Nazione: Irlanda
Lingua: inglese
Fonte: HPRA (Health Products Regulatory Authority)
DRY EXTRACT FROM MELISSA OFFICINALIS L. FOLIUM (LEMON BALM LEAF)
Holland & Barrett International Limited
DRY EXTRACT FROM MELISSA OFFICINALIS L. FOLIUM (LEMON BALM LEAF)
.
Capsule, hard
Product not subject to medical prescription
Authorised
2014-09-05
LEMON BALM HARD CAPSULES MELISSA LEAF DRY EXTRACT More information on back panel P A C K A G E L E A F L E T : I N F O R M A T I O N F O R T H E P A T I E N T IMPORTANT NOTES PLEASE READ THIS LEAFLET CAREFULLY BEFORE YOU TAKE THIS TRADITIONAL HERBAL MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU: • Always take this traditional herbal medicine exactly as described in this leaflet or as your doctor or pharmacist has told you • Keep this leaflet. You may need to read it again • Ask a healthcare professional e.g. a doctor or a pharmacist if you need more information or advice • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet • You must talk to a doctor if you feel worse or do not feel better after taking this traditional herbal medicine WHAT IS IN THIS LEAFLET 1 What this traditional herbal medicine is and what it is used for 2 What you need to know before you take this traditional herbal medicine 3 How to take this traditional herbal medicine 4 Possible side effects 5 How to store this traditional herbal medicine 6 Contents of the pack and other information 1 - WHAT THIS TRADITIONAL HERBAL MEDICINE IS AND WHAT IT IS USED FOR Nature’s Bounty Lemon Balm Hard Capsules is a traditional herbal medicinal product used for the temporary relief of symptoms of mild mental stress, to aid sleep and for mild digestive complaints such as bloating and flatulence. This is exclusively based upon long-standing use. 2 - WHAT YOU NEED TO KNOW BEFORE YOU TAKE THIS TRADITIONAL HERBAL MEDICINE Do not take this traditional herbal medicine if you are allergic to Lemon Balm Leaf or to any of the ingredients in this traditional herbal medicinal product (listed in section 6 of this leaflet). CHILDREN AND ADOLESCENTS Do not give this traditional herbal medicine to children or adolescents under 18 years as it is not known if it is safe to do so. OTHER MEDICINES AND NATURE’S BOUNTY LEMON BALM HARD CAPSULES Always remember to tell your doct Leggi il documento completo
Health Products Regulatory Authority 20 January 2020 CRN009KHR Page 1 of 3 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Nature’s Bounty Lemon Balm Hard Capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains: 171 mg of extract (as dry extract) from _Melissa officinalis _L., folium (equivalent to 684 mg – 1026 mg of Lemon Balm leaf). Extraction solvent: Ethanol 50 % v/v For the full list of excipients see section 6.1 3 PHARMACEUTICAL FORM Capsule, hard Two piece clear hard capsules with green/brown fill. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS A traditional herbal medicinal product used for the temporary relief of symptoms of mild mental stress, to aid sleep and for mild digestive complaints such as bloating and flatulence, exclusively based upon long-standing use. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For oral short-term use only _ADULTS AND OLDER PEOPLE_ Take 2 capsules 3 times daily. Swallow the whole capsule with water. Do not exceed the stated dose. DURATION OF USE: If symptoms persist, worsen or do not improve after 2 weeks use of Nature’s Bounty Lemon Balm Hard Capsules, a qualified healthcare professional e.g. a doctor or pharmacist should be consulted. Not recommended for use in children under 18 years (see 4.4 Special warnings and precautions for use). 4.3 CONTRAINDICATIONS Do not use in cases of known hypersensitivity to Lemon Balm or to any of the excipientslisted in section 6.1 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Do not exceed the stated dose The use in children and adolescents under 18 years of age has not been established due to lack of adequate data. If symptoms worsen or persist, or if new symptoms develop whilst taking this medicinal product, a qualified healthcare professional e.g. a doctor or pharmacist should be consulted. Health Products Regulatory Authority 20 January 2020 CRN009KHR Page 2 of 3 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTIONS Although no data is available addit Leggi il documento completo