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MUCODYNE Capsule, hard (2021)

Active ingredients: Carbocisteine

Product Name and Form

Mucodyne 375 mg Capsules, Hard.

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.

Qualitative and Quantitative Composition

Carbocisteine 375 mg.

For the full list of excipients, see section 6.1.

Chemical substance
Description
Carbocisteine

Carbocisteine (5-carboxymethyl L-cysteine) has been shown in normal and bronchitic animal models to affect the nature and amount of mucus glycoprotein that is secreted by the respiratory tract. An increase in the acid:neutral glycoprotein ratio of the mucus and a transformation of serous cells to mucus cells is known to be the initial response to irritation and will normally be followed by hypersecretion.

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 iron oxide (E172).

Pack sizes and Marketing

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 6 capsules.

Not all pack sizes may be marketed.

Marketing authorization holder
Authorization dates

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

7 February 2009

Marketing authorization number:

PL 04425/0203