Active ingredients: Cimetropium bromide
ALGINOR 5 mg / ml solution for injection
ALGINOR 50 mg tablets
ALGINOR Adults 50 mg / ml oral drops, solution
ALGINOR Children 10 mg / ml oral drops, solution
Indications Why is Alginor used? What is it for?
PHARMACOTHERAPEUTIC CATEGORY
Antispastic, anticholinergic, prokinetic belonging to the class of semisynthetic nightshade alkaloids, quaternary ammonium compounds
THERAPEUTIC INDICATIONS
Irritable colon, spastic-painful manifestations of the gastrointestinal tract. Premedication in gastrointestinal diagnostic and operative endoscopy. In pediatrics: abdominal colic, pyloric spasm, gastrointestinal spastic states.
Contraindications When Alginor should not be used
Alginor should be used with caution in diseases of the autonomic nervous system, in liver and / or kidney diseases, in chronic obstructive inflammatory diseases of the respiratory system, in hyperthyroidism, in coronary artery disease, in congestive heart failure, in cardiac arrhythmias, in hypertension. and, especially in children, in the presence of hyperpyrexia.
Precautions for use What you need to know before taking Alginor
In particular, in the presence of abdominal pain, before proceeding with the administration of Alginor solution for injection make sure that the pain symptom does not originate from a myocardial infarction.
Interactions Which drugs or foods can modify the effect of Alginor
Tell your doctor or pharmacist if you have recently taken any other medicines, even those without a prescription.
It is advisable to avoid co-administration with other drugs that can potentiate the anticholinergic effects of Alginor, such as: antihistamines, phenothiazines, tricyclic antidepressants and anticholinergics. The efficacy of cymeter bromide can be reduced or canceled by parasympathomimetic agents.
Warnings It is important to know that:
Particular caution requires the use of anticholinergics in infants, in which the drug can cause gastroesophageal reflux and obstructive respiratory reflex symptoms as well as, especially at high doses or in particularly predisposed subjects, signs of central stimulation with agitation, tremor, irritability and, occasionally, convulsive phenomena.
Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine.
Although it was not teratogenic in experimental animals, as with all drugs, Alginor should be used during pregnancy only in case of real need under the direct supervision of the doctor.
Effects on ability to drive and use machines
Since the product could cause drowsiness, those who may drive vehicles or attend to operations requiring integrity of the degree of vigilance must be warned of this. Important information about some of the ingredients The tablets contain lactose and the oral drops for children contain sorbitol in case of ascertained intolerance to sugars contact your doctor before taking the medicine. The solution for injection contains less than 1 mmol (23 mg) sodium per dose, i.e. it is practically sodium-free.
Oral drops for children contain methyl para-hydroxybenzoate, propyl para-hydroxybenzoate which can cause allergic reactions (even delayed).
Adult oral drops contain 23.8 vol% anhydrous ethanol.
Oral drops for children contain 14.5 vol% anhydrous ethanol.
The ethanol contained in oral drops can be harmful to alcoholics and in quantities that should be taken into account in pregnant or lactating women, in children and in high-risk groups such as people with liver disease or epilepsy.
For those who carry out sporting activities, the use of medicines containing ethyl alcohol can determine positive doping tests in relation to the alcohol concentration limits indicated by some sports federations.
Dosage and method of use How to use Alginor: Dosage
ALGINOR 5 mg / ml solution for injection
Solution for injection for intravenous use or for intramuscular use.
Intravenously inject the drug slowly.
- Hepatic colic and gastrointestinal spastic states: 1 ampoule for intravenous use or for intramuscular use at the onset of the painful spastic crisis; the injection can be repeated in case of pain relapse even 3-4 times a day.
- Preparation for instrumental investigations (hypotonic duodenography, gastro-duodenal endoscopy, retrograde cholangiography): 2 vials for intravenous use are able to induce duodenal hypotonia and release of the papilla of Vater for over 40 minutes.
Incompatibility
The solution obtained from the extemporaneous mixing of Alginor in vials and diazepam in vials must be used no later than 15 minutes from its constitution. After 30 minutes, in fact, the formation of a precipitate in the form of yellow needle-like crystals can be observed. No chemical alteration of the active ingredients is detectable after the constitution of the solution.
ALGINOR 50 mg tablets
1 tablet 2-3 times a day is an adequate dosage in most patients. In more severe cases or according to the doctor's judgment, the dose can be increased up to 2 tablets 3 times a day.
ALGINOR Adults 50 mg / ml oral drops, solution
20 drops 3 times a day, unless otherwise prescribed. In more severe cases or according to the doctor's judgment, the dose can be increased up to 40 drops 3 times a day.
