XYLOMETAZOLINE/DEXPANTHENOL 1 MG / 50 MG / ML NASAL SPRAY SOLUTION - patient leaflet, side effects, dosage

Xylometazoline/Dexpanthenol

1 mg/50 mg/ml nasal spray, solution

xylometazoline hydrochloride 1mg/ml dexpanthenol 50mg/ml

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 have 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 Xylometazoline/Dex­panthenol 1 mg/50 mg/ml nasal spray, solution is and what it is used for

• 2. What you need to know before you use Xylometazoline/Dex­panthenol 1 mg/50 mg/ml nasal spray, solution

• 3. How to use Xylometazoline/Dex­panthenol 1 mg/50 mg/ml nasal spray, solution 4. Possible side effects

5. How to store Xylometazoline/Dex­panthenol 1 mg/50 mg/ml nasal spray, solution 6. Contents of the pack and other information

1. what xylometazoline/dexpanthenol 1 mg/50 mg/ml nasal spray, solution is and what it is used for

Xylometazoline/Dex­panthenol 1 mg/50 mg/ml nasal spray, solution contains xylometazoline hydrochloride and dexpanthenol. Xylometazoline hydrochloride rapidly constricts blood vessels in the nasal mucous membrane and reduces the swelling of the nasal mucous membrane to ease congestion. Dexpanthenol is a derivative of the vitamin pantothenic acid, which promotes healing and protects the nasal mucous membrane.

Xylometazoline/Dex­panthenol 1 mg/50 mg/ml nasal spray, solution is used:

• ■ For reducing the swelling of the inflamed nasal mucous membrane (rhinitis) and relieving the symptoms of nasal congestion associated with the common cold, influenza, sinusitis, allergic and non-allergic rhinitis (vasomotor rhinitis) or other respiratory tract allergies.

This medicine is intended for use in adults and children aged 12 years or over.

2. what you need to know before you use xylometazoline/dexpanthenol

• 1 mg/50 mg/ml nasal spray, solution

Do not use Xylometazoline/Dex­panthenol 1 mg/50 mg/ml nasal spray, solution:

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

• ■ if you have a dry inflammation of the nasal mucous membrane with formation of crusts (rhinitis sicca),

• ■ if you have had a surgical removal of the pituitary gland or other surgery exposing the meninges (lining of the brain).

This medicine should not be used in children under 12 years of age.

A Warnings and precautions

Talk to your doctor or pharmacist before using Xylometazoline/Dex­panthenol

• 1 mg/50 mg/ml nasal spray, solution:

• ■ if you are taking monoamine oxidase inhibitors (MAOIs) or other medicines that can raise blood pressure,

• ■ if you have elevated pressure inside the eye (glaucoma), particularly if you suffer from narrow-angle glaucoma,

• ■ if you have severe cardiovascular disease (e.g. coronary heart disease, high blood pressure),

• ■ if you have a metabolic disease (e.g. if you have diabetes, increased activity of the thyroid gland)

• ■ if you have adrenal marrow tumour (pheochromocytoma),

• ■ if you have a metabolic disorder called porphyria,

• ■ if you have an enlarged prostate.

If any of the above apply to you, talk to your doctor or pharmacist before using Xylometazoline/Dex­panthenol 1 mg/50 mg/ml nasal spray, solution.

A Long-term and incorrect use

Use during chronic rhinitis may only be carried out under medical supervision owing to the danger of the atrophy of the nasal mucosa.

Incorrect use or use of the excessive amounts of the spray can cause systemic undesirable effects (see section Possible side effects).

Prolonged use or use of higher doses of this medicine may result in chronic swelling and possibly thinning (damage) of the nasal mucous membrane.

Avoid direct contact of this medicine with the eyes.

Other medicines and Xylometazoline/Dex­panthenol 1 mg/50 mg/ml nasal spray, solution

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Using Xylometazoline/Dex­panthenol 1 mg/50 mg/ml nasal spray, solution at the same time as some medicines for the treatment of depression (monoamine oxidase inhibitors of the tranylcypromine type or tricyclic antidepressants) as well as medicines which increase blood pressure may lead to an increase in blood pressure due to the cardiovascular effects of these substances.

Using Xylometazoline/Dex­panthenol 1 mg/50 mg/ml nasal spray, solution at the same time as some other medicines containing sympathomimetics (medicines used to treat nasal congestion such as pseudoephedrine, ephedrine, phenylephrine, oxymetazoline, xylometazoline, tramazoline, naphazoline, tuaminoheptane) may increase the undesirable effects on the cardiovascular and central nervous system.

Medicines to reduce blood pressure (e.g. methyldopa) should not be used together with xylometazoline due to its blood pressure increasing effect.

Consult a doctor before using Xylometazoline/Dex­panthenol 1 mg/50 mg/ml nasal spray, solution if you use any of the above- mentioned medicines.

Pregnancy, breast-feeding and fertility

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.

This medicine should not be used during pregnancy due to a lack of safety data in pregnant women.This medicine should not be used during breast-feeding, since it is not known whether xylometazoline hydrochloride passes into breast milk.

Driving and using machines

This medicine is not expected to affect your ability to drive or use machines when used as recommended.

