DOLORITIS 1500 Milligram Film Coated Tablet

국가: 아일랜드

언어: 영어

출처: HPRA (Health Products Regulatory Authority)

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환자 정보 전단 환자 정보 전단 (PIL)
15-05-2024
제품 특성 요약 제품 특성 요약 (SPC)
15-05-2024

유효 성분:

GLUCOSAMINE SULFATE SODIUM CHLORIDE

제공처:

AHA Medical Services Ltd

ATC 코드:

M01AX05

INN (International Name):

GLUCOSAMINE SULFATE SODIUM CHLORIDE

복용량:

1500 Milligram

약제 형태:

Film Coated Tablet

처방전 유형:

Product not subject to medical prescription

치료 영역:

Other antiinflammatory and antirheumatic agents, non-steroids

승인 상태:

Authorised

승인 날짜:

2013-11-25

환자 정보 전단

                                FRONT416. FURTHER INFORMATION
What Doloritis contains
The active substance is glucosamine sulfate. One tablet contains
1884.60 mg of glucosamine sulfate sodium chloride equivalent to
1500 mg glucosamine sulfate or 1178 mg glucosamine.
The other ingredients are
Core tablet
Povidone K30
Macrogol 4000
Magnesium Stearate
Coating material
Hypromellose
Titanium Dioxide (E171)
Talc
Propylene glycol
Polysorbate 80
What Doloritis looks like and contents of the pack
Doloritis is a white to off white, oval shaped, bi-convex film-coated
tablet 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.
Pack-sizes:
20, 30, 60 or 90 film-coated tablets in a HDPE bottles with HDPE
screw cap.
2, 4, 10, 20, 30, 45, 60, 90, 180 film coated tablets in Alu/PVC/PVDC
blister packs.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
AHA Medical Services Ltd
6 Cathedral Park, Belmont
Industrial Estate, Durham, DH1 1TF
United Kingdom. Doloritis1500 mg film-coated tablets
Glucosamine sulfateRead all of this leaflet carefully because it contains important
information for you.
This medicine is available without prescription. However, you still
need to take Doloritis carefully to get the best results from it.
 Keep this leaflet. You may need to read it again.
 If you have any further questions, ask your doctor or pharmacist.
 You must contact a doctor if your symptoms worsen or do not improve after 2 to 3 months.
 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 Doloritis is and what it is used for
2. Before you take Doloritis
3. How to take Doloritis
4. Possible side effects
5. How to store Doloritis
6. Further information
1. WHAT DOLORITIS IS AND WHAT IT IS USED FOR
Doloritis 1500 mg film-coated tablets belong to the group of other
anti-inflammatory and anti-rheumatic agents, non-steroids.
Glucosamine is a substance natural
                                
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제품 특성 요약

                                SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Doloritis 1500 mg Film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One film-coated tablet contains 1884.60 mg of glucosamine sulfate sodium chloride equivalent to 1500 mg
glucosamine sulfate or 1178 mg glucosamine.
'Excipient with known effect: Sodium 151mg per tablet'.
For a 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 breakline 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
In management of chronic knee stiffness and pain after periods of immobility. 
Doloritis 1500mg film-coated tablets are also used in Osteoarthritis, as pre-diagnosed by a doctor.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_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, the patient should consult their doctor and continued
treatment with glucosamine 
should be re-evaluated. Tablets can be taken
with or without food.
Additional information on special populations:
_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. 
 
_CHILDREN AND ADOLESCENTS:_
Doloritis 1500 mg film-coated tablets are not recommended for use in children and adolescents below the age of 18
years, due to lack of data on safety and efficacy.
_IMPAIRED RENAL AND/
                                
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