NASIVIN

NASIVIN Nasal Spray Adults and Schoolchildren

Important notes (mandatory information)

Nasivin Nasal Drops Adults and School Children 0.5 mg/ml Nasal Drops, Solution. Active ingredient: Oxymetazoline hydrochloride. Indications: Acute rhinitis, allergic rhinitis and paroxysmal rhinorrhea. To facilitate the drainage of secretions in inflammation of the paranasal sinuses and in tubal catarrh in conjunction with rhinitis. For diagnostic decongestion of the mucous membrane. For use in adults and children aged 6 years and over.

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

Nasivin Nasal Spray without Preservatives Toddlers 0.25 mg/ml Nasal Spray, Solution. Oxymetazoline hydrochloride. For use in children aged 1 year and over.

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 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 experience any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this leaflet. See section 4.
• If you do not feel better or if you feel worse after 7 days, contact your doctor.

What this leaflet contains

1. WHAT IS NASIVIN NASAL SPRAY WITHOUT PRESERVATIVES TODDLERS AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE USING NASIVIN NASAL SPRAY WITHOUT PRESERVATIVES TODDLERS?
3. HOW TO USE NASIVIN NASAL SPRAY WITHOUT PRESERVATIVES TODDLERS?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE NASIVIN NASAL SPRAY WITHOUT PRESERVATIVES TODDLERS?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT IS NASIVIN NASAL SPRAY WITHOUT PRESERVATIVES TODDLERS AND WHAT IS IT USED FOR?

Nasivin Nasal Spray without Preservatives Toddlers is a nasal medication (rhinologic) and contains the alpha-sympathomimetic oxymetazoline. Oxymetazoline has vasoconstrictive properties and thus causes decongestion of the mucous membrane. In addition, antiviral, immunomodulatory, anti-inflammatory and antioxidant effects have been demonstrated for the active ingredient.
Nasivin Nasal Spray without Preservatives Toddlers is used for:

• Acute rhinitis (Rhinitis acuta).
• Allergic rhinitis (Rhinitis allergica).
• Paroxysmal rhinorrhea (Rhinitis vasomotorica).
• To facilitate the drainage of secretions in inflammation of the paranasal sinuses and in tubal otitis media in conjunction with rhinitis.
• For diagnostic decongestion of the mucous membrane.

Nasivin Nasal Spray without Preservatives Toddlers is intended for toddlers.
If you do not feel better or if you feel worse after 7 days, contact your doctor.

2. WHAT SHOULD YOU CONSIDER BEFORE USING NASIVIN NASAL SPRAY WITHOUT PRESERVATIVES TODDLERS?

Nasal Spray without Preservatives Toddlers must not be used:

• If you are allergic to oxymetazoline hydrochloride or any of the other ingredients of this medicine listed in section 6.
• If you suffer from a specific form of chronic rhinitis (Rhinitis sicca).
• After surgical removal of the pituitary gland through the nose (transsphenoidal hypophysectomy) or other surgical procedures that expose the meninges (dura mater).
• In infants and children under 1 year of age.

Warnings and precautions

Please talk to your doctor or pharmacist before using Nasivin Nasal Spray without Preservatives Toddlers if:

• You have increased intraocular pressure, especially narrow-angle glaucoma.
• You have severe cardiovascular disease (e.g., coronary heart disease) or high blood pressure (hypertension).
• You are being treated with monoamine oxidase inhibitors (MAO inhibitors) or other potentially blood pressure-raising medicines.
• You have a tumor of the adrenal gland (pheochromocytoma).
• You suffer from metabolic disorders, such as overactive thyroid gland (hyperthyroidism) and diabetes mellitus.
• Your prostate is enlarged.
• You suffer from the metabolic disorder porphyria.

Prolonged use beyond the recommended period and overdose should be strictly avoided. The effect of decongestant nasal sprays may diminish with prolonged use and overdose (development of tolerance). This can lead to the use of higher doses or more frequent use, which in turn can result in continuous use. In case of prolonged use or overdose, treatment should be stopped immediately. Continuous use of decongestant nasal sprays can lead to chronic swelling and eventually atrophy of the nasal mucosa.

Children

Nasivin Nasal Spray without Preservatives Toddlers must not be used in infants and toddlers under one year of age.
Use of Nasivin Nasal Spray without Preservatives Toddlers together with other medicines:

• Tell your doctor or pharmacist if you are taking, have recently taken or plan to take any other medicines.
• Concomitant use of Nasivin Nasal Spray without Preservatives Toddlers and certain mood-elevating medicines (MAO inhibitors of the tranylcypromine type or tricyclic antidepressants) as well as blood pressure-raising medicines can cause an increase in blood pressure due to effects on cardiovascular function.
• Please note that this information may also apply to medicines that have been taken recently.

Pregnancy and breast-feeding:

• If you are pregnant or breast-feeding, or if you suspect you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
• Since the safety of using Nasivin Nasal Spray without Preservatives Toddlers during pregnancy and breast-feeding has not been sufficiently demonstrated, you should only use Nasivin Nasal Spray without Preservatives Toddlers on the advice of your doctor and only after he or she 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 operating machinery

Nasivin Nasal Spray without Preservatives Toddlers has no or negligible influence on the ability to drive and use machines.

3. HOW TO USE NASIVIN NASAL SPRAY WITHOUT PRESERVATIVES TODDLERS?

Always use this medicine exactly as described in this 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

Toddlers from 1 to 6 years of age

Apply one spray of Nasivin Nasal Spray without Preservatives Toddlers into each nostril as needed up to 3 times a day.

