Tefin 75 mg Suppositories

Šalis: Airija

kalba: anglų

Šaltinis: HPRA (Health Products Regulatory Authority)

Veiklioji medžiaga:

Ibuprofen

Prieinama:

Carysfort Healthcare Limited

ATC kodas:

M01AE; M01AE01

INN (Tarptautinis Pavadinimas):

Ibuprofen

Dozė:

75 milligram(s)

Vaisto forma:

Suppository

Recepto tipas:

Product not subject to medical prescription

Gydymo sritis:

Propionic acid derivatives; ibuprofen

Autorizacija statusas:

Marketed

Leidimo data:

2012-08-31

Pakuotės lapelis

PACKAGE LEAFLET: INFORMATION FOR THE USER
Tefin 75mg Suppositories
Ibuprofen
FOR RECTAL ADMINISTRATION ONLY
FOR INFANTS
Age 8 months up to 3 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
effects 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 STOMA

Prekės savybės

Health Products Regulatory Authority
31 July 2020
CRN009VCF
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Tefin 75 mg Suppositories
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each suppository contains 75 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 8 months or older and with body weight of at
least 7.5kg.
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 three days or if symptoms worsen, a doctor
should be consulted.
Age
Body weight
Single dose
Maximum daily dose
8 to 12 months
7.5 to 10 kilogram
1 Suppository
(75 milligram)
3 Suppositories
(225 milligram daily)
12 months to 3 years
10 to 15 kilogram
1 Suppository
(75 milligram)
4 Suppositories
(300 milligram daily)
_Method ofadministration and duration oftreatment:_
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