Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Calcium carbonate
Bayer Plc
A02AC01
Calcium carbonate
800mg
Chewable tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 01010201; GTIN: 0000050506378 5010605298035
_SOFT CHEWS 800MG _ _CHEWABLE TABLETS _ _ _ _ _ _ _ Bayer cross _ _ Calcium carbonate 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 Rennie Soft Chews tablets carefully to get the best results from them. Keep this leaflet, you may need to read it again. Ask your pharmacist if you need more information or advice. You must contact a doctor if your symptoms worsen or do not improve. If you have any unusual effects after taking Rennie Soft Chews, tell your doctor or pharmacist. IN THIS LEAFLET 1. What are Rennie Soft Chews and what are they used for? 2. Before you take Rennie Soft Chews 3. How to take Rennie Soft Chews 4. Possible side effects 5. How to store Rennie Soft Chews 6. Further information 1. WHAT ARE RENNIE SOFT CHEWS AND WHAT ARE THEY USED FOR? RENNIE SOFT CHEWS are soft and chewy antacid tablets, with a smooth freshmint taste, which quickly and effectively relieve the discomfort of indigestion, heartburn, acid indigestion, dyspepsia, nervous indigestion, flatulence, upset stomach, indigestion during pregnancy and biliousness. 2. BEFORE YOU TAKE RENNIE SOFT CHEWS DO NOT TAKE RENNIE SOFT CHEWS: • If you have severe kidney disease. • If you have high calcium in the urine or kidney stones. • If you have high calcium or low phosphate levels in the blood. • If you are allergic (hypersensitive) to any of the ingredients (_listed in Section 6. _ _Further Information_). SPECIAL PRECAUTIONS: Do not exceed the stated dose. 1.3.1 1 Rennie Soft Chews should not be used for a prolonged period without consulting a doctor. Please consult your doctor or pharmacist if you have any kidney problems. This product contains sucrose and glucose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. If symptoms persist consult your doctor. TAKING OTHER MEDICINES: • Please tell your doctor or pharmacist if you are tak Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Rennie Soft Chews 800mg chewable tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Calcium Carbonate 800.0 mg Also contains sucrose and glucose For full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Chewable Tablets. Square green soft chewable tablets 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the relief of indigestion, heartburn, nervous indigestion, hyperacidity, flatulence, upset stomach, dyspepsia, biliousness, overindulgence in food and drink, indigestion during pregnancy. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology: Tablets to be taken orally, sucked or chewed. Adults and children over 12 years: One or two tablets to be sucked or chewed as a single dose, preferably to be taken one hour after meals and before going to bed but also in between in case of heartburn or gastric pain. A maximum daily dose of 8 g calcium carbonate corresponding to 10 tablets a day must not be exceeded. Elderly: No special dosage regimen is required, but care should be taken to observe the contraindications and warnings. Children under 12 years: Not recommended. As with all antacids, if symptoms persist despite 14 days of continuous therapy, diagnostic measures are strongly recommended in order to rule out a more serious disease. 4.3 CONTRAINDICATIONS Rennie should not be administered to patients with: Nephrocalcinosis Severe renal function impairment (creatinine clearance below 30 ml/min) Hypophosphatemia Hypersensitivity to the active ingredients or any of the excipients, refer to section 6.1. Hypercalcaemia 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE • Prolonged use should be avoided. • Do not exceed the stated dose and if symptoms persist consult your doctor. • Caution should generally be exercised in the case of patients with impaired renal function. If Rennie is used in such patients, plasma calcium and phosphate levels should be regularly monitored. • Long term uses at high doses can result in undesirable effec Read the complete document