CALPOL 120 MG/5ml Oral Suspension

Երկիր: Իռլանդիա

Լեզու: անգլերեն

Աղբյուրը: HPRA (Health Products Regulatory Authority)

Ակտիվ բաղադրիչ:

PARACETAMOL

Հասանելի է:

McNeil Healthcare (Ireland) Ltd

ATC կոդը:

N02BE01

INN (Միջազգային անվանումը):

PARACETAMOL

Դոզան:

120 MG/5ml

Դեղագործական ձեւ:

Oral Suspension

Ռեկվիզորի տեսակը:

Product not subject to medical prescription

Թերապեւտիկ տարածք:

Analgesics and antipyretics

Լիազորման կարգավիճակը:

Authorised

Հաստատման ամսաթիվը:

1993-04-01

Տեղեկատվական թերթիկ

Package leaflet: Information for the user
_120 mg/5 ml_
_INFANT ORAL SUSPENSION_
_Contains Paracetamol_
Read all of this leaflet carefully before you start using 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 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.
What is in this leaflet
1. What Calpol is and what it is used for
2. What you need to know before you use Calpol
3. How to take Calpol
4. Possible side-effects
5. How to store Calpol
6. Contents of the pack and other information
1
What Calpol is and what it is
used for
The paracetamol in Calpol Infant Oral Suspension is used to relieve
pain such as tooth pain, headache, sore throat and aches and
pains that come with colds and flu. It also brings down fever (high
temperature).
2
What you need to know before
you use Calpol
Do not give your child this medicine…
■
If s/he is allergic to paracetamol or any of the other
ingredients of this medicine (listed in section 6).
■
If s/he is taking anything else with paracetamol in it.
■
If s/he weighs less than 4 kg.
If any of these applies, get advice from a doctor or
pharmacist without using Calpol.
Warnings and precautions
Talk to your doctor or pharmacist…
■
If your child has serious kidney or liver problems.
■
If your child has an inherited intolerance to fructose or
been diagnosed with an intolerance to some other sugars.
Other medicines and Calpol
Tell your doctor or pharmacist if your child is taking any other
medicines including:
■
_metoclopramide_ or _domperidone_ (used to treat nausea
and vomiting)
■
_colestyramine_ (used to treat high cholesterol)
■

Ապրանքի հատկությունները

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Calpol 120 mg/5 ml Infant Oral Suspension.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Calpol Infant Oral Suspension contains -
Excipients with known effect (per 5ml):
Sucrose
2202.48mg
Sorbitol Liquid (E420)
451.5mg
Methyl parahydroxybenzoate (E218)
5.0mg
Propyl parahydroxybenzoate (E216)
1.0mg
Ethyl parahydroxybenzoate (E214)
2.0mg
Carmoisine (E122)
0.075mg
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Oral suspension.
A viscous pink coloured suspension with a strawberry odour and taste.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Calpol Infant Suspension is indicated for the treatment of pain
(including teething pain), and as an antipyretic.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
INFANTS AGED 2-3 MONTHS:
Paracetamol 120 mg per 5 ml.
AGE : 2 – 3 MONTHS
DOSE
1. POST-VACCINATION FEVER
2.5 ml
If necessary, after 4-6 hours, give a
second
2.5 ml dose
2. OTHER CAUSES OF PAIN AND FEVER -
if your
baby weighs over
4 kg and
was born after 37 weeks
Do not give to babies less than 2 months of age.
Do not give more than 2 doses unless your doctor or nurse has advised
otherwise.
Leave at least 4 hours between doses.
If further doses are needed, talk to your doctor or pharmacist.
It is important to SHAKE THE BOTTLE for at least 10 seconds before
use.
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