SYNDOL TABLETS
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
30-05-2024
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Active ingredient:
PARACETAMOL CODEINE PHOSPHATE HEMIHYDRATE DOXYLAMINE SUCCINATE CAFFEINE
Available from:
Seton Products Ltd
Pharmaceutical form:
Tablets
Authorization date:
1994-04-17
Summary of Product characteristics
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Syndol Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
_For a full list of excipients, see section 6.1._
3 PHARMACEUTICAL FORM
Tablet.
Yellow, capsule shaped tablet, embossed ‘SYNDOL’ on one side with a single breakline on the reverse.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the symptomatic relief in tension headache and other pains of a similar tension state origin. For the symptomatic
relief of pain following surgical and dental operations and procedures.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Adults and children over 12 years
Take 1 or 2 tablets every four to six hours as need for relief. Do not exceed 8 tablets per day. Not recommended for
children under 12 years.
4.3 CONTRAINDICATIONS
Use in patients hypersensitive to any of the ingredients.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
The product should not be administered to children under the age of 12 years unless prescribed specifically by the
physician.
The use of this product may induce drowsiness. Persons should not drive or operate machinery unless this effect has
been shown not to occur.
It is dangerous to exceed the recommended dose. Prolonged regular use, except under medical supervision, may lead
to physical and psychological dependence (addiction) and result in withdrawal symptoms, such as restlessness and
irritability once the drug is stopped.
This product should only be used when clearly necessary. If symptoms persist or become worse, consult your doctor.
Paracetamol
450
mg
Codeine phosphate hemihydrate
10
mg
Doxylamine succinate
5
mg
Caffeine
30
mg
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 25/05/2010_
_CRN 2083312_
_pa
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