ANTISPASMINA COLICA*FTE 30TB

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 stomach and intestinal spasms and pain.

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 to any of the other ingredients of this medicine (listed in paragraph 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 condition due to high pressure inside the eye (glaucoma);
• if you have an enlarged gland called the prostate (prostatic hypertrophy);
• if you have a narrowing of the distal part of the stomach (pyloric stenosis);
• if you have conditions 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 tone of the intestinal muscles;
• if you have colon inflammation (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 coronary arteries that nourish the heart, heart rhythm disturbances, high blood pressure (arterial hypertension) and if your heart does not supply blood in adequate quantities (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
Consult your doctor or pharmacist before taking Antispasmina Colica.
After a short period of treatment without noticeable results, consult your doctor.
In the elderly, Antispasmina Colica should only be used if absolutely necessary and under direct medical supervision.
This medicine should not be taken concomitantly 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 refluxed from the stomach into the esophagus (gastroesophageal reflux),
• localized pain behind the sternum,
• accelerated heart rate,
• increased pressure inside the eye,
• difficulty urinating,
• constipation,
• dizziness,
• drowsiness,
• eye inflammation (conjunctivitis),
• allergic reactions, skin reactions, urticaria,
• yellowish-brown discoloration of the skin (jaundice) and alteration of laboratory tests of liver function,

At high doses, urinary retention, heart rhythm disturbances, breathing 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 any 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.