দেশ: আয়ার্লণ্ড
ভাষা: ইংরেজি
সূত্র: HPRA (Health Products Regulatory Authority)
Cranberry fruit juice refined dry extract
Laboratoire Pharmaceutique Pharmatoka SAS
G04BX
Cranberry fruit juice refined dry extract
Capsule, hard
Other urologicals
2023-10-20
PACKAGE LEAFLET: INFORMATION FOR THE USER Ellura ® hard capsules Cranberry fruit juice refined dry extract READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Always take this medicine 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. WHAT IS IN THIS LEAFLET 1. What Ellura is and what it is used for 2. What you need to know before you take Ellura 3. How to take Ellura 4. Possible side effects 5. How to store Ellura 6. Contents of the pack and other information 1. WHAT ELLURA IS AND WHAT IT IS USED FOR Ellura is a traditional herbal medicinal product containing a refined dry extract from the juice of cranberry fruit. Ellura is used to prevent recurrent uncomplicated acute urinary tract infections (UTIs) such as cystitis in adult women over the age of 18 years exclusively based on longstanding use. Ellura is for use in women only. Ellura is to be used if you suffer from recurrent uncomplicated acute UTIs, meaning that you have had at least 3 or more episodes in the past 12 months or 2 or more episodes in the past 6 months 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ELLURA 2.1 DO NOT TAKE ELLURA -If you are allergic (hypersensitive) to the active substance or any of the other ingredients of this medicine (listed in section 6). -if you are a man -If you are under 18 years old. -If you are pregnant or breastfeeding - If you suffer from: • Fluid retention caused by a kidney or heart problem • Current or previous kidney problems including kidney stones • A condition which requires you to restrict your fluid intake e.g. severe heart or kidney disease. - If you are taking any anticoagulant medicine used to help prevent blood clots e.g. warfarin সম্পূর্ণ নথি পড়ুন
Health Products Regulatory Authority 24 October 2023 CRN009L3H Page 1 of 4 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Ellura hard capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One capsule contains 195.7 to 216.9 mg of extract (as dry extract, refined) from the juice of _Vaccinium macrocarpon _Ait., fructus (cranberry fruit), corresponding to 36 mg of proanthocyanidins (PAC), calculated as PAC A2. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Hard capsule (capsule). Colourless capsule containing a dark purple powder. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS A traditional herbal medicinal product used to prevent recurrent uncomplicated acute urinary tract infections (UTIs) such as cystitis in women exclusively based on long standing use. Ellura hard capsules are indicated in adult women over the age of 18 years. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For oral use only. Ellura hard capsules should always be taken with a large glass of water. _ADULT WOMEN OVER 18 YEARS INCLUDING THE ELDERLY_ Ellura hard capsules are indicated for use in women who suffer from recurrent uncomplicated acute UTIs, meaning those who have had at least 3 or more episodes in the past 12 months or 2 or more episodes in the past 6 months. If these acute uncomplicated UTIs recur more often, a doctor should be consulted for advice including advice on the frequency of this prophylactic treatment. DURATION OF TREATMENT One capsule of Ellura to be taken per day as prophylactic treatment for a minimum of 15 consecutive days after the most recent UTI. Maximum duration of use is 6 months. If the patient experiences symptoms of a UTI during the use of the medicinal product, a doctor should be consulted. _CHILDREN AND ADOLESCENTS UNDER 18 YEARS OLD:_ _ _ This product is not recommended in children and adolescents under 18 years old (see section 4.4) _MEN:_ The use of Ellura hard capsules in men is not recommended (see section 4.4) 4.3 CONTRAINDICATIONS Hypersensitivity to cranberry (_V সম্পূর্ণ নথি পড়ুন