Antispasmin colic forte 50 mg + 10 mg 30 coated tablets

Antispasmina colica forte 50 mg + 10 mg 30 coated tablets is a drug specifically formulated for the symptomatic treatment of spastic-painful manifestations of the gastrointestinal tract . Thanks to the combination of papaverine hydrochloride (50 mg) and belladonna extract 1% hyoscyamine (10 mg) per tablet, this product acts effectively against abdominal spasms , abdominal pain , stomach ache and abdominal swelling , offering rapid relief in cases of intestinal and stomach disorders.

Papaverine hydrochloride has an antispasmodic and peripheral vasodilatory action, promoting the relaxation of the smooth muscles of the digestive system, while belladonna extract helps reduce intestinal motility and calm painful contractions. This synergy makes Antispasmina colica forte an ideal solution for those suffering from abdominal colic and other spastic disorders of the gastrointestinal system.

The coated tablets are designed to ensure a targeted release of the active ingredients directly into the intestine, maximizing the effectiveness of the treatment and minimizing gastric irritation. The 30-tablet format allows for prolonged therapeutic coverage, ideal for those who need continuous support against painful and spastic symptoms.

Produced by Recordati , a leading pharmaceutical company, Antispasmina colica forte is an over-the-counter drug of proven efficacy indicated for oral use in adults. Its formulation is particularly suitable for those seeking a powerful and reliable antispasmodic for the well-being of the gastrointestinal system.

ACTIVE INGREDIENTS

Active ingredients contained in Antispasmina colica forte 50 mg + 10 mg 30 coated tablets - What is the active ingredient of Antispasmina colica forte 50 mg + 10 mg 30 coated tablets?

Antispasmina Colica Each coated tablet contains 10 mg of papaverine hydrochloride (equivalent to 9.016 mg of papaverine) and 10 mg of belladonna extract 1% hyoscyamine Excipients with known effect: Each tablet contains 75 mg of lactose and 42.8 mg of sucrose and 0.2 mg of castor oil Antispasmina Colica Forte Each coated tablet contains 50 mg of papaverine hydrochloride (equivalent to 45.08 mg of papaverine) and 10 mg of belladonna extract 1% hyoscyamine Excipients with known effect: Each tablet contains 49 mg of lactose and 67.8 mg of sucrose and 0.3 mg of castor oil For the full list of excipients, see section 6.1.

EXCIPIENTS

Composition of Antispasmina colica forte 50 mg + 10 mg 30 coated tablets - What does Antispasmina colica forte 50 mg + 10 mg 30 coated tablets contain?

Antispasmina Colica Lactose, corn starch, povidone, magnesium stearate, precipitated silica, shellac, castor oil, cellulose acetophthalate, diethyl phthalate, magnesium carbonate, talc, vegetable carbon, gum arabic, sucrose. Antispasmina ColicaForte Lactose, corn starch, povidone, magnesium stearate, precipitated silica, shellac, castor oil, cellulose acetophthalate, diethyl phthalate, magnesium carbonate, talc, vegetable carbon, gum arabic, sucrose.

DIRECTIONS

Therapeutic indications Antispasmina colica forte 50 mg + 10 mg 30 coated tablets - Why is Antispasmina colica forte 50 mg + 10 mg 30 coated tablets used? What is it used for?

Symptomatic treatment of spastic-painful manifestations of the gastrointestinal tract.

CONTRAINDICATIONS AND SIDE EFFECTS

Contraindications Antispasmina colica forte 50 mg + 10 mg 30 coated tablets - When should Antispasmina colica forte 50 mg + 10 mg 30 coated tablets not be used?

Hypersensitivity to the active substances, to any of the excipients listed in paragraph 6.1. or to other closely related substances from a chemical point of view; in particular to atropine, methyl homatropine, scopolamine, drotaverine, moxaverine. Children under 12 years. Pregnancy and breastfeeding. Glaucoma, pyloric stenosis, prostatic hypertrophy and other stenosing diseases of the urinary tract; paralytic ileus and obstructive diseases of the gastrointestinal tract; intestinal atony in the elderly and debilitated subjects; ulcerative colitis, toxic megacolon, myasthenia gravis. In patients with autonomic nervous system disorders, in patients with hepatorenal disease, hyperthyroidism, coronary heart disease, cardiac tachyarrhythmias, arterial hypertension and congestive heart failure, concomitant intake of sulphonamides and beta blockers (see paragraph 4.5), intake of medicinal products belonging to different therapeutic groups but with anticholinergic action such as antihistamines, butyrophenones, phenothiazines, tricyclic antidepressants and amantadine (see paragraph 4.5).

DOSAGE

Quantity and method of taking Antispasmina colica forte 50 mg + 10 mg 30 coated tablets - How to take Antispasmina colica forte 50 mg + 10 mg 30 coated tablets?

