BUSCOPAN 30CPR RIV 10MG

BUSCOPAN 10 MG

active ingredients

Covered tablets A coated tablet contains: N-butylbromide of joxin 10 mg. Excipients: sucrose. Supposes A suppository contains: Jacquain n-butylbromide 10 mg. For the full list of excipients see paragraph 6.1.

Excellent

Covered tablets: Nucleus: hydrogenphosphate calcium, corn starch, soluble starch, anidra colloidal silica, tartaric acid, stearic acid. Coating: povidone, sucrose, talc, arabic rubber, titanium dioxide (E171), macrogol 6000, carnauba wax, white wax. Supposes: solid semisynthetic glycerides.

Therapeutic indications

Syntomatic treatment of spastic-dolorose manifestations of the gastroenteric tract.

Contraindications

- Hypersensitivity to the active ingredient or any of the excipients. - Glaucoma at acute angle. - Prostate hypertrophy or other causes of urinary retention. - Piloric stenosis and other conditions stenosant the gastroenteric channel. - Mechanical stenosis of the gastroenteric tract. - Paralytical or obstructive. - Megacolon. - ulcerative elite. - Reflux exophagi. - Elder's intestinal Atonia and debilitated subjects. - Mistress. - Children under the age of 6. In case of rare hereditary conditions of incompatibility with one of the excipients (see paragraph 4.4 "Special warnings and precautions of use") the use of the medicinal product is contraindicated.

Population

Population The following dosages are recommended for adults and children over the age of 14. Covered tablets 1-2 tablets coated 3 times a day. Supposes 1 supposes 3 times a day. Individual doses can be increased according to the doctor's judgment. In pediatrics in children aged between 6 and 14 years, you should follow the doctor's prescription exactly. Method of administration Tablets should be taken whole with an adequate amount of water. Buscopan should not be taken daily on a regular basis or for prolonged periods without seeking the cause of abdominal pain.

Conservation

Covered tablets: this medicinal product does not require any special conservation conditions. Supposes: do not store at temperature above 30 °C.

Warnings

In the presence of intense abdominal pain of which the cause is not known, which persists or worse, or manifests itself along with other symptoms such as fever, nausea, vomiting, alterations in the bowel movement, abdominal sensitivity, decreased blood pressure, fainting or blood in the feces, it is necessary to immediately address to the doctor. Anticholinergics must be used with prudence in the elderly, in patients with autonomous nervous system turbes, heart tachyritmies, arterial hypertension, congestive heart failure, hyperthyroidism and carriers of liver and kidney affections. Due to the potential risk of complications related to excessive anticolinergic effect, attention should be paid to patients subject to acute angle glaucoma as well as in patients susceptible to intestinal and urinary stasis and in those prone to tachiarithmia. Anticholinergics can prolong gastric emptying time and determine anthropo stasis. Due to the possibility that anticholinergics can reduce sweating, Buscopan must be administered carefully in patients with pyrexia. Treatment with high doses should not be abruptly interrupted. Minor side effects can be controlled by properly reducing the dose; the appearance of important secondary manifestations requires the interruption of therapy. A 10 mg coated tablet contains 41.2 mg of sucrose equal to 247.2 mg per recommended daily maximum dose. Therefore, patients with rare hereditary problems of fructose intolerance should not take this medicine.

Interactions

The anti-linergical effect of drugs such as tri- and tetracyclic antidepressants, phenotiazine, butirrofenoni, anti-istamines, antipsychotics, kinidine, amantadine, diisopiramide and other anti-linergics (e.g. thiotrope, ipratrope and atropin-like compounds) can be accentuated by Buscopan. Concurrent treatment with dopamine antagonists, such as metoclopramide, can lead to a reduction in the effect of both drugs on the gastro-intestinal tract. Tachycardia induced by β-adrenergic drugs can be accentuated by Buscopan. Do not take alcohol during therapy. Because antacids can reduce the intestinal absorption of anti-linergics, these drugs should not be administered simultaneously.

Effects

Many of the undesirable effects listed may be attributed to the anti-linergical properties of the Buscopan. The secondary anticholinergic effects of Buscopan are generally mild and self-limiting. Immune system disorders: Uncommon frequency: skin reactions, hives, itching. Frequency not known*: anaphylactic shock, anaphylactic reactions, dispnea, skin rash, erythema and other manifestations of hypersensitivity. *These adverse reactions were observed in the post-marketing experience. At 95% probability, the frequency category is not greater than non-common (3/1368), but may be lower. A precise frequency estimate is not possible since these adverse reactions did not occur in 1368 patients in clinical trial. Heart disease: Uncommon frequency: tachycardia. Gastrointestinal diseases: Uncommon frequency: dry mouth. Stypsis was also observed. Pathologies of skin and subcutaneous tissue: Uncommon frequency: alterations of sweating. Kidney and urinary pathologies: Rare frequency: urinary retention. The following side effects were also observed: Pathologies of the eye: midriasis, turbe of mating, increase of eye tone. Diseases of the nervous systemdrowsiness. High doses can determine signs of central stimulation and more serious signs of interference with the nervous system, state of consciousness and cardiorespiratory function. Reporting of suspicious adverse reactions The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction via the national reporting system at the address https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse

Overdosing

Synonyms In case of overdose, anticholinergic effects could occur (such as urinary retention, dry mouth, skin redness, tachycardia, gastrointestinal motility inhibition and transient visual disorders). Therapy If necessary administer parasimpaticomimetic drugs. In case of glaucoma it is necessary to address urgently to a specialist in ophthalmology. Cardiovascular complications must be treated according to the usual therapeutic principles. In case of respiratory paralysis: evaluate the opportunity to resort to intubation, artificial breathing. In case of orthostatic hypotension, it is sufficient that the patient relaxes. For urinary retention cateterization may be necessary. In addition, appropriate support therapies must be undertaken if necessary.

Limited data on the use of N-butylbromide in pregnant women are available. Animal studies show no direct or indirect harmful effects of reproductive toxicity (see paragraph 5.3). There is no sufficient 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 nursing. No studies have been conducted on the effects on human fertility (see paragraph 5.3).

Source: Farmadati