PACKAGE LEAFLET: INFORMATION FOR THE USER Glucosine 400 mg film-coated tablets Glucosamine Read all of this leaflet carefully because it contains important information for you. This medicine is available without prescription. However, you still need to use Glucosine carefully to get the best results of it. Keep this leaflet. You may need to read it again. Ask your pharmacist if you need more information or advice. You must contact a doctor if your symptoms worsen or do not improve after 1 month. If any of the side effects gets serious, or if you notice any side effect not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet you will find the following information: 1. What Glucosine is and what it is used for 2. Before you take Glucosine 3. How to take Glucosine 4. Possible side effects 5. How to store Glucosine 6. Further information 1. WHAT GLUCOSINE IS AND WHAT IT IS USED FOR Glucosine contains glucosamine, which is an endogenous substance formed by glucose (a sugar compound). The body needs glucosamine to be able to form larger molecules which can be found in cartilage and joint fluid. Glucosine is used for relief of symptoms in mild to moderate osteoarthritis. 2. BEFORE YOU TAKE GLUCOSINE Do not take Glucosine Glucosine should not be used if you are allergic (hypersensitive) to glucosamine or any of the other ingredients of Glucosine. Glucosine should not be used if you are allergic to shellfish, since the active substance, glucosamine, is obtained from shellfish. Take special care with Glucosine Glucosine should not be used by persons under the age of 18 years. If you have diabetes you should discuss with your doctor before using Glucosine and your blood glucose levels may have to be checked more often at the beginning of the treatment. Using other medicines Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. An increased effect of coumarin anticoagulants (e.g. warfarin) during concomitant treatment with glucosamine has been reported. Patients treated with such combinations should therefore be monitored extra carefully when initiating or ending glucosamine therapy. Pregnancy and breast-feeding If you are pregnant or breast feeding, do not use Glucosine. Driving and using machines Glucosine does not affect the ability to drive or use machines, but if you experience that you get tired or get a headache when taking the tablets, you should not drive. Important information about some of the ingredients of Glucosine Glucosine contains 50 mg sodium per tablet and this should be considered in patients on a controlled sodium diet. 3. HOW TO TAKE GLUCOSINE The starting dose is 1 tablet 3 times daily. Alternatively, the total daily dose can be taken on one occasion during the day. Glucosine is not indicated for the treatment of acute painful symptoms. At relief of symptoms the dose can be lowered to 1-2 tablets a day. Relief of symptoms (especially pain relief) may not be experienced until after several weeks of treatment and in some cases even longer. Glucosine should not be used for more than 1 month without a doctor being consulted. Always follow the dosage recommendations in this leaflet. Ask your doctor or pharmacist if you are not sure. If you take more Glucosine than you should If you have taken more Glucosine than you should or if a child has taken the drug by mistake contact a doctor, hospital. Signs and symptoms of overdose with glucosamine might include headache, dizziness, confusion, joint pain, nausea, vomiting, diarrhoea or constipation. Stop taking glucosamine at signs of overdose. If you forget to take Glucosine Do not take a double dose to make up for a forgotten dose. If you have any further questions on the use of this product, ask your doctor or pharmacist. 4. POSSIBLE SIDE EFFECTS Like all medicines, Glucosine can cause side effects, although not everybody gets them. Common (occur in more than one patient of 100): Headache, drowsiness, indigestion, stomach ache, diarrhoea, constipation, nausea. Less common (occur in less than one patient of 100 but in more than one of 1000): Skin rash, itching, flushing. Side effects occurring in an unknown frequency: Vomiting, swelling of face, tongue or throat (angioedema, see information below), hives, oedema/oedema in ankles, legs and feet, dizziness, blood glucose control worsened in patients with diabetes mellitus, hepatic enzyme elevation, jaundice. Stop taking Glucosine and immediately contact a doctor if you experience symptoms of angioedema, such as: swollen face, tongue or pharynx, difficulty to swallow, hives and difficulties to breath. 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. 5. HOW TO STORE GLUCOSINE Do not store above 25 ºC. Keep out of the reach and sight of children. To be used before the expiry date stated on the package. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment. 6. FURTHER INFORMATION What Glucosine contains The active substance is glucosamine sulphate-sodium chloride corresponding to 400 mg glucosamine. The other ingredients are povidone, anhydrous citric acid, colloidal anhydrous silica, magnesium stearate, microcrystalline cellulose, sodium starch glycolate (type A), macrogol 6000, hypromellose and paraffin. What Glucosine looks like and contents of the pack Glucosine film-coated tablets are white to beige tablets, oblong, 8,5 x 19 mm. Package sizes: 60, 90, 180, 270 and 360 tablets in plastic bottles with screw caps. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer Recip AB, Box 906, 170 09 Solna, Sweden. Tel. 020-35 05 05 (Customer information). E-mail: info@recip.se This medicinal product is authorised in the Member States of the EEA under the following names: Glucosine (Sweden, Norway, Finland and Portugal). Gluxine (Norway) This patient leaflet was last approved 2009-06-21