HYOSPASMOL SYRUP is indicated for the treatment of conditions associated with gastrointestinal spasm.
1. What HYOSPASMOL SYRUP is and what it is used for.
2. What you need to know before you take/use HYOSPASMOL SYRUP.
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.
Warnings and special precautions
- 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 Down’s 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.
3. How to take/use HYOSPASMOL SYRUP.
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
4. Possible side effects.
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
5. How to store HYOSPASMOL SYRUP.
Store at or below 25 °C in a well-closed container. Protect from light. Keep in original packaging until required for use. KEEP OUT OF REACH OF CHILDREN.