Fenopine 100mg/5ml Oral Suspension

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Ibuprofen

Available from:

Pinewood Laboratories Ltd

ATC code:

M01AE; M01AE01

INN (International Name):

Ibuprofen

Dosage:

100 mg/5ml

Pharmaceutical form:

Oral suspension

Prescription type:

Product not subject to medical prescription

Therapeutic area:

Propionic acid derivatives; ibuprofen

Authorization status:

Marketed

Authorization date:

2010-09-03

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
FENOPINE 100 MG/5 ML ORAL SUSPENSION
IBUPROFEN
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START GIVING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
This medicine is available without prescription.
Always use 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. See section 4.
- You must talk to a doctor if you/your child does not feel better or
if you/your child feel worse
after 1 day (infants
3-6 months weighing more than 5 kg) or 3 days (children aged over 6
months).
WHAT IS IN THIS LEAFLET
1. What Ibuprofen Oral Suspension is and what it is used for
2. What you need to know before you give Ibuprofen Oral Suspension
3. How to give Ibuprofen Oral Suspension
4. Possible side effects
5. How to store Ibuprofen Oral Suspension
6. Contents of the pack and other information
1. WHAT IBUPROFEN ORAL SUSPENSION IS AND WHAT IT IS USED FOR
Ibuprofen Oral Suspension contains Ibuprofen as the active ingredient.
This belongs to a group of medicines
called
NON-STEROIDAL ANTI-INFLAMMATORY DRUGS (NSAIDS).
Ibuprofen Oral Suspension is used for the treatment of fever and of
mild to moderate pain in children aged
from 3 months (weighing over 5 kg) to 12 years.
2. WHAT YOU NEED TO KNOW BEFORE YOU GIVE IBUPROFEN ORAL SUSPENSION
DO NOT GIVE THIS MEDICINE IF YOUR CHILD
:
•
is allergic (hypersensitive) to ibuprofen or any of the other
ingredients in this medicine (
_see_
_Section 6_
)
•
has had an asthma attack, runny nose, skin reactions (e.g. reddening,
hives) after taking aspirin
or other non-steroidal anti-inflammatory painkillers
•
has (or has had two or more episodes of) a stomach ulcer, perforation
or bleeding
•
has severe kidney, heart or liver problems
•
is sufferin

Summary of Product characteristics

Health Products Regulatory Authority
17 July 2023
CRN00DM10
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Fenopine 100mg/5ml Oral Suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 ml of suspension contains100 mg of Ibuprofen.
Excipients with known effect
Liquid Maltitol (E965) 1ml/5ml
Sodium Methyl Parahydroxybenzoate (E219) 9.0mg/5ml
Sodium Propyl Parahydroxybenzoate (E217) 1.0mg/5ml
Propylene Glycol (E1520) 5.2 mg/5ml
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Oral suspension
White uniform suspension.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Fenopine 100 mg/5 ml Paediatric Oral Suspension is indicated for the
symptomatic treatment of fever and of mild to moderate
pain in children from 3 months weighing more than 5 kg to 12 years
only.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
If in children aged from 6 months 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
persists.
Doses should be given approximately every 6 to 8 hours.
Undesirable effects may be minimised by using the lowest effective
dose for the shortest duration necessary to control
symptoms (see section 4.4).
Paediatric population:
This product is not recommended for use in children below 3 months (5
kg), as there is insufficient experience of treatment in
children of that age with ibuprofen.
The daily dosage is 20-30 mg/kg bodyweight in divided doses. Using the
dosing device provided this can be achieved as
follows:
Infants 3 – 6 months weighing more than 5 kg: One 2.5 ml (50 mg)
dose Ibuprofen may be taken 3 times in 24 hours.
Infants 6 – 12 months (weighing 8 – 10 kg): One 2.5 ml (50 mg)
dose Ibuprofen may be taken 3 times in 24 hours.
Infants and children 1 – 3 years (weighing 10 – 15 kg): One 5.0 ml
(100 mg) dose Ibuprofen may be taken 3 times in 24 hours.
Children 4 – 6 y