Dolenio 1178mg Film-coated Tablets

국가: 몰타

언어: 영어

출처: Medicines Authority

유효 성분:

GLUCOSAMINE

제공처:

Blue Bio Pharmaceuticals Limited 5th Floor, Beaux Lane House, Mercer Street Lower, Dublin 2, Ireland

ATC 코드:

M01AX05

INN (International Name):

GLUCOSAMINE 1178 mg

약제 형태:

FILM-COATED TABLET

구성:

GLUCOSAMINE 1178 mg

처방전 유형:

OTC

치료 영역:

ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS

승인 상태:

Authorised

승인 날짜:

2011-09-30

환자 정보 전단

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Dolenio 1178mg Film-coated tablets
Glucosamine
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU
.
- Always take this medicine exactly as described in this leaflet or as
your doctor has told
you.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist if you need more information or advice.
- If you get any side effects, talk to your doctor or pharmacist. This
includes any possible
side effects not listed in this leaflet. See section 4.
- You must talk to a doctor if you do not feel better or if you feel
worse after 2 to 3 months.
WHAT IS IN THIS LEAFLET:
1. What Dolenio is and what it is used for
2. What you need to know before you take Dolenio
3. How to take Dolenio
4. Possible side effects
5. How to store Dolenio
6. Contents of the pack and other information
1. WHAT DOLENIO IS AND WHAT IT IS USED FOR
Dolenio belongs to the group of other anti-inflammatory and
antirheumatic agents, non- steroids.
Dolenio tablet is a medical product used for the relief of symptoms in
mild to moderate
osteoarthritis of the knee in adults.
Dolenio contains the active substance glucosamine.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DOLENIO
A doctor should be consulted before starting the treatment by Dolenio:
only a doctor could
diagnose an osteoarthritis and rule out the presence of joint disease
for which other treatment
should be considered.
DO NOT TAKE DOLENIO:
- if you are allergic to glucosamine or any of the other ingredients
of this medicine (listed in
section 6).
- if you are allergic to shellfish, as the active ingredient,
glucosamine, is extracted from shellfish.
Dolenio must not be used in children under 2 years of age and is not
recommended for use in
children and adolescents below the age of 18 years, due to lack of
data on safety and efficacy.
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WARNINGS AND PRECAUTIONS
Dolenio is not indicated for the treatment of acute pain.
Talk to your doctor before taking Dolen

제품 특성 요약

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Dolenio 1178mg Film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One film-coated tablet contains 1884.60 mg of Glucosamine sulphate
sodium chloride equivalent to
1500 mg Glucosamine sulphate or 1178 mg glucosamine.
Excipient with known effect: Sodium 151 mg.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
White to off white, oval shaped, bi-convex film coated tablets with
break line on one side.
The score line 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
_ _
Posology
_Adults: _
One tablet daily
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.
_Paediatric population: _
Dolenio is not recommended for use in children and adolescents below
the age of 18 years, due to
lack of data on safety and efficacy.
_Older people: _
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 with this group.
Method of administration
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For oral use. Tablets can be taken with or without food.
4.3
CONTRAINDICATIONS
Hypersensitivity to shellfish as the active ingredient is obtained
from shellfish.
Hypersensitivity to the active substance or to any of the excipients.
Children under 2 years of age.
4.4
SPECIAL WARNINGS AND PR