COLDAN Nasal Spray – Decongestant nasal spray for colds, catarrh, and hay fever

COLDAN Nasal Spray is an over-the-counter medicine containing the active ingredient naphazoline hydrochloride for the local treatment of rhinitis, hay fever, and pharyngitis. It is also used as an adjunctive treatment for inflammation of the frontal and maxillary sinuses, as well as to facilitate rhinoscopy (examination of the nasal interior).

The active ingredient naphazoline constricts the blood vessels in the nasal mucosa, thereby acting as a decongestant. At the same time, it reduces the production of nasal secretion. Nasal breathing is made easier, and the unpleasant sensation of a blocked nose can be temporarily reduced.

The effect begins within a few minutes of application and lasts for up to 4 hours.

COLDAN Nasal Spray is suitable for adults as well as children and adolescents from the age of 6. For children between 2 and 6 years of age, it may only be used under medical supervision.

Properties and benefits of COLDAN Nasal Spray

• Decongestant effect: Naphazoline constricts the blood vessels of the nasal mucosa, thereby reducing swelling.

• Facilitates nasal breathing: Helps with a stuffy nose caused by mucosal swelling.

• For rhinitis and colds: For short-term symptomatic treatment.

• For hay fever: Can reduce swelling of the nasal mucosa during allergic rhinitis.

• For pharyngitis: For local treatment within the stated indications.

• Adjunctive therapy for sinusitis: For concomitant treatment of inflammation of the frontal and maxillary sinuses.

• Reduces nasal secretion: Decreases the increased production of nasal discharge.

• Rapid onset of action: The decongestant effect begins within a few minutes.

• Duration of effect up to 4 hours: For temporary relief of nasal breathing.

• Targeted application: The spray nozzle allows for easy distribution in the nose.

• Available without a prescription: Medication for sale in pharmacies without a doctor's prescription.

Mode of action – How does COLDAN Nasal Spray work?

COLDAN Nasal Spray contains naphazoline hydrochloride, a vasoconstrictor active ingredient from the group of sympathomimetics.

During colds, allergic reactions, or other irritations, the blood vessels in the nasal mucosa dilate. This can cause the mucosa to swell, produce increased secretions, and hinder nasal breathing.

Naphazoline causes these blood vessels to constrict. As a result, the swelling of the nasal mucosa subsides, and the nasal passages become clearer again.

At the same time, the formation of new nasal secretions is reduced.

The effect usually sets in within a few minutes and lasts for up to 4 hours.

COLDAN Nasal Spray alleviates the symptoms of a swollen nasal mucosa but does not treat the underlying cause of a cold or allergy.

Indications

COLDAN Nasal Spray is used for the local symptomatic treatment of various complaints in the area of the nose and upper respiratory tract.

Rhinitis and colds

During a cold, the nasal mucosa can swell and produce increased secretions. COLDAN Nasal Spray acts as a decongestant and can thereby facilitate nasal breathing.

Hay fever and allergic rhinitis

With hay fever, pollen and other allergens can trigger swelling of the nasal mucosa. The vasoconstrictive effect of naphazoline can temporarily reduce this swelling.

Pharyngitis

According to the stated indications, COLDAN Nasal Spray is also used for local treatment in connection with pharyngitis.

Inflammation of the frontal and maxillary sinuses

In cases of sinusitis, swollen mucous membranes can impede the drainage of secretions. COLDAN Nasal Spray can contribute to the decongestion of the nasal mucosa as part of an adjunctive treatment.

Facilitating rhinoscopy

During a rhinoscopy, the doctor examines the interior of the nose. Due to its decongestant effect, COLDAN can facilitate the examination of the nasal mucosa.

Dosage and recommendation for use

The dosage of COLDAN Nasal Spray depends on the age of the patient.

Adults and adolescents aged 12 and over

• 1 spray in each nostril.

• Application occurs 2 to a maximum of 4 times daily.

• A minimum interval of 4 hours must be maintained between individual applications.

• The maximum duration of treatment is 7 days.

Children from 6 to 12 years

• 1 spray in each nostril.

• Application occurs 1 to a maximum of 3 times daily.

