ratioSoft plus Dexpanthenol 1.0 mg/50 mg/ml Nasal Spray

ratioSoft plus Dexpanthenol 1.0 mg/50 mg/ml Nasal Spray contains the active ingredients xylometazoline hydrochloride and dexpanthenol.

Application

What is ratioSoft plus Dexpanthenol 1.0 mg/50 mg/ml Nasal Spray and what is it used for?

ratioSoft plus Dexpanthenol 1.0 mg/50 mg/ml Nasal Spray contains the active ingredients xylometazoline hydrochloride and dexpanthenol. Xylometazoline constricts the blood vessels and thus causes swelling of the nasal mucosa. The additionally contained active ingredient dexpanthenol is a derivative of the vitamin pantothenic acid, which promotes wound healing and protects the mucous membranes.

For decongestion of the nasal mucous membrane in the case of rhinitis and for supportive treatment of healing of skin and mucous membrane damage (lesions), episodic runny nose (rhinitis vasomotorica) and for treatment of nasal airway obstruction after surgical procedures on the nose.

For use in children 6 years and older and adults.

If you do not feel better or even worse after 7 days, consult your doctor.

How is it applied?

What is ratioSoft plus Dexpanthenol 1.0 mg/50 mg/ml Nasal Spray and what is it used for?

ratioSoft plus Dexpanthenol 1.0 mg/50 mg/ml Nasal Spray contains the active ingredients xylometazoline hydrochloride and dexpanthenol. Xylometazoline constricts the blood vessels and thus causes swelling of the nasal mucosa. The additionally contained active ingredient dexpanthenol is a derivative of the vitamin pantothenic acid, which promotes wound healing and protects the mucous membranes.

For decongestion of the nasal mucous membrane in the case of rhinitis and for supportive treatment of healing of skin and mucous membrane damage (lesions), episodic runny nose (rhinitis vasomotorica) and for treatment of nasal airway obstruction after surgical procedures on the nose.

For use in children 6 years and older and adults.

If you do not feel better or even worse after 7 days, consult your doctor.

What should you pay attention to before taking it?

What should you be aware of before using ratioSoft plus Dexpanthenol 1.0 mg/50 mg/ml Nasal Spray?
ratioSoft plus Dexpanthenol 1.0 mg/50 mg/ml Nasal Spray must not be used

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• If you are allergic to xylometazoline hydrochloride or dexpanthenol or any of the other ingredients of this medicine listed in section 6.
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• If you suffer from dry rhinitis (a chronic cold that leads to dry inflammation of the nasal mucous membranes with bark formation).
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• If you have recently undergone a neurosurgical procedure (transsphenoidal hypophysectomy or other surgical procedures that expose the meninges).
• for children aged 6 years or younger.

Warnings and precautions.
Please talk to your doctor or pharmacist before using this product. You ratioSoft plus Dexpanthenol. 1.0 mg/50
mg/ml Nasal Spray,

• If you are being treated with certain medicines for depression called monoamine oxidase inhibitors (MAO inhibitors) or with other potentially blood pressure-increasing medicines (e.g. doxapram, ergotamine, oxytocin)
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• If you are being treated with blood pressure-lowering medicines (e.g. methyldopa)
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• if you suffer from increased intraocular pressure, especially narrow-angle glaucoma.
• If you have heart disease (e.g. long QT syndrome), coronary heart disease or high blood pressure (hypertension)
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• If you suffer from a tumour of the adrenal gland (pheochromocytoma).
• If you suffer from metabolic disorders such as hyperthyroidism and diabetes.
• if you have a metabolic disease known as porphyria (a metabolic disorder that affects the skin and/or nervous system).
• If your prostate is enlarged (prostatic hyperplasia).

The application in chronic rhinitis must only be carried out under medical supervision because of the atrophy of the nasal mucosa (tissue in the nose).

Children
ratioSoft plus Dexpanthenol 1.0 mg/50 mg/ml Nasal Spray must not be used in children aged 6 years or younger. For the age group of children between 2 and 6 years, appropriate nasal sprays with a lower content of xylometazoline hydrochloride (the decongestant active ingredient) are available.

Long-term use and overdose, especially in children, should be avoided. Use at higher doses only under medical supervision.

Use of ratioSoft plus Dexpanthenol 1.0 mg/50 mg/ml 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.

In the case of simultaneous use of ratioSoft plus Dexpanthenol 1.0 mg/50 mg/ml nasal spray and certain mood-lifting medicines (MAO inhibitors of the tranylcypromine type or tricyclic antidepressants) and potentially blood pressure-increasing medicines (e.g. doxapram, ergotamine, oxytocin), an increase in blood pressure may occur due to effects on the cardiovascular functions.
Due to the possible vasoconstrictive (blood pressure-increasing) effect of xylometazoline, this medicine must not be used together with medicines that lower blood pressure (e.g. methyldopa).

Pregnancy, lactation and reproductive capacity.
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 taking this medicine.

Pregnancy
There are insufficient data for the use of xylometazoline hydrochloride and dexpanthenol in pregnant women. Therefore, ratioSoft plus Dexpanthenol 1.0 mg/50 mg/ml Nasal Spray should not be used during pregnancy.

