Rifaldin 20 mg/ml oral suspension

Patient Information Leaflet

Introduction

Patient Information Leaflet

Rifaldin 20 mg/ml oral suspension

Rifampicin

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 only, and you should not give it to other people, even if they have the same symptoms as you, because it may 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.

Leaflet contents:

1. What Rifaldin 20 mg/ml oral suspension is and what it is used for
2. What you need to know before taking Rifaldin 20 mg/ml oral suspension
3. How to take Rifaldin 20 mg/ml oral suspension
4. Possible side effects
5. How to store Rifaldin 20 mg/ml oral suspension
6. Contents of the pack and other information

1. What Rifaldin 20 mg/ml oral suspension is and what it is used for

Rifaldin is an antibiotic belonging to a group of antibiotics called rifamycins. It works by stopping the growth of bacteria that cause infections.

Rifaldin is indicated for the treatment of infections caused by bacteria against which this medication is active, such as:

• Tuberculosis in all its forms (in combination with other antituberculosis agents).

• Brucellosis.

• Eradication of meningococci in individuals without symptoms of the disease (asymptomatic carriers). It is not indicated for the treatment of established meningococcal infection.

Infections in which sensitivity to Rifaldin has previously been demonstrated, and when it is not appropriate to administer other antibiotics or chemotherapeutic agents to the patient, either due to allergy or the existence of contraindications making them inadvisable.

2. What you need to know before taking Rifaldin 20 mg/ml oral suspension

Do not take Rifaldin:

• if you are allergic to rifamycins or to any of the other ingredients of this medicine
  (listed in section 6).
• if you have liver disease and have yellowing of the skin (jaundice).
• if you are taking medicines containing:
  • saquinavir/ritonavir or elvitegravir/cobicistat combinations (antiretroviral medicines).
  • atazanavir, darunavir, fosamprenavir, tipranavir, rilpivirine, or dolutegravir/rilpivirine (antiretroviral medicines).
  • nifedipine, nimodipine, nisoldipine, or nitrendipine (antihypertensive medicines).
  • glecaprevir/pibrentasvir or elbasvir/grazoprevir (medicines for hepatitis C).
  • voriconazole (antifungal medicine).
  • artemether/lumefantrine (antimalarial medicine).
  • BCG live dried 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 Rifaldin with other medicines” below).

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

Warnings and precautions

Talk to your doctor or pharmacist before starting Rifaldin.

• If symptoms of tuberculosis return or worsen (see section “4. Possible side effects”).

• If you have any impairment of liver function. In this case, your doctor will reduce your dose and monitor your liver function periodically by blood tests before treatment and every 2–4 weeks during treatment. If liver cell damage occurs, your doctor will stop your 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.

• If you take rifampicin together with isoniazid (a medicine for tuberculosis), or if you are elderly or an adolescent, malnourished, or predisposed to nervous system disorders (e.g., if you are diabetic), your doctor may prescribe additional vitamin B6 supplementation.

• During treatment, a serious reaction such as drug reaction with eosinophilia and systemic symptoms (DRESS) may occur (see section 4. Possible side effects). If you develop early signs of hypersensitivity to Rifaldin such as fever, lymphadenopathy (swollen lymph nodes), or biological abnormalities (eosinophilia – increased levels of a specific type of white blood cells – or liver disturbances), with or without skin rash, contact your doctor immediately.

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

• If you develop a severe, widespread blistering 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 diabetic. Treatment with rifampicin may complicate the management of diabetic patients.

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

• Rifampicin may interfere with various medicines at the level of absorption and biochemical processing/metabolism, and therefore could reduce or increase the exposure, safety, and efficacy of these medicines (see “Use of Rifaldin 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 side 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 breathing problems and interfere with normal respiration due to fluid accumulation in the lungs, potentially leading to life-threatening conditions.

Contraception in men and women

Rifaldin may harm the unborn baby and may reduce the effectiveness of hormonal contraceptives (the "birth control pill"). If you are a man capable of fathering children, or a woman who could become pregnant, you must use effective non-hormonal contraceptive methods during treatment and for a period of time after treatment ends. A woman may be asked to take a pregnancy test before starting treatment (see sections “Other medicines” and “Pregnancy, breastfeeding and fertility”).

Use of Rifaldin with other medicines

Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines.

Rifampicin increases the elimination of many medicines from the body, which may reduce their activity. These include:

• medicines for epilepsy: phenytoin, phenobarbital

• medicines for irregular heartbeats (heart 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 such as digoxin (for heart failure)

• medicines for blood clotting disorders: warfarin

• medicines for mental disorders: haloperidol

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

• HIV medicines: cabotegravir, fostemsavir, 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 organ 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 vomiting: ondansetron

• medicines for cancer: irinotecan

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

• medicines with estrogenic and antiestrogenic 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 reduced 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.