• A minimum interval of 4 hours must be maintained between individual applications.

• The maximum duration of treatment is 5 days.

Children from 2 to 6 years

The use of COLDAN Nasal Spray is not recommended for children in this age group. If application is necessary, it must be performed exclusively under medical instruction.

Children under 2 years

COLDAN Nasal Spray must not be used on children under 2 years of age.

The specified dosages and the maximum frequency of use must not be exceeded.

Correct use of COLDAN Nasal Spray

COLDAN Nasal Spray is intended exclusively for use in the nose.

Step 1 – Clean the nose

Before application, clean the nose thoroughly by blowing it gently.

Step 2 – Remove the protective cap

Remove the protective cap from the spray nozzle.

Step 3 – Prepare the spray pump

Before initial use, actuate the spray pump until the first spray occurs.

Afterwards, the metered spray is ready for use with each pump stroke.

Step 4 – Apply the nasal spray

Hold your head upright and insert the spray nozzle carefully into one nostril.

Press the spray pump once and then repeat the process in the other nostril.

Step 5 – Inhale slightly

By inhaling slightly through the nose after spraying, the spray mist can be evenly distributed on the nasal mucosa.

Step 6 – Remove the spray nozzle

Remove the spray head from the nose before releasing the pressure on the spray nozzle.

Step 7 – Observe hygienic application

For hygienic reasons and to avoid the transmission of pathogens, each spray bottle should be used by only one person.

Duration of use and treatment breaks

COLDAN Nasal Spray is intended for short-term use.

For adults and adolescents 12 years and older, treatment may last no longer than 7 days.

For children from 6 to 12 years, treatment may last no longer than 5 days.

A minimum interval of 4 hours must be maintained between individual applications.

If symptoms worsen or if there is no significant improvement after 72 hours or 3 days, a doctor should be consulted.

Before starting a new course of treatment with COLDAN Nasal Spray, a break of at least 10 days must be observed.

Why must COLDAN Nasal Spray not be used long-term?

Prolonged or excessively frequent use of vasoconstrictive nasal sprays can lead to habituation.

After the effect wears off, the nasal mucosa may swell again. This so-called rebound effect can lead to the nasal spray being used more and more frequently.

Prolonged, uninterrupted use can favor drug-induced chronic swelling of the nasal mucosa, known as rhinitis medicamentosa.

Therefore, COLDAN Nasal Spray should only be used in the recommended dosage and for the specified duration of treatment.

Contraindications – When must COLDAN Nasal Spray not be used?

COLDAN Nasal Spray must not be used in the following cases:

• If you have a known allergy to naphazoline or any of the other ingredients of the medicine.

• In case of rhinitis sicca, a condition of the nasal mucosa accompanied by dryness, crust formation, mucosal atrophy, and possibly ulcers.

• In case of narrow-angle glaucoma, a specific form of glaucoma.

• After surgeries on the pituitary gland.

• After certain surgical procedures performed through the nose or mouth.

• During simultaneous treatment with monoamine oxidase inhibitors (MAO inhibitors), which are used, among other things, for the treatment of depression.

• If MAO inhibitors have been taken within the last two weeks.

• In children under 2 years of age.

Please observe all contraindications and warnings in the patient information leaflet.

Interactions with other medicines

The active ingredient naphazoline can interact with various medicines.

Inform your doctor or pharmacist about all medicines you are taking or using, even if they are available without a medical prescription.

Antidepressants

COLDAN Nasal Spray must not be used concomitantly with MAO inhibitors or within two weeks after taking them, as there is a risk of a severe increase in blood pressure or a hypertensive crisis.

Interactions can also occur with the simultaneous use of tri- or tetracyclic antidepressants. Concomitant use should be avoided.

Medicines acting on the heart and circulation

Certain anesthetics, atropine sulfate, propranolol, or insulin can enhance the effects on the heart and circulation when used together with COLDAN Nasal Spray.

Alcohol and central nervous system depressants

A potentially occurring depressant effect on the central nervous system can be intensified by alcohol, sleeping pills, tranquilizers, and neuroleptics.

