Rifater comprimidos recubiertos

Prospect: information for the user

Rifater coated tablets

Rifampicin/Isoniazid/Pyrazinamide

Read this prospect carefully before starting to take the medicine, as it contains important information for you

• Keep this prospect, as you may need to read it again.

• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for you and should not be given to others, even if they have the same symptoms, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

Content of the prospect:

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

Contents of the package and additional information

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

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 change treatment to a medication containing rifampicin and isoniazid.

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 jaundice (yellowing of the skin and/or conjunctiva of the eye).
• 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, rilpivirina, or dolutegravir/rilpivirina (antiviral medications).

- Nifedipino, nimodipino, nisoldipino, or nitrendipino (anti-hypertensive medications).

- Glecaprevir/pibrentasvir or elbasvir/grazoprevir (medications for hepatitis C).

- Voriconazol (antifungal medication).

- Artemetero/lumefantrina (antimalarial medication).

- BCG live attenuated culture (interferon).

• If you are taking a medication called lurasidona for schizophrenia and bipolar disorders, (see section “Use of Rifaldin with other medications” below).

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. The treatment with rifampicina may make it difficult to manage diabetic patients.

• Since this medication is the association of three medications (rifampicina, isoniazid, and pyrazinamide), each of which has been associated with liver function alteration. Therefore, your doctor will monitor your liver periodically by performing blood tests before treatment 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, and toxic epidermal necrolysis (NET) may occur, some of which are fatal (see section 4. Possible side effects). If you experience hypersensitivity symptoms to Rifater such as fever, lymphadenopathy (swelling of 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 the cause of these symptoms cannot be established.

• If you experience a severe generalized blistering skin rash, with blister formation or skin peeling, as well as signs of flu and fever (Stevens-Johnson syndrome), general discomfort, fever, chills, and muscle pain (toxic epidermal necrolysis) or a red, scaly rash with subcutaneous nodules and blisters (generalized acute pustular exanthema), consult your doctor as soon as possible, as treatment with rifampicina should be suspended immediately.
• If you are elderly, malnourished, or have a predisposition to neuropathy (e.g., if you are diabetic), you may need to take a vitamin B6 supplement.
• If you have or have had gout, and experience an acute gouty arthritis attack, your doctor will change your treatment to a medication that does not contain pyrazinamide.
• Due to rifampicina, your teeth, urine, sweat, sputum, tears, and feces may become yellow, orange, red, or brown without clinical significance. Similarly, it may cause permanent discoloration of soft contact lenses.

• Rifampicina may compete with various medications at the level of absorption, biochemical change, and metabolism, and may therefore 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 tendency to easily bruise. Rifampicina may cause vitamin K-dependent coagulopathy (this means it may decrease the blood's ability to coagulate) 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 experience 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 may cause severe respiratory problems and interfere with normal breathing due to fluid accumulation in the lungs, which may lead to life-threatening conditions.
• If you experience any 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 taking, have taken recently, or may need to take any other medication, including those purchased without a prescription.

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

Rifampicina increases the elimination of many medications from the body, which may result in a decrease in their activity. Among these medications are:

• Medications for the treatment of epilepsy: phenytoin, phenobarbital
• Medications for treating the heart when it beats irregularly (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, nifedipino, or verapamilo, cardiac glycosides such as digoxin (for the treatment of heart failure)

Medications for the treatment of blood clotting disorders: warfarin

Medications for the treatment of mental disorders: haloperidol

Medications for the treatment of fungal infections: caspofungina, fluconazol, itraconazol, ketoconazol

