MESTINON Tablet (2018)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Mestinon 60 mg Tablets.
Qualitative and quantitative composition
Each tablet contains 60 mg pyridostigmine bromide. For the full list of excipients, see section 6.1.
Pharmaceutical form
Tablet for oral administration. White to off-white, round, biplanar, bevel-edged tablets imprinted with V/M60 across one face and with two break marks forming a cross on the other.
Therapeutic indications
Myasthenia gravis, paralytic ileus and post-operative urinary retention.
Posology and method of administration
Posology Myasthenia gravis Adults Doses of 30 to 120mg are given at intervals throughout the day when maximum strength is needed (for example, on rising and before mealtimes). The usual duration of action ...
Contraindications
Mestinon is contra-indicated in patients with: Hypersensitivity to the active substance, bromides or to any of the excipients listed in section 6.1. Mechanical gastro-intestinal or urinary obstruction. ...
Special warnings and precautions for use
Extreme caution is required when administering Mestinon to patients with obstructive respiratory diseases like bronchial asthma and chronic obstructive pulmonary disease (COPD). Care should also be taken ...
Interaction with other medicinal products and other forms of interaction
Immunosuppressant drugs The requirement for pyridostigmine bromide could be decreased when additional therapy (steroids, immunosuppressant drugs) is given although peak plasma concentration and AUC of ...
Pregnancy and lactation
The safety of Mestinon during pregnancy or lactation has not been established. Although the possible hazards to mother and child must be weighed against the potential benefits in every case, experience ...
Effects on ability to drive and use machines
Due to miosis and accommodation disorders caused by pyridostigmine bromide or an inadequate treatment of Myasthenia gravis, Mestinon may impair visual acuity and consequently the ability to react as well ...
Undesirable effects
As with all cholinergic products, Mestinon may have unwanted functional effects on the autonomic nervous system. Muscarine-like adverse effects may be exhibited as nausea, vomiting, diarrhoea, abdominal ...
Overdose
Overdosage may lead to cholinergic crisis characterised by severe muscarinic and nicotinic symptoms of marked muscle weakness. Cardiovascular and respiratory failure may occur. Signs of overdosage due ...
Pharmacodynamic properties
Pharmacotherapeutic group: Nervous system, parasympathomimetics, anticholinesterases, pyridostigmine ATC code: N07AA02 Mestinon is an antagonist to cholinesterase, the enzyme which normally destroys acetylcholine. ...
Pharmacokinetic properties
Oral pyridostigmine bromide is poorly absorbed. Maximum plasma concentrations occur at 1 to 2 hours and it is eliminated by the kidney largely unchanged with a half-life of 3 to 4 hours.
Preclinical safety data
There are no preclinical data of relevance to the prescriber, which are additional to those already included in other sections of the SmPC.
List of excipients
<u>Each tablet contains:</u> Lactose Starch Precipitated silica Talc Magnesium stearate Purified water
Incompatibilities
Not applicable.
Shelf life
3 years.
Special precautions for storage
Store below 25°C. Store in the original package in order to protect from light and moisture.
Nature and contents of container
Amber glass bottles with aluminium screw or low density polyethylene caps and desiccant containing 200 tablets.
Special precautions for disposal and other handling
No special requirements for disposal.
Marketing authorization holder
Mylan Products Ltd, Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom
Marketing authorization number(s)
PL 46302/0133
Date of first authorization / renewal of the authorization
1 March 1998
Date of revision of the text
27 February 2018
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