Tefin 150 mg Suppositories

البلد: أيرلندا

اللغة: الإنجليزية

المصدر: HPRA (Health Products Regulatory Authority)

العنصر النشط:

Ibuprofen

متاح من:

Carysfort Healthcare Limited

ATC رمز:

M01AE; M01AE01

INN (الاسم الدولي):

Ibuprofen

جرعة:

150 milligram(s)

الشكل الصيدلاني:

Suppository

نوع الوصفة الطبية :

Product not subject to medical prescription

المجال العلاجي:

Propionic acid derivatives; ibuprofen

الوضع إذن:

Marketed

تاريخ الترخيص:

2012-08-31

نشرة المعلومات

PACKAGE LEAFLET: INFORMATION FOR THE USER
Tefin 150mg Suppositories
Ibuprofen
FOR RECTAL ADMINISTRATION ONLY
For children age 3 years up to 9 years
CONTAINS IBUPROFEN
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING TEFIN
BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU AND YOUR CHILD
-
Always take this medicine exactly as described in this leaflet or as
your pharmacist or doctor
has told you.
-
Keep this leaflet. You may need to read it again.
-
Ask your pharmacist or doctor if you need more information or advice.
-
If you get any side effects, talk to your pharmacist or doctor. This
includes any possible side ef-
fects not listed in this leaflet (See section 4).
-
If Tefin is required for three days or if symptoms worsen, you should
consult a doctor.
IN THIS LEAFLET:
1.
What Tefin is and what it is used for.
2.
What you need to know before you give Tefin to your child.
3.
How to use Tefin.
4.
Possible side effects.
5.
How to store Tefin.
6.
Contents of the pack and further information.
1.
WHAT TEFIN IS AND WHAT IT IS USED FOR
Tefin contains ibuprofen which is a non-steroidal anti-inflammatory
drug (NSAID). NSAIDs are
medicines
which
have
pain-relieving
(analgesic)
effects
and
also
have
the
effect
of
reducing
inflammation (anti-inflammatory), swelling and temperature. They are
also used to soothe away pain
from teething, toothache, earache, headache, cold and flu symptoms,
sore throats, strains and sprains.
Tefin is used in children for the symptomatic treatment of :
-
mild to moderate pain,
-
fever.
2.
WHAT YOU NEED TO KNOW BEFORE YOU GIVE TEFIN TO YOUR CHILD
DO NOT GIVE TEFIN TO YOUR CHILD IF:
*
your child is allergic (hypersensitive) to ibuprofen or any of the
other ingredients of Tefin (see
section 6);
*
in the past your child DEVELOPED ASTHMATIC ATTACKS, swelling of the
nasal mucosa or skin
reactions after taking aspirin (acetylsalicylic acid /ASA), ibuprofen
or other nonsteroidal anti-
inflammatory drugs;
*
your child has a BLOOD COUNT DISORDER;
*
your child has a HISTORY OF BLEEDING FROM THE ST

خصائص المنتج

Health Products Regulatory Authority
31 July 2020
CRN009VCF
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Tefin 150 mg Suppositories
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each suppository contains 150 mg of ibuprofen.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Suppository.
White, odourless, torpedo-shaped suppository.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the symptomatic treatment of mild to moderate pain and fever in
children of 3 years or older and with body weight of at
least 15kg.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_Posology:_
_Paediatric population_
Details on the posology are available in the following tables. The
dosage of Tefin for children and young persons depends on
the patient's age and body weight. In general, the single dose is 7 to
10 milligrams per kilogram body weight and the
maximum daily dose 30 milligrams per kilogram body weight
The dosage interval depends on the symptoms and the maximum daily dose
and should be at least six hours.
If Tefin is required for 3 days or if symptoms worsen, a doctor should
be consulted.
Age
Body weight
Single dose
Maximum daily dose
3 to 6 years
15 to 20 kilogram
1 Suppository
(150 milligram)
3 Suppositories
(450 milligram daily)
6 to 9 years
20 to 29 kilogram
1 Suppository
(150 milligram)
4 Suppositories
(600 milligram daily)
_Method of administration and duration of treatment:_
Tefin suppositories should be put deep 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.
The lowest effective dose should be used for the shortest duration
necessary to relieve symptoms (see section 4.4)
SPECIAL POPULATIONS
Elderly patients:
No adjustment of dosage is required. Due to possible side-effects (see
section 4.4), elderly people should be carefully
monitored
Health Products Regulatory Authority
31 July 2020
CRN009VCF
Page 2 of 11
Impaired renal function:
No reduction of dosage is requir