ANTISPASMINA COLICA 10 MG + 10 MG COATED TABLETS 30 TABLETS

Name
Antispasmina Colica 10 mg + 10 mg coated tablets
Antispasmina Colica Forte 50 mg + 10 mg 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 system).

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

Talk to your doctor if you do not feel better or if you feel worse after a short time of treatment.


What you need to know before taking the medicine
Do not take Antispasmina Colica
• if you are allergic to the active substances or to 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 increase in the size of a gland called the prostate (prostatic hypertrophy);
• if you have a narrowing of the terminal part of your stomach (pyloric stenosis);
• if you have diseases due to narrowing of the urinary tract (stenosis diseases of the urinary tract);
• if you have obstructions in your stomach and intestines (paralytic ileus and obstructive gastrointestinal diseases);
• if the patient is elderly or debilitated with decreased intestinal muscle tone;
• if you have inflammation of the colon (ulcerative colitis, toxic megacolon);
• if you have a serious muscle disease (myasthenia gravis);
• if you have autonomic nervous system disorders;
• if you have liver or kidney disease;
• if you have excessive thyroid activity (hyperthyroidism);
• if you have diseases of the vessels that supply the heart (coronary arteries), changes in the heart rhythm, high blood pressure (arterial hypertension) and if your heart does not supply adequate blood (congestive heart failure);
• if you are pregnant or breast-feeding (see “Pregnancy and breast-feeding”);
• if you are taking certain medicines that may 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 be used only in case of real need and under the direct supervision of a doctor.
This medicine should not be taken at the same time as certain medicines that may alter the effect of Antispasmina Colica (see “Other medicines and Antispasmina Colica”). The appearance of side effects requires the suspension 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 following treatment with normal doses of Antispasmina Colica:
• dry mouth nausea,
• vomit,
• presence in the esophagus of material refluxed from the stomach (gastroesophageal reflux),
• pain localized behind the sternum,
• acceleration of the heartbeat,
• increased pressure inside the eye,
• difficulty urinating,
• constipation,
• dizziness,
• drowsiness,
• inflammation of the eye (conjunctivitis),
• allergic reactions, skin reactions, hives,
• yellow-brownish coloration of the skin (jaundice) and alteration of laboratory tests of liver function,

At high doses, urinary retention, changes in heartbeat, 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 usually temporary. However, when they occur, it is advisable to consult your doctor or pharmacist.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. 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.