PACKAGE LEAFLET: INFORMATION FOR THE USER Glucosine 625 mg film-coated tablets Glucosamine Read all of this leaflet carefully before starting taking this medicine. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist. This drug has been prescribed for you. Do 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. 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. Such combination treatment should therefore be monitored extra carefully. 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 78 mg sodium per tablet and this should be considered in patients on a controlled sodium diet. 3. HOW TO TAKE GLUCOSINE Always take Glucosine exactly as your doctor has told you. You should check with your doctor if you are not sure. The dosage is determined by your doctor, who has adjusted it for you individually. The starting dose is 1 tablet 2 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 tablet a day. 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. 4. POSSIBLE SIDE EFFECTS Like all medicines, Glucosine can cause side effects, although not everybody gets them. Common (affects 1 to 10 users in 100): Headache, drowsiness, indigestion, stomach ache, diarrhoea, constipation, feeling sick . Uncommon (affects 1 to 10 users in 1000): Skin rash, itching, flushing. Rare (affects 1 to 10 users in 10000): Dizziness Not known: (frequency cannot be estimated from the available data): angiooedema/urticaria, swelling/swelling of arms and legs, blood glucose control worsened in patients with diabetes mellitus, increased liver enzyme levels, yellow skin and eye whites. Stop taking Glucosine and immediately contact a doctor if swelling of the face, tongue and/or throat and/or difficulties swallowing or urticaria in combination with breathing difficulties occurs. 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 625 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 and 180 tablets in plastic bottles with screw caps. Not all pack sizes may be marketed. Marketing Authorisation Holder Recip AB, Box 906, 170 09 Solna, Sweden Tel. 020-35 05 05 ( Customers information). E-post: info@recip.se Manufacturer Recipharm Stockholm AB, Lagervägen 7 136 50 Jordbro, Sweden This medicinal product is authorised in the Member States of the EEA under the following names: Glucosine (Sweden) Gluxine (Norway) This patient leaflet was last approved 2010-11-02