Krajina: Spojené kráľovstvo
Jazyk: angličtina
Zdroj: MHRA (Medicines & Healthcare Products Regulatory Agency)
Hops extract; Valerian extract; Passion flower extract
Omega Pharma Ltd
n/a
Hops extract; Valerian extract; Passion flower extract
200mg ; 160mg ; 130mg
Oral tablet
Oral
No Controlled Drug Status
Never Valid To Prescribe As A VMP
BNF: ; GTIN: 5000347029332
Perrigo component code: Artwork reference nr: FOR APPROVAL • Approval needs to be given within AMS. Please verify this proof carefully concerning lay-out, size, texts and bar code. For the PMS colours please refer to the latest PMS coulour guide. After your approval on the above we can proceed to the next stage of your project. Graphic Design Nytol Tablets LF23224A P20821 United Kingdom 125 x 178 mm Herbal 20tabs Leaflet English LR01293 IVC Brunel - - - 0 10/05/19 1 16/05/19 - - - - - - - - - - - - LF23224A - 02 - - Black - - - - - - P20821 Nytol Leaflet cutter 125x178 - - 522 - - - - - FRONT 125mm First Bar Last Bar 17mm 178mm PROFILE KEYS: Pharma Code Copy/Text Free 17mm BACK 125mm 17mm 178mm P20821 LF23224A HERBAL TABLETS With extracts of Hop Strobile, Valerian and Passion Flower READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU TAKE THIS PRODUCT BECAUSE IT CONTAINS IMPORTANT INFORMATION YOU NEED TO KNOW. This product is available without prescription; however, you still need to use this product carefully to get the best results from it. Keep this leaflet as you may need to read it again. Ask your doctor, pharmacist or qualified healthcare practitioner if you need more information or advice. IN THIS LEAFLET: 1. What this product is and what it is used for. 2. Before you take this product. 3. How to take this product. 4. Possible side effects. 5. How to store this product. 6. Further information. 1. What this product is and what it is used for THIS MEDICINE CONTAINS EXTRACTS OF: • hop strobile • valerian root • passion flower herb. A traditional herbal medicinal product used for the temporary relief of sleep disturbances based on traditional use only. 2. Before you take this product DO NOT TAKE THIS PRODUCT IF YOU ARE: • allergic to any of the ingredients (see section 6) • under 18 years of age • already taking a medicine for sleep or anxiety PREGNANCY AND BREAST FEEDING • DO NOT TAKE this product if you are pregnant or breast feeding, because there is no evidence that it is safe to do so. • The e Prečítajte si celý dokument
OBJECT 1 NYTOL HERBAL TABLETS Summary of Product Characteristics Updated 27-Sep-2019 | Omega Pharma Ltd • 1. Name of the medicinal product • 2. Qualitative and quantitative composition • 3. Pharmaceutical form • 4. Clinical particulars • 4.1 Therapeutic indications • 4.2 Posology and method of administration • 4.3 Contraindications • 4.4 Special warnings and precautions for use • 4.5 Interaction with other medicinal products and other forms of interaction • 4.6 Fertility, pregnancy and lactation • 4.7 Effects on ability to drive and use machines • 4.8 Undesirable effects • 4.9 Overdose • 5. Pharmacological properties • 5.1 Pharmacodynamic properties • 5.2 Pharmacokinetic properties • 5.3 Preclinical safety data • 6. Pharmaceutical particulars • 6.1 List of excipients • 6.2 Incompatibilities • 6.3 Shelf life • 6.4 Special precautions for storage • 6.5 Nature and contents of container • 6.6 Special precautions for disposal and other handling • 7. Marketing authorisation holder • 8. Marketing authorisation number(s) • 9. Date of first authorisation/renewal of the authorisation • 10. Date of revision of the text 1. Name of the medicinal product Superdrug Quiet Night Tablets Sainsbury's Healthcare Sleep Aid Tablets Tesco Herbal Sleep Aid Sominex Herbal Nytol Herbal Tablets Gerard House Somnus Sleep Aid Boots Sleepeaze Herbal Plus Tablets HERBALSTORE Sleep Aid Wilko Sleep Aid Tablets Asda Sleep Aid My Protein Sleep Aid Tablet Health Essentials Herbal Sleep Aid 2. Qualitative and quantitative composition EACH FILM COATED TABLET CONTAINS: Each film coated tablet contains: 34 mg of extract (as dry extract) from Hop strobile (Humulus lupulus L.) (4- 6:1) Extraction solvent: Methanol 30% (v/v) 30.8 mg of extract (as dry extract) from Valerian root (Valeriana officinalis L.) (4.5-6:1) Extraction solvent: Ethanol 60% (v/v) 18.2 mg of extract (as dry extract) of Passion Flower herb (Passiflora incarnata L.) (3-7:1) Extraction solvent: Ethanol 70% (v/v) For full list of ex Prečítajte si celý dokument