Tipol Max 1000 mg suppositories

Maa: Irlanti

Kieli: englanti

Lähde: HPRA (Health Products Regulatory Authority)

Aktiivinen ainesosa:

Paracetamol

Saatavilla:

Clonmel Healthcare Ltd

ATC-koodi:

N02BE; N02BE01

INN (Kansainvälinen yleisnimi):

Paracetamol

Annos:

1000 milligram(s)

Lääkemuoto:

Suppository

Terapeuttinen alue:

Anilides; paracetamol

Valtuutuksen tilan:

Marketed

Valtuutus päivämäärä:

2013-09-06

Pakkausseloste

Page 1 of 5 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 43
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 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.
What you need to know before you use Tipol Max
3.
How to use Tipol Max
4.
Possible side effects
5.
How to store Tipol Max
6.
Contents of the pack and other information
1. WHAT TIPOL 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. WHAT YOU NEED TO KNOW BEFORE YOU USE TIPOL
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, Contents of the pack and other
information).
-
If you or your child are allergic to soya or peanut (Tipol Max
contains soya lecithin)
-
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 ki

Valmisteyhteenveto

Health Products Regulatory Authority
02 August 2022
CRN00CWPP
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Tipol Max 1000 mg suppositories
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each suppository contains 1000 mg of paracetamol.
Excipient(s) with known effect
Contains soya lecithin (25 mg).
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 34 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
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.
Health Products Regulatory Authority
02 August 2022
CRN00CWPP
Page 2 of 8
Severe renal insufficiency
Severe renal insuf