactions, itching, pruritic skin rash, urticaria, allergic dermatitis, blistering skin lesions (pemphigus).
• Change in sweat color.
• Muscle weakness, myopathy (muscle disorder).
• Bone pain.
• Acute kidney damage due to kidney cell death (tubular necrosis) or kidney inflammation (tubulointerstitial nephritis).
• Chromaturia (abnormal urine color).
• Postpartum hemorrhage.
• Fetomaternal hemorrhage (entry of fetal blood into the mother).
• Menstrual disorder.
• Porphyria.
• Edema (skin swelling due to fluid accumulation).
• Decrease in blood pressure.
• Increased creatinine in the blood.
• Increased liver enzymes.
• Lung inflammation (interstitial lung disease/pneumonitis): inform your doctor immediately if you develop new or worsening difficulty breathing, possibly with cough or fever.

Due to isoniazid:

Adverse effects infrequent(may affect up to 1 in 100 patients):

• Hepatitis: symptoms such as yellowing of the skin and whites of the eyes (jaundice), dark urine, and pale stools, fatigue, weakness, discomfort, loss of appetite, nausea, or vomiting, which can be severe and sometimes fatal.

• Seizures, toxic encephalopathy (brain disorder caused by a neurological disorder caused by toxic substances), optic neuritis (inflammation of the optic nerve that can cause sudden partial or complete loss of vision), optic nerve atrophy, memory alteration, and toxic psychosis (psychotic disorder caused by substance abuse).
• Nausea, vomiting, stomach pain.

Adverse effects rare(may affect up to 1 in 1,000 patients):

• Generalized rash with blisters and skin peeling, particularly around the mouth, nose, eyes, and genitals, causing generalized skin peeling (more than 30% of the body surface) (toxic epidermal necrolysis or TEN).
• Flu-like symptoms with skin rash, fever, gland inflammation, and abnormal blood test results such as increased white blood cells (eosinophilia) and elevated liver enzymes [drug reaction with eosinophilia and systemic symptoms (DRESS)].
• Anemia (decrease in the number of red blood cells in the blood).

Adverse effects very rare(may affect up to 1 in 10,000 patients):

• Thrombocytopenia (reduction in the number of platelets),
• Eosinophilia (increase in white blood cells)
• Agranulocytosis (decrease in a type of white blood cell, granulocytes).
• Anaphylactic reactions (severe allergic reaction that causes respiratory difficulty and even loss of consciousness)
• Pellagra (digestive disorders, pain in the limbs, weakness, and redness with skin peeling and nervous system disorders).
• Polyneuritis (inflammation of multiple nerves) that presents as paresthesia (tingling sensation), muscle weakness, and loss of tendon reflexes.
• Rash (skin rash)
• Acne
• Exfoliative dermatitis (skin inflammation with peeling)
• Stevens-Johnson syndrome (SSJ): generalized rash with blisters and skin peeling, particularly around the mouth, nose, eyes, and genitals.
• Pemphigus (skin disorder with blisters).
• Systemic lupus erythematosus-like syndrome (severe skin and mucous membrane disease of unknown origin that sometimes causes fatigue and weight loss, fever, arthritis, kidney involvement, seizures, mental disorders, and gastrointestinal disorders).
• Fever.

Adverse effects of frequency not known(cannot be estimated from available data):

• Pancreatitis (inflammation of the pancreas), which causes intense abdominal and back pain.
• Gynecomastia (pathological enlargement of one or both mammary glands).
• Vasculitis (inflammation of blood vessels).
• Cerebellar syndrome that includes: poor movement coordination, lack of balance, changes in speech, involuntary eye movements.

Due to pyrazinamide:

Adverse effects infrequent(may affect up to 1 in 100 patients):

• Nausea
• Vomiting
• Worsening of peptic ulcer (if present).

Adverse effects very rare(may affect up to 1 in 10,000 patients):

• Sideroblastic anemia (disorder in which the bone marrow produces ringed sideroblasts instead of healthy red blood cells), thrombocytopenia (decrease in the number of platelets) with or without purpura (purple spots on the skin).
• Gout, anorexia (loss of appetite).
• Hepatitis (liver disease), so your doctor will monitor your liver function. The hepatic reaction is the most common of the adverse reactions, ranging from an asymptomatic alteration of liver cell function (detected only through liver function tests) to a mild syndrome of fever, discomfort, and soft liver, to more serious reactions such as jaundice and, in isolated cases, acute liver atrophy and death.
• Drug reaction with eosinophilia and systemic symptoms (DRESS): flu-like symptoms with skin rash, fever, gland inflammation, and abnormal blood test results such as increased white blood cells (eosinophilia) and elevated liver enzymes.
• Urticaria
• Pruritus (itching)
• Erythema (red spots)
• Rash (skin rash)
• Angioedema (generalized urticaria accompanied by inflammation of feet, hands, throat, lips, and respiratory tract).
• Arthralgia (joint pain).
• Dysuria (discomfort while urinating).
• Fever
• Discomfort.

Adverse effects of frequency not known(cannot be estimated from available data):

• Increased sensitivity of the skin to sunlight and ultraviolet light (photosensitivity).

Reporting of 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 prospectus. 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. Conservation of Rifater coated tablets

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

Do not store at a temperature above 25°C.

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

Medications should not be thrown down the drain or into the trash. Deposit the packaging and unused medications at the SIGRE Point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and unused medications. This way, you will help protect the environment.

6. Package contents and additional information

Composition of Rifater coated tablets

The active ingredients are rifampicin, isoniazid, and pyrazinamide. Each coated tablet contains 120 mg of rifampicin; 50 mg of isoniazid; and 300 mg of pyrazinamide.

The other components are: povidone K-30, sodium carmellose, sodium lauryl sulfate, calcium stearate. Coating: sucrose, arabic gum, talc, povidone K-30, titanium dioxide (E-171), kaolin, magnesium carbonate, colloidal silica, aluminum hydroxide, iron oxide.

Appearance of the product and package contents

Rifater is presented in the form of pale pink, smooth, shiny, round, and convex coated tablets.

Each package contains 100 tablets in blisters.

The marketing authorization holder is:

sanofi-aventis, S.A.

C/ Rosselló i Porcel, 21

08016 Barcelona

Spain

The manufacturer is:

Sanofi S.r.l.

Via Valcanello, 4

03012 Anagni (FR) Italy

Date of the last revision of this prospectus:August 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/.