Somazina

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

CITICOLINE

Available from:

Ferrer Internacional S.A. Gran Vía Carlos III, 94 08028 Barcelona, Spain

ATC code:

N06BX06

INN (International Name):

CITICOLINE 100 mg/ml

Pharmaceutical form:

ORAL SOLUTION

Composition:

CITICOLINE 100 mg/ml

Prescription type:

POM

Therapeutic area:

PSYCHOANALEPTICS

Authorization status:

Authorised

Authorization date:

2005-09-29

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
Somazina 100 mg/ml oral solution
CITICOLINE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them,
even if their symptoms are the same as yours.
-
If any of the side effects gets serious, or if you notice any side
effects not listed in this
leaflet, please tell your doctor or pharmacist
WHAT IS IN THIS LEAFLET:
1.
What Somazina 100 mg/ml oral solution is and what it is used for.
2.
Before you take 100 mg/ml oral solution.
3.
How to take Somazina 100 mg/ml oral solution.
4.
Possible side effects.
5.
How to store Somazina 100 mg/ml oral solution.
6.
Additional information
1.
WHAT SOMAZINA 100 MG/ML ORAL SOLUTION IS AND WHAT IT IS USED
FOR
Somazina belongs to a group of medicines called psychostimulants and
nootropics that act
improving brain function.
Somazina is used for the treatment of memory and behaviour disorders
associated with:
-cerebrovascular accidents which is an interruption of blood supply in
the brain by a clot
or by a ruptured blood vessel.
-cranial trauma, blow to the head.
2.
BEFORE YOU TAKE SOMAZINA 100 MG/ML ORAL SOLUTION
DO NOT TAKE SOMAZINA
-
If you are allergic to citicoline or any of the excipients of
Somazina.
-
If you suffer from hypertonia of the parasympathetic nervous system
which is a serious state
with hypotension, perspiration, tachycardia and fainting.
TAKE SPECIAL CARE WITH SOMAZINA
-
If you are allergic to aspirin, as it can cause asthma
TAKING OTHER MEDICINES
Please tell your doctor or pharmacist if you are taking or have
recently taken any other
medicines, including medicines obtained without a prescription.
Somazina increases the effects of L-DOPA so it should not be taken at
the same time that
medicines containing L-DOPA without checking with your doctor. These
medicines with
L-DOPA are usually used for treati

Summary of Product characteristics

Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Somazina 100 mg/ml oral solution
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Somazina 100 mg/ml oral solution is packaged in glass bottles
containing 30 ml. Each ml contains
100 mg of citicoline (as sodium salt).
Excipients:
Both formats contain per ml of solution: 0.005 mg of Ponceau 4-R red
colour; 0.4 mg of propyl
parahydroxybenzoate; 1.6 mg of methyl parahydroxybenzoate; 200 mg of
liquid sorbitol and other
excipients in q.s.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Oral solution.
Somazina 100 mg/ml oral solution: Glass bottle containing 30 ml of a
transparent and pink-
coloured solution, with strawberry smell and taste.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS

Treatment of cognitive and neurological disorders associated with
acute and sub-acute
stroke.

Treatment of cognitive and neurological disorders associated with
traumatic brain injuries.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults: _
The recommended dose is from 500 to 2,000 mg/day, depending on the
severity of the symptoms
to be treated.
_Older people: _
Somazina does not need any specific dose adjustment for this age
group.
Page 2 of 6
_Children: _
The experience in children is limited; therefore it may only be
administered when the expected
therapeutical benefit is higher than any possible risk.
Method of administration
See the instructions for preparation of the medicine in section 6.6.
4.3
CONTRAINDICATIONS
Hypersensitivity to citicoline or to any of the excipients.
It is contraindicated for patients with hypertonia of the
parasympathetic nervous system.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Due to cochineal red (Ponceau 4-R or E-124) it may cause allergic
reactions.
It may cause asthma, especially in patients with allergy to
acetylsalicylic acid.
Somazina
contains
Sorbitol
(E-420)
as
excipient,
because
of
that,
patients
with
hereditary
problems of fructose intolerance should not take this medicine.
S