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Spasmocin ampoules

Composition:-
Each ampoule contains:
Hyoscine - N - butyl bromide 20 mg

Properties:-
Spasmocin is an antispasmodic drug which relaxes the smooth muscle of the gastrointestinal, biliary and urinary tracts.

Indications & Usage:-
Spasmocin ampoules are indicated:
- For relief of acute genitourinary or gastrointestinal spasm (e.g. renal or biliary colic).
- To produce smooth muscle relaxation prior to radiological procedures such as pyelography.

Contraindications:-
Spasmocin ampoules are contraindicated in patients with:
- Hypersensitivity to hyoscine or atropinics or to any of the product excepients.
- Myasthenia gravis, glaucoma, prostatic hypertrophy with urinary retention, stenotic lesions of the gastrointestinal tract, tachycardia, angina, cardiac failure and megacolon.

Side effects:-
Some of the following side effects may occur in some cases:-
Dry mouth, visual accommodation disturbances, tachycardia, dyspnea and urinary retention.

Warnings & Precautions:-
- Cases of anaphylaxis, including episodes of shock are observed, so patients receiving Spasmocin ampoules should be kept under observation.
- Patients should be cautioned about potential visual problems and the need to exercise care while driving or operating machinery after receiving Spasmocin ampoules.
- Due care is necessary while receiving Spasmocin ampoules in patients with cardiac disease.
- Exercise caution in patients with reflux oesophagitis or gastrointestinal tract obstructive disease due to the ability of Spasmocin to decrease smooth muscle motility and tone.

Pregnancy:-
The usual precautions regarding the use of drugs during pregnancy, especially during the first trimester, should be observed.

Lactation:-
The benefits of Spasmocin use during lactation should be weighed against possible effects on the infant.

Drug interactions:-
- Tricyclic antidepressants, antihistamines, quinidine, amantadine and disopyramide can potentiate the effect of Spasmocin.
- Concurrent use of Spasmocin with MAO inhibitors may intensify the side effects of Spasmocin.
- Concomitant treatment with dopamine antagonists such as metoclopramide may result in diminution of the effects of both drugs on the gastrointestinal tract.
- The tachycardiac effects of ß-adrenergic agents may be enhanced by Spasmocin.

Dosage & administration:-

½ to 1 ampoule IM or SC or IV at an injection rate of 1 ml/min.
The maximum dose should not exceed 5 ampoules.
Spasmocin ampoules may be used IM 10 to 15 minutes before radiological examinations of the stomach to slow peristaltic movements.

Therapeutic category: Antispasmodic.

Legal category: POM.

Package: Box containing 6 ampoules each 1 ml.
                Box containing 100 ampoules each of 1 ml.
 
Storage: Store at a temperature below 30° C, protect from light.
 

THIS IS A MEDICAMENT
Medicament is a product, which affects your health and its consumption contrary to instructions is dangerous for you. Follow strictly the doctor’s prescription, the method of use and the instructions of the pharmacist who sold the medicament.
- The doctor and the pharmacist are the experts in medicines, their benefits and risks.
- Do not by yourself interrupt the period of treatment prescribed.
- Do not repeat the same prescription without consulting your doctor.
- Keep all medicaments out of reach of children.

Council of Arab Health Ministers, Union of Arab Pharmacists.