AUROBEVERINE Modified-release capsule, hard (2019)
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Περιεχόμενα
Name of the medicinal product
Aurobeverine MR 200 mg modified-release capsules, hard.
Qualitative and quantitative composition
Each capsule contains 200 mg mebeverine hydrochloride. Excipient with known effect: Each capsule contains up to 23.81 mg sucrose. For the full list of excipients, see section 6.1.
Pharmaceutical form
Modified-release capsule, hard. Creamy white body and creamy white cap, hard gelatin capsule (approximately 9.8 mm x 6.9 mm) filled with white to off white spherical pellets.
Therapeutic indications
Adults and children over 10 years. For the symptomatic relief of irritable bowel syndrome.
Posology and method of administration
Posology Adults and children over 10 years One capsule of 200 mg twice daily; one in the morning and one in the evening. There are no safety risks for continued use up to a period of 1 year. However, once ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Special warnings and precautions for use
Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrose-isomaltese insufficiency should not take this medicine.
Interaction with other medicinal products and other forms of interaction
No interactions of mebeverine are known.
Fertility, pregnancy and lactation
Pregnancy There are no or limited amounts of data from the use of mebeverine in pregnant women. Animal studies are insufficient with respect to reproductive toxicity (see section 5.3). Mebeverine is not ...
Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed. The pharmacodynamic and pharmacokinetic profile as well as postmarketing experience do not indicate any harmful effect ...
Undesirable effects
The following adverse reactions have been reported spontaneously during postmarketing use. A precise frequency cannot be estimated from available data. Allergic reactions mainly but not exclusively limited ...
Overdose
Theoretically CNS excitability may occur in cases of overdose. In cases where mebeverine was taken in overdose, symptoms were either absent or mild and usually rapidly reversible. Observed symptoms of ...
Pharmacodynamic properties
Pharmacotherapeutic group: Synthetic anticholinergics, esters with tertiary amino group ATC code: A03AA04 Mechanism of action and pharmacodynamics effects Mebeverine is a musculotropic antispasmodic with ...
Pharmacokinetic properties
Absorption Mebeverine is rapidly and completely absorbed after oral administration of tablets. The modified release formulation permits a twice daily dosing scheme. Distribution No significant accumulation ...
Preclinical safety data
Effects in repeat-dose toxicity studies, after oral and parenteral doses, were indicative of central nervous involvement with behavioural excitation, mainly tremor and convulsions. In the dog, the most ...
List of excipients
Capsule core: Sugar spheres (sucrose, maize starch) Povidone Hypromellose SR coating: Ethylcellulose Macrogol Magnesium stearate Capsule shell: Gelatin Titanium dioxide (E171)
Incompatibilities
Not applicable.
Shelf life
For blister packs: 36 months. For HDPE container packs: 24 months. In use shelf life for HDPE container packs: 3 months.
Special precautions for storage
<u>Blister Pack:</u> Do not store above 30°C. Do not refrigerate or freeze. Store in the original package in order to protect from moisture. <u>HDPE container pack:</u> Store below 25°C. Store in the original ...
Nature and contents of container
<u>Blister pack:</u> PVC/PVdC – Aluminium blisters in cartons. Pack sizes of blister: 30 and 60 capsules. <u>HDPE container pack:</u> HDPE bottles fitted with round white screw type continuous thread cap. ...
Special precautions for disposal and other handling
No special requirements for disposal.
Marketing authorization holder
Milpharm Limited, Ares Block, Odyssey Business Park, West End Road, Ruislip HA4 6QD, United Kingdom
Marketing authorization number(s)
PL 16363/0492
Date of first authorization / renewal of the authorization
28/04/2017
Date of revision of the text
07/10/2019
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