DIMOTANE CO
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
19-04-2024
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Active ingredient:
BROMPHENIRAMINE MALEATE PSEUDOEPHEDRINE HYDROCHLORIDE CODEINE PHOSPHATE
Available from:
Pfizer Consumer Healthcare Ltd
Dosage:
2/30/10 MG/5ml
Pharmaceutical form:
Oral Solution
Authorization date:
2001-03-14
Summary of Product characteristics
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Dimotane Co. Oral solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 ml of liquid contains:
For full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral solution
A clear, dark pink solution with the odour of raspberry.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the treatment of cough associated with colds and other similar conditions for the upper respiratory tract.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Taken orally.
ADULTS:
1 x 10 ml measures 3 times daily.
CHILDREN:
6 - 12 years:
1 x 5 - 7.5 ml measures 3 times daily.
4 - 6 years:
1 x 5 ml measure 3 times daily.
2 - 4 years:
1 x 2.5 ml measures 3 times daily.
Under 2 years:
Not to be used.
4.3 CONTRAINDICATIONS
Use in patients hypersensitive to the active ingredients.
Use in patients, especially children with glaucoma, urinary retention, high blood pressure, diabetes or thyroid disease.
Brompheniramine Maleate
2.0 mg
Pseudoephedrine Hydrochloride
30.0 mg
Codeine Phosphate (as hemihydrate)
10.0 mg
Excipients:
Sorbitol (E420)
1187.2 mg
Ethanol
95.6 mg
Amaranth (E123)
0.13 mg
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 23/01/2007_
_CRN 2032625_
_page number: 1_
Use in patients who are currently receiving other sympathomimetic drugs.
Use in patients who are receiving or have received within 14 days tricyclic anti-depressants or monoamine oxidase
inhibitors.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
This product may cause drowsiness and patients receiving it should not drive or operate machinery unless it has been
shown that their physical and mental capacity remains unaffected.
This product may potentiate the effects of alcohol and ot
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