Remstar 150 mg / 75 mg / 400 mg / 275 mg film-coated tablets, rifampicin / isoniazid / pyrazinamide / ethambutol hydrochloride.
What Is Remstar And What Rimstar Used For?
Strips belong to the group of antituberculosis drugs. It is a combination drug consisting of four very effective antituberculosis drugs. It is used to treat infections caused by mycobacteria.
These mycobacteria cause tuberculosis. Rimstar used for the first phase of tuberculosis treatment. Rifampicin, isoniazid, pyrazinamide, and ethambutol hydrochloride contained in Rimstar may also be approved for treating other conditions not mentioned in this product information.
Ask your doctor, pharmacist, or another healthcare professional if you have further questions, and always follow their instructions.
What You Need To Know Before Using Remstar
Do Not Use Remstar
- If you are allergic to rifamycins, isoniazid, pyrazinamide, ethambutol hydrochloride, 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 have acute gout
- If you suffer from severe renal impairment
- If you are taking any of the following medicines:
- Voriconazole
- Protease inhibitors, except ritonavir, if you are being treated with the maximum dose or 600 mg twice daily.
- Do not take Rimstar if any of the above apply to you.
Talk to your doctor or pharmacist if you are unsure about anything.
Warnings And Cautions
Talk to your doctor or pharmacist before using Remstar. 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
- Gout
- Diabetes
- Epilepsy
- Inflammation of the peripheral nerves or the optic nerve
- Eye diseases
- Chronic alcoholism
- Malnutrition
You should not use Rimstar if your body weight is below 30 kg. You should use an extra contraceptive in addition to birth control pills while you are being treated with Remstar. You should not stop taking Rimstar without consulting your doctor.
Other Medicines And Remstar
Tell your doctor or pharmacist if you have recently taken or might take any other medicines, including those obtained without a prescription.
Tell your doctor if you are taking any of the following medicines: You should not use Rimstar with the following medicines:
- Voriconazole
- Protease inhibitors, except ritonavir if you are being treated with the maximum dose or 600 mg twice daily
You should not use Rimstar with the following medicines:
- Nevirapine
- Simvastatin
- Ritonavir
- Birth control pills. You should use an extra contraceptive during treatment with Remstar.
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
- Cardiovascular or blood pressure medicinal products:
- Calcium channel blockers (such as diltiazem, nifedipine, verapamil, nimodipine, isradipine, nicardipine, nisoldipine, amlodipine)
- Digitoxin
- Digoxin
- Carvedilol
- Beta-blockers (such as bisoprolol, metoprolol , imoprolilol, propranolol, propanil enalapril
- 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
- Antifungals such as:
- 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
- Zidovudine
- Nevirapine
- Stavudine
- Antiepileptic drugs such as:
- Tiagabine
- Carbamazepine
- Phenytoin
- Etosuximide
- Medicines for sleep disorders 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:
- Volatile halogenated 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 going to switch to another medicine while you are being treated with Remstar. 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 Rimstar at least one hour before these medicines.
The following examination methods may not be used while you are being treated with Remstar. 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.
Strips With Food And Drink
You should not drink alcohol while taking Rimstar. Avoid foods with high levels of histamine or tyramine (such as ripe cheeses, canned meat, certain fish such as tuna, salmon, mackerel, wine, and beer). During treatment with Rimstar, these foods can cause symptoms such as:
- Headache
- Sweating
- Redness
- Fast
- Irregular or heavy heartbeat (palpitations)
- Dizziness
- Feeling weak (due to low blood pressure )
Avoid these foods if you are getting Rimstar. Your doctor can give further advice. 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 Rimstar. If you are taking Rimstar during pregnancy, your doctor should give you vitamin B 6 and K during the last month of pregnancy.
This medicine passes into breast milk, so do not use Rimstar while breastfeeding. You must tell your doctor if you are breastfeeding or planning to breastfeed before taking Rimstar.
Driving And Using Machines
Strips can cause side effects such as:
- Dizziness
- Confusion
- Cloudy eyesight
The ability to drive or work with machines may therefore be impaired when using Rimstar. You are responsible for assessing whether you can drive a motor vehicle or perform work requiring sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and 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.
This medicine contains less than 1 mmol (23 mg) sodium per film-coated tablet, essentially ‘sodium-free’.
How To Use Rimstar?
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 Rimstar dose is:
Adults:
The number of tablets of Rimstar 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 Rimstar dose for you.
Use for children
Strips are not recommended for children under 8 years or with a body weight of less than 30 kg.
