Rifater tablets coated

Patient Information Leaflet

Introduction

Patient Information Leaflet

Rifater coated tablets

Rifampicin/Isoniazid/Pyrazinamide

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

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

• If you have any questions, consult your doctor or pharmacist.

• This medicine has been prescribed for you and should not be given to other people, even if they have the same symptoms as you, because it could harm them.

• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Package leaflet:

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

Contents of the pack and other information

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

Rifater comes in blisters containing 100 coated tablets and is an antibiotic belonging to the group of antituberculosis combinations. Antibiotics stop the growth of bacteria that cause infections.

Antibiotics are used to treat bacterial infections and are not effective against viral infections such as influenza or the common cold.

It is important that you follow your doctor's instructions regarding dose, dosing interval, and duration of treatment.

Do not store or reuse this medicine. If you have any antibiotic left after completing the treatment, return it to the pharmacy for proper disposal. Medicines must not be disposed of via wastewater or household waste.

Rifater is indicated for the intensive phase of short or ultrashort treatment of pulmonary tuberculosis.

During this phase, which usually lasts 2 months, Rifater is generally administered daily in combination with another antituberculosis medicine.

After completion of this phase, it is appropriate to switch to a treatment with a medicine containing rifampicin and isoniazid.

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

Do not take Rifater

• If you are allergic to rifamycins, isoniazid, pyrazinamide, or any of the other components of this medicine (see section 6).

• If you have liver disease or suffer from jaundice (yellowing of the skin and/or the eye's conjunctiva).

• If you are pregnant or breastfeeding.

• If you are under 12 years of age.

• If you are taking medications containing:

• Combinations of saquinavir/ritonavir or elvitegravir/cobicistat (antiretroviral medicines).

• Atazanavir, darunavir, fosamprenavir, tipranavir, rilpivirine, or dolutegravir/rilpivirine (antiviral medicines).

• Nifedipine, nimodipine, nisoldipine, or nitrendipine (antihypertensive medicines).

• Glecaprevir/pibrentasvir or elbasvir/grazoprevir (medicines for hepatitis C).

• Voriconazole (an antifungal medicine).

• Artemether/lumefantrine (an antimalarial medicine).

• Live, dried BCG culture (interferon).

  • If you are currently taking any of the following medicines:
    • Sofosbuvir: an antiviral medicine used to treat hepatitis C virus infections.
    • Cabotegravir, fostemsavir, lenacapavir: medicines for HIV.
    • Lurasidone: a medicine for schizophrenia and bipolar disorders (see section “Use of Rifater with other medicines” below).

Because rifampicin may reduce blood concentrations of various medicines, including those listed above.

• If you have ever developed a severe skin rash, skin peeling, blisters, and/or mouth sores after taking Rifater.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Rifater:

• If symptoms of tuberculosis reappear or worsen (see section 4. Possible adverse effects).

• If you are diabetic. Treatment with rifampicin may complicate the management of diabetic patients.

• Since this medicine is a combination of three drugs (rifampicin, isoniazid, and pyrazinamide), each of which has been associated with impaired liver function, your doctor will periodically monitor your liver by performing blood tests before treatment and every 2–4 weeks during treatment. If liver cell damage occurs, your doctor will discontinue the 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 injury.

• During treatment, serious skin reactions may occur, such as drug reaction with eosinophilia and systemic symptoms (DRESS), Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN), some of which can be fatal (see section 4. Possible adverse effects). If you develop signs of hypersensitivity to Rifater such as fever, lymphadenopathy (swelling of lymph nodes), biological abnormalities (eosinophilia—an increase in a certain type of white blood cells, liver disturbances), with or without skin rash, blisters, or mucosal lesions, contact your doctor immediately.

Rifater should be discontinued if no other cause for these symptoms can be established.

• If you develop a severe, widespread blistering skin rash, with blister formation or skin peeling, along with flu-like symptoms and fever (Stevens-Johnson syndrome), general malaise, 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 must be stopped 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 supplemental vitamin B6.

• If you have or have had gout and experience an acute gout attack, your doctor will switch your treatment to a medicine that does not contain pyrazinamide.

• Due to rifampicin, discoloration (yellow, orange, red, brown) may occur in your teeth, urine, sweat, sputum, tears, and feces, which is clinically insignificant. Similarly, it may cause permanent staining of soft contact lenses.

