Source: Υπουργείο Υγείας (CY) Revision Year: 2020 Publisher: MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus
Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.
Individuals who are taking or have taken monoamine oxidase inhibitors within the preceding two weeks. The concomitant use of pseudoephedrine and this type of product may occasionally cause a rise in blood pressure (see section 4.5).
Patients with severe hypertension or severe coronary artery disease.
Concurrent administration of Medofed Compound and furazolidone (see section 4.5).
Medofed Compound should not be administered to patients where cough is associated with asthma or where cough is accompanied by excessive secretions.
Dextromethorphan, in common with other centrally acting antitussive agents, should not be given to patients in, or at risk of developing respiratory failure.
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.
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 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 Compound should be discontinued and appropriate measures taken if needed.
Medofed Compound may cause drowsiness and impair performance in tests of auditory vigilance (see section 4.7).
Although there are no objective data, users of Medofed Compound should avoid the concomitant use of alcohol or other centrally acting sedatives (see section 4.5).
Although pseudoephedrine has virtually no pressor effects in patients with normal blood pressure, Medofed Compound should be used with caution in patients taking antihypertensive agents, tricyclic antidepressants, 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 (see section 4.5).
As with other sympathomimetic agents, caution should be exercised in patients with uncontrolled diabetes, hyperthyroidism, elevated intraocular pressure, hypertension, heart disease and prostatic enlargement.
There have been no specific studies of Medofed Compound in patients with hepatic and/or renal dysfunction. Caution should be exercised in the presence of severe renal or hepatic impairment.
Cases of dextromethorphan abuse have been reported. Caution is particularly recommended for adolescents and young adults as well as in patients with a history of drug abuse or psychoactive substances.
Medofed Compound should not be used for persistent or chronic cough, such as occurs with asthma, or where cough is accompanied by excessive secretions, unless directed by a physician.
If urine is collected within 24 hours of a dose of Medofed Compound, a metabolite of guaiphenesin may cause a colour interference with laboratory determinations of urinary 5-hydroxyindoleacetic acid (5-HIAA) and vanillylmandelic acid (VMA).
Dextromethorphan is metabolised by hepatic cytochrome P450 2D6. The activity of this enzyme is genetically determined. About 10% of the general population are poor metabolisers of CYP2D6. Poor metabolisers and patients with concomitant use of CYP2D6 inhibitors may experience exaggerated and/or prolonged effects of dextromethorphan. Caution should therefore be exercised in patients who are slow metabolizers of CYP2D6 or use CYP2D6 inhibitors (see also section 4.5).
This medicine contains 250 mg propylene glycol in each 5 ml oral solution.
This medicine contains 2960 mg sorbitol 70% in each 5 ml oral solution. The additive effect of concomitantly administered products containing sorbitol (or fructose) and dietary intake of sorbitol (or fructose) should be taken into account. The content of sorbitol in medicinal products for oral use may affect the bioavailability of other medicinal products for oral use administered concomitantly. Patients with hereditary fructose intolerance (HFI) should not take/be given this medicinal product. Sorbitol may cause gastrointestinal discomfort and mild laxative effect.
This medicine contains 1150 mg sucrose in each 5 ml oral solution. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
Concomitant use of Medofed Compound with sympathomimetic agents (such as decongestants, appetite suppressants and amphetamine-like psychostimulants) or with monoamine oxidase inhibitors, which interfere with the catabolism of sympathomimetic amines, may occasionally cause a rise in blood pressure (See section 4.3 and 4.4).
The antibacterial agent furazolidone is known to cause a dose-related inhibition of monoamine oxidase. Although there are no reports of hypertensive crises caused by the concurrent administration of Medofed Compound and furazolidone, they should not be taken together.
Because of its pseudoephedrine content, Medofed Compound may partially reverse the hypotensive action of drugs which interfere with sympathetic activity including bretylium bethanidine, guanethidine, debrisoquine, methyldopa, alpha and beta-adrenergic blocking agents. (See section 4.4).
Although there are no objective data, users of Medofed Compound should avoid concomitant use of alcohol or other centrally acting sedatives (see section 4.4).
Dextromethorphan is metabolized by CYP2D6 and has an extensive first-pass metabolism. Concomitant use of potent CYP2D6 enzyme inhibitors can increase the dextromethorphan concentrations in the body to levels multifold higher than normal. This increases the patient’s risk for toxic effects of dextromethorphan (agitation, confusion, tremor, insomnia, diarrhoea and respiratory depression) and development of serotonin syndrome. Potent CYP2D6 enzyme inhibitors include fluoxetine, paroxetine, quinidine and terbinafine. In concomitant use with quinidine, plasma concentrations of dextromethorphan have increased up to 20-fold, which has increased the CNS adverse effects of the agent. Amiodarone, flecainide and propafenone, sertraline, bupropion, methadone, cinacalcet, haloperidol, perphenazine and thioridazine also have similar effects on the metabolism of dextromethorphan. If concomitant use of CYP2D6 inhibitors and dextromethorphan is necessary, the patient should be monitored and the dextromethorphan dose may need to be reduced.
Although pseudoephedrine and triprolidine have been in widespread use for many years without apparent ill consequence, there are no specific data on their use during pregnancy. Caution should therefore be exercised by balancing the potential benefit of treatment to the mother against any possible hazards to the developing foetus.
In rats and rabbits systemic administration of triprolidine up to 75 times the human dose did not produce teratogenic effects. Systemic administration of pseudoephedrine, up to 50 times the human dose in rats and up to 35 times the human dose in rabbits, did not produce teratogenic effects.
Insufficient information is available on the effects of administration of Medofed Compound during human pregnancy. Like most medicines, it should not be used during pregnancy unless the potential benefit of treatment to the mother outweighs any possible risk to the developing foetus.
Pseudoephedrine and triprolidine are excreted in breast milk in small amounts but the effect of this on breast fed infants is not known. It has been estimated that 0.5-0.7% of a single dose of pseudoephedrine ingested by a mother will be excreted in the breast milk over 24 hours.
It is not known whether dextromethorphan or its metabolites are excreted in breast milk.
Guaiphenesin is excreted in breast milk in small amounts with no effect expected on the infant.
No studies have been conducted in animals to determine whether triprolidine or pseudoephedrine have potential to impair fertility. There is no information on the effect of Medofed Compound on human fertility.
Medofed Compound may cause drowsiness and impair performance in tests of auditory vigilance. Patients should not drive a vehicle or operate machinery until they have determined their own response.
Adverse reactions are listed below, by system organ class and by frequency. Frequencies are defined 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) and not known (cannot be estimated from available data).
Rare: hallucinations.
Not known: Central nervous system (CNS) depression or excitation, sleep disturbance
Very common: drowsiness (reported most frequently).
Not known: Ischaemic optic neuropathy.
Uncommon: Side effects attributed to dextromethorphan are uncommon; occasionally nausea, vomiting or gastro-intestinal disturbance may occur.
Not known: Ischaemic colitis.
Uncommon: Skin rashes with or without irritation.
Not known: Severe skin reactions, including acute generalized exanthematous pustulosis (AGEP).
Uncommon: dryness of mouth, nose and throat.
Uncommon: tachycardia.
Uncommon: Urinary retention has been reported occasionally in men receiving pseudoephedrine, prostatic enlargement could have been an important predisposing factor.
Side effects resulting from guaiphenesin administration are very rare.
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 to Pharmaceutical Services, Ministry of Health, CY-1475, www.moh.gov.cy/phs, Fax: +357 22608649.
None known.
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