Ibuprofen 200mg Coated Tablets

Country: Irlanda

Lingwa: Ingliż

Sors: HPRA (Health Products Regulatory Authority)

Ingredjent attiv:

Ibuprofen

Disponibbli minn:

Galpharm Healthcare Limited

Kodiċi ATC:

M01AE; M01AE01

INN (Isem Internazzjonali):

Ibuprofen

Dożaġġ:

200 milligram(s)

Għamla farmaċewtika:

Coated tablet

Tip ta 'preskrizzjoni:

Product not subject to medical prescription

Żona terapewtika:

Propionic acid derivatives; ibuprofen

L-istatus ta 'awtorizzazzjoni:

Marketed

Data ta 'l-awtorizzazzjoni:

2013-11-29

Fuljett ta 'informazzjoni

PACKAGE LEAFLET: INFORMATION FOR THE USER
IBUPROFEN 200MG COATED TABLETS
For adults and adolescents weighing from 40kg body weight (12 years
and above)
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 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 contact a doctor if you do not feel better or if you feel
worse after 3 days with fever and 4
days with pain.
1. WHAT IBUPROFEN 200MG COATED TABLETS ARE AND WHAT THEY ARE USED FOR
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE IBUPROFEN 200MG COATED
TABLETS
3. HOW TO TAKE IBUPROFEN 200MG COATED TABLETS
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE IBUPROFEN 200MG COATED TABLETS
6. CONTENTS OF THE PACK AND OTHER INFORMATION WHAT IBUPROFEN 200MG COATED TABLETS ARE AND WHAT THEY ARE USED FOR
Ibuprofen 200mg Coated Tablets contain ibuprofen, which belongs to a
group of medicines called Non-
Steroidal Anti-Inflammatory Drugs (NSAIDs) which work to reduce pain
and fever.
This medicine is used for the short term relief of mild to moderate
pain such as headache, period pain,
dental pain, and fever and pain associated with the common cold. You
must talk to a doctor if you
do not feel better or if you feel worse after 3 days with fever and 4
days with pain.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE IBUPROFEN 200MG COATED TABLETS
DO NOT TAKE IBUPROFEN 200MG COATED TABLETS IF YOU
:
• are allergic to ibuprofen or any of the other ingredients of this
medicine (listed in section 6)
• have ever suffered from shortness of breath, asthma, a runny nose,
swelling or hives after using
acetylsalicylic acid (known as aspirin) or other similar painkillers
(NSAIDs)
• have (or have had two or more episodes of

Karatteristiċi tal-prodott

Health Products Regulatory Authority
26 October 2018
CRN008L6Y
Page 1 of 17
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ibuprofen 200mg Coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 200mg Ibuprofen.
Excipients with known effect: 123mg Lactose monohydrate per tablet.
For the full list of excipients, see 6.1.
3 PHARMACEUTICAL FORM
Coated Tablet
White, capsule-shaped, biconvex, film-coated tablets with no markings.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For short term symptomatic treatment of mild to moderate pain such as
headache,
dysmenorrhea (period pain), dental pain, and fever and pain in the
common cold.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For oral administration and short term use only.
Undesirable effects may be minimised by using the lowest effective
dose for the
shortest duration necessary to control symptoms (see section 4.4).
Adults:
200mg – 400mg, up to three times a day as required.
Leave at least four hours between doses of 200mg and six hours between
doses of
400mg and do not take more than 1200mg in any 24 hour period.
If this medicinal product is required for more than 3 days in the case
of fever or for
more than 4 day for the treatment of pain, or if the symptoms do not
improve or
worsen a doctor should be consulted.
Adolescents ≥ 40 kg (12 years of age and above):
200mg – 400mg, up to three times a day as required.
Leave at least four hours between doses of 200mg and six hours between
doses of
400mg and do not take more than 1200mg in any 24 hour period.
Health Products Regulatory Authority
26 October 2018
CRN008L6Y
Page 2 of 17
If this medicinal product is required for more than 3 days or if
symptoms worsen a
doctor should be consulted.
It is recommended that patients with a sensitive stomach take
Ibuprofen 200mg
coated Tablets with food.
Special patient groups
_Paediatric Population:_
Not recommended for adolescents weighing under 40 kg or children under
12 years
of age.
_Elderly Population:_
The elderly are at incr