Rimactan 300 mg capsulas duras

Prospect: information for the patient

Rimactán 300 mg hard capsules

rifampicina

Read this prospect carefully before starting to take this 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 only to you, and you must not give it to other people even if they have the same symptoms as you, 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.

Contentsoftheprospect

1.What Rimactán is and for what it is used

2.What you need to knowbeforestarting totake Rimactán

3.How to take Rimactán

4.Possible adverse effects

5Storage of Rimactán

6.Contents of the package and additional information

Rimactán contains rifampicin, which belongs to a group of antibiotics called rifamycins. It acts by stopping the growth of bacteria that cause infections.

Rimactán is indicated for the treatment of infections such as:

• Tuberculosis in all its forms(in association with other antitubercular medications).
• Non-mycobacterial infections:other infections distinct from tuberculosis for which your doctor considers it appropriate to prescribe Rimactán. Take Rimactán in combination with other antibiotics.
• Brucellosis.Used in combination with a tetracycline.

Rimactán is also indicated for the prevention of:

• Meningococcal meningitis:you can only take Rimactán if you have been in direct contact with patients with meningococcal meningitis (at home, in daycare, in school, shared accommodations) and have not yet developed the disease.

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

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

Do not take Rimactán:

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Rimactán:

• resistances to bacteria may appear. To avoid resistances in the treatment of infections, use Rimactán in combination with other antibiotics/chemotherapeutic drugs,
• if you have severe complications such as changes in blood cells, small purple spots on the skin, difficulty breathing, and asthma-like attacks, shock, renal insufficiency, fever, or other skin reactions, your doctor will suspend treatment,
• if you have chronic liver disease, if you are an alcoholic, or if you are malnourished. Your doctor may reduce the dose of rifampicin,
• if you use hormonal contraceptives, as the effectiveness of these may be reduced and you will need to adopt additional contraceptive measures,
• in premature and newborn children. It will be used only in emergency cases and with special caution since their hepatic enzyme system is not fully developed,
• Rimactán is not recommended for children under 6 years of age due to the risk of aspiration,
• do not take rifampicin and pyrazinamide simultaneously for the treatment of latent tuberculosis infections due to the risk of severe liver damage,
• During treatment, a severe reaction such as drug reaction with eosinophilia and systemic symptoms (DRESS) (see section 4. Possible adverse effects) may occur. If you experience early signs of hypersensitivity to rifampicin such as fever, lymphadenopathy (swelling of lymph nodes), or biological alterations (eosinophilia; increase of 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 the origin of these symptoms cannot be established otherwise.
• if you experience a severe and 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 and scaly rash with bumps under the skin and blisters (acute generalized pustular psoriasis), consult your doctor as soon as possible, as treatment with rifampicin should be suspended.
• if you are diabetic. Treatment with rifampicin may make it difficult to manage diabetic patients.
• a discoloration (yellow, orange, red, brown) in your teeth, urine, sweat, sputum, tears, and feces without clinical significance. Similarly, it may cause permanent discoloration of soft contact lenses,
• rifampicin may compete with various medications at the level of absorption and biochemical/metabolic change and, therefore, may reduce exposure, safety, and efficacy of these medications (see "Other medications and Rimactán"),
• rifampicin may compete with various medications at the level of absorption and biochemical/metabolic change and, therefore, may reduce exposure, safety, and efficacy of these medications (see "Other medications and Rimactán"),
• if you have a bleeding problem or tendency to bruise easily. Rifampicin may cause vitamin K-dependent coagulopathy (this means it may reduce the ability of blood to clot) and severe bleeding (see section "Possible adverse effects"),
• if you are taking other antibiotics at the same time.

At the beginning of treatment and in prolonged treatments, it is recommended to perform periodic blood cell counts and liver function tests.

Other medications and Rimactán

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

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

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

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

The simultaneous use of ketoconazole and rifampicin reduces the serum levels of both medications

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

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

Do not take rifampicin with para-aminosalicylic acid (a medication used to treat tuberculosis) as this reduces the levels of rifampicin in the blood, so it is advisable to leave an interval of 8 hours between the intake of both medications.