• 3. Howto useXylometazo­line/Dexpanthe­nol 1 mg/50 mg/ml nasal spray, solution

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.

The recommended dose for adults is one spray into each nostril up to 3 times a day as needed unless otherwise directed by your doctor. Do not use this medicine for more than 7 days. If you do not feel better or feel worse after 7 days of treatment, please consult the doctor. Next use is possible only after a break of several days. After first opening of the container, the product should be used within 3 months.

If the product is dropped without the protective cap, ensure that the spray is directed upwards when the bottle is held upright (refer to image 1). If not, the product should be discarded. If the product is retained after being dropped without the cap, the nozzle should be cleaned thoroughly with an antiseptic wipe.

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Method of administration

Xylometazoline/Dex­panthenol 1 mg/50 mg/ml nasal spray, solution is intended for nasal use.

First remove the protective cap from the sprayer.

Before the first use press the spray head 5 times away from the face until a fine spray appears. If the spray has not been used for a long period of time the head should be pressed two times away from the face before use.

Insert the sprayer tip as upright as possible into one nostril and press the spray head once. Gently inhale through the nose while spraying. If necessary, repeat the procedure for the other nostril (up to 3 times a day as needed). After each use, wipe the sprayer tip with a paper tissue and place the protective cap back on the sprayer.

For hygiene reasons and to avoid infections, each spray bottle should only be used by the same person.

If you use more Xylometazoline/Dex­panthenol 1 mg/50 mg/ml nasal spray, solution than you should

If you use more of this medicine than you should or if you accidentally ingest large quantities of the medicine, the following side effects might occur:

• ■ constriction of the eye pupils (meiosis),

• ■ expansion of the eye pupils (mydriasis),

• ■ fever,

• ■ sweating,

• ■ paleness of the skin,

• ■ blue coloration of the skin or lips (cyanosis),

• ■ nausea,

• ■ convulsions,

• ■ cardiac and vascular disorders (increased heart rate, slow heart rate, heart rhythm disorders, circulatory failure, cardiac arrest, high blood pressure (hypertension),

• ■ respiratory disorders (swelling of the lungs, breathing problems),

• ■ mental disorders (anxiety, agitation, hallucinations),

• ■ you may also experience drowsiness, decreased body temperature, heart rate decelerations, and decrease in blood pressure, respiratory arrest and coma.

If you notice any of these symptoms, contact your doctor immediately.

If you forget to use Xylometazoline/Dex­panthenol 1 mg/50 mg/ml nasal spray, solution

Do not use a double dose to make up for a forgotten dose. Continue administration as described in the dosage instruction.

4. possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Uncommon (may affect up to 1 in 100 people):

• ■ hypersensitivity reaction such as swelling of the skin and mucous membranes, skin rash, itching.

• ■ Nosebleeds

Rare (may affect up to 1 in 1,000 people):

• ■ palpitations (feeling your heartbeat), tachycardia (faster heartbeat), hypertension (high blood pressure).

Very rare (may affect up to 1 in 10,000 people):

• ■ restlessness, difficulty in sleeping, fatigue (drowsiness, sedation), headache, hallucinations,

• ■ heart rhythm disorders (arrhythmias),

• ■ swelling of the nasal mucous membrane (after discontinuation of the treatment), nosebleed,

• ■ seizures (convulsion).

Not known (frequency cannot be estimated from the available data):

• ■ burning and dryness of the nasal mucous membrane, sneezing.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist.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 xylometazoline/ dexpanthenol 1 mg/50 mg/ml nasal spray, solution

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 packaging after EXP. The expiry date refers to the last day of that month.

Do not store above 25°C.

After first opening of the container, the product should be used within 3 months.

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 Xylometazoline/Dex­panthenol 1 mg/50 mg/ml nasal spray, solution contains

• ■ The active substances are xylometazoline hydrochloride and dexpanthenol.

Each ml of nasal spray, solution, contains 1 mg xylometazoline hydrochloride and 50 mg dexpanthenol.

One spray contains 0.1 ml of nasal spray, solution, containing 0.1 mg xylometazoline hydrochloride and 5.0 mg dexpanthenol.

• ■ The other ingredients are potassium dihydrogen phosphate, disodium phosphate dodecahydrate and water for injections.

What Xylometazoline/Dexpanthenol 1 mg/50 mg/ml nasal spray, solution looks like and contents of the pack

Clear, colourless to slightly yellowish solution.

Xylometazoline/Dex­panthenol 1 mg/50 mg/ml nasal spray, solution is available in boxes of 10 ml of nasal spray, solution, in a HDPE bottle with spray pump. 10 ml of nasal spray, solution is sufficient for 80 sprays.

Marketing Authorisation Holder

McNeil Products Limited, High Wycombe, Buckinghamshire, HP12 4EG, UK.

Manufacturer

Famar Health Care Services Madrid, S.A.U., Avda. Leganes, 62, Alcorcon, 28923, Madrid.

or

Ursapharm Arzneimittel GmbH, Industriestrasse 35,66129 Saar­brucken, Germany.

This leaflet was last revised in January 2022.

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