PACKAGE LEAFLET: INFORMATION FOR THE USER

Transcription

1 Dear Patient! You have been prescribed Terbinafine "Genericon" 250 mg - tablets by your doctor, who, in the interests of improving your state of health, considers this product to be suitable for the treatment of your condition. Always use Terbinafine "Genericon" 250 mg - tablets exactly as your doctor has told you. PACKAGE LEAFLET: INFORMATION FOR THE USER Terbinafine "Genericon" 250 mg - tablets Active substance: Terbinafine hydrochloride Composition: What Terbinafine "Genericon" 250 mg - tablets contain Active substance: 1 tablet contains 250 mg terbinafine The other ingredients are: microcrystalline cellulose, croscarmellose sodium colloidal silicon dioxide, hypromellose, magnesium stearate. Pharmaceutical form White, round, flat tablets, scored on both sides with side scores, embossed with "T" and "1" on one side; diameter: 11mm. Pack sizes Blister Packs contain 7, 10,14, 28, 30, 42 50, 56, 98 or 112 film-coated tablets. Bottle contains 50 or 100 tablets. Marketing authorisation holder Genericon Pharma Gesellschaft m.b.h., A-8054 Graz, Austria Manufacturer Actavis Ltd., Malta Actavis Ltd., Iceland Therapeutic indications: When should Terbinafine "Genericon" 250 mg - tablets be used? Terbinafine "Genericon" is used in the treatment of: terbinafine-sensitive fungal infections such as tinea corporis, tinea cruris and tinea pedis (caused by dermatophytes), when such treatment is considered appropriate in relation to the site, severity and extent of infection. terbinafine-sensitive fungal infections of the finger nails and toenails (onychomycosis), caused by dermatophytes. NB: Terbinafine "Genericon" - tablets are not effective against infections of the type pityriasis (tinea) versicolor. 1

2 Contraindications: Do not take Terbinafine "Genericon" 250 mg - tablets if you are hypersensitive (allergic) to terbinafine or any of the other ingredients of Terbinafine "Genericon". if you suffer from severe kidney dysfunction. if you suffer from severe liver dysfunction. Pregnancy and breastfeeding: Taking Terbinafine "Genericon" 250 mg - tablets during pregnancy and breastfeeding There are no clinical data on the use of terbinafine in pregnant women. You must therefore not take Terbinafine "Genericon" during pregnancy, unless your doctor considers it absolutely necessary. Terbinafine, the active substance, passes into breast milk. You must therefore not take Terbinafine "Genericon" if you are breastfeeding. Should treatment become necessary, you must stop breastfeeding in advance. Special warnings and precautions for use: Which warnings and precautions should be observed when taking Terbinafine "Genericon" 250 mg - tablets? There have been rare cases of bile flow stoppage (cholestasis) and liver inflammation (hepatitis), generally appearing within the first two months of treatment. If you should notice any of the following signs or symptoms, you must inform your doctor immediately, as they may be an indication of liver dysfunction: itchiness (pruritus); unexplained, persistent nausea; loss of appetite; tiredness; jaundice; vomiting; exhaustion; stomach pains; dark urine; light-coloured stools. The possibility of underlying liver disease must be investigated, and if necessary treatment with Terbinafine "Genericon" stopped (see Side effects"). Single-dose pharmacokinetic studies on patients already suffering from liver dysfunction have shown that excretion of terbinafine may decrease by 50%. The therapeutic use of terbinafine in patients with chronic or active liver disease has not been clinically studied, and is therefore not recommended. If you suffer from psoriasis, you should use terbinafine with caution, as there have been very rare reports of a deterioration in psoriasis symptoms. If you should develop high fever or sore throat whilst taking terbinafine, you must inform your doctor, so that he/she can perform some blood tests. Terbinafine strongly inhibits a certain metabolic enzyme (known as the CYP2D6 isoenzyme). This must be borne in mind when Terbinafine "Genericon" is used together with other individually dosed drugs, which are metabolised by this isoenzyme (see Interactions ). If necessary, your doctor will make any dosage adjustments. Driving and operating machinery: Terbinafine "Genericon" has no or negligible influence on the ability to drive and use machinery. 2

3 Please tell your doctor at once, if you should become pregnant whilst being treated with Terbinafine "Genericon". Keep out of the reach of children. Interactions: Should Terbinafine "Genericon" 250 mg - tablets be taken at the same time as other medicines? Please tell your doctor or pharmacist if you are taking/using - or have recently taken/used - any other medicines, including medicines obtained without a prescription. The time that terbinafine remains in blood plasma may be: a) reduced by drugs that stimulate the metabolism (e.g. rifampicin, a drug used to treat tuberculosis); or b) prolonged by drugs that inhibit a certain liver enzyme known as cytochrome P450 (e.g. cimetidine, a stomach drug). If you are required to take these drugs at the same time as Terbinafine "Genericon", your doctor may consider it necessary to adjust the terbinafine dose accordingly. Studies have shown that terbinafine inhibits CYP2D6-mediated metabolism (CYP2D6 is a metabolic enzyme). Regular medical supervision is therefore important for patients who are concurrently taking other drugs which are mostly metabolised by this enzyme and have a narrow therapeutic window, such as drugs used to treat depression (tricyclic antidepressants, selective serotonin reuptake inhibitors [SSRIs] and monoamine oxidase type B inhibitors) and drugs used to treat high blood pressure (beta blockers). Other studies indicate that terbinafine has a negligible effect (reduced or increased) on the metabolism of drugs metabolised by other cytochrome P450 enzymes (e.g. cyclosporine [immunosuppressant], tolbutamide [antidiabetic drug], terfenadine [antiallergy drug], triazolam [sleeping tablet], oral contraceptives [the "Pill"]). There have been a few reported cases of menstruation disorders, such as irregular bleeding and periods, in patients who were taking terbinafine at the same time as oral contraceptives (the Pill ). Posology and method of administration: How and how often to take Terbinafine "Genericon" 250 mg - tablets Always take Terbinafine "Genericon" exactly as your doctor has told you. The tablets may be taken before, during or after mealtimes. You should swallow the film-coated tablets whole (unchewed) with sufficient water (preferably a glass of water). Unless otherwise prescribed by your doctor, the usual dose is: Adults: 1 Terbinafine "Genericon" 250 mg - tablet (equivalent to 250 mg terbinafine), taken once daily. For patients with impaired kidney function (creatinine clearance < 50 ml/min or serum creatinine > 300 µmol/l), the usual dose should be halved. 3

