ATROPINE Tablet (2016)
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Περιεχόμενα
Name of the medicinal product
Atropine Sulfate 600 micrograms Tablets.
Qualitative and quantitative composition
Atropine sulfate 600 micrograms. Excipients: lactose. For a full list of excipients, see section 6.1.
Pharmaceutical form
Tablet for oral use.
Therapeutic indications
Non ulcer dyspepsia Irritable bowel syndrome Diverticular disease
Posology and method of administration
Adults: 0.6mg-1.2mg as a single night time dose. Elderly and Children: Atropine should be used with caution employing a suitably reduced dose.
Contraindications
Atropine is contraindicated in patients with prostatic enlargement, as it may lead to urinary retention. Atropine should not be used in patients with paralytic ileus or pyloric stenosis. Atropine is contraindicated ...
Special warnings and precautions for use
Use with caution in patients with urinary retention, acute myocardial infarction, hypertension, conditions associated with tachycardia (including hyperthyroidism, cardiac insufficiency, cardiac surgery), ...
Interaction with other medicinal products and other forms of interaction
Alcohol: Marked impairment of attention can occur with alcohol, sufficient to make driving more hazardous (see 4.7 Effects on Ability to Drive and Use Machinery). Anti-arrhythmics: Increased antimuscarinic ...
Pregnancy and lactation
Atropine crosses the placenta and traces are found in breast milk. It should therefore only be used with caution.
Effects on ability to drive and use machines
Atropine may cause visual disturbances, giddiness and staggering. In addition, marked impairment of attention can occur with alcohol (see 4.5 Interactions). If affected, patients should be cautioned against ...
Undesirable effects
Some of the central effects of atropine seen at toxic doses (see section 4.9) may also occur at therapeutic doses. Immune system disorders: Hypersensitivity. In rare cases a fever may develop. Psychiatric ...
Overdose
There is considerable variation in susceptibility to atropine; recovery has occurred even after 1g, whereas deaths have been reported from doses of 100mg or less for adults and 10mg for children. Symptoms ...
Pharmacodynamic properties
Atropine is an antimuscarinic agent. These substances are competitive inhibitors of acetylcholine at muscarinic receptors of autonomic effector sites with parasympathetic innervation.
Pharmacokinetic properties
Atropine is readily absorbed from the gastro-intestinal tract and mucous membranes. It is absorbed from the eye and to a lesser extent through intact skin. It is rapidly cleared from the blood and is distributed ...
Preclinical safety data
There are no preclinical data of relevance to the prescriber which are additional to those already included in other sections.
List of excipients
Maize starch Lactose Magnesium stearate Stearic acid Ethanol 96%
Incompatibilities
None known.
Shelf life
Three years in polypropylene/polyethylene containers. Two years in strip packs.
Special precautions for storage
Do not store above 25°C. Store in the original container.
Nature and contents of container
Polyethylene or polypropylene containers with tamper evident closure strips of 28, 30, 56, 60, 84, 90 or 100 tablets. Strip packs of 28, 30, 56, 60, 84 or 90 tablets.
Special precautions for disposal and other handling
None.
Marketing authorization holder
Wockhardt UK Ltd, Ash Road North, Wrexham, LL13 9UF
Marketing authorization number(s)
PL 29831/0021
Date of first authorization / renewal of the authorization
Date of first authorisation: 19/10/1983 Date of latest renewal: 25/05/2002
Date of revision of the text
23/02/2016
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