NASENSPRAY

NASAL SPRAY-ratiopharm Children's preservative-free

Important notes (mandatory information)

NasenSpray-ratiopharm Children. Active ingredient: Xylometazoline hydrochloride 0.05%. Areas of application: for decongesting the nasal mucosa (short-term treatment) for colds, intermittent rhinorrhea (rhinitis vasomotorica) or allergic rhinitis (rhinitis allergica) and for facilitating the drainage of secretions in the inflammation of the paranasal sinuses as well as in catarrh of the middle ear tube in connection with colds.

For risks and side effects, read the package leaflet and ask your doctor or pharmacist!


PACKAGE LEAFLET: INFORMATION FOR THE USER

NasenSpray-ratiopharm Children Nasal spray, solution for use in children from 2 to 6 years of age
Active ingredient: Xylometazoline hydrochloride 0.05%

Read the entire package leaflet carefully before you start using this medicine, because it contains important information. Always use this medicine exactly as described in this package leaflet or exactly as directed by your doctor or pharmacist.

• Keep the package leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If you notice any side effects, contact your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. See section 4.
• If you do not feel better or even worse after 7 days, contact your doctor.

What this package leaflet contains

1. WHAT IS NASENSPRAY–RATIOPHARM AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE USING NASENSPRAY–RATIOPHARM?
3. HOW TO USE NASENSPRAY–RATIOPHARM?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE NASENSPRAY–RATIOPHARM?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT IS NASENSPRAY-RATIOPHARM AND WHAT IS IT USED FOR?

NasenSpray-ratiopharm is a nasal medication (rhinologic) and contains the alpha-sympathomimetic xylometazoline. Xylometazoline has vasoconstrictive properties and thus causes a decongestion of the mucous membrane. NasenSpray-ratiopharm is used to decongest the nasal mucosa (short-term treatment) for colds, intermittent rhinorrhea (rhinitis vasomotorica) or allergic rhinitis (rhinitis allergica) and to facilitate the drainage of secretions in the inflammation of the paranasal sinuses as well as in catarrh of the middle ear tube in connection with colds. NasenSpray-ratiopharm is intended for adults and school children.

2. WHAT SHOULD YOU CONSIDER BEFORE USING NASENSPRAY-RATIOPHARM?

NasenSpray-ratiopharm must not be used:

• if you are allergic to xylometazoline or any of the other ingredients of this medicine listed in section 6.
• if you suffer from a certain form of chronic rhinitis (rhinitis sicca, dry inflammation of the nasal mucosa with crust formation).
• after surgical removal of the pituitary gland through the nose (transsphenoidal hypophysectomy) or other surgical procedures that expose the meninges.
• in infants, toddlers and children under 6 years of age.

Warnings and precautions

Please talk to your doctor or pharmacist before using NasenSpray-ratiopharm:

• if you are being treated with certain mood-elevating medicines (monoamine oxidase inhibitors [MAO inhibitors]) and other potentially blood pressure-raising medicines.
• if you suffer from increased intraocular pressure, especially narrow-angle glaucoma.
• if you have a heart condition (e.g. long-QT syndrome).
• if you suffer from severe cardiovascular diseases (e.g. coronary heart disease [CHD], high blood pressure).
• if you suffer from a tumor of the adrenal gland (pheochromocytoma).
• if you have metabolic disorders such as hyperthyroidism (hyperthyroidism) or diabetes mellitus.
• if you have an enlarged prostate.
• if you suffer from the metabolic disorder porphyria.

The continuous use of decongestant cold medicines can lead to chronic swelling and eventually to atrophy of the nasal mucosa.

Children

NasenSpray-ratiopharm must not be used in infants and toddlers under 2 years of age.

Use of NasenSpray-ratiopharm together with other medicines

Tell your doctor or pharmacist if you are taking/using, have recently taken/used or intend to take/use any other medicines. When NasenSpray-ratiopharm is used together with certain mood-elevating medicines (MAO inhibitors of the tranylcypromine type or tricyclic antidepressants) and blood pressure-raising medicines, an increase in blood pressure can occur due to effects on cardiovascular functions.

Pregnancy and

breastfeeding

If you are pregnant or breastfeeding, or if you suspect you may be pregnant or intend to become pregnant, ask your doctor or pharmacist for advice before using this medicine. During pregnancy and breastfeeding, the recommended dosage must not be exceeded, as an overdose can impair the blood supply to the unborn child or reduce milk production.

Pregnancy

NasenSpray-ratiopharm can be used during pregnancy for no more than one week if used as directed.

Breastfeeding

It is not known whether xylometazoline passes into breast milk. A risk to the infant cannot be ruled out. A decision must be made whether to discontinue breastfeeding or to refrain from/discontinue treatment with NasenSpray-ratiopharm. The benefit of breastfeeding for the child and the benefit of therapy for the woman must be taken into account.

Driving and operating machinery

No impairments are to be expected if used as directed.