Older
Most elderly patients tolerate Rimstar well, but if you have liver or kidney disease, tell your doctor. Sometimes, your doctor may recommend taking extra vitamin B 6 during treatment with Rimstar.
Method of administration
- You should take Rimstar tablets once a day for the first two months.
- Swallow the tablets whole with water.
- Strips should be taken at least one hour before a meal.
Processing time:
Strips are usually given for 2 months at the beginning of tuberculosis treatment. Your doctor will determine your treatment time.
If You Use More Rimstar 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 Rimstar Tablet
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.
If You Stop Using Rimstar
Always take the tablets until the treatment is over, even if you 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 Rimstar Side Effects
This medicine can cause side effects like all medicines, although not everybody gets them.
Serious rimstar side effects:
If you get any of the following symptoms of a severe allergic reaction, stop taking this medicine and contact your doctor immediately or go to the nearest emergency department:
- Sudden difficulty breathing, speaking, and swallowing, swollen lips, tongue, face, or throat (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 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).
- Diarrhea that is severe, prolonged, or with blood in it and 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 Rimstar, there is a risk of cerebral hemorrhage (bleeding may occur in up to 1 in 1,000 users).
- Visual disturbances such as blurred vision, eye pain, red-green color blindness, or even loss of vision (may affect up to 1 in 1,000 users).
- Lack of white blood cells, followed by sudden high fever, sore throat, and mouth ulcers ( agranulocytosis may occur in up to 1 in 1,000 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
- 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
- Muscle or joint pain
- Increase in liver enzymes
- Disorder of liver function which can cause:
- Loss of appetite
- Nausea
- Vomiting
- Fatigue
- Malaise
- Weakness
- Reddish discoloration of body fluids and secretions such as:
- Urine
- Tear fluid
- Sweat
- Mucus
- Feces
- Saliva
- Increase in uric acid in the blood, acute gout (chills, pain, and swelling of joints, especially big toe, ankle, or knee)
Uncommon (may affect up to 1 in 100 people):
- Hallucinations
- Disorientation
- Confusion
- Malaise
Rare (may affect up to 1 in 1,000 people):
- Changes in the number of white and red blood cells
- Changes in the number of platelets, anemia
- Disorders of the blood’s ability to clot, 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)
- The appearance of severe symptoms of Addison’s disease (a special form of hormonal disorder)
- Psychosis, hyperactivity
- Elation
- Insomnia
- Seizures
- 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
- Numbness
- Tingling
- Burning pain, or weakness in hands and feet
- Gastric inflammation
- Jaundice
- Hepatomegaly
- 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
- Rash
- Photosensitivity
- Rise of kidney enzymes, acute kidney failure, kidney inflammation, problems with urination
- Occurrence of porphyria characterized by:
- Photosensitivity
- Skin damage
- Anemia
- Psychosis
- 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 Rimstar after an interruption.
- Fever,
- Chills
- Possible headaches
- Dizziness
- Skeletal and muscle pain characterize it
- In rare cases:
- Bleeding in the skin
- Difficulty breathing
- Asthma-like attacks
- Anemia
- Shock
- Kidney failure may develop
How To Store Rimstar?
- Keep this medicine out of sight and reach of children.
- Do not use this medicine after the expiry date stated on the carton and label and the blister after EXP or EXP.
- The expiration date is the last day of the specified month.
- Do not store above 25 ° C.
- Blister: Store in the original package. Moisture sensitive.
- Jar: Close the jar tightly. Moisture sensitive.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are 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, isoniazid, pyrazinamide, and ethambutol hydrochloride. Each tablet contains 150 mg rifampicin, 75 mg isoniazid , 400 mg pyrazinamide and 275 mg ethambutol hydrochloride.
- The other ingredients are pregelatinized maize starch, maize starch, sodium lauryl sulfate, microcrystalline cellulose, povidone K30, crospovidone, magnesium stearate, talc, povidone, hypromellose, titanium dioxide (E171), macrogol 400, macrogol 6000 (E172 iron oxide).
What The Medicine Looks Like And The Contents Of The Pack
- Rimstar film-coated tablets are brown, oval, biconvex film-coated tablets without labels.
- The tablets are packaged in aluminum/aluminum blisters of PVC / PE / PVDC aluminum blisters contained in a folding box or a white, opaque polypropylene jar with a polyethylene lid.
- Pack sizes:
- Blisters: 30, 60, 120, 240, 672 or 1,000 film-coated tablets
- Jar: 500 film-coated tablets
- Packages of 500 and 1,000 film-coated tablets are intended for hospital use only.
- 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 or SC Sandoz SRL, Str. Livezeni nr. 7A, 540472, Targu – Mures, Romania