SNUP

SNUP cold spray 0.05% nasal spray

Important notes (mandatory information)

Snup Nasal Spray 0.05%, nasal spray, solution. Active ingredient: Xylometazoline hydrochloride. Areas of application: for decongesting the nasal mucosa in the case of a cold, intermittent rhinitis (rhinitis vasomotorica), allergic rhinitis (rhinitis allergica) and/or to facilitate the drainage of secretions in the case of inflammation of the paranasal sinuses as well as in the case of catarrh of the middle ear tube in conjunction with a cold.

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

Snup Nasal Spray 0.05%, nasal spray, solution for use in children between 2 and 6 years of age
Active ingredient: Xylometazoline hydrochloride

Read the entire package leaflet carefully before you start using this medicine, because it contains important information for you. 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 SNUP AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE USING SNUP?
3. HOW IS SNUP USED?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD SNUP BE STORED?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT IS SNUP AND WHAT IS IT USED FOR?

Snup is a medicine for use in the nose (rhinologic) and contains the alpha-sympathomimetic xylometazoline. Xylometazoline has vasoconstrictive properties and thus causes a decongestion of the mucous membrane. Snup is used to decongest the nasal mucosa in the case of a cold, intermittent rhinitis (rhinitis vasomotorica), allergic rhinitis (rhinitis allergica) and/or to facilitate the drainage of secretions in the case of inflammation of the paranasal sinuses as well as in the case of catarrh of the middle ear tube in conjunction with a cold. Snup is intended for children between 2 and 6 years of age.

2. WHAT SHOULD YOU CONSIDER BEFORE USING SNUP?

Snup must not be used:

• if you are allergic to xylometazoline hydrochloride or any of the other ingredients of this medicine listed in section 6.
• in the case of a certain form of chronic rhinitis (rhinitis sicca).
• in the case of a condition after surgical removal of the pineal gland through the nose (transsphenoidal hypophysectomy) or other surgical interventions that expose the meninges.
• by infants and toddlers up to 2 years of age.

Warnings and precautions

There are individual reports of serious side effects (in particular respiratory arrest) when using the recommended dose. Overdosing must be avoided under all circumstances. You may only use Snup in the following illnesses and situations after consulting your doctor:

• in the case of increased intraocular pressure, in particular narrow-angle glaucoma.
• severe cardiovascular diseases (e.g. coronary heart disease, long QT syndrome) and high blood pressure (hypertension).
• if you are being treated with monoamine oxidase inhibitors (MAO inhibitors) and other medicines that can potentially increase blood pressure.
• pheochromocytoma of the adrenal gland.
• metabolic disorders, such as hyperthyroidism (hyperthyroidism) and diabetes mellitus.
• enlarged prostate.
• metabolic disorder porphyria.

The continuous use of decongestant nasal sprays can lead to chronic swelling and ultimately to atrophy of the nasal mucosa. In order to maintain at least part of the nasal breathing, Snup should only be used in one nostril and discontinued on the other side after the symptoms have subsided.

Children

Snup must not be used in infants and toddlers up to 2 years of age.

Use of Snup together with other medicines

Inform your doctor or pharmacist if you are using, have recently used or intend to use other medicines. When Snup is used together with certain mood-elevating medicines (MAO inhibitors of the tranylcypromine type or tricyclic antidepressants) as well as medicines that increase blood pressure, an increase in blood pressure can occur due to effects on cardiovascular functions. Please note that this information may also apply to medicines that have been used recently.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, or if you suspect you may be pregnant or intend to become pregnant, ask your doctor or pharmacist for advice before using this medicine. Since the safety of using Snup during pregnancy and breast-feeding has not been sufficiently proven, you may only take Snup on the advice of your doctor and only after your doctor has carefully weighed the benefits and risks. During pregnancy and breast-feeding, the recommended dosage must not be exceeded, as an overdose can impair the blood supply to the unborn child or reduce milk production.

Driving and ability to operate machinery

No impairments are to be expected if used as intended.

3. HOW IS SNUP USED?

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

The recommended dose is

Do not exceed the recommended dosage and application times. Unless otherwise prescribed by your doctor, children aged 2 - 6 years should receive one spray of Snup into each nostril as needed up to 3 times a day.

Method of administration
Snup is intended for nasal use.

Instructions

Remove the protective cap. Before using for the first time, pump several times into the air until an even spray mist is produced. The nasal spray is ready for use immediately for all further applications. However, repeat the procedure if you have not used your Snup for more than 3 days. After use, carefully wipe the spray head from the outside with a clean tissue and replace the protective cap. For hygienic reasons and to avoid the transmission of pathogens, each nasal spray should only be used by one and the same person.

