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Actifedrin (Naphazoline hydrochloride)

Components:
Naphazoline Hydrochloride
Method of action:
Alpha-Adrenomimetic, Anticonvulsant, Anti-Inflammatory, Decongestant, Vasoconstrictive
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Medically reviewed by Kovalenko Svetlana Olegovna, PharmD. Last updated on 2019.11.17

Name of the medicinal product

Actifedrin (Naphazoline hydrochloride)

Qualitative and quantitative composition

Naphazoline Hydrochloride

Therapeutic indications

The information provided in Therapeutic indications of Actifedrin (Naphazoline hydrochloride) is based on data of another medicine with exactly the same composition as the Actifedrin (Naphazoline hydrochloride) of the medicine (Naphazoline Hydrochloride). Be careful and be sure to specify the information on the section Therapeutic indications in the instructions to the drug Actifedrin (Naphazoline hydrochloride) directly from the package or from the pharmacist at the pharmacy.
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Redness and minor irritations of the eye caused by, for example, dusty atmosphere, wind, swimming, smoke, air pollutants, and close work.

Dosage (Posology) and method of administration

The information provided in Dosage (Posology) and method of administration of Actifedrin (Naphazoline hydrochloride) is based on data of another medicine with exactly the same composition as the Actifedrin (Naphazoline hydrochloride) of the medicine (Naphazoline 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 Actifedrin (Naphazoline hydrochloride) directly from the package or from the pharmacist at the pharmacy.
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Ocular

Adults and children 12 years and over

The recommended dosage is one or two drops into each eye two or three times daily.

Children under 12 years: Not recommended. There is no recorded experience with the product in this age group.

Contraindications

The information provided in Contraindications of Actifedrin (Naphazoline hydrochloride) is based on data of another medicine with exactly the same composition as the Actifedrin (Naphazoline hydrochloride) of the medicine (Naphazoline Hydrochloride). Be careful and be sure to specify the information on the section Contraindications in the instructions to the drug Actifedrin (Naphazoline hydrochloride) directly from the package or from the pharmacist at the pharmacy.
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Glaucoma, corneal damage, acute iritis and other serious eye disease.

Hypersensitivity to any ingredients.

Do not use at the same time as contact lenses. It is generally recommended that a short interval be allowed between the use of Actifedrin (Naphazoline hydrochloride) and replacement of contact lenses, and that the duration of this 'short interval' should be about 15 minutes.

This product should not be used prior to peripheral iridectomy in eyes susceptible to angle closure because mydriatic action may precipitate angle block.

Special warnings and precautions for use

The information provided in Special warnings and precautions for use of Actifedrin (Naphazoline hydrochloride) is based on data of another medicine with exactly the same composition as the Actifedrin (Naphazoline hydrochloride) of the medicine (Naphazoline 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 Actifedrin (Naphazoline hydrochloride) directly from the package or from the pharmacist at the pharmacy.
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Actifedrin (Naphazoline hydrochloride) should not be used if there is an eye condition characterised by continued redness, pain or blurring of vision.

Actifedrin (Naphazoline hydrochloride) should not be used if there is raised pressure inside the eyeball (glaucoma), damage to the corneas, inflammation of the iris (acute iritis) or any other serious eye disease.

If there is any eye pain, vision changes, continued redness or irritation of the eye, or if the condition worsens or persists for more than 24 hours, use of the product should be discontinued and the doctor or pharmacist should be informed.

Discontinue use prior to use of anaesthetics which sensitise the myocardium to sympathomimetics (e.g. cyclopropane, halothane).

As with other sympathomimetics, use with caution in the presence of hypertension, diabetes, hyperthyroidism, cardiovascular abnormalities and arteriosclerosis.

Contains benzalkonium chloride which may cause eye irritation. Avoid contact with soft contact lenses; remove contact lenses prior to application and wait at least 15 minutes before re-insertion; known to discolour soft contact lenses.

