Active ingredients: Otilonium bromide, Diazepam
SPASMOMEN SOMATIC 20mg + 2mg coated tablets
Spasmomen Somatic package inserts are available for pack sizes:- SPASMOMEN SOMATIC 20mg + 2mg coated tablets
- SPASMOMEN SOMATIC 40mg + 2mg coated tablets
Why is Somatic Spasmomen used? What is it for?
Pharmacotherapeutic group
Antispasmodics in association with psycholeptics.
THERAPEUTIC INDICATIONS
Spastic-painful manifestations, with an anxious component, of the gastrointestinal tract.
Contraindications When Somatic Spasmomen should not be used
Hypersensitivity to the active substances or to any of the excipients.
Do not administer in the first trimester of pregnancy. In the further period of pregnancy and during breastfeeding, the drug should be administered only in case of real need and under direct medical supervision.
Subjects with glaucoma, prostatic hypertrophy, intestinal obstruction or urinary retention syndromes. Myasthenia gravis.
Precautions for use What you need to know before taking Somatic Spasmomen
Due to the highly variable individual reactivity to psychotropic drugs, the dosage of Somatic Spasmomen should be fixed within prudent limits in elderly or debilitated patients. Patients under treatment with Somatic Spasmomen, as well as with any other psychotropic drug, should refrain from consuming alcoholic beverages while under the effect of the drug, as individual reactions are unpredictable.
The use of benzodiazepines in early childhood is not generally recommended.
Interactions Which drugs or foods can modify the effect of Somatic Spasmomen
Tell your doctor or pharmacist if you have recently taken any other medicines, even those without a prescription.
Associated with centrally active drugs such as neuroleptics, antidepressants, hypnotics, analgesics and anesthetics, the Somatic Spasmomen can reinforce their sedative action.
The association with other psychotropic drugs requires particular caution and vigilance on the part of the physician, to avoid unexpected undesirable effects from interaction.
Warnings It is important to know that:
Predisposed subjects, if treated with benzodiazepines at high doses and for prolonged periods, may be addictive as occurs with other drugs with hypnotic, sedative and ataraxic activity. In case of prolonged treatment it is advisable to carry out checks on the blood picture and liver function.
Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine.
Do not administer in the first trimester of pregnancy. In the "further period of pregnancy and during lactation", the drug should be administered only in case of real need when, in the opinion of the doctor, the possible benefits outweigh the possible risks. This medicine contains sucrose therefore if the doctor has diagnosed a intolerance to some sugars, contact him before taking this medicine.
This medicine contains methyl parahydroxybenzoate therefore may cause allergic reactions (including delayed).
Effects on ability to drive and use machines
According to the modalities of use, the dose and the individual sensitivity, the Somatic Spasmomen, like other drugs of the same type of action, can influence the ability to react (eg. In the attitude to drive a vehicle, in the behavior of the road traffic, in operating on machinery that requires particular attention).
Dose, Method and Time of Administration How to use Somatic Spasmomen: Posology
1-2 tablets, 2-3 times a day, preferably after meals, according to the doctor's judgment. However, the posology must be guided by the characteristics of the association and not by those of the individual components. In the treatment of elderly patients, the dosage must be carefully established by the physician who will have to evaluate a possible reduction in the dosages indicated above.
Duration of treatment
According to medical prescription.
Overdose What to do if you have taken too much Somatic Spasmomen
In animals, otilonium bromide has been shown to be practically free of toxicity. Consequently, also in man should not arise particular problems due to excessive dose.
Manifestations of diazepam overdose include drowsiness, confusion, coma, reduced reflexes. Respiration, pulse, blood pressure should be checked although generally these effects are minimal in case of an overdose. General supportive measures should be used in conjunction with immediate gastric lavage.
In case of accidental ingestion / intake of an excessive dose of Spasmomen Somatico, notify your doctor immediately or go to the nearest hospital.
Side Effects What are the side effects of Somatic Spasmomen
Like all medicines, Spasmomen Somatico can cause side effects, although not everybody gets them.
Nervous system disorders
Somnolence, dizziness. Rare: ataxia and headache.
Gastrointestinal disorders
Rare: nausea, vomiting, diarrhea, constipation, abdominal pain
Cardiac pathologies
Rare: palpitations.
Visual disturbances, hypotension, pruritus, dry mouth, rash, drooling, depression, confusion, hallucinations, cases of granulocytopenia, changes in blood levels of transaminases, phosphatase, bilirubin.
Psychiatric disorders
Rare: confusion, irritability.
These side effects are more frequent in elderly or debilitated patients.
If these are signs of relative overdose, they disappear spontaneously within a few days or after dosage adjustment.
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. Undesirable effects can also be reported directly through the national reporting system at "https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse". By reporting side effects you can help provide more information on the safety of this medicine.
Expiry and Retention
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 label after EXP. The expiry date refers to the last day of that month.
Do not use this medicine if you notice visible signs of deterioration.
Do not disperse in the environment after use
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.
Composition and pharmaceutical form
What Somatic Spasmomen contains
Each tablet contains:
Active ingredients: otilonium bromide 20 mg, diazepam 2 mg.
Excipients: microcrystalline cellulose, pregelatinized starch, magnesium stearate, benzoin, titanium dioxide, talc, precipitated silica, polyvinylpyrrolidone, chlorophyll, sodium carboxymethylcellulose, carnauba wax, methyl p-hydroxybenzoate, sucrose.
Description of the appearance of Somatic Spasmomen and contents of the pack
Coated tablets, 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
SPASMOMEN SOMATICO 20 MG + 2 MG COATED TABLETS
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
Active principles: otylonium bromide 20,000 mg, diazepam 2,000 mg.
