150 mg / 75 mg film-coated tablets
rifampicin/isoniazid
What Rimactazide is and what it is used for
Rimactazide belongs to the group of antituberculosis drugs. It is a combination drug consisting of two very effective antituberculosis drugs that stop the growth of mycobacteria. These mycobacteria cause tuberculosis.
Rimactazide is used for the continuous treatment of tuberculosis.
Rifampicin and isoniazid contained in Rimactazid may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you use Rimactazid
Do not use Rimactazide
- if you are allergic to rifamycins, isoniazid, or any of the other ingredients of this medicine (listed in section 6)
- 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 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 Rimactazid if the above applies to you.
Talk to your doctor or pharmacist if you are unsure about anything.
Warnings and cautions
Talk to your doctor or pharmacist before taking Rimactazid.
Tell your doctor if you have had any of the following conditions before using this medicine:
- Hepatic impairment and chronic liver disease
- Impaired renal function
- Diabetes
- Epilepsy
- Inflammation of peripheral nerves
- Chronic alcoholism
- Malnutrition
You should not use Rimactazid if your body weight is below 30 kg.
You should not stop taking Rimactazid without consulting your doctor.
You should use an extra non-hormonal contraceptive in addition to the contraceptive pill while you are being treated with Rimactazid.
Other medicines and Rimactazid
Tell your doctor or pharmacist if you are taking, have recently taken, or might take 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 Rimactazid 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 Rimactazid with the following medicines:
- nevirapine
- simvastatin
- ritonavir
- birth control pills. You should use an extra non-hormonal contraceptive during treatment with Rimactazid.
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, tocainide, Lorraine
- Medicines for the heart or blood pressure et: calcium antagonists (such as diltiazem, nifedipine, verapamil, nimodipine, isradipine, nicardipine, nisoldipine, amlodipine), digitoxin, digoxin, beta-blockers (such as bisoprolol, metoprolol, propranolapilol , propranolapril, losranilaprol
- Diuretics such as eplerenone
- Immune-inhibiting drugs such as cyclosporine, tacrolimus, sirolimus, leflunomide, azathioprine
- Corticosteroid is
- Medicines for fungal infections ( antifungals such as fluconazole , itraconazole, ketoconazole , voriconazole, terbinafine)
- Antibiotics such as clarithromycin, telithromycin, dapsone, doxycycline, fluoroquinolones , chloramphenicol, linezolid
- Medicines for malaria: atovaquone, quinine
- Mood drugs such as haloperidol, clozapine, aripiprazole, tricyclic antidepressants (such as amitriptyline, nortriptyline)
- Drugs that prevent blood clots such as oral anticoagulants, warfarin
- Hormone therapy such as antiestrogen (such as gestrinone, tamoxifen, toremifene), estrogen and progestagen given as hormone replacement therapy or birth control pills, thyroid hormones (levothyroxine)
- Painkillers such as morphine, etoricoxib, rofecoxib
- AIDS drugs such as saquvinavir , indinavir, efavirenz, amprenavir, nelfinavir, atazanavir, lopinavir, nevirapine, zidovudine, nevirapine, stavudine
- Antiepileptic drugs such as tiagabine, carbamazepine, phenytoin , etosuximide
- Drugs for insomnia such as diazepam , benzodiazepines, buspirone, zopiclone , zolpidem, zaleplon, hexobarbital
- Medicines for asthma such as theophylline
- Antidiabetic drugs such as repaglinide and nateglinide or sulfonuride-type oral antidiabetics
- p-aminosalicylic acid (a drug used to treat tuberculosis and inflammatory bowel disease)
- Methadone (a drug used by heroin addicts)
- Medicines for stomach problems such as cimetidine
- Medicines for high blood fats such as clofibrate, fluvastatin, simvastatin
- Medicines for nausea such as tropisetron, ondansetron
- Anesthetics such as halogenated volatile anesthetics
- Drugs for the treatment of cancer such as imatinib, gefitinib, irinotecan
- Fexofenadine (a medicine used to treat hay fever)
- Prazikvantel (medicine for tapeworm)
- 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 Rimactazid. 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 Rimactazid at least one hour before these medicines.
The following test methods are not recommended while you are being treated with Rimactazid. 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 B 12 (cyanocobalamin) in blood plasma
Rimactazide with food and drink
You should not drink alcohol while taking Rimactazid.
Avoid foods that are high in tyramine (such as cheese and red wine) or histamine (such as tuna). These can cause side effects such as headache, palpitations, and redness of the skin during treatment with Rimactazid.
Take this medicine at least one hour before a meal.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Your doctor will decide if it is appropriate to continue treatment with Rimactazid.
Rimactazide passes into breast milk, so do not use Rimactazide while breastfeeding. You must tell your doctor if you are breastfeeding or planning to breastfeed before taking Rimactazid.
Driving and using machines
Rimactazide may cause side effects such as dizziness, confusion, and blurred vision. This can affect your ability to perform certain things, such as driving or working with machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. 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.
Rimactazide contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per film-coated tablet, ie essentially ‘sodium-free’.
How to use Rimactazid
Always use this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
The following doses are intended for adults and children weighing more than 30 kg. Children who weigh less should not take these tablets.
The recommended dose is:
Adults
The number of Rimactazid 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.
