Land: Bretland
Tungumál: enska
Heimild: MHRA (Medicines & Healthcare Products Regulatory Agency)
Topotecan hydrochloride
Novartis Pharmaceuticals UK Ltd
L01XX17
Topotecan hydrochloride
1mg
Capsule
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 08010500; GTIN: 5000123112579
PACKAGE LEAFLET: INFORMATION FOR THE USER HYCAMTIN ® 0.25 MG HARD CAPSULES HYCAMTIN ® 1 MG HARD CAPSULES topotecan READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Keep this 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 pass it on to others. It may harm them, even if their symptoms seem to be the same as yours. If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET : 1. What Hycamtin is and what it is used for 2. What you need to know before you take Hycamtin 3. How to take Hycamtin 4. Possible side effects 5. How to store Hycamtin 6. Contents of the pack and other information 1. WHAT HYCAMTIN IS AND WHAT IT IS USED FOR Hycamtin helps to destroy tumours. HYCAMTIN IS USED TO TREAT SMALL CELL LUNG CANCER that has come back after chemotherapy. Your doctor will decide with you whether Hycamtin therapy is better than further treatment with your initial chemotherapy. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE HYCAMTIN DO NOT TAKE HYCAMTIN: if you are allergic to topotecan or any of the other ingredients of this medicine (listed in section 6). if you are breast-feeding. if your blood cell counts are too low. Your doctor will tell you whether this is the case, based on the results of your last blood test. TELL YOUR DOCTOR if any of these applies to you. WARNINGS AND PRECAUTIONS Before you are given this medicine your doctor needs to know: if you have any kidney or liver problems. Your dose of Hycamtin may need to be adjusted. if you are pregnant or plan to become pregnant. See section “Pregnancy and breast-feeding” below. if you plan to father a child. See section “Pregnancy and breast-feeding” below. TELL YOUR DOCTOR if any of these applies to you. OTHER MEDICINES AND HYCAMTIN Lestu allt skjalið
OBJECT 1 HYCAMTIN 0.25MG HARD CAPSULE Summary of Product Characteristics Updated 03-May-2018 | Novartis Pharmaceuticals UK Ltd 1. Name of the medicinal product HYCAMTIN ® 0.25 mg hard capsules HYCAMTIN ® 1 mg hard capsules 2. Qualitative and quantitative composition HYCAMTIN 0.25 mg hard capsules Each capsule contains 0.25 mg of topotecan (as hydrochloride). HYCAMTIN 1 mg hard capsules Each capsule contains 1 mg of topotecan (as hydrochloride). For the full list of excipients, see section 6.1. 3. Pharmaceutical form Hard capsule. HYCAMTIN 0.25 mg hard capsules The capsules are opaque, white to yellowish white and imprinted with “HYCAMTIN” and “0.25 mg”. HYCAMTIN 1 mg hard capsules The capsules are opaque, pink and imprinted with “HYCAMTIN” and “1 mg”. 4. Clinical particulars 4.1 Therapeutic indications HYCAMTIN capsules are indicated as monotherapy for the treatment of adult patients with relapsed small cell lung cancer (SCLC) for whom re-treatment with the first-line regimen is not considered appropriate (see section 5.1). 4.2 Posology and method of administration HYCAMTIN capsules should only be prescribed and therapy supervised by a physician experienced in the use of chemotherapeutic agents. Posology Prior to administration of the first course of topotecan, patients must have a baseline neutrophil count of ≥1.5 x 10 9 /l, a platelet count of ≥100 x 10 9 /l and a haemoglobin level of ≥9 g/dl (after transfusion if necessary). _Initial dose _ The recommended dose of HYCAMTIN capsules is 2.3 mg/m 2 body surface area per day administered for five consecutive days with a three-week interval between the start of each course. If well tolerated, treatment may continue until disease progression (see sections 4.8 and 5.1). The capsule(s) must be swallowed whole, and must not be chewed crushed or divided. Hycamtin capsules may be taken with or without food (see section 5.2). _Subsequent doses _ Topotecan should not be re-administered unless the neutrophil count is ≥1 x 10 9 /l, the platelet coun Lestu allt skjalið