MEDOFED COMPOUND Oral solution Ref.[28366] Active ingredients: Demorphan Guaifenesin Pseudoephedrine

Source: Υπουργείο Υγείας (CY)  Revision Year: 2020  Publisher: MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus

4.1. Therapeutic indications

Medofed Compound is indicated for the symptomatic relief of upper respiratory tract disorders accompanied by productive or dry cough, which benefit from the administration of a nasal decongestant, a histamine H1 receptor antagonist, an antitussive and an expectorant combination.

4.2. Posology and method of administration

Posology

Adults

10 ml every 4-6 hours up to 4 times a day.

Paediatric population

Children over 12 years: as for adults.

Children 6-12 years: 5 ml every 4-6 hours up to 4 times a day.

Children 2-5 years: 2.5 ml every 4-6 hours up to 4 times a day.

Children under 2 years old: Not recommended.

Use in the elderly

No specific studies have been carried out in the elderly, but triprolidine and pseudoephedrine have been widely used in older people.

Hepatic impairment

Caution should be exercised when administering Medofed Compound to patients with severe hepatic impairment.

Renal impairment

Caution should be exercised when administering Medofed Compound to patients with moderate to severe renal impairment.

Method of administration

Oral administration. Measuring spoon is provided inside the carton box.

4.9. Overdose

Symptoms

The effects of acute toxicity from Medofed Compound may include drowsiness, lethargy, dizziness, ataxia, weakness, hypotonicity, respiratory depression, dryness of the skin and mucous membranes, tachycardia, hypertension, palpitations hyperpyrexia, hyperactivity, irritability, convulsions, tremor and difficulty with micturition, nausea and vomiting.

Management

Necessary measures should be taken to maintain and support respiration and control convulsions. Gastric lavage should be performed up to 3 hours after ingestion if indicated. Catheterisation of the bladder may be necessary. If desired, the elimination of pseudoephedrine can be accelerated by acid diuresis or by dialysis.

Naloxone has been used successfully as a specific antagonist to dextromethorphan toxicity in children.

6.3. Shelf life

36 months.

6.4. Special precautions for storage

Store below 25°C in the original package in order to protect from light.

6.5. Nature and contents of container

Amber glass bottles having metal roll-on closures or plastic screw caps. Each cap type is pilfar proof lined with atoxic polyvinyl chloride liner. Bottles containing either 100 ml, 150 ml or 200 ml of Medofed Compound are available. Measuring spoon is provided inside the carton box.

Not all pack sizes may be available.

6.6. Special precautions for disposal and other handling

No special requirements for disposal.

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