PROVIN 100 MG/5ml Oral Suspension

Country: Ireland

Bahasa: Inggeris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

IBUPROFEN

Boleh didapati daripada:

McNeil Healthcare (Ireland) Ltd

Kod ATC:

M01AE01

INN (Nama Antarabangsa):

IBUPROFEN

Dos:

100 MG/5ml

Borang farmaseutikal:

Oral Suspension

Jenis preskripsi:

Product not subject to medical prescription

Kawasan terapeutik:

Propionic acid derivatives

Status kebenaran:

Authorised

Tarikh kebenaran:

2006-05-26

Risalah maklumat

PIL‐ tracked V4 24.07.2017
Page 1 of 6
PACKAGE LEAFLET: INFORMATION FOR THE USER
PROVIN 100MG/5ML ORAL SUSPENSION
IBUPROFEN
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
Always use this medicine exactly as described in this leaflet or as
your doctor, pharmacist or nurse has told
you.

Keep this leaflet. You may need to read it again.

Ask your pharmacist if you need more information or advice.

If your child gets 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 your child does not feel better or feels
worse after 3 days or for infants
aged 3 -5 months, after 24 hours.
WHAT IS IN THIS LEAFLET
1. What Provin Oral Suspension is and what it is used for.
2. What you need to know before you use Provin Oral Suspension
3. How to use Provin Oral Suspension
4. Possible side effects
5. How to store Provin Oral Suspension
6. Contents of the pack and other information
1 WHAT PROVIN ORAL SUSPENSION IS AND WHAT IT IS USED FOR
Ibuprofen belongs to a group of medicines called non-steroidal
anti-inflammatory painkillers (NSAIDs).
This medicine is used for the relief of pain from teething and
toothache, earache, backache, minor muscular
pains, aches and sprains. It can also be used to bring down high
temperature (also called fever) and relieve
the symptoms of colds and flu.
This product is intended for use in children aged 3 months to 12
years.
2 WHAT YOU NEED TO KNOW BEFORE YOU USE PROVIN ORAL SUSPENSION
X DO NOT GIVE YOUR CHILD THIS MEDICINE:

If s/he is allergic to ibuprofen or any of the ingredients of this
medicine (listed in section 6).

If s/he has had a
BAD ALLERGIC REACTION
(e.g. asthma, runny nose, swelling of face, tongue and throat,
rash) after taking Ibuprofen, or any other ingredient (see section 6),
ASPIRIN
or
NON-STEROIDAL ANTI-
INFLAMMATORY (NSAIDS) PAINKILLERS
.

If s/he weighs less than 5 kg.

If

Ciri produk

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Provin 100 mg / 5 ml Oral Suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Ibuprofen 100 mg/5ml.
Excipients with known effect :
Sodium methylhydroxybenzoate (E219) - 9mg per 5ml
Sodium propylhydroxybenzoate (E217) - 1mg per 5ml
Maltitol - 1ml per 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
Ibuprofen 100 mg/5 ml
Oral
Suspension is used as an analgesic for relief of mild to moderate
muscular pain,
symptomatic relief of headache,
earache,
dental pain and backache.
It can also be used in minor injuries such as
sprains and strains. Ibuprofen 100 mg/5 ml Oral Suspension is
effective in the relief of feverishness and 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).
_Children:_
Not recommended for children weighing less than 5 kg.
For pain and fever - 20mg/kg/day in divided doses
Infants 3-6 months
weighing more than 5kg:
One 2.5ml dose may be taken 3 times in 24 hours
Infants 6-12 months:
2.5ml three times a day.
Children 1-2 years:
2.5ml three to four times a day
Children 3-7 years:
5ml three to four times a day
Children 8-12 years:
10ml three to four times a day.
A minimum of 4 hours can be left between each dose.
Do not use more than 4 times a day.
Do not give to children under 3 months of age.
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