ALGINOR Children 10 mg / ml oral drops, solution
The recommended dosage is 3-5 drops per kg of weight 4-6 times a day unless otherwise prescribed. In children weighing more than 15-20 kg it is possible to use ½ tablet 2-3 times a day.
Instructions for Use
Vials
Pre-cut vial no file is required
Drops
To open, press and unscrew at the same time
Overdose What to do if you have taken too much Alginor
In case of acute intoxication due to overdose, proceed with the administration of physostigmine salicylate (1-2 mg i.m.) and adopt conventional emergency measures to control the symptoms.
Side Effects What are the side effects of Alginor
Like all medicines, Alginor can cause side effects, although not everybody gets them.
Especially in parenteral administration, a transient sense of dry mouth can be observed. Disturbances in visual accommodation and a sense of heartbeat with tachycardia have been observed in some patients treated at the higher doses.
Disturbances in urination, increased intraocular pressure, headache, dizziness, flushing of the face, euphoria and drowsiness, asthenia, constipation, nausea, allergic skin reactions may also occur.
Compliance with the instructions contained in the package leaflet reduces the risk of undesirable effects.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please inform your doctor or pharmacist.
Expiry and Retention
Expiry: see the expiry date indicated on the package.
Warning: do not use the medicine after the expiry date indicated on the package.
The expiry date indicated refers to the product in intact packaging, correctly stored.
This medicine does not require any special storage conditions. Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.
COMPOSITION
ALGINOR 5 mg / ml solution for injection
One ampoule contains: active ingredient: cymeter bromide 5 mg;
Excipients: sodium chloride, water for injections. ALGINOR 50 mg tablets One tablet contains: active ingredient: 50 mg cymeter bromide; Excipients: lactose, corn starch, magnesium stearate
ALGINOR Adults 50 mg / ml oral drops, solution
100 ml of solution contain: active ingredient: cymeter bromide 5 g; Each drop has an active ingredient content of approximately 2.5 mg.
Excipients: citric acid, tribasic sodium citrate, sodium saccharinate, ammonium glycyrrhizinate, propylene glycol, ethyl alcohol, colors E 104 and E 131, mint flavor, purified water.
ALGINOR Children 10 mg / ml oral drops, solution
100 ml of solution contain: active ingredient: 1 g cymeter bromide; Each drop has an active ingredient content of approximately 0.4 mg.
Excipients: citric acid, tribasic sodium citrate, sodium saccharinate, ammonium glycyrrhizinate, methyl para-hydroxybenzoate, propyl para-hydroxybenzoate, ethyl alcohol, purified water, 70% sorbitol solution.
PHARMACEUTICAL FORM AND CONTENT
ALGINOR 5 mg / ml solution for injection - 6 ampoules of 1 ml
ALGINOR 50 mg tablets - 20 tablets
ALGINOR Adults 50 mg / ml oral drops, solution
ALGINOR Children 10 mg / ml oral drops, solution
Polyethylene bottle with dropper 30 ml. Bottle with child resistant safety closure.
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
ALGINOR
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
ALGINOR 5 mg / ml solution for injection
One ampoule contains: active ingredient: cymeter bromide 5 mg;
Excipients: sodium chloride
ALGINOR 50 mg tablets
One tablet contains: active ingredient: 50 mg cymeter bromide;
Excipients: lactose
ALGINOR Adults 50 mg / ml oral drops, solution
100 ml of solution contain: active ingredient: cymeter bromide 5 g;
Each drop has an active ingredient content of approximately 2.5 mg.
Excipients: ethanol
ALGINOR Children 10 mg / ml oral drops, solution
100 ml of solution contain: active ingredient: 1 g cymeter bromide;
Each drop has an active ingredient content of approximately 0.4 mg.
Excipients: methyl para-hydroxybenzoate, propyl para-hydroxybenzoate, ethanol, sorbitol
For the full list of excipients see section 6.1
03.0 PHARMACEUTICAL FORM
Solution for injection - tablet - oral drops, solution
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Irritable colon, spastic-painful manifestations of the gastrointestinal tract. Premedication in gastrointestinal diagnostic and operative endoscopy.
In pediatrics: abdominal colic, pyloric spasm, gastrointestinal spastic states.
04.2 Posology and method of administration
ALGINOR 5 mg / ml solution for injection
Solution for intravenous use and for intramuscular use
Intravenously inject the drug slowly.
