Active ingredients: Papaverine hydrochloride, Belladonna
Colic antispasmin 10 mg + 10 mg coated tablets
Antispasmin Colica Forte 50 mg + 10 mg coated tablets
Why is Colic Antispasmin used? What is it for?
Antispasmin 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 to treat 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 period of treatment.
Contraindications When Colic Antispasmin should not be used
Do not take Antispasmin Colic
- if you are allergic to the active substances 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 Colic Antispasmin in particular atropine, methyl homatropine, scopolamine, drotaverine, moxaverine;
- if you have a disease due to "high pressure" in the eye (glaucoma);
- if you have an increase in the volume of a gland called the prostate (prostatic hypertrophy);
- if you have a narrowing of the end of your stomach (pyloric stenosis);
- if you have diseases due to narrowing of the urinary tract (stenosing diseases of the urinary tract);
- if you have obstructions in the stomach and intestines (paralytic ileus and obstructive pathologies of the gastrointestinal system);
- if you are an elderly or debilitated patient with decreased bowel muscle tone;
- if you have "inflammation of the colon (ulcerative colitis, toxic megacolon);
- if you have severe muscle disease (myasthenia gravis);
- if you have disorders of the autonomic nervous system;
- if you have liver and kidney disease;
- if you have excessive thyroid activity (hyperthyroidism);
- if you have diseases of the vessels that feed the heart (coronary arteries), changes in the rhythm of the heart, 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 may change the effect of Colic Antispasmin (see "Other medicines and Colic Antispasmin").
Antispasmin Colic is contraindicated in children under 12 years of age
Precautions for use What you need to know before taking Antispasmin Colic
Talk to your doctor or pharmacist before taking Colic Antispasmin.
After a short period of treatment without noticeable results, consult your doctor.
In the elderly, Antispasmin Colic should only be used when clearly needed and under direct medical supervision.
This medicine must not be taken at the same time as some medicines that can modify the effect of Antispasmin Colic (see "Other medicines and Antispasmin Colic"). The appearance of side effects requires discontinuation of treatment.
Children
Antispasmin Colic is contraindicated in children under 12 years of age
Interactions Which drugs or foods can modify the effect of Antispasmin Colica
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Do not use Antispasmin Colic if you are following a therapy based on:
- antihistamines (used in the treatment of allergies),
- butyrophenones (used in the treatment of psychosis, mental illness),
- phenothiazines (used to treat allergies, nausea and vomiting or in mental illness),
- tricyclic antidepressants (used to treat depression),
- amantadine (used in the treatment of Parkinson's disease),
- sulfonamides (used against bacterial infections),
- beta blockers (used to regulate heart rhythm, chest pain (angina) and high blood pressure).
Warnings It is important to know that:
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 or pharmacist for advice before taking this medicine.
Colic Antispasmin should not be used during pregnancy and / or breastfeeding.
Driving and using machines
Antispasmin Colic impairs the ability to drive or use machines as it can induce drowsiness; you must take this into account if you carry out operations that require attention (driving vehicles and using machines).
Colic Antispasmin contains:
- sucrose and lactose; If you have been told by your doctor that you have "intolerance to some sugars, contact your doctor before taking this medicinal product.
- castor oil which can cause stomach upset and diarrhea.
Dose, Method and Time of Administration How to use Colic Antispasmin: Posology
Always take this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
The recommended dose for adults is:
- 2 to 6 tablets per day for Colic Antispasmin 10 mg + 10 mg
- 1 to 3 tablets per day for Antispasmin Colica Forte 50 mg + 10 mg.
Warning: do not exceed the indicated doses without medical advice.
The tablets should be swallowed before meals or when needed.
The tablets should not be chewed, but swallowed whole because they must reach the intestine intact to carry out their action.
Consult your doctor if the disorder occurs repeatedly or if you have noticed any recent changes in its characteristics.
Warning: use only for short periods of treatment.
In case of diarrhea 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.
Use in children
Antispasmin Colic is contraindicated in children under 12 years of age.
