Ratiopharm

Ratiosoft nasal spray plus dexpanthenol 0.05%

For the whole family Relieves blocked and stuffy noses Decongestant effect Supports healing Without preservatives With nourishing dexpanthenol Good to know! ratioSoft® plus Dexpanthenol 0.05% Nasal Spray Is suitable for children between 2 and 6 years of age. Is suitable for adults during pregnancy (max. application time: one week). Must not be used during breastfeeding. May only be given on doctor's orders. Contains a low dose of the decongestant active ingredient xylometazoline compared to ratioSoft® plus Dexpanthenol 0.1% Nasal Spray and is therefore suitable for school children. Please be sure to talk to your (pediatrician) or pharmacist before treating your toddler with ratioSoft®plus Dexpanthenol for a cold or using ratioSoft® plus Dexpanthenol during pregnancy.

Application

Always use this medicine exactly as described in this leaflet or exactly 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 children between 2 and 6 years of age is up to a maximum of 3 sprays of ratioSoft plus Dexpanthenol 0.5 mg/50 mg/ml Nasal Spray into each nostril as needed. The dosage depends on individual sensitivity and clinical effect.

How is it used?

What is ratioSoft plus Dexpanthenol 0.5 mg/50 mg/ml Nasal Spray and what is it used for?

ratioSoft plus Dexpanthenol 0.5 mg/50 mg/ml Nasal Spray contains the active ingredients xylometazoline hydrochloride and dexpanthenol. Xylometazoline constricts the blood vessels and thus causes the nasal mucosa to swell. The additionally contained active ingredient dexpanthenol is a derivative of pantothenic acid, which promotes wound healing and protects the mucous membranes.

For decongesting the nasal mucosa in case of a cold and for the supportive treatment of healing of skin and mucous membrane damage (lesions), episodic rhinitis (rhinitis vasomotorica) and for the treatment of nasal breathing difficulties after surgical interventions on the nose.

For use in children between 2 and 6 years of age.
May only be given to children between 2 and 6 years of age on doctor's orders.

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

Ingredients

Active ingredients 0.05 mg Xylometazoline hydrochloride 5 mg Dexpanthenol Excipients 0.5 mg/ml --> 50 mg/ml --> Potassium dihydrogen phosphate Disodium hydrogen phosphate Water for injections

What should you consider before taking it?

What should you consider before using ratioSoft plus Dexpanthenol 0.5 mg/50 mg/ml Nasal Spray?

ratioSoft plus Dexpanthenol 0.5 mg/50 mg/ml Nasal Spray must not be used,

• if you are allergic to xylometazoline hydrochloride or dexpanthenol or any of the other ingredients of this medicine listed in section 6.
• if you suffer from a dry cold (a chronic cold that leads to dry inflammation of the nasal mucous membranes with crust formation).
• if you have recently undergone neurosurgery
  (transsphenoidal hypophysectomy or other surgical interventions that expose the meninges).
• in children under 2 years of age.

Warnings and precautions
Please talk to your doctor or pharmacist before using ratioSoft plus Dexpanthenol 0.5 mg/50
mg/ml Nasal Spray if

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

The use in chronic rhinitis may only be carried out under medical supervision due to the atrophy of the nasal mucosa (tissue in the nose).

Children
ratioSoft plus Dexpanthenol 0.5 mg/50 mg/ml Nasal Spray must not be used in children under 2 years of age.
May only be given to children between 2 and 6 years of age on doctor's orders.

Long-term use and overdose, especially in children, should be avoided. Use at a higher dosage may only be carried out under medical supervision.

Use of ratioSoft plus Dexpanthenol 0.5 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.

When ratioSoft plus Dexpanthenol 0.5 mg/50 mg/ml Nasal Spray is used at the same time as certain mood-elevating medicines (MAO inhibitors of the tranylcypromine type or tricyclic antidepressants) and potentially blood pressure-raising medicines (e.g. doxapram, ergotamine, oxytocin), an increase in blood pressure can occur due to effects on the cardiovascular functions.
Due to the possible vasoconstrictive (blood pressure-raising) effect of xylometazoline, this medicine must not be used together with medicines that lower blood pressure (e.g. methyldopa).

Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, 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 is insufficient data on the use of xylometazoline hydrochloride and dexpanthenol in pregnant women. Therefore, ratioSoft plus Dexpanthenol 0.5 mg/50 mg/ml Nasal Spray should not be used during pregnancy.

Breastfeeding
It is not known whether xylometazoline and dexpanthenol pass into breast milk. A risk to the infant cannot be excluded. A decision must be made whether to discontinue breastfeeding or to refrain from/discontinue treatment with ratioSoft plus Nasal Spray. The benefit of breastfeeding for the child and the benefit of therapy for the woman must be taken into account.