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

The simultaneous use of rifampicin with halothane or isoniazid increases the potential for liver toxicity. Do not use rifampicin with halothane. If you have a treatment with rifampicin and isoniazid, your doctor will monitor your liver function periodically (see section "Warnings and precautions").

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

It is also not recommended to use concomitantly with maraviroc, another antiretroviral medication; if clinically justified, dose adjustment is required.

It is recommended to avoid the concomitant use of rifampicin with other antibiotics that cause vitamin K-dependent coagulopathy (reduction of blood clotting ability), such as cefazolin (or other cefalosporins of the same group), as this may cause severe coagulation disorders that may lead to a fatal outcome (especially with high doses).

Do not take rifampicin with the combination of saquinavir/ritonavir (antiretroviral medications).

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

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

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

In patients treated with rifampicin, 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.

Taking Rimactán with food, drinks, and alcohol

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

at least 30 minutes before eating, or

at least 2 hours after eating.

Pregnancy, breastfeeding, and fertility

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

Pregnancy

Rifampicin should be used in pregnant women or fertile women only when the potential benefits justify the potential risks to the fetus. When rifampicin is administered during the last weeks of pregnancy, it may cause postpartum hemorrhage in the mother and the newborn, for whom treatment with vitamin K1 is prescribed.

Breastfeeding

Rifampicin is excreted in breast milk, patients receiving rifampicin should not breastfeed unless their doctor considers that the benefit to the patient outweighs the potential risks to the baby.

Driving and using machines

The influence of rifampicin on the ability to drive and use machines is small to moderate. Rifampicin may cause certain adverse effects that may interfere with the ability to drive and use machines. If you experience these adverse effects (difficulty breathing, nausea, vomiting, muscle weakness), do not use machines.

Rimactán contains lactose.

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

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

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

If you estimate that the action 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 treatment with rifampicin for tuberculosis are: isoniazid, pyrazinamide, ethambutol, and streptomycin.

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

The recommended dose is:

• In adults and adolescents 10 mg/kg per day with a maximum dose of 600 mg, for adults and adolescents over 40 kg the usual doses are:

• Weight less than 50 kg: 450 mg of rifampicin per day (use oral rifampicin solution)
• Weight over 50 kg: 600 mg of rifampicin per day (2 Rimactán capsules)

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

In children weighing less than 15 kg, there are other rifampicin presentations that are more suitable (rifampicin suspension).

Prevention of meningococcal meningitis

Nota: rifampicin should not be used for the treatment of meningococcal meningitis.

The recommended dose is:

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

You should not continue taking Rimactán if you have developed the disease.

Brucelosis

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

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

The duration of treatment should be around 45 days.

Non-mycobacterial infections

The usual dose of Rimactán is:

• Adults: 600-1200 mg (2 to 4 Rimactán 300 mg capsules) per day, divided into 2 doses.

Your doctor will inform you of the combination of antibiotics with which you should take Rimactán 300 mg capsules.

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

Use in children and adolescents

Tuberculosis:

Children ≤ 3 months: there are not enough data to establish a recommendation for children under three months.

Brucelosis and non-mycobacterial infections

There are not enough data for a posological recommendation in children and adolescents.

If you take more Rimactán than you should

If you have taken more Rimactán than you should, consult your doctor, pharmacist, or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount used.

The symptoms of overdose are: brownish-red or orange discoloration of skin, sputum, tears, sweat, and feces, nausea, vomiting, abdominal pain, liver inflammation, jaundice (yellowish skin), drowsiness, confusion, and convulsions.

If you forget to take Rimactán

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

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

If you interrupt the treatment with Rimactán

Continue your treatment as indicated by your doctor, do not stop taking this medication even if you feel better.

If you stop taking this medication too soon, your infection may return. Even the bacteria may become resistant to treatment.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

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

Severe side effects:

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

Rifampicin should be discontinued immediately if severe hypersensitivity reactions such as thrombocytopenia, purpura, hemolytic anemia, dyspnea, and asthma attacks occur, or if shock or renal insufficiency occurs, as these are adverse reactions that rifampicin may cause in exceptional cases. Patients who develop these reactions should not be treated with rifampicin again.