Overdose What to do if you have taken an overdose of Antispasmin Colic
If you take more Antispasmin Colic than you should
At high doses, Colic Antispasmin can cause:
- difficulty urinating (urinary retention),
- changes in the rhythm of the heart,
- difficulty breathing,
- agitation,
- state of mental confusion.
In case of accidental ingestion / intake of an overdose of Antispasmin Colic, notify your doctor immediately or go to the nearest hospital.
If you forget to take Antispasmin Colic
Do not take a double dose to make up for a forgotten tablet.
If you stop taking Colic Antispasmin
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Side Effects What are the side effects of Colic Antispasmin
Like all medicines, this medicine can cause side effects, although not everybody gets them.
- Following treatment with normal doses of Colic Antispasmin the following side effects have been reported: dry mouth, nausea,
- He retched,
- presence in the esophagus of material that has risen from the stomach (gastroesophageal reflux)
- localized pain behind the breastbone,
- acceleration of the heartbeat,
- increased pressure inside the eye,
- difficulty urinating,
- constipation.
- dizziness,
- drowsiness.
- inflammation of the eye (conjunctivitis),
- allergic reactions, skin reactions, hives,
- brownish-yellow discoloration of the skin (jaundice) and abnormal liver function laboratory tests,
At high doses, urinary retention, changes in heart rate, difficulty breathing, agitation, mental confusion may occur.
Compliance with the instructions contained in the package leaflet reduces the risk of undesirable effects. These side effects are generally transient. 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 www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects you can help provide more information on the safety of this medicine.
Expiry and Retention
This medicine does not require any special storage conditions.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton after "Expiry". The expiry date refers to the last day of that month.
Do not throw any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.
It is important to have the information about the medicine available at all times, so keep both the box and the package leaflet.
Composition and pharmaceutical form
What Colic Antispasmin contains
Coated tablets 10 mg + 10 mg (Colic Antispasmin)
- The active ingredients are: papaverine hydrochloride and belladonna. Each coated tablet contains 10 mg of papaverine hydrochloride (equivalent to 9.016 mg of papaverine) and 10 mg of belladonna extract 1% josciamina.
- The other ingredients are: lactose, corn starch, povidone, magnesium stearate, precipitated silica, shellac, castor oil, cellulose acetophthalate, diethyl phthalate, magnesium carbonate, talc, vegetable carbon, gum arabic, sucrose.
Coated tablets 50 mg + 10 mg (Antispasmin Colica Forte)
- The active ingredients are: papaverine hydrochloride and belladonna. Each coated tablet contains 50 mg of papaverine hydrochloride (equivalent to 45.08 mg of papaverine) and 10 mg of belladonna extract 1% josciamina.
- The other ingredients are: lactose, corn starch, povidone, magnesium stearate, precipitated silica, shellac, castor oil, cellulose acetophthalate, diethyl phthalate, magnesium carbonate, talc, vegetable carbon, gum arabic, sucrose.
Description of the appearance of Antispasmin Colica and contents of the pack
Antispasmin Colica comes in the form of coated tablets for oral use.
It is available in packs of 30 tablets.
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT
ANTISPASMINA COLIC COATED TABLETS
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
Colic antispasmin
Each coated tablet contains 10 mg papaverine hydrochloride (equivalent to 9.016 mg papaverine) and 10 mg belladonna extract 1% josciamina
Excipients with known effects:
Each tablet contains 75 mg of lactose and 42.8 mg of sucrose and 0.2 mg of castor oil
Antispasmin Colic Forte
Each coated tablet contains 50 mg of papaverine hydrochloride (equivalent to 45.08 mg of papaverine) and 10 mg of belladonna extract 1% josciamina
Excipients with known effects:
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.
03.0 PHARMACEUTICAL FORM
Coated tablets.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Symptomatic treatment in the spastic-painful manifestations of the gastro-enteric system.
04.2 Posology and method of administration
Colic antispasmin: 2 to 6 tablets per day
Antispasmin Colica Forte: 1 to 3 tablets per day
Do not exceed the recommended dose
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 , being expelled whole; in this case it is advisable, at least for a few days, to swallow the tablets after having fragmented them.
Antispasmin Colic is contraindicated in children (see section 4.3).
