Rimactan 300 mg hard capsules

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Rimactán 300 mg hard capsules

rifampicin

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, 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.

Contents of the leaflet

1. What Rimactán is and what it is used for
2. What you need to know before taking Rimactán
3. How to take Rimactán
4. Possible side effects
5. Storage of Rimactán
6. Contents of the pack and other information

1. What Rimactán is and what it is used for

Rimactán contains rifampicin, which belongs to a group of antibiotics known as rifamycins. It works by stopping 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 dosage, frequency, and duration of treatment.

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

Rimactán is indicated for the treatment of infections such as:

• Tuberculosis in all its forms (in combination with other antituberculosis medications).
• Non-mycobacterial infections: other infections different from tuberculosis, when your doctor considers Rimactán appropriate. Rimactán must be taken in combination with other antibiotics.
• Brucellosis: used in combination with a tetracycline.

Rimactán is also indicated for prevention of:

• Meningococcal meningitis: Rimactán may only be taken if you have had direct contact with a person suffering from meningococcal meningitis (at home, in daycare, at school, or in collective housing) and have not yet developed the disease.

Rimactán must not be used for the treatment of meningococcal meningitis.

This treatment should follow official recommendations for tuberculosis management, particularly those of the World Health Organization (WHO).

2. What you need to know before taking Rimactan

Do not take Rimactan:

• if you are allergic to rifampicin or to any of the other ingredients of this medicine (listed in section 6),
• if you have a history of liver disease caused by medications or acute hepatitis of any origin, or if you have yellowing of the skin (jaundice),
• if you suffer from porphyria (a group of disorders characterized by light sensitivity, skin lesions, anemia, psychosis, and acute abdominal pain),
• if you are taking voriconazole (a medicine used to treat fungal infections) or protease inhibitors except ritonavir (medicines for the treatment of human immunodeficiency virus (HIV) infection causing AIDS),
• if you have severe renal impairment.

If you are currently taking any of the following medicines:

• Sofosbuvir: an antiviral medicine for the treatment of hepatitis C virus infections,
• cabotegravir, fostemsavir, lenacapavir: HIV medicines,
• lurasidone,

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

Warnings and precautions

Talk to your doctor or pharmacist before taking Rimactan:

• bacterial resistance may develop. To prevent resistance during treatment of infections, Rimactan must be used in combination with other antibiotics/chemotherapeutic agents,
• if you experience serious complications such as changes in blood cells, purple spots on the skin, difficulty breathing and asthma-like attacks, shock and renal failure, fever or other skin reactions, your doctor will stop treatment,
• if you have chronic liver disease, are alcoholic, or are malnourished. Your doctor may reduce your dose of rifampicin,
• if you are using hormonal contraceptives, as their effectiveness may be reduced and you will need to adopt additional contraceptive measures,
• in premature infants and newborns. It will be used only in emergencies and with special caution, as their hepatic enzyme system is not fully developed,
• Rimactan is not recommended in children under 6 years of age due to the risk of aspiration,
• you should not take rifampicin and pyrazinamide simultaneously for the treatment of latent tuberculosis infection due to the risk of severe liver damage,
• 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 experience early signs of hypersensitivity to rifampicin such as fever, lymphadenopathy (swollen lymph nodes), or biological abnormalities (eosinophilia; increase in a certain group of white blood cells, liver disorders), with or without skin rash, contact your doctor immediately. The use of rifampicin 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, as well as 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 should be stopped,
• if you are diabetic. Treatment with rifampicin may complicate the management of diabetic patients,
• a 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 the absorption and biochemical/metabolic processing of various drugs and thus could reduce the exposure, safety, and efficacy of these drugs (see "Other medicines and Rimactan"),
• rifampicin may interfere with the absorption and biochemical/metabolic processing of various drugs and thus could reduce the exposure, safety, and efficacy of these drugs (see "Other medicines and Rimactan"),
• 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.

At the beginning of treatment and during prolonged therapy, periodic blood cell counts and liver function tests are recommended.

Inform your doctor immediately while taking this medicine

• if symptoms of tuberculosis reappear or worsen (see section 4 "Possible side effects").

