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ALATERIS 625MG TABLETS

Active substance(s): GLUCOSAMINE HYDROCHLORIDE

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Transcript
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 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
Belgium
Cyprus
Czech Republic
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Lithuania
Luxembourg
Netherlands
Norway
Poland
Portugal
Slovakia
Spain
Sweden
United Kingdom

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This leaflet was last approved on: March 2012

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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