Manx Healthcare Clear Nose spray, Xylometazoline Decongestant nasal spray 0.1% w/v – patient leaflet, side effects, dosage

1. WHAT THE NASAL SPRAY IS AND WHAT IT IS USED FOR

Xylometazoline Decongestant Nasal Spray (hereinafter referred to as nasal spray) contains a nasal decongestant. Nasal decongestants help clear blocked noses associated with a number of conditions including colds, sinusitis, and hay fever. A blocked nose, such as occurs with a cold, is caused by excessive nasal secretions and the swelling up of many tiny blood vessels that line the nose. The air passages become narrower and the nasal secretions may block the nose completely. The nasal decongestant in this product helps to open up the nasal passages by reducing the excessive nasal secretions and reducing the swollen blood vessels to their normal size. It will help you breathe more easily and so feel better. You must talk to a doctor if you do not feel better or if you feel worse after 7 days.

2. WHAT YOU NEED TO KNOW BEFORE YOU USE THE NASAL SPRAY

Do not use the nasal spray if you:

are allergic to xylometazoline hydrochloride or any of the other ingredients of this medicine (listed in section 6)

are pregnant or breast feeding

are a child under 12 years of age

have vasomotor rhinitis or atrophic rhinitis have had trans-sphenoidal hypophysectomy or surgery exposing the dura-mater

Warnings and precautions

Talk to your doctor or pharmacist before using the nasal spray if you:

have heart disease, raised blood pressure, diabetes, an overactive thyroid gland, or are under a doctor’s care for another illness have experienced a strong reaction [for example difficulty in sleeping or dizziness] with similar medicines

are using any other medicines including any that you can buy without a prescription. Use with medicines known as “sympathomimetics”, such as ephedrine or phenylephrine, may increase the risk of side-effects. Do not use this nasal spray if you are taking or have taken within the last two weeks a medicine known as a “monoamine oxidase inhibitor”.

Other medicines and the nasal spray

Tell your doctor or pharmacist if you are taking or using, have recently taken or used or might take or use any other medicines, including medicines (especially monoamine oxidase inhibitors or other antidepressants) including medicines obtained without a prescription.

Pregnancy and breast-feeding

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 using this medicine.

Xylometazoline Decongestant Nasal Spray contains benzalkonium chloride and sodium

This medicine contains 1.5mg benzalkonium chloride in each 10ml which is equivalent to 1.5mg/10ml. Benzalkonium chloride may cause irritation or swelling inside the nose, especially if used for a long time.

This medicine contains less than 1mmol sodium (23mg) per dose, that is to say essentially ‘sodium-free’.

3. HOW TO USE THE NASAL SPRAY

For adults and children over 12 years of age:

One application in each nostril 2 or 3 times daily

1. 1. Clear the nose.
2. 2. Shake the bottle gently and remove the cap.
3. 3. Hold spray with your forefinger and middle finger either side of the nozzle and your thumb underneath the bottle as shown in the diagram.
4. 4.

   Close one nostril and put the

   nozzle in the other nostril. Tilt your head forward slightly and keep the spray upright.

5. 5. Start to breathe in through your nose and while breathing in press down with your fingers once to release a spray.
6. 6. Repeat steps 5 and 6 with the other nostril.
7. 7.

   Wipe the nozzle with a clean tissue or handkerchief and replace the cap.

   (continued overleaf) Not recommended for use in children under 12 years of age.

To avoid the possible spread of infection, these drops should be used by one person only. If you use more nasal drops than you should

Consult your doctor if you think that you have used too much solution or have taken it accidentally by mouth.

If you forgot to use the nasal drops

If you forget to use the nasal drops, use as soon as you remember. If it is almost time for your next dose, wait until that is due and then continue as normal. Do not take a double dose to make up for a forgotten dose.

If you have any further questions on this use of this medicine, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects have been reported occasionally:

A burning sensation in the nose and throat Local irritation

Nausea

Headache

Dryness of the nasal lining

The frequency of these side effects is not known: Allergic reactions

Visual disturbances (temporary)

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

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 in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard, or search for MHRA Yellow Card in the Google Play or Apple App store. By reporting side effects you can help provide more information on the safety of this medicine.

5. HOW TO STORE THE NASAL SPRAY Keep this medicine out of the sight and reach of children.

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

Store below 30°C

For reasons of hygiene do not use the spray for more than 28 days after first opening the bottle. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What the nasal spray contains

The nasal spray contains xylometazoline hydrochloride 0.1%w/v as the active ingredient. They also contain benzalkonium chloride, disodium edetate, sodium phosphate dihydrate, sodium acid phosphate, sodium chloride and purified water.

What the nasal spray looks like and contents of the pack

The nasal spray is a clear and colourless solution available in a 10ml bottle.

MA Holder:

Manx Healthcare Ltd

Taylor Group House, Wedgnock Lane, Warwick CV34 5YA

Manufacturer:

Basic Pharma Manufacturing BV

Burgemeester Lemmensstraat 352, 6163 JT Geleen,

The Netherlands

Other formats

To request a copy of this leaflet in Braille, large print or audio, please call 01926 482511.

This leaflet was last revised in March 2021

WIP URN: 100321-XXXX-PIL-02