• Rifampicin may interact with various medications at the level of absorption, biochemical transformation, and metabolism, and thus could reduce or increase the exposure, safety, and efficacy of these medications (see “Use of Rifater with other medicines”).

• If you have a bleeding disorder or a tendency to bruise easily. Rifampicin may cause vitamin K-dependent coagulopathy (meaning it may reduce blood clotting ability) and severe bleeding (see section “Possible adverse effects”).

• If you are taking other antibiotics at the same time.

• If you have a history of lung inflammation (interstitial lung disease/pneumonitis).

• If you experience new or sudden worsening of breathing difficulty, possibly with dry cough or fever unresponsive to antibiotic treatment. These may be symptoms of lung inflammation (interstitial lung disease/pneumonitis) and may lead to serious respiratory problems and interfere with normal breathing due to fluid accumulation in the lungs, which can result in life-threatening conditions.

• If you notice any symptoms related to cerebellar syndrome described in section 4—Possible adverse effects. This syndrome has been mainly reported in patients with chronic kidney disease. Your healthcare provider may reduce the dose or instruct you to stop treatment.

Use of Rifater with other medicines

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

The interactions of Rifater when taken with other medicines may be due to rifampicin, isoniazid, and pyrazinamide, which are the active substances in this medicine.

Rifampicin increases the elimination of many drugs from the body, potentially reducing their activity. These include:

• medicines for epilepsy: phenytoin, phenobarbital

• medicines for heart rhythm disorders (arrhythmias): disopyramide, mexiletine, quinidine, propafenone, tocainide

• medicines for other heart problems: beta-blockers and losartan (for high blood pressure), calcium channel blockers such as diltiazem, nifedipine, or verapamil, cardiac glycosides like digoxin (for heart failure)

• medicines for blood clotting disorders: warfarin

• medicines for mental disorders: haloperidol

• medicines for fungal infections: caspofungin, fluconazole, itraconazole, ketoconazole

• medicines for HIV: cabotegravir, fostemsavir, and lenacapavir

• medicines for HIV infection: zidovudine, saquinavir, indinavir, efavirenz

• medicines used as anesthetics: thiopental

• some antibiotics: chloramphenicol, clarithromycin, doxycycline, fluoroquinolones, telithromycin

• corticosteroids (e.g., prednisolone)

• medicines to prevent transplant rejection: cyclosporine, tacrolimus, sirolimus

• systemic hormonal contraceptives (including estrogens and progestogens)

• other medicines for infections: dapsone (for leprosy and/or malaria) and quinine (for malaria)

• medicines for diabetes: sulfonylureas (glipizide, glyburide), rosiglitazone

• medicines for depression: nortriptyline

• medicines for anxiety and/or insomnia: diazepam, zopiclone, zolpidem

• medicines for pain: opioid analgesics (oxycodone, morphine)

• medicines for high cholesterol: clofibrate, statins (e.g., simvastatin)

• medicines for nausea and vomiting: ondansetron

• medicines for cancer: irinotecan

• medicines for neurodegenerative diseases such as amyotrophic lateral sclerosis: riluzole

• medicines with estrogenic and anti-estrogenic activity (tamoxifen, toremifene)

• antiviral medicines for hepatitis C (daclatasvir, simeprevir, sofosbuvir, telaprevir, velpatasvir, voxilaprevir)

• other medicines: hexobarbital (barbiturate), levothyroxine (for hypothyroidism), methadone, theophylline (for asthma), praziquantel (for helminthic parasites)

• some medicines used to thin the blood, such as clopidogrel

• dapsone: if you are taking dapsone (an antibiotic) with rifampicin, hematological toxicity may occur, including decreased blood cells and bone marrow suppression, and methemoglobinemia (reduced oxygen in the blood due to changes in red blood cells).

• lurasidone for schizophrenia and bipolar disorders, as rifampicin may reduce blood levels of lurasidone.

If you are taking any of these medicines, your doctor may need to adjust your 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.

Concurrent use of ketoconazole and rifampicin decreases serum levels of both drugs.

If you are taking enalapril (a medicine for high blood pressure) at the same time as Rifater, your doctor will adjust the enalapril dose, as rifampicin reduces its blood concentration and thus its effectiveness.

