Χώρα: Ιρλανδία
Γλώσσα: Αγγλικά
Πηγή: HPRA (Health Products Regulatory Authority)
TAMOXIFEN CITRATE
Rosemont Pharmaceuticals Ltd
L02BA; L02BA01
TAMOXIFEN CITRATE
10 mg/5ml
Oral solution
Product subject to prescription which may be renewed (B)
Anti-estrogens; tamoxifen
Marketed
2002-05-17
TAMOXIFEN CITRATE 10MG/5ML ORAL SOLUTION MODULE 1.3.1 LEAFLET – IE VERSION: NOVEMBER 2017 PAGE 1 PACKAGE LEAFLET: INFORMATION FOR THE USER 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 your pharmacist. This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are 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 Tamoxifen Rosemont is and what it is used for 2. What you need to know before you take Tamoxifen Rosemont 3. How to take Tamoxifen Rosemont 4. Possible side effects 5. How to store Tamoxifen Rosemont 6. Contents of the pack and other information 1. WHAT TAMOXIFEN ROSEMONT IS AND WHAT IT IS USED FOR The name of your medicine is Tamoxifen Rosemont (called Tamoxifen in this leaflet). It contains tamoxifen citrate. This belongs to a group of medicines called anti-oestrogens. Tamoxifen is used to treat breast cancer. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE TAMOXIFEN ROSEMONT DO NOT TAKE TAMOXIFEN: if you are allergic (hypersensitive) to tamoxifen or any other ingredients in this medicine (listed in Section 6 below). The signs of an allergic reaction include a rash, itching or shortness of breath if you are pregnant or breast feeding (see Section ‘Pregnancy and breast-feeding’) if you are taking anastrozole to treat breast cancer. Children should not have this medicine. Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking this medicine. WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking Tamoxifen if: you or any member of your family have ever had strokes or blood clots. TAMOXIFEN ROSEMO Διαβάστε το πλήρες έγγραφο
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Tamoxifen Rosemont 10 mg/5 ml Oral Solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 5ml dose of oral solution contains tamoxifen 10mg (as tamoxifen citrate) Excipients with known effect: Ethanol - 750mg per 5ml Sorbitol solution (non-crystallising) (E420) - 1g per 5ml For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Oral Solution A clear colourless liquid. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS - Adjuvant treatment of oestrogen-receptor positive early breast cancer - Treatment of oestrogen-receptor positive locally advanced or metastatic breast cancer 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Adjuvant treatment of breast cancer, Adults (including elderly): The recommended dose is 20mg, given either in divided doses twice daily or as a single dose once daily. The current recommended treatment duration is five years; however the optimum duration has not been established. Treatment of locally advanced or metastatic breast cancer: The recommended dose is 20mg to 40mg, given either in divided doses twice daily or as a single dose once daily. Paediatric Population Children: Not applicable. Method of Administration For oral use. 4.3 CONTRAINDICATIONS Pregnancy and lactation Hypersensitivity to tamoxifen or to any of the excipients listed in section 6.1 Concurrent anastrozole therapy (see section 4.5) 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Premenopausal patients must be carefully examined before treatment to exclude pregnancy. H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ __ Διαβάστε το πλήρες έγγραφο