Alateris 625mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Glucosamine hydrochloride

Available from:

Lexon (UK) Ltd

ATC code:

M01AX05

INN (International Name):

Glucosamine hydrochloride

Dosage:

625mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 10010500

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
ALATERIS
® 625MG TABLETS
(GLUCOSAMINE HYDROCHLORIDE)
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.

The name of your medicine is Alateris 625mg tablets, but will be
referred to as Alateris in the remainder of this leaflet.
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
Alateris belongs to the group of medicines called anti-inflammatory
and
anti-rheumatic agents, non-steroids.
Alateris is used for the relief of symptoms in mild to moderate
osteoarthritis of the knee.
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.
You should stop taking Alateris and see your doctor immediately if you

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Alateris 625 mg tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 625 mg of glucosamine (as glucosamine
hydrochloride).
For a full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Tablet
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.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Relief of symptoms in mild to moderate osteoarthritis of the knee.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
Two tablets (1250 mg Glucosamine) once daily for relief of symptoms.
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 glucosamine should be
re-evaluated.
Tablets can be taken with or without food.
Additional information on special populations.
_Children and Adolescents _
Alateris
TM
should not be used in children and adolescents below the age of 18
(See
4.4).
_Elderly _
No specific studies have been performed in the elderly, but according
to clinical
experience dosage adjustment is not required when treating otherwise
healthy, elderly
patients.
_Impaired renal and/or liver function _
In patients with impaired renal and/or liver function no dose
recommendations can be
given, since no studies have been performed.
4.3
CONTRAINDICATIONS
Known hypersensitivity to glucosamine or any of the excipients.
Alateris must not be given to patients who are allergic to shellfish
as the active
substance is obtained from shellfish.
4.4.
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Alateris
TM
should not be used in children and adolescents below the age of 18,
due to
lack of data on safety and efficacy.
A doctor must be consulted to rule out the presence of joint diseases
for which oth