Calpol Six Plus Fastmelts 250 mg Paracetamol orodispersible tablets

Valsts: Īrija

Valoda: angļu

Klimata pārmaiņas: HPRA (Health Products Regulatory Authority)

Aktīvā sastāvdaļa:

Paracetamol

Pieejams no:

Johnson & Johnson (Ireland) Limited

ATĶ kods:

N02BE; N02BE01

SNN (starptautisko nepatentēto nosaukumu):

Paracetamol

Deva:

250 milligram(s)

Zāļu forma:

Orodispersible tablet

Receptes veids:

Product not subject to medical prescription

Ārstniecības joma:

Anilides; paracetamol

Autorizācija statuss:

Marketed

Autorizācija datums:

2001-02-23

Lietošanas instrukcija

Package leaflet: Information for the user
CALPOL ® SIX PLUS FASTMELTS 250 MG PARACETAMOL ORODISPERSIBLE TABLETS
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 use 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 SIXPLUS FASTMELTS™ 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 HAS EVER HAD A BAD REACTION to paracetamol or any of the other
ingredients in this medicine
(see section 6).
■
IF S/HE IS TAKING ANYTHING ELSE WITH PARACETAMOL IN IT.
■ IF S/HE HAS PHENYLKETONURIA (A HEREDITARY DISEASE DISCOVERED AT
BIRTH.)
■
If any of these apply, 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 GILBERT’S SYNDROME (familial non-haemolytic
jaundice).
■
If your child has a condition called GLUCOSE-6-PHOSPHATE DEHYDROGENASE
DEFICIENCY.
■
If your child has HAEMOLYTIC ANAEMIA.
■
If your child has GLUTATHIONE DEFICIENCY.
■
If your child is DEHYDRATED or C

Produkta apraksts

Health Products Regulatory Authority
11 April 2022
CRN00CSYF
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Calpol Six Plus Fastmelts 250 mg Paracetamol Orodispersible Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains -
Paracetamol Ph Eur 250 mg
Excipients with known effect:
Aspartame (E951) 8mg
Benzyl alcohol 0.00064mg
Glucose 1.144mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Orodispersible tablet. (Tablet).
White, round, biconvex tablets with a central concave depression and a
characteristic strawberry odour.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Calpol Six Plus Fastmelts are indicated for the treatment of mild to
moderate pain such as headache, teething pain and sore
throat, and as an antipyretic (e.g. fever associated with colds and
flu).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Adults and children
Child's Age
How Much
How often (in 24 hours)
UNDER 6 YEARS
NOT RECOMMENDED
N/A
6 - 9 years
1 tablet
4 times
9 - 12 years
2 tablets
4 times
12 – 16 years
2 to 3 tablets
4 times
Adults and children over 16 years
2 to 4 tablets
4 times

Do not give more than 4 doses in any 24-hour period

Leave at least 4 hours between doses

Do not give this medicine to your child for more than 3 days without
speaking to your doctor or pharmacist
RENAL IMPAIRMENT:
It is recommended, when giving paracetamol to patients with renal
impairment, to reduce the dose and to increase the
minimum interval between each administration to at least 6 hours
unless directed otherwise by a physician.
Recommended Dose for Adults with Renal Impairment:
Glomerular filtration rate
Dose
10-50 ml/min
500 mg (2 tablets) every 6 hours
<10ml/min
500 mg (2 tablets) every 8 hours
Health Products Regulatory Authority
11 April 2022
CRN00CSYF
Page 2 of 7
HEPATIC IMPAIRMENT:
In patients with hepatic impairment or Gilbert's Syndrome, the dose
should be reduced or the dosing interval prolonged. For
adults, the daily dose should not exceed 2g per day unless oth