150 mg / 75 mg / 400 mg Film-coated tablet
What does Rimcure® contain?
The active substances are rifampicin, isoniazid, and pyrazinamide. Each tablet contains 150 mg rifampicin, 75 mg isoniazid and 400 mg pyrazinamide.
Other ingredients are:
Tablet core: pregelatinized maize starch, maize starch, sodium lauryl sulfate, crospovidone, magnesium stearate, talc.
Film coating: copovidone, hypromellose, talc, titanium dioxide (E171), opadry pink 03B54929 [hypromellose, titanium dioxide (E171), macrogol 400, red iron oxide (E172)], opadry clear OY-S-29019 [hypromellose, macrogol 6000].
Marketing Authorisation Holder
Sandoz A / S
Edvard Thomsens Vej 14
2300 Copenhagen S
Denmark
WHAT IS RIMCURE® AND WHAT IS IT USED FOR?
The appearance of the drug:
Rimcure tablets are oval, pink, and film-coated.
Rimcure tablets are supplied in blister packs.
Pharmaceutical group
What is Rimcure® used for?
Rimcure belongs to the group of antituberculosis drugs. It is a combination drug consisting of three very effective antituberculosis drugs that stop the growth of mycobacteria. These mycobacteria cause tuberculosis.
Rimcure is used for the first phase of the treatment of tuberculosis.
BEFORE YOU USE RIMCURE®
Do not use Rimcure®
• if you are allergic (hypersensitive) to
rifamycins, isoniazid, pyrazinamide
– any of the other ingredients in Rimcure.
• if you have acute liver disease or have previously had a liver disease caused by a medicine.
• if you have a condition called porphyria.
• if you have acute gout.
• if you suffer from severe renal impairment.
• if you are taking any of the following medicines:
– voriconazole.
– protease inhibitors, other than ritonavir, if you are being treated with a maximum dose of 600 mg twice daily.
Do not take Rimcure if the above applies to you.
Talk to your doctor or pharmacist if you are unsure about anything
Take special care with Rimcure®:
Tell your doctor if you have had any of the following conditions before using this medicine:
• impaired liver function and chronic liver disease
• impaired renal function
• gout
• diabetes
• epilepsy
• inflammation of the peripheral nerves
• eye diseases
• chronic alcoholism
• malnutrition
You should not use Rimcure if your body weight is below 30 kg.
You should not stop taking Rimcure without consulting your doctor.
You should use an extra non-hormonal contraceptive in addition to birth control pills while you are being treated
Rimcure.
Taking Rimcure® with food and drink:
You should not drink alcohol while taking Rimcure.
Avoid foods that are high in tyramine (such as cheese and red wine) or histamine (such as tuna). These can, during treatment with Rimcure, cause side effects such as headaches, palpitations, and redness of the skin.
Take this medicine at least one hour before a meal.
Pregnancy
Tell your doctor as soon as possible if you are pregnant or think you may be pregnant. Your doctor will decide if it is appropriate to continue treatment with Rimcure. If you are taking Rimcure during pregnancy, your doctor should give you vitamin B6 during pregnancy and vitamin K during the last month of pregnancy.
Breast-feeding
This medicine passes into breast milk, so do not use Rimcure while breastfeeding. You must tell your doctor if you are breastfeeding or planning to breastfeed before taking Rimcure.
Driving and using machines:
Rimcure can cause side effects such as dizziness, confusion, and cloudy eyesight. The ability to drive or use machines may be impaired when using Rimcure. You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened vigilance. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects . Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Use of other medicines:
Tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Tell your doctor if you are taking any of the following medicines:
You should not use Rimcure with the following medicines:
• voriconazole
• protease inhibitors, except ritonavir if you are being treated with a maximum dose of 600 mg twice daily
You should not use Rimcure with the following medicines:
• nevirapine
• simvastatin
Ritonavir
• birth control pills . You should use an extra non-hormonal contraceptive during treatment with Rimcure.
