SCOPALIN
Tablets

Antispasmodic drugs and antiemetic

  • Chemical Composition

    Hyocine butylbromide 10 mg

  • Packing

    20Coated Tablets

  • Medical Id

    T71

  • License Number

    206/2009

  • License date

    28/6/2009

Mechanism Of Action SCOPALIN tablets exert a spasmolytic action on the smooth muscle of the gastrointestinal, biliary and genito-urinary tracts. Peripheral anticholinergic action results from a ganglion-blocking action within the visceral wall as well as from inhibiting the muscarinic receptors..
INDICATIONS SCOPALIN is used for: -Abdominal pain associated with menstrual periods -Abdominal pain caused by painful spasms in the muscles of the stomach or bladder regions (colic) -Irritable Bowel Syndrome
CONTRAINDICATIONS SCOPALIN tablets should not be administered to patients with myasthenia gravis, megacolon and glaucoma. In addition, they should not be given to patients with a known sensitivity to Hyoscine-N-butylbromide or any other component of the product.
Side EFFECTS Constipation, dry mouth, trouble urinating, or nausea could occur. If these continue or are bothersome, notify your doctor promptly. The effects that may occur rarely include rash, itching, trouble breathing, tachycardia, dizziness, diarrhea, vision problems, and eye pain.
WARNINGS Scopalin Tablets should be used with caution in conditions characterised by tachycardia such as thyrotoxicosis, cardiac insufficiency or failure and in cardiac surgery where it may further accelerate the heart rate. Due to the risk of anticholinergic complications, caution should be used in patients susceptible to intestinal or urinary outlet obstructions. Because of the possibility that anticholinergics may reduce sweating, Scopalin should be administered with caution to patients with pyrexia. Elevation of intraocular pressure may be produced by the administration of anticholinergic agents, such as Hyoscine-N-Butylbromide, in patients with undiagnosed and therefore untreated narrow angle glaucoma. Therefore, patients should seek urgent ophthalmological advice in case they should develop a painful, red eye with loss of vision whilst or after taking Scopalin. Caution is advised when this drug is used in the elderly. Because of possible visual accommodation disturbances patients should not drive or operate machinery if affected.
DRUG INTERACTIONS The anticholinergic effect of other drugs, for example tricyclic antidepressants, antihistamines, quinidine, amantadine, butyrophenones, phenothiazines and disopyramide may be intensified by SCOPALIN tablets. Concomitant treatment with dopamine antagonists such as metoclopramide may result in diminution of the effects of both drugs on the gastrointestinal tract. Dosage & Administration: Adults and Children 12 years or over: The recommended starting dose is 1 tablet three times daily; this can be increased up to 2 tablets four times daily if necessary. Overdosage & Treatment: In the case of overdosage, anticholinergic effects such as urinary retention, dry mouth, reddening of the skin, tachycardia, inhibition of gastrointestinal motility and transient visual disturbances may occur. In the case of oral poisoning, gastric lavage with medicinal charcoal should be followed by magnesium sulphate (15%). Symptoms of Hyocine butylbromide overdosage respond to parasympathomimetics. For patients with glaucoma, pilocarpine should be given locally. Cardiovascular complications should be treated according to usual therapeutic principles. In case of respiratory paralysis, intubation and artificial respiration may be used. Catheterisation may be required for urinary retention. In addition, appropriate supportive measures should be administered as required.
Pregnancy And lactations Long experience has shown no evidence of ill effects during human pregnancy. However, the usual precautions regarding the use of drugs at this time, especially during the first trimester, should be observed. Safety during lactation has not yet been established, however, adverse effects on the new born have not been reported.
Dosage And Administration Adults and Children 12 years or over: The recommended starting dose is 1 tablet three times daily; this can be increased up to 2 tablets four times daily if necessary.
OVERDOSE : In the case of overdosage, anticholinergic effects such as urinary retention, dry mouth, reddening of the skin, tachycardia, inhibition of gastrointestinal motility and transient visual disturbances may occur. In the case of oral poisoning, gastric lavage with medicinal charcoal should be followed by magnesium sulphate (15%). Symptoms of Hyocine butylbromide overdosage respond to parasympathomimetics. For patients with glaucoma, pilocarpine should be given locally. Cardiovascular complications should be treated according to usual therapeutic principles. In case of respiratory paralysis, intubation and artificial respiration may be used. Catheterisation may be required for urinary retention. In addition, appropriate supportive measures should be administered as required.
Storage Conditions Store below 25 C” “Keep out of reach of children”