4 For patients with impaired liver function, see sections Taking other medicines and Special warnings and precautions for use. Children and adolescents under 17 years of age: There is not enough clinical experience on the oral use of terbinafine in children and adolescents. Its use is therefore not recommended. Elderly patients: There is no evidence to suggest that elderly patients require different dosages. How long should I continue to take Terbinafine "Genericon"? Length of treatment depends on the type (therapeutic indication) and severity of infection to be treated. Skin infections In the case of fungal infections affecting the feet (tinea pedis), skin (tinea corporis) and hair follicles in the area of lower leg (tinea cruris), the average length of treatment is 2-4 weeks. In the case of moccasin-type athlete s foot (tinea pedis; occurring between the toes and on the soles), a treatment period of up to six weeks is recommended. In some cases, symptoms may only completely disappear after a few weeks following the treatment. Fungal infection of the nails (onychomycosis) Generally speaking, treatment should last for 6-12 weeks. Fungal infection of the fingernails: In most cases, a treatment period of six weeks is sufficient. Fungal infection of the toenails: In most cases, a treatment period of 12 weeks is sufficient. However, some patients may require up to six months treatment. Slow nail growth during the first weeks of treatment may indicate that a longer treatment period is necessary. In some cases, signs and symptoms of infection may only completely disappear after a few weeks following treatment. This may only become apparent a few months after treatment has finished, as healthy nails need time to grow. If you forget to take Terbinafine "Genericon": Do not take a double dose to make up for a forgotten dose. Take your next dose at the usual time. If you have the impression that the effect of Terbinafine "Genericon" is too strong or too weak, please talk to your doctor. Measures to take in case of overdose: What should you do if you take more Terbinafine "Genericon" 250 mg - tablets than you should Few cases of overdose (up to 5 g) have been reported, resulting in headaches, nausea, pains in the upper abdomen and dizziness. 4

5 If you suspect an overdose, seek medical advice immediately. A doctor will decide on any measures that may be required. Side effects: What undesirable effects can Terbinafine "Genericon" 250 mg - tablets have (although these do not occur in all patients)? For the assessment of side effects, the following descriptions of frequency have been used: Very common: in more than 1 in 10 patients treated Common: in less than 1 in 10, but more than 1 in 100 patients treated Uncommon: in less than 1 in 100, but more than 1 in 1,000 patients treated Rare: in less than 1 in 1000, but more than 1 in 10,000 patients treated less than one in 10,000 patients, including isolated cases Blood and lymphatic system disorders Changes in blood count, e.g. reduction in certain white blood cells (neutropenia, agranulocytosis) and reduction in blood platelets (thrombocytopenia). Immune system disorders Onset or deterioration of already existing cutaneous/ systemic lupus erythematosus (a type of autoimmune disorder). Severe allergic reactions (anaphylactic shock). Psychiatric disorders Depression, anxiety. Nervous system disorders Common: Headaches. Gastrointestinal disorders Common: Gastrointestinal complaints: feeling of fullness, loss of appetite, digestive disorders, nausea, stomach pains, diarrhoea. Uncommon: Taste disorders including taste loss, which generally clear up within a few weeks after treatment has stopped. Isolated cases of persistent taste disorders have been 5

6 reported. In a very few severe cases, considerable weight loss was observed as a result of reduced food intake. Hepatobiliary disorders (liver and bile duct) Rare: Bile flow stoppage (cholestasis), liver dysfunction. Severe liver failure. (see section: "Special warnings and precautions for use ) Skin and subcutaneous tissue disorders Common: Transient skin rash, nettle rash (urticaria). Rare: Severe skin changes (e.g. Stevens-Johnson syndrome, toxic epidermal necrolysis, sensitivity to light (photosensitivity) and allergic reactions (including swelling of the face and neck area [angioneurotic oedema]). If skin rash should persist, treatment with Terbinafine "Genericon" should be stopped (see section: Special warnings and special precautions for use ). Exacerbation (worsening) of psoriasis, hair loss. Musculoskeletal and connective tissue disorders Rare: Joint pain (arthralgia), muscle pain (myalgia). These side effects may occur as part of a hypersensitive reaction (allergy), in association with allergic skin reactions (rash, swelling). Tell your doctor or pharmacist if you are worried about any side effects that are listed in the package leaflet, or if you notice any side effects that are not mentioned in this leaflet. Expiry date and storage information: How and how long to store Terbinafine "Genericon" 250 mg - tablets Do not use Terbinafine "Genericon" after the expiry ( use by ) date which is stated on the carton. This medicinal product does not require any special storage conditions. This leaflet was last approved in February 2008 For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder: Ecopharm EOOD 14, Cherni vrah Blvd., bl.3, Sofia 1421 Tel.: ; Fax: