EMSER

EMSER nasal spray

Important notes (mandatory information)

Emser Nasal Spray. 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 rhinitis and sinusitis 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 consult your doctor or pharmacist.


PACKAGE LEAFLET: INFORMATION FOR PATIENTS

Emser Nasal Spray
Solution
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 directed by your doctor or pharmacist.
- Keep the package leaflet. You may want to read it again later.
- If you have any further questions, ask your doctor or pharmacist
- 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.

What this package leaflet contains

1. WHAT IS EMSER NASAL SPRAY AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE USING EMSER NASAL SPRAY?
3. HOW TO USE EMSER NASAL SPRAY?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE EMSER NASAL SPRAY?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT IS EMSER NASAL SPRAY AND WHAT IS IT USED FOR?

Substance or indication group

Emser Nasal Spray is a saline topical therapeutic for the treatment of respiratory diseases.

Areas of application:
Emser Nasal Spray 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 CONSIDER BEFORE USING EMSER NASAL SPRAY?

Emser Nasal Spray must not be used:
There are no known restrictions for the use of Emser Nasal Spray.

Warnings and precautions

Please talk to your doctor or pharmacist before using Emser Nasal Spray.

Children, pregnancy, breastfeeding and fertility:
Emser Nasal Spray 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.

Use of Emser Nasal Spray together with other medicines:
The effectiveness of Emser Nasal Spray is not known to be affected by other medicines.

Driving and operating machinery

No studies have been conducted on this.

3. HOW TO USE EMSER NASAL SPRAY?

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: Depending on the need, adults, children and infants should spray 1 to 2 sprays of Emser Nasal Spray into each nostril 1 to several times a day. The duration of use of Emser Nasal Spray is not limited.

Note: Before using Emser Nasal Spray for the first time, remove the protective cap and pump 2 to 3 times to remove the air from the spray pump. For hygienic reasons and to avoid the transmission of diseases, each spray bottle should only be used by one person. Furthermore, please wipe the spray head dry after each use and replace the protective cap. The technology of the spray pump prevents germs from entering the container, so that the addition of preservatives could be dispensed with. Nevertheless, please observe the use-by dates under point 5 of this package leaflet.

If you have used more Emser Nasal Spray than you should or if you have forgotten to use Emser Nasal Spray

Risks from using too much or too little Emser Nasal Spray are not known.

If you stop using Emser Nasal Spray

Risks from discontinuing the use of Emser Nasal Spray are not known. If you have any further questions about taking the 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. When using Emser Nasal Spray, mild irritation such as burning and tingling in the nose and headaches can occur rarely (less than 1 in 1000 but more than 1 in 10,000 patients treated), and very rarely (less than 1 in 10,000 patients treated, including isolated cases) some nosebleeds can occur. Countermeasures are not necessary.

Reporting side effects

If you notice any side effects, contact 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, Department of Pharmacovigilance, Kurt-Georg-Kiesinger Allee 3, D-53175 Bonn, website: http://www.bfarm.de. By reporting side effects, you can help provide more information about the safety of this medicine.

5. HOW TO STORE EMSER NASAL SPRAY?

Storage conditions

Keep this medicine out of the reach of children. Do not store Emser Nasal Spray below 4 °C or above 50 °C.

Notes and information on the shelf life of Emser Nasal Spray:
The expiry date is stated on the outer packaging and the container. Do not use this pack after this date! The expiry date refers to the last day of the month. Emser Nasal Spray does not contain any preservatives. Therefore, you should not use opened containers for longer than 6 months.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Emser Nasal Spray contains

The active ingredient is: Natural Emser Salt.
1 spray contains: Active ingredient: 1.645 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, Sulfate 9.24, Hydrogencarbonate 474.4, Carbonate 14.0)
The other ingredient is: Purified water

What Emser Nasal Spray looks like and contents of the pack:
20 ml nasal spray, solution

Pharmaceutical entrepreneur and manufacturer:
SIEMENS & CO
56119 Bad Ems
Tel.: 02603-9604-0
Fax: 02603-9604-40
www.emser.de
info@emser.de

This package leaflet was last revised in: July 2013.

Source: Information from the package leaflet
Status: 12/2015
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 rhinitis and sinusitis and as an accompanying treatment measure to accelerate the healing process after endonasal sinus surgery.