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Alateris

PACKAGE LEAFLET:

INFORMATION FOR THE USER

Alateris 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 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

1.    WHAT ALATERIS IS

AND WHAT IT IS USED FOR

Alateris belongs to the group of medicines called anti-inflammatory and anti-rheumatic agents, nonsteroids.

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

2.    BEFORE YOU TAKE ALATERIS

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 years.

You should stop taking Alateris 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 Alateris 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 Alateris 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

Alateris should not be used during pregnancy.

The use of Alateris during breast-feeding 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 ALATERIS

Dosage

Always take Alateris 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 Alateris should be re-evaluated.

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

If you take more Alateris 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 Alateris

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 Alateris as scheduled.

If you stop taking Alateris

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, Alateris 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 1000):

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 Alateris), 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.

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 ALATERIS

Keep out of the reach and sight of children.

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

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.

Store below 30°C.

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 Alateris 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 Alateris looks like and content of the pack

Alateris 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

92419 COURBEVOIE Cedex - FRANCE

Manufacturers:

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

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

Flexove

Flexove

Glucomed

Flexove

Glucomed

Glucomed

Glucomed

Flexea

Mobilat Glucosaminhydrochlorid

Zantris

Flexove

Glucomed

Flexove

Alateris

Glucomed

Glucomed

Glucomed

Glucomed

Flexove

Flexove

Glucomed

Glucomed

Glucomed

Glucomed

Alateris

This leaflet was last approved on: March 2012

EXPANSCIENCE⁸

LAE RATOIRES