- Approval Id
- ec807b1df4b4f164
- Drug Approval Emc Name
- Carbocisteine 750 mg Capsules, Hard
- Drug Name
- Carbocisteine 750 mg Capsules, Hard
- Company Name
- Brown & Burk UK Ltd
- Company Address
- Brown & Burk UK Limited, Micro House, Bury Street, Ruislip, HA4 7TL, UK
- Company Website
- //www.bbukltd.com
- Company Telephone
- +44 (0)203 384 7188
- Company Medical Info Direct Line
- +44 (0)203 384 7188
- Company Medical Info Email
- pv@bbukltd.com
- Company Customer Care Direct Line
- +44 (0)203 384 7188
- Company Medical Info Fax
- +44 (0)208 588 5411
- Company Stock Availability
- +44 (0)203 384 7188
- Atc Code
- R05CB03
- Legal Category
- Prescription only medicine
- Authorisation Holder
- Brown & Burk UK Limited
5 Marryat Close, Hounslow West
Middlesex, TW4 5DQ
United Kingdom
- Authorisation Number
- PL 25298/0226
- Authorisation Date
- 20/05/2025
- Instruction Authorisation Holder
- Brown & Burk UK Limited
5 Marryat Close, Hounslow West
Middlesex, TW4 5DQ
United Kingdom
- Instruction Authorisation Number
- PL 25298/0226
- Instruction Authorisation Date
- 20/05/2025
- Instruction Composition
- Each capsule contains 750 mg of Carbocisteine.
Excipient (s) with known effect: Lactose (each capsule contains 27.50 mg of Lactose monohydrate)
For full list of excipients, see section 6.1
- Instruction Dosage Form
- Capsule, hard.
Turmeric yellow coloured cap/ Turmeric yellow coloured body, size “00” hard gelatin capsules imprinted “6C2” on cap and “750” on body with black ink, containing white to off white granular powder.
- 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
\*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 obtained e.g. one capsules three times a day reducing to one capsule two times a day.
\*Paediatric population\*:
This formulation is not recommended for children. The normal daily dosage is 20 mg/kg body weight in divided doses. It is recommended that this is achieved with carbocisteine paediatric syrup.
\*Method of administration\*
Carbocisteine 750 mg Capsules are for oral use.4.3 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.4.4 Special warnings and precautions for use
Caution is recommended in the elderly, in those with a history of gastro duodenal ulcers, or those taking concomitant medications known to cause gastrointestinal bleeding. If gastrointestinal bleeding occurs, patients should discontinue medication.
Patients with rare hereditary problems of galactose intolerance, total 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
\*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 in pregnant women is not recommended, especially during the first trimester.
\*Breast-feeding\*
There are no available data on the presence of carbocisteine in human milk, milk production, or the effects on the breastfed infant. No conclusions can be drawn regarding whether or not carbocisteine is safe for use during breastfeeding. The use of carbocisteine in breastfeeding women is not recommended.
\*Fertility\*
Experimental data did not demonstrate any effect on male and female fertility in rat.4.7 Effects on ability to drive and use machines
Carbocisteine has no or negligible influence on the ability to drive and use machines.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 anaphylactic reactions, allergic skin eruption and fixed drug eruption.
Gastrointestinal disorders
There have been reports of diarrhoea, nausea, epigastric discomfort and gastrointestinal bleeding occurring during treatment with Carbocisteine.
Frequency not known: vomiting, gastrointestinal bleeding.
Skin and subcutaneous tissue disorders
There have been reports of skin rashes and allergic skin eruptions. Isolated cases of dermatitis bullous 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 national reporting system, Yellow Card Scheme at: www.mhra.gov.uk/yellowcard4.9 Overdose
Gastric lavage may be beneficial, followed by observation. Gastrointestinal disturbance is the most likely symptom of Carbocisteine overdose.
