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Therapeutic Category
- GASTROINTESTINAL DRUGS
- ANTISPASMODIC DRUGS AND ANTIEMETICS
- Pharmaceutical Form : Syrup
- Composition : Hyoscine Butylbromide 5 mg / 5 mL
- Active Substance : Hyoscine Butylbromide
PHARMACOLOGICAL ACTION:
Hyoscine butylbromide is a Quaternary ammonium derivative that acts at the parasympathetic ganglia in the walls of the viscera, where it exerts a specific antispasmodic action on the smooth muscle of the gastro-intestinal, biliary and urinary tracts.
INDICATIONS:
BUSCOMED Syrup is used in the treatment of conditions associated with gastro-intestinal spasm.
CONTRA-INDICATIONS:
BUSCOMED syrup should not be used in patients with:
– Myasthenia gravis
– Closed-angle glaucoma
– Narrow angle between the iris and the cornea
– With a high ambient temperature, especially in children
– porphyria
BUSCOMED syrup should not be used in patients who have experienced prior hypersensitivity to Hyoscine butylbromide.
– Intestinal obstruction or ileus.
WARNINGS:
Do not exceed the prescribed dose.
INTERACTIONS:
The effects of BUSCOMED Syrup may be enhanced by the concomitant administration of other medicines with antimuscarinic properties, such as amantadine, some antihistamines, butyrophenones, phenothiazines and tricyclic antidepressants. The absorption of other medicines may also be affected due to the reduction in gastric motility.
PREGNANCY AND LACTATION:
BUSCOMED syrup should not be used during Pregnancy and Lactation.
DOSAGE AND DIRECTIONS FOR USE:
- Babies older than 1 month up to 3 months: 2,5 ml three times daily.
– Infants older than 3 months up to a year: 2,5 – 5 ml three times daily.
– Children older than 1 year up to 3 years: 5 – 10 ml three times daily.
– Children older than 3 years up to 6 years: 10 ml three times daily.
– Children older than 6 years up to 12 years: 10 – 20 ml three times daily.
– Children older than 12 years and adults: 20 ml four times daily.
– The initial dose must be the lowest recommended for age.
SIDE EFFECTS AND SPECIAL PRECAUTIONS:
SIDE EFFECTS:
-General Disorders:
- Dryness of the mouth
- Difficulty in swallowing and talking
- Thirst
-Cardiac Disorders:
- Transient bradycardia
- Tachycardia
- Palpitations
- Arrhythmias
-Disorders of the eye:
- Dilatation of the pupils
- Loss in accommodation and photophobia
-Respiratory Disorders:
- reduced bronchial secretions
-Gastrointestinal Disorders:
- Reduction in the tone and motility of the gastrointestinal tract leading to constipation.
-Skin Disorders:
- Flushing and dryness of the skin
-Renal and Urinary Disorders:
- Difficulty in micturation
SPECIAL PRECAUTIONS:
-General Disorders:
- Fever
-Cardiac Disorders:
- Tachycardia
- Myocardial infarction
-Gastrointestinal Disorders:
- Paralytic ileus
- Pyloric stenosis
- Ulcerative colitis
- exacerbate reflux
- Diarrhea
-Renal and Urinary Disorders:
- Prostatic enlargement
- impaired kidney function
-Disorders of Metabolism:
- impaired metabolic function
-Vascular Disorders:
- Hypertension
-Hepato – biliary Disorders:
- Impaired liver function
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
In toxic doses Anticholinergic effects predominate. These include tachycardia, hyperpyrexia, restlessness, confusion, excitement, hallucinations and delirium. A flushing of the face and upper trunk may be a prominent feature.
Overdose may cause postural hypotension. Toxic doses may cause non-depolarizing neuromuscular block.
Treatment is symptomatic and supportive.
STORAGE INSTRUCTIONS:
-Store below 25°C. Protect from light.
-Keep well closed.
-keep out of reach of children
PRESENTATION:
100 ml amber glass bottle.