EMSER

EMSER saline inhalation solution for nebulizer

Important notes (mandatory information)

Emser Sole Inhalat, solution. Active ingredient: Natural Emser salt. Areas of application: for supportive treatment by moistening, cleaning and decongesting the nasal mucosa in the case of common acute infections of the upper respiratory tract and chronic rhinosinusitis and as an accompanying treatment measure to accelerate the healing process after endonasal sinus surgery.

For risks and side effects, read the package leaflet and ask your doctor or pharmacist.


PACKAGE LEAFLET: INFORMATION FOR THE USER

Emser Sole Inhalat, solution for a nebuliser
Active ingredient: Natural Emser salt

Read the entire package leaflet carefully before you start using this medicine, because it contains important information. Always use this medicine exactly as described in this package leaflet or exactly as instructed by your doctor or pharmacist.

• Keep the package leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If you notice any side effects, contact your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. See section 4.
• If you do not feel better or if you feel worse after 14 days, contact your doctor.

What this package leaflet contains

1. WHAT IS EMSER SOLE-INHALAT AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU BE AWARE OF BEFORE USING EMSER SOLE-INHALAT?
3. HOW SHOULD EMSER SOLE-INHALAT BE USED?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD EMSER SOLE-INHALAT BE STORED?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT IS EMSER SOLE-INHALAT AND WHAT IS IT USED FOR?

Substance or indication group

Emser Sole-Inhalat is a saline local therapeutic for the treatment of respiratory diseases. Areas of application: Emser Sole-Inhalat is used for supportive treatment by moistening, cleaning and decongesting the nasal mucosa in the case of common acute infections of the upper respiratory tract and chronic rhinosinusitis and as an accompanying treatment measure to accelerate the healing process after endonasal sinus surgery.

2. WHAT SHOULD YOU BE AWARE OF BEFORE USING EMSER SOLE-INHALAT?

Emser Sole-Inhalat must not be used if you are hypersensitive (allergic) to any of the components of Natural Emser salt. Emser Sole-Inhalat must not be inhaled if acute shortness of breath has already occurred during previous inhalation with isotonic Emser salt solution.

Warnings and precautions

Special care should be taken in patients with pronounced hypersensitivity of the respiratory tract (such as bronchial asthma), as inhalations in these patients can lead to bronchoconstriction with acute shortness of breath in very rare cases.

Use of Emser Sole-Inhalat together with other medicines

The effectiveness of Emser Sole-Inhalat is not known to be affected by other medicines. Emser Sole-Inhalat may slightly enhance the effect of medicines that dilate the bronchi.

Children, pregnancy and breastfeeding

Emser Sole-Inhalat contains a solution of Natural Emser salt in a salt concentration adapted to the blood. It is well tolerated by all people and can therefore be used in all of the above cases when used as intended.

Driving and operating machinery

No studies have been conducted on this.

3. HOW SHOULD EMSER SOLE-INHALAT BE USED?

Always use this medicine exactly as described in this package leaflet or exactly as agreed with your doctor or pharmacist. Check with your doctor or pharmacist if you are not sure. The recommended dose is: Emser Sole-Inhalat should be inhaled 3 to 4 times a day, with 5 ml of solution being inhaled through the nose each time. The inhalation should always be carried out with a suitable nebuliser. Pressurised air or ultrasonic nebulisers are suitable. Depending on the type of device, the volume that must be used for nebulisation can vary greatly. In this case, enough solution should be filled into the nebuliser to ensure an inhalation time of 10 to 15 minutes. The duration of use of Emser Sole-Inhalat is not limited, please follow the instructions of your doctor.

If you have used more Emser Sole-Inhalat than you should or if you have forgotten to use Emser Sole-Inhalat

Risks from using too much or too little Emser Sole-Inhalat are not known.

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

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, this medicine can cause side effects, although not everybody gets them. In the case of inhalation of Emser Sole-Inhalat, patients with bronchial asthma and hyperreactive bronchial system could experience a spasmodic constriction of the bronchi with acute shortness of breath in very rare cases (less than 1 in 10,000 patients treated, including isolated cases). In this case, the inhalation should be stopped and a doctor should be consulted if the shortness of breath persists.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Dept. of Pharmacovigilance, Kurt-Georg-Kiesinger Allee 3, D-53175 Bonn, website: www.bfarm.de. By reporting side effects, you can help to provide more information on the safety of this medicine.

5. HOW SHOULD EMSER SOLE-INHALAT BE STORED?

Storage conditions: Keep this medicine out of the reach of children. Emser Sole-Inhalat should be stored at room temperature, in particular not below 4°C and not above 50°C. Do not use this medicine after the expiry date which is stated on the carton after "Use by". The expiry date refers to the last day of the month indicated. Emser Sole-Inhalat does not contain any preservatives. Therefore, you should always use opened ampoules immediately.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Emser Sole-Inhalat contains

The active ingredient is: Natural Emser salt 1 ampoule contains: Active ingredient: 58.75 mg Natural Emser salt (analysis data of the ions in g/kg: Lithium 0.21, Sodium 308.7, Potassium 6.11, Magnesium 0.291, Calcium 0.016, Manganese 0.0001, Iron (II, III) 0.003, Fluoride 0.078, Chloride 188.4, Bromide 0.202, Iodide 0.005, Nitrate 0.355, Sulphate 9.24, Hydrogencarbonate 474.4, Carbonate 14.0). The other ingredient is: Purified water.

What Emser Sole-Inhalat looks like and contents of the pack

20 ampoules of 5 ml solution for a nebuliser.

Pharmaceutical entrepreneur and manufacturer

SIEMENS & CO
56119 Bad Ems
Tel.: 02603-96040
Fax: 02603-960440
www.emser.de
info@emser.de

This package leaflet was last revised in January 2015.

Source: Information from the package leaflet
Status: 02/2018
Active ingredient: Natural Emser salt. Areas of application: for supportive treatment by moistening, cleaning and decongesting the nasal mucosa in the case of common acute infections of the upper respiratory tract and chronic rhinosinusitis and as an accompanying treatment measure to accelerate the healing process after endonasal sinus surgery.