MUCODYNE Capsule, hard (2021)
Βιβλιογραφική αναφορά
Στοιχεία εκδότη
| Εκδότης | SANOFI |
|---|---|
| Διεύθυνση | 1 Onslow Street, Guildford, Surrey, GU1 4YS, UK |
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Περιεχόμενα
Name of the medicinal product
Mucodyne 375 mg Capsules, Hard.
Qualitative and quantitative composition
Carbocisteine 375 mg. For the full list of excipients, see section 6.1.
Pharmaceutical form
Capsule, hard. Yellow, size 1 capsules, hard marked MUCODYNE 375 in black and containing a white to off-white powder or friable plug.
Therapeutic indications
Carbocisteine is a mucolytic agent for the adjunctive therapy of respiratory tract disorders characterised by excessive, viscous mucus, including chronic obstructive airways disease.
Posology and method of administration
Posology Adults including the elderly Dosage is based upon an initial daily dosage of 2250 mg Carbocisteine in divided doses, reducing to 1500 mg daily in divided doses when a satisfactory response is ...
Contraindications
Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1. Use in patients with active peptic ulceration.
Special warnings and precautions for use
Caution is recommended in the elderly, in those with a history of gastroduodenal ulcers, or those taking concomitant medications known to cause gastrointestinal bleeding. If gastrointestinal bleeding occurs, ...
Interaction with other medicinal products and other forms of interaction
None stated.
Pregnancy and lactation
Pregnancy There are no available data on carbocisteine use in pregnant women. No conclusions can be drawn regarding whether or not carbocisteine is safe for use during pregnancy. The use of carbocisteine ...
Effects on ability to drive and use machines
Mucodyne has no or negligible influence on the ability to drive and use machines.
Undesirable effects
The following CIOMS frequency rating is used, when applicable: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to ≤1/100); rare (≥1/10,000 to ≤1/1,000); very rare (≤1/10,000); not known ...
Overdose
Gastric lavage may be beneficial, followed by observation. Gastrointestinal disturbance is the most likely symptom of Mucodyne overdose.
Pharmacodynamic properties
<b>ATC code:</b> R05CB03 Carbocisteine (S-carboxymethyl L-cysteine) has been shown in normal and bronchitic animal models to affect the nature and amount of mucus glycoprotein which is secreted by the ...
Pharmacokinetic properties
Carbocisteine is rapidly absorbed from the GI tract. In an in-house study, at steady state (7 days) Mucodyne capsules 375 mg given as 2 capsules t.d.s. to healthy volunteers gave the following pharmacokinetic ...
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
Magnesium stearate (E572) Silica, anhydrous collodial (E551) Lactose monohydrate (spray dried) Sodium lauril sulfate Size 1 yellow opaque gelatin capsules containing titanium dioxide (E171) and yellow ...
Incompatibilities
Not applicable.
Shelf life
36 months.
Special precautions for storage
Store below 25°C.
Nature and contents of container
Grey HDPE tampertainer bottles with white LDPE cap or child resistant cap, or grey polypropylene securitainer bottles with white LDPE cap, containing 100 or 30 capsules. Blister packs of 120, 30, 18 or ...
Special precautions for disposal and other handling
No special requirements.
Marketing authorization holder
Aventis Pharma Limited, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK Trading as: Sanofi, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK
Marketing authorization number(s)
PL 04425/0203
Date of first authorization / renewal of the authorization
7 February 2009
Date of revision of the text
18/03/2021
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