Ibuprofen Chanelle Medical 200 mg capsules, soft

Šalis: Airija

kalba: anglų

Šaltinis: HPRA (Health Products Regulatory Authority)

Veiklioji medžiaga:

Ibuprofen lysine

Prieinama:

Chanelle Medical

ATC kodas:

M01AE; M01AE01

INN (Tarptautinis Pavadinimas):

Ibuprofen lysine

Dozė:

200 milligram(s)

Vaisto forma:

Capsule, soft

Gydymo sritis:

Propionic acid derivatives; ibuprofen

Leidimo data:

2019-12-06

Pakuotės lapelis

ID: PL 205M (NL/H/4401/001-2/DC) Day 210
Version: 01
Revision Date: December
2019
Page 11 of 11
PACKAGE LEAFLET: INFORMATION FOR THE USER
IBUPROFEN CHANELLE MEDICAL 200 MG CAPSULES, SOFT
For use in adults, adolescents and children from 20 kg body weight (7
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 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 is for use in adults, adolescents and
children from 20 kg body
weight (aged 7 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)
ID: PL 205M (NL/H/44

Prekės savybės

Health Products Regulatory Authority
03 February 2020
CRN009HC7
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ibuprofen Chanelle Medical 200 mg capsules, soft
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each soft capsule contains 200 mg of ibuprofen (equivalent to 342 mg
ibuprofen lysine)
Excipients with known effect
Each 200mg soft capsule contains 94mg of Sorbitol
Ibruprofen Chanelle Medical contains soya oil.
Ibruprofen Chanelle Medical contains azoderivative Allura red (E129).
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Opaque red, oval soft capsule with "200" printed in white ink.
Each capsule is approximately 16.8 to 18.8 mm long.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the short-term symptomatic treatment of mild to moderate pain
and/or fever.
Ibruprofen Chanelle Medical 200 mg is indicated for use in adults,
adolescents and children from 20 kg body weight (7 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)
_Paediatric population_
The recommended dose for children 20 kg - 39 kg (7 – 11 years old):
Ibruprofen Chanelle Medical 200 mg should only be used for children
with at least 20 kg bodyweight. The maximum total daily
dose of ibuprofen is 20-30 mg per kg of body weight, divided into 3 to
4 single doses with dosing intervals of 6 to 8 hours. The
maximum recommended daily dose should not be exceeded. A total dose of
30 mg/kg ibuprofen should not be exceeded in
any 24-hour period. Do not give to children weighing under 20 kg
(below 7 years).
For Ibruprofen Chanelle Medical 200 mg for children the following
dosing instruction applies:
BODY WEIGHT
SINGLE DOSE IN NUMBER OF CAPSULES
MAXIMUM DAILY DOSE IN NUMBER OF CAPSULES
Children 20 kg – 29 kg
1(equivalent to 200 mg ibuprofen)
3 (equivalent up to 600 mg i