Country: Malta
Language: English
Source: Medicines Authority
CASCARA, CASSIA SENNA, ALOIN
G. R. Lane Health Products Limited Sisson Road, Gloucester, GL2 0GR, United Kingdom
A06AB
CASCARA 130 mg CASSIA SENNA 32 mg ALOIN 10 mg
COATED TABLET
CASCARA 130 mg CASSIA SENNA 32 mg ALOIN 10 mg
OTC
DRUGS FOR CONSTIPATION
Withdrawn
2005-12-23
6. FURTHER INFORMATION What Lanes Modern Herbals Laxative 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 Lanes Modern Herbals Laxative Tablets look like and contents of the pack Lanes Modern Herbals Laxative Tablets are brown, circular, coated tablets. They are available in blister packs containing 14 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: modernherbals@laneshealth.com This leaflet was last approved November 2009 573030 _LAXATIVE TABLETS_ HERBALS M O D E R N 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 Lanes Modern Herbals Laxative 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 Lanes Modern H Read the complete document
Page 1 of 8 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Lanes Modern Herbals Laxative 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 allergic to these ingredients. Patients taking cardiac glycosides, antiarrhythmic medicinal products, medicinal products inducing QT-prolongation, diuretics, corticosteroids or liquorice root, have to consult a doctor before taking senna leaves or cascara concomitantly. Like all laxatives, senna leaves should not be taken by patients suffering from faecal impaction and undiagnosed, acute or p Read the complete document