Ibuprofen Tablet, film coated 600mg

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

IBUPROFEN

Available from:

Accord Healthcare Limited

ATC code:

M01AE01

INN (International Name):

IBUPROFEN

Pharmaceutical form:

FILM-COATED TABLET

Composition:

IBUPROFEN 600 mg

Prescription type:

POM

Therapeutic area:

ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS

Authorization status:

Authorised

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE
USER
Ibuprofen 600 mg
film-coated tablets
IBUPROFEN
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
or pharmacist.
•
This medicine has been prescribed for you only.
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 or
pharmacist. This includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. What Ibuprofen tablets is and what it is used for
2. What you need to know before you take
Ibuprofen tablets
3. How to take Ibuprofen tablets
4. Possible side effects
5. How to store Ibuprofen tablets
6. Contents of the pack and other information 1.
WHAT IBUPROFEN TABLETS IS
AND WHAT IT IS USED FOR
Ibuprofen tablets belong to a group of medicines
called NSAIDs (non-steroidal anti-inflammatory
drugs). Ibuprofen tablets reduces fever, relieves
pain and has an anti-inflammatory effect.
They can be used in symptomatic treatment of pain
and inflammation in rheumatoid arthritis (including
systemic Juvenile Idiopathic Arthritis [sJIA]),
osteoarthritis, seronegative arthropathies and in
painful swelling and inflammation after soft tissue
injuries. 2.
WHAT YOU NEED TO KNOW BEFORE
YOU TAKE IBUPROFEN TABLETS
DO NOT TAKE IBUPROFEN TABLETS:
•
if you are allergic (hypersensitive) to ibuprofen or
any of the other ingredients of this medicine (listed
in section 6).
•
if you are in the last three months of pregnancy.
•
if you have an increased tendencY to bleed.
•
if you have severe liver and kidney disease.
•
if you have severe heart failure or coronary heart
disease.
•
if you have a stomach ulcer, duodenal ulcer, or if
you have had a stomach ulcer or duodenal ulcer
previously when treated with ibuprofen or a similar
product.
•
if you have experienced allergic

Summary of Product characteristics

Page 1 of 14
1.3.1.1 SUMMARY OF PRODUCT CHARACTERISTICS
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Memantine Sandoz 10 mg film-coated tablets
Memantine Sandoz 20 mg film-coated tablets
Memantine Sandoz 10 mg/ml oral solution
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10 mg memantine hydrochloride which is equivalent
to 8.31 mg of memantine.
Excipient(s) with known effect: each tablet contains 132 mg lactose
monohydrate.
Each tablet contains 20 mg memantine hydrochloride which is equivalent
to 16.62 mg of
memantine.
Excipient(s) with known effect: each tablet contains 242 mg lactose
monohydrate.
Each ml of memantine oral solution contains 10 mg memantine
hydrochloride which is equivalent
to 8.31 mg of memantine.
Excipient(s) with known effect: each ml contains 89 mg sorbitol,
liquid (non
crystallising).
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Film-coated tablet 10 mg:
White film-coated tablet of oval shape (6.1 x 11.6 mm) with a breaking
line on both sides.
The tablet can be divided into equaldoses.
Film-coated tablet 20 mg:
Light red film-coated tablet of round shape (diameter 11.1 mm) with
two crossed breaking lines on
one side.
The tablet can be divided into equal quarters.
Oral solution.
Colourless and clear solution.
Page 2 of 14
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of patients with moderate to severe Alzheimer's disease.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment should be initiated and supervised by a physician
experienced in the diagnosis and
treatment of Alzheimer's dementia.
Posology
Therapy should only be started if a caregiver is available who will
regularly monitor the intake of
the medicinal product by the patient. Diagnosis should be made
according to current guidelines. The
tolerance and dosing of memantine should be reassessed on a regular
basis, preferably within three
months after start of treatment.
Thereafter, the clinical benefit of memantine and the patient's
t