Carbocisteine 375 Mg Capsules Hard
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Carbocisteine 375 mg capsules, hard
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 375 mg carbocisteine.
Excipients with known effect:
Lactose monohydrate (13.75 mg/capsule).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Capsules, hard
Turmeric yellow, size 1 gelatin capsule, imprinted “6C1” on cap and “375” on body with black ink, containing white to off-white granular powder.
4 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. two capsules three times a day reducing to one capsule four times a day.
Paediatric population
Carbocisteine capsules should not be used in children.
Method of administration
For oral administration.
4.3 Contraindications
Hypersensitivity to the active substance 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
This product contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine. Caution is recommended in patients with peptic ulcers.
4.5 Interaction with other medicinal products and other forms of interaction
None stated.
4.6 Fertility, pregnancy and lactation
Pregnancy
Studies in animals have shown no evidence of teratogenicity. Carbocisteine is not recommended during the first trimester of pregnancy.
Breast-feeding
There is no data on excretion of carbocisteine into breast milk.
4.7 Effects on ability to drive and use machines
Not applicable.
4.8 Undesirable effects
The frequencies of adverse events are ranked according to the following: 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).
The following side effects have been reported:
Immune System Disorders
Frequency unknown: There have been reports of anaphylactic reactions and
fixed drug eruption.
Gastrointestinal disorders Rare: Nausea, diarrhoea
Very rare: Abdominal pain
Frequency unknown: There have been rare reports of gastrointestinal bleeding occurring during treatment with carbocisteine.
Skin and subcutaneous tissue disorders
Very rare: Allergic skin reactions such as pruritus, urticaria and rash 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.
4.9 Overdose
Gastric lavage may be beneficial, followed by observation. Gastrointestinal disturbance is the most likely symptom of carbocisteine overdosage.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Cough and cold preparations, mucolytics 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 one 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 |
|
T/ (Hr) |
1.87 |
1.4-2.5 |
|
Kel (Hr-1 ) |
0.387 |
0.28-0.50 |
|
AUCo-75 (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.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Lactose monohydrate Sodium laurilsulfate
Silica, colloidal anhydrous
Magnesium stearate
Capsule cap/body: Gelatin
Sodium laurilsulfate Iron oxide yellow (E172) Titanium dioxide (E171)
Shellac
Black iron oxide (E172) Propylene glycol Potassium hydroxide
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
36 months.
6.4 Special precautions for storage
Do not store above 25°C
6.5 Nature and contents of container
Aluminium/PVC/PE/PVdC blister pack containing 30, 100 or 120 capsules.
Polypropylene container with polypropylene screw cap (160 ml) containing 100 capsules.
Not all pack sizes may be marketed.
6.6 Special precautions for disposal
None stated.
7 MARKETING AUTHORISATION HOLDER
Teva UK Limited,
Brampton Road,
Hampden Park,
Eastbourne,
East Sussex,
BN22 9AG,
UNITED KINGDOM
8 MARKETING AUTHORISATION NUMBER(S)
PL 00289/1500
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
18/09/2012
10 DATE OF REVISION OF THE TEXT
26/10/2016