Dona 500mg Capsules

국가: 아일랜드

언어: 영어

출처: HPRA (Health Products Regulatory Authority)

유효 성분:

Glucosamine sulfate sodium chloride; GLUCOSAMINE SULPHATE

제공처:

Mylan IRE Healthcare Limited

ATC 코드:

M01AX; M01AX05

INN (국제 이름):

Glucosamine sulfate sodium chloride; GLUCOSAMINE SULPHATE

복용량:

500 milligram(s)

약제 형태:

Capsule, hard

처방전 유형:

Product not subject to medical prescription

치료 영역:

Other antiinflammatory and antirheumatic agents, non-steroids; glucosamine

승인 상태:

Marketed

승인 날짜:

2006-07-14

환자 정보 전단

PACKAGE LEAFLET: INFORMATION FOR THE USER
DONA 500MG CAPSULES
glucosamine sulfate
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
pharmacist 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 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 30 days.
What is in this leaflet:
1. What Dona is and what it is used for
2. What you need to know before you take Dona
3. How to take Dona
4. Possible side effects
5. How to store Dona
6. Contents of the pack and other information
1.
WHAT DONA IS AND WHAT IT IS USED FOR
Dona contains glucosamine sulfate which belongs to a group of
medicines called non-steroidal anti-
inflammatory and anti-rheumatic agents.
Dona is used for the relief of symptoms in mild to moderate
osteoarthritis of the knee, as diagnosed by
your doctor.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE DONA
DO NOT TAKE DONA:

If you are allergic (hypersensitive) to glucosamine or any of the
other ingredients of Dona.

If you are allergic to shellfish, as glucosamine is obtained from
shellfish.
WARNINGS AND PRECAUTIONS
Consult your doctor before taking Dona:

If you have diabetes; in this case closer monitoring of blood sugar
levels and where relevant
insulin requirements may be necessary at the beginning of the
treatment and periodically during
treatment with Dona.

If you suffer from asthma; when starting on glucosamine, you should be
aware of potential
worsening of symptoms.

If you have severe liver or kidney problems.

If you are on a controlled sodium diet.
The presence of another joint disease, which would require alternative
treatment, should be excluded.
If unusual signs or symptoms appear, or if a

제품 특성 요약

Health Products Regulatory Authority
20 January 2021
CRN009YX1
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Dona 500mg Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains:
Glucosamine sulfate 500 mg
Excipient(s) with known effect: each capsule contains:
_ _
- Sodium 50.3mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Capsule, hard (Capsule)
Hard gelatine, snap-fit, red-red capsule (size 0), reporting the logo
ROTTA printed in black ink on the body and the head.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Relief of symptoms in mild to moderate osteoarthritis of the knee, as
diagnosed by a doctor.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
One capsule should be taken three times daily, preferably at meals.
Pivotal proof of efficacy has been demonstrated for periods of up to
three months, with a residual effect evident for two
months after drug withdrawal. The safety and the efficacy of the
product were also confirmed in pivotal clinical trials for
treatment up to three years. Continuous treatment beyond 3 years
cannot be recommended as the safety has not been
established beyond this period.
Glucosamine is not indicated for the treatment of acute painful
symptoms. Relief of symptoms (especially pain relief) may not
be experienced until after some 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 by the patient’s healthcare practitioner.
Patients should seek medical advice if their symptoms deteriorate
after commencing treatment with glucosamine.
_OLDER PEOPLE:_
No specific studies have been performed in older patients, but
according to clinical experience dosage adjustment is not
required when treating otherwise healthy, older patients.
_PATIENT WITH 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 b