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

Logo PEDIMED PAEDIATRIC SUSPENSION
SCHEDULING STATUS:
Not scheduled

PROPRIETARY NAME
(and dosage form):

PEDIMED PAEDIATRIC SUSPENSION

COMPOSITION:
Each 10 mL contains:
Aluminium hydroxide equivalent to
Aluminium Oxide		 200 mg
Magnesium oxide 200 mg
Methylpolysiloxane 50 mg
Preservatives: 
Chloroform 0,2% v/v
Benzyl alcohol 0,30% v/v
Nipastat 0,20% m/v

PHARMACOLOGICAL CLASSIFICATION:
Category A 11.4.1 Antacid - Acid neutralisers.

PHARMACOLOGICAL ACTION:
Pedimed contains antacids and a surfactant. The antacids neutralize excessive stomach acid, while the surfactant, methylpolysiloxane, reduces the surface tension of the frothy gastric contents and so allows gas to coalesce and escape.

INDICATIONS:
For the relief of concurrent symptoms of gas/flatulence associated with hyperacidity in children.

CONTRA-INDICATIONS:
Sensitivity to any of the active ingredients and impaired renal function.

DOSAGE AND DIRECTIONS FOR USE:
NOTE: 1 medicine measure = 5 mL
Children:
  Older than 1 month to 24 months = 2,5 mL
  2 to 5 years = 5 mL
  5 to 10 years = 7,5 mL
To be taken 15 minutes before meals, or as directed by a doctor. Not to be used in children under the age of one month.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Aluminium: Nausea, vomiting and constipation. Large doses can cause obstruction. Excessive or normal doses in patients with low phosphate diet may cause phosphate depletion accompanied by increased resorbtion and urinary excretion of calcium with the risk of osteomalacia. Osteomalacia, with chronic renal failure on high aluminium dose as a phosphate-binding agent.
Magnesium: May cause diarrhoea. Hypomagnesaemia may occur if renal function is impaired.
Aluminium and magnesium may alter the absorption of other medicines from the gastro-intestinal tract if administered concomitantly.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Constipation or diarrhoea. Treatment is symptomatic and supportive.

IDENTIFICATION:
White suspension.

PRESENTATION:
150 mL glass bottle.

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

REGISTRATION NUMBER:
E/11.4.1/944

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
ADCOCK INGRAM LIMITED
Adcock Ingram Park
17 Harrison Avenue
Bryanston Ext.77, 2021
Private Bag X69
Bryanston, 2021

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
12/09/1994

New addition to this site: May 2004
Source: Pharmaceutical Industry

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