Carbocisteine

Carbocisteine 375 mg Capsules, hard

Each hard capsule contains 375 mg of carbocisteine

Excipient(s) with known effect:

Each capsule contains 22 mg lactose

For the full list of excipients, see section 6.1.

Capsule, hard (capsule)

Yellow, size 1 capsules marked “MUCODYNE 375” in black and containing a white to off-white powder or friable plug.

Carbocisteine is a mucolytic agent for the adjunctive therapy of respiratory tract disorders characterised by excessive, viscous mucus, including chronic obstructive airways disease.

Adults including the elderly:

Dosage is based upon an initial daily dosage of 2250mg carbocisteine in divided doses, reducing to 1500mg daily in divided doses when a satisfactory response is obtained e.g. two capsules three times a day reducing to one capsule four times a day.

Children:

This formulation is not recommended for children.

The normal daily dosage is 20mg/kg body weight in divided doses. It is recommended that this is achieved with Paediatric Syrup.

Method of Administration

Carbocisteine capsules are for oral use.

Hypersensitivity to carbocisteine or to any of the excipients (listed in section 6.1).

Use in patients with active peptic ulceration.

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, patients should discontinue medication.

Lactose

Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

None stated.

Although tests in mammalian species have revealed no teratogenic effects, carbocisteine is not recommended during the first trimester of pregnancy.

Use in lactation: Effects not known.

None stated.

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 (cannot be estimated from the available data).

Immune System Disorders

There have been reports of allergic skin eruptions, anaphylactic reactions and fixed drug eruption.

Gastrointestinal disorders

There have been reports of gastrointestinal bleeding occurring during treatment with carbocisteine, however the frequency is not known. Epigastric discomfort, vomiting, nausea and diarrhoea have also been observed, though the frequency of this occurrence is not known.

Skin and subcutaneous tissue disorders

There have been reports of skin rashes and allergic skin eruptions. Isolated cases of bullous dermatitis such as Stevens–Johnson syndrome and erythema multiforme have also been reported.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Gastric lavage may be beneficial, followed by observation. Gastrointestinal disturbance is the most likely symptom of carbocisteine over dosage.

ATC code: 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 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. The administration of carbocisteine to animals exposed to irritants indicates that the glycoprotein that is secreted remains normal; administration after exposure indicates that return to the normal state is accelerated. Studies in humans have demonstrated that carbocisteine reduces goblet cell hyperplasia. Carbocisteine can therefore be demonstrated to have a role in the management of disorders characterised by abnormal mucus.

Carbocisteine is rapidly absorbed from the GI tract. In an 'in-house' study, at steady state (7 days) carbocisteine 375mg capsules given as 2 capsules t.d.s. to healthy volunteers gave the following pharmacokinetic parameters:

There are no preclinical data of relevance to the prescriber, which are additional to those already included in other sections of the SmPC.

Capsule contents

Magnesium stearate (E572)

Silica, anhydrous collodial (E551)

Lactose monohydrate

Sodium lauril sulfate

Capsule Shell

Gelatin

Quinoline yellow (E104)

Sunset yellow (E110)

Titanium dioxide (E171)

Not applicable.

36 months.

Store below 25°C.

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.

PVC/PVDC/AL Blister packs of 120, 30, 18 or 6 capsules.

Not all pack sizes may be marketed.

No special requirements.

Zentiva Pharma UK Limited

12 New Fetter Lane

London

EC4A 1JP

United Kingdom

PL 17780/0597

21/08/2013

11/10/2021