Kraj: Irlandia
Język: angielski
Źródło: HPRA (Health Products Regulatory Authority)
Milk thistle extract (as dry root)
Holland & Barrett International Limited
Milk thistle extract (as dry root)
.
Capsule, hard
Product not subject to medical prescription
Authorised
2014-09-26
PACKAGE LEAFLET: Information for the Patient MILK THISTLE HARD CAPSULES MILK THISTLE STANDARDISED FRUIT EXTRACT IMPORTANT NOTES WHAT IS IN THIS LEAFLET 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 eg 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 1 week of taking this traditional herbal medicine 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 A traditional herbal medicinal product for the symptomatic relief of digestive disorders such as indigestion, feeling of fullness and flatulence, exclusively based upon long-standing use. Do not take this traditional herbal medicine if you are: ◆ Under 18 years of age ◆ Allergic to Milk Thistle or plants of the Asterceae/Compositae family such as daisies, marigolds or artichokes ◆ Allergic to any ingredients in this traditional herbal medicine (listed in section 6 of this leaflet) Warnings and Precautions Talk to your doctor or pharmacist before taking this traditional herbal medicine if you are currently suffering from active liver disease. 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 Holland & Barrett Milk Thistle Hard Capsules including traditional herbal medicines: Tell your doctor or pharmacist if you are taking, have recently or might take any other medicines, includi Przeczytaj cały dokument
Health Products Regulatory Authority 29 May 2020 CRN008V4T Page 1 of 4 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Holland & Barrett Milk Thistle Hard Capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 133 mg – 324 mg of extract (as dry extract) from _Silybum marianum _L. Gaertn, fructus (milk thistle fruit) (equivalent to 3325 – 9720 mg of milk thistle fruit) corresponding to 108 mg of silymarin, calculated as silibinin. Extraction solvent: Acetone 99.9% v/v. For full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Capsules, hard A two piece clear, hard capsule with a beige / brown fill. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS A traditional herbal medicinal product for the symptomatic relief of digestive disorders such as indigestion, feelings of fullness and flatulence exclusively based on long-standing use. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For oral short-term use only. This product is not indicated in patients less than 18 years of age _ADULTS AND THE ELDERLY_ Take 1 capsule 2 times daily. Swallow the whole capsule with water. Do not exceed the stated dose. DURATION OF USE: If symptoms worsen or do not improve after 1 weeks use of Holland & Barrett Milk Thistle Hard Capsules, a qualified healthcare professional e.g. a doctor or pharmacist should be consulted. The safety of Milk Thistle in children and adolescents under 18 years of age has not been established as no data are available. 4.3 CONTRAINDICATIONS - Do not use in cases of known hypersensitivity to Milk Thistle or to plants of the Asteraceae (Compositae) family or to any of the excipients in Holland & Barrett Milk Thistle Hard Capsules - Patients under 18 years of age - Pregnancy and lactation 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE - Do not exceed the stated dose - Patients suffering from active liver disease should consult their doctor before taking the product Health Products Regulatory Authority 29 May 2020 CRN008V4T Page 2 of 4 - Milk Thistle may alter the wa Przeczytaj cały dokument