Symptomatic treatment of spasms of the digestive tract, the biliary tract, urinary tract and the genitals: galkolieken, colic, spastic colon, esophagus spasms, stomach spasms, spasms with diarrhea or gastroenteritis.
Qualitative and quantitative composition:
Buscopan 10 mg coated tablets: a coated tablet contains 10 mg butylhyoscine bromide.
Buscopan 10 mg suppositories: a suppository containing 10 mg butylhyoscine bromide.
Buscopan 20 mg / 1 ml solution for injection: 1 ml solution for injection contains 20 mg butylhyoscine bromide.
For excipients, see List of excipients.
Solution for injection.
Posology and method of administration:
Adults and children over 6 years.
coated tablets: 1 – 2 tablets, 3 to 5 times a day, to swallow a little water.
Suppository: 1 to 2 suppositories, 3 to 5 times a day.
Solution for Injection : 1 ampoule sc, im or iv, may be repeated several times a day.
Children younger than 6 years: 1 mg/kg/24 hours.
Buscopan is contraindicated in children younger than 1 years.
In any route in adults and adolescents should not exceed 100 mg/24 hours are given to children and never more than 1.5 mg / kg body weight / 24 hours.
not administer more than 7 days without medical advice.
Because the risk of drug intestinal atony, prolonged use is contraindicated.
Clinical experience has shown that no special dosage required in renal failure .
This is a medicine, no prolonged use without medical advice, keep away from children, read the leaflet carefully. Ask your doctor or pharmacist. In case of side effects, contact your doctor.
Prostaatadenoom, prostatic with urinary retention, untreated closed-angle glaucoma, pylorobulbaire stenosis, intestinal atony, tachycardia, mechanical gastrointestinal obstruction, myasthenia gravis, megacolon and sensitivity to N-butylhyoscine or any of the ingredients.
Buscopan is contraindicated in children younger than 1 ; years.
Special warnings and precautions for use:
It is essential that treatment be limited duration and in function of the symptoms to consult a doctor: – increased body temperature associated with abdominal pain – associated urinary disorders: pollakiuria, dysuria, mictalgie, lumbar pain.
The treatment should last no longer than the symptomatic period, to avoid drug intestinal atony.
Caution required in patients with intestinal or urinary obstructions easily show and in patients with an irregular heart rhythm.
Buscopan is not recommended to submit to gastro-oesophageal (gastro-esophageal) reflux.
In children younger than 6 years is recommended for the treatment of abdominal pain of unknown cause, directly consult a doctor first and not to set their own treatment.
Administration of anticholinergics, such as Buscopan, to patients with closed-angle glaucoma (diagnosis made, not treated) can lead to an increase in intraocular pressure. One must be careful in older persons. If so, after administration of Busopan, finds pain associated with redness of the eye and vision loss, it is necessary to consult an ophthalmologist.
We must ensure that an intravenous injection slowly happening.
Pregnancy and lactation:
Buscopan was already used by some women during pregnancy or sexually mature age. Never was considered a direct or indirect effects on the fetus reported. However, it is better this medicine during pregnancy, and especially during the first 3 months, except where their use is strictly necessary. Although no neonatal adverse effects were identified, the safety of the use of Buscopan never shown during the lactation period.
Like all anticholinergics, Buscopan may inhibit lactation.
anticholinergic side effects may occur, such as mouth dryness (xerostomia), inhibition of zweetsecretie (dyshidrose), visual accommodation disturbances, arrhythmia (eg tachycardia), vertigo, delay intestinal transit and urinary retention.
These events are usually little pronounced and transient. Rare cases of hypersensitivity reactions were reported: pruritus, rash, urticaria, angioedema, dyspnoea.
Was rarely observed sudden drop in blood pressure and exceptional anaphylactic reactions and anaphylactic shock. Sometimes pain also found t.h.v. the injection site, particularly after an intramuscular injection.
Effects on ability to drive and use machines:
One must take into account any visual accommodation disturbances.
Buscopan induce, in overdosage, peripheral anticholinergic symptoms such as urinary retention, dry mucous membranes, reddening of the skin, inhibition of gastrointestinal motility, transient visual disturbances, drowsiness, tachycardia, mydriasis.
In poisoning by oral ingestion of an overdose, gastric lavage is recommended only with activated carbon, and then with a solution to 15% magnesium sulfate. Symptoms of overdose Buscopan respond parasympathomimetics. In very severe cases may be useful neostigmine (adults: 0.5 to 2.5 mg im or iv, repeated if necessary after 1 to 2 hours). In glaucoma patients, treatment with a collyrium with pilocarpine needed.
The cardiovascular complications should be treated according to the usual therapeutic methods. In respiratory paralysis: intubation and artificial respiration. In urinary retention, placing a catheter needed.
Hospitalization appears to be necessary only when symptoms of atropine intoxication, such as: increasing excitement with extreme anxiety, confusion and disorientation. So far, such symptoms have not been described in intoxication caused by quaternary ammonium derivatives such butylhyoscine.
List of excipients:
coated tablets : Calcium hydrogen phosphate anhydrous – Maize – Soluble starch – Colloidal anhydrous – Tartaric acid – stearic acid – povidone – Sucrose – Talk – Arabic gum – Titanium Dioxide – Macrogol – Carnauba wax – white beeswax.
Suppositories : Hard fat – Purified water.
Solution for injection : Sodium chloride – Water for injection.
Interaction with other medicinal products and other forms of interaction:
The anticholinergic effects of some drugs, including tricyclic antidepressants, the antihistamines, quinidine, disopyramide and amantadine, which can enhance and Buscopan reversed.
His influence on the maagdarmmotiliteit, Buscopan may affect the absorption of some medicines. In practice, however, was no interaction signifikante shown.
Concomitant use of dopaminergic antagonists such as metoclopramide, cisapride, and domperidone alizapride, the effects of these products to reduce the gastrointestinal tract.
Buscopan may also cause the tachycardia using beta-mimetics increase.