Source: Υπουργείο Υγείας (CY) Revision Year: 2020 Publisher: MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus
Medofed syrup contains a decongestant and antihistamine and is indicated for the management of upper respiratory tract conditions such as the common cold, hay fever, allergic and vasomotor rhinitis and aerotitis (otitis barotrauma).
10 ml every 4-6 hours up to four times a day.
5 ml every 4-6 hours, up to three times a day.
Maximum daily dose: 15 ml syrup.
A pharmacist or other healthcare professional should be consulted before use in children aged 6 to 12 years.
It is recommended to be used only when simple measures have failed to provide adequate relief.
It is not recommended to be used for more than 5 consecutive days.
This medicine is contraindicated in children under 6 years (see section 4.3).
No specific studies have been carried out in the elderly. Experience has indicated that normal adult dosage is appropriate, although it may be advisable to monitor renal and/or hepatic function. If there is serious impairment then caution should be exercised.
Caution should be exercised when administering Medofed Syrup to patients with severe hepatic impairment.
Caution should be exercised when administering Medofed Syrup to patients with mild to moderate renal impairment.
Oral use.
The effects of acute toxicity from this combination may include drowsiness, incoordination, weakness, irritability, palpitations, hypertension, convulsions and difficulty with micturition.
Pseudoephedrine overdose may result in:
Metabolism and nutrition disorders: hyperglycaemia, hypokalaemia.
Psychiatric disorders: CNS stimulation, insomnia; irritability, restlessness, anxiety, agitation; confusion, delirium, hallucinations, psychoses.
Nervous system disorders: seizures, tremor, intracranial haemorrhage including intracerebral haemorrhage, drowsiness in children.
Eye disorders: mydriasis.
Cardiac disorders: palpitations, tachycardia, reflex bradycardia, supraventricular and ventricular arrhythmias, dysrhythmias, myocardial infarction.
Vascular disorders: hypertension, hypertensive crisis.
Gastrointestinal disorders: nausea, vomiting, ischaemic bowel infarction.
Musculoskeletal and connective tissue disorders: rhabdomyolysis.
Renal and urinary disorders: acute renal failure, difficulty in micturition.
Triprolidine overdose, an H1 receptor antagonist, may result in CNS depression, hyperthermia, anticholinergic syndrome (mydriasis, flushing, fever, dry mouth, urinary retention, decreased bowel sounds), tachycardia, hypotension, hypertension, nausea, vomiting, agitation, confusion, hallucinations, psychosis, seizures, or dysrhythmias. Rhabdomyolysis and renal failure may rarely develop in patients with prolonged agitation, coma or seizures.
The treatment of overdosage is likely to be symptomatic and supportive.
Necessary measures should be taken to maintain and support respiration and control convulsions. Gastric lavage should be performed if indicated. Catheterisation of the bladder may be necessary.
Alpha-adrenergic blockade may be required to treat hypertensive crises and beta-adrenergic blockade for the control of supra-ventricular dysrhythmias.
If desired, the elimination of pseudoephedrine can be accelerated by acid diuresis or by dialysis.
36 months unopened.
Store below 25°C, in the original package in order to protect from light.
Amber glass bottles having metal roll on closures or plastic screw caps. Each cap type pilar proof lined with atoxic polyvinyl chloride liner.
Bottles containing either 100 ml or 150 ml or 200 ml of Medofed are available. Measuring spoon is provided inside the carton box.
Not all pack sizes may be marketed.
Not applicable.
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
