Maa: Malta
Kieli: englanti
Lähde: Malta Medicines Authority
CINACALCET HYDROCHLORIDE
PharmSol Europe Limited The Victoria Centre Unit 2, Lower Ground Floor, Valletta Road, Mosta MST 9012 , Malta
H05BX01
CINACALCET HYDROCHLORIDE 90 mg
FILM-COATED TABLET
CINACALCET HYDROCHLORIDE 90 mg
POM
CALCIUM HOMEOSTASIS
Licence number in the source country: NOT APPLICAPABLE
Authorised
2020-11-12
Page 1 of 7 PACKAGE LEAFLET: INFORMATION FOR THE USER CINACALCET PHARMSOL 30 MG FILM-COATED TABLETS CINACALCET PHARMSOL 60 MG FILM-COATED TABLETS CINACALCET PHARMSOL 90 MG FILM-COATED TABLETS Cinacalcet 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, pharmacist or nurse. - 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET : 1. What Cinacalcet PharmSol is and what it is used for 2. What you need to know before you take Cinacalcet PharmSol 3. How to take Cinacalcet PharmSol 4. Possible side effects 5. How to store Cinacalcet PharmSol 6. Contents of the pack and other information 1. WHAT CINACALCET PHARMSOL IS AND WHAT IT IS USED FOR Cinacalcet PharmSol works by controlling the levels of parathyroid hormone (PTH), calcium and phosphorous in your body. It is used to treat problems with organs called parathyroid glands. The parathyroids are four small glands in the neck, near the thyroid gland, that produce parathyroid hormone (PTH). Cinacalcet PharmSol is used in adults: • to treat secondary hyperparathyroidism in adults with serious kidney disease who need dialysis to clear their blood of waste products. • to reduce high levels of calcium in the blood (hypercalcaemia) in adult patients with parathyroid cancer. • to reduce high levels of calcium in the blood (hypercalcaemia) in adult patients with primary hyperparathyroidism when removal of the gland is not possible. Cinacalcet PharmSol is used in children aged 3 years to less than 18 years of age: • to treat secondary hyperparathyroidism in patients with serious kidney disease who need dialysis to clear the Lue koko asiakirja
Page 1 of 18 1. NAME OF THE MEDICINAL PRODUCT Cinacalcet PharmSol 30 mg film-coated tablets Cinacalcet PharmSol 60 mg film-coated tablets Cinacalcet PharmSol 90 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 30 mg, 60 mg or 90 mg cinacalcet (as hydrochloride). Excipient(s) with known effect: _Cinacalcet PharmSol_ _30 mg film-coated tablets _ Each 30 mg tablet contains 2.24 mg of lactose monohydrate. _Cinacalcet PharmSol_ _60 mg film-coated tablets_ Each 60 mg tablet contains 4.48 mg of lactose monohydrate. _Cinacalcet PharmSol_ _90 mg film-coated tablets_ Each 90 mg tablet contains 6.72 mg of lactose monohydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. Cinacalcet PharmSol 30 mg film-coated tablets Green, oblong, biconvex film-coated tablets, engraved with ‘30’on one side and plain on the other side with a length of 9.8 mm (±0.2 mm) and a width of 6.2 mm (±0.2 mm). Cinacalcet PharmSol 60 mg film-coated tablets Green, oblong, biconvex film-coated tablets, engraved with ‘60’ on one side and plain on the other side with a length of 12.4 mm (±0.2 mm) and a width of 7.8 mm (±0.2 mm). Cinacalcet PharmSol 90 mg film-coated tablets Green, oblong, biconvex film-coated tablets, engraved with ‘90’on one side and plain on the other side with a length of 14.2 mm (±0.2 mm) and a width of 8.9 mm (±0.2 mm). 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Secondary hyperparathyroidism _ _ _Adults _ Treatment of secondary hyperparathyroidism (HPT) in adult patients with end-stage renal disease (ESRD) on maintenance dialysis therapy. _ _ _Paediatric population _ Page 2 of 18 Treatment of secondary hyperparathyroidism (HPT) in children aged 3 years and older with end-stage renal disease (ESRD) on maintenance dialysis therapy in whom secondary HPT is not adequately controlled with standard of care therapy (see section 4.4). Cinacalcet PharmSol may be used as part of a therapeutic regimen including phosphate binders and/ Lue koko asiakirja