Tipol 125 mg suppositories

Χώρα: Ιρλανδία

Γλώσσα: Αγγλικά

Πηγή: HPRA (Health Products Regulatory Authority)

Δραστική ουσία:

Paracetamol

Διαθέσιμο από:

Clonmel Healthcare Ltd

Φαρμακολογική κατηγορία (ATC):

N02BE; N02BE01

INN (Διεθνής Όνομα):

Paracetamol

Δοσολογία:

125 milligram(s)

Φαρμακοτεχνική μορφή:

Suppository

Θεραπευτική περιοχή:

Anilides; paracetamol

Καθεστώς αδειοδότησης:

Marketed

Ημερομηνία της άδειας:

2013-09-06

Φύλλο οδηγιών χρήσης

Page 1 of 5
PACKAGE LEAFLET: INFORMATION FOR THE USER
TIPOL 125 MG SUPPOSITORIES
PARACETAMOL FOR INFANTS (6 MONTHS TO 2 YEARS) WITH A BODY WEIGHT OF 7 KG OR MORE
READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
This medicine is available without prescription. However, you still
need to use Tipol carefully to get the
best results from it.
-
Keep this leaflet. You may need to read it again.
-
Ask your pharmacist, if you need more information or advice.
-
You must contact a doctor if the symptoms worsen or do not improve
after three days.
-
If any of the side effects gets serious, or if you notice any side
effect not listed in this leaflet, please
tell your doctor or pharmacist.
-
Contains paracetamol
-
Do not take any other paracetamol-containing products
-
Do not exceed the stated dose
-
Immediate medical advice should be sought in the event of overdosage,
because of the risk of
irreversible liver damage.
IN THIS LEAFLET
1.
What Tipol is and what it is used for
2.
What you need to know before you use Tipol
3.
How to use Tipol
4.
Possible side effects
5.
How to store Tipol
6.
Contents of the pack and other information
1.
WHAT TIPOL IS AND WHAT IT IS USED FOR
Tipol contains paracetamol which belongs to a group of medicines known
as analgesics. Paracetamol is a
medicine that relieves pain and reduces fever.
Tipol is used in infants with a body weight of 7 kg or more to treat:
-
mild to moderate pain and fever.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE TIPOL
DO NOT USE TIPOL
-
If your child is allergic (hypersensitive) to paracetamol or any of
the other ingredients of Tipol (See
section 6, Contents of the pack and other information).
-
If your child weighs less than 7 kilograms.
-
If your child has
SEVERE LIVER PROBLEMS
.
TAKE SPECIAL CARE WITH TIPOL
SPEAK TO YOUR DOCTOR IF YOU OR YOUR CHILD HAS:
-
moderate liver problems;
-
severe kidney problems;
-
a rare inherited metabolic disease, named Gilbert’s disease (also
known as Meulengracht's disease)
which is accompanied by elevated b

Αρχείο Π.Χ.Π.

Health Products Regulatory Authority
02 August 2022
CRN00CWPP
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Tipol 125 mg suppositories
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each suppository contains 125 mg of paracetamol.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Suppository.
White to ivory coloured, odourless, torpedo-shaped suppository with an
approximate length of 26 mm.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Symptomatic treatment of mild to moderate pain and/or fever.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Details on the posology are available in the following table. The dose
of paracetamol depends on the patient’s age and body
weight. The single dose is usually between 10 - 15 mg/kg body weight,
to a maximum up to 60 mg/kg body weight for a total
daily dose.
The interval between doses depends on the symptomatology and the
maximum daily dose. It should be at least six hours.
If symptoms are persisting for more than three days medical attention
must be received.
BODY WEIGHT
(AGE)
SINGLE DOSE
(EQUIVALENT DOSE OF PARACETAMOL)
MAXIMUM DAILY DOSE (24 HOURS)
(EQUIVALENT DOSE OF PARACETAMOL)
7 kg
(6 – 7 months)
1 suppository
(equivalent to 125 mg of paracetamol)
3 suppositories
(equivalent to 375 mg of paracetamol)
8 - 12 kg
(7 months – 2 years)
1 suppository
(equivalent to 125 mg of paracetamol)
4 suppositories
(equivalent to 500 mg of paracetamol)
The maximum daily dose (24 hours) must not be exceeded.
METHOD OF ADMINISTRATION
Tipol suppositories should be put deeply into the rectum after bowel
movement. They may be warmed up in the hands or
dipped for a short time into warm water to improve their sliding
properties.
SPECIAL GROUPS OF PATIENTS
Hepatic insufficiency and mild renal insufficiency
For patients with impaired liver and kidney function or Gilbert´s
syndrome the dose should be reduced or the interval between
doses should be increased.
Severe renal insufficiency
Severe renal insuffciency (creatinine clearance below 10