Fenopine 200 mg/5 ml Oral Suspension

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Ibuprofen ph. eur.

Available from:

Pinewood Laboratories Ltd

ATC code:

M01AE01

INN (International Name):

Ibuprofen ph. eur.

Dosage:

200/5 milligram(s)/millilitre

Pharmaceutical form:

Oral suspension

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

ibuprofen

Authorization status:

Not marketed

Authorization date:

2019-02-01

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
FENOPINE 200 MG/5 ML ORAL SUSPENSION
Ibuprofen
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING/GIVING 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 symptoms 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 Fenopine 200 mg/5 ml Oral Suspension is and what it is used for
2.
What you need to know before you give/take Fenopine 200 mg/5 ml Oral
Suspension
3.
How to give/take Fenopine 200 mg/5 ml Oral Suspension
4.
Possible side effects
5.
How to store Fenopine 200 mg/5 ml Oral Suspension
6.
Contents of the pack and other information
_ _
1. WHAT FENOPINE 200MG/5ML ORAL SUSPENSION IS AND WHAT IT IS USED FOR
Fenopine 200 mg/5 ml Oral Suspension contains Ibuprofen as the active
ingredient. This belongs to a
group of medicines called
NON-STEROIDAL ANTI-INFLAMMATORY DRUGS (NSAIDS).
Fenopine 200 mg/5 ml Oral Suspension is given to children under 12 as
a painkiller for relief of mild
to moderate muscular pain, headache, teething pain and toothache. It
also reduces the temperature in
fever (e.g. colds, influenza and post-immunisation fever). For adults
and children over 12 it can also
be used for backache, migraines, neuralgia and relief from non-serious
arthritic conditions.
2.
WHAT YOU NEED TO KNOW BEFORE YOU GIVE/TAKE FENOPINE 200 MG/5 ML ORAL
SUSPENSION
DO NOT GIVE/TAKE FENOPINE 200 MG/5 ML ORAL SUSPENSION IF YOU OR YOUR
CHILD:
•
has an allergy or hypersensitivity to Ibuprofen or any of the other
ingredients in this medicine
(see
_Section 6_
and Section 2: Important information about ingredients)
•
has had an allergic reaction or wheezing e.g. an asthma attack, runny
no

Summary of Product characteristics

Health Products Regulatory Authority
17 July 2023
CRN00DM4T
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Fenopine 200 mg/5 ml Oral Suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 ml of suspension contains 200 mg of Ibuprofen.
Excipients with known effect
Liquid Maltitol
4.25g/5ml
Sodium Benzoate (E 211)
10 mg/5ml
Propylene Glycol (E1520)
5.2 mg/5ml
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral Suspension
White/cream suspension.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Children under 12 years
Ibuprofen 200 mg/5 ml Oral Suspension is indicated for rheumatic or
muscular pain, headache, dental pain, feverishness
(including post-immunisation pyrexia), symptoms of cold and influenza.
Over 12 years
Ibuprofen 200 mg/5 ml Oral Suspension is indicated for R heumatic or
muscular pain, pain of non-serious arthritic conditions,
backache, neuralgia, migraine, headache, dental pain, dysmenorrhoea,
feverishness, symptoms of colds and influenza.
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).
Leave at least four hours between doses and do not take more than the
recommended amount in any 24 hour period.
Not to be given to children under 3 months of age, except on the
advice of a doctor
This product should only be given to infants who weigh more than 5kg.
If in children aged from 6 months and in adolescents this medicinal
product is required for more than 3 days, or if symptoms
worsen a doctor should be consulted. For infants aged 3 - 5 months,
medical advice should be sought if symptoms worsen or
not later than 24 hours if symptoms persist.
The daily dosage for children is 20- 30mg/kg bodyweight in divided
doses. Using the dosing device provided
this can be
achieved as follows:
3 to 6 months (weighing more than 5 kg): 1.25ml (50mg), up to 3 times
in 24 hour