MEDOFED Oral solution Ref.[28365] Active ingredients: Pseudoephedrine

Medofed Syrup may cause drowsiness. This product should not be used to sedate a child.

If any of the following occur, this product should be stopped:

• Hallucinations
• Restlessness
• Sleep disturbances

Ischaemic colitis

Some cases of ischaemic colitis have been reported with pseudoephedrine. Pseudoephedrine should be discontinued and medical advice sought if sudden abdominal pain, rectal bleeding or other symptoms of ischaemic colitis develop.

Ischaemic optic neuropathy

Cases of ischaemic optic neuropathy have been reported with pseudoephedrine.

Pseudoephedrine should be discontinued if sudden loss of vision or decreased visual acuity such as scotoma occurs.

Severe Skin reactions

Severe skin reactions such as acute generalized exanthematous pustulosis (AGEP) may occur with pseudoephedrine-containing products. This acute pustular eruption may occur within the first 2 days of treatment, with fever, and numerous, small, mostly non-follicular pustules arising on a widespread oedematous erythema and mainly localized on the skin folds, trunk, and upper extremities. Patients should be carefully monitored. If signs and symptoms such as pyrexia, erythema, or many small pustules are observed, administration of Medofed should be discontinued and appropriate measures taken if needed.

There have been rare cases of posterior reversible encephalopathy (PRES)/reversible cerebral vasoconstriction syndrome (RCVS) reported with sympathomimetic drugs, including pseudoephedrine. Symptoms reported included sudden onset of severe headache, nausea, vomiting, and visual disturbances. Most cases improved or resolved within a few days following appropriate treatment. Psuedoephedrine should be discontinued immediately and medical advice sought if signs/symptoms of PRES/RCVS develop.

There have been no specific studies of this combination in patients with hepatic and/or renal dysfunction. Caution should be exercised in the presence of mild to moderate renal impairment or severe hepatic impairment.

Although pseudoephedrine has virtually no pressor effects in patients with normal blood pressure, this medicine should be used with caution in patients taking antihypertensive agents and tricyclic antidepressants or other sympathomimetic agents, such as decongestants, appetite suppressants and amphetamine-like psychostimulants. The effects of a single dose on the blood pressure of these patients should be observed before recommending repeated or unsupervised treatment.

The physician or pharmacist should check that sympathomimetic containing preparations are not simultaneously administered by several routes i.e. orally and topically (nasal, aural and eye preparations).

Patients with the following conditions should be advised to consult a physician before using this medicine: difficulty in urination due to enlargement of the prostate; or susceptibility to angle closure.

Patients with the following conditions should not use this medicine unless directed by a physician: acute or chronic bronchial asthma chronic bronchitis or emphysema.

Patients with thyroid disease who are receiving thyroid hormones should not take pseudoephedrine unless directed by a physician.

Triprolidine may enhance the sedative effects of central nervous system depressants including alcohol, sedatives, and tranquilizers. While taking Medofed Syrup, patients should be advised to avoid alcoholic beverages and consult a healthcare professional prior to taking with central nervous system depressants.

This product may act as a cerebral stimulant in children and occasionally adults giving rise to insomnia, nervousness, hyperpyrexia, tremors and epileptiform convulsions. Care should be taken when used in epileptic patients.

Use with caution in occlusive vascular disease.

Pseudoephedrine may induce positive results in certain anti-doping tests.

Medofed contains sucrose. Each 5 ml dose of this medicine contains 3.5 g of sucrose.

Patients with rare hereditary problems of fructose intolerance, glucose – galactose malabsorption or sucrase –isomaltase insufficiency should not take the medicine.

This should be taken into account in patients with diabetes mellitus.

The excipients methyl para-hydroxybenzoate and tartrazine yellow lake may cause allergic reactions (possibly delayed for methyl para-hydroxybenzoate).