If you are using systemic hormonal contraceptives, your doctor will advise you to switch to a non-hormonal contraceptive method during treatment with Rifater, as its contraceptive effect may be reduced.

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

Concomitant use with a group of antiretroviral drugs, 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 medicine, is also not recommended; if clinically justified, dose adjustment is required.

Concomitant use of rifampicin with other antibiotics that cause vitamin K-dependent coagulopathy (reduced blood clotting ability), such as cefazolin (or other cephalosporins of the same group), should be avoided, as it may lead to serious coagulation disorders (when blood loses its liquidity and forms a gel-like clot), potentially resulting in fatal outcomes (especially with high doses).

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

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

Para-aminosalicylic acid (a medicine used to treat tuberculosis) increases blood concentrations of isoniazid.

Interference with laboratory tests

Rifater may alter the results of certain laboratory tests, such as:

• blood tests for folate and vitamin B12,
• bromsulphthalein test,
• blood bilirubin levels,
• it may impair the elimination of contrast agents used in gallbladder imaging.

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

In patients treated with rifampicin, false-positive results for opioids in urine have been reported when tested using the ICMS (ImmunoChemistry MicroParticle System) assay. For this reason, alternative methods such as gas chromatography and mass spectrometry are recommended for these patients.

Inform your doctor or pharmacist if you are pregnant or if you are planning or require termination of pregnancy with mifepristone.

Taking Rifater with food, drinks, and alcohol

Isoniazid interacts with foods containing a substance called tyramine, found in foods such as cheese and red wine. Also, if taken with foods containing histamine (e.g., tuna or other tropical fish), it may cause an exaggerated response with headache, sweating, palpitations, flushing, and low blood pressure. Therefore, your doctor will advise you not to consume foods containing tyramine or histamine during treatment with Rifater.

Pregnancy, lactation, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine.

This medicine should not be taken during pregnancy.

Rifampicin, isoniazid, and pyrazinamide are excreted in breast milk; therefore, you should not breastfeed during treatment.

Consult your doctor or pharmacist before taking any medicine.

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

Driving and use of machines

Rifampicin may cause certain adverse effects that could interfere with the ability to drive and operate machinery. If you experience these adverse effects (difficulty breathing, nausea, vomiting, muscle weakness), you should not drive or operate machinery.

Rifater contains saccharose

This medicinal product contains saccharose. If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicinal product. Patients with diabetes mellitus should be aware that this medicine contains 105 mg of saccharose per coated tablet.

Rifater contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per tablet, i.e., essentially "sodium-free".

3. How to take Rifater coated tablets

Follow exactly the instructions for use of Rifater provided by your doctor. If in doubt, consult your doctor or pharmacist again.

Remember to take your medicine.

Your doctor will determine your daily dose and the duration of your treatment. Do not stop your treatment prematurely. The dosage is individualized and may be adjusted by your doctor depending on your response to treatment.

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

The absorption of Rifater is affected by food; therefore, to ensure proper absorption, Rifater must be taken on an empty stomach, that is:

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

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

The recommended dose in adults varies according to body weight as follows:

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 medicine is not recommended for use in children due to differing dosage requirements.

If you take more Rifater than you should

Contact your doctor immediately or go to the nearest hospital emergency department, taking this leaflet with you.

After an overdose of this medicine, nausea, vomiting, stomach pain, itching, headache, and increasing drowsiness may occur. If you have severe liver disease, loss of consciousness may occur. Dizziness, difficulty speaking, blurred vision, visual hallucinations (bright colors and strange shapes), serious breathing difficulties, and severe seizures may also occur.

A temporary increase in liver enzymes and/or bilirubin may occur, potentially leading to liver toxicity and increased blood urate concentrations.

Additionally, due to rifampicin, a reddish discoloration may appear in the skin, urine, sweat, saliva, tears, and feces; the intensity of this coloration varies depending on the amount of medicine taken. It may also cause permanent staining of soft contact lenses.

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

If you forget to take Rifater

Do not take a double dose to make up for a missed dose.

If you stop taking Rifater

It is important to follow your doctor's instructions, as taking the treatment intermittently (less than 2 or 3 times per week) may cause serious allergic reactions. If treatment is interrupted and then restarted, it should be resumed with small doses that are gradually increased.