Fertility
There is insufficient data on the effects of xylometazoline hydrochloride and/or dexpanthenol on fertility in humans.

Driving and operating machinery
No side effects are to be expected when used as intended.

How should the medicine be taken?

How should ratioSoft plus Dexpanthenol 0.5 mg/50 mg/ml Nasal Spray be used?

Always use this medicine exactly as described in this leaflet or exactly 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 children between 2 and 6 years of age is up to a maximum of 3 sprays of ratioSoft plus Dexpanthenol 0.5 mg/50 mg/ml Nasal Spray into each nostril as needed.
The dosage depends on individual sensitivity and clinical effect.

Type of use
This medicine is intended for use in the nose. After
removing the protective cap, insert the spray opening into the nostril
and press the pump once. Breathe calmly through the nose during
the spraying process. After use, carefully wipe the spray head with a
clean paper towel and replace the protective cap.


Notes:
Before using for the first time and after a treatment break of more than
7 days, press the pump several times until an even spray mist is dispensed. The dosing spray is ready for use immediately for subsequent applications.

Blow your nose gently before using the nasal spray. It is recommended to use the last dose of the day before going to bed.

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

Duration of use
ratioSoft plus Dexpanthenol 0.5 mg/50 mg/ml Nasal Spray should not be used for longer than 7 days, unless the doctor expressly orders further use.

Re-use should only take place after a break of several days.
The doctor should always be consulted about the duration of use in children.

Continuous use of this medicine can lead to chronic swelling and ultimately to atrophy of the nasal mucosa.
Patients with increased intraocular pressure (glaucoma, especially narrow-angle glaucoma) should consult a doctor before using this medicine.

Please talk to your doctor or pharmacist if you have the impression that the effect of ratioSoft plus Dexpanthenol 0.5 mg/50 mg/ml Nasal Spray is too strong or too weak.

If you have used more ratioSoft plus Dexpanthenol 0.5 mg/50 mg/ml Nasal Spray than you should
e.g. as a result of an overdose or accidental ingestion, the following effects may occur: constriction of the pupils (miosis), dilation of the pupils (mydriasis), fever, sweating, pallor, blue discoloration of the lips (cyanosis), nausea, cramps, cardiovascular disorders, such as heart rhythm disorders (tachycardia, bradycardia, cardiac arrhythmia), circulatory collapse, cardiac arrest, high blood pressure (hypertension), pulmonary function disorders (pulmonary edema, respiratory disorders), mental disorders. In addition, drowsiness, lowering of body temperature, decreased heart rate, shock-like drop in blood pressure, cessation of breathing and unconsciousness (coma) may occur.

If you suspect an overdose, please contact your doctor immediately. He or she can initiate any necessary measures.

If you forget to use ratioSoft plus Dexpanthenol 0.5 mg/50 mg/ml Nasal Spray
Do not use double the amount the next time, but continue using as described in the dosage instructions.

What side effects are possible?

How should ratioSoft plus Dexpanthenol 0.5 mg/50 mg/ml Nasal Spray be stored?

Keep this medicine out of the reach of children.

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

This medicinal product does not require any special storage conditions.

After opening, ratioSoft plus Dexpanthenol 0.5 mg/50 mg/ml Nasal Spray should be used within 6 months.

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 should ratioSoft plus Dexpanthenol 0.5 mg/50 mg/ml Nasal Spray be stored?

Keep this medicine out of the reach of children.

Do not use this medicine after the expiry date which is stated on the carton and label after ,,Use by:" The expiry date refers to the last day of the month indicated.

This medicinal product does not require any special storage conditions.

After opening, ratioSoft plus Dexpanthenol 0.5 mg/50 mg/ml Nasal Spray should be used within 6 months.

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 information on the content

Contents of the pack and further information

What ratioSoft plus Dexpanthenol 0.5 mg/50 mg/ml Nasal Spray contains

The active ingredients are: Xylometazoline hydrochloride/Dexpanthenol.
One spray (equivalent to 0.1 ml solution) contains 0.05 mg xylometazoline hydrochloride and 5.0 mg dexpanthenol.
1 ml solution contains: 0.5 mg xylometazoline hydrochloride and 50 mg dexpanthenol.
The other ingredients are:
Potassium dihydrogen phosphate
Disodium hydrogen phosphate
Water for injections

What ratioSoft plus Dexpanthenol 0.5 mg/50 mg/ml Nasal Spray looks like and contents of the pack
A bottle with 10 ml solution contains not less than 90 individual spray applications.

ratioSoft plus Dexpanthenol 0.5 mg/50 mg/ml Nasal Spray is a clear, almost colorless solution in a round plastic bottle with a snap closure, which contains 10 ml of solution and is closed with a spray pump with a nasal adapter and protective cap.