Also, tell your doctor if you are taking any of the following medicines:
• Drugs for irregular heartbeat such as class 1A antiarrhythmics ( quinidine, disopyramide ), propafenone, mexiletine
• Medicines for the heart or blood pressure et: calcium antagonists, carvedilol, digoxin, beta-blocker blockers (such as metoprolol, propranolol), imidapril
• Immunosuppressive drugs such as ciclosporin, tacrolimus, sirolimus ,
• Corticosteroids are
• Medicines for infection such as azole-type antifungals, terbinafine, clarithromycin, telithromycin, dapsone, atovaquone, chloramphenicol, linezolid
• Drugs such as haloperidol , benzodiazepines, tricyclic antidepressants, buspirone, clozapine
• Medicines that prevent blood clots such as oral anticoagulants , warfarin
Hormone therapy such as gestrinone, estrogen, and progestagen given as hormone replacement therapy and thyroid hormones
• Painkillers such as morphine, etoricoxib, rofecoxib
• AIDS medicines such as efavirenz, zidovudine, nevirapine, stavudine
• Epilepsy medicines such as tiagabine, carbamazepine, phenytoin, ethosuximide
• Medicines for insomnia such as zolpidem, zaleplon
• Medicines for asthma such as theophylline
• Diabetes drugs such as repaglinide or sulfonamide-type oral antidiabetics
• p-aminosalicylic acid (a medicine used to treat tuberculosis and inflammatory bowel disease)
• Methadone (a drug used for heroin addicts)
• Medicines for stomach problems such as cimetidine
• Medicines for high blood fats such as fluvastatin, simvastatin
• Medicines for nausea such as tropisetron
• Anesthetics such as halogenated volatile anesthetics
• Medicines for gout such as probenecid, sulfinpyrazone
• oral typhoid vaccine
If you are taking any of these medicines, check with your doctor if you are switching to another medicine while you are being treated with Rimcure. There are usually other medicines that you can take instead.
If you are being treated with medicines for indigestion, such as antacids, you should take Rimcure at least one hour before these medicines.
The following examination methods are not recommended while you are being treated with Rimcure. If these tests are performed, the results should be evaluated with caution.
• contrast X-ray of the gallbladder
• microbiological measurement of folic acid in blood plasma
• microbiological measurement of vitamin B12 (cyanocobalamin) in blood plasma
HOW TO USE RIMCURE®
Dosage instructions
Always follow your doctor’s instructions on how and when to take your tablets. You should ask your doctor or pharmacist if you are not sure. The following doses are intended for adults and children weighing more than 30 kg. Children who weigh less should not take these tablets.
You should swallow Rimcure tablets once a day for the first two months. Swallow the tablets whole with water. Rimcure should be taken at least one hour before a meal.
Adults:
The number of Rimcure tablets may vary from person to person depending on body weight. The following dosage is usually given:
• If you weigh 30 kilograms (kg) to 39 kg – take 2 tablets every day
• If you weigh 40 kg to 54 kg – take 3 tablets every day
• If you weigh 55 kg to 70 kg – take 4 tablets every day
• If you weigh over 70 kg – take 5 tablets every day
Your doctor will prescribe the appropriate dose for you.
Children
Rimcure is not recommended for children under 6 years of age or with a body weight of less than 30 kg.
Older
The elderly usually tolerate Rimcure, but if you have liver or kidney disease, tell your doctor. In some cases, your doctor may recommend that you take extra vitamin B6 during treatment with Rimcure.
Processing time:
Rimcure is usually given for 2 months at the beginning of tuberculosis treatment. Your doctor will determine your treatment time.
Administration
If you use more Rimcure® than you should:
If you accidentally take one tablet too much, nothing will probably happen. If you have accidentally taken several tablets too much or if, for example, a child has ingested the medicine, contact a doctor or hospital for risk assessment and advice. If possible, bring your tablet or pack to your doctor.
If you forget to take Rimcure®:
If you forget to take a dose, take it as soon as possible. However, if it is close to time to take the next dose, skip the missed dose and take the next tablet at the usual time.
Effects that may occur when stopping treatment with Rimcure®:
Always take the tablets until the treatment is over, even if you start to feel better. If you stop taking the tablets too soon, the infection may return. The bacteria can also become resistant to the drug.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
POSSIBLE SIDE EFFECTS
Like all medicines, Rimcure can cause side effects, although not everybody gets them.