4. Possible adverse effects

Like all medicines, Rifater can cause adverse effects, although not everybody will experience them.

Due to Rifater

Common adverse effects (may affect up to 1 in 10 patients):

• Paradoxical drug reaction: Symptoms of tuberculosis may reappear or new symptoms may arise after initial improvement during treatment. Paradoxical reactions have been reported as early as 2 weeks and as late as 18 months after starting tuberculosis treatment. Paradoxical reactions are usually associated with fever, lymph node swelling (lymphadenitis), difficulty breathing, and cough. Patients experiencing paradoxical drug reactions may also have headache, loss of appetite, and weight loss.

Due to rifampicin:

Like all medicines, this medicine can cause adverse effects, although not everybody will 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):

• Renal failure (kidneys unable to adequately filter toxins).
• Thrombocytopenia (decrease in the number of platelets in the blood).
• Hemolytic anemia (destruction of red blood cells in the blood earlier than normal).

Your doctor will instruct you to immediately discontinue treatment with rifampicin and not to take this medicine again.

Very common adverse effects (may affect more than 1 in 10 patients):

• Fever, chills.

Common adverse effects (may affect up to 1 in 10 patients):

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

Uncommon adverse effects (may affect up to 1 in 100 patients):

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

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

• Pseudomembranous colitis (severe inflammation of the intestine that may occur after antibiotic treatment).
• Influenza.
• Disseminated intravascular coagulation (widespread blood clotting problems within blood vessels).
• Eosinophilia (increase in a certain group of white blood cells).
• Agranulocytosis (decrease in a type of white blood cells, granulocytes).
• Hemolytic anemia (decrease in the number of red blood cells due to their destruction).
• Vitamin K-dependent coagulation disorders.
• Anaphylactic reaction (severe allergic reaction with breathing difficulty and even loss of consciousness).
• Adrenal insufficiency (impaired function of adrenal glands in patients with kidney disorders).
• Decreased appetite.
• Psychotic disorder (mental state involving loss of contact with reality).
• Cerebral hemorrhage and death in cases where treatment with rifampicin was continued or restarted after the appearance of purpura (purple skin spots).
• Change in the color of tears.
• Shock (cardiovascular failure syndrome), flushing (reddening of the skin), vasculitis (inflammation of blood vessels), severe bleeding.
• Dyspnea (shortness of breath or difficulty breathing), wheezing (breathing sounds), change in sputum color.
• Gastrointestinal disorder, abdominal discomfort, discoloration of teeth (which may be permanent).
• Hepatitis (liver inflammation), hyperbilirubinemia (elevated bilirubin in blood), cholestasis (reduced bile flow) (see section 2. Warnings and precautions).
• Erythema multiforme.
• Severe skin reactions such as acute generalized exanthematous pustulosis (red, scaly rash with bumps under the skin and blisters), Stevens-Johnson syndrome (widespread rash with blisters and skin peeling, especially around the mouth, nose, eyes, and genitals), and toxic epidermal necrolysis [widespread rash with blisters and skin peeling, especially around the mouth, nose, eyes, and genitals, causing widespread skin peeling (more than 30% of body surface area)], drug reaction with eosinophilia and systemic symptoms [(DRESS) flu-like symptoms with skin rash, fever, swollen glands, and abnormal blood test results such as increased white blood cells (eosinophilia) and elevated liver enzymes] (see section 2. Warnings and precautions).
• 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 injury usually due to death of kidney cells (renal tubular necrosis) or inflammation of the kidneys (tubulointerstitial nephritis).
• Chromaturia (abnormally colored urine).
• Postpartum hemorrhage.
• Fetomaternal hemorrhage (fetal blood entering maternal circulation).
• Menstrual disorder.
• Porphyria.
• Edema (skin swelling due to fluid accumulation).
• Low blood pressure.
• Increased blood creatinine.
• Increased liver enzymes.
• Lung inflammation (interstitial lung disease/pneumonitis): inform your doctor immediately if you develop new or sudden worsening of breathing difficulty, possibly with cough or fever.

Due to isoniazid:

Uncommon adverse effects (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, malaise, loss of appetite, nausea or vomiting, which may be severe and occasionally fatal.

