Tipol 125 mg suppositories

দেশ: আয়ার্লণ্ড

ভাষা: ইংরেজি

সূত্র: HPRA (Health Products Regulatory Authority)

সক্রিয় উপাদান:

PARACETAMOL

থেকে পাওয়া:

Carysfort Healthcare Limited

এটিসি কোড:

N02BE; N02BE01

INN (আন্তর্জাতিক নাম):

PARACETAMOL

ডোজ:

125 milligram(s)

ফার্মাসিউটিকাল ফর্ম:

Suppository

প্রেসক্রিপশন টাইপ:

Product not subject to medical prescription

থেরাপিউটিক এলাকা:

Anilides; paracetamol

অনুমোদন অবস্থা:

Marketed

অনুমোদন তারিখ:

2013-09-06

তথ্য লিফলেট

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
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 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.
Before you use Tipol
3.
How to use Tipol
4.
Possible side-effects
5.
How to store Tipol
6.
Further 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.
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, Further information).
-
If your child weighs less than 7 kilograms.
2
-
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 bilirubin-levels in the
blood (this causes yellow
jaundice that runs i

পণ্য বৈশিষ্ট্য

Health Products Regulatory Authority
08 June 2020
CRN008LN5
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 125mg of paracetamol
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Suppository, approximate length 26mm
White to 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
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 ml/min)
requires