Serious side effects:
If you get any of the following symptoms of a severe allergic reaction, stop taking this medicine and contact your doctor or hospital immediately:
• Sudden difficulty breathing, speaking and swallowing
• Swollen lips, tongue, face, or throat
• Severe dizziness or collapse
• Severe or itchy skin rash, especially if blisters and eyes, mouth, and genitals become sore
If you get any of these side effects, talk to your doctor as soon as possible:
• Severe, prolonged diarrhea with blood in along with abdominal pain or fever. This may be a sign of severe intestinal inflammation.
• Bleeding in the skin; if you continue to take Rimstar there is a risk of a cerebral hemorrhage
Yellowing of the skin or whites of the eyes, darker urine and paler stools, fatigue, weakness, malaise, loss of appetite, nausea, or vomiting caused by liver problems ( hepatitis )
• Inflammation of the pancreas which can cause severe abdominal and back pain ( pancreatitis )
Lack of white blood cells , followed by a sudden high fever, very sore throat and sores in the mouth ( agranulocytosis ).
These are all serious side effects . You may need immediate medical attention. Serious side effects are rare (affecting less than 1 in 1,000 users) or very rare (affecting less than 1 in 10,000 users).
Other side effects:
Common (less than 1 in 10 users):
• Fatigue, drowsiness, headache, slight intoxication, dizziness
• Damage to peripheral nerves
Eye redness, permanent discoloration of soft contact lenses
• Nausea, vomiting, loss of appetite, abdominal pain, bloating, upper abdominal discomfort
Redness, itching with or without rash, hives
• Allergic or other reactions such as skin rash, fever, muscle or joint pain
• Increase in liver enzymes
• Disorder of liver function which may cause loss of appetite, nausea, vomiting, fatigue, malaise and weakness
Reddish discoloration of body fluids and secretions such as urine, tear fluid, sweat, mucus, feces and saliva
Increase in uric acid in the blood, acute gout (chills, pain, and swelling of joints, especially big toe, ankle, or knee)
Rare (less than 1 in 1000 users):
• Changes in the number of white and red blood cells , changes in the number of platelets, anemia, disorders of blood clotting ability, swelling of the spleen
• Edema / swelling due to fluid retention
• Diarrhea
• Menstrual disorders, enlargement of the mammary glands in men, premature puberty, difficult-to-control diabetes, high blood sugar, Cushing’s syndrome (a disease caused by increased corticoid hormone), sudden onset of severe symptoms of Addison’s disease (a special form of hormonal disorder)
• Seizures, confusion, psychosis, hyperactivity, elation, insomnia
• Muscle weakness, problems with coordination of will-controlled muscles ( ataxia ), increased seizure frequency in epileptics
• Visual disturbances, damage to the optic nerve
• Gastritis, jaundice, enlargement of the liver, hepatitis (rarely severe)
• Allergic and other reactions such as dry mouth, heartburn, urinary problems, signs of rheumatic problems, pellagra (conditions characterized by gastrointestinal problems, redness of the skin, nerve and mental disorders), swelling of lymph nodes, acne, skin rash, photosensitivity
• Increase in kidney enzymes, acute kidney failure, kidney inflammation, problems with urination
• Occurrence of porphyria (characterized by photosensitivity, skin damage, anemia, psychosis, and abdominal pain)
If A flu-like condition may occur if resume treatment with Rimcure after an interruption, it is characterized by fever, chills and possible headaches, dizziness, and skeletal and muscle pain. In rare cases, bleeding in the skin, difficulty breathing, asthma-like attacks, anemia, shock, and kidney failure may develop.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
STORING RIMCURE®
Keep out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label and carton after EXP. and on blisters after EXP. The expiration date is the last day of the specified month.
Store below 30 o C.
Blister: Store in the original package. Moisture sensitive.
Jar: Close the jar tightly to protect against moisture.
The medicine should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
FURTHER INFORMATION
This medicinal product is authorized under the European Economic Area under the names:
Belgium: Rimcure, film-coated tablet
Denmark: Rimcure, film-coated tablet
Finland: Rimcure, tablets, calvapäällysteinen
France: Rimcure, compressed pellicle
Ireland, UK: Rimcure, film-coated tablet
Italien: Rimcure, compressed rivestita con film
The Netherlands: Rimcure, film-wrapped tablet
Norway: Rimcure, tablet, film-coated
Spanien: Rimcure, compressed recovered with film
Sweden: Rimcure, film-coated tablet