Țară: Malta
Limbă: engleză
Sursă: Medicines Authority
CASCARA, ALOIN, SENNA LEAF
G. R. Lane Health Products Limited Sisson Road, Gloucester, GL2 0GR, United Kingdom
A06AB
CASCARA 130 mg ALOIN 10 mg SENNA LEAF 32 mg
COATED TABLET
CASCARA 130 mg ALOIN 10 mg SENNA LEAF 32 mg
OTC
DRUGS FOR CONSTIPATION
Withdrawn
2005-12-23
6. FURTHER INFORMATION What Dual-Lax Extra Strong Tablets contain The active substances per tablet are: Senna Leaf (_Cassia senna_ L. folium)......................32mg Extract (as dry extract) from Cascara bark (_Rhamnus purshianus_ D.C.), Extraction solvent: water ......................................130mg Aloin ......................................................................................10mg The other ingredients are: Core: Calcium Phosphate, Magnesium Stearate, Pregelatinised Maize Starch, Silicon Dioxide, Sodium Starch Glycolate, Stearic Acid. Coating: Acacia, Calcium Carbonate, Carnauba Wax, Ethyl Acetate, Hydrochloric Acid, Iron Oxide, Polyvinyl Acetate Phthalate, Sodium Propyl Parahydroxybenzoate (E217), Sodium Methyl Parahydroxybenzoate (E219), Sucrose, Stearic Acid, Talc, Titanium Dioxide, Yellow Beeswax. What Dual-Lax Extra Strong Tablets look like and contents of the pack Dual-Lax Extra Strong Tablets are brown, circular, coated tablets. They are available in bottles containing 100 tablets. Marketing Authorisation Holder and Manufacturer G. R. Lane Health Products Limited, Sisson Road, Gloucester, GL2 0GR, United Kingdom. Tel: +44 (0)1452 524012 Email: duallax@laneshealth.com This leaflet was last approved November 2009 533036 D UAL- L AX EXTRA STRONG TABLETS 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 Dual-Lax Extra Strong 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 after 7 days. • If any of the side effects become serious, or if you notice any side effect not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet: 1. What Dual-Lax Extra Strong Tablets are and what Citiți documentul complet
Page 1 of 8 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Dual Lax Extra Strong Coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Ingredients mg/tablet Senna leaf (_Cassia senna _L. folium) 32 Aloin 10 Extract (as dry extract) from Cascara bark (_Rhamnus purshianus _D.C. (_Frangula purshiana _ (D.C.) A Gray ex J.C. Cooper), Extraction solvent: water 130 Excipients: Sucrose (92mg/tablet), sodium propyl parahydroxybenzoate E217 and sodium methyl parahydroxybenzoate E219. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Coated tablet. Brown circular biconvex sugar coated tablet. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the relief of temporary constipation. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For oral use. Adults and children aged 12 and over: Swallow 1 or 2 tablets with water at night. Not recommended for children under 12 years old. 4.3 CONTRAINDICATIONS Children under 12 years old. Hypersensitivity to the active substances or to any of the excipients. Page 2 of 8 Cases of intestinal obstructions and stenosis, atony, appendicitis, inflammatory colon diseases (e.g. Crohn’s disease, ulcerative colitis), abdominal pain of unknown origin, severe dehydration state with water and electrolyte depletion. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE This product contains sodium propyl parahydroxybenzoate (E217) and sodium methyl parahydroxybenzoate (E219) and should not be used by patients who are Citiți documentul complet