Use for children
Rimactazid 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 Rimactazide, but if you have liver or kidney disease, tell your doctor. In some cases, your doctor may recommend that you take extra vitamin B 6 during treatment with Rimactazid.
Treatment time
Rimactazide is usually given for 4 months during the further treatment phase. Your doctor will determine your treatment time.
Method of administration
You should swallow Rimactazid once daily during the ongoing phase of treatment.
Swallow the tablets whole with water.
Rimactazide should be taken at least one hour before a meal.
If you use more Rimactazide than you should
If you accidentally take one tablet too much, nothing will probably happen. If you have ingested too much medicine or if e.g. If a child has ingested the medicine by mistake, contact a doctor or hospital for risk assessment and advice. If possible, bring your tablet or pack to your doctor.
If you forget to use Rimactazid
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.
Do not take a double dose to make up for a forgotten dose.
If you stop using Rimactazid
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, this medicine 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 neck (may affect up to 1 in 1,000 people)
- Severe dizziness or collapse (may affect up to 1 in 1,000 people)
If you get any of these side effects, talk to your doctor as soon as possible:
- Inflammation of the pancreas, which causes severe pain in the abdomen and back ( pancreatitis, has been reported – occurs in an unknown number of users).
- Severe skin damage (dermal detachment of the epidermis and superficial mucous membranes) ( toxic epidermal necrolysis, TEN, may affect up to 1 in 1,000 users).
- Drug reaction that causes skin rash, fever, inflammation of internal organs, altered blood picture, and systemic disease (DRES syndrome, can occur in up to 1 in 1,000 users).
- 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, may affect up to 1 in 100 people).
- Severe, prolonged diarrhea with blood in along with abdominal pain or fever. This may be a sign of severe intestinal inflammation (may affect up to 1 in 1,000 people).
- Bleeding in the skin; if you continue to take Rimactazid there is a risk of cerebral hemorrhage (which may affect up to 1 in 1,000 people).
- Lack of white blood cells, followed by sudden high fever, very sore throat, and mouth ulcers ( agranulocytosis, may occur in up to 1 in 10,000 users).
These are all serious side effects. You may need immediate medical attention.
Other side effects:
Common (may affect up to 1 in 10 people):
- Fatigue, drowsiness, headache, slight intoxication, dizziness
- Damage to peripheral nerves
- Reddening of the eyes, permanent discoloration of soft contact lenses
- Nausea, vomiting, loss of appetite, abdominal pain, bloating, upper abdominal discomfort
- Redness, itching with or without skin rash, hives
- Allergic or other reactions such as rash, fever
- Increase in liver enzymes
- Disorder of liver function which can 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
Rare (may affect up to 1 in 1,000 people):
- Change in the number of white and red blood cells, changes in the number of platelets, anemia
- 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, muscle disease ( myopathy ), problems with coordination of will-controlled muscles ( ataxia ), increased seizure frequency in epileptics
- Visual disturbances, damage to the optic nerve
- Gastric inflammation, jaundice, hepatitis (rarely severe)
- Allergic and other reactions such as dry mouth, heartburn, urinary problems, signs of rheumatic disorders, pellagra (conditions characterized by gastrointestinal problems, redness of the skin, nerve and mental disorders), swelling of lymph nodes, acne, skin rash
- Increase in renal enzymes, acute renal failure, nephritis
- Occurrence of porphyria (characterized by photosensitivity, skin damage, anemia, psychosis, and acute abdominal pain)
Has been reported (occurs in an unknown number of users):
- Inflammation of the blood vessels.
A flu-like condition may occur if you resume treatment with Rimactazid 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.
How to store Rimactazid
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label, carton, and blister after EXP. or EXP. The expiration date is the last day of the specified month.
Blister: Do not store above 25 ° C.
Jar: Do not store above 30 ° C.
Blister: Store in the original package. Moisture sensitive.
Jar: Close the jar tightly to protect against moisture.
Medicines 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.
Contents of the pack and other information
Content declaration
- The active substances are rifampicin and isoniazid. Each film-coated tablet contains 150 mg rifampicin and 75 mg isoniazid.
- The other ingredients are pregelatinized maize starch, maize starch, sodium lauryl sulfate, crospovidone, magnesium stearate, talc, povidone, hypromellose 3 cPs, hypromellose 6 cPs, hypromellose 50 cPs, titanium dioxide (E 171), macrogol 6, macrogol 400, macrogol 400, macrogol 400.
What the medicine looks like and the contents of the pack
Round, biconvex, dark pink film-coated tablets, that is
9.5 ± 0.4 mm in diameter and smooth on both sides.
Rimactazide 150 mg / 75 mg film-coated tablets are supplied in the following packs:
Carton of blister containing: 30, 60, 120, 240, 672 or 1000 film-coated tablets
White, opaque polypropylene jar with polyethylene lid, containing 500 film-coated tablets.
White opaque polyethylene jar with a polypropylene lid, containing 500 film-coated tablets
Pack sizes of 500 and 1000 film-coated tablets are intended for hospital use.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder:
Sandoz A / S, Edvard Thomsens Vej 14, 2300 Copenhagen S, Denmark
Manufacturer:
Sandoz GmbH, Biochemiestrasse 10, 6250 Kundl, Austria