MAOIs and/or RIMAs: Pseudoephedrine exerts its vasoconstricting properties by stimulating α-adrenergic receptors and displacing noradrenaline from neuronal storage sites. Since MAOIs impede the metabolism of sympathomimetic amines and increase the store of releasable norepinephrine in adrenergic nerve endings, MAOIs may potentiate the pressor effect of pseudoephedrine. This medicine should not be used in patients treated with MAOIs or within 14 days of stopping treatment as there is an increased risk of hypertensive crisis.

Moclobemide: risk of hypertensive crisis.

Oxytocin: risk of hypertension.

Cardiac glycosides: increased risk of dysrhythmias.

Ergot alkaloids (ergotamine and methysergide): increased risk of ergotism.

Anticholinergic drugs: The effects of anti-cholinergics e.g., some psychotropic drugs (such as tricyclic antidepressants) and atropine, may be potentiated by this product giving rise to tachycardia, mouth dryness, gastrointestinal disturbances, e.g., colic, urinary retention and headache.

Sympathomimetic agents: Concomitant use of this medicine with tricyclic antidepressants, other sympathomimetic agents (such as decongestants, appetite suppressants and amphetamine-like psychostimulants) may cause a rise in blood pressure.

Antihypertensives: The effect of antihypertensive agents which interfere with sympathetic activity may be partially reversed by the pseudoephedrine in this medicine, e.g. bretylium, betanidine, guanethidine, reserpine, debrisoquine, methyldopa, adrenergic neurone blockers and beta-blockers.

Anaesthetic agents: Concurrent use with halogenated anaesthetic agents such as chloroform, cyclopropane, halothane, enflurane or isoflurane may provoke or worsen ventricular arrhythmias.

CNS depressants: Triprolidine may enhance the sedative effects of alcohol and other central nervous system depressants including barbiturates, hypnotics, opioid analgesics, anxiolytic sedatives and antipsychotics.

There are no adequate and well-controlled studies for pseudoephedrine, triprolidine in pregnant or breast-feeding women.

Pregnancy

This product should not be used during pregnancy unless the potential benefit of treatment to the mother outweighs the possible risks to the developing foetus.

Breast-feeding

Pseudoephedrine distributes into and is concentrated in breast milk.

Triprolidine is excreted in breast milk, it has been estimated that approximately 0.06 to 0.2% of a single 2.5 mg dose of triprolidine ingested by a nursing mother will be excreted in the breast-milk over 24 hours.

This product should not be used during lactation unless the potential benefit of treatment to the mother outweighs the possible risks to the nursing infant.

Fertility

There is no information on the effects of this conbination on human fertility.

Medofed Syrup may have a moderate influence on the ability to drive and use machines. This combination may cause dizziness or drowsiness and impair performance in tests of auditory vigilance. Patients should be cautioned about engaging in activities requiring mental alertness, such as driving a car or operating machinery, until they have established their own response to the drug.

It is recommended that patients are advised not to undertake tasks requiring mental alertness whilst under the influence of alcohol or other CNS depressants. Concomitant administration of this medicine may, in some patients, produce additional impairment.

Placebo-controlled studies with sufficient adverse event data were not available for the combination of pseudoephedrine and triprolidine.

Adverse drug reactions identified during clinical trials and post-marketing experience with pseudoephedrine, triprolidine or the combination are listed below by System Organ Class (SOC). The frequencies are defined in accordance with current guidance, as: Very common (≥1/10); Common (≥1/100 to <1/10); Uncommon (≥1/1,000 to <1/100); Rare (≥1/10,000 to <1/1,000); Very rare (<1/10,000); Not known (cannot be estimated from the available data).

ADRs are presented by frequency category based on 1) incidence in adequately designed clinical trials or epidemiology studies, if available, or 2) when incidence cannot be estimated, frequency category is listed as ‘Not known’.

^† Adverse events reported by ≥1% of subjects in randomised, placebo-controlled trials with single-ingredients pseudoephedrine

No differences between adult and paediatric safety profiles have been identified.

Reporting of suspected adverse reactions:

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via Pharmaceutical Services, Ministry of Health, CY-1475, www.moh.gov.cy/phs Fax: +357 22608649.

Not applicable.