04.3 Contraindications
Hypersensitivity to the active substances, to any of the excipients listed in section 6.1. or to other closely related substances from a chemical point of view; in particular towards 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 tract; intestinal atony of the elderly and debilitated subjects, ulcerative colitis, toxic megacolon, myasthenia gravis.
In patients with autonomic nervous system disorders, in carriers of hepato-renal diseases, hyperthyroidism, coronary heart disease, cardiac tachyarrhythmias, arterial hypertension and congestive heart failure, concomitant use of sulfonamides and beta blockers (see section 4.5) , taking medicines belonging to different therapeutic groups but with anticholinergic action such as antihistamines, butyrophenones, phenothiazines, tricyclic antidepressants and amantadine (see section 4.5).
04.4 Special warnings and appropriate precautions for use
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 suspension of therapy.
The medicine contains sucrose and lactose, this should be taken 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 so patients with rare hereditary problems of galactose intolerance, lactase deficiency should not take it.
04.5 Interactions with other medicinal products and other forms of interaction
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.
04.6 Pregnancy and lactation
Antispasmin Colic is contraindicated in pregnancy and lactation (see section 4.3).
04.7 Effects on ability to drive and use machines
Antispasmin Colic impairs the ability to drive or use machines.
As the product may induce drowsiness, those who may be driving motor vehicles or attending to operations requiring integrity of vigilance should be advised of this.
04.8 Undesirable effects
The following side effects have been reported following treatment with Antispasmin Colic:
At high doses, anticholinergics can cause urinary retention, cardiac arrhythmias, breathing difficulties, agitation, mental confusion.
Reporting of suspected adverse reactions
Reporting of suspected adverse reactions occurring after authorization 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. "Street address www.aifa.gov.it/responsabili
04.9 Overdose
In case of overdose consult your doctor immediately.
At high doses, anticholinergics can cause urinary retention, cardiac arrhythmias, difficulty breathing, agitation, mental confusion.
As in all cases of overdose, treatment should be symptomatic with generic supportive measures. A specific antidote is not known.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: Drugs for functional gastrointestinal disorders.
ATC code: A03AD01
Antispasmin Colic carries out the pharmacological action of papaverine, which acts directly on the spasm of the intestinal smooth muscle, together with the mediated anticholinergic action of belladonna.
05.2 Pharmacokinetic properties
The principles are well absorbed from the gastrointestinal tract; they have a maximum plasma concentration that varies between 4 - 6 hours. They are metabolized by the liver and excreted in the urine.
05.3 Preclinical safety data
Experimental animal data reveal no special hazard for humans based on conventional studies of safety, repeated dose toxicity, genotoxicity, carcinogenic potential, reproductive toxicity.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Colic antispasmin
Lactose, corn starch, povidone, magnesium stearate, precipitated silica, shellac, castor oil, cellulose acetophthalate, diethyl phthalate, magnesium carbonate, talc, vegetable carbon, gum arabic, sucrose.
Strong colic antispasminLactose, corn starch, povidone, magnesium stearate, precipitated silica, shellac, castor oil, cellulose acetophthalate, diethyl phthalate, magnesium carbonate, talc, vegetable carbon, gum arabic, sucrose.
06.2 Incompatibility
Not relevant.
06.3 Period of validity
5 years.
06.4 Special precautions for storage
This medicine does not require any special storage conditions.
06.5 Nature of the immediate packaging and contents of the package
PVC and aluminum blisters.
Box of 30 coated tablets
06.6 Instructions for use and handling
No special instructions.
07.0 MARKETING AUTHORIZATION HOLDER
RECORDATI Chemical and Pharmaceutical Industries S.p.A. - Via Civitali n. 1 - MILAN
08.0 MARKETING AUTHORIZATION NUMBER
Antispasmin Colica 10 mg + 10 mg coated tablets, 30 tablets AIC n. 002918047
Antispasmin ColicaForte 50 mg + 10 mg coated tablets, 30 tablets AIC n. 002918050
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
Date of first authorization: 21 February 1950
Date of most recent renewal: May 31, 2010
10.0 DATE OF REVISION OF THE TEXT
17/06/2015
