Hyospasmol Syrup 5 ml SYRUP

For the treatment of conditions associated with gastrointestinal spasm.

The initial dose must be the lowest recommended for the age group. Do not exceed the maximum recommended dose for each age group. Take 30 minutes to 1 hour before meals in order to maximise absorption.

• Babies older than 1 month up to 3 months: 2,5 ml (half a medicine measure) three times daily
• Infants older than 3 months up to 1 year: 2,5 ml to 5 ml (half to one medicine measure) three times daily
• Children older than 1 year up to 3 years: 5 ml to 10 ml (one to two medicine measures) three times daily
• Children older than 3 years up to 6 years: 10 ml (two medicine measures) three times daily
• Children older than 6 years up to 12 years: 10 ml to 20 ml (two to four medicine measures) three times daily
• Children older than 12 years and adults: 20 ml (four medicine measures) four times daily

HYOSPASMOL SYRUP is contraindicated in patients with:

• A known hypersensitivity to hyoscine-N-butylbromide
• Closed angle glaucoma or patients with a narrow angle between the iris and cornea
• Myasthenia gravis
• Porphyria
• Fever
• Tachycardia
• Megacolon
• Paralytic ileus, pyloric stenosis and other mechanical stenosis/obstruction of the gastrointestinal tract

HYOSPASMOL SYRUP is contraindicated in pregnancy and lactation.

• The sedative effect of HYOSPASMOL SYRUP may be enhanced by alcohol or other central nervous system depressants.
• When given to patients, especially children, where the environmental temperature is high, there is a risk of rapid increase in body temperature due to suppression of sweat gland activity.
• Infants with Downu2019s syndrome, and children with spastic paralysis or brain damage may show an increased response to anticholinergics, thus increasing the potential for side effects.
• Geriatric or debilitated patients may respond to usual doses of anticholinergics with excitement, agitation, drowsiness, or confusion.
• Caution is advised in patients with impaired metabolic, liver or kidney function, as adverse central nervous system effects may be more likely in these patients.
• Needs to be used with caution in patients with, or at risk of urinary retention, including those with prostatic enlargement.
• Use with caution in conditions characterised by tachycardia such as thyrotoxicosis, heart failure, and in cardiac surgery, where they may further accelerate heart rate.
• Care is required in patients with acute myocardial infarction, as ischaemia and infarction may be made worse, and in patients with hypertension.

• The effects of HYOSPASMOL SYRUP may be enhanced by the concomitant administration of the other medicines with antimuscarinic properties, such as amantadine, some antihistamines, phenothiazine antipsychotics and tricyclic antidepressants.
• Inhibition of medicine-metabolising enzymes by monoamine oxidase inhibitors may possibly enhance the effects of HYOSPASMOL SYRUP.
• The reduction in gastric motility caused by HYOSPASMOL SYRUP may affect the absorption of other medicines.
• HYOSPASMOL SYRUP and parasympathomimetics may counteract each otheru2019s effects.
• Concomitant treatment with dopamine antagonists, e.g. metoclopramide, may enhance the reduction of motility of the gastrointestinal tract caused by HYOSPASMOL SYRUP.
• HYOSPASMOL SYRUP may enhance tachycardia caused by beta adrenergic medicines.

The safety of HYOSPASMOL SYRUP in pregnancy and lactation has not been established. HYOSPASMOL SYRUP is contraindicated in pregnancy and lactation (see CONTRAINDICATIONS).

The sedative effect of HYOSPASMOL SYRUP may be enhanced by alcohol or other central nervous system depressants.

Gastrointestinal disorders

• Frequent: Reduction in tone and motility of the gastrointestinal tract leading to constipation
• Less frequent: Vomiting may occur occasionally

Eye disorders

• Less frequent: Dilatation of the pupils with loss of accommodation and photophobia

Cardiac disorders

• Frequency unknown: Transient bradycardia followed by tachycardia, with palpitations and dysrhythmias

Renal and urinary disorders

• Less frequent: Difficulty in micturition

Respiratory, thoracic and mediastinal disorders

• Frequency unknown: Reduced bronchial secretions

Skin and subcutaneous tissue disorders

• Frequent: Flushing and dryness of the skin

Endocrine disorders

• Frequent: Dyshidrosis

General disorders

• Frequent: Dryness of mouth with difficulty in swallowing and talking, thirst
• Frequency unknown: Hypersensitivity reactions, particularly skin reactions

Symptoms

In overdosage, the peripheral effects become more pronounced and other symptoms such as hyperthermia, hypertension, increased respiratory rate, and nausea and vomiting may occur. A rash may appear on the face or upper trunk. Toxic doses also cause CNS stimulation marked by restlessness, confusion, excitement, ataxia, incoordination, paranoid and psychotic reactions, hallucinations and delirium, and occasionally seizures. However, in severe intoxication, central stimulation may give way to CNS depression, coma, circulatory and respiratory failure and death.

Treatment

In cases of overdosage, the stomach should be emptied. Activated charcoal has been suggested to reduce absorption. Supportive therapy should be given as required.