국가: 아일랜드
언어: 영어
출처: HPRA (Health Products Regulatory Authority)
SABALIS SERRULATAE EXTRACTUM SPISSUM
Bioforce (UK) Ltd
SABALIS SERRULATAE EXTRACTUM SPISSUM
Capsules, Soft
Product not subject to medical prescription
Authorised
2012-05-25
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 8 weeks. What is in this leaflet 1. What Prostasan is and what it is used for 2. What you need to know before you take Prostasan 3. How to take Prostasan 4. Possible side effects 5. How to store Prostasan 6. Contents of the pack and other information Information Package Leaflet: Information for the user _Please turn over..._ Do's and Don'ts for taking Prostasan Prostasan ® soft capsules Saw Palmetto soft extract 41530IN3 1. What Prostasan is and what it is used for Prostasan is a traditional herbal medicinal product containing the extract of Saw Palmetto fruit. It is used to relieve urinary discomfort in men with an enlarged prostate (also known as benign prostatic hyperplasia or BPH). This is exclusively based on long-standing use. Used to help relieve symptoms including: The need to urinate frequently (especially at night). Weak or interrupted urinary flow. A feeling that you cannot empty your bladder completely. This product is used to treat an enlarged prostate in men over 18. The prostate gland is found just below the bladder in men. As men get older this gland may enlarge causing urinary discomfort. 2. What you need to know before you take Prostasan Do not take Prostasan If you are allergic to: Saw Palmetto fruit. This product contains Saw Palmetto fruit. Any of the other ingredients of this product (listed in Section 6). Warnings and precautions This product is for use in men only. It is not suitable for use in women, children or adole 전체 문서 읽기
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Prostasan soft capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 320 mg of extract (as soft extract) from_ Serenoa repens_ (Bartram) Small fructus (_Sabal serrulata_ (Michaux) Nichols fructus) (saw palmetto fruit) (9-12:1). Extraction solvent: ethanol 96% v/v. Excipients with known effect: Each capsule contains 7.7 mg sorbitol (as dry matter). For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Soft capsules (capsules) It is an oval-shaped, dark brown coloured soft capsule containing a clear, yellow-brown coloured oil. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS A traditional herbal medicinal product used for the relief of lower urinary tract symptoms in men who have a confirmed diagnosis of benign prostatic hyperplasia (BPH). This is exclusively based on long-standing use. Prior to treatment other serious conditions should have been ruled out by a doctor. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY Adults and older people: One capsule daily to be taken with food. There is no relevant use of Prostasan in women, or in children or adolescents under the age of 18 (see Section 4.1). Patients with hepatic and/or renal impairment: The safety of Saw palmetto has not been studied in patients with hepatic and/or renal impairment. Due to a lack of data the safety of this product for long term use has not been established. If symptoms persist, worsen or do not improve after 8 weeks use of Prostasan a qualified healthcare professional e.g. a doctor or pharmacist should be consulted. METHOD OF ADMINISTRATION For oral use only. 4.3 CONTRAINDICATIONS Hypersensitivity to saw palmetto or any of the excipients listed in section 6.1. 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 ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ _ 전체 문서 읽기