If you are taking systemic hormonal contraceptives, you should use another non-hormonal contraceptive method during treatment with Rifaldin.

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

Concurrent use of Rifaldin and enalapril reduces enalapril activity. If your clinical condition allows, your doctor may need to adjust your dose.

When atovaquone and Rifaldin are used together, atovaquone concentrations decrease and rifampicin concentrations increase.

You must not take Rifaldin with para-aminosalicylic acid (a medicine used to treat tuberculosis), as it reduces blood levels of rifampicin. Therefore, an 8-hour interval between the administration of both medicines is recommended.

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

Concurrent use of rifampicin with halothane or isoniazid increases the potential for hepatotoxicity. Rifaldin must not be used with halothane. If you are being treated with both rifampicin and isoniazid, your doctor will monitor your liver function periodically (see section 2. Warnings and precautions).

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

Concomitant use with maraviroc, another antiretroviral medicine, is also not recommended; if use is 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 in the same group), should be avoided, as it may cause severe coagulation disorders (when blood loses its liquidity and turns into a gel to form a clot), potentially leading to fatal outcomes (especially with high doses).

You must not take Rifaldin with the combination saquinavir/ritonavir (antiretroviral medicines).

Rifaldin alters the results of certain laboratory tests, such as:

• blood tests for folate and vitamin B12,
• bromsulphthalein test,
• blood bilirubin levels,
• it may interfere with contrast agents used to examine your gallbladder.

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

In patients treated with rifampicin, false positive results for urinary opioids have been reported when tested with the ICMS (Kinetic Interaction of Microparticles in Solution) assay. For this reason, alternative techniques such as gas chromatography and mass spectrometry are recommended in these patients.

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

Taking Rifaldin with food, drinks, and alcohol

The absorption of Rifaldin is affected by food. Therefore, to ensure adequate absorption, take Rifaldin on an empty stomach, i.e.:

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

Pregnancy, breastfeeding, and fertility

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.

Pregnancy

Since rifampicin crosses the placental barrier and sufficient data are not available to establish its safety during pregnancy, your doctor will carefully assess whether the use of Rifaldin during pregnancy is appropriate. Under no circumstances will it be administered during the first three months of pregnancy.

Animal studies and laboratory tests have shown a potential risk of DNA damage.

If you are a man capable of fathering children, you must use effective contraceptive methods to avoid fathering a child during treatment and for 3 months after treatment ends.

If you are a woman who could become pregnant, you must use effective contraceptive methods during treatment and for 6 months after treatment ends. Rifaldin may reduce the effectiveness of hormonal contraceptives (the "birth control pill"). Therefore, you should use other methods (barrier contraceptives) during treatment with Rifaldin. If you have any questions or are unsure which contraceptive methods to use, consult your doctor or pharmacist.

Breastfeeding

Although rifampicin is excreted in small amounts in breast milk, no harmful effects on infants have been established. If treatment of the mother with this medicine is necessary, breastfeeding may continue.

Fertility

There are no data on the long-term ability of rifampicin to affect fertility.

It is unknown whether Rifaldin may affect fertility in humans; however, data from animal studies and laboratory tests suggest that fertility may be affected.

Driving and using machines

Rifampicin may cause certain adverse effects that may impair your ability to drive or use machines. If you experience these adverse effects (difficulty breathing, nausea, vomiting, muscle weakness), do not drive or operate machinery.

Rifaldin 20 mg/ml oral suspension contains sucrose, ethanol, sodium metabisulfite, methyl parahydroxybenzoate, and propyl parahydroxybenzoate.

This medicine contains sucrose. If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medicine.

Patients with diabetes mellitus should be aware that this medicine contains 2 g of sucrose per 5 ml dose of oral suspension. It may cause dental caries.

This medicine contains 0.95 mg of alcohol (ethanol) per ml of oral suspension, equivalent to 0.1% (w/v). The amount in 1 ml of this medicine is equivalent to less than 0.023 ml of beer or 0.009 ml of wine.

The small amount of alcohol in this medicine does not produce any noticeable effect.

This medicine may cause severe allergic reactions and bronchospasm (sudden sensation of suffocation) because it contains sodium metabisulfite (E223).

It may cause allergic reactions (possibly delayed) and, rarely, bronchospasm (sudden sensation of suffocation) because it contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216).

This medicine contains less than 23 mg of sodium (1 mmol) per bottle; hence, it is essentially “sodium-free”.

3. How to take Rifaldin 20 mg/ml oral suspension

Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. If in doubt, consult your doctor or pharmacist again.

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

Shake well before use.

Under no circumstances should the daily dose exceed 600 mg.

Use in children:

The dose for children is based on body weight. It usually ranges between 10 mg and 20 mg per kg of body weight per day.

The usual dose for children in the treatment of tuberculosis is 15 mg/kg/day. In children with altered body weight, a dose reduction may be necessary. In severe infections, such as meningitis, a higher dose may be used, for example 20 mg per kg of body weight per day.