Hepatic colic and gastrointestinal spastic states : 1 vial for intravenous use and for intramuscular use at the onset of the painful spastic crisis; the injection can be repeated in case of pain relapse even 3-4 times a day.
Preparation for instrumental investigations : (hypotonic duodenography, gastroduodenal endoscopy, retrograde cholangiography): 2 vials for intravenous use are able to induce duodenal hypotonia and release of the papilla of Vater for over 40 minutes.
ALGINOR 50 mg tablets
1 tablet 2-3 times a day is an adequate dosage in most patients. In more severe cases or according to the doctor's judgment, the dose can be increased up to 2 tablets 3 times a day.
ALGINOR Adults 50 mg / ml oral drops, solution
20 drops 3 times a day, unless otherwise prescribed. In more severe cases or according to the doctor's judgment, the dose can be increased up to 40 drops 3 times a day.
ALGINOR Children 10 mg / ml oral drops, solution
The recommended dosage is 3-5 drops per kg of weight 4-6 times a day unless otherwise prescribed. In children weighing more than 15-20 kg it is possible to use ½ tablet 2-3 times a day.
04.3 Contraindications
Alginor is contraindicated in patients with hypersensitivity to the active substance or to any of the excipients, prostatic hypertrophy, glaucoma, urinary retention or intestinal obstruction syndromes (pyloric stenosis), paralytic ileus, ulcerative colitis, megacolon, reflux oesophagitis, myasthenia gravis.
04.4 Special warnings and appropriate precautions for use
Alginor should be used with caution in diseases of the autonomic nervous system, in liver and / or kidney diseases, in chronic obstructive inflammatory diseases of the respiratory system, in hyperthyroidism, in coronary artery disease, in congestive heart failure, in cardiac arrhythmias, in hypertension. and, especially in children, in the presence of hyperpyrexia.
In particular, in the presence of abdominal pain, before proceeding with the administration of Alginor solution for injection make sure that the pain symptom does not originate from a myocardial infarction.
Particular caution requires the use of anticholinergics in infants, in which the drug can cause gastroesophageal reflux and obstructive respiratory reflex symptoms and, moreover, especially at high doses or in particularly predisposed subjects, signs of central stimulation with agitation, tremor, irritability and, occasionally, convulsive phenomena.
At the moment it seems to be possible to exclude the existence of addiction and dependence phenomena.
Important information about some of the ingredients
The solution for injection contains less than 1 mmol (23 mg) sodium per dose, i.e. it is practically sodium-free.
The tablets contain lactose. Patients with rare hereditary problems of galactose intolerance, lactase deficiency or glucose-galactose malabsorption should not take this medicine.
The oral drops for children contain methyl para-hydroxybenzoate, propyl para-hydroxybenzoate which can cause allergic reactions (including delayed) and sorbitol therefore patients with rare hereditary problems of fructose intolerance should not take this medicine.
Adult oral drops contain 23.8 vol% anhydrous ethanol.
Oral drops for children contain 14.5 vol% anhydrous ethanol.
The ethanol contained in oral drops can be harmful to alcoholics and in quantities that should be taken into account in pregnant or lactating women, in children and in high-risk groups such as people with liver disease or epilepsy.
04.5 Interactions with other medicinal products and other forms of interaction
It is advisable to avoid the simultaneous administration of other drugs that can potentiate the anticholinergic effects of Alginor, such as: antihistamines, phenothiazines, tricyclic antidepressants and anticholinergics. The efficacy of cymeter bromide can be reduced or canceled by parasympathomimetic agents.
04.6 Pregnancy and lactation
Although it was not teratogenic in experimental animals, Alginor, like all drugs, should be used during pregnancy only in case of real need under the direct supervision of the doctor.
04.7 Effects on ability to drive and use machines
Since the product could cause drowsiness, those who may drive vehicles or attend to operations requiring integrity of the degree of vigilance must be warned of this.
04.8 Undesirable effects
Especially after parenteral administration, a transient sense of dry mouth can be observed; disturbances of visual accommodation and a sense of heartbeat with tachycardia have been observed in some patients treated at the higher doses.
Disturbances in urination, increased intraocular pressure, headache, dizziness, flushing of the face, euphoria and drowsiness, asthenia, constipation, nausea, allergic skin reactions may also occur.
04.9 Overdose
In case of acute intoxication due to overdose, proceed with the administration of physostigmine salicylate (1-2 mg i.m.) and adopt conventional emergency measures to control the symptoms.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: Drugs for functional intestinal disorders, semi-synthetic belladonna alkaloids, quaternary ammonium compounds.
