Otrivine Extra Dual Relief Nasal Spray

Description

Otrivine Extra Dual Relief Nasal spray is a combination medicinal product consisting of two different substances (xylometazoline hydrochloride and ipratropium bromide). One of the active ingredients (ipratropium bromide) helps with the runny nose, the other (xylometazoline hydrochloride) has a decongesting effect.

Otrivine Extra Dual Relief Nasal spray is used for the treatment of nasal congestion with runny nose (rhinorrhea) in connection with common colds.

 

How To Use

Always use this medicine exactly as described in the patient information leaflet or your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. 

The recommended dose is:

Adults: One puff in each nostril as needed, up to 3 times daily for maximum 7 days. Leave at least 6 hours between two doses. Do not exceed 3 applications daily into each nostril.

It is recommended that you stop treatment with Otrivine Extra Dual Relief Nasal spray as soon as your symptoms improve, even if this is sooner than 7 days, in order to minimise the risk of adverse reactions.

If you think the effect of this medicine is too strong or too weak, consult your doctor or pharmacist.

Instructions for use:

  • Always blow your nose before using the nasal spray
  • Remove the dust cap
  • Do not cut the nozzle. The metered dose spray is ready to prime before use
  • Before the first application, prime the pump by pumping 4 times. Once primed the pump will normally remain charged throughout regular daily treatment periods. Should the spray not be ejected during the full actuation stroke, or if the product has not been used for longer than 6 days, the pump will need to be reprimed with 4 pumps as initially performed
  • Hold the bottle upright
  • Bend your head slightly forward
  • Close one nostril by placing your finger against the side of your nose and insert the spray tip into the other nostril. Press the pump quickly while inhaling through the nose
  • Repeat this procedure in the other nostril

The effect occurs within 5-15 minutes.

Avoid spraying Otrivine Extra Dual Relief Nasal spray in or around the eyes. If this happens thoroughly rinse the eyes with cold water. Your vision may become temporarily blurred and the eye irritated, painful and red. If this happens contact your doctor for advice.

 

Do not use Otrivine Extra Dual Relief Nasal spray

  • In children below 18 years of age, as adequate information on safety and efficacy is not available
  • If you are allergic to Xylometazoline hydrochloride or ipratropium bromide or any of the other ingredients of this medicine.
  • If you are allergic to atropine or similar substances, e.g. hyoscyamine and scopolamine
  • If you had your pituitary gland removed by surgery carried out through the nose
  • If you have had brain surgery where the operation was carried out through the nose or mouth
  • If you suffer from glaucoma (increased pressure in the eye)
  • If you have a very dry nose (inflammatory nasal dryness, rhinitis sicca)

 

 

Warnings and Precautions 

  • Please read the enclosed package leaflet carefully before use.
  • Tell your doctor or pharmacist if you are taking any other medicines.
  • Talk to your doctor or pharmacist before using Otrivine Extra Dual Relief Nasal spray if you suffer from:
    • Heart Disease (e.g. long QT syndrome)
    • Raised blood pressure
    • Diabetes
    • An overactive thyroid gland (hyperthyroidism)
    • Difficulty in urinating and/or an enlarged prostate gland
    • Narrow-angle glaucoma (sudden build-up of pressure in the eye)
    • A tendency to have nosebleeds
    • Obstruction of the gut (small intestine)
    • Cystic fibrosis
    • Benign tumour of the adrenal gland that produces high amounts of adrenaline and nor-adrenaline (phaeochromocytoma) or a particular sensitivity to adrenaline and nor-adrenaline as you may experience dizziness, tremor, rapid heart rate, raised blood pressure and sleeplessness.
  • Immediate hypersensitivity (allergic reaction) may occur in rare cases. This may be seen as itchy red rash with raised inflammation of the skin (hives), difficulty breathing or speaking, difficulty swallowing due to swelling of the lips, face or throat. These symptoms may appear individually or all combined as a severe allergic reaction. If this occurs, immediately STOP using this medicine and seek medical help immediately.
  • Worsening of narrow-angle glaucoma may also occur.
  • Prolonged or excessive use may cause stuffiness in the nose to return or worsen and swelling of the nasal mucosa.
  • Otrivine Extra Dual Relief Nasal spray is not recommended for use in children and adolescents below 18 years or in the elderly above 70 years of age, as adequate information on safety and efficacy is not available.
  • Other medicines and Otrivine Extra Dual Relief Nasal spray.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. It is particularly important that you mention the following:

    • Monoamine oxidase inhibitors (used for treatment of depression). If you are taking or have taken these in the last two weeks, dangerous rises of the blood pressure may occur
    • Tri-cyclic and tetra-cyclic antidepressants (if you are taking or have taken these in the last two weeks)
    • Medicines used for travel sickness (medicines containing anticholinergic substances)
    • Medicines used for gut disorders (particularly those for abnormal motility) (medicines containing anticholinergic substances).

If you use any of the above medicines, consult a doctor before using Otrivine Extra Dual Relief Nasal spray. 

  • Pregnancy and breast-feeding: Otrivine Extra Dual Relief Nasal spray should not be used during pregnancy unless your doctor recommends it. During breast-feeding Otrivine Extra Dual Relief Nasal spray should not be used unless your doctor decides the advantages outweigh the potential risks to the infant. If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
  • Driving and using machines: Visual disturbances (including blurred vision and dilation of the pupil), dizziness and fatigue have been reported with Otrivine Extra Dual Relief Nasal spray. If affected, you should avoid driving, operating machinery or taking part in activities where these symptoms may put yourself or others at risk.

 

Active Ingredients

The active substances are xylometazoline hydrochloride and ipratropium bromide. 1 ml contains 0.5 mg xylometazoline hydrochloride and 0.6 mg ipratropium bromide. 1 puff contains 70 micrograms xylometazoline hydrochloride and 84 micrograms ipratropium bromide. The other ingredients are disodium edetate, glycerol (85%), purified water, sodium hydroxide and hydrochloric acid.

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