Pediacare Children's Decongestant

Components:
Phenylephrine Hydrochloride
Method of action:
Alpha-Adrenomimetic, Mydriatic-Cycloplegic, Nasal Preparations, Ophthalmologicals, Vasoconstrictive
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Medically reviewed by Militian Inessa Mesropovna, PharmD Last updated on 2019.07.22

Name of the medicinal product

Pediacare Children's Decongestant

Qualitative and quantitative composition

Phenylephrine Hydrochloride

Therapeutic indications

The information provided in Therapeutic indications of Pediacare Children's Decongestant is based on data of another medicine with exactly the same composition as the Pediacare Children's Decongestant of the medicine (Phenylephrine Hydrochloride). Be careful and be sure to specify the information on the section Therapeutic indications in the instructions to the drug Pediacare Children's Decongestant directly from the package or from the pharmacist at the pharmacy.
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For the Pediacare Children's Decongestant of nasal congestion associated with colds and hayfever.

Dosage (Posology) and method of administration

The information provided in Dosage (Posology) and method of administration of Pediacare Children's Decongestant is based on data of another medicine with exactly the same composition as the Pediacare Children's Decongestant of the medicine (Phenylephrine Hydrochloride). Be careful and be sure to specify the information on the section Dosage (Posology) and method of administration in the instructions to the drug Pediacare Children's Decongestant directly from the package or from the pharmacist at the pharmacy.
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Adults and children over 12 years: One capsule if necessary, up to four times daily.

Children under 12 years: Not recommended.

Elderly: There is no need for dosage reduction in the elderly.

Contraindications

The information provided in Contraindications of Pediacare Children's Decongestant is based on data of another medicine with exactly the same composition as the Pediacare Children's Decongestant of the medicine (Phenylephrine Hydrochloride). Be careful and be sure to specify the information on the section Contraindications in the instructions to the drug Pediacare Children's Decongestant directly from the package or from the pharmacist at the pharmacy.
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Hypersensitivity to any of the ingredients. Avoid in patients with cardiovascular disease, high blood pressure, diabetes mellitus, closed angle glaucoma, hyperthyroidism, prostatic enlargement and phaeochromocytoma. Patients being treated with monoamine oxidase inhibitors or within 14 days of ceasing such treatment.

Special warnings and precautions for use

The information provided in Special warnings and precautions for use of Pediacare Children's Decongestant is based on data of another medicine with exactly the same composition as the Pediacare Children's Decongestant of the medicine (Phenylephrine Hydrochloride). Be careful and be sure to specify the information on the section Special warnings and precautions for use in the instructions to the drug Pediacare Children's Decongestant directly from the package or from the pharmacist at the pharmacy.
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This medicine should be used with caution in patients with occlusive vascular disease including Raynaud's Phenomenon.

Do not take for longer than 7 days, unless your doctor agrees.

If symptoms do not go away talk to your doctor.

Keep all medicines out of the reach of children.

Warning: Do not exceed the stated dose.

Patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Effects on ability to drive and use machines

The information provided in Effects on ability to drive and use machines of Pediacare Children's Decongestant is based on data of another medicine with exactly the same composition as the Pediacare Children's Decongestant of the medicine (Phenylephrine Hydrochloride). 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 Pediacare Children's Decongestant directly from the package or from the pharmacist at the pharmacy.
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No adverse effects known.

Undesirable effects

The information provided in Undesirable effects of Pediacare Children's Decongestant is based on data of another medicine with exactly the same composition as the Pediacare Children's Decongestant of the medicine (Phenylephrine Hydrochloride). Be careful and be sure to specify the information on the section Undesirable effects in the instructions to the drug Pediacare Children's Decongestant directly from the package or from the pharmacist at the pharmacy.
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Adverse effects may include tachycardia, cardiac arrhythmias, palpitations, hypertension, nausea, vomiting, headache and occasionally urinary retention in males.