- Instruction Pharmacology
- 5.1 Pharmacodynamic properties
ATC code: R05CB03
Mechanism of action
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 capsules 375 mg 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 study5.3 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 content:
Carbocisteine
Lactose monohydrate
Sodium Laurilsulfate
Silica, colloidal anhydrous
Magnesium Stearate
Capsule Shell:
Gelatin
Sodium Laurilsulfate
Iron oxide yellow
Titanium dioxide
Printing Ink:
Shellac
Isopropyl alcohol
Butyl alcohol
Dehydrated alcohol
Propylene glycol
Strong Ammonium solution
Black Iron Oxide
Potassium hydroxide6.2 Incompatibilities
Not Applicable.6.3 Shelf life
3 years6.4 Special precautions for storage
Store below 30°C.6.5 Nature and contents of container
PVC/PE/PVdC-Aluminium blister packs of 30 or 60 capsules
Not all pack sizes may be marketed.6.6 Special precautions for disposal and other handling
No special requirements.
- Instruction Content
- ## Composition
Each capsule contains 750 mg of Carbocisteine.
Excipient (s) with known effect: Lactose (each capsule contains 27.50 mg of Lactose monohydrate)
For full list of excipients, see section 6.1
## Pharmaceutical Form
Capsule, hard.
Turmeric yellow coloured cap/ Turmeric yellow coloured body, size “00” hard gelatin capsules imprinted “6C2” on cap and “750” on body with black ink, containing white to off white granular powder.
## 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
\*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 obtained e.g. one capsules three times a day reducing to one capsule two times a day.
\*Paediatric population\*:
This formulation is not recommended for children. The normal daily dosage is 20 mg/kg body weight in divided doses. It is recommended that this is achieved with carbocisteine paediatric syrup.
\*Method of administration\*
Carbocisteine 750 mg Capsules are for oral use.4.3 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.4.4 Special warnings and precautions for use
Caution is recommended in the elderly, in those with a history of gastro duodenal ulcers, or those taking concomitant medications known to cause gastrointestinal bleeding. If gastrointestinal bleeding occurs, patients should discontinue medication.
Patients with rare hereditary problems of galactose intolerance, total 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
\*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 in pregnant women is not recommended, especially during the first trimester.
\*Breast-feeding\*
There are no available data on the presence of carbocisteine in human milk, milk production, or the effects on the breastfed infant. No conclusions can be drawn regarding whether or not carbocisteine is safe for use during breastfeeding. The use of carbocisteine in breastfeeding women is not recommended.
\*Fertility\*
Experimental data did not demonstrate any effect on male and female fertility in rat.4.7 Effects on ability to drive and use machines
Carbocisteine has no or negligible influence on the ability to drive and use machines.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 anaphylactic reactions, allergic skin eruption and fixed drug eruption.
Gastrointestinal disorders
There have been reports of diarrhoea, nausea, epigastric discomfort and gastrointestinal bleeding occurring during treatment with Carbocisteine.
Frequency not known: vomiting, gastrointestinal bleeding.
Skin and subcutaneous tissue disorders
There have been reports of skin rashes and allergic skin eruptions. Isolated cases of dermatitis bullous 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 national reporting system, Yellow Card Scheme at: www.mhra.gov.uk/yellowcard4.9 Overdose
Gastric lavage may be beneficial, followed by observation. Gastrointestinal disturbance is the most likely symptom of Carbocisteine overdose.
## Pharmacological Properties
5.1 Pharmacodynamic properties
ATC code: R05CB03
Mechanism of action
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 capsules 375 mg 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 study5.3 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 content:
Carbocisteine
Lactose monohydrate
Sodium Laurilsulfate
Silica, colloidal anhydrous
Magnesium Stearate
Capsule Shell:
Gelatin
Sodium Laurilsulfate
Iron oxide yellow
Titanium dioxide
Printing Ink:
Shellac
Isopropyl alcohol
Butyl alcohol
Dehydrated alcohol
Propylene glycol
Strong Ammonium solution
Black Iron Oxide
Potassium hydroxide6.2 Incompatibilities
Not Applicable.6.3 Shelf life
3 years6.4 Special precautions for storage
Store below 30°C.6.5 Nature and contents of container
PVC/PE/PVdC-Aluminium blister packs of 30 or 60 capsules
Not all pack sizes may be marketed.6.6 Special precautions for disposal and other handling
No special requirements.
