Ibuprofen Algik 20mg/ml Oral Suspension

Valsts: Malta

Valoda: angļu

Klimata pārmaiņas: Malta Medicines Authority

Pieejams no:

Laboratorios Azevedos - Industria Farmaceutica SA Estrada Nacional 117-2 Alfragide, 2614-503 Amadora, Portugal

ATĶ kods:

M01AE01

SNN (starptautisko nepatentēto nosaukumu):

IBUPROFEN 20 mg/ml

Zāļu forma:

ORAL SUSPENSION

Kompozīcija:

IBUPROFEN 20 mg/ml

Receptes veids:

OTC

Ārstniecības joma:

ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS

Autorizācija statuss:

Authorised

Autorizācija datums:

2022-11-23

Lietošanas instrukcija

PACKAGE LEAFLET: INFORMATION FOR THE USER
IBUPROFEN ALGIK 20 MG/ML ORAL SUSPENSION
Ibuprofen
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 have told you.
-
Keep this leaflet. You may need to read it again.
-
Ask your pharmacist if you need more information or advice.
-
Ask your doctor in case of worsening or persistence of symptoms.
-
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 after 3 days
(fever) or 7 days (pain).
WHAT IS IN THIS LEAFLET:
1.
What Ibuprofen Algik is and what it is used for
2.
What you need to know before you take Ibuprofen Algik
3.
How to take Ibuprofen Algik
4.
Possible side effects
5.
How to store Ibuprofen Algik
6.
Contents of the pack and other information
1. WHAT IBUPROFEN ALGIK IS AND WHAT IT IS USED FOR
Pharmacotherapeutic group
Anti-inflammatory and anti-rheumatic products, non-steroids; propionic
acid derivatives
This medicine is available as an oral solution for oral use.
The active substance is ibuprofen, which is a propionic acid
derivative with anti-
inflammatory, analgesic and antipyretic action.
Ibuprofen Algik is indicated in:
-
symptomatology associated with flu and colds (fever and pain);
-
odynophagia and pharyngitis;
-
mild to moderate migraine (headaches);
-
mild to moderate muscular pain;
-
bruises;
-
fever (not more than 3 days);
-
primary dysmenorrhea (period pain).
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE IBUPROFEN ALGIK
DO NOT TAKE IBUPROFEN ALGIK:
-
If you are allergic to ibuprofen or any of the other ingredients of
this medicine
(listed in section 6).
-
If
you
have
or
ever
had
asthma,
rhinitis,
rash,
angioneurotic
oedema
or
bronchospasm associated to the use of acetylsalicylic acid or other
non-steroidal
anti-inflammatory d

Produkta apraksts

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Ibuprofen Algik 20 mg/ml Oral Suspension
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 ml of oral suspension contains 20 mg of Ibuprofen, as active
substance.
Excipients with known effect:
Glycerol - 50 mg/ml
Azorrubine (E 122) - 0.015 mg/ml
Maltitol - 500 mg/ml
Sodium – 3.590 mg/ml (as sodium chloride, sodium benzoate, sodium
citrate,
sodium saccharin.)
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Oral Suspension.
Viscous suspension, pink coloured with a characteristic strawberry
flavour.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
-symptomatology associated with flu states and colds (fever and pain);
-odynophagia and pharyngitis;
-mild to moderate headaches;
-mild to moderate muscle aches;
-bruises;
-fever (not more than 3 days);
-primary dysmenorrhoea
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_▪ Children _
The recommended daily dose is 20-30 mg per Kg of body weight, spread
over
several doses throughout the day:
Age
Dose
Number of doses in 24
hours
6 months – 1 year
2.5 ml (50 mg)
3 to 4
1 year – 6 years
5 ml (100 mg)
3 to 4
6 years – 12 years
10 ml (200 mg)
3 to 4
The administration in children less than 6 months should only be made
by medical
prescription.
_▪ Adults _
Although it usually resorts to other pharmaceutical forms of Ibuprofen
for adults, in
case of difficulty in swallowing, Ibuprofen Algik can be administered
in a dose of 3
measuring spoons (300 mg), 4 times per day.
_▪ Renal failure patients _
Cautions should be taken when a NSAID is administrated in patients
with renal
failure.
In patients with mild to moderate renal dysfunction the initial dose
should be
reduced.
Ibuprofen should not be administered in patients with severe renal
failure (see
section 4.3 contraindications).
_▪ Hepatic failure patients _
Ibuprofen should not be taken by patients with severe liver failure
(see section 4.3
contraindications).
_▪ Elderly _
Ibuprofen should be administered with caut