INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo SOLMUCOL 200 and SOLMUCOL granules for solution
SOLMUCOL lozenges

SCHEDULING STATUS:
S2

PROPRIETARY NAME
(and dosage form):

SOLMUCOL 200 and SOLMUCOL granules for solution
SOLMUCOL lozenges

COMPOSITION:
Each Solmucol 200 sachet contains
N-acetylcysteine 200,0 mg
Each Solmucol 400 sachet contains N-acetylcysteine 400,0 mg
Each Solmucol lozenge contains N-acetylcysteine 100,0 mg

PHARMACOLOGICAL CLASSIFICATION:
A 10.2.2 Medicines acting on the respiratory system - other.

PHARMACOLOGICAL ACTION:
N-acetylcysteine has mucolytic action on mucoid secretions in the respiratory tract. It acts mostly on the mucoproteins, through its free sulfhydryl groups, to open disulphide bonds and lower the viscosity of the mucus.
The action of N-acetylcysteine in limiting hepatotoxicity after paracetamol overdosage is probably due to the replenishing of hepatic stores of glutathione.

INDICATIONS:
Solmucol is indicated as adjunctive therapy in respiratory conditions and to reduce the viscosity of non-infective secretions in patients with cystic fibrosis.
N-acetylcysteine is also effective in the treatment of paracetamol overdosage.

CONTRA-INDICATIONS:
Hypersensitivity to N-acetylcysteine. Safety in pregnancy has not been established.

WARNINGS
Use with caution in elderly patients with respiratory insufficiency or in asthmatic patients.

DOSAGE AND DIRECTIONS FOR USE:
The granules should be dissolved in a glass of water before administration.

The following dosages are recommended for the treatment of respiratory disorders:
Children up to 2 years: Solmucol 200 mg once daily
Children 2 - 6 years: Solmucol 200 mg twice daily
Adults: Solmucol 200 mg three times daily
For mucolytic therapy in cystic fibrosis, the following dosages are recommended:
(10 - 30 mg/kg/day)
Children 2 - 6 years: Solmucol 200 mg three times daily
Adults: Solmucol 200 - 400 mg three times daily.
In the treatment of paracetamol overdosage, the treatment regimen is a loading dose of 140 mg/kg, followed by the administration of 70 mg/kg every 4 hours for 17 doses.
The Solmucol therapy must be started as soon as possible. There are indications that it is still effective up to 16 hours after the ingestion of the paracetamol, and maybe longer.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Nausea, vomiting, stomatitis, rhinorrhea and bronchospasm have been reported.
Chills, fever, headache, tinnitus and urticaria have occurred. Haemoptysis has been reported.
Anaphylactic reactions have been reported. Solmucol should be used with caution in patients with recent gastro-duodenal ulceration.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
See side-effects above. Treatment is supportive and symptomatic.

IDENTIFICATION:
Solmucol 200 and Solmucol 400: Sachets containing orange-coloured granules with an orange odour. The reconstituted solution has an orange colour, taste, and odour, and is slightly opalescent.
Solmucol lozenges: Blisterpack containing 4 square white tablets with slightly rounded corners.

PRESENTATION:
Solmucol 200: Unit carton containing 20 sachets
Solmucol 400: Unit carton containing 30 sachets
Solmucol lozenges: Unit carton containing 6 blisterstrips, each containing 4 lozenges.

STORAGE INSTRUCTIONS:
Store in a cool dry place, below 25°C.
Protect from light.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
Solmucol 200: 28/10.2.2/0128
Solmucol 400: 28/10.2.2/0129
Solmucol lozenges: 28/10.2.2/0451

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Lagamed (Pty) Ltd
Reg no 68/11632/07
7 Eastern Service Road,
Eastgate Ext 8, Sandton

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
3 December 1993

IBSA
Institut Biochemique SA - 6903 Lugano - Suisse
                01.3137

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