RIMSTAR Film-Coated Tablets

2. What you need to know before you take Rimstar

Do not take Rimstar if:

• you are allergic (hypersensitive) to rifampicin, isoniazid, pyrazinamide, ethambutol hydrochloride, or any of the other components of this medicine (listed in section 6),
• you have acute liver problems or have had a previous liver problem caused by the use of medicines,
• you have been confirmed to suffer from a disease called porphyria,
• you suffer from acute gouty arthritis,
• you suffer from severe kidney problems,
• you are currently taking any of the following medicines:
• • voriconazole,
  • protease inhibitors except ritonavir when prescribed at a full dose or 600 mg twice a day.

• if you have ever developed a severe skin rash or skin peeling, blisters, and/or sores in the mouth after taking ethambutol.

Do not take Rimstar if you are in any of the above circumstances.

If you have any doubts, consult your doctor or pharmacist.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Rimstar.

Tell your doctor if you have any of the following diseases before taking this medicine:

• liver problems and chronic liver disease,
• kidney problems,
• gout,
• diabetes mellitus,
• epilepsy,
• inflammation of the peripheral nerves or optic nerve,
• eye defects,
• chronic alcoholism,
• malnutrition.

You must not take Rimstar if your body weight is less than 30 kg.

Severe skin reactions, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported in association with Rimstar treatment. Stop taking Rimstar and seek immediate medical attention if you notice any of the symptoms related to these severe skin reactions described in section 4.

Do not interrupt treatment with Rimstar without consulting your doctor.

You must use additional contraceptive methods besides the birth control pill while taking Rimstar.

Other medicines and Rimstar

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription.

Tell your doctor if you are taking any of the following medicines:

Do not take Rimstar with any of the following medicines:

• voriconazole,
• protease inhibitors except ritonavir, if prescribed at a full dose or 600 mg twice a day.

• You should not take Rimstar with any of the following medicines:

• nevirapine,
• simvastatin,
• ritonavir,
• oral contraceptives. You must use additional contraceptive methods while taking Rimstar.

Tell your doctor if you are taking any of the following medicines:

• medicines for irregular heartbeatsuch as class Ia antiarrhythmics (quinidine, disopyramide), propafenone, mexiletine, tocainide, lorcainide,
• medicines for heart or blood pressure:calcium antagonists (such as diltiazem, nifedipine, verapamil, nimodipine, isradipine, nicardipine, nisoldipine, amlodipine), digitoxin, digoxin, beta-blockers (such as bisoprolol, metoprolol, propranolol, carvedilol), losartan, imidapril, enalapril,
• diureticssuch as eplerenone,
• immunosuppressive medicinessuch as cyclosporine, tacrolimus, sirolimus, leflunomide, azathioprine,
• corticosteroids,
• medicines for fungal infections(antifungals such as fluconazole, itraconazole, ketoconazole, voriconazole, terbinafine),
• antibioticssuch as clarithromycin, telithromycin, dapsone, doxycycline, fluoroquinolones, chloramphenicol, linezolid,
• medicines for malaria: atovaquone, quinine,
• medicines for moodsuch as haloperidol, clozapine, aripiprazole, tricyclic antidepressants (such as amitriptyline, nortriptyline),
• medicines to prevent blood clotssuch as oral anticoagulants, warfarin,
• hormonal treatmentssuch as antiestrogens (such as gestrinone, tamoxifen, toremifene), estrogens and progestogens administered as hormone replacement therapy or contraceptives, thyroid hormones (levothyroxine),
• medicines for painsuch as morphine, etoricoxib, rofecoxib,
• medicines for HIVsuch as saquinavir, indinavir, efavirenz, amprenavir, nelfinavir, atazanavir, lopinavir, zidovudine, nevirapine, stavudine,
• medicines for epilepsysuch as tiagabine, carbamazepine, phenytoin, ethosuximide,
• medicines for sleep disorderssuch as diazepam, benzodiazepines, buspirone, zopiclone, zolpidem, zaleplon, hexobarbital,
• medicines for asthmasuch as theophylline,
• medicines for diabetessuch as repaglinide and nateglinide or oral antidiabetics of the sulfonylurea type,
• p-aminosalicylic acid(a medicine for tuberculosis and inflammatory bowel disease),
• methadone(a medicine for heroin addicts),
• medicines for stomach problemssuch as cimetidine,
• medicines for hyperlipidemiasuch as clofibrate, fluvastatin, simvastatin,
• medicines for nauseasuch as tropisetron, ondansetron,
• medicines for narcosissuch as volatile halogenated anesthetics,
• medicines for cancersuch as imatinib, gefitinib, irinotecan,
• fexofenadine(a medicine for hay fever),
• praziquantel(an antihelmintic medicine),
• oral typhoid vaccine.

If you are currently taking any of these medicines, ask your doctor if you could change the medication while taking Rimstar. Often, there are other products that you can take instead of these.

If you need to take a medicine for indigestion, such as an antacid, take the tablets at least one hour before taking the antacids.