Excipients: methyl p-hydroxybenzoate, sucrose.
For the full list of excipients, see section 6.1.
03.0 PHARMACEUTICAL FORM
Coated tablet.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Spastic-painful manifestations, with an anxious component, of the gastrointestinal tract.
04.2 Posology and method of administration
1-2 sugared almonds, 2-3 times a day, preferably after meals, according to the doctor's judgment. However, the posology must be guided by the characteristics of the association and not by those of the individual components. In the treatment of elderly patients, the dosage must be carefully established by the physician who will have to evaluate a possible reduction in the dosages indicated above.
04.3 Contraindications
Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.
Subjects with glaucoma; prostatic hypertrophy, intestinal obstruction or urinary retention syndromes.
Myasthenia gravis.
Do not administer in the first trimester of pregnancy.
04.4 Special warnings and appropriate precautions for use
Predisposed subjects, if treated with benzodiazepines at high doses and for prolonged periods, may be addictive as occurs with other drugs with hypnotic, sedative and ataraxic activity. In case of prolonged treatment it is advisable to carry out checks on the blood picture and liver function.
Due to the highly variable individual reactivity to psychotropic drugs, the dosage of Somatic Spasmomen should be fixed within prudent limits in elderly or debilitated patients. Patients under treatment with Somatic Spasmomen, as well as with any other psychotropic drug, should refrain from consuming alcoholic beverages while under the influence of the drug, as individual reactions are unpredictable.
The use of benzodiazepines in early childhood is not generally recommended.
Do not leave medicines within the reach of children.
This medicinal product contains sucrose therefore patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption, or sucrase isomaltase insufficiency should not take this medicinal product.
This medicine contains methyl parahydroxybenzoate therefore may cause allergic reactions (including delayed).
04.5 Interactions with other medicinal products and other forms of interaction
Associated with centrally active drugs such as neuroleptics, antidepressants, hypnotics, analgesics and anesthetics, the Somatic Spasmomen can reinforce their sedative action.
The association with other psychotropic drugs requires particular caution and vigilance on the part of the physician to avoid unexpected undesirable effects from interaction.
04.6 Pregnancy and lactation
Do not administer in the first trimester of pregnancy. In the further period of pregnancy and during lactation, the drug should be administered only in case of real need when, in the opinion of the physician, the possible benefits outweigh the possible risks (see section 4.3).
04.7 Effects on ability to drive and use machines
According to the modalities of use, the dose and the individual sensitivity, the Somatic Spasmomen, like other drugs of the same type of action, can influence the ability to react (eg. In the attitude to drive a vehicle, in the behavior of the road traffic, in operating on machinery that requires particular attention).
04.8 Undesirable effects
Nervous system disorders
Somnolence, dizziness. Rare: ataxia and headache.
Gastrointestinal disorders
Rare: nausea, vomiting, diarrhea, constipation, abdominal pain
Cardiac pathologies
Rare: palpitations.
Visual disturbances, hypotension, pruritus, dry mouth, rash, drooling, depression, confusion, hallucinations, cases of granulocytopenia, changes in blood levels of transaminases, phosphatase, bilirubin.
Psychiatric disorders
Rare: confusion, irritability.
These side effects are more frequent in elderly or debilitated patients.
If these are signs of relative overdose, they disappear spontaneously within a few days or after dosage adjustment.
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. "address https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
04.9 Overdose
In animals, otilonium bromide has been shown to be practically free of toxicity. Consequently, in humans too, no particular problems should arise due to overdose. Manifestations of diazepam overdose include drowsiness, confusion, coma, reduced reflexes. Breathing, pulse, blood pressure should be monitored although generally these effects are minimal in case Overdose General supportive measures should be used in conjunction with immediate gastric lavage.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Otilonium bromide, produced by Menarini research, has an intense spasmolytic action on the smooth muscles of the digestive system. Experimental data have shown that after oral administration the absorption is very poor; most of the absorbed amount is eliminated via the biliary route. Diazepam, benzodiazepine derivative with anxiolytic action, administered orally at a dose of 2 mg, is rapidly absorbed reaching the blood peak at the 2nd hour. Otilonium bromide administered simultaneously does not interfere with the absorption of diazepam. The oral LD50 of the Somatic Spasmomen is 3445 times higher than the DTS and 575 times higher than the DTD; in chronic administration the drug was found to be well tolerated even for doses several times higher than human therapeutic doses In doses 10 times higher than the DTD the drug has neither teratogenic effects nor negative effects on reproductive function.
05.2 Pharmacokinetic properties
05.3 Preclinical safety data
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Each tablet contains:
Excipients: microcrystalline cellulose, pregelatinised starch, precipitated silica, magnesium stearate.
Coating: benzoin, titanium dioxide, talc, precipitated silica, polyvinylpyrrolidone, chlorophyll (E 140), sodium carboxymethylcellulose, carnauba wax, methyl p-hydroxybenzoate, sucrose.
06.2 Incompatibility
To date they are not known.
06.3 Period of validity
3 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
Cardboard box containing 30 tablets packed in blisters.
No special instructions.
06.6 Instructions for use and handling
No special instructions.
07.0 MARKETING AUTHORIZATION HOLDER
A. Menarini Industrie Farmaceutiche Riunite s.r.l. - Via Sette Santi, 3 - Florence.
08.0 MARKETING AUTHORIZATION NUMBER
A.I.C. n. 024350011.
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
31st March 1981/31st May 2010
10.0 DATE OF REVISION OF THE TEXT
AIFA determination of January 2014