Duration of use

Snup must not be used for longer than 7 days, unless prescribed by a doctor. It should only be used again after a break of several days. Use in the case of chronic rhinitis may only be carried out under medical supervision due to the risk of atrophy of the nasal mucosa.

Please talk to your doctor if you have the impression that the effect of Snup is too strong or too weak.

If you have used more Snup than you should

Inform your doctor immediately. Poisoning can occur due to significant overdose or accidental ingestion of the medicine. The clinical picture of poisoning with Snup can be confusing, as phases of stimulation can alternate with phases of suppression of the central nervous system and the cardiovascular system. Particularly in children, overdose often leads to central nervous effects with convulsions and coma, slow heart rate, respiratory arrest and an increase in blood pressure, which can be followed by a drop in blood pressure. Symptoms of stimulation of the central nervous system are anxiety, agitation, hallucinations and convulsions. Symptoms due to inhibition of the central nervous system are lowering of body temperature, lethargy, drowsiness and coma. The following additional symptoms may occur: constriction of the pupils (miosis), dilation of the pupils (mydriasis), fever, sweating, pallor, bluish discoloration of the skin due to a decrease in the oxygen content of the blood (cyanosis), palpitations, respiratory depression (shallow, slow breathing) and respiratory arrest (apnea), nausea and vomiting, psychogenic disorders, increase or decrease in blood pressure, irregular heartbeat, too fast/too slow heartbeat, cardiac arrest, pulmonary edema (accumulation of water in the lungs). In cases of poisoning, a doctor must be informed immediately; monitoring and therapy in hospital are necessary.

If you forget to use Snup

Do not use a double dose if you have forgotten the previous application, but continue using it according to the dosage instructions.

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

4. WHAT SIDE EFFECTS ARE POSSIBLE?

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

Common (may affect up to 1 in 10 people):

• Burning and dryness of the nasal mucosa, sneezing.

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

• After the effect has subsided, a stronger feeling of a "blocked" nose (increased swelling of the mucous membrane), nosebleeds.
• Hypersensitivity reactions (skin rash, itching, swelling of the skin and mucous membrane).

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

• Palpitations, accelerated heart rate (tachycardia).
• Increase in blood pressure.

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

• Cardiac arrhythmias.
• Headaches, convulsions (especially in children).
• Respiratory arrest (reported when xylometazoline was used in young infants and newborns).
• Fatigue (drowsiness, sedation).
• Restlessness, insomnia, hallucinations (primarily in children).

Reporting of side effects

If you notice any side effects, contact 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 to provide more information on the safety of this medicine.

5. HOW SHOULD SNUP BE STORED?

Keep out of reach of children. This medicinal product does not require any special storage conditions. Do not use this medicine after the expiry date which is stated on the carton and the container after "use by". The expiry date refers to the last day of the month.

Shelf life after opening the container

Do not use for more than 12 months after opening the container.

Medicines should not be disposed of via wastewater. Ask your pharmacist how to dispose of the medicine when you no longer need it. This measure helps to protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Snup Nasal Spray 0.05%

Nasal spray, solution contains

The active ingredient is: Xylometazoline hydrochloride. 1 ml nasal spray, solution contains 0.5 mg xylometazoline hydrochloride. 1 spray (approx. 0.09 ml solution) contains 0.045 mg xylometazoline hydrochloride. The other ingredients are potassium dihydrogen phosphate, seawater, purified water.

How Snup Nasal Spray 0.05%

Nasal spray, solution looks like and contents of the pack

Clear, colorless solution. Snup Nasal Spray 0.05% Nasal spray, solution is available in packs of 10 ml nasal spray, solution.

Pharmaceutical entrepreneur

Stada Consumer Health Deutschland GmbH
Stadastraße 2 - 18
61118 Bad Vilbel
Telephone: 06101 603-0
Fax: 06101 603-259
Internet: www.stada.de

Manufacturer

Stada Arzneimittel AG
Stadastraße 2 - 18
61118 Bad Vilbel

This package leaflet was last revised in July 2020.

Source: Information from the package leaflet
Status: 10/2020
Active ingredient: Xylometazoline hydrochloride. Areas of application: for decongesting the nasal mucosa in the case of a cold, intermittent rhinitis (rhinitis vasomotorica), allergic rhinitis (rhinitis allergica) and/or to facilitate the drainage of secretions in the case of inflammation of the paranasal sinuses as well as in the case of catarrh of the middle ear tube in conjunction with a cold.