Medications for HIV infection: zidovudina, saquinavir, indinavir, efavirenz

Medications used as anesthetics: thiopental

• Some antibiotics: chloramphenicol, clarithromycin, doxiciclina, fluoroquinolones, telitromicina
• Corticosteroids (e.g., prednisolona)
• Medications to prevent transplant rejection: ciclosporina, tacrolimus, sirolimus
• Systemic hormonal contraceptives (including estrogens and progestagens)
• Other medications for the treatment of infections: dapsona (for the treatment of leprosy and/or malaria) and quinina (for the treatment of malaria)
• Medications for the treatment of diabetes: sulfonilureas (glipizida, gliburida), rosiglitazona
• Medications for the treatment of depression: nortriptilina
• Medications for the treatment of anxiety and/or insomnia: diazepam, zopiclona, zolpidem
• Medications for the treatment of pain: opioid analgesics (oxycodona, morfina)
• Medications for treating high cholesterol levels: clofibrato, statins (e.g., simvastatina)
• Medications for the treatment of vomiting: ondansetrón
• Medications for the treatment of cancer: irinotecán
• Medications for the treatment of degenerative nervous diseases such as amyotrophic lateral sclerosis: riluzol
• Medications with estrogenic and antiestrogenic activity (tamoxifeno, toremifeno)
• Medications for the treatment of hepatitis C (daclatasvir, simeprevir, sofosbuvir, telaprevir, velpatasvir, voxilaprevir)
• Other medications: hexobarbital (barbiturate), levotiroxina (for the treatment of hypothyroidism), metadona, teofilina (for the treatment of asthma), praziquantel (for the treatment of helminthic parasites)
• Some medications used to dilute blood, such as clopidogrel
• Dapsona: If you are taking dapsona (an antibiotic) with rifampicina, toxicity may occur, including a decrease in blood cells and bone marrow, and methemoglobinemia (decrease in oxygen in the blood caused by changes in red blood cells).

• Lurasidona for schizophrenia and bipolar disorders, as rifampicina may reduce lurasidona blood levels.

In the case of taking any of these medications, your doctor may need to adjust your dose.

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

When atovacuona and Rifater are taken together, a decrease in atovacuona concentrations and an increase in rifampicina concentrations are observed.

The simultaneous use of ketoconazol and rifampicina decreases the serum levels of both medications.

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

If you are taking systemic hormonal contraceptives, your doctor will advise you to replace them with a non-hormonal contraceptive method during treatment with Rifater, as it decreases its anticonceptive effect.

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

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

The concomitant use of Rifater with maraviroc, another antiretroviral medication, is not recommended; if clinically justified, dose adjustment is required.

The concomitant use of rifampicina with other antibiotics that cause vitamin K-dependent coagulopathy (decrease in the blood's ability to coagulate) such as cefazolina (or other cefalosporins of the same group) should be avoided, as it may cause severe coagulation disorders that may lead to a fatal outcome (especially with high doses).

The concomitant use of Rifater with the combination saquinavir/ritonavir increases the risk of hepatotoxicity. Therefore, the 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).

Acid para-aminosalicylic (medication used for the treatment of tuberculosis) increases the 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 bromosulftaleína test,

- The levels of bilirubin in blood,

- May interfere with the elimination of contrast agents used to examine the gallbladder.

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

In patients treated with rifampicina, cases of falsely positive results for the presence of opiates in urine have been reported when the analysis was performed with a test called ICMS (Interacción Cinética de Micropartículas en Solución). With this in mind, 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 and found 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 may occur with headache, sweating, palpitations, flushing, and decreased blood pressure. Therefore, your doctor will advise you not to take foods that contain tyramine or histamine during your treatment with Rifater.

Pregnancy, lactation, and fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor before using this medication.

This medication should not be taken during pregnancy.

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

Consult your doctor or pharmacist before taking any medication.

No data are available in humans on the long-term ability of Rifater to alter fertility.

Driving and operating machinery

Rifampicina may cause certain side effects that may interfere with driving and operating machinery. If you experience these side effects (difficulty breathing, nausea, vomiting, muscle weakness), do not drive or operate machinery.

Rifater contains saccharose

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

Rifater contains sodium

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

Follow exactly the administration instructions for Rifater 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 according to your response to treatment.