While taking this medicine, the following diagnostic tests or results should be interpreted with caution:

• radiographic examination of the gallbladder with contrast medium,
• microbiological determination of plasma concentrations of folic acid,
• microbiological determination of plasma concentrations of cyanocobalamin (vitamin B12).

Taking Rimstar with food and drinks

Do not drink alcohol while taking this medicine.

Do not take foods with high histamine and tyramine content (such as mature cheese, cured meat, some fish like tuna, salmon, and mackerel, wine, and beer). Taking these foods with Rimstar can cause headaches, sweating, hot flashes, fasting, irregular or energetic heartbeats (palpitations), dizziness, feeling dizzy or fainting (due to low blood pressure) or flushing. You should avoid these foods while taking this medicine.

Your doctor can give you more information.

Take this medicine at least one hour before eating.

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 whether it is possible to continue treatment with this medicine. If you take Rimstar during pregnancy, your doctor must give you vitamin B6 supplements during pregnancy and vitamin K during the last month of gestation.

This medicine passes into breast milk, so you must not take Rimstar during breastfeeding. It is important that you inform your doctor if you are breastfeeding or if you intend to breastfeed before taking Rimstar.

Driving and using machines

This medicine can cause adverse reactions such as dizziness, confusion, and blurred vision. This may limit your ability to perform certain tasks, such as driving or using machines.

Rimstar contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, which is essentially "sodium-free".

3. How to take Rimstar

Follow exactly the administration instructions of this medicine as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again. These doses correspond to adults and children weighing more than 30 kg. Children with a weight of less than 30 kg should not take these tablets.

The recommended dose is:

Adults:

The amount of Rimstar administered to each person may be different, depending on their body weight. Normally, you will receive the following amount of tablets:

• If you weigh from 30 kilograms (kg) to 39 kg:take 2 tablets daily.
• If you weigh from 40 kg to 54 kg:take 3 tablets daily.
• If you weigh from 55 kg to 70 kg:take 4 tablets daily.
• If you weigh more than 70 kg:take 5 tablets daily.

Your doctor will prescribe the correct dose for you.

Use in children

This medicine is not recommended for children under 8 years of age or with a body weight of less than 30 kg.

Elderly

Rimstar is well tolerated by most elderly patients, but you must inform your doctor if you suffer from liver or kidney disease. In some cases, the doctor may recommend that you take more vitamin B6 while taking this medicine.

Method of administration

You must take Rimstar once a day during the first two months of treatment.

Swallow the tablets whole with a little water.

Rimstar must be taken at least one hour before eating.

Duration of treatment

Rimstar is usually administered for two months at the beginning of tuberculosis treatment. Your doctor will decide the duration of treatment for you.

If you take more Rimstar than you should

If you accidentally take one more tablet, it is unlikely to cause any problems. If you take several more tablets, contact your doctor or pharmacist or talk to the emergency department of the nearest hospital immediately. If possible, bring the tablets or the box with you to show the doctor what you have taken.

You can also call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount used.

If you forget to take Rimstar

If you forget to take a dose, take it as soon as possible. However, if it is almost time for the next dose, skip the missed dose and take the next tablet at the usual time.

If you stop taking Rimstar

Continue to take the tablets until the end of the treatment, even if you feel better. If you stop taking the tablets too soon, the infection may come back. Also, the bacteria may become resistant to the medicine.

If you have any other 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 all people suffer from them.

Severe Adverse Effects:

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

• sudden difficulty breathing, speaking, and swallowing; swelling of the lips, tongue, face, or neck (may affect up to 1 in 1,000 people),
• extreme dizziness or collapse (may affect up to 1 in 1,000 people),
• red patches, not raised, in a target or circular shape on the torso, often with central blisters, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin rashes can be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis) (may affect up to 1 in 1,000 people).
• widespread skin rash, elevated body temperature, and enlarged lymph nodes (DRESS or drug hypersensitivity syndrome) (may affect up to 1 in 1,000 people).

If you experience any of the following adverse effects, inform your doctor as soon as possible:

• inflammation of the pancreas, which causes severe abdominal and back pain (pancreatitis, frequency not known),
• yellowing of the skin or the white part of the eyes, or darkening of urine and pale coloring of stools, fatigue, weakness, discomfort, loss of appetite, nausea, or vomiting due to liver problems (hepatitis, may affect up to 1 in 100 people),
• severe, prolonged, or bloody diarrhea with stomach pain or fever: may be a sign of severe intestinal inflammation (may affect up to 1 in 1,000 people),
• bleeding in the skin; if you continue taking Rimstar, you are at risk of cerebral hemorrhage (bleeding, may affect up to 1 in 1,000 people),
• vision problems such as blurred vision, eye pain, red-green color blindness, or even vision loss (may affect up to 1 in 1,000 people),
• reduction in the number of white blood cells, accompanied by sudden high fever, severe sore throat, and mouth ulcers (agranulocytosis, may affect up to 1 in 1,000 people).

These are severe adverse effects. You may need urgent medical attention.