ATC code: A03BB05
Cymeter bromide is a spasmolytic that exerts its action by blocking the muscarinic receptors of visceral smooth muscle. To its antimuscarinic action is added a marked direct myolytic activity which enhances its pharmacological effect.
05.2 Pharmacokinetic properties
The pharmacokinetic behavior of cymeter bromide has been studied in various animal species (rat, dog) and in humans.
Pharmacokinetics in animals
The drug is well absorbed into the general circulation both after intramuscular and rectal administration. However, as with all quaternary ammonium compounds, oral absorption is limited. 36% of the dose administered in intestinal loops of anesthetized rats is absorbed after 3 hours. Once absorbed, cymeter bromide is preferentially distributed in the intestine and liver, that is, in the districts of therapeutic action. The compound is eliminated mainly unchanged in the bile and urine.
Pharmacokinetics in man
The drug (10 mg) administered intravenously after a very rapid and wide tissue distribution, is eliminated with a half-life of about 1.5 hours.
The drug is excreted, both after intravenous and intramuscular administration, in unchanged form in the urine for about 50%.
After oral administration of 200 mg of cymeter bromide, the plasma levels of the unchanged drug are already detectable after 30 minutes and reach the maximum concentration (20-30 ng • ml-1) approximately 1.5 - 2 hours after administration. Once peak concentration is reached, plasma levels decrease with a terminal half-life of approximately 2 hours. However, as with other quaternary ammonium compounds, oral bioavailability appears limited.
05.3 Preclinical safety data
Acute toxicity studies conducted in mice and rats by i.m., i.v. and os, have shown that the molecule is well tolerated for all routes of administration (LD50 by the iv route: 22.0 mg / kg in the mouse and 31.5 mg / kg in the rat; LD50 by the im route 311.0 mg / kg in the mouse and 720.0 mg / kg in the rat; LD50 per os: 3000 mg / kg in the mouse and 3000 mg / kg in the rat).
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
ALGINOR 5 mg / ml solution for injection
sodium chloride, water for injections
ALGINOR 50 mg tablets
lactose, corn starch, magnesium stearate
ALGINOR Adults 50 mg / ml oral drops, solution
citric acid, sodium citrate, sodium saccharinate, ammonium glycyrrhizinate, propylene glycol, ethanol, colors E 104 and E 131, mint flavor, purified water.
ALGINOR Children 10 mg / ml oral drops, solution
citric acid, tribasic sodium citrate, sodium saccharinate, ammonium glycyrrhizinate, methyl para-hydroxybenzoate, propyl para-hydroxybenzoate, ethanol, purified water, 70% sorbitol solution
06.2 Incompatibility
The solution obtained from the extemporaneous mixing of Alginor in vials and diazepam in vials must be used no later than 15 minutes from its constitution. After 30 minutes, in fact, the formation of a precipitate in the form of yellow needle-like crystals can be observed. No chemical alteration of the active ingredients is detectable after the constitution of the solution.
06.3 Period of validity
tablets and drops: 5 years
solution for injection: 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
ALGINOR 5 mg / ml solution for injection
1ml amber glass vials
ALGINOR 50 mg tablets
PVC / Aluminum blister of 20 tablets
ALGINOR Adults 50 mg / ml oral drops, solution
ALGINOR Children 10 mg / ml oral drops, solution
Polyethylene bottle with dropper 30 ml. Bottle with child resistant safety closure.
06.6 Instructions for use and handling
Vials
Pre-cut vials do not need a file
Drops
The bottle has a child resistant closure, to open follow the instructions below:
To open, press and unscrew at the same time
07.0 MARKETING AUTHORIZATION HOLDER
Boehringer Ingelheim Italia S.p.A.
Reggello (Florence) - Loc. Prulli n. 103 / c
Astellas Pharma S.p.A.
Carugate (MI) - Via Delle Industrie, 1
08.0 MARKETING AUTHORIZATION NUMBER
ALGINOR 5 mg / ml solution for injection No. 025494016
ALGINOR 50 mg tablets n. 025494030
ALGINOR Adults 50 mg / ml oral drops, solution no. 025494055
ALGINOR Children 10 mg / ml oral drops, solution no. 025494028
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
ALGINOR 5 mg / ml solution for injection 20.12.1984 / 01.06.2010
ALGINOR 50 mg tablets 20.12.1984 / 01.06.2010
ALGINOR Adults 50 mg / ml oral drops, solution 28.10.1994 / 01.06.2010
ALGINOR Children 10 mg / ml oral drops, solution 20.12.1984 / 01.06.2010
10.0 DATE OF REVISION OF THE TEXT
AIFA Determination of 7 February 2011
