Tipol Max 1000 mg suppositories

Valsts: Īrija

Valoda: angļu

Klimata pārmaiņas: HPRA (Health Products Regulatory Authority)

Aktīvā sastāvdaļa:

PARACETAMOL

Pieejams no:

Carysfort Healthcare Limited

ATĶ kods:

N02BE; N02BE01

SNN (starptautisko nepatentēto nosaukumu):

PARACETAMOL

Deva:

1000 milligram(s)

Zāļu forma:

Suppository

Receptes veids:

Product not subject to medical prescription

Ārstniecības joma:

Anilides; paracetamol

Autorizācija statuss:

Marketed

Autorizācija datums:

2013-09-06

Lietošanas instrukcija

PACKAGE LEAFLET: INFORMATION FOR THE USER
TIPOL MAX 1000 MG SUPPOSITORIES
PARACETAMOL
FOR ADULTS AND CHILDREN OVER 12 YEARS OF AGE WITH A BODY WEIGHT OF
43KG OR MORE
Active substance: paracetamol.
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 Max
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 Max is and what it is used for
2.
Before you use Tipol Max
3.
How to use Tipol Max
4.
Possible side-effects
5.
How to store Tipol Max
6.
Further information
1.
WHAT TIPOL MAX IS AND WHAT IT IS USED FOR
Tipol Max contains paracetamol which belongs to a group of medicines
known as analgesics.
Paracetamol is a medicine that relieves pain and reduces fever.
Tipol Max is used to treat:
-
mild to moderate pain and fever.
2.
BEFORE YOU USE TIPOL MAX
DO NOT USE TIPOL MAX
-
if you or your child are allergic (hypersensitive) to paracetamol,
soya, or any of the other
ingredients of Tipol Max (See section 6, Further information).
-
If you or your child are allergic to soya or peanut (Tipol Max
contains soya lecithin)
2
-
If your child is under 12 years of age or weighs less than 43
kilograms.
-
If you or your child have SEVERE LIVER PROBLEMS.
TAKE SPECIAL CARE WITH TIPOL MAX
SPEAK TO YOUR DOCTOR IF YOU OR YOUR CHILD HAVE:
-
moderate liver problems;
-
severe kidney problems;
-
alcoholism or regularly abuses alcohol;
-
a

Produkta apraksts

Health Products Regulatory Authority
08 June 2020
CRN008LN5
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Tipol Max 1000 mg suppositories
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each suppository contains 1000mg of paracetamol
Contains soya lecithin (25mg)
For a full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Suppository, approximate length 34 mm
White top ivory coloured, odourless, torpedo-shaped suppositories.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Symptomatic treatment of mild to moderate pain and/or fever.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
The dose of paracetamol depends on the patient’s age and body
weight. Details on the posology are available in the following
table. 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)
more than 43 kg
(Children from 12 years and adults)
1 suppository
(equivalent to 1000 mg of paracetamol)
4 suppositories
(equivalent to 4000 mg of paracetamol)
The maximum daily dose (24 hours) must not be exceeded
METHOD OF ADMINISTRATION
Tipol Max 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
Health Products Regulatory Authority
08 June 2020
CRN008LN5
Page 2 of 9
Severe renal insufficiency (creatinine clearance below 10 ml/min)
r