Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Dry extract salvia officinalis l.
Bioforce (UK) Ltd
Dry extract salvia officinalis l.
Tablet
Product not subject to medical prescription
Authorised
2013-05-03
Bioforce UK Salvia tablets GB – Irvine, Ayrshire CTD Module 1 May 2018 ___________________________________________________________________________________ PACKAGE LEAFLET Page 1 of 4 Salvia off. Tabl (2) Art. no. 01103800 PACKAGE LEAFLET: INFORMATION FOR THE USER MENOFORCE Sage tablets Sage dry extract READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS PRODUCT BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Always take this product exactly as described in this leaflet or as your doctor, pharmacist or nurse has told you. • Keep this leaflet. You may need to read it again. • Ask your pharmacist if you need more information or advice. • If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. • You must talk to a doctor if you do not feel better or if you feel worse after 12 weeks. WHAT IS IN THIS LEAFLET: 1. What Menoforce is and what it is used for 2. What you need to know before you take Menoforce 3. How to take Menoforce 4. Possible side effects 5. How to store Menoforce 6. Contents of the pack and other information 1. WHAT MENOFORCE IS AND WHAT IT IS USED FOR Menoforce is a traditional herbal medicinal product containing the extract of fresh Sage leaves. It is used to relieve: • Menopausal hot flushes • Excessive sweating This is based exclusively on long-standing use. Menoforce is for use in adults. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MENOFORCE DO NOT TAKE MENOFORCE • If you are allergic to Sage or any of the other ingredients in this product (listed in section 6). • If you are pregnant or breast-feeding. Bioforce UK Salvia tablets GB – Irvine, Ayrshire CTD Module 1 May 2018 ___________________________________________________________________________________ PACKAGE LEAFLET Page 2 of 4 Salvia off. Tabl (2) Art. no. 01103800 WARNINGS AND PRECAUTIONS • Talk to your doctor if your symptoms worsen or do not improve within 12 weeks. • Excessive sweating can sometimes be a sign Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Menoforce Sage tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One tablet contains 51 mg of dry extract from fresh Sage (Salvia officinalis L.) leaves (equivalent to 795 - 1370 mg of fresh herb). Extraction solvent: ethanol 68% v/v. Excipients with known effect: One tablet contains 10.2 mg sucrose laurate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet It is an olive green to yellowish-brown, slightly dotted, oblong, biconvex, bevelled tablet with a slightly aromatic odour. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS A traditional herbal medicinal product used for the relief of menopausal hot flushes and excessive perspiration, exclusively based on long-standing use. This product is indicated for use in adults. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Adults (18 years and over): 1 tablet daily. This product is not indicated in patients less than 18 years. If the symptoms worsen during the use of Menoforce or do not improve after 12 weeks a qualified healthcare professional e.g. a doctor or pharmacist should be consulted. Due to a lack of data the safety of this product for long term use has not been established. Method of Administration For oral use only. 4.3 CONTRAINDICATIONS Do not use in cases of known hypersensitivity to Sage preparations or to any of the excipients listed in section 6.1. Do not use if pregnant or breast-feeding. H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ _D_ _a_ _t_ _e_ _ _ _P_ _r_ _i_ _n_ Read the complete document