Other medicines and Rimactan

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Rifampicin increases the elimination of many drugs from the body, which may result in reduced activity of these drugs. These include:

• medicines for the treatment of epilepsy: e.g., phenytoin, phenobarbital,
• medicines for heart rhythm disorders (arrhythmias): e.g., disopyramide, mexiletine, quinidine, propafenone, tocainide,
• medicines for other heart problems: e.g., beta-blockers, losartan and amlodipine (for the treatment of high blood pressure), calcium channel blockers such as diltiazem, nifedipine or verapamil, cardiac glycosides such as digoxin (for the treatment of heart failure),
• medicines for blood clotting disorders: warfarin,
• medicines for mental disorders: e.g., haloperidol or aripiprazole,
• medicines for fungal infections: e.g., fluconazole, itraconazole, ketoconazole, voriconazole,
• medicines for HIV infection: e.g., saquinavir, indinavir, efavirenz, amprenavir, nelfinavir, atazanavir,
• antiviral medicines for the treatment of hepatitis C, e.g., daclatasvir, simeprevir, sofosbuvir, telaprevir, velpatasvir, voxilaprevir,
• some antibiotics: e.g., chloramphenicol, clarithromycin, dapsone, doxycycline, fluoroquinolones, telithromycin,
• medicines used as anesthetics, e.g., thiopental,
• corticosteroids,
• medicines to prevent transplant rejection: e.g., cyclosporine, tacrolimus, sirolimus,
• systemic hormonal contraceptives (including estrogens and progestogens),
• other medicines for the treatment of infections: dapsone (for the treatment of leprosy and/or malaria) and quinine (for the treatment of malaria),
• medicines for the treatment of diabetes: e.g., chlorpropamide, tolbutamide, sulfonylureas, rosiglitazone,
• medicines for the treatment of depression: e.g., amitriptyline, nortriptyline,
• medicines for the treatment of anxiety and/or insomnia: e.g., diazepam, benzodiazepines, zopiclone, zolpidem,
• medicines for pain relief, opioid analgesics (oxycodone, morphine),
• medicines for treating high cholesterol levels: e.g., clofibrate, statins, e.g., simvastatin,
• medicines for the treatment of nausea and vomiting: e.g., ondansetron,
• medicines for the treatment of cancer: e.g., irinotecan,
• medicines for the treatment of neurodegenerative diseases such as amyotrophic lateral sclerosis: e.g., riluzole,
• medicines with estrogenic and antiestrogenic activity, e.g., tamoxifen, toremifeno,
• antiviral medicines for the treatment of hepatitis C (daclatasvir, simeprevir, sofosbuvir, telaprevir, velpatasvir, voxilaprevir),
• other medicines: levothyroxine (for the treatment of hypothyroidism), methadone, theophylline (for the treatment of asthma), praziquantel (for the treatment of helminthic parasites), and gestrinone (for the treatment of hormonal disorders).

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

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

The concomitant use of ketoconazole and rifampicin reduces serum levels of both medicines.

The concomitant use of rifampicin and enalapril reduces enalapril's activity. If your clinical condition allows, your doctor may need to adjust your dose.

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

You should not take rifampicin together with para-aminosalicylic acid (a medicine used for the treatment of tuberculosis), as it reduces blood levels of rifampicin; therefore, an interval of 8 hours should be maintained between the administration of both medicines.

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

The concomitant use of rifampicin with halothane or isoniazid increases the potential for hepatotoxicity. Rifampicin should not be used with halothane. If you are receiving treatment with both rifampicin and isoniazid, your doctor will periodically monitor your liver function (see section "Warnings and precautions").

The concomitant use of rifampicin 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), 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 in the same group), should be avoided, as it may lead to severe coagulation disorders (when blood loses its liquidity and turns into a gel to form a clot), which could result in a fatal outcome (especially with high doses).

You should not take rifampicin together with the combination saquinavir/ritonavir (antiretroviral medicines).

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

• blood tests for folate and vitamin B12,
• the bromsulphthalein test,
• blood levels of bilirubin,
• 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 Rimactan.

In patients receiving rifampicin, false-positive results for opiates in urine have been reported when tested using the ICMS (Kinetic Interaction of Microparticles in Solution) assay. For this reason, other techniques such as gas chromatography and mass spectrometry are recommended in these patients.

Taking Rimactan with food, drinks, and alcohol

The absorption of Rimactan is affected by food; therefore, to ensure adequate absorption, you should take Rimactan 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

Rifampicin should be used in pregnant women or women of childbearing age only if the potential benefits outweigh the potential risks to the fetus. When rifampicin is administered during the last weeks of pregnancy, it may cause postnatal hemorrhage in both the mother and the newborn, for whom treatment with vitamin K1 is recommended.

