- Approval Id
- b8488023ad852a28
- Drug Approval Emc Name
- Carbocisteine 375 mg Capsules, hard
- Drug Name
- Carbocisteine 375 mg Capsules, hard
- Company Address
- First Floor, Andrews House, College Road, Guildford, Surrey, GU1 4QB, UK
- Company Website
- https://www.zentiva.co.uk/contact/mi-form
- Company Medical Info Direct Line
- +44 (0)800 090 2408
- Company Medical Info Email
- UKMedInfo@zentiva.com
- Company Customer Care Direct Line
- +44 (0)844 8793 188
- Atc Code
- R05CB03
- Legal Category
- Prescription only medicine
- Authorisation Holder
- Zentiva Pharma UK Limited
12 New Fetter Lane
London
EC4A 1JP
United Kingdom
- Authorisation Number
- PL 17780/0597
- Authorisation Date
- 21/08/2013
- Instruction Authorisation Holder
- Zentiva Pharma UK Limited
12 New Fetter Lane
London
EC4A 1JP
United Kingdom
- Instruction Authorisation Number
- PL 17780/0597
- Instruction Authorisation Date
- 21/08/2013
- Instruction Composition
- 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.
- Instruction Dosage Form
- Capsule, hard (capsule)
Yellow, size 1 capsules marked “MUCODYNE 375” in black and containing a white to off-white powder or friable plug.
- Instruction Clinical Particulars
- 4.1 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.4.2 Posology and method of administration
\*\*\*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.4.3 Contraindications
Hypersensitivity to carbocisteine or to any of the excipients (listed in section 6.1).
Use in patients with active peptic ulceration.4.4 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, 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.4.5 Interaction with other medicinal products and other forms of interaction
None stated.4.6 Fertility, pregnancy and lactation
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.4.7 Effects on ability to drive and use machines
None stated.4.8 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 (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.4.9 Overdose
Gastric lavage may be beneficial, followed by observation. Gastrointestinal disturbance is the most likely symptom of carbocisteine over dosage.
- Instruction Pharmacology
- 5.1 Pharmacodynamic properties
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.5.2 Pharmacokinetic properties
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:
| | | |
| --- | --- | --- |
| \*\*Plasma Determinations\*\* | \*\*Mean\*\* | \*\*Range\*\* |
| T Max (Hr) | 2.0 | 1.0-3.0 |
| T½ (Hr) | 1.87 | 1.4-2.5 |
| KEL (Hr-1) | 0.387 | 0.28-0.50 |
| AUC0-7.5 (mcg.Hr.ml-1) | 39.26 | 26.0-62.4 |
| \*\*Derived Pharmacokinetic Parameters\*\* | | |
| \\*CLS (L.Hr-1) | 20.2 | - |
| CLS (ml.min-1) | 331 | - |
| VD (L) | 105.2 | - |
| VD (L.Kg-1) | 1/75 | - |
| \\*Calculated from dose for day 7 of study | | |5.3 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.
- Instruction Pharmaceutical Particulars
- 6.1 List of excipients
\*\*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)6.2 Incompatibilities
Not applicable.6.3 Shelf life
36 months.6.4 Special precautions for storage
Store below 25°C.6.5 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.
PVC/PVDC/AL Blister packs of 120, 30, 18 or 6 capsules.
Not all pack sizes may be marketed.6.6 Special precautions for disposal and other handling
No special requirements.
- Instruction Content
- ## Composition
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.
## Pharmaceutical Form
Capsule, hard (capsule)
Yellow, size 1 capsules marked “MUCODYNE 375” in black and containing a white to off-white powder or friable plug.
## Clinical Particulars
4.1 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.4.2 Posology and method of administration
\*\*\*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.4.3 Contraindications
Hypersensitivity to carbocisteine or to any of the excipients (listed in section 6.1).
Use in patients with active peptic ulceration.4.4 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, 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.4.5 Interaction with other medicinal products and other forms of interaction
None stated.4.6 Fertility, pregnancy and lactation
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.4.7 Effects on ability to drive and use machines
None stated.4.8 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 (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.4.9 Overdose
Gastric lavage may be beneficial, followed by observation. Gastrointestinal disturbance is the most likely symptom of carbocisteine over dosage.
## Pharmacological Properties
5.1 Pharmacodynamic properties
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.5.2 Pharmacokinetic properties
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:
| | | |
| --- | --- | --- |
| \*\*Plasma Determinations\*\* | \*\*Mean\*\* | \*\*Range\*\* |
| T Max (Hr) | 2.0 | 1.0-3.0 |
| T½ (Hr) | 1.87 | 1.4-2.5 |
| KEL (Hr-1) | 0.387 | 0.28-0.50 |
| AUC0-7.5 (mcg.Hr.ml-1) | 39.26 | 26.0-62.4 |
| \*\*Derived Pharmacokinetic Parameters\*\* | | |
| \\*CLS (L.Hr-1) | 20.2 | - |
| CLS (ml.min-1) | 331 | - |
| VD (L) | 105.2 | - |
| VD (L.Kg-1) | 1/75 | - |
| \\*Calculated from dose for day 7 of study | | |5.3 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.
## Pharmaceutical Particulars
6.1 List of excipients
\*\*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)6.2 Incompatibilities
Not applicable.6.3 Shelf life
36 months.6.4 Special precautions for storage
Store below 25°C.6.5 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.
PVC/PVDC/AL Blister packs of 120, 30, 18 or 6 capsules.
Not all pack sizes may be marketed.6.6 Special precautions for disposal and other handling
No special requirements.
- Company Detail Path
- /organization/sanofi-ilac-sanayi-ve-ticaret-anonim-sirketi
