Nchi: Israeli
Lugha: Kiingereza
Chanzo: Ministry of Health
ANAGRELIDE AS HYDROCHLORIDE
RAFA LABORATORIES LTD
L01XX35
CAPSULES
ANAGRELIDE AS HYDROCHLORIDE 0.5 MG
PER OS
Required
RAFA LABORATORIES LTD, JERUSALEM
ANAGRELIDE
ANAGRELIDE
Indicated for the treatment of patients with Essential Thrombocythemia to reduce the elevated platelet count and the risk of thrombosis and to ameliorate associated symptoms.
2017-08-31
1 PATIENT LEAFLET ACCORDING TO THE PHARMACISTS' REGULATIONS (PREPARATIONS) – 1986 This medicine is sold with a doctor's prescription only ANAGRID 0.5 CAPSULES ACTIVE INGREDIENT: Each capsule of Anagrid 0.5 contains: 0.5 mg of Anagrelide (as HCl) For the list of the additional ingredients, see section 6. See also ‘Important information about some of the medicine’s ingredients’ in section 2. READ THIS ENTIRE LEAFLET CAREFULLY BEFORE USING THE MEDICINE. This leaflet contains concise information about the medicine. If you have any further questions, please refer to your doctor or pharmacist. This medicine has been prescribed to treat your illness. Do not pass it on to others. It may harm them, even if it seems to you that their illness is similar to yours. 1. WHAT IS THE MEDICINE INTENDED FOR? The medicine is intended for treatment of patients with essential thrombocythemia in order to reduce the high blood platelet count and the risk of thrombosis, and to improve the associated symptoms. Essential thrombocythemia is a condition where the bone marrow produces too many platelets (type of blood cells). A high level of platelets in the blood can cause serious problems in the blood circulation and clotting. THERAPEUTIC GROUP: Thrombolytic medicines 2. BEFORE USING THE MEDICINE DO NOT USE THE MEDICINE IF: • You are sensitive (allergic) to the active ingredient or to any of the additional ingredients the medicine contains (for the list of the additional ingredients, see section 6). An allergic reaction is characterized amongst others by the appearance of a rash, itching, swelling of the face, lips or shortness of breath. • You suffer from moderate or severe liver problems. • You suffer from moderate or severe kidney problems (creatinine clearance below 50 ml/min). SPECIAL WARNINGS REGARDING THE USE OF THIS MEDICINE: BEFORE (AND DURING) TREATMENT WITH ANAGRID, TELL YOUR DOCTOR IF: • You have or think you might have a heart problem. • You suffer from a congenital disorder of prolonged QT interval (is seen o Soma hati kamili
1 Anagrid_0.5_May 2022-03 1. NAME OF THE MEDICINAL PRODUCT Anagrid 0.5 Capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 0.5 mg anagrelide (as anagrelide hydrochloride). Excipient(s) with known effect Each capsule contains lactose monohydrate (about 123 mg). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Capsule. An off-white capsule. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Indicated for the treatment of patients with Essential Thrombocythemia to reduce the elevated platelet count and the risk of thrombosis and to ameliorate associated symptoms. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment with Anagrid should be initiated by a clinician with experience in the management of essential thrombocythaemia. The recommended starting dose of anagrelide is 1 mg/day, which should be administered orally in two divided doses (0.5 mg/dose). The starting dose should be maintained for at least one week. After one week the dose may be titrated, on an individual basis, to achieve the lowest effective dose required to reduce and/or maintain a platelet count below 600 x 10 9 /l and ideally at levels between 150 x 10 9 /l and 400 x 10 9 /l. The dose increment must not exceed more than 0.5 mg/day in any one-week and the recommended maximum single dose should not exceed 2.5 mg (see section 4.9). During clinical development doses of 10 mg/day have been used. The effects of treatment with anagrelide must be monitored on a regular basis (see section 4.4). If the starting dose is > 1 mg/day platelet counts should be performed every two days during the first week of treatment and at least weekly thereafter until a stable maintenance dose is reached. Typically, a fall in the platelet count will be observed within 14 to 21 days of starting treatment and in most patients an adequate therapeutic response will be observed and maintained at a dose of 1 to 3 mg/day (for further information on the clinical effects refer to section 5.1). _Older people_ The observed pharmacokinetic Soma hati kamili