Buscopan 10mg Joscina N-butylbromide Antispasmodic 6 Suppositories

Suppositories based on hyoscine N-butylbromide.

Therapeutic indications

Buscopan Suppositories is used in the symptomatic treatment of spastic and painful manifestations of the gastrointestinal and genitourinary tract.

Dosage and Posology

The drug should be taken according to the following doses and methods. The following dosages are recommended for adults and children over 14 years of age: 1 suppository 3 times a day. Single doses can be increased according to the physician's judgment. In pediatrics in children between the ages of 6 and 14, the doctor's prescription must be followed exactly.

Buscopan should not be taken daily on a regular basis or for prolonged periods without looking for the cause of the abdominal pain.

Overdose

Anticholinergic effects (such as urinary retention, dry mouth, redness of the skin, tachycardia, inhibition of gastrointestinal motility and transient visual disturbances) may occur in the event of overdose.

If necessary, administer parasympathomimetic drugs. In case of glaucoma it is necessary to urgently consult an ophthalmology specialist. Cardiovascular complications must be treated according to the usual therapeutic principles. In case of respiratory paralysis: evaluate the opportunity to resort to intubation, artificial respiration. In case of orthostatic hypotension, it is sufficient for the patient to lie down. Catheterization may be required for urinary retention. In addition, if necessary, appropriate supportive care should be undertaken.

Contraindications

• Hypersensitivity to the active substance or to any of the excipients
• Acute angle glaucoma
• Prostatic hypertrophy or other causes of urinary retention
• Pyloric stenosis and other conditions stenosing the gastrointestinal canal
• Paralytic ileus, ulcerative colitis, megacolon
• Reflux esophagitis
• Intestinal atony of the elderly and debilitated subjects
• Myasthenia gravis
• Children under the age of 6
• In case of rare hereditary conditions of incompatibility with one of the excipients, the use of the medicinal product is contraindicated.

Side effects

Many of the listed side effects can be attributed to the anticholinergic properties of Buscopan Suppositories. The anticholinergic side effects of Buscopan Suppositories are generally mild and self-limiting:

- Immune system disorders:

• Frequency uncommon: skin reactions, urticaria, pruritus.
• Frequency not known *: anaphylactic shock, anaphylactic reactions, dyspnoea, skin rash, erythema and other manifestations of hypersensitivity. * These adverse reactions have been observed in post-marketing experience. 95% likely, the frequency category is not greater than uncommon (3/1368), but it could be lower. A precise estimate of the frequency is not possible as these adverse reactions did not occur in 1368 patients in clinical trials.

- Cardiac disorders:

• Uncommon frequency: tachycardia.

- Gastrointestinal disorders:

• Uncommon frequency: dry mouth. Constipation has also been observed.

- Skin and subcutaneous tissue disorders:

• Uncommon frequency: changes in sweating.

- Renal and urinary disorders:

• Frequency rare: urinary retention.

The following side effects have also been observed:

• Eye disorders: mydriasis, accommodation disturbances, increased ocular tone.
• Nervous system disorders: drowsiness.

High doses can lead to signs of central stimulation and more serious signs of interference with the nervous system, state of consciousness and cardiorespiratory function.

Pregnancy and breastfeeding

There are limited data from the use of hyoscine N-butylbromide in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. There is insufficient information on the excretion of Buscopan and its metabolites in human milk. As a precautionary measure, it is preferable to avoid the use of Buscopan during pregnancy and breastfeeding. Studies on the effects on human fertility have not been conducted.

Special warnings

If you have severe abdominal pain of which the cause is not known, which persists or worsens, or which occurs in conjunction with other symptoms such as fever, nausea, vomiting, changes in bowel movement, abdominal tenderness, decreased blood pressure, fainting or blood in the feces, you need to seek immediate medical attention. Anticholinergics should be used with caution in the elderly, in patients with autonomic nervous system disorders, cardiac tachyarrhythmias, arterial hypertension, congestive heart failure, hyperthyroidism and in patients with liver and kidney disease. Due to the potential risk of complications related to an excessive anticholinergic effect, caution should be exercised in patients prone to acute angle glaucoma as well as in patients susceptible to intestinal and urinary stasis and in those prone to tachyarrhythmias.

Anticholinergics can prolong gastric emptying time and lead to stasis of the antrum. Due to the possibility that anticholinergics may reduce sweating, Buscopan should be administered with caution to patients with pyrexia. Treatment with high doses should not be abruptly stopped. Minor side effects can be controlled by appropriately reducing the dose; the appearance of important secondary manifestations requires the interruption of therapy. One 10 mg coated tablet contains 41.2 mg of sucrose corresponding to 247.2 mg per maximum recommended daily dose. Therefore patients with rare hereditary problems of fructose intolerance should not take this medicine.

Expiration and retention

Check the expiration date indicated on the package. The expiry date indicated on the package refers to the product in intact packaging, correctly stored. Do not store above 30 ° C.

Warning : do not use the medicine after the expiry date indicated on the package.

Composition

One Buscopan suppository contains:

Active principle

Hyoscine N-Butylbromide 10 mg

Excipients

Solid semisynthetic glycerides.