ratioSoft 0,1 % - nasal spray

The active substance in ratioSoft 0.1% nasal spray is xylometazoline hydrochloride.

Application

WHAT IS RATIOSOFT 0.1% NOSE SPRAY AND WHAT IS IT USED FOR?

The active ingredient in ratioSoft 0.1% Nasal Spray is xylometazoline hydrochloride. This substance reduces the swelling of the mucous membranes of the nose and throat; this makes it easier for patients with a cold to breathe through the nose. Even in patients with very sensitive mucous membranes, xylometazoline generally does not cause irritation of the mucous membranes.

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

How is it applied?

What is ratioSoft 0.1% Nasal Spray and what is it used for?

The active ingredient in ratioSoft 0.1% Nasal Spray is xylometazoline hydrochloride. This substance reduces the swelling of the mucous membranes of the nose and throat, making it easier for patients with colds to breathe through the nose. Even in patients with very sensitive mucous membranes, xylometazoline generally does not cause irritation of the mucous membranes.

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

What should you pay attention to before taking it?

What should you be aware of before using ratioSoft 0.1 % Nasal Spray?

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

ratioSoft 0.1% 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 (hypophysis) 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 an engwinkelgaukom.
• If you are using medicines at the same time that belong to the group of so-called
  monoamine oxidase inhibitors (MAO inhibitors, such as selegiline or moclobemide)
.

Warnings and precautions.
Please talk to your doctor or pharmacist before using ratioSoft 0.1% nasal spray.

• If you have untreated, significant high blood pressure.
• If they have a severe heart condition (e.g. long QT syndrome).
• if you have a 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 follow the dosage instructions given on the packaging and in the package leaflet. The medicine can be used continuously for a maximum of 7 days.

Application of ratioSoft 0.1% Nasal Spray together with other medicines.
Inform your doctor or pharmacist if you are taking/using, have recently taken/used or intend to take/use any other medicines.

Simultaneous use of certain antidepressants (tricyclic or tetracyclic) can cause a
Cause an increase in your blood pressure.

When used in combination with MAO inhibitors, there is a risk of high blood pressure. Therefore, this combination must be avoided (see section 2 "ratioSoft 0.1% nasal spray must not be used...").

Pregnancy and breastfeeding.
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 are insufficient data on the use of xylometazoline during pregnancy and breastfeeding. As long as no further information is available, you should only use ratioSoft 0.1 % Nasal Spray during pregnancy and breast-feeding after consulting your doctor.

Driving ability and ability to operate machinery.
If used as intended, no adverse effects are to be expected.

How should the medicine be taken?

How to use ratioSoft 0.1% 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.

The recommended dose is:
Adults and children over 10 years:
1 spray (0.14 ml) in each nostril no more than 3 times a day, if necessary.

After using the medicine, you must wait at least 6 hours before using the next dose. The medicine can be used continuously for a maximum of 7 days.
Use of 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 paper tissue and replace the protective cap.

Useful tips
A new spray may not work the first time you use it. You need to get the bottle ready to spray by pumping a few times until a fine spray comes out.
The spray is now ready for all further applications. For reasons of hygiene, ratioSoft 0.1 % Nasal Spray should always be used by the same person.

If you have used a larger amount of ratioSoft 0.1 % Nasal Spray than you shouldAs a result of a severe overdose or accidental ingestion of the medicine, the following conditions may occur:

.

• Dilation or constriction of the pupils
• Nausea and vomiting
• Paleness, blue colouring of skin and lips
.
• Fever, sweating or drop in body temperature
.
• Cardiovascular disorders such as heartbeat that is too slow, too fast or irregular, increase or decrease in blood pressure
.
• Breathing arrest
• Lessness, drowsiness and coma
.
• Anxiety, agitation, hallucinations and seizures.

Children

Especially in children, an overdose can often lead to seizures and coma, slowed heartbeat, respiratory arrest and a rise in blood pressure, which may be followed by a drop in blood pressure.

In case 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 are the possible side effects?

How should ratioSoft 0.1% Nasal Spray be stored?

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

You must not use this medicine after the expiry date which is stated on the outer carton after "Use by:". The expiry date refers to the last day of the month indicated.

Do not dispose of medicines in waste water or household waste. Ask your pharmacist how to dispose of the medicine when you stop using it. In doing so, they contribute to the protection of the environment.

Special instructions for storage

HOW TO STORE RATIOSOFT 0.1% NOSAL SPRAY?

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

You must not use the medicinal product after the expiry date which is stated on the outer carton after ,,Use by:". The expiry date refers to the last day of the month.

The medicinal product must not be disposed of in waste water or household waste. Ask your pharmacist how to dispose of the medicine when you no longer need it. This measure helps to protect the environment.

Special notes on the content

Contents of the pack and other information
What ratioSoft 0.1 % Nasal Spray contains
- The active substance is xylometazoline hydrochloride.
1 ml solution contains 1.0 mg xylometazoline hydrochloride.

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

How ratioSoft 0.1 % Nasal Spray looks and contents of the pack
Clear, almost colourless solution. ratioSoft 0.1% nasal spray is available in glass bottles of 10 ml.