Algidrin pediatric 20mg/ml oral suspension

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

IBUPROFEN

Available from:

Laboratorio de Aplicaciones Farmacodinamicas S.A. Grassot, 16, 08025, Barcelona, Spain

ATC code:

M01AE01

INN (International Name):

IBUPROFEN 20 mg

Pharmaceutical form:

ORAL SUSPENSION

Composition:

IBUPROFEN 20 mg

Prescription type:

OTC

Therapeutic area:

ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS

Product summary:

Licence number in the source country: NOT APPLICAPABLE

Authorization status:

Authorised

Authorization date:

2020-11-11

Patient Information leaflet

Page 1 of
10
PACKAGE LEAFLET: INFORMATION FOR THE USER
ALGIDRIN PEDIATRIC 20 MG/ML ORAL SUSPENSION
Ibuprofen (lysine)
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 after 3 days.
WHAT IS IN THIS LEAFLET
1.
What Algidrin pediatric is and what it is used for
2.
What you need to know before you take Algidrin pediatric
3.
How to take Algidrin pediatric
4.
Possible side effects
5.
How to store Algidrin pediatric
6.
Contents of the pack and other information
1.
WHAT ALGIDRIN PEDIATRIC IS AND WHAT IT IS USED FOR
Algidrin pediatric belongs to the group of medicines known as
non-steroidal anti-inflammatory
drugs (NSAIDs). Ibuprofen, the active substance in this medicine,
which is in the soluble salt
form, ibuprofen (lysine), reduces feber and relieves pain and
inflammation.
It is used in children aged over 3 months of age for the symptomatic
treatment of fever and mild
or moderate pain.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ALGIDRIN PEDIATRIC
DO NOT TAKE ALGIDRIN PEDIATRIC:
•
If you are allergic (hypersensitive) to ibuprofen or any other NSAID,
acetylsalicylic acid or
any of the other ingredients of this medicine (listed in section 6).
Reactions indicating allergy
are rash with itching, swelling of the face, lips or tongue, runny
nose, shortness of breath and
asthma.
•
If you suffer from severe liver or kidney disease.
•
If you have had a stomach or duodenal ulcer or haemorrhage or have
suffered perforation of
the digestive system.
•
If you vomit blood.
•
If you have black faeces or diarrhoea wi

Summary of Product characteristics

Page 1 of 16
SUMMARY OF PRODUCT CHARACTERISTICS
Page 2 of 16
1.
NAME OF THE MEDICINAL PRODUCT
Algidrin pediatric 20 mg/ml oral suspension
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of oral suspension contains:
20 mg of ibuprofen (provided by 34.17 mg of ibuprofen lysine).
Excipients with known effect: Sorbitol (E-420) 25 mg, maltitol
(E-965)100 mg, Allura Red AC
dye
(E-129)
0.0786
mg,
methyl
para-hydroxybenzoate
(E-218)
1.45
mg,
ethyl
para-
hydroxybenzoate (E-214) 0.32 mg propyl para-hydroxybenzoate (E-216)
0.22 mg.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Oral suspension.
Red coloured oral suspension with wild berry aroma and flavour.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Algidrin pediatric is indicated in children aged over 3 months of age
and adolescents for the:
•
Symptomatic treatment of fever
•
Symptomatic treatment of mild to moderate pain
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The lowest effective dose should be used for the shortest duration
necessary to relieve symptoms
(see section 4.4).
PAEDIATRIC POPULATION:
The dose of ibuprofen depends on the age and weight of the child. For
children aged between 3
months and 12 years, the daily recommended dose of ibuprofen is 20 to
30 mg/kg of body weight,
divided into three or four individual doses (see table below).
The use of this medicinal product is not recommended in children under
3 months of age or under
5 kg of body weight.
The interval between doses will depend on the course of the symptoms,
but should never be less
than 4 hours.
Page 3 of 16
By way of guidance, follow the recommended doses in the table below.
Doses may be repeated
every 6-8 hours, without exceeding the daily amounts in the last
column:
POSOLOGY FOR CHILDREN
AGE/WEIGHT
FREQUENCY
DOSAGE
MAXIMUM DAILY DOSE
3 to 6 months
5 to 7.6 kg approx.
3 times a day
50 mg (2.5 ml)/dose
150 mg (7.5 ml)
6 at 12 months
7.7 to 9 kg approx.
3 to 4 times a day
50 mg (2.5 ml)/dose
150-200 mg (7.5-10 ml)
1 to 3 years
10 to 15 kg approx.
3