מדינה: הממלכה המאוחדת
שפה: אנגלית
מקור: MHRA (Medicines & Healthcare Products Regulatory Agency)
Calcium gluconate
Accord-UK Ltd
A12AA03
Calcium gluconate
1gram
Effervescent tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 09050101; GTIN: 5012617010209
130x210 Leaflet Reel Fed Profile (BST) Dimensions: Component: Date Sent: Technologist: TECHNICALLY APPROVED Pharmacode: JDE No.: Effervescent Calcium Gluconate, 28 Tablets BP, 1g - UK 130x210 (Reel Fed) 50994023 Leaflet for Bottles 2109 RH 28-08-20 * Please note that ONLY Artwork Studio is permitted to make changes to the above artwork. No changes are permitted by any 3rd party other than added notes and mark ups for required changes. approved for print/date PROOF ROUND Technical Approval NON PRINTING COLOURS COLOURS DATE SENT: DATE RECEIVED: Item number: ORIGINATOR: ORIGINATION DATE: REVISION DATE: REVISED BY: DIMENSIONS: MIN BODY TEXT SIZE: SUPPLIER: 1. 2. 3. 4. 5. 6. 1. 2. 3. EU-Artwork-Support@accord-healthcare.com CALCIUM GLUCONATE 1G EFFERVESCENT TABLETS PIL - UNITED KINGDOM Black Profile BBBA8894 RH 07-09-20 130 x 210 7.3pt Accord Barnstaple na na 01 Version 7 12.02.2020 German GTIN 14 (incorporating PZN): Cartons and label leaflets only (labels only when specified) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Always take this medicine exactly as described in this leaflet or as your doctor, or pharmacist has told you. • Keep this leaflet. You may need to read it again. • Ask your pharmacist if you need more information or advice. • If you get any side effects, talk to your doctor or pharmacist. This includes any possible effects not listed in this leaflet. See section 4. • You must talk to a doctor if you do not feel better or if you feel worse. WHAT IS IN THIS LEAFLET 1 WHAT EFFERVESCENT CALCIUM GLUCONATE TABLETS ARE AND WHAT THEY ARE USED FOR 2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE EFFERVESCENT CALCIUM GLUCONATE TABLETS 3 HOW TO TAKE EFFERVESCENT CALCIUM GLUCONATE TABLETS 4 POSSIBLE SIDE EFFECTS 5 HOW TO STORE EFFERVESCENT CALCIUM GLUCONATE TABLETS 6 CONTENTS OF THE PACK AND OTHER INFORMATION 1 WHAT EFFERVESCENT CALCIUM GLUCONATE TABLETS ARE AND WHAT THEY ARE USED FOR Effervescent Calcium Gluconate tablets may be used: קרא את המסמך השלם
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Effervescent Calcium Gluconate Tablets BP 1g 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 1g Calcium Gluconate BP equivalent to 2.23mmol of calcium (Ca 2+ ) Excipient with known effect Each tablet contains 102.8 mg sodium. For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM White uncoated tablets. White, circular, flat bevelled-edge uncoated tablets impressed “C” and the identifying letters “CN” on one face. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS 1) As an adjunct to conventional therapy in the arrest or slowing down of bone demineralisation in osteoporosis where other effective treatment is contraindicated. 2) In the arrest or slowing down of bone demineralisation in osteoporosis where other effective treatment is contraindicated. 3) Therapeutic supplementation in osteomalacia, rickets, post-gastrectomy malabsorption, pregnancy, lactation, malnutrition or dietary deficiency. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION _Posology _ The tablets must be dissolved in one third to one half a tumblerful of water. In health the concentration of calcium in serum is maintained close to 2.5mmol/l (normal range 2.25-2.75mmol or 4.5-5.5mEq/l). Treatment or therapeutic supplementation should aim to restore or maintain this level. _ _ _Adults (including elderly): _ _Osteoporosis: _A daily supplement of 800mg (20mmol) calcium or 8-9 tablets may reduce the rate of bone loss, but larger doses have not been shown to be more effective._ _ INDICATION: DAILY DOSAGE: OSTEOPOROSIS POST-GASTRECTOMY MALABSORPTION 12-20 tablets OSTEOMALACIA AND RICKETS LACTATION PREGNANCY SUPPLEMENT 1-10 tablets PREGNANCY CRAMPS _Children: _Children require approximately half the adult dosage. _Infants: _A more suitable dosage form should be used for this age group. _Method of Administration _ To be dissolved in water for oral administration. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients קרא את המסמך השלם