Method of administration:

• Nasivin Nasal Spray without Preservatives Toddlers is intended for nasal use.
• The spray mechanism works by pressing the finger rest.
• Remove the protective cap when using for the first time.
• Take the nasal spray in your hand as shown in the diagram and pump several times until an even spray mist is emitted.
• Hold the spray opening to one nostril at a time and press once.
• Clean the spray opening after use and replace the protective cap.

Duration of use:

• Nasivin Nasal Spray without Preservatives Toddlers should not be used for longer than 7 days, unless otherwise directed by a doctor.
• Prolonged use beyond the recommended period and overdose should be strictly avoided.
• 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.

Use in children
Nasivin Nasal Spray without Preservatives Toddlers must not be used in infants and toddlers under one year of age.

If you have used more Nasivin Nasal Spray without Preservatives Toddlers than you should

If you have accidentally used too much Nasivin Nasal Spray without Preservatives Toddlers, you should inform your doctor immediately. Poisoning can occur through massive misuse and overdose or accidental ingestion of Nasivin Nasal Spray without Preservatives Toddlers. The clinical picture of poisoning with Nasivin Nasal Spray without Preservatives Toddlers can be confusing, as phases of stimulation alternate with phases of inhibition of the central nervous system and the cardiovascular system.

Especially in children, overdose often leads to central nervous effects with convulsions and coma, to a slowing of the heartbeat, respiratory arrest and an increase in blood pressure, which can be followed by a decrease in blood pressure.
Symptoms of stimulation of the central nervous system are:

• Anxiety, agitation, hallucinations and seizures (convulsions).

Symptoms due to inhibition of the central nervous system are:

• Lowering of body temperature, drowsiness (lethargy), sleepiness and coma.

The following other symptoms may occur:

• Constriction of the pupils (miosis), dilation of the pupils (mydriasis), fever, sweating, pallor, bluish discoloration of the skin due to decreased oxygen content in the blood (cyanosis), palpitations, respiratory depression and respiratory arrest (apnea), nausea and vomiting, psychogenic disorders, increase or decrease in blood pressure, irregular heartbeat, too fast/too slow heartbeat.

In cases of poisoning, a doctor must be informed immediately, monitoring and therapy in hospital are necessary.

If you forget to use Nasivin Nasal Spray without Preservatives Toddlers:

• Do not use a double dose to make up for a forgotten previous application.
• Continue using as directed in the dosage instructions.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may occur when using Nasivin* Dosedrops without Preservatives Baby:
Common

(may affect up to 1 in 10 people)

Burning and dryness of the nasal mucosa, sneezing.

Uncommon

(may affect up to 1 in 100 people)

After the effect has worn off, increased feeling of a "blocked" nose, nosebleeds, hypersensitivity reactions (skin rash, itching, swelling of the skin and mucous membranes).

Rare

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

Palpitations, rapid heart rate (tachycardia), increased blood pressure.

Very rare

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

Restlessness, insomnia, exhaustion, fatigue, drowsiness, sedation, headache, hallucinations (primarily in children), cardiac arrhythmias, respiratory arrest in young infants and newborns, convulsions (especially in children).

Not known

(cannot be estimated from the available data)

Development of tolerance (with long-term use or overdose.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this 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 about the safety of this medicine.

5. HOW TO STORE NASIVIN NASAL SPRAY WITHOUT PRESERVATIVES TODDLERS?

Keep this medicine out of the reach of children.Do not use this medicine after the expiry date which is stated on the label and carton. The expiry date refers to the last day of the month indicated.

Shelf life after opening the container

After opening, Nasivin Nasal Spray without Preservatives Toddlers should not be used for longer than 12 months.
Do not dispose of medicines in wastewater. Ask your pharmacist how to dispose of the medicine when you stop using it. You help to protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION.

What Nasivin Nasal Spray without Preservatives Toddlers looks like and contents of the pack

Nasivin Nasal Spray without Preservatives Toddlers is a clear, colorless, aqueous solution.

The active ingredient is: Oxymetazoline hydrochloride.

• 1 ml Nasivin Nasal Spray without Preservatives Toddlers contains 0.25 mg oxymetazoline hydrochloride corresponding to 0.025%.
• 1 spray with 45 microliters of solution contains 11.25 micrograms of oxymetazoline hydrochloride.
• The container contains at least 143 sprays.
• The other ingredients are: Citric acid monohydrate, sodium citrate 2 H2O, glycerol 85%, purified water.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

P&G Health Germany GmbH
Sulzbacher Strasse 40
65824 Schwalbach am Taunus
Phone 0800 588 92 02

Co-distributor

WICK Pharma
Zweigniederlassung der Procter & Gamble GmbH
65823 Schwalbach am Taunus

Manufacturer

Famar Healthcare Services Madrid
S.A.U Avda. Leganes 62
Alcorcon
28923 (Madrid)
Spain

This package leaflet was last revised in December 2021.

Source: Information from the package leaflet
Status: 06/2023
Active ingredient: Oxymetazoline hydrochloride. Indications: Acute rhinitis, allergic rhinitis and paroxysmal rhinorrhea. To facilitate the drainage of secretions in inflammation of the paranasal sinuses and in tubal catarrh in conjunction with rhinitis. For diagnostic decongestion of the mucous membrane. For use in adults and children aged 6 years and over.