When a pharmaceutical company changes an SPC or PIL, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.
The rate of absorption of paracetamol may be increased by metoclopramide or domperidone and absorption reduced by cholestyramine.
Chronic alcohol intake can increase the hepatotoxicity of paracetamol overdose. Acute alcohol intake may diminish an individual's ability to metabolise large doses of paracetamol, the plasma half-life of which can be prolonged.
The use of drugs that induce hepatic micosomal enzymes, such as anticonvulsants and oral contraceptives, may increase the extent of metabolism of paracetamol, resulting in reduced plasma concentrations of the drug and a faster elimination rate.
Diphenhydramine hydrochloride may enhance the sedative effects of CNS depressants including barbituates, hypnotics, opioid analgesics, anxiolytic sedatives, antipsychotics and alcohol. It may also have an additive muscarinic action with other drugs such as atropine and some antidepressants.
A review of a group of patients with chronic active hepatitis failed to reveal differences in the abnormalities of liver function in those who were long-term users of paracetamol nor was the control of the disease improved after paracetamol withdrawal.
Mild cases of overdose with antihistamines are mainly characterised by prominent anticholinergic effects including dry mouth, headache, nausea, tachycardia and urinary retention. Larger overdoses will have additional antihistamine effects which may depress or stimulate the CNS. In small children, the stimulatory effects predominate and clinical features include hallucinations, ataxia and convulsions. The child may be hot, flushed and have dilated pupils. Cardiorespiratory depression and coma can subsequently develop followed by rapid death. Overdosing diphenhydramine in adults usually results in drowsiness followed by convulsions and coma. Fever and flushing are uncommon. Overdosed patients are best treated by gastric lavage and supportive measures. Administration of activated charcoal may be useful. Convulsions can be controlled with diazepam. Peripheral anticholinergic effects can be controlled with subcutaneous neostigmine.
Section 10 revised to May 2011
4.1 Therapeutic Indications
In the relief of teething pains, irritability associated with injections or feverishness, aches or pains, colds and flu, sleeplessness associated with the above conditions.
4.2 Posology and Method of Administration
Children aged 2 to 6 years: The usual dose is 5ml to 10ml (1-2 teaspoonsful) three to four times daily.
This product is no longer suitable for children under the age of two.4.3 Contraindications
Addition of: This medicine should not be used in children under two years of age.
4.4 Special Warnings and Precautions for Use
Removal of point 5 Do not give to children under three months except on doctor's advice, and addition of
8. Not more than 4 doses should be given in any 24 hours.
9. Patients should be instructed not to take any other cough and cold medicines with Teedex Oral Solution.
10. Parents should consult a pharmacist or other healthcare professional before use in children under years of age.
10. Date of (partial) revision of the text
September 2008
1. TRADE NAME OF THE MEDICINAL PRODUCT
Teedex Oral Solution
Paracetamol 120mg/5ml
Diphenhydramine Hydrochloride 12.5mg/5ml
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5ml contains: Paracetamol 120mg and Diphenhydramine hydrochloride 12.5mg.
Excipients: Also contains:
Propylene glycol 500mg/5ml
Sorbitol liquid (non-crystallising) (E420) 1.5g/5ml
Maltitol liquid (E965) 250mg/5ml
Amaranth Red (E123) 180 micrograms/5ml
E214 0.4mg/5ml
E218 1.825mg/5ml
and E216 0.275mg/5ml
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
Date of first authorisation: 01 April 1978
Date of last renewal: 01 April 2008
10. DATE OF REVISION OF THE TEXT
August 2008