Terbexin 250mg 14 tablets

Form

tableti

Dosage mg

250

Pack

14

TERBEXIN 250mg TABLETS Terbinafine Read the package leaflet carefully before you start taking this medicine because it contains important information for you Keep the leaflet. You may need to read it again If you have any further questions, ask your doctor or pharmacist This medicine has been prescribed for you. Do not give it to others. It may harm them, even if their symptoms are the same as yours If you get any side effects, or if you notice any side effects not listed here, please tell your doctor. See section 4 Contents: 1) What Terbexin is and what it is used for 2) What you need to know before you take Terbexin 3) How to take Terbexin 4) Possible side effects 5) How to store Terbexin 6) What Terbexin contains and other information 1. What Terbexin is and what it is used for Terbexin is used to treat fungal infections of the nails of the feet and hands. Terbexin is also used to treat fungal infections of the hair, scalp, groin and other areas of the body (dermatophytes) and the foot ("athlete's foot"), as well as skin infections caused by yeasts. Terbinafine belongs to a group of antifungal medicines and is used to treat fungal infections of the skin, hair, and nails. Terbinafine is taken orally, reaches the site of infection, kills the fungus or stops its growth. 2. What you need to know before you take Terbexin Terbexin has been prescribed for you. Follow the instructions given by your doctor or pharmacist carefully, even if they differ from the general information in this leaflet. Do not take Terbexin: * if you are allergic (hypersensitive) to terbinafine or any of the other ingredients of this medicine (listed in section 6). * if you have kidney or liver problems. If any of the above applies to you, talk to your doctor before taking Terbexin. Warnings and precautions * if you are taking Terbexin with other medicines (see "Taking Terbexin with other medicines"); * if you experience symptoms such as: nausea, vomiting, abdominal pain, loss of appetite, fatigue; if you notice yellowing of the skin or the whites of the eyes, dark urine or pale stools; * if you develop serious allergic skin reactions, such as: rash, redness, blisters on the lips, eyes or mouth, peeling of the skin; * if you experience weakness, unusual bleeding, bruising or frequent infections. Stop taking Terbexin and contact your doctor or pharmacist immediately. Children and adolescents The use of Terbexin in children under 2 years of age is not recommended. Taking Terbexin with other medicines Tell your doctor or pharmacist if you are currently taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription or herbal products or oral contraceptives. These include: * Rifampicin - used to treat infections; * Antidepressants - such as desipramine; * Antifungal medicines - used to treat fungal infections, such as: fluconazole or ketoconazole; * Medicines used to treat heart problems, such as propafenone; * Medicines used to treat high blood pressure, such as metoprolol; * Medicines for stomach ulcers, such as cimetidine; * Combination products containing cough medicines, such as dextromethorphan; * Painkillers containing caffeine; * Cyclosporine, used to regulate the immune system after transplants. Taking Terbexin with food and drink Terbexin can be taken with or without food. Pregnancy and breastfeeding If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. Use of Terbexin during pregnancy is recommended only if the potential benefit outweighs the risks. Terbexin is excreted in breast milk. Do not take Terbexin during breastfeeding. Driving or operating machinery Patients who experience dizziness after taking Terbexin should not drive or operate machinery. 3. How to take Terbexin Always take this medicine exactly as your doctor or pharmacist has told you. If you are unsure, ask your doctor or pharmacist. Adults In adults and elderly patients, the recommended dose is 250 mg once a day (one Terbexin tablet). Children There is no experience with the use of Terbexin in children under 2 years of age (usually children weighing up to 12 kg). The recommended dose is 250 mg per day. The single dose depends on body weight: * 62.5 mg (¼ of a 250mg tablet) once a day for children weighing up to 20 kg; * For children weighing more than 40 kg, the recommended dose is 250 mg once a day. Duration of treatment The duration of treatment depends on the type and severity of the infection. Generally, the duration of treatment is: For dermatophyte and athlete's foot infections, Terbexin is taken for 2-6 weeks. For dermatophyte and yeast infections of the groin and other areas of the body, Terbexin is taken for 2-4 