Quốc gia: Vương quốc Anh
Ngôn ngữ: Tiếng Anh
Nguồn: MHRA (Medicines & Healthcare Products Regulatory Agency)
Glucosamine hydrochloride
Lexon (UK) Ltd
M01AX05
Glucosamine hydrochloride
625mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 10010500
PACKAGE LEAFLET: INFORMATION FOR THE USER ALATERIS ® 625MG TABLETS (GLUCOSAMINE HYDROCHLORIDE) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. Keep this leaflet. You may need to read it again. If you have further questions, please ask your doctor or your pharmacist. This medicine has been prescribed for you personally and you should not pass it on to others. It may harm them, even if their symptoms are the same as yours. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. The name of your medicine is Alateris 625mg tablets, but will be referred to as Alateris in the remainder of this leaflet. IN THIS LEAFLET: 1) What Alateris is and what it is used for 2) Before you take Alateris 3) How to take Alateris 4) Possible side effects 5) How to store Alateris 6) Further information Alateris belongs to the group of medicines called anti-inflammatory and anti-rheumatic agents, non-steroids. Alateris is used for the relief of symptoms in mild to moderate osteoarthritis of the knee. DO NOT TAKE ALATERIS IF YOU: are ALLERGIC (hypersensitive) to GLUCOSAMINE or to ANY OF THE OTHER INGREDIENTS of Alateris. are ALLERGIC (hypersensitive) to SHELLFISH, since glucosamine is manufactured from shellfish. TAKE SPECIAL CARE WITH ALATERIS (AND SPEAK TO YOUR DOCTOR) IF YOU: suffer from IMPAIRED GLUCOSE TOLERANCE. More frequent controls of your blood glucose levels may be necessary when starting treatment with Alateris. have impaired KIDNEY or LIVER FUNCTION. have a KNOWN RISK FACTOR FOR CARDIOVASCULAR (HEART) DISEASE, since an abnormally high level of cholesterol in the blood has been observed in a few patients treated with Alateris. suffer from ASTHMA. When starting on Alateris, you should be aware of potential worsening of symptoms. Alateris should not be used in children and adolescents below the age of 18. You should stop taking Alateris and see your doctor immediately if you Đọc toàn bộ tài liệu
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Alateris 625 mg tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 625 mg of glucosamine (as glucosamine hydrochloride). For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Tablet White to light beige, oval tablet marked with “G” and a score line. The scoreline is only to facilitate breaking for ease of swallowing and not to divide into equal doses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Relief of symptoms in mild to moderate osteoarthritis of the knee. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION Two tablets (1250 mg Glucosamine) once daily for relief of symptoms. Glucosamine is not indicated for the treatment of acute painful symptoms. Relief of symptoms (especially pain relief) may not be experienced until after several weeks of treatment and in some cases even longer. If no relief of symptoms is experienced after 2-3 months, continued treatment with glucosamine should be re-evaluated. Tablets can be taken with or without food. Additional information on special populations. _Children and Adolescents _ Alateris TM should not be used in children and adolescents below the age of 18 (See 4.4). _Elderly _ No specific studies have been performed in the elderly, but according to clinical experience dosage adjustment is not required when treating otherwise healthy, elderly patients. _Impaired renal and/or liver function _ In patients with impaired renal and/or liver function no dose recommendations can be given, since no studies have been performed. 4.3 CONTRAINDICATIONS Known hypersensitivity to glucosamine or any of the excipients. Alateris must not be given to patients who are allergic to shellfish as the active substance is obtained from shellfish. 4.4. SPECIAL WARNINGS AND PRECAUTIONS FOR USE Alateris TM should not be used in children and adolescents below the age of 18, due to lack of data on safety and efficacy. A doctor must be consulted to rule out the presence of joint diseases for which oth Đọc toàn bộ tài liệu