Antispasmina Colica: 2 to 6 tablets per day Antispasmina Colica Forte: 1 to 3 tablets per day Do not exceed the recommended doses The tablets should be swallowed before meals or when needed and should be swallowed whole because they must reach the intestine intact, where they carry out their action at the level of the spasm. In case of diarrhoea or intestinal hypermotility, the tablets may, exceptionally, be expelled whole; in this case it is advisable, at least for a few days, to swallow the tablets after having broken them up. Antispasmina Colica is contraindicated in children (see paragraph 4.3).

CONSERVATION

Storage Antispasmina colica forte 50 mg + 10 mg 30 coated tablets - How is Antispasmina colica forte 50 mg + 10 mg 30 coated tablets stored?

This medicinal product does not require any special storage conditions.

WARNINGS

Warnings Antispasmina colica forte 50 mg + 10 mg 30 coated tablets - About Antispasmina colica forte 50 mg + 10 mg 30 coated tablets it is important to know that:

After a short period of treatment without appreciable results, consult your doctor. Preparations containing anticholinergics should be used only in case of real need and under the direct supervision of a doctor in the elderly. The effects of these compounds are accentuated by the simultaneous administration of substances belonging to different therapeutic groups but with anticholinergic action such as antihistamines, butyrophenones, phenothiazines, tricyclic antidepressants, amantadine, which therefore should not be taken at the same time. Likewise, sulphonamides and beta blockers should not be taken at the same time; the appearance of secondary manifestations requires suspension of therapy. The medicine contains sucrose and lactose, this should be taken into account in case of diabetes or low-calorie diets. Antispasmina Colica contains sucrose, therefore patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltase insufficiency should not take this medicine; Furthermore, the medicine contains lactose, therefore patients with rare hereditary problems of galactose intolerance or lactase deficiency should not take it.

INTERACTIONS

Interactions Antispasmina colica forte 50 mg + 10 mg 30 coated tablets - Which medicines or foods can modify the effect of Antispasmina colica forte 50 mg + 10 mg 30 coated tablets?

Do not administer simultaneously with sulphonamides and beta blockers. The effects of preparations containing anticholinergics are accentuated by the simultaneous administration of substances belonging to different therapeutic groups but with anticholinergic action such as antihistamines, butyrophenones, phenothiazines, tricyclic antidepressants and amantadine, which therefore should not be taken simultaneously.

SIDE EFFECTS

Like all medicines, Antispasmina colica forte 50 mg + 10 mg 30 coated tablets can cause side effects - What are the side effects of Antispasmina colica forte 50 mg + 10 mg 30 coated tablets?

The following side effects have been reported following treatment with Antispasmina Colica:

MedDRA system organ classification	Side Effects (Preferred Terms)
Immune system disorders	Allergic reactions
Nervous system disorders	Drowsiness
	Vertigo
Eye pathologies	Conjunctival irritation
Heart disease	Tachycardia
Gastrointestinal disorders	Dry mouth
	Nausea
	Vomit
	Gastroesophageal reflux
	Constipation
Hepatobiliary pathologies	Jaundice
Skin and subcutaneous tissue disorders	Urticaria
	Skin reactions
Kidney and urinary disorders	Difficulty urinating
Systemic disorders and conditions related to the administration site	Retrosternal pain
Investigations	Increased intraocular pressure
	Liver function test abnormalities

At high doses, anticholinergics may cause urinary retention, cardiac arrhythmias, breathing difficulties, agitation, mental confusion. Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur after authorisation of the medicinal product is important, as it allows continuous monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili

OVERDOSE

Overdose Antispasmina colica forte 50 mg + 10 mg 30 coated tablets - What are the risks of Antispasmina colica forte 50 mg + 10 mg 30 coated tablets in case of overdose?

In case of overdose, consult a doctor immediately. At high doses, anticholinergics may cause urinary retention, cardiac arrhythmias, respiratory difficulty, agitation, and mental confusion. As in all cases of overdose, treatment should be symptomatic, with general supportive measures. There is no known specific antidote.

PREGNANCY AND BREASTFEEDING

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking Antispasmina colica forte 50 mg + 10 mg 30 coated tablets.

Antispasmina Colica is contraindicated during pregnancy and breastfeeding (see section 4.3).

DRIVING AND USE OF MACHINERY

Taking Antispasmina colica forte 50 mg + 10 mg 30 coated tablets before driving or using machines - Does Antispasmina colica forte 50 mg + 10 mg 30 coated tablets affect driving or using machines?

Antispasmina Colicacompromises the ability to drive vehicles or use machinery. Since the product can induce drowsiness, those who may drive vehicles or attend to operations that require integrity of the degree of alertness should be warned of this.