ratioSoft 0.05 % - nasal spray

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The active ingredient in ratioSoft 0.05% Nasal Spray is xylometazoline hydrochloride.

Application

WHAT IS RATIOSOFT 0.05% NASAL SPRAY AND WHAT IS IT USED FOR?

The active ingredient in ratioSoft 0.05% Nasal Spray is xylometazoline hydrochloride. This substance reduces the swelling of the mucous membranes of the nose and throat; this makes breathing through the nose easier for patients with a cold. Even in patients with very sensitive mucous membranes, xylometazoline generally does not lead to irritation of the mucous membrane.

The medicine is suitable for the temporary treatment of swelling of the nasal mucosa (blocked nose), e.g. in the case of a cold.

How is it used?

What is ratioSoft 0.05% Nasal Spray and what is it used for?

The active ingredient in ratioSoft 0.05% Nasal Spray is xylometazoline hydrochloride. This substance reduces the swelling of the mucous membranes of the nose and throat, this makes breathing through the nose easier for patients with a cold. Even in patients with very sensitive mucous membranes, xylometazoline generally does not lead to irritation of the mucous membrane.

The medicine is suitable for the temporary treatment of swelling of the nasal mucosa (blocked nose), e.g. in the case of a cold.

What should you consider before taking it?

What should you consider before using ratioSoft 0.05% Nasal Spray?

The 0.05% Nasal Spray (0.5 mg/ml) is particularly suitable for children aged 2 to 10 years. A strength of 0.1% (1 mg/ml) is also available for adults and children over 10 years of age.

ratioSoft 0.05% Nasal Spray must not be used,
- if you are allergic to xylometazoline or any of the other ingredients of this medicine listed in section 6.
- if your pituitary gland (pituitary gland) has been removed via the sphenoid bone.
- if you have inflammation of the skin and mucous membrane of the nasal cavity and crusting (rhinitis sicca).
- if you have narrow-angle glaucoma.
- if you are taking medicines that belong to the group of so-called monoamine oxidase inhibitors (MAO inhibitors, such as selegiline or moclobemide) at the same time.

Warnings and precautions
Please talk to your doctor or pharmacist before using ratioSoft 0.05% Nasal Spray,

- if you have untreated, significant high blood pressure.
- if you have a serious heart condition (e.g. Long-QT syndrome).
- if you have pronounced hyperthyroidism.
- if you have diabetes.
- if you have porphyria, a metabolic disorder.
- if your prostate gland is enlarged.
- if you are taking bromocriptine.

Please carefully observe the dosage instructions given on the packaging and in the package leaflet. The medicine can be used continuously for a maximum of 7 days.

Use of ratioSoft 0.05% Nasal Spray 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.

The simultaneous use of certain antidepressants (tricyclic or tetracyclic) can cause an increase in your blood pressure.

There is a risk of high blood pressure when used in combination with MAO inhibitors. This combination must therefore be avoided (see section 2 "ratioSoft 0.05% Nasal Spray must not be used...").

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.

There is insufficient data on the use of xylometazoline during pregnancy and breast-feeding. As long as no further information is available, you should only use ratioSoft 0.05% Nasal Spray during pregnancy and breast-feeding after consulting your doctor.

Driving and using machines
No impairments are to be expected if used as intended.

How should the medicine be taken?

How to use ratioSoft 0.05% Nasal Spray?

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

May only be given to children under 6 years of age on doctor's orders.

The recommended dose is:
Children from 2 to 10 years:
1 spray (0.07 ml) in each nostril a maximum of 3 times a day, if necessary.

After using the medicine, you must wait at least 8 hours before using the next dose. The medicine can be used continuously for a maximum of 7 days.

Using the spray
Your nasal spray has a protective cap that protects the spray head and keeps it clean. Remember to remove this protective cap before using the spray.
Gently blow your nose.
Insert the spray head into one nostril and hold the bottle upright.
Pump once while slowly inhaling through your nose.
After use, clean the spray head with a tissue and replace the protective cap.

Useful tips:
A new spray may not work the first time it is used. You need to prime the bottle by pumping a few times until a fine mist comes out.
The spray is now ready to use for all further applications. For hygienic reasons, ratioSoft 0.05% Nasal Spray should always be used by the same person.


If you have used more ratioSoft 0.05% Nasal Spray than you should The following conditions may occur as a result of a severe overdose or accidental ingestion of the medicine:

- Dilation or constriction of the pupils
- Nausea and vomiting
- Pallor, blue discoloration of the skin and lips
- Fever, sweating or a drop in body temperature
- Cardiovascular disorders such as too slow, too fast or irregular heartbeat, increase or decrease in blood pressure
- Respiratory arrest
- Apathy, drowsiness and coma
- Anxiety, agitation, hallucinations and seizures.

Children

An overdose can often lead to seizures and coma, slowed heart rate, respiratory arrest, and an increase in blood pressure, which can be followed by a drop in blood pressure, especially in children.

In the event of poisoning/overdose, you must inform your doctor immediately. Monitoring and treatment in hospital is necessary.


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

What side effects are possible?

How to store ratioSoft 0.05% Nasal Spray?

Do not store above 25 °C.
Shelf life after opening: 6 months
Keep this medicine out of the reach of children.

Do not use this medicine after the expiry date which is stated on the carton after "Usable until:". The expiry date refers to the last day of the month indicated.

Do not dispose of medicines in wastewater or household waste. Ask your pharmacist how to dispose of the medicine when you stop using it. You help to protect the environment.

Special storage instructions

HOW TO STORE RATIOSOFT 0.05% NASAL SPRAY?

Do not store above 25 °C.
Shelf life after opening: 6 months
Keep medicines out of the reach of children.

Do not use the medicine after the expiry date which is stated on the carton after "Usable until:". The expiry date refers to the last day of the month.

The medicine must not be disposed of in wastewater or household waste. Ask your pharmacist how to dispose of the medicine when you stop using it. This measure helps to protect the environment.

Special information on the content

Contents of the pack and further information

What ratioSoft 0.05% Nasal Spray contains
- The active ingredient is xylometazoline hydrochloride.
1 ml of solution contains 0.5 mg of xylometazoline hydrochloride.

- The other ingredients are:
Citric acid monohydrate, sodium citrate dihydrate, glycerol 85% and water for injections.

What ratioSoft 0.05% Nasal Spray looks like and contents of the pack
Clear, almost colorless solution. ratioSoft 0.05% Nasal Spray is available in 10 ml glass bottles.