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

The absorption of Rifater is affected by food, therefore, to ensure proper absorption, you should take Rifater with an empty stomach, that is:

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

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

The recommended dose in adults varies according to 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 nearest hospital emergency department accompanied by this leaflet.

After a massive intake of this medication, you can expect the appearance of nausea, vomiting, stomach pain, itching, headache, and progressive drowsiness; in case of suffering from a severe liver disease, it could lead to loss of consciousness. Vertigo, difficulty speaking, blurred vision, and visual hallucinations (bright colors and strange shapes) may also occur, as well as severe breathing difficulties and severe convulsions.

A temporary increase in liver enzymes and/or bilirubin may occur, which could lead to liver toxicity and increased urate concentrations in the blood.

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

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

If you forget to take Rifater

Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Rifater

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

Like all medicines, Rifater can cause side effects, although not everyone will experience them.

Due to Rifater

Side effectscommon(may affect up to 1 in 10 patients):

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

Due to rifampicin:

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

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

• Renal insufficiency (kidneys are unable to filter out toxins properly).
• Trombocytopenia (decrease in the number of platelets in the blood).
• Anemia hemolítica (destruction of red blood cells before normal).

Your doctor will instruct you to stop taking rifampicin immediately and not to take this medicine again.

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

• Fever, chills.

Side effectscommon(may affect up to 1 in 10 patients):

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

Side effectsuncommon(may affect up to 1 in 100 patients):

• Leucopenia (decrease in the number of white blood cells).
• Diarrea.

Other side effectsfrequency unknown(cannot be estimated from available data)that may occur with rifampicin are:

• Pseudomembranous colitis (severe intestinal inflammation that may occur after antibiotic treatment).
• Influenza.
• Disseminated intravascular coagulation (problems with coagulation within blood vessels in general).
• Eosinophilia (increase in a certain group of white blood cells).
• Agranulocytosis (decrease in a type of white blood cells, granulocytes).
• Anemia hemolítica (decrease in the number of red blood cells produced by their destruction).
• Vitamin K-dependent coagulopathy.
• Anaphylactic reaction(severe allergic reaction that may cause difficulty breathing and even loss of consciousness).
• Adrenal insufficiency (alteration of the function of the adrenal glands in patients with renal impairment).
• Decreased appetite.
• Psychotic disorder (mental state consisting of a loss of contact with reality).
• Brain hemorrhage and death, in cases where, after the appearance of purpura (purple patches on the skin), the treatment with rifampicin was continued or resumed.
• Change in tear color.
• Shock (cardiogenic shock syndrome), rubefaction (skin redness), 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 may be permanent).
• Hepatitis (inflammation of the liver), 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 generalized pustular psoriasis (red and scaly rash with blisters under the skin and vesicles), Stevens-Johnson syndrome (generalized rash with blisters and peeling of the skin, particularly around the mouth, nose, eyes, and genitals) and toxic epidermal necrolysis [generalized rash with blisters and peeling of the skin, particularly around the mouth, nose, eyes, and genitals causing widespread peeling of the skin (more than 30% of the body surface)],Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) [grip-like symptoms with skin rash, fever, glandular inflammation, and abnormal blood test results such as eosinophilia and elevated liver enzymes](see section 2. Warnings and precautions).
• Reactions to the skin, itching, pruritic rash, urticaria, allergic dermatitis, skin lesions with blisters (pemphigus).
• Change in sweat color.
• Weakness, myopathy (muscle disorder).
• Bone pain.
• Acute kidney damage due to normal cell death in the kidneys (tubular necrosis) or inflammation of the kidneys (tubulointerstitial nephritis).
• Chromaturia (abnormal urine color).
• Postpartum hemorrhage.
• Fetomaternal hemorrhage (entry of fetal blood into the mother).
• M menstrual disorder.
• Porphyria.
• Edema (skin swelling due to accumulation of fluids).
• Decreased blood pressure.
• Elevation of creatinine in the blood.
• Elevation of liver enzymes.
• Pulmonary inflammation (interstitial lung disease/pneumonitis): report to your doctor immediately if you develop a new or sudden worsening of difficulty breathing, possibly with cough or fever.

