Ibuprofen 400mg tablets

Pajjiż: Ingilterra

Lingwa: Ingliż

Sors: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredjent attiv:

Ibuprofen

Disponibbli minn:

Crescent Pharma Ltd

Kodiċi ATC:

M01AE01

INN (Isem Internazzjonali):

Ibuprofen

Dożaġġ:

400mg

Għamla farmaċewtika:

Oral tablet

Rotta amministrattiva:

Oral

Klassi:

No Controlled Drug Status

Tip ta 'preskrizzjoni:

Valid as a prescribable product

Sommarju tal-prodott:

BNF: 10010100; GTIN: 5017123291067

Fuljett ta 'informazzjoni

Package leaflet: Information for the patient
Ibuprofen film coated Tablets BP 200 mg, 400 mg and 600 mg
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 film coated Tablets is and what it is used for
2. What you need to know before you take Ibuprofen film coated Tablets
3. How to take Ibuprofen film coated Tablets
4. Possible side effects
5. How to store Ibuprofen film coated Tablets
6. Contents of the pack and other information
1.
What Ibuprofen film coated Tablets is and what it is used for
Ibuprofen belongs to a group of medicines called NSAID (non-steroidal
anti- inflammatory
drugs) which work by reducing pain inflammation and fever.
Ibuprofen is used for the symptomatic treatment of mild to moderate
pain including migraine
headache period pain and/or fever. In addition, Ibuprofen is used for
the symptomatic treatment
of pain and inflammation in arthritic diseases (e.g. rheumatoid
arthritis), degenerative arthritic
conditions (e.g. osteoarthritis) and in painful swelling and
inflammation aftersoft tissue injuries.
2.
What you need to know before you take Ibuprofen film coated Tablets
Do not take ibuprofen:
•
You are allergic to ibuprofen or any of the other ingredients of this
medicine (listed in
section 6)
•
If you are suffering from an ulcer or bleeding in the stomach or small
intestine
(duodenum) or if you have had two or more of these episodes in the
past
•
If you have suffered from gastrointestinal bleeding or perforation
related to previous
use of drugs for pai

Karatteristiċi tal-prodott

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Ibuprofen Tablets BP 400 mg
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Ibuprofen BP 400 mg per tablet.
Excipient with known effect: 450.89mg Sucrose.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
The product is presented in the form of a pink, sugar coated, deep
convex tablet.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the relief of migraine-headaches, backache, dental pain, neuralgia
and period
pains as well as rheumatic and muscular pains.
Ibuprofen Tablets relieves pain and reduces inflammation and
temperature as well as
relieving headaches and other types of pain. It also relieves cold and
flu symptoms.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
For short-term use only.
The lowest effective dose should be used for the shortest duration
necessary to
relieve symptoms (see section 4.4).
Adults and the elderly:
The patient should consult a doctor if symptoms persist or worsen, or
if the
product is required for more than 10 days.
Adults, the elderly and children over 12 years:
1 tablet (400mg), up to three times a day as required.
Leave at least four hours between doses and do not take more than
1200mg in
any 24 hour period.
_ _
_Paediatric population_
Children under 12 years:
Not recommended for use in children under 12 years of age.
In adolescents (age range
≥
12 years to < 18 years):
If in adolescents this medicinal product is required for more than 3
days, or if
symptoms worsen a doctor should be consulted.
Method of administration
For oral administration.
4.3
CONTRAINDICATIONS
Hypersensitivity to ibuprofen or to any of the excipients
listed in section 6.1
.
Patients who have previously shown hypersensitivity reactions (e.g.
asthma,
rhinitis, angioedema or urticaria) in response to ibuprofen, 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 gastrointestinal b