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Buy carbocisteine Online

1. Respect of the healing product

Carbocisteine 375 mg Capsules, Hard

2. Qualitative and quantitative composition

Each capsule contains 375 mg of Carbocisteine.

Excipient (s) with known implication: Lactose (each capsule contains 13.750 mg of Lactose monohydrate)

For stacked schedule of excipients, meaning of part 6.1

3. Pharmaceutical form

Capsule, hard.

Golden yellow colored cap/ White-haired yellow colored trunk, volume “ 1” hard gelatin capsules imprinted “ 6C1” on head covering and “ 375” on portion with sinister ink, containing whey-faced to off hoary granulated powder.

4. Clinical particulars
4.1 Restorative indications

Carbocisteine is a mucolytic vehicle for the adjunctive remedial programme of respiratory dissertation disorders characterised by unreasonable, viscous mucus, including inveterate obstructive airways disease.

4.2 Posology and method of administration

Posology

Adults including the elderly:

Dosage is based upon an endorse daily dosage of 2250mg Carbocisteine in divided doses, reducing to 1500mg regularly in divided doses when a all right retort is obtained e.g. two capsules three times a prime reducing to one capsule four times a day.

Paediatric population:

This formulation is not recommended exchange for children. It is recommended that syrup formulation of this anaesthetize be administered at a conformist everyday amount of 20 mg/kg cadaver moment in divided doses.

Method of administration

Carbocisteine 375 mg Capsules are representing spoken use.

4.3 Contraindications

• Hypersensitivity to the operative theme(s) or to any of the excipients listed in division 6.1.

• Use in patients with on the move peptic ulceration.

4.4 Noteworthy warnings and precautions to use

• Caution is recommended in the elderly, in those with a history of gastro duodenal ulcers, or those attractive concomitant medications known to give rise to gastrointestinal bleeding. If gastrointestinal bleeding occurs, patients should discontinue medication.

• Patients with rare hereditary problems of galactose bigotry, total lactase deficiency or glucose-galactose malabsorption should not fill up e deal with 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 at one's fingertips facts on carbocisteine turn to account in weighty women. No conclusions can be exhausted regarding whether or not carbocisteine is tried payment utilization during pregnancy. The use of carbocisteine in suggestive women is not recommended, singularly during the first trimester.

Breast-feeding There are no to hand observations on the cool of carbocisteine in human being milk, exploit moulding, or the effects on the breastfed infant. No conclusions can be pinched in re whether or not carbocisteine is safe in return avail oneself of during breastfeeding. The use of carbocisteine in breastfeeding women is not recommended.

Fertility

There is no consistent verification on the effects of this product on fertility in males or females.

4.7 Effects on knack to goad and make use of machines

Carbocisteine has no or slight bias on the wit to journey and expend machines.

4.8 Undesirable effects

The following CIOMS frequency rating is acclimatized, when germane: Very conventional (≥ 1/10); shared (≥ 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 matter).

Immune Technique Disorders

There obtain been reports of anaphylactic reactions, allergic skin eruption and established poison eruption.

Gastrointestinal disorders

There possess been reports of diarrhoea, nausea, epigastric ache and gastrointestinal bleeding occurring during treatment with Carbocisteine.

Frequency not known: vomiting, gastrointestinal bleeding.

Skin and subcutaneous combination disorders

There have been reports of hull rashes and allergic veneer eruptions. Special cases of dermatitis bullous such as Stevens– Johnson syndrome and erythema multiforme be subjected to also been reported.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal commodity is important. It allows continued monitoring of the benefit/risk equalize of the medicinal product. Healthcare professionals are asked to record any suspected adverse reactions via the national reporting approach, Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

4.9 Overdose

Gastric lavage may be efficacious, followed sooner than observation. Gastrointestinal disarrangement is the most undoubtedly symptom of Carbocisteine Capsules overdose.

5. Pharmacological properties
5.1 Pharmacodynamic properties

ATC lex scripta 'statute law': R05CB03

Mechanism of action

Carbocisteine (S-carboxymethyl L-cysteine) has been shown in run-of-the-mill and bronchitic crude models to put on the make-up and amount of mucus glycoprotein which is secreted through the respiratory tract. An multiplication in the acid: non-partisan glycoprotein correspondence of the mucus and a modification of serous cells to mucus cells are known to be the introductory reply to irritation and will normally be followed via hyper secretion. The administering of Carbocisteine to animals exposed to irritants indicates that the glycoprotein that is secreted remains common; regulation after risk indicates that restitution yield to the standard state is accelerated. Studies in humans suffer with demonstrated that Carbocisteine reduces goblet cubicle hyperplasia. Carbocisteine can thus be demonstrated to set up a function in the top brass of disorders characterised by way of unusual mucus.

5.2 Pharmacokinetic properties

Carbocisteine is lickety-split rapt from the gastrointestinal tract. In an 'in-house' over, at unremitting official (7 days) Carbocisteine 375 mg Capsules given as two capsules three times constantly to sturdy 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

-

*Planned from dispense for day 7 of on

5.3 Preclinical safety data

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

6. Pharmaceutical particulars
6.1 Beadroll of excipients

Capsule volume:

Carbocisteine

Lactose monohydrate

Sodium Lauryl sulfate

Silica, colloidal anhydrous

Magnesium Stearate

Capsule Disburse:

Gelatin

Sodium Lauryl sulfate

Size 1 gold yellow gelatin capsules containing iron oxide yellow (E172)

Titanium dioxide (E171)

6.2 Incompatibilities

Not Applicable.

6.3 Shelf life

36 months.

6.4 Valued precautions for storage

Store below 30° C.

6.5 Temperament and contents of container

Polypropylene container with polypropylene screw beat, containing 30 or 100 capsules.

PVC/PE/PVDC-Aluminium blister packs of 6, 18, 30 or 120 capsules

Not all kit sizes may be marketed.

6.6 Specific precautions with a view disposal and other handling

No special requirements.

7. Marketing authorisation holder

Brown & Burk UK Limited

5 Marryat Confined, Hounslow West

Middlesex, TW4 5DQ

United Kingdom

8. Marketing authorisation number(s)

PL 25298/0247

9. Date of at the outset authorisation/renewal of the authorisation

24/10/2019

10. Stage of re-examination of the text

30/10/2020

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