Effects on ability to drive and use machines

The information provided in Effects on ability to drive and use machines of Actifedrin (Naphazoline hydrochloride) is based on data of another medicine with exactly the same composition as the Actifedrin (Naphazoline hydrochloride) of the medicine (Naphazoline 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 Actifedrin (Naphazoline hydrochloride) directly from the package or from the pharmacist at the pharmacy.
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Do not drive or operate machinery if vision is blurred.

Undesirable effects

The information provided in Undesirable effects of Actifedrin (Naphazoline hydrochloride) is based on data of another medicine with exactly the same composition as the Actifedrin (Naphazoline hydrochloride) of the medicine (Naphazoline Hydrochloride). Be careful and be sure to specify the information on the section Undesirable effects in the instructions to the drug Actifedrin (Naphazoline hydrochloride) directly from the package or from the pharmacist at the pharmacy.
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May cause slight dilation of pupil.

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 national reporting system:

Yellow Card Scheme: Website: www.mhra.gov.uk/yellowcard

Overdose

The information provided in Overdose of Actifedrin (Naphazoline hydrochloride) is based on data of another medicine with exactly the same composition as the Actifedrin (Naphazoline hydrochloride) of the medicine (Naphazoline Hydrochloride). Be careful and be sure to specify the information on the section Overdose in the instructions to the drug Actifedrin (Naphazoline hydrochloride) directly from the package or from the pharmacist at the pharmacy.
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Overdosage or accidental administration by mouth may cause depression of CNS, reduction of body temperature, bradycardia, sweating, drowsiness and coma, particularly in children. Hypertension may be followed by rebound hypotension. In addition, overdosage may cause increased redness of the eye. Treatment of side-effects is symptomatic.

Pharmacodynamic properties

The information provided in Pharmacodynamic properties of Actifedrin (Naphazoline hydrochloride) is based on data of another medicine with exactly the same composition as the Actifedrin (Naphazoline hydrochloride) of the medicine (Naphazoline Hydrochloride). Be careful and be sure to specify the information on the section Pharmacodynamic properties in the instructions to the drug Actifedrin (Naphazoline hydrochloride) directly from the package or from the pharmacist at the pharmacy.
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ATC Code: S01GA01

Naphazoline is a sympathomimetic agent with marked alpha-adrenergic activity. It is a vasoconstrictor with a rapid and prolonged action in reducing swelling and congestion when applied to mucous membrane.

Pharmacokinetic properties

The information provided in Pharmacokinetic properties of Actifedrin (Naphazoline hydrochloride) is based on data of another medicine with exactly the same composition as the Actifedrin (Naphazoline hydrochloride) of the medicine (Naphazoline Hydrochloride). Be careful and be sure to specify the information on the section Pharmacokinetic properties in the instructions to the drug Actifedrin (Naphazoline hydrochloride) directly from the package or from the pharmacist at the pharmacy.
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Absorbed following instillation into conjunctival sacs.

Preclinical safety data

The information provided in Preclinical safety data of Actifedrin (Naphazoline hydrochloride) is based on data of another medicine with exactly the same composition as the Actifedrin (Naphazoline hydrochloride) of the medicine (Naphazoline Hydrochloride). Be careful and be sure to specify the information on the section Preclinical safety data in the instructions to the drug Actifedrin (Naphazoline hydrochloride) directly from the package or from the pharmacist at the pharmacy.
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There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SmPC.

Incompatibilities

The information provided in Incompatibilities of Actifedrin (Naphazoline hydrochloride) is based on data of another medicine with exactly the same composition as the Actifedrin (Naphazoline hydrochloride) of the medicine (Naphazoline Hydrochloride). Be careful and be sure to specify the information on the section Incompatibilities in the instructions to the drug Actifedrin (Naphazoline hydrochloride) 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 Actifedrin (Naphazoline hydrochloride) is based on data of another medicine with exactly the same composition as the Actifedrin (Naphazoline hydrochloride) of the medicine (Naphazoline 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 Actifedrin (Naphazoline hydrochloride) directly from the package or from the pharmacist at the pharmacy.
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Do not use if the solution changes colour or becomes cloudy.

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