Breastfeeding

Rifampicin is excreted in breast milk. Patients receiving rifampicin should not breastfeed unless your doctor considers that the benefit to the patient outweighs the potential risks to the infant.

Driving and using machines

The effect of rifampicin on the ability to drive and use machines is minor to moderate. Rifampicin may cause certain adverse effects that could interfere with the ability to drive and use machines. If you experience such adverse effects (difficulty breathing, nausea, vomiting, muscle weakness), you should not operate machinery.

Rimactan contains lactose

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

3. How to take Rimactán

Follow exactly the instructions for administration of this medicine given by your doctor. 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 prematurely. The dosage is individual for you and may be adjusted by your doctor depending on your response to treatment.

If you feel that the effect of Rimactán is too strong or too weak, inform your doctor or pharmacist. You must take Rimactán on an empty stomach, half an hour before a meal, with a glass of water.

Tuberculosis

The antibiotics currently used in combination with rifampicin for the treatment of tuberculosis are: isoniazid, pyrazinamide, ethambutol, and streptomycin.

Your doctor will indicate the most suitable combination of antibiotics for you and the dose you should take for each antibiotic.

The recommended dose is:

• In adults and adolescents: 10 mg/kg once daily, with a maximum dose of 600 mg. For adults and adolescents weighing more than 40 kg, the usual doses are:

  • Weight below 50 kg: 450 mg of rifampicin daily (use oral solution of rifampicin)
  • Weight above 50 kg: 600 mg of rifampicin daily (2 capsules of Rimactán)

• Children and infants over 3 months of age: 15 (10–20) mg/kg body weight of rifampicin daily. The maximum daily dose of rifampicin is 600 mg (2 capsules of Rimactán daily). In children with altered body weight, a dose reduction to 10 mg/kg/day may be necessary. In severe infections, such as meningitis, a higher dose may be used, for example, 20 mg per kg body weight daily.

In children weighing less than 15 kg, other formulations of rifampicin are more appropriate (rifampicin suspension).

Prevention of meningococcal meningitis

Note: Rifampicin should not be used for the treatment of meningococcal meningitis.

The recommended dose is:

• Adults and adolescents (from 12 years of age): 600 mg (2 capsules of Rimactán) every 12 hours for 2 days.
• Children ≥ 1 month of age: 10 mg/kg every 12 hours for 2 days. Maximum dose of 600 mg every 12 hours.
• Children ≤ 1 month of age: 5 mg/kg every 12 hours for 2 days.

Do not continue taking Rimactán if you have developed the disease.

Brucellosis

The usual dose of Rimactán in adults is 900 mg of rifampicin daily (3 capsules of Rimactán 300 mg) as a single dose in the morning on an empty stomach.

Rimactán 300 mg capsules must be taken in combination with a tetracycline, such as doxycycline.

The duration of treatment should be approximately 45 days.

Non-mycobacterial infections

The usual dose of Rimactán is:

• Adults: 600–1200 mg (2 to 4 capsules of Rimactán 300 mg) daily, divided into 2 doses.

Your doctor will indicate which antibiotics should be used in combination with Rimactán 300 mg capsules.

Your doctor will inform you about the duration of your treatment.

Use in children and adolescents

Tuberculosis:

Children ≤ 3 months: There are insufficient data to establish a recommendation for children under three months of age.

Brucellosis and non-mycobacterial infections

There are insufficient data to make a dosing recommendation in children and adolescents.

If you take more Rimactán than you should

If you have taken more Rimactán than you should, contact your doctor, pharmacist, or call the Toxicology Information Service immediately at telephone: 91 562 04 20, indicating the medicine and the amount taken.

Symptoms of overdose include: red-brown or orange discoloration of the skin, sputum, tears, sweat, and feces; nausea, vomiting, abdominal pain, liver enlargement, jaundice (yellowing of the skin), somnolence, confusion, and seizures.

If you forget to take Rimactán

If you forget a dose, take it as soon as you remember. However, if the next dose is due soon, skip the missed dose and take your next dose at the usual time.

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

If you stop taking Rimactán

Continue your treatment as directed by your doctor. Do not stop taking this medicine even if you feel better.

