Okitask 25 mg Coated Granules in Sachet

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

KETOPROFEN LYSINE

Available from:

Dompé Farmaceutici S.p.A.

ATC code:

M01AE03

INN (International Name):

KETOPROFEN LYSINE

Dosage:

25 milligram(s)

Pharmaceutical form:

Coated granules in sachet

Therapeutic area:

ketoprofen

Authorization status:

Not marketed

Authorization date:

2019-03-01

Patient Information leaflet

PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE USER
OKITASK 25 MG COATED GRANULES IN SACHET
ketoprofen (as lysine salt)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
Always take this medicine exactly as described in this leaflet or as
your doctor or pharmacist has told
you.
•
Keep this leaflet. You may need to read it again.
•
Ask your pharmacist if you need more information or advice.
•
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
•
You must talk to a doctor if you do not feel better or if you feel
worse.
WHAT IS IN THIS LEAFLET
1.
What Okitask 25 mg Coated Granules in Sachet is and what it is used
for
2.
What you need to know before you take Okitask 25 mg Coated Granules in
Sachet
3.
How to take Okitask 25 mg Coated Granules in Sachet
4.
Possible side effects
5.
How to store Okitask 25 mg Coated Granules in Sachet
6.
Contents of the pack and other information
1.
WHAT OKITASK 25 MG COATED GRANULES IN SACHET IS AND WHAT IT IS USED
FOR
The active substance of this medicine is ketoprofen which belongs to a
group of medications called
“Non-Steroidal Anti-Inflammatory Drugs” (NSAID). Ketoprofen acts
by blocking the chemical
substances that normally cause inflammation in your body. Ketoprofen
Lysine Salt is a salt of
ketoprofen which is absorbed quicker by the body. It is used to
relieve mild to moderate pain and
fever associated with cold and flu, rheumatic and muscular pain,
headache, toothache and period pain
in adults 18 years and over.
YOU MUST TALK TO A DOCTOR IF YOU DO NOT FEEL BETTER OR IF YOU FEEL
WORSE.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE
OKITASK 25 MG COATED GRANULES IN SACHET
DO NOT TAKE OKITASK 25 MG COATED GRANULES IN SACHET:
•
if you are
ALLERGIC
(hypersensitive) to any of the other ingredients in this medicine
(listed in
section 6)
•
if you suffer from
ASTHMA
or have a history of
ALLERGIC
reactions

Summary of Product characteristics

Health Products Regulatory Authority
11 February 2021
CRN00C24N
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Okitask 25 mg Coated Granules in Sachet
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each sachet contains 25 mg Ketoprofen (as lysine salt).
Excipients with known effect:
Aspartame (E951) 350 micrograms
Glucose 63 micrograms
Sucrose 6.13 milligrams
Sodium 6.9 micrograms
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Coated granules in sachet
White to ivory granules.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Okitask 25 mg Coated Granules in Sachet is recommended in the
symptomatic treatment of acute mild to moderate pain such
as rheumatic and muscular pain, headache, toothache, menstrual pain,
and for pain and fever associated with common cold
and flu symptoms.
Okitask 25 mg Coated Granules in Sachet is indicated in adults aged 18
years and over.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
INDICATION
AGE GROUP
DOSE
DURATION
Symptomatic relief of pain and
fever
Adults aged 18 years and over
1 sachet as a single dose
repeated 2 to 3 times a
day as needed.*
The minimum
effective dose should be
used for the shortest time
necessary to relieve
symptoms (see section 4.4).
*Leave at least 4 hours between doses.
For short term use only.
Consult a doctor if symptoms persist or worsen, or if the product is
required for more than 10 days.
Do not take more than 3 sachets in any 24-hour period.
Elderly
Ketoprofen Lysine Salt should be used with caution in the elderly.
For elderly patients, a dose of 1 sachet a day is recommended.
Health Products Regulatory Authority
11 February 2021
CRN00C24N
Page 2 of 9
Paediatrics
Ketoprofen should not be used in children and adolescents under the
age of 18 years.
METHOD OF ADMINISTRATION
The contents of the sachet must only be placed onto the tongue and
swallowed. Okitask 25 mg Coated Granules in Sachet can
be taken with or without water.
4.3 CONTRAINDICATIONS
The medicinal product should not be used in the follo