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 the Yellow Card Scheme at www.mhra.gov.uk/yellowcard.

Overdose

The information provided in Overdose of Pediacare Children's Decongestant is based on data of another medicine with exactly the same composition as the Pediacare Children's Decongestant of the medicine (Phenylephrine Hydrochloride). Be careful and be sure to specify the information on the section Overdose in the instructions to the drug Pediacare Children's Decongestant directly from the package or from the pharmacist at the pharmacy.
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Symptoms of overdosage include irritability, restlessness, palpitations, hypertension, difficulty in micturition, nausea, vomiting, thirst and convulsions. In severe overdosage gastric lavage and aspiration should be performed. Symptomatic and supportive measures should be undertaken, particularly with regard to cardiovascular and respiratory systems. Convulsions should be controlled with intravenous diazepam. Chlorpromazine may be used to control marked excitement and hallucinations. Severe hypertension may need to be treated with an alpha-adrenoreceptor blocking drug, such as phentolamine. A beta blocker may be required to control cardiac arrhythmias.

Pharmacodynamic properties

The information provided in Pharmacodynamic properties of Pediacare Children's Decongestant is based on data of another medicine with exactly the same composition as the Pediacare Children's Decongestant of the medicine (Phenylephrine Hydrochloride). Be careful and be sure to specify the information on the section Pharmacodynamic properties in the instructions to the drug Pediacare Children's Decongestant directly from the package or from the pharmacist at the pharmacy.
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Phenylephrine is a sympathomimetic agent with mainly direct effects on adrenergic receptors. It has predominantly alpha adrenergic activity and is without stimulating effects on the central nervous system. The sympathomimetic effect of phenylephrine produces vasoconstriction which in turn relieves nasal congestion.

Pharmacokinetic properties

The information provided in Pharmacokinetic properties of Pediacare Children's Decongestant is based on data of another medicine with exactly the same composition as the Pediacare Children's Decongestant of the medicine (Phenylephrine Hydrochloride). Be careful and be sure to specify the information on the section Pharmacokinetic properties in the instructions to the drug Pediacare Children's Decongestant directly from the package or from the pharmacist at the pharmacy.
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Phenylephrine is readily absorbed after oral administration but is subject to extensive presystemic metabolism, much of which occurs in the enterocytes. As a consequence, systemic bioavailability is only about 40%. Following oral administration, peak plasma concentrations are achieved in 1-2 hours. The mean plasma half life is in the range 2-3 hours. Penetration into the brain appears to be minimal.

Following absorption, the drug is extensively metabolised in the liver. Both phenylephrine and its metabolites are excreted in the urine.

The volume of distribution is between 200 and 500 litres, but there are no data on the extent of plasma protein binding.

Preclinical safety data

The information provided in Preclinical safety data of Pediacare Children's Decongestant is based on data of another medicine with exactly the same composition as the Pediacare Children's Decongestant of the medicine (Phenylephrine Hydrochloride). Be careful and be sure to specify the information on the section Preclinical safety data in the instructions to the drug Pediacare Children's Decongestant directly from the package or from the pharmacist at the pharmacy.
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There are no preclinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.

Incompatibilities

The information provided in Incompatibilities of Pediacare Children's Decongestant is based on data of another medicine with exactly the same composition as the Pediacare Children's Decongestant of the medicine (Phenylephrine Hydrochloride). Be careful and be sure to specify the information on the section Incompatibilities in the instructions to the drug Pediacare Children's Decongestant directly from the package or from the pharmacist at the pharmacy.
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Not applicable.

Special precautions for disposal and other handling

The information provided in Special precautions for disposal and other handling of Pediacare Children's Decongestant is based on data of another medicine with exactly the same composition as the Pediacare Children's Decongestant of the medicine (Phenylephrine Hydrochloride). 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 Pediacare Children's Decongestant directly from the package or from the pharmacist at the pharmacy.
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Not applicable.