Rifampicin should be discontinued if other signs of hypersensitivity, such as fever or skin reactions, appear. For safety reasons, treatment should not be continued or resumed with rifampicin.

Other side effects

Frequent side effects(may affect up to 1 in 10 patients):

• thrombocytopenia (reduction in platelet count), with or without the appearance of red skin patches formed by small subcutaneous blood hemorrhages (purpura),
• nausea, vomiting,
• increased bilirubin in the blood, increased aspartate aminotransferase, increased alanine aminotransferase.

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

• leucopenia (reduction in white blood cell count),
• diarrhea.

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

• jaundice, hepatorenal syndrome.

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

• clostridioides difficile-associated diarrhea (severe intestinal inflammation that may occur after antibiotic treatment),
• flu, headache, dizziness
• disseminated intravascular coagulation (generalized blood clotting problems), eosinophilia (increase in a certain type of white blood cell), granulocytosis (reduction in a type of white blood cell, granulocytes), hemolytic anemia (reduction in red blood cell count due to malnutrition), vitamin K-dependent coagulation disorders,
• anaphylactic reaction (severe allergic reaction that may cause respiratory difficulty and even loss of consciousness),
• adrenal insufficiency (alteration of adrenal gland function in patients with renal impairment),
• anorexia,
• psychosis (mental state characterized by a loss of contact with reality),
• cerebral hemorrhage and death, in cases where purpura (purple skin patches) appears after continued or resumed treatment with rifampicin,
• change in tear color,
• shock (cardiocirculatory insufficiency syndrome), rubefaction (skin redness), vasculitis (inflammation of blood vessels), severe bleeding
• shortness of breath (dyspnea), wheezing (respiratory sounds), change in sputum color,
• gastrointestinal disorder, abdominal discomfort, tooth discoloration (which may be permanent)
• hepatitis (inflammation of the liver), hyperbilirubinemia (elevated bilirubin in the blood), cholestasis (reduced bile flow),
• erythema multiforme,
• severe skin reactions such as generalized acute exanthematous pustulosis (red and scaly rash with subcutaneous nodules and blisters), Stevens-Johnson syndrome (generalized rash with blisters and skin peeling, particularly around the mouth, nose, eyes, and genitals), toxic epidermal necrolysis (generalized 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)), drug reaction with eosinophilia and systemic symptoms (DRESS) (see section 4.4), flu-like symptoms with skin rash, fever, gland inflammation, and abnormal blood test results such as increased leukocytes (eosinophilia) and elevated liver enzymes (see section 2. Warnings and precautions),
• skin reactions, itching, pruritic skin rash, urticaria, allergic dermatitis, skin lesions with blisters (pemphigus),
• change in sweat color,
• muscle weakness, myopathy (muscle disorder)
• bone pain,
• acute renal damage, usually due to cell death in the kidneys (tubular necrosis) or inflammation of the kidneys (tubulointerstitial nephritis),
• chromaturia (abnormal urine color),
• postpartum hemorrhage, fetal-maternal bleeding, discoloration of breast milk,
• menstrual disorder,
• porphyria,
• edema (skin swelling due to fluid accumulation),
• decreased blood pressure,
• increased creatinine in the blood,
• increased liver enzymes.

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 theSistema Español de Farmacovigilancia de Medicamentos de Uso Humano:https//www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Store in the original packaging to protect it from heat and humidity

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

Do not usethis medicationafter the expiration date that appears on thecontainerafter CAD/EXP. 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 containers and medications you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Rimactán 300 mg capsules

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

Appearance of the product and content of the packaging

Durable capsule, opaque of type 1, two-colored, the lower part brownish-red and the upper part brown.

Rimactán 300 mg hard capsules are presented in packaging containing Al/PVC/PE/PVDC blisters of 10 and 60 hard capsules of 300 mg rifampicin.

Holder of the marketing authorizationand responsible for manufacturing

Holder of the marketing authorization

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Responsible for manufacturing:

Sandoz GmbH

Biochemiestraße, 10

A-6250 Kundl

Austria

Last review date of this leaflet:April 2022

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