Oxymetazoline Nasal Spray 0.05% w/v Taj Pharma

 

  1. Name of the medicinal product

Oxymetazoline Nasal Spray 0.05% w/v

  1. Qualitative and quantitative composition

Active ingredient

Oxymetazoline hydrochloride              0.05%w/v

  1. Pharmaceutical form

Nasal Spray

  1. Clinical particulars

4.1 Therapeutic indications

For the fast relief of stuffy noses due to head colds and hayfever.

4.2 Posology and method of administration

Hold the bottle upright and insert nozzle into nostril.

Adults and children over 12 years

1-2 sprays up each nostril every 6-8 hours.

Children under 12 years

Not to be administered to children under 12 years.

Elderly

There is no need for dosage reduction in the elderly.

For nasal administration.

4.3 Contraindications

Hypersensitivity to any of the ingredients, patients with cardiovascular disease, hyperthyroidism, angle closure glaucoma or prostatic enlargement.

4.4 Special warnings and precautions for use

Keep away from the eyes.

Not to be used for children under 12 years without medical advice.

The spray should not be used in excess of the stated dosage nor for longer than seven days without medical advice.

Keep all medicines out of the reach of children.

4.5 Interaction with other medicinal products and other forms of interaction

Boots Nasal Spray should not be given to patients being treated with monoamine oxidase inhibitors or within 14 days of ceasing such treatment.

4.6 Pregnancy and lactation

The safety of Boots Nasal Spray during pregnancy and lactation has not been established, but is not thought to constitute a hazard during these periods.

4.7 Effects on ability to drive and use machines

No adverse effects known.

4.8 Undesirable effects

Occasionally may cause local irritation and dryness of the mouth and throat. Prolonged use may cause rebound congestion and rhinitis medicamentosa.

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.

4.9 Overdose

Overdosage may give rise to local irritation and rebound congestion. Treatment need only be symptomatic.

  1. Pharmacological properties

5.1 Pharmacodynamic properties

Oxymetazoline hydrochloride is a sympathomimetic amine having vasoconstrictor properties which are utilised in the relief of nasal congestion.

5.2 Pharmacokinetic properties

Oxymetazoline enters tissues rapidly and local vasoconstriction is normally achieved within 5-10 minutes of intranasal administration. The full effect lasts for 5-6 hours and then gradually subsides over the next 6 hours. Plasma half-life is 5-8 days with 30% of any absorbed drug being excreted in the urine unchanged and 10% being excreted in the faeces.

5.3 Preclinical safety data

There are no preclinical data of relevance to the prescriber which are additional to that already included.

  1. Pharmaceutical particulars

6.1 List of excipients

Monosodium phosphate fine crystal, Disodium phosphate crystal, Methyl hydroxybenzoate, Cetrimide, Levomenthol natural, Or Levomenthol synthetic, Camphor racemic, Eucalyptol, Alcohol 96%, Purified water

6.2 Incompatibilities

Not applicable

6.3 Shelf life

18 months

6.4 Special precautions for storage

Do not store above 25°C.

6.5 Nature and contents of container

A 22ml polypropylene bottle with a polythene plug and elongated nozzle dip tube fitted with a wadless polythene cap that fits the elongated nozzle.

6.6 Special precautions for disposal and other handling

Not applicable.

  1. Manufactured in India by:
    TAJ PHARMACEUTICALS LTD.
    Mumbai, India
    Unit No. 214.Old Bake House,
    Maharashtra chambers of Commerce Lane,
    Fort, Mumbai – 400001
    at:Gujarat, INDIA.
    Customer Service and Product Inquiries:
    1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
    Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
    E-mail: tajgroup@tajpharma.com

 

Oxymetazoline Nasal Spray 0.05% w/v Taj Pharma

PACKAGE LEAFLET: INFORMATION FOR THE USER

Oxymetazoline Hydrochloride 0.05 % w/v Nasal Spray

Oxymetazoline Hydrochloride

Lasts up to 12 hours

  • Rapid relief for blocked nose

Read all of this carton for full instructions.

What this medicine is for

This medicine contains a decongestant, which acts to relieve nasal congestion. It can be used for fast relief of stuffy noses due to head colds and hayfever.

Before you use this medicine

Do not use:

  • If you are allergic to any of the ingredients
  • If you have heart or blood vessel disease
  • If you are taking monoamine oxidase inhibitors (for depression) or have taken them in the last 14 days
  • If you have an overactive thyroid
  • If you have glaucoma
  • If you are a man with prostate problems

Talk to your pharmacist or doctor:

  • If you are pregnant or breastfeeding
    Methyl hydroxybenzoate may cause allergic reactions (possibly delayed).

How to use this medicine

Check the seal is not broken before first use. If it is, do not use the medicine.

Hold the bottle upright and insert nozzle into nostril.

Adults and children of 12 years and over: Use one or two sprays in each nostril, every 6 to 8 hours.

For use in the nose only.

Do not use for children under 12 years.

Do not use more than the amount recommended above.

Do not use this medicine for more than 7 days unless your doctor tells you to.

If symptoms do not go away talk to your doctor.

If you use too much: Talk to a doctor.

Possible side effects

Most people will not have problems, but some may get some of these:

  • Irritation to the nose
  • Dry mouth and throat
  • Return of your symptoms if used for a long time

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed on this carton.

How to store this medicine

Do not store above 25°C.

Keep all medicines out of the sight and reach of children.

Use by the date on the side panel.

Active ingredient

This spray contains Oxymetazoline Hydrochloride 0.05% w/v.

Also contains: purified water, disodium phosphate, monosodium phosphate, ethanol, methyl hydroxybenzoate, cetrimide, levomenthol, camphor racemic, eucalyptol.

  1. Manufactured in India by:
    TAJ PHARMACEUTICALS LTD.
    Mumbai, India
    Unit No. 214.Old Bake House,
    Maharashtra chambers of Commerce Lane,
    Fort, Mumbai – 400001
    at:Gujarat, INDIA.
    Customer Service and Product Inquiries:
    1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
    Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
    E-mail: tajgroup@tajpharma.com