Ibuprofen Dr. Max 200mg

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

IBUPROFEN

Available from:

Dr. Max Pharma Limited First Floor Roxbourghe House, 273-287 Regent Street, London W1B 2HA, United Kingdom

ATC code:

M01AE01

INN (International Name):

IBUPROFEN 200 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

IBUPROFEN 200 mg

Prescription type:

OTC

Therapeutic area:

ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS

Authorization status:

Withdrawn

Authorization date:

2013-12-06

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE USER
IBUPROFEN DR.MAX 200 MG FILM-COATED TABLETS
Ibuprofen
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
This medicine is available without prescription. However, you still
need to take Ibuprofen Dr.Max 200
mg carefully to get the best results from it.
-
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. See section 4.
-
You must talk to a doctor if you do not feel better or if you feel
worse after 3-5 days.
IN THIS LEAFLET:
1.
What Ibuprofen Dr.Max 200 mg is and what it is used for
2.
What you need to know before you take Ibuprofen Dr.Max 200 mg
3.
How to take Ibuprofen Dr.Max 200 mg
4.
Possible side effects
5.
How to store Ibuprofen Dr.Max 200 mg
6.
Contents of the pack and other information
1.
WHAT IBUPROFEN DR.MAX 200 MG IS AND WHAT IT IS USED FOR
Ibuprofen Dr.Max 200 mg belongs to a group of medicines called NSAID
(non-steroidal anti-
inflammatory drugs) which work by reducing pain, inflammation and
fever.
Ibuprofen Dr.Max 200 mg is used to provide relief from mild to
moderate pain such as headache,
including migraine headache, dental pain, pain in soft tissue injuries
such as bruises and sprains,
period pain and fever.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE IBUPROFEN DR.MAX 200 MG
DO NOT TAKE IBUPROFEN DR.MAX 200 MG
-
if you are allergic to ibuprofen or any of the other ingredients of
this medicine (listed in section
6).
-
if you have had allergic reactions such as asthma, runny nose, itchy
skin rash or swelling of the
lips, face, tongue, or throat after you have taken medicines
containing acetylsalicylic acid or
other drugs for pain and inflammation (NSAIDs).
-
if you have suffered from an ulcer or bleeding in the stomach or small
intestine (duodenum)
related to previous use of drugs for pain and

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Ibuprofen Dr.Max 200 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 200 mg ibuprofen.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
200 mg tablet:
White, oval, biconvex film-coated tablets with a score on one face.
The tablet can be divided into equal halves.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Mild to moderate pain, such as headache including migraine headache,
dental pain, pain in soft tissue
injuries such as bruises and sprains.
Primary dysmenorrhoea.
Fever.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Undesirable effects may be minimised by using the lowest effective
dose for the shortest duration
necessary to control symptoms (see section 4.4). This product is for
short-term use only, not longer
than 7 days. If symptoms persist or worsen a doctor should be
consulted. If in children and adolescents
this medicinal product is required for more than 3 days, or if
symptoms worsen a doctor should be
consulted.
_MILD TO MODERATE PAIN AND FEVER _
_Adults and adolescents older than 12 years (≥40 kg): _
200-400 mg given as a single dose or 3-4 times a day with an interval
of 4 to 6 hours. The dosage in
migraine headache should be: 400 mg given as a single dose, if
necessary 400 mg with intervals of 4
to 6 hours.
The maximum daily dose should not exceed 1200 mg.
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_Children 6-12 years (>20 kg): _
Children 6-9 years (20-29 kg): 200 mg 1-3 times a day with intervals
of 4 to 6 hours as required.
The maximum daily dose should not exceed 600 mg.
Children 10-12 years (30-40 kg): 200 mg 1-4 times a day with intervals
of 4 to 6 hours as required.
The maximum daily dose should not exceed 800 mg.
_PRIMARY DYSMENORRHOEA _
_Adults and adolescents over 12 years of age: _
200-400 mg 1-3 times a day, with an interval of 4-6 hours, as needed.
The maximum daily dose should
not exceed 1200 mg.
_ELDERLY _
The elderly are at increased risk of s