ANTISPASMINA COLICA 30CPR RIV

ANTISPASMINA COLICA EXTERNAL REQUIREMENTS

active ingredients

Antispasmin Colica Each coated tablet contains 10 mg of papaverin hydrochloride (equal to 9,016 mg of papaverin) and 10 mg of belladonna extract 1% josciamina Eccipienti with known effects: Each tablet contains 75 mg of lactose and 42.8 mg of sucrose and 0.2 mg of castor oil Antispasmin Colica Forte Each coated tablet contains 50 mg of papaverin hydrochloride (equal to 45.08 mg of papaverin) and 10 mg of belladonna extract 1% josciamina Eccipienti with known effects: Each tablet contains 49 mg of lactose and 67.8 mg of sucrose and 0.3 mg of castor oil For the complete list of excipients, see paragraph 6.1.

Excellent

Antispamine Colica Lactose, corn starch, povidone, magnesium stearate, silica precipitate, lacquer gum, castor oil, cellulose acetoftalate, diethylphalate, magnesium carbonate, talc, vegetable coal, arabic rubber, sucrose. Antispamine ColicaForte Lactose, corn starch, povidone, magnesium stearate, silica precipitate, lacquer gum, castor oil, cellulose acetoftalate, diethylphalate, magnesium carbonate, talc, vegetable coal, arabic rubber, sucrose.

Therapeutic indications

Syntomatic treatment in spastic–dolorose manifestations of the gastro-enteric apparatus.

Contraindications

Hypersensitivity to active ingredients, to any of the excipients listed in paragraph 6.1. or other substances closely related to chemical; in particular towards atropine, methyl homatropin, purposelamine, drotaverin, moxaverine. Children under 12. Pregnancy and nursing. Glaucoma, pyloric stenosis, prostate hypertrophy and other stenosant diseases of the urinary tract; paralytical ileum and obstructive pathologies of the gastrointestinal apparatus; intestinal atonia of the elderly and debilitated subjects; ulcerative colitis, toxic megacolons, severe myasthenia. In patients with turbes of the autonomic nervous system, in carriers of hepato-renal affections, of hyperthyroidism, of coronaropathy, in cardiac tachyrhythmias, in arterial hypertension and in congestive heart failure, contemporary intake of sulfamidics and beta blockers (see paragraph 4.5), intake of medicines belonging to different therapeutic groups but equipped with anti-inflammatory action.

Population

Antispasmine Colica: 2 to 6 tablets per day Antispasmina Colica Forte: from 1 to 3 tablets daily Do not exceed the recommended doses Tablets must be swallowed before meals or at the time of need, and must be swallowed whole because they must be intact in the intestine, where they carry out their action at the level of spasm. In case of diarrhea or hypermotility of the intestine, tablets may, exceptionally, be expelled whole; in this case it is advisable, at least for a few days, to ingest the tablets after having fragmented them. Antispasmine Colica is contraindicated in children (see paragraph 4.3).

Conservation

This medicine does not require any special condition of conservation.

Warnings

After a short period of treatment without appreciable results, consult your doctor. Preparations containing anticholinergics must be used only in case of actual need and under direct control of the doctor in the elderly. The effects of these compounds are accentuated by the simultaneous administration of substances belonging to different therapeutic groups but endowed with anti-linergical action such as antihistamines, butirrophenons, phenotiazines, antidepressants, amantadine, which therefore should not be taken simultaneously. Also should not be assumed at the same time sulfamidic and beta blockers; the appearance of secondary manifestations requires suspension of therapy. The medicinal product contains sucrose and lactose, which is taken into account in the case of diabetes or hypocaloric diets. Antispasmine Colica contains sucrose therefore patients suffering from rare hereditary problems of fructose intolerance, from glucose–galactose mal absorption, or from insufficiency of isomaltase sucrasis should not take this medicine; moreover, the medicinal product contains lactose, so patients with rare hereditary problems of galactose intolerance, from lactase deficiency.

Interactions

Do not administer sulfamidic and beta blockers simultaneously. The effects of preparations containing anticholinergics are accentuated by the simultaneous administration of substances belonging to different therapeutic groups but equipped with anti-cholinergic action such as antihistamines, butirrophenons, phenotiazines, antidepressants and amantadine, which therefore should not be taken simultaneously.

Effects

Following treatment with Antispasmine Colica, the following side effects were reported:

Organic system classification according to MedDRA	Undesirable Effects (Preferred Terms)
Immune system disorders	Allergic reactions
Diseases of the nervous system	Sleep
	Vertigo
Pathologies of the eye	Conjunctive irritation
Heart disease	Tachycardia
Gastrointestinal diseases	Bucket dryness
	Nausea
	Vote
	Gastroesophageal reflux
	Stipsis
Hepatobiliary diseases	It is
Pathologies of skin and subcutaneous tissue	Orticaria
	Skin reactions
Kidney and urinary pathologies	Difficulty of urination
Systemic pathologies and conditions for administration	Retrosteral pain
Investigations	Increased intraocular pressure
	Increased liver function tests

At high doses, anticholinergics can determine urinary retention, heart arrhythmias, respiratory difficulty, agitation, state of mental confusion. Reporting of suspicious adverse reactions The reporting of suspicious adverse reactions occurring 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 www.agenziafarmaco.gov.it/it/responsabili

Overdosing

In case of overdose, consult your doctor immediately. At high doses anticholinergics can determine urinary retention, heart arrhythmias, respiratory difficulty, agitation, state of mental confusion. As in all cases of overdose, the treatment must be symptomatic, adopting generic support measures. A specific antidote is not known.

Antispasmine Colica is contraindicated in pregnancy and during nursing (see paragraph 4.3).

Source: Farmadati