Moment 200, 200 mg coated tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

IBUPROFEN

Available from:

A. C. R. A. F. SpA (Aziende Chimiche Riunite Angelini Francesco) Viale Amelia 70, Rome 00181, Italy

ATC code:

M01AE01

INN (International Name):

IBUPROFEN 200 mg

Pharmaceutical form:

COATED TABLET

Composition:

IBUPROFEN 200 mg

Prescription type:

OTC

Therapeutic area:

ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS

Authorization status:

Authorised

Authorization date:

2006-03-15

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
MOMENT 200, 200 MG COATED TABLETS
Ibuprofen
_ _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, or pharmacist has have 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.
- You must talk to a doctor if you don’t feel better or if you feel
worse after few days
WHAT IS IN THIS LEAFLET:
1.
What Moment 200 is and what is used for
2.
What you need to know before you take Moment 200
3.
How to take Moment 200
4.
Possible side effects
5.
How to store Moment 200
6. Contents of the pack and other information
1.
WHAT MOMENT 200 IS AND WHAT IS USED FOR
Moment 200 belongs to the analgesic anti-inflammatory group, that is
the
group
of
medicinal
products
designed
to
relieve
pain
and
inflammation.
Moment 200 is used for pain of various types and origin (headache,
toothache, neuralgia, osteoarticular and muscular pain, menstrual
pain).
It is an adjunct to the treatment of the symptoms of fever and flu.
You must talk to a doctor if you do not feel better or if you feel
worse
after few days.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE MOMENT 200
DO NOT TAKE MOMENT 200
If you are allergic to ibuprofen or any of the other ingredients of
this
medicine (listed in section 6).
Moment 200 should not be used:
•
In
hypersensitivity
to
other
antirheumatic
drugs
(e.g.
acetylsalicylic acid etc.) or to any of the product excipients.
•
In children aged under 12 years old.
•
In pregnancy and breastfeeding (see " Pregnancy, breast-feeding
and fertility").
•
In the case of severe or active gastroduodenal ulcer or other
gastric disease.
•
In
subjects
with
a
history
of
gastrointestinal
bleeding
or
perforation related to previous active treatmen

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME
OF
THE
MEDICINAL
PRODUCT
Moment 200, 200 mg coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each coated tablet contains:
Active ingredient: ibuprofen mg 200
Excipients
with known effect: saccharose, sodium
For the full list of excipients see section 6.1.
3.
PHARMACEUTICAL FORM
Glossy, white, round coated tablet 4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Pain of various origins and nature (headache, toothache, neuralgia,
osteoarticular and
muscular pain, menstrual pain). Adjuvant in the symptomatic treatment
of temperature and
flu.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults and children over 12 years of age: 1-2 coated tablets, 2-3
times a day.
Do not exceed the dose of 6 coated tablets a day.
Do not exceed the recommended dosage; elderly patients should keep to
the minimum
dosage specified above.
Method of administration
Take the product on a full stomach.
If in adolescent this medicinal product is required for more than 3
days, or if symptoms
worsen a doctor should be consulted.
Undesirable effects may be minimised by using the lowest effective
dose for the shortest
duration necessary to control symptoms (see section 4.4).
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
•
Do not administer to children under 12 years old.
•
When pregnant or breastfeeding.
•
In hypersensitivity to other antirheumatic drugs (acetylsalicylic acid
etc.)
•
In the case of severe or active gastroduodenal ulcer or other gastric
disease.
•
In subjects with a history of gastrointestinal bleeding or perforation
related to previous
active treatments or a history of recurrent peptic haemorrhage/ulcer
(two or more distinct
episodes of established ulceration or bleeding).
•
In the case of severe liver or kidney disorders.
•
In the case of severe heart failure (NYHA Class IV)
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
•
In asthmatic patients, the product must be used with caution, after