Package leaflet: Information for the user
Xylometazoline HCl nasal spray 1 mg/ml <[To be completed nationally]>
xylometazoline hydrochloride
Nasal spray for adults and children over 12 years of age
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 Xylometazoline HCl nasal spray 1 mg/ml is and what it is used for 2. What you need to know before you use Xylometazoline HCl nasal spray 1 mg/ml 3. How to use Xylometazoline HCl nasal spray 1 mg/ml 4. Possible side effects 5. How to store Xylometazoline HCl nasal spray 1 mg/ml 6. Contents of the pack and other information
1. What Xylometazoline HCl nasal spray 1 mg/ml is and what is it used for
Xylometazoline HCl is used for short-term treatment of nasal congestion due to inflammation of mucous membranes of the nose or sinuses with a congested or runny nose, sneezing and mucus (rhinitis or sinusitis) for adults and children over 12 years of age.
Xylometazoline HCl nasal spray 1 mg/ml ensures fast and long lasting relief of nasal congestion, it reduces the swelling of the mucous membrane in the nose and thus helps to maintain a clear nasal passageway, making it easier for you/your child to breathe.The effect of this medicine starts within 2 minutes and lasts for up to 12 hours.
Xylometazoline HCl nasal spray 1 mg/ml is used in adults and children over 12 years of age. Do not use Xylometazoline HCl nasal spray 1 mg/ml for children under 12 years of age. For children aged 2 to 12 years a different strength is available.
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 Xylometazoline HCl nasal spray 1 mg/ml
Do not use Xylometazoline HCl nasal spray 1 mg/ml: - if you are allergic to xylometazoline hydrochloride or any of the other ingredients of this medicine (listed in section 6). - if you have recently undergone nasal surgery. In this case, consult your doctor before you start using Xylometazoline HCl nasal spray 1 mg/ml. - in children under the age of 12.
Warnings and precautions Talk to your doctor or pharmacist before using Xylometazoline HCl nasal spray 1 mg/ml if you suffer from one of the following conditions: - hypertension - heart and cardiovascular diseases (e.g. prolonged QT syndrome) - thyroid disorder - diabetes - enlarged prostate - a tumor of the adrenal medulla (phaeochromocytoma) - narrow angle glaucoma
As with other comparable medicinal products, Xylometazoline HCl nasal spray 1 mg/ml can cause sleep disturbances, dizziness and tremor in people who are sensitive to this. Please contact your doctor if these kind of symptoms become annoying.
As with other medicinal products which reduce swelling of the nasal mucosa, you may not use Xylometazoline HCl nasal spray 1 mg/ml contineously for more than a week at a time. Prolonged or excessive use can cause ‘rebound’-congestion (rebound: worsened symptoms of the condition return). If no improvement occurs within a week, contact your doctor.
Avoid contact with eyes and mouth.
The recommended dose should not be exceeded, especially in children and elderly.
Children Xylometazoline HCl nasal spray 1 mg/ml should not be used in children under 12 years of age. For children aged 2 to 12 years another strength is available. Other medicines and Xylometazoline HCl nasal spray 1 mg/ml Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
The effects of Xylometazoline HCl nasal spray 1 mg/ml may be increased if you are using antidepressant medicines. The effect of beta-blockers (medicines against high blood pressure, certain heart conditions and increased eye pressure) may also change.
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 taking this medicine.
Pregnancy Ask your doctor or pharmacist for advice before taking this medicine if you are pregnant. Use this medicine only if your doctor has decided that you can do this safely.
Breastfeeding It is not known whether xylometazoline is excreted in human milk. A risk to the suckling child can not be excluded. You should either interupt breastfeeding or refrain from xylometazoline hydrochloride therapy, considering the benefits of breastfeading for your baby and the benefit of therapy for you.
Driving and using machines There are no data available on the effect of this medicine on the ability to drive and use machines. However, an effect is unlikely.
Xylometazoline HCl nasal spray 1 mg/ml contains benzalkonium chloride This medicine contains 0.1 mg benzalkonium chloride in each ml of nasal spray. Benzalkonium chloride may cause irritation or swelling inside the nose, especially if used for a long time.
