ratioSoft 0.05% Nasal Spray

Product Details & Mandatory Information

ratioSoft 0.05% nasal spray contains the active ingredient xylometazoline hydrochloride. This causes the nasal mucous membrane to decongest, thereby facilitating nasal breathing when the nose is blocked.

What is the product for?

ratioSoft 0.05% nasal spray is used for the temporary treatment of a swollen and blocked nasal mucous membrane, for example, during a cold.

The nasal spray is intended for children aged 2 to 10 years. It should only be given to children under 6 years of age on a doctor's orders.

Application and Dosage

Children aged 2 to 10 years:

If required, 1 spray (0.07 ml) into each nostril, up to 3 times daily.

There must be at least 8 hours between two applications.

The nasal spray may be used continuously for a maximum of 7 days.

Before use, gently blow your nose. Insert the spray head into one nostril, hold the bottle upright and spray once while slowly inhaling through the nose.

Before the first use, pump several times until a fine spray mist emerges. After use, clean the spray head and replace the protective cap.

For hygienic reasons, one bottle should only be used by one person.

Contraindications

ratioSoft 0.05% nasal spray must not be used:

• if you are allergic to xylometazoline or any of the other ingredients

• after surgical removal of the pituitary gland through the sphenoid bone

• in case of rhinitis sicca with inflammation and crusting of the nasal mucous membrane

• in case of narrow-angle glaucoma

• concurrently with MAO inhibitors such as selegiline or moclobemide

Interactions

When certain antidepressants are used at the same time, especially tricyclic or tetracyclic antidepressants, an increase in blood pressure may occur.

Concurrent use with MAO inhibitors must be avoided due to the risk of a strong increase in blood pressure.

Pregnancy and Breastfeeding

As there are insufficient data on the use of xylometazoline during pregnancy and breastfeeding, ratioSoft 0.05% nasal spray should only be used during this time after consulting a doctor.

Important Notes

• Do not use more than 3 times a day.

• Wait at least 8 hours between two applications.

• Do not use continuously for longer than 7 days.

• Use for longer than recommended can lead to a reduced effect and, after discontinuation, to a severe renewed swelling of the nasal mucous membrane.

• Please read the full package leaflet before use.

Active ingredient and ingredients

1 ml solution contains 0.5 mg xylometazoline hydrochloride.

Other ingredients: Citric acid monohydrate, sodium citrate dihydrate, glycerol 85% and water for injections.

Side effects and tolerability

Like all medicines, ratioSoft 0.05% nasal spray can cause side effects, although not everybody gets them.

Burning and dryness of the nasal mucous membrane can frequently occur.

Occasionally, irritation of the nose, mouth and throat, nosebleeds, and allergic reactions such as angioedema, skin rash, and itching may occur.

Accelerated heart rate, palpitations and increased blood pressure have rarely been observed.

Very rarely, cardiac arrhythmias, nervousness, sleep disturbances, fatigue, headaches, dizziness, nausea, temporary visual disturbances, and especially in children, hallucinations or seizures may occur.

With prolonged use beyond what is recommended, the effect may decrease, and after discontinuation, increased swelling of the nasal mucous membrane may occur.

For full details on side effects, contraindications, and interactions, please refer to the package leaflet.