weeks. Hair and scalp infections For hair and scalp infections (dermatophytes), the duration of treatment is four weeks. Nail infections Hand nail infections: 250 mg (one 250mg Terbexin) once a day for 6 weeks. Foot nail infections: 250 mg (one 250mg Terbexin) once a day for 12 weeks. Complete cure of the infection will occur within a few weeks after the end of the treatment course. Healthy nail growth takes several months. It is important to take the tablets daily and continue treatment according to your doctor's recommendations. This is necessary for complete cure of the infection. Other measures are also necessary for complete cure of the infection. For example, the affected area should be kept dry and clothing that comes into direct contact with the affected area should be changed daily. Patients with kidney disease Your doctor will prescribe a lower dose of Terbexin for you. Overdose If you take too much Terbexin, contact your doctor or go to the nearest medical facility immediately. Symptoms of overdose include: headache, nausea, chest pain, and dizziness. Missed dose Take it as soon as you remember, if there is at least 4 hours until the next dose. Do not take a double dose to make up for a missed dose. 4. Possible side effects Like all medicines, this medicine may cause side effects, although not everybody gets them. The following side effects may occur: Some side effects may be serious * Liver dysfunction or liver failure; * Vomiting, stomach problems, loss of appetite or fatigue or weakness; * Yellowing of the skin or the whites of the eyes. Dark urine or pale stools; * Sore throat, fever and chills; * Unusual bleeding or bruising - there are signs that this medicine is affecting your blood cells; * Fatigue or weakness or shortness of breath during physical exertion - may be signs of blood cell disorders; * Difficulty breathing, dizziness, swelling of the face and throat, sudden flushing of the face, abdominal pain, rash, fever or enlarged lymph nodes - possible signs of serious allergic reactions; * Symptoms such as: rash, fever, itching, fatigue or if you notice red-purple spots under the skin - signs of inflammation of the blood vessels; * Severe pain in the upper abdomen radiating to the back - possible signs of pancreatitis; * Muscle weakness or pain or dark urine (red-brown) – possible signs of "muscle necrosis"; Very common (occurs in more than 1 in 10 patients): * Loss of appetite, indigestion, nausea, chest pain and diarrhea. If diarrhea lasts for several days, consult your doctor, it may be necessary to change the treatment regimen; * Skin rash; * Muscle and joint pain. Common (occurs in 1 in 10 patients): * Headache Uncommon (occurs in 1 in 100 patients): * Taste disturbances, loss of taste sensation. This symptom usually disappears within a few weeks after stopping the medicine. Rare (occurs in 1 in 1,000 patients): * Liver-related problems. Very rare (occurs in 1 in 10,000 patients): * Reduction in the number of blood cell elements, lupus (autoimmune disease), serious skin diseases, allergic reactions, hair loss, dizziness, mood changes, itching. The following side effects are also known: * Reduction in red blood cell count, severe allergic reactions, inflammation of blood vessels, loss or reduction of sense of smell, inflammation of the pancreas, necrosis of muscle tissue, flu-like symptoms (fatigue, muscle and joint pain), fever, increased levels of the muscle enzyme creatine phosphokinase in the blood, increased skin sensitivity. Unknown (frequency cannot be estimated from the available data): * Worsening of psoriasis - skin rash, fatigue, inflammatory skin reactions. Reporting of side effects If you notice any side effects, including any side effects not listed in the package leaflet, tell your doctor or pharmacist. 5. How to store Terbexin Keep this medicine out of the sight and reach of children. Store below 25°C, in the original packaging. Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month. Do not dispose of medicines down the drain or with household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment. 6. What Terbexin contains and other information What Terbexin contains: * The active substance is terbinafine. Each tablet contains terbinafine hydrochloride, equivalent to 250 mg of terbinafine. * Other ingredients are: microcrystalline cellulose, corn starch, anhydrous colloidal silica, methylcellulose, hypromellose, talc and magnesium stearate. Appearance of Terbexin and contents of the pack The pack contains 14 tablets in a blister. The tablets are white to off-white, round and flat, size: 11 mm diameter. Dispensing category: Pharmaceutical product group III, available without prescription.