Breastfeeding time
It is not known whether xylometazoline and dexpanthenol pass into breast milk. A risk for the infant cannot be excluded. A decision must be made as to whether breastfeeding should be interrupted or whether treatment with ratioSoft plus nasal spray should be dispensed with/interrupted. Both the benefit of breastfeeding for the child and the benefit of the therapy for the woman must be considered.

Procreative capacity
There are insufficient data on the effects of xylometazoline hydrochloride and/or dexpanthenol on reproductive capacity in humans.

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

How should the medicine be taken?

How to use ratioSoft plus Dexpanthenol 1.0 mg/50 mg/ml Nasal Spray?

Always use this medicine exactly as described in this leaflet or as agreed with your doctor or pharmacist. Check with your doctor or pharmacist if you are not sure.

Unless otherwise prescribed by your doctor, the usual dose for adults and children over
is6 years of age as required up to a maximum of 1 spray of ratioSoft plus dexpanthenol 1.0 mg/50 mg/ml nasal spray into each nostril 3 times a day.
The dosage depends on the individual sensitivity and the clinical effect.

Protective cap
Mode of administration
Spray orifice
This medicinal product is intended for use in the nose. After removing the protective cap, insert the spray opening into the pump direction
and operate the pump once.
Breathe calmly through the nose during spraying. After use, carefully wipe the spray head with a clean paper towel and replace the protective cap.

Notes:
Before the first application and after a break in treatment of more than 7 days, operate the pump several times until an even spray is delivered. For subsequent applications, the dosing spray is immediately ready for use.

Before using the nasal spray, blow your nose carefully. It is recommended to use the last dose of the day before going to bed.

For hygiene reasons and to avoid infections, a spray bottle should only be used by one person.

Duration of use
ratioSoft plus Dexpanthenol 1.0 mg/50 mg/ml Nasal Spray should not be used for longer than 7 daysunless the doctor specifically orders further use.

A new application should only take place after a break of several days.

The doctor should always be consulted about the duration of use in children.

Permanent use of this medicine may lead to chronic swelling and eventually to atrophy of the nasal mucosa.
Patients with increased intraocular pressure (glaucoma, especially narrow-angle glaucoma) should consult their doctor before using this medicine.
Please talk to your doctor or pharmacist if you have the impression that the effect of ratioSoft plus Dexpanthenol 1.0 mg/50 mg/ml Nasal Spray is too strong or too weak.

If you have used a larger amount of ratioSoft plus Dexpanthenol 1.0 mg/50 mg/ml Nasal Spray than you should
z. The following effects may occur as a result of an overdose or accidental ingestion:pupil constriction (miosis), pupil dilation (mydriasis), fever, sweating, pallor, blue colouring of lips (cyanosis), nausea, cramps, cardiac and circulatory disorders, such as tachycardia, bradycardia, cardiac arrhythmia, circulatory collapse, cardiac arrest, high blood pressure (hypertension), cardiac arrest, cardiac arrest, cardiac arrest. E.g. cardiac arrhythmias (tachycardia, bradycardia, cardiac arrhythmia), circulatory collapse, cardiac arrest, high blood pressure (hypertension), pulmonary dysfunction (pulmonary oedema, respiratory disorders), mental disorders. In addition, drowsiness, lowering of body temperature, reduction of heart rate, shock-like drop in blood pressure, cessation of breathing and unconsciousness (coma) may occur.

If you suspect an overdose, please notify your doctor immediately. The doctor can take any necessary measures.

If you forget to use ratioSoft plus Dexpanthenol 1.0 mg/50 mg/ml Nasal Spray
Do not use twice the amount next time, but continue using as described in the dosing instructions.

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What are the possible side effects?

How to store ratioSoft plus Dexpanthenol 1.0 mg/50 mg/ml Nasal Spray?

Keep this medicine out of the reach of children.

You must not use this medicine after the expiry date which is stated on the carton and label after "EXP:". The expiry date refers to the last day of the month stated.

No special storage conditions are required for this medicinal product.

Once opened, ratioSoft plus Dexpanthenol 1.0 mg/50 mg/ml Nasal Spray should be used within 6 months.

Do not dispose of medicinal products 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 plus Dexpanthenol 1.0 mg/50 mg/ml Nasal Spray?

Keep this medicine out of the reach of children.

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

No special storage conditions are required for this medicinal product.

Once opened, ratioSoft plus Dexpanthenol 1.0 mg/50 mg/ml Nasal Spray should be used within 6 months.

Do not dispose of medicinal products 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 notes on the content

Contents of the pack and other information

What ratioSoft plus Dexpanthenol 1.0 mg/50 mg/ml Nasal Spray contains

The active ingredients are: Xylometazoline hydrochloride/Dexpanthenol.
One spray (equivalent to 0.1 ml solution) contains 0.1 mg xylometazoline hydrochloride and 5 mg dexpanthenol. 1 ml solution contains: 1 mg xylometazoline hydrochloride and 50 mg dexpanthenol

The other ingredients are:
potassium dihydrogen phosphate
disodium hydrogen phosphate
water for injections

.What ratioSoft plus Dexpanthenol 1.0 mg/50 mg/ml Nasal Spray looks like and contents of the pack
A bottle containing 10 ml of solution contains not less than 90 individual spray applications.

ratioSoft plus Dexpanthenol 1.0 mg/50 mg/ml Nasal Spray is a clear, almost colourless solution in a round plastic bottle with a snap cap, containing 10 ml of solution and closed with a spray pump with a nose adapter and protective cap.