If you take more Rifaldin 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. In patients with severe liver (hepatic) disease, loss of consciousness could occur. In pediatric patients, facial or periorbital edema has also been reported. In some fatal cases, hypotension, sinus tachycardia, ventricular arrhythmias, seizures, and cardiac arrest have been reported.

A temporary increase in liver enzymes and/or bilirubin may also occur.

Additionally, a reddish-brown or orange discoloration may appear in the skin, urine, sweat, saliva, tears, and feces. The intensity of this coloration will vary depending on the amount of medicine taken.

Your doctor will provide appropriate symptomatic treatment, such as gastric lavage and/or induction of vomiting, administration of medications for symptom relief, and monitoring of liver and kidney function.

In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicology Information Service at: 915620420, indicating the medicine and the amount ingested.

If you forget to take Rifaldin

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

4. Possible adverse effects

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

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

• Renal failure (kidneys are unable to filter toxins properly).
• Thrombocytopenia (reduction in the number of platelets in the blood).
• Haemolytic anaemia (destruction of red blood cells in the blood earlier than normal).

Your doctor will instruct you to immediately stop 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 bleeding (purpura).
• Headache, dizziness.
• Nausea, vomiting.
• Increased blood bilirubin, elevated transaminases [aspartate aminotransferase (AST), alanine aminotransferase (ALT)].
• Paradoxical drug reaction: Symptoms of tuberculosis may reappear or new symptoms may develop 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 inflammation (lymphadenitis), difficulty breathing, and cough. Patients with paradoxical drug reactions may also experience headache, loss of appetite, and weight loss.

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

• Leucopenia (reduction in the number of white blood cells).
• Diarrhoea.

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-like illness.
• Disseminated intravascular coagulation (widespread blood clotting problems within blood vessels).
• Eosinophilia (increase in a specific group of white blood cells).
• Agranulocytosis (reduction in a type of white blood cells, granulocytes).
• Haemolytic anaemia (reduction 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 the adrenal glands in patients with kidney impairment).
• Decreased appetite.
• Psychotic disorder (mental state involving loss of contact with reality).
• Cerebral haemorrhage and death, in cases where treatment with rifampicin has been continued or restarted after the onset of purpura (purple skin spots).
• Change in the colour of tears.
• Shock (cardiogenic circulatory failure syndrome), rubefaction (skin redness), vasculitis (inflammation of blood vessels), severe bleeding.
• Dyspnoea (shortness of breath or difficulty breathing), wheezing (noises during breathing), change in sputum colour.
• Gastrointestinal disorder, abdominal discomfort, discolouration of teeth (which may be permanent).
• Hepatitis (inflammation of the liver), hyperbilirubinaemia (elevated bilirubin in blood), cholestasis (reduced bile flow) (see section 2. Warnings and precautions).
• Erythema multiforme.
• Severe skin reactions such as acute generalised exanthematous pustulosis (red, scaly rash with bumps under the skin and blisters), Stevens-Johnson syndrome (widespread rash with blisters and skin peeling, particularly around the mouth, nose, eyes and genitals), and toxic epidermal necrolysis [widespread rash with blisters and skin peeling, particularly around the mouth, nose, eyes and genitals, causing widespread skin detachment (more than 30% of body surface)], drug reaction with eosinophilia and systemic symptoms [(DRESS) influenza-like symptoms with skin rash, fever, gland swelling, 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 colour.
• 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 coloured urine).
• Postpartum haemorrhage.
• Fetomaternal haemorrhage (fetal blood entering maternal circulation).
• Menstrual disorder.
• Porphyria.
• Oedema (skin swelling due to fluid accumulation).
• Decreased blood pressure.
• Increased blood creatinine.
• Increased liver enzymes.
• Lung inflammation (interstitial lung disease/pneumonitis): inform your doctor immediately if you develop a new or sudden worsening of breathing difficulty, possibly with cough or fever.

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may 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 Rifaldin 20 mg/ml oral suspension

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

Do not store above 25°C.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Rifaldin

• The active substance is rifampicin. Each ml of suspension contains 20 mg of rifampicin.
• The other components (excipients) are: agar-agar, sucrose, potassium sorbate (E202), methylparahydroxybenzoate (E218), propylparahydroxybenzoate (E216), sodium metabisulfite (E223), polysorbate, saccharin, diethanolamine (q.s. pH= 4.65), raspberry flavour (containing ethanol), and purified water.

Appearance of the medicinal product and contents of the pack

Rifaldin 20 mg/ml oral suspension is supplied in bottles containing 120 ml.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

sanofi-aventis, S.A.

C/ Rosselló i Porcel, 21

08016 Barcelona

Spain

Manufacturer

Sanofi S.r.l.

Via Valcanello, 4

03012 Anagni (FR) Italy

Date of the most recent review of this leaflet: March 2026

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