ERDOTIN Capsules, hard (2019)
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Περιεχόμενα
Name of the medicinal product
Erdotin 300 mg capsules.
Qualitative and quantitative composition
Each capsule contains 300 mg of erdosteine. For full list of excipients, see section 6.1.
Pharmaceutical form
Capsules, hard. The product appears as a capsule with a green cap and a yellow body.
Therapeutic indications
As an expectorant. For the symptomatic treatment of acute exacerbations of chronic bronchitis in adults.
Posology and method of administration
Elderly and adults above 18 years: 300 mg twice daily for maximum 10 days. The capsules must be swallowed whole with a glass of water.
Contraindications
Hypersensitivity to the active substance or to any of the other excipients. Since there are no data in patients with creatinine clearance <25ml/min, or with severe liver failure, the use of erdosteine ...
Special warnings and precautions for use
No increase in adverse events has been observed with erdosteine in patients with mild liver failure; however these patients should not exceed a dose of 300 mg per day.
Interaction with other medicinal products and other forms of interaction
No adverse interactions have been reported.
Pregnancy and lactation
Pregnancy There is no experience for the use of erdosteine in pregnant women. Lactation Experience is missing. Therefore, the use of erdosteine in pregnant or breast-feeding women is not recommended. ...
Effects on ability to drive and use machines
Erdotin has minor or negligible influence on the ability to drive and use machines.
Undesirable effects
Nervous system disorders Uncommon (≥1/1,000 to <1/100): Headache Respiratory, thoracic and mediastinal disorders Uncommon (≥1/1,000 to <1/100): Cold, dyspnoea Gastrointestinal disorders Uncommon (≥1/1,000 ...
Overdose
No experience of acute overdosage is available. Symptomatic treatment and general supportive measures should be followed in all cases of overdosage. Gastric lavage may be beneficial, followed by observation. ...
Pharmacodynamic properties
Pharmacotherapeutic group: Mucolytic agent ATC Code: R05CB15 Mucolytic agent reducing the viscosity of mucus and purulent sputum. Erdosteine is a prodrug, becoming active after metabolism whereby free ...
Pharmacokinetic properties
Absorption Erdosteine is quickly absorbed after oral administration and rapidly transformed through a first-pass metabolism to its biologically active metabolite – N-thiodiglycolyl-homocysteine (M1). ...
Preclinical safety data
Preclinical safety data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and toxicity to reproduction.
List of excipients
Capsule content: Microcrystalline cellulose Povidone Magnesium stearate Capsule shell: Gelatin Titanium dioxide (E171) Iron oxide, yellow (E172) Indigotine (E132)
Incompatibilities
Not applicable.
Shelf life
Shelf life: 3 years.
Special precautions for storage
Do not store above 25°C.
Nature and contents of container
Each PVC/PVdC/Aluminium blister pack contains 10 capsules. Pack-sizes of 20 or 60 capsules per carton. Not all pack sizes may be marketed.
Special precautions for disposal and other handling
No special requirements.
Marketing authorization holder
Galen Limited, Seagoe Industrial Estate, Craigavon, BT63 5UA, UK
Marketing authorization number(s)
PL 27827/0039
Date of first authorization / renewal of the authorization
27/09/2011
Date of revision of the text
23 May 2019
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