Ibuprofen 200mg capsules

Land: Storbritannia

Språk: engelsk

Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiv ingrediens:

Ibuprofen

Tilgjengelig fra:

Ennogen Healthcare Ltd

ATC-kode:

M01AE01

INN (International Name):

Ibuprofen

Dosering :

200mg

Legemiddelform:

Oral capsule

Administreringsrute:

Oral

Klasse:

No Controlled Drug Status

Resept typen:

Valid as a prescribable product

Produkt oppsummering:

BNF: 10010100

Informasjon til brukeren

IBUPROFEN 200MG CAPSULES
PATIENT INFORMATION LEAFLET
Read this leaflet carefully because it contains
important information for you.
• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more
information or advice.
• You must contact a doctor or pharmacist if your
symptoms worsen or do not improve.
IN THIS LEAFLET:
1. What this medicine is for
2. Before you take the medicine
3. How to take the medicine
4. Possible side effects
5. Storing the medicine
6. Further information
WHAT THIS MEDICINE IS FOR
Ibuprofen 200mg Capsules contain ibuprofen,
which belongs to a group of medicines called
Non-Steroidal Anti-Inflammatory Drugs (NSAIDs).
These medicines work by changing how the body
responds to pain, swelling and high temperature.
This medicine is used to relieve:
• rheumatic and muscular pain, backache
• neuralgia (nerve pain)
• headache, migraine
• dental pain, period pain
• fever (high temperature)
• the symptoms of colds and flu.
BEFORE YOU TAKE THE MEDICINE
Do not take Ibuprofen 200mg Capsules if you:
• have or have had a stomach ulcer, perforation or
bleeding of the stomach
• are allergic to ibuprofen, to any of the ingredients
(listed in section 6), or to aspirin or other
painkillers (an allergic reaction may be
recognised as shortness of breath, runny nose,
skin rash or itching)
• have kidney or heart failure or severe liver failure
• are taking more than 75mg of aspirin a day
• are in the last 3 months of pregnancy.
Warnings and precautions
Anti-inflammatory/pain-killer medicines like
ibuprofen may be associated with a small
increased risk of heart attack or stroke, particularly
when used at high doses. Do not exceed the
recommended dose or duration of treatment.
Skin reactions
Serious skin reactions have been reported in
association with Ibuprofen 200mg Capsules
treatment. You should stop taking Ibuprofen
200mg Capsules and seek medical attention
immediately, if you develop any skin rash, lesions of
the mucous membranes, blisters or other signs of
al

Preparatomtale

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Ibuprofen 200mg Capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Ibuprofen 200mg
For excipients, see 6.1.
3.
PHARMACEUTICAL FORM
Capsule, hard.
White and pink capsule printed with “IBU 200”.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Rheumatic or muscular pain, pain of non-serious arthritic conditions,
backache, neuralgia, migraine, headache, dental pain, dysmenorrhea
(period
pain), feverishness, symptoms of colds and influenza.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
For oral administration and short term use only:
_Adults, the elderly and children over 12 years: _
The minimum effective dose should be used for the shortest time
necessary to
relieve symptoms.
Swallow 200mg – 400mg (1-2 capsules), preferably with water, up to
three
times a day, as required. Leave at least four hours between doses and
do not
take more than 1200mg (6 capsules) in any 24 hour period.
If in adults this medicinal product is required for more than 10 days,
or if
symptoms worsen the patient should consult a doctor.
If in children and adolescents between 12 and 18 years this medicinal
product
is required for more than 3 days, of if symptoms worsen a doctor
should be
consulted.
Not to be given to children under 12 years.
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 ibuprofen or any of the excipients in the product.
Patients who have previously shown hypersensitivity reactions (e.g.
asthma,
rhinitis,
or
urticaria)
in
response
to
aspirin
or
other
non-steroidal
anti-
inflammatory drugs.
Active or history of recurrent peptic ulcer/haemorrhage (two or more
distinct
episodes of proven ulceration or bleeding).
History of upper gastrointestinal bleeding or perforation, related to
previous
NSAIDs therapy.
Severe heart failure
(NYHA Class IV)
, renal failure or hepatic failure (see section
4.4 Special Warnings and Preca