3. HOW TO USE NASENSPRAY-RATIOPHARM?

Always use this medicine exactly as described in this package leaflet or exactly as agreed with your doctor or pharmacist. Check with your doctor or pharmacist if you are not sure. Unless otherwise prescribed by your doctor, the recommended dose is: For children aged 2 - 6 years, 1 spray of NasenSpray-ratiopharm is administered into each nostril as needed, but no more than 3 times a day.

Method of administration

After removing the protective cap, insert the spray opening into the nostril and pump once. Inhale gently through the nose during spraying. After use, carefully wipe the nasal tube with a clean tissue and replace the protective cap.

Notes

Perform several pumping actions before using for the first time until an even spray mist is produced. For all further applications, the dosing spray is ready for use immediately. It is advisable to blow your nose thoroughly before using the product. The last application on each day of treatment should preferably be made before going to bed. For hygienic reasons and to avoid transmission of pathogens, each dosing spray should only be used by one and the same person.

Duration of use

NasenSpray-ratiopharm must not be used for longer than 7 days, unless prescribed by a doctor. Re-application should only take place after a break of several days. Use in chronic rhinitis should only be under medical supervision due to the risk of atrophy of the nasal mucosa.

Please talk to your doctor or pharmacist if you have the impression that the effect of NasenSpray-ratiopharm is too strong or too weak.

If you have used more NasenSpray-ratiopharm than you should

The following effects may occur as a result of a significant overdose or accidental ingestion of the medicine:

• Pupil dilation or constriction
• Nausea and vomiting
• Pallor, blue discoloration of the skin and lips
• Fever, sweating or even a drop in body temperature
• Cardiovascular disorders such as too slow, too fast or irregular heartbeat, increase or decrease in blood pressure
• Respiratory arrest
• Lethargy, drowsiness and coma
• Anxiety, agitation, hallucinations and convulsions

Especially in children, convulsions and coma, slow heartbeat, respiratory arrest and an increase in blood pressure, which can be followed by a drop in blood pressure, often occur after an overdose. In cases of poisoning, you must inform your doctor immediately, monitoring and therapy in hospital are necessary.

If you forget to use NasenSpray-ratiopharm

Do not use twice the amount the next time you forget the previous application, but continue the application as described in the dosage instructions.

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

4. WHAT SIDE EFFECTS ARE POSSIBLE?

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

The following frequency information is used to evaluate side effects:
Very common:	more than 1 in 10 treated persons
Common:	1 to 10 in 100 treated persons
Uncommon:	1 to 10 in 1,000 treated persons
Rare:	1 to 10 in 10,000 treated persons
Very rare:	less than 1 in 10,000 treated persons
Not known:	frequency cannot be estimated from the available data.

Immune system

Uncommon: Hypersensitivity reactions (skin rash, itching, swelling of the skin and mucous membranes).

Nervous system

Very rare: Restlessness, insomnia, fatigue, headache, dizziness. Nausea, hallucinations (primarily in children).

Cardiovascular system

Rare: Palpitations, rapid heartbeat, increased blood pressure.
Very rare: Cardiac arrhythmias.

Respiratory tract and chest

Common: transient mild irritation (burning or dryness of the nasal mucosa, sneezing).
Uncommon: after the effect has subsided, stronger feeling of a "blocked" nose, nosebleeds.

Skeletal muscle, connective tissue and bones

Very rare: Convulsions (especially in children).

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Dept. of Pharmacovigilance, Kurt-Georg-Kiesinger Allee 3, D 53175 Bonn, website: www.bfarm.de. By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE NASENSPRAY-RATIOPHARM?

Keep this medicine out of the reach of children. Do not use this nasal spray after the expiry date which is stated on the carton and label after "Use by". The expiry date refers to the last day of the month indicated. Do not store above 25°C. NasenSpray-ratiopharm should not be used for more than 6 months after opening.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What NasenSpray-ratiopharm contains

The active ingredient is: Xylometazoline hydrochloride. Each spray (equivalent to 0.09 ml solution) contains 0.045 mg xylometazoline hydrochloride. The other ingredients are: Citric acid monohydrate, sodium citrate x 2 H20, glycerol 85%, purified water.

What NasenSpray-ratiopharm looks like and contents of the pack

Clear, colorless to slightly yellow solution. NasenSpray-ratiopharm is available in packs of 10 ml solution.

Pharmaceutical entrepreneur

ratiopharm GmbH
Graf-Arco-Straße 3
89079 Ulm

Manufacturer

Merckle GmbH
Ludwig-Merckle-Straße 3
89143 Blaubeuren

This package leaflet was last revised in December 2018.

Source: Information from the package leaflet
Status: 07/2020
Active ingredient: Xylometazoline hydrochloride 0.05%. Areas of application: for decongesting the nasal mucosa (short-term treatment) for colds, intermittent rhinorrhea (rhinitis vasomotorica) or allergic rhinitis (rhinitis allergica) and for facilitating the drainage of secretions in the inflammation of the paranasal sinuses as well as in catarrh of the middle ear tube in connection with colds.