Other Adverse Effects:

Adverse Effectsfrequently(may affect up to 1 in 10 people):

• fatigue, drowsiness, headache, dizziness, lightheadedness,
• damage to peripheral nerves,
• redness of the eyes, permanent change in color of soft contact lenses,
• nausea, vomiting, loss of appetite, abdominal pain, swelling, epigastric discomfort,
• flushing, itching with or without skin rash, hives,
• allergic reactions or other types such as skin rash, fever, muscle or joint pain,
• elevation of liver enzymes,
• alteration of liver function that could manifest as loss of appetite, nausea, vomiting, fatigue, discomfort, and weakness,
• change to reddish color of body fluids and secretions such as urine, tears, sweat, sputum, stools, and saliva,
• increase in blood uric acid, acute gouty arthritis (chills, pain, and swelling of joints, especially the big toe, ankle, or knee).

Adverse Effectsinfrequently(may affect up to 1 in 100 people):

• hallucinations, disorientation, confusion, malaise.

Adverse Effectsrarely(may affect up to 1 in 1,000 people):

• changes in white blood cell and red blood cell counts, changes in platelet count, anemia, coagulation disorders, splenomegaly,
• edema/swelling due to fluid retention,
• diarrhea,
• menstrual disorders, breast tissue swelling, precocious puberty, difficulties in controlling diabetes, hyperglycemia, Cushing's syndrome (disease caused by corticosteroid hormones), induction of crisis in patients with Addison's disease (patients with a special form of hormonal disorder),
• psychosis, hyperactivity, euphoria, insomnia, convulsions,
• muscle weakness, myopathy, problems with voluntary muscle coordination (ataxia), increased frequency of epileptic seizures,
• vision problems, damage to the optic nerve,
• numbness, tingling, burning, or weakness in hands or feet,
• gastritis, jaundice, liver hypertrophy, liver inflammation (severe in isolated cases),
• allergic reactions and other types such as dry mouth, heartburn, urinary disorders, rheumatic syndromes and symptoms, pellagra (condition characterized by gastrointestinal disorders, skin redness, nervous and mental disorders), lymph node swelling, acne, skin rash, photosensitivity,
• elevation of liver enzymes, acute renal failure, kidney inflammation, urinary problems,
• induction of a condition called porphyria (a group of disorders characterized by photosensitivity, skin lesions, anemia, psychosis, and acute abdominal pain).

Frequency Unknown(cannot be estimated from available data):

• inflammation of blood vessels.

If you resume treatment after a temporary interruption of treatment with Rimstar, you may experience what is known as a pseudo-influenza syndrome.

It is characterized by fever, chills, and possibly headache, dizziness, and bone and muscle pain. In rare cases, skin bleeding, respiratory difficulties, asthma-like crises, shock, and renal failure may develop.

Reporting Adverse Effects

If you experience adverse effects, consult your pediatrician or pharmacist, even if they are not listed in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Rimstar

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiration date shown on the box, label, or blister pack after "EXP". The expiration date is the last day of the month indicated.

Do not store above 25 °C.

Blister pack: Store in the original packaging to protect from moisture.

Bottle: Keep the container tightly closed to protect from moisture.

Medicines should not be disposed of through wastewater or household waste. Deposit the packaging and medicines you no longer need at the pharmacy's SIGRE point. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Rimstar Composition

The active ingredients are: rifampicin, isoniazid, pyrazinamide, and ethambutol hydrochloride.

Each tablet contains 150 mg of rifampicin, 75 mg of isoniazid, 400 mg of pyrazinamide, and 275 mg of ethambutol hydrochloride.

• The other ingredients are: pregelatinized corn starch, corn starch, sodium lauryl sulfate, microcrystalline cellulose, povidone K 30, crospovidone, magnesium stearate, talc, copovidone, hypromellose, titanium dioxide (E171), macrogol 400, macrogol 6000, and red iron oxide (E172).

Product Appearance and Package Contents

Rimstar, film-coated tablets are brown, oval, biconvex, film-coated, and smooth on both sides.

The tablets are packaged in aluminum/aluminum or PVC/PE/PVDC-aluminum blister packs, which are packaged in a cardboard box or in a white and opaque polypropylene bottle with a polyethylene cap or in a white and opaque polyethylene bottle with a polypropylene cap.

Blister packs containing 30, 60, 120, 240, 672, or 1,000 film-coated tablets.

Bottles containing 500 film-coated tablets.

The package sizes of 500 and 1,000 film-coated tablets are for clinical use.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sandoz GmbH

Biochemiestrasse, 10

A-6250-Kundl

Austria

Manufacturer

Sandoz GmbH

Biochemiestrasse, 10

A-6250-Kundl

Austria

or

Sandoz S.R.L.

Livezeni Street, 7th

540472-Targu Mures

Romania

This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) with the following names:

Denmark: Rimstar

Norway: Rimstar, tablet, film-coated

Sweden: Rimstar 150 mg/75 mg/400 mg/275 mg film-coated tablet

Date of the last revision of this prospectus: November 2024.

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/