ANTISPASMINA COLICA*30COATED TABS

Antispasmina Colica 10 mg + 10 mg film-coated tablets
Antispasmina Colica Forte 50 mg + 10 mg film-coated tablets
Papaverine hydrochloride + belladonna

What it is and what it is used for
Antispasmina Colica contains two active ingredients, papaverine hydrochloride and belladonna, and is used to promote relaxation of the muscles of the intestine and stomach (gastrointestinal tract).

Antispasmina Colica is used in the treatment of spasms and pain of the stomach and intestine.

Consult your doctor if you do not feel better or if you feel worse after a short period of treatment.

What you need to know before taking the medicine
Do not take Antispasmina Colica
• if you are allergic to the active ingredients or any of the other ingredients of this medicine (listed in section 6);
• if you are allergic to other medicines belonging to the same class as Antispasmina Colica, in particular atropine, methyl homatropine, scopolamine, drotaverine, moxaverine;
• if you have a disease due to high pressure inside the eye (glaucoma);
• if you have an enlarged prostate gland (prostatic hypertrophy);
• if you have a narrowing of the terminal part of the stomach (pyloric stenosis);
• if you have diseases due to narrowing of the urinary tract (stenosing diseases of the urinary system);
• if you have obstructions in the stomach and intestine (paralytic ileus and obstructive diseases of the gastrointestinal tract);
• if you are an elderly or debilitated patient with decreased muscle tone of the intestine;
• if you have inflammation of the colon (ulcerative colitis, toxic megacolon);
• if you have a severe muscle disease (myasthenia gravis);
• if you have autonomic nervous system disorders;
• if you have liver and kidney diseases;
• if you have an overactive thyroid (hyperthyroidism);
• if you have diseases of the vessels that nourish the heart (coronary arteries), heart rhythm abnormalities, high blood pressure (arterial hypertension) and if your heart does not supply enough blood (congestive heart failure);
• if you are pregnant or breastfeeding (see "Pregnancy and breastfeeding");
• if you are taking certain medicines that can alter the effect of Antispasmina Colica (see "Other medicines and Antispasmina Colica").

Antispasmina Colica is contraindicated in children under 12 years of age

Warnings and precautions
Talk to your doctor or pharmacist before taking Antispasmina Colica.
After a short period of treatment without appreciable results, consult your doctor.
In the elderly, Antispasmina Colica should only be used if strictly necessary and under direct medical supervision.
This medicine should not be taken concurrently with certain medicines that can alter the effect of Antispasmina Colica (see "Other medicines and Antispasmina Colica"). The appearance of side effects requires discontinuation of treatment.

Children
Antispasmina Colica is contraindicated in children under 12 years of age.

Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects have been reported after treatment with normal doses of Antispasmina Colica:
• dry mouth, nausea,
• vomiting,
• presence of material from the stomach rising into the esophagus (gastroesophageal reflux),
• pain located behind the sternum,
• increased heart rate,
• increased pressure inside the eye,
• difficulty urinating,
• constipation,
• dizziness,
• drowsiness,
• eye inflammation (conjunctivitis),
• allergic reactions, skin reactions, urticaria,
• yellowish-brown skin discoloration (jaundice) and alteration of laboratory tests of liver function,

At high doses, urinary retention, heart rhythm disturbances, respiratory difficulties, agitation, and mental confusion may occur.
Following the instructions in the package leaflet reduces the risk of side effects.
These side effects are generally temporary. However, if they occur, it is advisable to consult your doctor or pharmacist.

Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazionireazioni-avverse.
By reporting side effects you can help provide more information on the safety of this medicine.