If you stop taking this medicine too early, your infection may return. In addition, bacteria may become resistant to treatment.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

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

Serious adverse effects:

If you experience any of the following symptoms of a severe allergic reaction, stop taking this medicine immediately and contact your doctor or go to the nearest hospital:

Rifampicin must be discontinued immediately if severe hypersensitivity reactions occur, such as thrombocytopenia, purpura, haemolytic anaemia, dyspnoea, asthmatic attacks, shock, or renal failure, as these are adverse reactions that rifampicin may exceptionally cause. Patients who develop these reactions must not be re-treated with rifampicin.

Rifampicin should be withdrawn if other signs of hypersensitivity occur, such as fever or skin reactions. For safety reasons, treatment with rifampicin must not be continued or restarted.

Other adverse effects

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

• thrombocytopenia (reduced platelet count), with or without appearance of red skin spots caused by small subcutaneous haemorrhages (purpura),
• nausea, vomiting,
• increased blood bilirubin, increased aspartate aminotransferase, increased alanine aminotransferase,
• 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 anti-tuberculosis treatment. Paradoxical reactions are usually associated with fever, lymph node inflammation (lymphadenitis), difficulty breathing, and cough. Patients experiencing paradoxical drug reactions may also have headache, loss of appetite, and weight loss.

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

• leucopenia (reduced white blood cell count),
• diarrhoea.

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

• jaundice, hepatorenal syndrome.

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

• pseudomembranous colitis (severe intestinal inflammation that may occur after antibiotic treatment),
• flu-like symptoms, headache, dizziness,
• disseminated intravascular coagulation (widespread blood clotting problems within blood vessels), eosinophilia (increase in a specific group of white blood cells), granulocytosis (decrease in a type of white blood cells, granulocytes), haemolytic anaemia (reduction in red blood cells due to their destruction), vitamin K-dependent coagulation disorders,
• anaphylactic reaction (severe allergic reaction presenting with breathing difficulties and even loss of consciousness),
• adrenal insufficiency (impaired function of the adrenal glands in patients with kidney impairment),
• anorexia,
• psychosis (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 tear colour,
• shock (cardiovascular failure syndrome), rubefaction (skin redness), vasculitis (inflammation of blood vessels), severe bleeding,
• dyspnoea (shortness of breath or difficulty breathing), wheezing (breathing sounds), change in sputum colour,
• gastrointestinal disorder, abdominal discomfort, tooth discoloration (which may be permanent),
• hepatitis (liver inflammation), hyperbilirubinaemia (increased bilirubin in blood), cholestasis (reduced bile flow),
• erythema multiforme,
• severe skin reactions such as acute generalised exanthematous pustulosis (red, scaly rash with subcutaneous bumps and blisters), Stevens-Johnson syndrome (widespread blistering rash with skin peeling, particularly around the mouth, nose, eyes, and genitals), toxic epidermal necrolysis (widespread blistering and skin peeling, particularly around the mouth, nose, eyes, and genitals, causing widespread skin detachment (more than 30% of body surface area), drug reaction with eosinophilia and systemic symptoms (DRESS) (see section 4.4), flu-like symptoms with skin rash, fever, glandular 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, pruritus, 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 kidney inflammation (tubulointerstitial nephritis),
• chromaturia (abnormal urine colour),
• postnatal haemorrhage, fetal-maternal blood passage, discoloration of breast milk,
• menstrual disorder,
• porphyria,
• oedema (skin swelling due to fluid accumulation),
• decreased blood pressure,
• increased blood creatinine,
• increased liver enzymes.

Reporting of adverse effects

If you experience any adverse effect, talk to 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 Rimactán

Keep in the original packaging to protect from heat and moisture.

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

Do not use this medicine after the expiry date stated on the container after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at a SIGRE point in your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their containers. This way, you will help protect the environment.

6. Contents of the container and additional information

Composition of Rimactan 300 mg capsules

• The active substance is rifampicin. Each capsule contains 300 mg of rifampicin.
• The other components are: lactose and calcium stearate.

Appearance of the product and contents of the container

Hard, opaque size 1 capsule, two-colored, with the lower part reddish-brown and the upper part brown.

Rimactan 300 mg hard capsules are available in packages containing Al/PVC/PE/PVDC blisters of 10 and 60 hard capsules of 300 mg rifampicin.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sandoz Farmacéutica, S.A.

Parque Norte Business Park

Roble Building

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer:

Sandoz GmbH

Biochemiestraße, 10

A-6250 Kundl

Austria

Date of the most recent revision of this leaflet: April 2022

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.