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Pumpkin seed soft extract
Omega Pharma Ltd
Pumpkin seed soft extract
500 mg
Capsule, hard.
Oral use
Packs of 20, 40, 80 or 140 hard capsules
GSL - General Sales List
Omega Pharma Manufacturing
A traditional herbal medicinal product used for the relief of lower urinary tract symptoms in men related to an overactive bladder, such as urgency to urinate and frequent urination, or who have a confirmed diagnosis of benign prostatic hyperplasia (BPH), based on traditional use only.
Authorised
2015-06-08
PACKAGE LEAFLET: INFORMATION FOR THE USER PUMPKIN SEED SOFT 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 qualified healthcare practitioner 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 qualified healthcare practitioner. This includes any possible side effects not listed in this leaflet. See section 4. • You must talk to a doctor or qualified healthcare practitioner if you do not feel better or if you feel worse. WHAT IS IN THIS LEAFLET 1. What UROSTEMOL ™ Prosta is and what it is used for 2. What you need to know before you take UROSTEMOL ™ Prosta 3. How to take UROSTEMOL ™ Prosta 4. Possible side effects 5. How to store UROSTEMOL ™ Prosta 6. Contents of the pack and other information 1. WHAT UROSTEMOL ™ PROSTA IS AND WHAT IT IS USED FOR UROSTEMOL ™ Prosta is a traditional herbal medicinal product used for the relief of lower urinary tract symptoms in men related to an overactive bladder, or who have a confirmed diagnosis of enlarged prostate (benign prostatic hyperplasia; BPH). This is based on traditional use only. Used to relieve symptoms such as: • urgency to urinate • frequent urination day and night • incomplete emptying of the bladder • weak or interrupted urinary flow. Prior to treatment other serious conditions should have been ruled out by a doctor. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE UROSTEMOL ™ PROSTA DO NOT TAKE UROSTEMOL ™ PROSTA: • if you are allergic to pumpkin seeds or other pumpkin-like plants (such as watermelon, courgettes, etc.), or any of the other ingredients of this medicine (l Aqra d-dokument sħiħ
5/7/2015 Urostemol Prosta capsules (eMC) print friendly http://www.medicines.org.uk/emc/printdocument?documentId=30417 1/3 Urostemol Prosta capsules Summary of Product Characteristics Updated 08Jun2015 | Omega Pharma Ltd 1. Name of the medicinal product Urostemol Prosta capsules 2. Qualitative and quantitative composition Each hard capsule contains: 500 mg of Pumpkin seed soft extract (_Cucurbita pepo _L. convar. _citrullina _I_._ Greb. var. _styriaca _I. Greb) (1525 : 1), Extraction solvent: ethanol 92% (m/m). For the full list of excipients, see section 6.1. 3. Pharmaceutical form Capsule, hard. Brown gelatin capsules, hard. 4. Clinical particulars 4.1 Therapeutic indications A traditional herbal medicinal product used for the relief of lower urinary tract symptoms in men related to an overactive bladder, such as urgency to urinate and frequent urination, or who have a confirmed diagnosis of benign prostatic hyperplasia (BPH), based on traditional use only. Prior to treatment, other serious conditions should have been ruled out by a doctor. 4.2 Posology and method of administration For oral use only. _Adults and the elderly:_ One capsule to be taken twice a day. The use in children and adolescents under 18 years of age is not recommended (see section 4.4 'Special warnings and precautions for use.'). Method of administration The capsules should be taken with water, ideally before meals. Duration of use Longterm use is possible on the advice of a doctor or qualified healthcare practitioner (see section 4.4 'Special warnings and precautions for use'). 4.3 Contraindications Hypersensitivity to the active substance, to other members of the Cucurbitaceae family (such as watermelon, courgettes etc.), or to any of the excipients. 4.4 Special warnings and precautions for use Do not Aqra d-dokument sħiħ