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

Logo FLEMEX
FLEMEX-20 PLUS
SCHEDULING STATUS:
S2

PROPRIETARY NAME
(and dosage form):

FLEMEX
(syrup)
FLEMEX-20 PLUS
(capsule)

COMPOSITION:
Flemex:
Each 5 mL of syrup contains:
  Carbocisteine        250 mg
  Preservative: Sodium methylparaben 0,2% m/v
Flemex-20 Plus:
Each capsule contains:
  Carbocisteine        375 mg

PHARMACOLOGICAL CLASSIFICATION:
A: 10.1 Antitussives and Expectorants

PHARMACOLOGICAL ACTION:
Carbocisteine reduces the viscosity of non-infected secretions from mucus cells in the respiratory tract.

INDICATIONS:
Adjunctive therapy in respiratory tract disorders characterised by excessive, viscous mucus in the absence of infection.

CONTRA-INDICATIONS:
Hypersensitivity to the drug.
Active peptic ulcer.

DOSAGE AND DIRECTIONS FOR USE:
Flemex:
Adults: Two or three 5 mL medicine measuresful (10 - 15 mL) 3 times daily.
Children 5 - 12 years: One 5 mL medicine-measureful (5 mL) 3 times daily.
  2 - 5 years: Half 5 mL medicine-measureful (2,5 mL) 2 to 4 times daily (according to age).
Flemex-20 Plus:
Adults: Two capsules 3 times daily initially; reduce to 1 capsule four times daily after a satisfactory response has been obtained.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Nausea, diarrhoea, headache, gastric discomfort, gastro-intestinal bleeding and skin rash have occasionally been reported.
Caution must be exercised in patients with a history of gastric or duodenal ulcer.
Safe use in pregnancy and lactation has not been established.
Incompatibilities
Dilution with syrups containing codeine or pholcodine will cause precipitation.
The use of concomitant antitussive agents is not recommended.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
No known symptoms of overdosage.

IDENTIFICATION:
Flemex:        A red, raspberry flavoured syrup.
Flemex-20 Plus: A hard gelatin capsule having a turquoise opaque body and an aubergine opaque cap, imprinted in white ink with “FLEMEX 20 PLUS”and “PARKE DAVIS”.

PRESENTATION:
Flemex:        Bottles of 100 mL and 200 mL.
Flemex-20 Plus: Blister packs containing 30 capsules.

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

REGISTRATION NUMBERS:
Flemex:                M/10.1/248
Flemex-20 Plus:         Q/10.1/178

NAME AND BUSINESS ADDRESS OF APPLICANT:
PFIZER CONSUMER HEALTHCARE, Division of
Warner-Lambert S.A. (Pty) Ltd.
241 Main Road
RETREAT
7945

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
9 June 1983

Zimbabwe Details
Flemex: 90/22.2.4/2376 P
Flemex-20 Plus: 94/22.2.4/2827 P

Revised: MAR2002;DEC2001;JAN.95

Updated on this site: February 2005
Source: Pharmaceutical Industry

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