Country: Evrópusambandið
Tungumál: enska
Heimild: EMA (European Medicines Agency)
ospemifene
Shionogi B.V.
G03XC05
ospemifene
Sex hormones and modulators of the genital system,
Postmenopause
Senshio is indicated for the treatment of moderate to severe symptomatic vulvar and vaginal atrophy (VVA) in post-menopausal women.
Revision: 13
Authorised
2015-01-14
21 B. PACKAGE LEAFLET 22 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT SENSHIO 60 MG FILM-COATED TABLETS ospemifene 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 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 Senshio is and what it is used for 2. What you need to know before you take Senshio 3. How to take Senshio 4. Possible side effects 5. How to store Senshio 6. Contents of the pack and other information 1. WHAT SENSHIO_ _IS AND WHAT IT IS USED FOR Senshio contains the active substance ospemifene. Ospemifene belongs to a group of medicines that do not contain hormones called Selective Estrogen Receptor Modulators (SERMs). SENSHIO IS USED TO treat women with moderate to severe post-menopausal symptoms in and outside the vagina, such as itching, dryness, burning and pain during sex (dyspareunia). This is known as vulvar and vaginal atrophy. It is caused by a lowering in the levels of the female hormone oestrogen in your body. When this happens, the vaginal walls can become thinner. This happens naturally after menopause (post-menopause). SENSHIO WORKS in a similar way to some of the helpful effects of oestrogen, helping to improve these symptoms and the underlying causes of vulvar and vaginal atrophy. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE SENSHIO DO NOT TAKE SENSHIO - If you are allergic to ospemifene or any of the other ingredients of this medicine (listed in section 6). - If you have or have ever had a BLOOD CLOT IN A VEIN (thrombosis), for example, in your legs (deep vein thrombosis), lungs (pulmonary embolism), or eyes (retinal thro Lestu allt skjalið
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Senshio 60 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 60 mg ospemifene. Excipient with known effect Each film-coated tablet contains 1.82 mg lactose as monohydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet). Oval biconvex, white to off-white, film-coated tablets of dimensions 12 mm x 6.45 mm, debossed with “60” on one side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Senshio is indicated for the treatment of moderate to severe symptomatic vulvar and vaginal atrophy (VVA) in post-menopausal women. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The recommended dose is one 60 mg tablet once daily with food taken at the same time each day. If a dose is missed it should be taken with food as soon as the patient remembers. A double dose should not be taken in the same day. Special populations _ _ _Elderly (>65 years old) _ No dose adjustment is necessary in patients above the age of 65 years (see section 5.2). _Renal impairment _ No dose adjustment is necessary for patients with mild, moderate or severe renal impairment (see section 5.2). _Hepatic impairment _ No dose adjustment is necessary for patients with mild to moderate hepatic impairment_. _Ospemifene has not been studied in patients with severe hepatic impairment, therefore Senshio is not recommended for use in such patients (see section 5.2). 3 _Paediatric population_ There is no relevant use of ospemifene in the paediatric population for the indication of the treatment of moderate to severe symptomatic VVA in post-menopausal women. Method of administration Oral use. One tablet should be swallowed whole once daily with food and should be taken at the same time each day. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Active or past history of venous thromboembolic events (VTEs), includin Lestu allt skjalið