Antispasmin Colica Forte 50mg + 10mg Papaverine Belladonna 30 Tablets

WARNINGS
After a short period of treatment without noticeable results, consult your doctor. Preparations containing anticholinergics should be used only in case of real need and under direct medical supervision 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 must not be taken at the same time. Similarly, sulfonamides and beta blockers should not be taken at the same time; the appearance of secondary manifestations requires the discontinuation of therapy. The medicine contains sucrose and lactose, what 'take into account in case of diabetes or low-calorie diets. Antispasmin Colic contains sucrose therefore patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption, or sucrase isomaltase insufficiency should not take this medicine; in addition, the medicine contains lactose.
PHARMACOTHERAPEUTIC CATEGORY
Medicines for functional gastrointestinal disorders.
STORAGE
This medicine does not require any special storage conditions.
CONTRAINDICATIONS / SECONDARY EFFECT
Hypersensitivity to the active ingredients, to any of the excipients 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 old. Pregnancy and breastfeeding. Glaucoma, pyloric stenosis, prostatic hypertrophy and other stenosing diseases of the urinary tract; paralytic ileus and obstructive pathologies of the gastrointestinal system; intestinal atony of the elderly and debilitated subjects; ulcerative colitis, toxic megacolon, myasthenia gravis. In patients with autonomic nervous system disorders, carriers of hepato-renal diseases, hyperthyroidism, coronary heart disease, cardiac tachyarrhythmias, arterial hypertension and congestive heart failure, concomitant intake of sulfonamides and beta blockers, intake of medicines belonging to different therapeutic groups but with anticholinergic action such as antihistamines, butyrophenones, phenothiazines, tricyclic antidepressants and amantadine.
NAME
ANTISPASMINA COLIC COATED TABLETS
EXCIPIENTS
Colic antispasmin: lactose, corn starch, povidone, magnesium stearate, precipitated silica, shellac, castor oil, cellulose acetophthalate, diethyl phthalate, magnesium carbonate, talc, charcoal, gum arabic, sucrose. Antispasmin Colica Forte: lactose, starch dimais, povidone, magnesium stearate, precipitated silica, shellac, castor oil, cellulose acetophthalate, diethyl phthalate, magnesium carbonate, talc, vegetable carbon, gum arabic, sucrose.
SIDE EFFECTS
Immune system disorders: allergic reactions. Nervous system disorders: drowsiness, dizziness. Eye disorders: conjunctival irritation. Cardiac disorders: tachycardia. Gastrointestinal disorders: dry mouth, nausea, vomiting, gastroesophageal reflux, constipation. Hepatobiliary disorders: jaundice. Skin and subcutaneous tissue disorders: urticaria, skin reactions. Renal and urinary disorders: difficulty in urination. General Disorders and Administration Site Conditions: Retrosternal pain. Investigations: increased intraocular pressure, alteration of liver function tests. At high doses, anticholinergics can cause urinary retention, cardiac arrhythmias, breathing difficulties, agitation, mental confusion. Report any suspected adverse reactions via the national reporting system.
PREGNANCY AND BREASTFEEDING
Contraindicated in pregnancy and lactation.
INDICATIONS
Symptomatic treatment in the spastic-painful manifestations of the gastro-enteric system.
INTERACTIONS
Do not administer simultaneously with sulfonamides 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 must not be taken at the same time.
DOSAGE
Colic antispasmin: 2 to 6 tablets per day. Colic Strong Antispasmin: 1 to 3 tablets per day. Do not exceed the recommended doses The tablets must be swallowed before meals or at the time of need and must be swallowed whole because they must reach the intestine intact, where they perform their action at the level of the spasm. In case of diarrhea or hypermotility of the intestine, the tablets can, exceptionally, be expelled whole; in this case it is advisable, at least for a few days, to swallow the tablets after having fragmented them. Contraindicated in children.
ACTIVE PRINCIPLES
Cholic antispasmin: each coated tablet contains 10 mg of papaverine hydrochloride (equivalent to 9.016 mg of papaverine) and 10 mg of belladonna extract 1% josciamina. Strong colic antispasmin: each coated tablet contains 50 mg of papaverine hydrochloride (equivalent to 45.08 mg of papaverine) and 10 mg of belladonna extract 1% josciamina.