• Seizures, toxic encephalopathy (brain dysfunction due to neurological disorder caused by toxic substances), optic neuritis (inflammation of the optic nerve that may cause sudden partial or complete vision loss, although visual function often recovers), optic atrophy, memory impairment, and toxic psychosis (psychotic disorder caused by substance abuse).

• Nausea, vomiting, stomach pain.

Rare adverse effects (may affect up to 1 in 1,000 patients):

• Widespread rash with blisters and skin peeling, particularly around the mouth, nose, eyes, and genitals, causing widespread skin peeling (more than 30% of body surface area) (toxic epidermal necrolysis or TEN).
• Flu-like symptoms with skin rash, fever, swollen glands, 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).

Very rare adverse effects (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 cells, granulocytes).
• Anaphylactic reactions (severe allergic reaction with breathing difficulty and even loss of consciousness).
• Pellagra (digestive disorders, limb pain, weakness, redness with skin peeling, and nervous system disturbances).
• Polyneuritis (inflammation of several nerves) presenting as paresthesia (tingling sensation), muscle weakness, and loss of tendon reflexes.
• Rash (skin eruption).
• Acne.
• Exfoliative dermatitis (skin inflammation with peeling).
• Stevens-Johnson syndrome (SJS): widespread rash with blisters and skin peeling, particularly around the mouth, nose, eyes, and genitals.
• Pemphigus (skin disorder with blisters).
• Systemic lupus erythematosus-like syndrome (serious skin and mucous membrane disease of unknown origin, sometimes causing fatigue and weight loss, fever, arthritis, kidney involvement, seizures, mental disorders, and gastrointestinal disturbances).
• Fever.

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

• Inflammation of the pancreas (pancreatitis), causing severe abdominal and back pain.
• Gynecomastia (pathological enlargement of one or both mammary glands).
• Vasculitis (inflammation of blood vessels).
• Cerebellar syndrome including: poor coordination of movements, loss of balance, speech changes, involuntary eye movements.
• Hair loss.

Due to pyrazinamide:

Uncommon adverse effects (may affect up to 1 in 100 patients):

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

Very rare adverse effects (may affect up to 1 in 10,000 patients):

• Sideroblastic anemia (a 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 skin spots).
• Active gout, anorexia (decreased appetite).
• Hepatitis (liver disease), so your doctor will monitor your liver function. Hepatic reactions are the most common adverse reactions, ranging from asymptomatic alterations in liver cell function (detected only through liver function tests) to mild syndrome with fever, malaise, and soft liver, to more serious reactions such as jaundice (yellowing of the skin and/or eye conjunctiva), and in isolated cases acute liver atrophy and death.
• Drug reaction with eosinophilia and systemic symptoms (DRESS): flu-like symptoms with skin rash, fever, swollen glands, and abnormal blood test results such as increased white blood cells (eosinophilia) and elevated liver enzymes.
• Urticaria.
• Pruritus (itching).
• Erythema (red spots).
• Rash (skin eruption).
• Angioedema (generalized hives accompanied by swelling of feet, hands, throat, lips, and airways).
• Arthralgia (joint pain).
• Dysuria (painful urination).
• Fever.
• Malaise.

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

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

Stop taking Rifater and seek immediate medical attention if you notice any of the following symptoms with frequency not known (cannot be estimated from available data):

• Red, non-elevated, target-shaped or circular spots on the trunk, often with central blisters, skin peeling, and ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).

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 not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Rifater coated tablets

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

Do not store above 25°C.

Do not use Rifater after the expiry date indicated on the packaging after EXP. The expiry date refers to the last day of the month stated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Rifater coated tablets

The active substances 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, gum arabic, talc, povidone K-30, titanium dioxide (E-171), kaolin, magnesium carbonate, colloidal silica, aluminium hydroxide, iron oxide.

Appearance of the product and contents of the pack

Rifater is presented as pale pink, smooth, glossy, round and convex coated tablets.

Each pack contains 100 tablets in blisters.

Marketing Authorization Holder:

sanofi-aventis, S.A.

C/ Rosselló i Porcel, 21

08016 Barcelona

Spain

Manufacturer responsible for manufacturing:

Sanofi S.r.l.

Via Valcanello, 4

03012 Anagni (FR) Italy

Date of the most recent revision of this leaflet: February 2026

Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.