Ibuprofen Chanelle Medical 400 mg capsules, soft

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Ibuprofen lysine

Available from:

Chanelle Medical

ATC code:

M01AE; M01AE01

INN (International Name):

Ibuprofen lysine

Dosage:

400 milligram(s)

Pharmaceutical form:

Capsule, soft

Therapeutic area:

Propionic acid derivatives; ibuprofen

Authorization date:

2019-12-06

Patient Information leaflet

ID: PL 205M (NL/H/4401/001-2/DC) Day 210
Version: 01
Revision Date: December
2019
Page 1 of 10
PACKAGE LEAFLET: INFORMATION FOR THE USER
IBUPROFEN CHANELLE MEDICAL 400 MG CAPSULES, SOFT
For use in adults and adolescents from 40 kg body weight (12 years and
above)
Ibuprofen as ibuprofen lysine
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
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 or
nurse. This includes
any possible side effects not listed in this leaflet. See section 4.

You must talk to your doctor if you do not feel better or if you feel
worse,
- after 3 days for children and adolescents.
- after 3 days for adolescents
- after 3 days in case of fever for adults
- after 4 days in case of pain for adults.
WHAT IS IN THIS LEAFLET:
1.
What Ibuprofen Chanelle Medical is and what it is used for
2.
What you need to know before you take Ibuprofen Chanelle Medical
3.
How to take Ibuprofen Chanelle Medical
4.
Possible side effects
5.
How to store Ibuprofen Chanelle Medical
6.
Contents of the pack and other information
1.
WHAT IBUPROFEN CHANELLE MEDICAL IS AND WHAT IT IS USED FOR
Ibuprofen Chanelle Medical belongs to a group of medicines known as
non-steroidal anti-
inflammatory drugs (NSAIDs). NSAIDs provide relief by changing the
body’s response to
pain, and high temperature.

For the short-term symptomatic treatment of mild to moderate pain
and/or fever.
Ibuprofen Chanelle Medical 400 mg is for use in adults and adolescents
from 40 kg body
weight (aged 12 years and above).
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE IBUPROFEN CHANELLE MEDICAL
DO NOT TAKE IBUPROFEN CHANELLE MEDICAL:

if you are allergic to Ibuprofen or any of the other ingredients of
this medicine (listed
in section 6)
�

Summary of Product characteristics

Health Products Regulatory Authority
03 February 2020
CRN009HC7
Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ibuprofen Chanelle Medical 400 mg capsules, soft
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each soft capsule contains 400 mg of ibuprofen (equivalent to 684 mg
ibuprofen lysine)
Excipients with known effect
Each 400mg soft capsule contains 171mg of Sorbitol
Ibuprofen Chanelle Medical contains soya oil.
Ibuprofen Chanelle Medical contains azoderivative Allura red (E129).
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Opaque red, oblong capsule with "400" printed in white ink.
Each capsule is approximately 25.7 to 27.7 mm long.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the short-term symptomatic treatment of mild to moderate pain
and/or fever.
Ibuprofen Chanelle Medical 400 mg is for use in adults and adolescents
from 40 kg body weight (12 years old)
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
For oral use and short-term use only. Capsules should not be chewed.
Undesirable effects may be minimised by using the lowest effective
dose for the shortest duration necessary to control the
symptoms (see section 4.4)
_Adults and adolescents_
Adults and adolescents ≥ 40 kg (12 years and older):
Initial dose 400 mg ibuprofen. If necessary additional doses of 1
capsule (400 mg ibuprofen) can be taken. The respective
dosing interval should be chosen in line with the observed symptoms
and the maximum recommended daily dose. It should
not be below 6 hours. A total dose of 1200 mg ibuprofen should not be
exceeded in any 24-hour period.
Body weight
Single dose in number of capsules
Maximum daily dose in number of capsules
≥40kg
Adolescents, adults and the elderly
1 capsule (equivalent to 400 mg ibuprofen)
3 capsules (equivalent to 1200 mg
ibuprofen)
In adolescents between 12 and 17 years:
If in adolescents this medicinal product is required for more than 3
days, or if symptoms persist or worsen a doctor should be
consulted.
In adults:
If in ad