Nurofen for Children 60 mg Suppositories Age 3 months to 2 years

দেশ: আয়ার্লণ্ড

ভাষা: ইংরেজি

সূত্র: HPRA (Health Products Regulatory Authority)

সক্রিয় উপাদান:

Ibuprofen

থেকে পাওয়া:

Reckitt Benckiser Ireland Ltd

এটিসি কোড:

M01AE; M01AE01

INN (আন্তর্জাতিক নাম):

Ibuprofen

ডোজ:

60 milligram(s)

ফার্মাসিউটিকাল ফর্ম:

Suppository

প্রেসক্রিপশন টাইপ:

Product not subject to medical prescription

থেরাপিউটিক এলাকা:

Propionic acid derivatives; ibuprofen

অনুমোদন অবস্থা:

Marketed

অনুমোদন তারিখ:

2008-09-12

তথ্য লিফলেট

PACKAGE LEAFLET: INFORMATION FOR THE USER
Nurofen for Children
60mg Suppositories Age 3 months to 2 years
Ibuprofen
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU USE THIS MEDICINE
BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
Always use this medicine exactly as described in this leaflet or as
your doctor or pharmacist has told you.
Keep this leaflet: you might 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 if
your child feels worse after 3 days.
WHAT IS IN THIS LEAFLET:
1.
What Nurofen for Children is and what it is used for
2.
What you need to know before giving Nurofen for Children to your child
3.
How to use Nurofen for Children
4.
Possible side-effects
5.
How to store Nurofen for Children
6.
Contents of the pack and other information
1.
WHAT NUROFEN FOR CHILDREN 60MG SUPPOSITORIES AGE 3 MONTHS TO 2 YEARS
IS AND WHAT IT IS
USED FOR?
The active ingredient (which makes this medicine work) is ibuprofen
which is a non-steroidal anti-
inflammatory (NSAID) painkiller. Ibuprofen is used as an analgesic
(painkiller) for the relief of teething
and toothache pain, earache, headache, muscular minor aches and
sprains, sore throats and cold and flu
symptoms. Nurofen for Children Suppositories Age 3 months to 2 years
also reduces a high temperature
(fever).
2.
WHAT YOU NEED TO KNOW BEFORE GIVING NUROFEN FOR CHILDREN SUPPOSITORIES
AGE 3 MONTHS TO 2
YEARS TO YOUR CHILD
This medicine is suitable for the majority of children but certain
children should not use it. Talk to your
pharmacist or doctor if you are at all unsure
DO NOT GIVE THIS MEDICINE TO YOUR CHILD IF:
They suffer from hypersensitivity to any of the ingredients in this
medicine (see section 6)
They have ever had a reaction (e.g. asthma, runny nose, rash, swelling
of the face, tongue, lips or
throat or stomach bl

পণ্য বৈশিষ্ট্য

Health Products Regulatory Authority
13 January 2023
CRN00D5XN
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Nurofen for Children 60 mg Suppositories Age 3 months to 2 years
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each suppository contains: Ibuprofen 60 mg
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Suppository
White or yellowy-white cylindrical suppositories
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Reduction of fever and relief of mild to moderate pain, such as
teething pain, toothache, headache, sprains and strains and to
ease the pain of sore throats and earache.
Relief of pain and fever associated with colds and influenza.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
For short term use only.
Do not use in children under 3 months of age without medical advice.
The maximum total daily dose of Nurofen for Children 60 mg
Suppositories Age 3 months to 2 years is 20-30 mg/Kg of body
weight, administered in three to four single doses. This can be
achieved as follows:
AGE (WEIGHT)
SINGLE DOSE
DAILY DOSE
3-9 months (6.0–8.0 Kg)
1 suppository
3 times a day, leaving 6-8 hours between doses
9 months -2 years (8.0–12.0 Kg)
1 suppository
4 times a day, leaving 6 hours between doses
Do not use this product in children weighing less than 6kg.
For children aged 3-5 months medical advice should be sought if
symptoms worsen or not later than 24 hours if symptoms
persist. If in children aged from 6 months this medicinal product is
required for 3 days, or if symptoms worsen a doctor should
be consulted.
The lowest effective dose should be used for the shortest duration
necessary to relieve symptoms (see section 4.4).
METHOD OF ADMINISTRATION
For rectal use only.
4.3 CONTRAINDICATIONS
Patients with severe hepatic failure, severe renal failure or severe
heart failure (see section 4.4).
History of gastrointestinal bleeding or perforation related to
previous NSAIDs therapy. Active, or history of recurrent peptic
ulcer/haemorrhage (two or more distinct