Glucomed

Document: Glucomed tablet ENG PL change

PACKAGE LEAFLET: INFORMATION FOR THE USER

Glucomed 625 mg tablets

Glucosamine

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.

In this leaflet:

1. What Glucomed is and what it is used for

2. Before you take Glucomed

3. How to take Glucomed

4. Possible side effects

5 How to store Glucomed

6. Further information

1. WHAT GLUCOMED IS AND WHAT IT IS USED FOR

Glucomed belongs to the group of medicines called other anti-inflammatory and anti-rheumatic agents, non-steroids.

Glucomed is used for the relief of symptoms in mild to moderate osteoarthritis of the knee.

2. BEFORE YOU TAKE GLUCOMED

Do not take Glucomed if you:

are allergic (hypersensitive) to glucosamine or to any of the other ingredients of Glucomed.
are allergic (hypersensitive) to shellfish, since glucosamine is manufactured from shellfish.

Take special care with Glucomed (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 withGlucomed.
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 Glucomed.
suffer from asthma. When starting onGlucomed, you should be aware of potential worsening of symptoms.

Glucomed should not be used in children and adolescents below the age of 18 years.

You should stop taking Glucomed and see your doctor immediately if you experience symptoms of angioedema, such as

swollen face, tongue or throat
difficulty to swallow
hives and difficulties to breath

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines including medicines obtained without a prescription.

Caution should be exercised if Glucomed has to be combined with other medicines, especially:

warfarin

- tetracycline

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.

Please contact your doctor for medical advice.

Taking Glucomed with food and drink

You can take the tablets with or without food and they should be swallowed together with some water or other suitable liquid.

Pregnancy and breast-feeding

Glucomed should not be used during pregnancy.

The use of Glucomed during breastfeeding is not recommended

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines:

No studies on the effects on the ability to drive and use machines have been performed. If you experience dizziness or drowsiness from the tablets, you should not drive or operate machinery.

3. HOW TO TAKE GLUCOMED

Dosage

Always take Glucomed exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

The usual starting dose is 2 tablets (1250 mg of glucosamine) once daily, taken orally.

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 Glucomed should be re-evaluated.

The tablets should be swallowed together with some water or other suitable liquid.

If you take more Glucomed than you should

If you have taken large quantities you must consult your doctor or a hospital. Signs and symptoms of overdose with glucosamine might include headache, dizziness, confusion, joint pain, feeling sick, vomiting (being sick), diarrhoea or constipation. Stop taking glucosamine at signs of overdose.

If you forget to take Glucomed

Do not take a double dose to make up for a forgotten dose. If it is almost time for your next dose, skip the forgotten dose and carry on taking Glucomed as scheduled.

If you stop taking Glucomed

Your symptoms may reoccur.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Glucomed can cause side effects, although not everybody gets them.

The following have been reported:

Common (affects 1 to 10 users in 100):

headache, tiredness, feeling sick, abdominal pain, indigestion, diarrhoea, constipation.

Uncommon (affects 1 to 10 users in 1,000):

rash, itching, flushing.

Not known (frequency cannot be estimated from the available data):

swelling of face, tongue, or throat (angioedema, see Take special care with Glucomed), hives, swelling/swelling of ankles, legs and feet, dizziness, vomiting (being sick), blood glucose control worsened in patients with diabetes mellitus, hepatic enzyme elevation, jaundice.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5. HOW TO STORE GLUCOMED

Keep out of the reach and sight of children.

Do not use Glucomed after the expiry date which is stated on the blister/carton or tablet container.

Store below 30˚C.

Bottle:

Keep the bottle tightly closed. Store in the original package in order to protect from moisture.

Blister:

Store in the original package in order to protect from moisture.

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 Glucomed contains

The active substance is glucosamine. Each tablet contains 625 mg of glucosamine (as glucosamine hydrochloride)
The other ingredients are microcrystalline cellulose, hydroxypropyl cellulose, low substituted hydroxypropyl cellulose (L-HPC) and magnesium stearate.

What Glucomed looks like and content of the pack

Glucomed is a 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.

PVC/PVDC-aluminium blisters packed in paper cartons.
Pack-sizes of 20, 40, 60 or 180 tablets.

HDPE tablet container with a silica gel desiccant in paper bags.
Pack-sizes of 60 or 180 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder:

Laboratoires Expanscience

10 avenue de l’Arche, 92400 Courbevoie , France

Manufacturer:

Haupt Pharma Wülfing GmbH, Bethelner Landstr. 18, 31028 Gronau, Germany

This medicinal product is authorised in the Member States of the EEA under the following names:

Austria	Flexove


Czech Republic	Flexove
Denmark	Glucomed


France	Flexea
Germany	Mobilat Glucosaminhydrochlorid

Hungary	Flexove
Iceland	Glucomed
Ireland	Flexove
Italy	Alateris

Lithuania	Glucomed

Netherlands	Glucomed
Norway	Flexove
Poland	Flexove
Portugal	Glucomed
Slovakia	Glucomed

Sweden	Glucomed
United Kingdom	Alateris

This leaflet was last approved on:

2014-12-17