Country: United Kingdom
Bahasa: Inggeris
Sumber: MHRA (Medicines & Healthcare Products Regulatory Agency)
Calcium lactate gluconate; Calcium carbonate
Haleon UK Ltd
A12AA20
Calcium lactate gluconate; Calcium carbonate
2.263gram ; 1.75gram
Effervescent tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 09050101; GTIN: 5012131744000
Pharma code XXXX Read all of this leaflet carefully because it contains important information for you. This medicine is available without prescription. However, you still need to take Calvive carefully to get the best results from it. • Keep this leaflet. You may need to read it again. • Ask your pharmacist if you need more information or advice. • If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet 1. What Calvive is and what it is used for 2. Before you take Calvive 3. How to take Calvive 4. Possible side effects 5. How to store Calvive 6. Further information 1. WHAT CALVIVE IS AND WHAT IT IS USED FOR Calvive contains a rich source of calcium which is an essential mineral, necessary for bone formation and maintenance. Calvive is used in the prevention and treatment of calcium deficiency, and may be used, with other medicines, to prevent and treat a condition called osteoporosis (weakening of the bones).Calvive is also used, together with vitamin D 3 , for the treatment of rickets (softening of growing bones in children) and osteomalacia (softening of adults bones). Calcium is absorbed from the intestine and distributed throughout the body in the blood. Calcium plays an important role in several body functions. It is essential for nerve, muscle and heart function as well as for the clotting of blood. In addition, it is necessary for many hormones to work properly in the body. To carry out these various roles, calcium must be available in the appropriate concentration. 2. BEFORE YOU TAKE CALVIVE Do not take Calvive... • If you are allergic to calcium and any of the other ingredients of Calvive (see the list of ingredients in section 6 at the end of the leaflet). • If you are suffering from raised levels of blood calcium (hypercalcaemia); • If you are suffering from increased calcium in your urine (hypercalciuria); • If you are suffering from certain kidney problems including: kidney stones (neph Baca dokumen lengkap
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Calvive 1000 Effervescent Tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each effervescent tablet of 1000 mg contains 2263 mg of calcium lactate gluconate and 1750 mg of calcium carbonate (equivalent to 1000 mg or 25 mmol of calcium). Excipients with known effect Each effervescent tablet of 1000 mg contains 30 mg of aspartame (E 951), 136.90 mg of sodium (5.95 mmol), 30 mg of orange flavour powder (containing 630 microgram sorbitol (E 420), 180 nanogram of benzyl alcohol, 210 nanogram sulphur dioxide (E 220) and 13.08 mg glucose). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Effervescent tablet White, circular, flat faced, bevelled edge effervescent tablets with an orange odour 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS - Prevention and treatment of calcium deficiency - Calcium supplement as an adjunct to specific therapy in the prevention and treatment of osteoporosis - Rickets and osteomalacia, in addition to vitamin D 3 therapy 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults and children: 1000mg per day. The effervescent tablets should be dissolved in a glass of water (approx. 200 ml) and drunk immediately. Calvive 1000 effervescent tablet may be taken with or without food. 4.3 CONTRAINDICATIONS - Hypersensitivity to the active substances or to any of the excipients listed in section 6.1 of the effervescent tablet - Diseases and/or conditions resulting in hypercalcaemia and/or hypercalciuria - Nephrocalcinosis, nephrolithiasis 4.4. SPECIAL WARNINGS AND PRECAUTIONS FOR USE For patients with mild hypercalciuria (exceeding 300 mg/24 hours or 7.5 mmol/24 hours), or with a history of urinary calculi, monitoring of calcium excretion in the urine is required. If necessary, the calcium dose should be reduced or therapy should be discontinued. An increased fluid intake is recommended for patients prone to formation of calculi in the urinary tract. In patients with impaired renal function, calcium salts should be Baca dokumen lengkap