KAMISTAD-N GEL 10G

ATC code: A01AD11 

Active substances: Lidocaini Hydrochloridum, Matricariae Extractum Fluidum

Vendor, principal: Stada Arzneimittel Ag. 
No prescription needed/Patient care products, dressings, gloves, medical devices,...

KAMISTAD N 20MG/+185MG/1G 10G

Package leaflet: Information for the user

Kamistad N, 20 mg + 185 mg/g oral cavity gel

Lidocaine hydrochloride and chamomile flower extract
Read all of this leaflet carefully before you start using this medicine because it contains important information for you. Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.
-   Keep this leaflet. You may need to read it again.
-   Ask your pharmacist if you need more information or advice.
-   If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
-   You must talk to a doctor if you do not feel better or if you feel worse after 1 week.

What is in this leaflet:

1.   What Kamistad N is and what it is used for
2.   What you need to know before you use Kamistad N
3.   How to use Kamistad N
4.   Possible side effects
5.   How to store Kamistad N
6.   Contents of the pack and other information

1. What Kamistad N is and what it is used for Kamistad N is indicated for

Numbing of gums and the oral cavity and alleviating inflammation symptoms. You must talk to a doctor if the inflammation symptoms do not improve within a week.

2. What you need to know before you use Kamistad N Do not use Kamistad N

- if you are allergic to lidocaine or other local anaesthetics in the amid group, chamomile or other plants in the sunflower family (Asteraceae), cinnamon, Balsam of Peru or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor or pharmacist before using Kamistad N.
Kamistad N may not come into contact with the eyes or open wounds. Wash your hands carefully after applying Kamistad N.

Children

As not enough studies have been carried out, Kamistad N should not be used in children under the age of 12.

Other medicines and Kamistad N

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Interaction is unknown in the case of doses prescribed in this leaflet.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
The safety of using Kamistad N gel during pregnancy and breast-feeding has not been proven. Therefore, this medicine is not recommended during these periods.

Driving and using machines

So far, no effect has been observed on driving and using machines.
Kamistad N contains benzalkonium chloride. Benzalkonium chloride may cause skin irritation.

3. How to use Kamistad N

Always use this medicine exactly as described in this leaflet or 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 above the age of 12 An approximately 0.5 cm line of gel three times a day.

Method of application

Apply a line of gel on inflamed areas and rub in gently.
Duration of use
You must talk to a doctor if you do not feel better or if you feel worse after 1 week.

If the medicine is effective, the use is not limited in duration.

If you forget to use Kamistad N

Continue treatment according to instructions. Do not apply more gel than usual.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

4.   Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Uncommon (may affect up to 1 user in 100)

A mild momentary burning sensation may follow the application of the gel.

Very rare (may affect up to 1 user in 10,000)

As the medicine contains lidocaine, cinnamon and chamomile, you may develop allergic reactions (e.g. contact dermatitis). Such reactions may also occur in patients who are hypersensitive to plants in the sunflower family (such as mugwort) and Balsam of Peru (risk of cross-allergy).

If you experience hypersensitivity of the skin or mucous membranes, stop using Kamistad N gel and talk to a doctor.

As Kamistad N contains benzalkonium chloride, skin irritation may occur during the use of this medicine.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effect directly via www.ravimiamet.ee. By reporting side effects you can help provide more information on the safety of this medicine.

5.   How to store Kamistad N

Keep this medicine out of the sight and reach of children!
Do not use the gel after the expiry date which is stated on the package and tube. The expiry date refers to the last day of that month.
Do not store at a temperature higher than 25 °C. After the initial opening of the tube, use the gel within 12 months.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Kamistad N contains

•   The active substances are lidocaine hydrochloride and chamomile flower extract
1 g of gel contains 20 mg of lidocaine hydrochloride and 185 mg of chamomile flower extract (1:4-5). Extraction solvent: 50% (V/V) ethanol with 1.37% trometamol (adjusted to pH 7.3 by 98% formic acid).
•   The other ingredients are benzalkonium chloride solution, ethanol 96%, formic acid, carbomers, sodium saccharin, trometamol and purified water. Ceylon cinnamon tree branch oil.

What Kamistad N looks like and contents of the pack

Yellowish-brown gel.
Kamistad N gel is available in a tube containing 10 g of oral cavity gel.

Marketing Authorisation Holder and Manufacturer

STADA Arzneimittel AG
Stadastrasse 2-18
D 61118 Bad
Vilbel
Germany
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
Almar Sehver Tartu mnt 16 10117 Tallinn Telephone 6605910 [email protected]
This leaflet was last revised in March 2014