Pays: Malte
Langue: anglais
Source: Medicines Authority
PASSIFLORA INCARNATA, HUMULUS LUPULUS, VALERIANA OFFICINALIS, LACTUCA VIROSA, LEONURUS CARDIACA
G. R. Lane Health Products Limited Sisson Road, Gloucester, GL2 0GR, United Kingdom
N05CM
PASSIFLORA INCARNATA 58 mg HUMULUS LUPULUS 75 mg VALERIANA OFFICINALIS 50 mg LACTUCA VIROSA 29 mg LEONURUS CARDIACA 34 mg
COATED TABLET
PASSIFLORA INCARNATA 58 mg HUMULUS LUPULUS 75 mg VALERIANA OFFICINALIS 50 mg LACTUCA VIROSA 29 mg LEONURUS CARDIACA 34 mg
OTC
PSYCHOLEPTICS
Withdrawn
2005-12-23
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 Quiet Life 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 4 weeks. • If you notice any side effect, please tell your doctor or pharmacist. In this leaflet: 1. What Quiet Life Tablets are and what they are used for 2. Before you take Quiet Life Tablets 3. How to take Quiet Life Tablets 4. Possible side effects 5. How to store Quiet Life Tablets 6. Further information 6. FURTHER INFORMATION What Quiet Life Tablets contain The active substances per tablet are: Motherwort herb (_Leonurus cardiaca_ L.) ........... 34mg Hop strobiles (_Humulus lupulus_ L.) ........................ 75mg Passion Flower herb (_Passiflora incarnata_ L.) ... 58mg Dry extract from Wild Lettuce (_Lactuca virosa_ L.) (equivalent to 29 mg of Wild Lettuce leaf) Extraction solvent: Water ....................................... 5.8mg Dry extract from Valerian root (_Valeriana officinalis_ L.) (equivalent to 50 mg of Valerian root) Extraction solvent: Ethanol 60%V/V .............. 12.5mg Thiamine Hydrochloride (Vit B1) ...................... 0.71mg Riboflavin (Vit B2) ....................................................... 0.57mg Nicotinamide ................................................................. 4.49mg The other ingredients are: Core: Acacia, Icing Sugar, Magnesium Stearate, Silicon Dioxide, Sodium Starch Glycolate, Stearic Acid. Coating: Acacia, Calcium Carbonate, Carnauba Wax, Mastercote Pink SP0415G, Purified Talc, Shellac Varnish, Sucrose, Titanium Dioxide, Yellow Beeswax. What Quiet Life Tablets look like and contents of the pack Quiet Life Tablets are Lire le document complet
Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Quiet Life Tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Ingredients mg/tablet Motherwort_ _herb (_Leonurus cardiac L._) 34.00 Dry extract from_ _Wild Lettuce (_Lactuca virosa_ L.) (equivalent to 29 mg of Wild Lettuce leaf) Extraction solvent: Water 5.80 Hop strobiles (_Humulus lupulus _L.) 75.00 Dry extract from Valerian root (_Valeriana _ _officinalis_ L. _s.l_.,) (equivalent to 50 mg of Valerian root) Extraction solvent: Ethanol 60%V/V 12.50 Passion Flower herb (_Passiflora incarnata_ L.) 58.00 Thiamine Hydrochloride 0.71 Riboflavin 0.57 Nicotinamide 4.49 Excipient: Each coated tablet contains 89 mg of sucrose. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Coated tablet. Pink circular, biconvex, sugar coated tablet. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS A traditional medicinal product: (i) To relieve periods of worry, irritability, and exogenous stresses and strains. (ii) To promote natural sleep. Page 2 of 5 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For oral use. Adults: Swallow 2 tablets twice per day with water after meals plus 3 tablets at bedtime. Not recommended for children or adolescents under 18 years old. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substances or to any of the excipients. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine. The product should not be used in children or adolescents under 18 years of age. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE As treatment effects m Lire le document complet