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XYLOMETAZOLINE DECONGESTANT NASAL DROPS 0.1% ADULT FORMULA, MANX HEALTHCARE CLEAR NOSE DROPS - ADULT FORMULA - patient leaflet, side effects, dosage

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Patient leaflet - XYLOMETAZOLINE DECONGESTANT NASAL DROPS 0.1% ADULT FORMULA, MANX HEALTHCARE CLEAR NOSE DROPS - ADULT FORMULA

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.

  • Keep this leaflet. You may need to read it again
  • Ask your pharmacist if you need more information or advice
  • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4
  • You must talk to a doctor if you do not feel better or if you feel worse after 7 days.

What is in this leaflet

  • 1. What the nasal drops are and what they are used for

  • 2. What you need to know before you use the nasal drops

  • 3. How to use the nasal drops

  • 4. Possible side effects

  • 5. How to store the nasal drops

  • 6. Contents of the pack and other information

1. What the nasal drops are and what they are used for

Xylometazoline Decongestant Nasal Drops 0.1%w/v Adult Formula (hereinafter referred to as the nasal drops) contain 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. The effects start within minutes and last for up to about 10 hours.

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

  • if you are pregnant or breast feeding
  • for children under 12 years of age
  • if you have vasomotor rhinitis or atrophic rhinitis
  • if you have had trans-sphenoidal hypophysectomy or surgery exposing the dura-mater

Warnings and precautions

Talk to your doctor or pharmacist before using the nasal drops:

  • if you have heart disease, raised blood pressure, diabetes, an overactive thyroid gland, or are under a doctor’s care for another illness
  • If you have experienced a strong reaction [for example difficulty in sleeping or dizziness] with similar medicines
  • if you 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 these nasal drops if you are taking or have taken within the last two weeks a medicine known as “monoamine oxidase inhibitor".

Other medicines and the nasal drops

Tell your doctor or pharmacist if you are taking or using, have recently taken or used or might take or use any other 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 Drops Adult Formula 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 drops

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

These nasal drops, like any other nasal decongestants, should not be used for more than seven consecutive days, otherwise it may worsen your condition because of a rebound action. If symptoms persist, consult your doctor.

For adults and children over 12 years of age:

  • 2 or 3 drops of solution in each nostril 2 or 3 times daily

  • 1. Clear the nose

  • 2. Shake the bottle gently and remove the cap

  • 3. Lean head right back as far as is comfortable and apply two or three drops of solution to each

nostril.

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.

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

If you forget 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)

Reporting of side effects

If you get any side effects, talk to a 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: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 drops

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 drops 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 informationthe nasal drops contain 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.

The nasal drops are a clear and colourless solution available in a 10ml dropper bottle.

MA Holder:

Manx Healthcare Ltd Taylor Group House Wedgnock Lane Warwick

CV34 5YA

Manufacturer:

INyX PHARMA Ltd

9 Arkwright Road

Astmoor Industrial Estate

Runcorn

Cheshire

WA7 1NU

Other formats

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

Date of leaflet revision: September 2019