Theophylline

The simultaneous use of theophylline or related active ingredients in high doses can enhance certain undesirable effects.

Guanethidine and reserpine

Concomitant use with these blood-pressure-affecting drugs can lead to an increase in blood pressure.

Medicines for Parkinson's disease and circulatory support medications

The simultaneous use of trihexyphenidyl as well as adrenaline or noradrenaline may result in an intensification of effects.

Other possible interactions

A reduction in effect may occur with the simultaneous use of certain medicines, including:

• Some medicines for gout or rheumatic complaints

• Phenytoin, a medicine for the treatment of epilepsy

• Anticoagulants to inhibit blood clotting

• Barbiturates

• Griseofulvin for the treatment of fungal infections

• Corticosteroids

• Para-aminosalicylic acid

• Certain anesthetics, especially halogenated hydrocarbons

Interactions can also occur with the simultaneous use of medicines for high blood pressure, especially alpha- and beta-receptor blockers.

Pregnancy and lactation

Pregnancy

COLDAN Nasal Spray should not be used during pregnancy.

If you are pregnant, suspect you are pregnant, or are planning to become pregnant, ask your doctor for advice before use.

Lactation

Use of COLDAN Nasal Spray should be avoided during breastfeeding, as it is not known whether naphazoline passes into breast milk.

Possible side effects

Like all medicines, COLDAN Nasal Spray can cause side effects, although not everyone gets them.

Psychiatric disorders

Occasionally, the following complaints may occur:

• Anxiety

• Insomnia

• Restlessness

Heart disorders

Rarely, the following side effects may occur:

• Rapid pulse

• Increased blood pressure

• Cardiac arrhythmias

General disorders and reactions at the application site

Rarely, the following may occur:

• Nausea

• Headache

• Drowsiness

Side effects with unknown frequency

• Burning pain after local application

Approximately 6 hours after application, a temporary increase in blood flow to the nasal mucosa may occur.

As a result, the normal function of the cilia in the nose, which are important for the removal of mucus and foreign particles, can be temporarily impaired.

If side effects occur or complaints worsen, medical or pharmaceutical advice should be sought.

Active ingredient and composition

Active ingredient:

1 ml of solution contains:

• 1.0 mg naphazoline hydrochloride

Other ingredients:

• Benzalkonium chloride

• Sodium chloride

• Sodium dihydrogen phosphate

• Sodium monohydrogen phosphate

• Sodium edetate

• Purified water

Dosage amount:

1 spray corresponds to 0.14 ml of solution.

Note on benzalkonium chloride

COLDAN Nasal Spray contains benzalkonium chloride as a preservative.

Benzalkonium chloride can cause irritation of the skin and mucous membranes.

In sensitive individuals or with prolonged use, mucous membrane irritation may occur.

The recommended duration of use should therefore not be exceeded.

Dosage form and pack size

• Dosage form: Nasal spray, solution

• Pack size: 10 ml

• Packaging: Glass bottle with spray attachment

• Active ingredient: Naphazoline hydrochloride

• Active ingredient concentration: 1 mg/ml

• Dosage: 0.14 ml per spray

• Application: For nasal spray application

• Dispensing: Available over-the-counter at pharmacies

Further product information

COLDAN Nasal Spray is a non-prescription medication for the local treatment of colds, hay fever, and pharyngitis, as well as for supportive treatment for sinusitis and maxillary sinus inflammation.

The active ingredient naphazoline hydrochloride constricts the blood vessels in the nasal mucosa, thereby reducing swelling. At the same time, the excessive production of nasal secretion is reduced.

The effect begins within a few minutes and lasts for up to 4 hours.

The nasal spray is intended for adults as well as children and adolescents from 6 years of age. For children aged 2 to 6 years, use must only occur under medical supervision.

The maximum duration of treatment is 7 days for adults and adolescents aged 12 and over, and 5 days for children between 6 and 12 years of age.

COLDAN is also available in the form of nasal drops.

Mandatory text

For information on the effects and possible undesirable side effects, please consult the package leaflet, your doctor, or your pharmacist.

Please read the package leaflet before use and observe the dosage instructions, contraindications, interactions, and warnings stated therein.