The package insert of the medicine Somazina

the package insert of the medicine Somazina. Active principles Citicoline.

what For?

SOMAZINA (citicoline) is indicated in the treatment of patients with severe brain injuries etiology for vascular or traumatic, with or without loss of consciousness. It is also indicated in the treatment of the sequelae of vascular lesions of the brain or head trauma and in neurological manifestations of vascular insufficiency of the brain, including mental disorders and decreased intellectual.

In senile dementia, for the treatment of the injury degenerative and vascular disease, cerebral chronic.

Contraindications

When should I not use?

SOMAZINA (citicoline) should not be administered in patients with hypersensitivity to citicoline or to the constituents of the formula of the product.

SOMAZINA is contraindicated to patients with disorders characterized by stimulation of the parasympathetic nervous system.

This medicine should not be used by pregnant women without medical advice.

This medicine is contraindicated in the pediatric age group.

Dosage

How to use?

it is Recommended to administer 500 mg to 1000 mg a day, according to physician’s discretion.

doses should be individualized according to medical criterion, not having recommendations of dosages and differentiated for adults and the elderly.

This medicine is contraindicated to children, pregnant women or infants.

The forgetfulness of the intake of the daily dose can be worked around with the simple suppression of the dose, returning the next day to a prescription usual.

there are No reports of adverse reactions secondary to abrupt cessation of the drug.

in This way, by interrupting the treatment with SOMAZINA, it is not necessary to a gradual reduction of dosage.

Follow the guidance of your doctor, always respecting the schedules, doses and duration of treatment.

do Not stop treatment without the knowledge of your doctor.

do Not use medicine with the term of validity expired. Before use, note the appearance of the medicine.

This medicine should not be broken or chewed.

Side Effects

What are the evils that can cause me?

The most frequent adverse reactions (approximately 4% of patients) affect the gastrointestinal system and are: dyspepsia (pain or discomfort in the upper abdominal region, nausea, vomiting, epigastralgia (pain in the epigastrium and diarrhea. It also occurs in lesions of the central nervous system with headache (headache).

The adverse reactions are less frequent (0.6% of patients) affect the cardiovascular system and is characterized by changes in blood pressure causing from mild hypotension (low blood pressure) until rarely to shock (disability intake blood). In the case of shock, to interrupt the administration of citicoline and implement appropriate treatment.

Among the adverse reactions which occur rarely are: liver dysfunction (changes in the liver), anorexia (loss or absence of appetite), insomnia (inability to sleep), anxiety, agitation, convulsion (involuntary contraction of muscles), tremors, diplopia (perception of two images of a single object), allergic skin reaction, depression, and urinary incontinence (involuntary loss of urine).

in Case of allergic reaction in the skin, the treatment should be discontinued.

you can Also occur increasing feeling of paralysis local, when citicoline is administered in patients with partial paralysis, after stroke.

Tell your doctor the appearance of undesirable reactions.

Warnings and Precautions

what should I know before using?

In cases of intracranial hemorrhage, the recommended dose of 500 mg, once a day.

citicoline does not have action hipotensora lasting, but if necessary, the effect hipotensor can be treated with corticosteroids or with drugs that stimulate the sympathetic nervous system.

in the Event that the patient has the acute ischemic stroke, brain damage progressive or unconsciousness due to brain surgery, SOMAZINA should be administered in conjunction with conventional treatment for these diseases.

Effects on ability to drive vehicles or operate machinery: the effect of
SOMAZINA in the ability to drive or operate machinery have not been studied, however, considering the characteristics of the medicine, are not expected to have significant effects on the ability to drive or operate machinery.

do Not use this medicine without the knowledge of your doctor. It can be dangerous to your health.

the Elderly: doses should be individualized according to medical criterion, not having recommendations of dosages and differentiated for adults and the elderly.

Pregnancy: not yet established the safe use of SOMAZINA (citicoline) during pregnancy.

there are No studies with SOMAZINA in animals and pregnant women. In these cases, the medicine should only be used with medical advice and if the potential benefits justify the potential risks to the fetus.

Lactation: the safe use of SOMAZINA during lactation has not been established.

it is Not known whether the citicoline is excreted in human milk, therefore it is recommended that the SOMAZINA is not used if you are breastfeeding.

Overdose

what to do if someone use a larger amount than is recommended?

Not expected, in cases of overdose, the onset of signs of intoxication due to the low toxicity of the drug. In cases of accidental ingestion, if necessary, to institute symptomatic therapy.