Active ingredients: Otilonium Bromide
OBIMAL 40 mg coated tablets
Why is Obimal used? What is it for?
Pharmacotherapeutic group
Synthetic anticholinergics, quaternary ammonium compounds.
Therapeutic indications
Irritable colon and spastic-painful manifestations of the distal enteric tract.
Contraindications When Obimal should not be used
Hypersensitivity to the active substance or to any of the excipients.
Precautions for use What you need to know before taking Obimal
To be used with caution in subjects with glaucoma, prostatic hypertrophy, pyloric stenosis.
Interactions Which drugs or foods can change the effect of Obimal
Tell your doctor or pharmacist if you have recently taken any other medicines, even those without a prescription.
Warnings It is important to know that:
Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine.
Although no embryotoxic, teratogenic or mutagenic effects have been reported in animals, as for all drugs its use in pregnancy and during lactation must be limited to cases of recognized necessity and under the direct supervision of the physician.
Effects on ability to drive and use machines
OBIMAL does not affect the ability to drive or use machines.
In case of ascertained intolerance to sugars, contact your doctor before taking the medicine.
Dose, Method and Time of Administration How to use Obimal: Posology
1 coated tablet 2-3 times a day, according to the doctor's judgment.
Duration of treatment: according to medical prescription
Overdose What to do if you have taken too much Obimal
In the animal, otilonium bromide has been shown to be practically free of toxicity. Consequently, also in men, particular problems due to overdose should not arise. In this specific case, a possible symptomatic and supportive therapy is recommended. In case of accidental ingestion / intake of an excessive dose of OBIMAL, notify your doctor immediately or go to the nearest hospital.
IF YOU HAVE ANY DOUBT ABOUT THE "USE OF OBIMAL, CONTACT YOUR DOCTOR OR PHARMACIST
Side Effects What are the side effects of Obimal
Like all medicines, OBIMAL can cause side effects, although not everybody gets them
Post marketing the following side effects have been reported:
Urticaria.
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 tell your doctor or pharmacist.
Expiry and Retention
Expiry: see the expiry date printed on the package.
The expiry date refers to the product in intact packaging, correctly stored.
Warning: do not use the medicine after the expiry date shown on the package.
Medicines should not be disposed of via wastewater or household waste. Ask your doctor or pharmacist for advice on throwing away medicines you no longer use. This will help protect the environment.
KEEP OUT OF THE SIGHT AND REACH OF CHILDREN
It is important to always have the information on the medicine available, therefore keep both the box and the package leaflet
The expiry date refers to the last day of the month.
Do not use this medicine if you notice visible signs of deterioration
Composition.
Each tablet contains:
Active ingredient: otilonium bromide 40 mg.
Excipients - Nucleus: lactose, starch, sodium starch glycolate, magnesium stearate.
Coating: hypromellose, titanium dioxide, macrogol, talc.
Pharmaceutical form and content
40 mg coated tablets, for oral use.
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
OBIMAL 40 MG COATED TABLETS
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each coated tablet contains:
Active principle: Otilonium bromide 40 mg
Excipients with known effects: lactose
For the full list of excipients, see section 6.1.
03.0 PHARMACEUTICAL FORM
Coated tablet.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Irritable colon and spastic-painful manifestations of the distal enteric tract.
04.2 Posology and method of administration
Dosage
One coated tablet 2-3 times a day, according to the doctor's judgment.
Duration of treatment: according to medical prescription.
Method of administration
Oral use
04.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
04.4 Special warnings and appropriate precautions for use
To be used with caution in subjects with glaucoma, prostatic hypertrophy, pyloric stenosis.
This medicine contains lactose, therefore patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption should not take this medicine.
04.5 Interactions with other medicinal products and other forms of interaction
No interaction studies have been performed
04.6 Pregnancy and lactation
Although no embryotoxic, teratogenic or mutagenic effects have been reported in animals, as with all drugs, its use in pregnant and lactating women should be limited in cases of recognized necessity and under direct medical supervision.
04.7 Effects on ability to drive and use machines
OBIMAL does not affect the ability to drive or use machines.
04.8 Undesirable effects
Spontaneous reports of the following adverse reactions have been collected in post-marketing experience. It is not possible to realistically estimate the frequency of these reactions and therefore is not known.
Skin and subcutaneous tissue disorders : Hives
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: www.agenziafarmaco.gov.it/it/responsabili.
04.9 Overdose
In the animal, otilonium bromide has been shown to be practically free of toxicity.
Consequently, also in men, particular problems due to overdose should not arise. In this specific case, a possible symptomatic and supportive therapy is recommended.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: synthetic anticholinergics, quaternary ammonium compounds, ATC code: A03AB06
Otilonium bromide has an intense spasmolytic action on the smooth muscles of the digestive system. Its action is carried out through the inhibition of the contraction of the smooth muscle cells, through the interference of the mobilization of the extra and intra cellular Ca ++ ions.
05.2 "Pharmacokinetic properties
Experimental data have shown that after oral administration, absorption is very poor (about 5% of the administered dose); most of the absorbed portion is eliminated via the biliary route.
05.3 Preclinical safety data
Acute toxicity: per os no mortality up to 1500 mg / kg in rats and up to 1000 mg / kg in dogs.
Chronic toxicity: in experimental animals the oral administration of otilonium bromide at a dose of 80 mg / kg administered for 180 days did not cause any modification of the haematochemical and histological tests.
Teratology: no embryotoxic or teratogenic effect in rats and rabbits even for doses of 60 mg / kg.
Mutagenesis: no mutagenic effect in the numerous tests carried out.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Each coated tablet contains:
Nucleus: lactose, starch, sodium starch glycolate, magnesium stearate.
Coating: hypromellose, titanium dioxide, macrogol, talc.
06.2 Incompatibility
Not relevant.
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 coated tablets packed in PVC and Aluminum blisters.
06.6 Instructions for use and handling
No special instructions for disposal.
Unused medicine and waste derived from this medicine must be disposed of in accordance with local regulations.
07.0 MARKETING AUTHORIZATION HOLDER
Malesci Istituto Farmacobiologico S.p.A. - Via Lungo l "Ema, 7 - Bagno a Ripoli - Florence.
08.0 MARKETING AUTHORIZATION NUMBER
A.I.C. n ° 027172030
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
Date of first authorization: 2 November 1989
Date of most recent renewal: May 31, 2010
10.0 DATE OF REVISION OF THE TEXT
December 2015
