Dolgit 600

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

IBUPROFEN

Available from:

Dolorgiet GmbH & Co. KG Otto-von-Guericke-Str. 1, 53757 Sankt Augustin / Bonn, Germany

ATC code:

M01AE01

INN (International Name):

IBUPROFEN 600 mg

Pharmaceutical form:

COATED TABLET

Composition:

IBUPROFEN 600 mg

Prescription type:

POM

Therapeutic area:

ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS

Authorization status:

Withdrawn

Authorization date:

2006-11-24

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
DOLGIT® 600
COATED TABLETS
Active substance: Ibuprofen 600 mg
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor, pharmacist or
nurse.
-
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any
possible side effects not listed in this leaflet. See section 4.
1.
What Dolgit® 600 is and what it is used for
2.
What you need to know before you take Dolgit® 600
3.
How to take Dolgit® 600
4.
Possible side effects
5.
How to store Dolgit® 600
6.
Contents of the pack and other information
1.
WHAT DOLGIT® 600 IS AND WHAT IT IS USED FOR
Dolgit® 600 is an anti-inflammatory and analgesic medicine
(non-steroidal
antiphlogistic/antirheumatic agent).
Indications for Dolgit® 600:
Dolgit® 600 is used for:
symptomatic treatment of pain and inflammation in case of:
-
acute arthritis (including gout attack),
-
chronic arthritis, particularly rheumatoid arthritis (chronic
polyarthritis)
-
ankylosing spondylitis (Morbus Bechterew) and other inflammatory
rheumatic affections of
the vertebral column,
-
irritations in case of degenerative affections of the joints and of
the vertebral column
(arthrosis, spondylarthrosis),
-
inflammatory rheumatism of the soft tissues,
-
painful swellings and inflammations following lesions.
2
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE DOLGIT® 600
DO NOT TAKE DOLGIT® 600
-
in case you are hypersensitive (allergic) to the active ingredient
ibuprofen or one
-
of the other ingredients of this medicinal product mentioned in
section 6;
-
in case you reacted with asthma attacks, nasal mucosa swellings or
skin reactions after
the intake of acetyl salicylic acid or other non-steroidal
anti-inflammatory agents in
t

Summary of Product characteristics

Page 1 of 14
SUMMARY OF PRODUCT CHARACTERISTICS 1.
NAME OF THE MEDICINAL PRODUCT
Dolgit 600 coated tablet
Active ingredient: Ibuprofen 600 mg 2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 coated tablet contains 600 mg of ibuprofen
OTHER EXCIPIENTS WITH KNOWN EFFECT: Sucrose
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
White, round, biconvex coated tablet, imprinted with 600 on one half
of the coated tablet
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Dolgit 600 is indicated in adults and adolescents as from 15 years.
Symptomatic treatment of pain and inflammation in case of
-
acute arthritis (including gout attack),
-
chronic arthritis, particularly rheumatoid arthritis (chronic
polyarthritis),
-
ankylosing spondylitis (Morbus Bechterew) and other inflammatory
rheumatic
affections of the vertebral column,
-
irritations in case of degenerative affections of the joints and of
the vertebral column
(arthrosis, spondylarthrosis),
-
inflammatory rheumatism of the soft tissues,
-
painful swellings and inflammations following lesions.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Dosage
For the treatment of rheumatic diseases:
Page 2 of 14
The ibuprofen dose depends on the patient's age and body weight,
respectively. The
recommended dosage range for adults and juveniles as from 15 years is
between 1200 and 2400
mg of ibuprofen daily. The maximum single dose should not exceed 800
mg of ibuprofen.
Age:
Single dose:
coated tablets
Dolgit 600
Total daily dose:
coated tablets
Dolgit 600
Juveniles (as from 15
years) and adults
1 (corresponding to
600 mg of ibuprofen)
2 – 4 (corresponding to
1200 - 2400 mg of
ibuprofen)
Dolgit 600 is taken unchewed with plenty of liquid and not on an empty
stomach. In case of a
sensitive stomach it is recommended to take Dolgit 600 during the
meals.
The duration of treatment is determined by the physician. In case of
rheumatic diseases the
treatment with Dolgit 600 over a prolonged period may be necessary.
Undesirable effects may be minimised by using the lowest