Due to isoniazid:

Side effectsuncommon(may affect up to 1 in 100 patients):

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

• Convulsions, toxic encephalopathy (brain damage due to a neurological disorder caused by toxic substances), optic neuritis (inflammation of the optic nerve that may cause sudden partial or complete loss of vision, although in many cases visual ability is recovered), optic nerve atrophy, memory impairment, and toxic psychosis (psychotic disorder caused by substance abuse).
• Nausea, vomiting, stomach pain.

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

• Generalized rash with blisters and peeling of the skin, particularly around the mouth, nose, eyes, and genitals, causing widespread peeling of the skin (more than 30% of the body surface) (Necrólisis epidérmica tóxica or NET).
• Grip-like symptoms with skin rash, fever, glandular inflammation, and abnormal blood test results such as 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).

Side effectsvery rare(may affect up to 1 in 10,000 patients):

• Trombocytopenia (decrease in the number of platelets),
• Eosinophilia (increase in white blood cells)
• Agranulocytosis (decrease in a type of white blood cells, granulocytes).
• Anaphylactic reactions (severe allergic reaction that may cause difficulty breathing and even loss of consciousness)
• Pelagra (digestive disorders, pain in the extremities, weakness, and redness with peeling of the skin and nervous system alterations).
• Polineuritis (inflammation of several nerves) that presents as paresthesia (tingling sensation), muscle weakness, and loss of reflexes at the junction of tendons and bones
• Rash (skin rash)
• Acne
• Dermatitis exfoliativa (inflammation of the skin with peeling)
• Stevens-Johnson syndrome (SSJ): Generalized rash with blisters and peeling of the skin, particularly around the mouth, nose, eyes, and genitals.
• Pemphigus (skin alteration with blisters).
• Syndrome similar to systemic lupus erythematosus (serious skin and mucous membrane disease of unknown origin that may cause fatigue and weight loss, fever, arthritis, kidney impairment, convulsions, mental disorders, and gastrointestinal disorders).
• Fever.

Side effects offrequency unknown(cannot be estimated from available data):

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

Due to pyrazinamide::

Side effectsuncommon(may affect up to 1 in 100 patients):

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

Side effectsvery rare(may affect up to 1 in 10,000 patients):

• Anemia sideroblástica (disorder in which the bone marrow produces sideroblasts with rings instead of healthy red blood cells), trombocytopenia (decrease in the number of platelets) with or without purpura (purple patches on the skin).
• Gouty arthritis, anorexia (decrease in appetite).
• Hepatitis (liver disease), so your doctor will monitor your liver function. The hepatic reaction is the most common adverse reaction, ranging from a change in 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 rare cases, acute liver atrophy and death.
• Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS): grip-like symptoms with skin rash, fever, glandular inflammation, and abnormal blood test results such as eosinophilia and elevated liver enzymes.
• Urticaria
• Pruritus (itching)
• Erythema (red patches)
• Rash(skin rash)
• Angioedema (generalized urticaria accompanied by inflammation of feet, hands, throat, lips, and respiratory tract).
• Arthralgia (pain in the joints).
• Disuria (discomfort while urinating).
• Fever
• Discomfort.

Side effects offrequency unknown(cannot be estimated from available data):

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

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

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 packagingafter CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medicines you no longer need atthe SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Rifater coated tablets

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

Appearance of the product and content of the packaging

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

Each package contains 100 tablets in blisters.

The holder of the marketing authorization is:

sanofi-aventis, S.A.

C/ Rosselló i Porcel, 21

08016 Barcelona

Spain

The manufacturer responsible is:

Sanofi S.r.l.

Via Valcanello, 4

03012 Anagni (FR) Italy

Date of the last review of this leaflet:August 2024

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