3. How to use Xylometazoline HCl nasal spray 1 mg/ml
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.
Dose Do not use Xylometazoline HCl nasal spray 1 mg/ml for children under 12 years of age. For children aged 2 to 12 years a different strength is available.
The recommended dose is: Adults and children over 12 years of age 1 spray in each nostril, 3 times a day. There should be 8 to 10 hours between 2 administrations. Not more than 3 administrations per nostril a day.
Instructions for use 1. Blow the nose. 2. Remove the protective cap. 3. If you use the bottle for the first time, you should first press the pump 5 times until an even spray is released. The next time you use the bottle this will no longer be necessary. If you have not used the bottle for 14 days maximum (after first use), press the pump 1 time to prepare the bottle for use again. Make sure not to spray into the eyes or mouth. 4. Keep the bottle upright between thumb and fingers. 5. Keep the nozzle upright properly, tilt your head forward slightly and place the nozzle in a nostril. 6. Spray once in each nostril. Breath in through your nose whilst pressing down the pump. 7. Clean and dry the nozzle before placing the dust cap.
To avoid possible spread of infection, the bottle should be used by one person only.
If you use more Xylometazoline HCl nasal spray 1 mg/ml than you should If you accidentally used too much of this medicine, contact your doctor or pharmacist immediately.
If you forget to use Xylometazoline HCl nasal spray 1 mg/ml Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the 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.
STOP using this medicine and immediately seek medical attention if you or your child show any of the following symptoms, as these may be signs of an allergic reaction (very rare: may affect up to 1 in 10,000 people): • difficulty breathing and swallowing; • swelling of the face, lips, tongue or throat; • severe itching, accompanied by red rashes and hives (urticaria).
Other side effects that may occur:
Common (may affect up to 1 in 10 people): • headache; • dry nose or pain in the nose; • nausea; • burning sensation.
Uncommon (may affect up to 1 in 100 people): • nose bleed.
Very rare (may affect up to 1 in 10,000 people): • tremor; • dizziness; • insomnia; • disturbances of vision (visual disturbances), which are transient; • increased blood pressure ; • irregular or rapid heartbeat.
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 national reporting system. By reporting side effects you can help us provide more information on the safety of this medicine.
5. How to store Xylometazoline HCl nasal spray 1 mg/ml
Keep this medicine out of sight and reach of children.
Do not store above 25 °C.
Do not freeze.
Do not use this medicine after the expiry date which is stated on the carton and on the bottle label after “EXP”. The expiry date refers to the last day of that month. An opened bottle can be used up to 1 month after first opening.
Do not throw away medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use in a responsible manner. These measures will help protect the environment.
6. Contents of the pack and other information
What Xylometazoline HCl nasal spray 1 mg/ml contains • The active substance is xylometazoline hydrochloride. Contains 1 mg xylometazoline hydrochloride per 1 ml. • The other ingredients are benzalkonium chloride, disodium edetate, sodium dihydrogen phosphate dihydrate, disodium phosphate dodecahydrate, sodium chloride and purified water.
What Xylometazoline HCl nasal spray 1 mg/ml looks like and contents of the pack Xylometazoline HCl nasal spray 1 mg/ml is a clear, colourless to almost colourless solution. Xylometazoline HCl nasal spray 1 mg/ml is packed in a brown bottle (content 10 ml) with a dosing mechanism and a cover.
Marketing Authorisation Holder and Manufacturer Marketing authorisation holder <[To be completed nationally]>
Manufacturer Basic Pharma Manufacturing bv Burgemeester Lemmensstraat 352 6163 JT Geleen The Netherlands
This medicinal product is authorised in the Member States of the EEA under the following names:
Netherlands Xylometazoline HCl neusspray 1 mg/ml, neusspray, oplossing Belgium Rhinivex 1 mg/ml neusspray, oplossing Sweden Xylometazolin Apofri 1 mg/ml nässpray, lösning
This leaflet was last approved in <[To be completed nationally]>