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1. WHAT OTRIVINE ADULT MEASURED DOSE SINUSITIS SPRAY IS AND WHAT IT IS USED FOR

Otrivine Adult Measured Dose Sinusitis Spray contains the active ingredient xylometazoline

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Otrivine®

Adult Measured Dose

Sinusitis spray

Xylometazoline

Hydrochloride

Read all of this leaflet carefully because it

contains important information for you.

This medicine is available without a prescription.

However, you still need to use Otrivine Adult

Measured Dose Sinusitis Spray carefully to get the

best results from it.

-    Keep this leaflet. You may need to read it again.

-    Ask your pharmacist if you need more information or advice.

-    You must contact a doctor if the symptoms worsen or do not improve after 7 days.

-    If any of the side effects gets serious, or if you notice any side effect not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1.    What Otrivine Adult Measured Dose Sinusitis Spray is and what it is used for

2.    Before you use Otrivine Adult Measured Dose Sinusitis Spray

3.    How to use Otrivine Adult Measured Dose Sinusitis Spray

4.    Possible side effects

5.    How to store Otrivine Adult Measured Dose Sinusitis Spray

6.    Further information

Otrivine Adult Measured Dose Sinusitis Spray is for application in the nose to give relief from:

•    nasal congestion (blocked nose, including colds)

•    perennial and allergic rhinitis (recurring inflammation of the nasal mucous membranes, including hay fever)

•    sinusitis.

hydrochloride which helps to open up and clear the nasal passages by reducing the excessive nasal secretions and returning the swollen blood vessels to their normal size.

2. BEFORE YOU USE OTRIVINE ADULT MEASURED DOSE SINUSITIS SPRAY

DO NOT use the spray if you:

•    are allergic to xylometazoline hydrochloride or any of the other ingredients in the spray (see Section 6)

•    have had recent neurosurgery.

Do not use this spray for children under 12 years old.

Take special care

Before using the spray tell your doctor if you:

•    have an overactive thyroid gland (hyperthyroidism)

•    have glaucoma

•    have diabetes mellitus

•    have heart or circulatory disease

•    are pregnant or breast-feeding.

•    have hypertension

Do not take decongestants for more than 7 days in a row.

Using other medicines

Please tell your doctor or pharmacist before using this product if you are taking or have recently taken any medicines (especially monoamine oxidase inhibitors or other antidepressants) including those obtained without a prescription.

Pregnancy or breast-feeding

If you are pregnant or breast-feeding, consult your doctor before using Otrivine.

Ask your doctor or pharmacist for advice before taking any medicine.

3. HOW TO USE OTRIVINE ADULT MEASURED DOSE SINUSITIS SPRAY

Dosage:

For Adults and Children over 12 years of age:

1 spray in each nostril 1 to 3 times daily.

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Administration:

1.    Clear your nose.

2.    Lean forward slightly and insert the nozzle into a nostril (see diagram).

3.    Depress pump and sniff at the same time.

4.    Repeat for the other nostril.

To avoid possible spread of infection, this pack should only be used by one person.

For reasons of hygiene do not use this bottle for more than 28 days after opening it.

5. HOW TO STORE OTRIVINE ADULT MEASURED DOSE SINUSITIS SPRAY

Do not exceed the recommended dosage.

If you use more Otrivine Adult Measured Dose Sinusitis Spray than you should, consult your doctor or pharmacist.

Keep this medicine out of the sight and reach of children.

Do not use after the expiry date which is stated on the bottle after “EXP”. The expiry date refers to the last day of that month.

Do not use this bottle for more than 28 days after opening it.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

4. POSSIBLE SIDE EFFECTS

6. FURTHER INFORMATION

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Like all medicines, Otrivine Adult Measured Dose Sinusitis Spray can cause side effects, although not everybody gets them. Local discomfort may be felt after applying the spray if you have sensitive nasal passages.

Occasionally the following side effects have been reported:

•    A burning sensation in the nose and throat

•    local irritation

•    nausea

•    headache

•    dryness of the nasal membranes

•    temporary and passing visual disturbances

•    allergic reactions.

Cardiovascular effects, for example, palpitations may also occur especially if you have heart problems.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Also you can help to make sure that medicines remain as safe as possible by reporting any unwanted side effects via the internet at www.mhra.gov.uk/yellowcard. Alternatively you can call Freephone 0808 100 3352 (available from 10 a.m. to 2 p.m. Mondays to Fridays) or fill in a paper form available from your local pharmacy.

What Otrivine Adult Measured Dose Sinusitis Spray contains

The active ingredient is xylometazoline hydrochloride (0.1% w/v).

The other ingredients are Benzalkonium chloride, sodium phosphate, disodium edetate, sodium acid phosphate, sodium chloride, sorbitol, hypromellose and purified water.

What Otrivine Adult Measured Dose Sinusitis Spray looks like and the contents of the pack

Otrivine Adult Measured Dose Sinusitis Spray is a clear, colourless aqueous solution packed in 10 ml bottles.

Marketing Authorisation Holder

GlaxoSmithKline Consumer Healthcare (UK)

Trading Limited, Brentford, TW8 9GS, U.K.

Manufacturer

GlaxoSmithKline Consumer Healthcare (UK)

Trading Limited, Brentford, TW8 9GS, U.K.

This leaflet was last revised in February 2016

Otrivine® is a registered trademark owned by or licensed to the GSK group of companies.

GB 316937 - XXXXXX

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