Components:
Pseudoephedrine
Method of action:
Antitussive, Nasal Preparations
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Medically reviewed by Oliinyk Elizabeth Ivanovna, Pharmacy Last updated on 2019.06.26

Name of the medicinal product

Genaphed

Qualitative and quantitative composition

Pseudoephedrine

Therapeutic indications

The information provided in Therapeutic indications of Genaphed is based on data of another medicine with exactly the same composition as the Genaphed of the medicine (Pseudoephedrine). Be careful and be sure to specify the information on the section Therapeutic indications in the instructions to the drug Genaphed directly from the package or from the pharmacist at the pharmacy.
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For the relief of nasal congestion and congestion of mucous membranes of the upper respiratory tract associated with the common cold.

Dosage (Posology) and method of administration

The information provided in Dosage (Posology) and method of administration of Genaphed is based on data of another medicine with exactly the same composition as the Genaphed of the medicine (Pseudoephedrine). Be careful and be sure to specify the information on the section Dosage (Posology) and method of administration in the instructions to the drug Genaphed directly from the package or from the pharmacist at the pharmacy.
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Oral

Adults and Children aged 12 years and over:

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

Children 6 - 12 years

5 ml elixir every 4-6 hours up to 4 times a day. Not to be used for more than five days without the advice of a doctor. Parents or carers should seek medical attention if the child's condition deteriorates during treatment.

This product may be diluted 1:1 (1 in 2) or 1:3 (1 in 4) with syrup BP. These dilutions are stable for 4 weeks if stored at 25°C.

Children under 6 years

This product is contraindicated in children under the age of 6 years.

Use in the Elderly

There have been no specific studies of this product in the elderly, experience has indicated that normal adult dosage is appropriate.

Hepatic Dysfunction

Caution should be exercised when administering this product to patients with severe hepatic impairment.

Renal Dysfunction

Caution should be exercised when administering this product to patients with moderate to severe renal impairment.

Do not exceed the stated dose.

Keep out of the reach and sight of children.

Contraindications

The information provided in Contraindications of Genaphed is based on data of another medicine with exactly the same composition as the Genaphed of the medicine (Pseudoephedrine). Be careful and be sure to specify the information on the section Contraindications in the instructions to the drug Genaphed directly from the package or from the pharmacist at the pharmacy.
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This product is contraindicated in individuals with known hypersensitivity to the product or any of its components.

Concomitant use of other sympathomimetic decongestants, beta-blockers and monoamine oxidase inhibitors (MAOIs), or within 14 days of stopping MAOI treatment

Cardiovascular disease including hypertension

Diabetes mellitus

Phaeochromocytoma

Hyperthyroidism

Closed angle glaucoma

Severe renal impairment

Not to be used in children under the age of 6 years.

Special warnings and precautions for use

The information provided in Special warnings and precautions for use of Genaphed is based on data of another medicine with exactly the same composition as the Genaphed of the medicine (Pseudoephedrine). Be careful and be sure to specify the information on the section Special warnings and precautions for use in the instructions to the drug Genaphed directly from the package or from the pharmacist at the pharmacy.
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Use with caution in occlusive vascular disease

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

- Hallucinations

- Restlessness

- Sleep disturbances

Caution in moderate renal impairment

Effects on ability to drive and use machines

The information provided in Effects on ability to drive and use machines of Genaphed is based on data of another medicine with exactly the same composition as the Genaphed of the medicine (Pseudoephedrine). Be careful and be sure to specify the information on the section Effects on ability to drive and use machines in the instructions to the drug Genaphed directly from the package or from the pharmacist at the pharmacy.
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None known.

Undesirable effects

The information provided in Undesirable effects of Genaphed is based on data of another medicine with exactly the same composition as the Genaphed of the medicine (Pseudoephedrine). Be careful and be sure to specify the information on the section Undesirable effects in the instructions to the drug Genaphed directly from the package or from the pharmacist at the pharmacy.
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Cardiovascular effects

- Tachycardia/palpitations

- Other cardiac dysrhythmias and hypertension

CNS effects

- Irritability

- Anxiety

- Restlessness

- Excitability

- Insomnia

- Hallucinations and paranoid delusion

Skin reactions including rash

Hypersensitivity reactions - cross-sensitivity may occur with other sympathomimetics.

Other reactions

- Nausea and/or vomiting

- Headache

- Urinary retention

Overdose

The information provided in Overdose of Genaphed is based on data of another medicine with exactly the same composition as the Genaphed of the medicine (Pseudoephedrine). Be careful and be sure to specify the information on the section Overdose in the instructions to the drug Genaphed directly from the package or from the pharmacist at the pharmacy.
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As with other sympathomimetic agents, symptoms of overdose include irritability, restlessness, tremor, convulsions, palpitations, hypertension and difficulty in micturition.

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. If desired, the elimination of pseudoephedrine can be accelerated by acid diuresis or by dialysis.

Pharmacodynamic properties

The information provided in Pharmacodynamic properties of Genaphed is based on data of another medicine with exactly the same composition as the Genaphed of the medicine (Pseudoephedrine). Be careful and be sure to specify the information on the section Pharmacodynamic properties in the instructions to the drug Genaphed directly from the package or from the pharmacist at the pharmacy.
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Psuedoephedrine has direct and indirect sympathlomimetic activity and is an orally effective upper respiratory tract decongestant. Psuedoephedrine is substantially less potent than ephedrine in producing both tachycardia and elevation in systolic blood pressure and considerably less potent in causing stimulation of the central nervous system.

Pharmacokinetic properties

The information provided in Pharmacokinetic properties of Genaphed is based on data of another medicine with exactly the same composition as the Genaphed of the medicine (Pseudoephedrine). Be careful and be sure to specify the information on the section Pharmacokinetic properties in the instructions to the drug Genaphed directly from the package or from the pharmacist at the pharmacy.
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Pseudoephedrine is rapidly and completely absorbed after oral administration. After an oral dose of 180 mg to man, peak plasma concentrations of 500-900 ng/ml were obtained about 2 hours post dose. The plasma half life was about 5.5 hours and was increased in subjects with alkaline urine and decreased in subjects with acid urine. The only metabolism was n-demethylation which occurred to a small extent. Excretion was mainly via the urine.

Preclinical safety data

The information provided in Preclinical safety data of Genaphed is based on data of another medicine with exactly the same composition as the Genaphed of the medicine (Pseudoephedrine). Be careful and be sure to specify the information on the section Preclinical safety data in the instructions to the drug Genaphed directly from the package or from the pharmacist at the pharmacy.
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None stated.

Incompatibilities

The information provided in Incompatibilities of Genaphed is based on data of another medicine with exactly the same composition as the Genaphed of the medicine (Pseudoephedrine). Be careful and be sure to specify the information on the section Incompatibilities in the instructions to the drug Genaphed directly from the package or from the pharmacist at the pharmacy.
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None known

Special precautions for disposal and other handling

The information provided in Special precautions for disposal and other handling of Genaphed is based on data of another medicine with exactly the same composition as the Genaphed of the medicine (Pseudoephedrine). Be careful and be sure to specify the information on the section Special precautions for disposal and other handling in the instructions to the drug Genaphed directly from the package or from the pharmacist at the pharmacy.
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Not applicable

Administrative data