Ülke: İrlanda
Dil: İngilizce
Kaynak: HPRA (Health Products Regulatory Authority)
GLUCOSAMINE SULFATE SODIUM CHLORIDE
Meda Health Sales Ireland Limited
M01AX05
GLUCOSAMINE SULFATE SODIUM CHLORIDE
500 Milligram
Capsules Hard
Product not subject to medical prescription
Other antiinflammatory and antirheumatic agents, non-steroids
Authorised
2015-11-19
Package Leaflet: Information for the user DONA 500MG CAPSULES Glucosamine Sulfate 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 pharmacist 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 pharmacist. 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 30 days. What is in this leaflet: 1. What Dona is and what it is used for 2. What you need to know before you take Dona 3. How to take Dona 4. Possible side effects 5. How to store Dona 6. Contents of the pack and other information 1. WHAT DONA IS AND WHAT IT IS USED FOR Dona contains glucosamine sulfate which belongs to a group of medicines called non-steroidal anti-inflammatory and anti-rheumatic agents. Dona is used for the relief of symptoms in mild to moderate osteoarthritis of the knee, as diagnosed by your doctor. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DONA DO NOT TAKE DONA: • If you are allergic (hypersensitive) to glucosamine or any of the other ingredients of Dona. • If you are allergic to shellfish, as glucosamine is obtained from shellfish. WARNINGS AND PRECAUTIONS Consult your doctor before taking Dona: • If you have diabetes; in this case closer monitoring of blood sugar levels and where relevant insulin requirements may be necessary at the beginning of the treatment and periodically during treatment with Dona. • If you suffer from asthma; when starting on glucosamine, you should be aware of potential worsening of symptoms. • If you have severe liver or kidney problems. • If you are on a controlled sodium diet. The presence of another joint disease, which would require alternative treatment, should be excluded. If unusual signs or symptoms appear, or if any change Belgenin tamamını okuyun
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Dona 500mg Capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains: Glucosamine sulfate sodium chloride 628 mg equivalent to: glucosamine sulfate 500 mg sodium chloride 128 mg The content of sodium in each capsule is 2.2 mmol. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Capsule, hard (Capsule) Hard gelatine, snap-fit, red-red capsule (size 0), reporting the logo ROTTA printed in black ink on the body and the head. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Relief of symptoms in mild to moderate osteoarthritis of the knee, as diagnosed by a doctor. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology One capsule should be taken three times daily, preferably at meals. Pivotal proof of efficacy has been demonstrated for periods of up to three months, with a residual effect evident for two months after drug withdrawal. The safety and the efficacy of the product were also confirmed in pivotal clinical trials for treatment up to three years. Continuous treatment beyond 3 years cannot be recommended as the safety has not been established beyond this period. Glucosamine is not indicated for the treatment of acute painful symptoms. Relief of symptoms (especially pain relief) may not be experienced until after some 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 by the patient’s healthcare practitioner. Patients should seek medical advice if their symptoms deteriorate after commencing treatment with glucosamine. _OLDER PEOPLE:_ No specific studies have been performed in older patients, but according to clinical experience dosage adjustment is not required when treating otherwise healthy, older patients. 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 ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ Belgenin tamamını okuyun