KAMISTAD

KAMISTAD Gel

Important notes (mandatory information)

Kamistad Gel. Areas of application: for the treatment of mild inflammations of the gums and oral mucosa.

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

Kamistad Gel, 20 mg lidocaine hydrochloride/185 mg extract of chamomile flowers per 1 g gel for use in the oral cavity
Active ingredients: lidocaine hydrochloride and extract of chamomile flowers

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 exactly as your doctor or pharmacist has told you.

• Keep the leaflet. You may need to read it again later.
• Ask your pharmacist if you need more information or advice.
• If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this leaflet. See section 4.
• If you do not feel better or if you feel worse after 1 week, contact your doctor.

What this leaflet contains

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

1. WHAT IS KAMISTAD GEL AND WHAT IS IT USED FOR?

Kamistad Gel is a mild traditional medicine. Kamistad Gel is used to treat mild inflammations of the gums and oral mucosa. If the signs of inflammation do not improve within 1 week, a doctor should be consulted.

2. WHAT SHOULD YOU CONSIDER BEFORE USING KAMISTAD GEL?

Kamistad Gel must not be used if you are allergic to lidocaine or other local anaesthetics (amide-type local anaesthetics), to chamomile or other daisy family plants, to cinnamon, Peruvian balsam or any of the other ingredients of this medicine listed in section 6. Warnings and precautions Avoid contact of Kamistad Gel with eyes and open wounds. Wash hands thoroughly after applying Kamistad Gel.

Children

As there are no sufficient studies, Kamistad Gel should not be used in children under 12 years of age.

Use of Kamistad Gel with other medicines

Tell your doctor or pharmacist if you are using, have recently used or intend to use any other medicines. Interactions with other agents are not known in the specified dose range.

Pregnancy and breast-feeding

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 using this medicine. As there are no sufficient studies, Kamistad Gel should not be used during pregnancy and breast-feeding.

Driving and using machines

No effects on the ability to drive and use machines have been observed to date.

Kamistad Gel contains benzalkonium chloride

Benzalkonium chloride can cause skin irritation.

3. HOW TO USE KAMISTAD GEL?

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 recommended dose is

Adults and children over 12 years of age apply a gel strand of about 1/2 cm in length 3 times a day.

Type of application

The gel is applied to the inflamed areas and gently massaged in.

Duration of use

The duration of use is in principle not limited. If the signs of inflammation do not improve within one week, a doctor should be consulted.

If you forget to use Kamistad Gel

Do not use double the amount (e.g. do not apply the gel more often or more thickly) if you have forgotten the previous application. Continue treatment as described in this leaflet.

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.

The following frequency information is used to evaluate side effects:
Very common:	more than 1 in 10 treated persons
Common:	1 to 10 in 100 treated persons
Uncommon:	1 to 10 in 1,000 treated persons
Rare:	1 to 10 in 10,000 treated persons
Very rare:	less than 1 in 10,000 treated persons
Not known:	frequency cannot be estimated from the available data.

Skin and subcutaneous tissue disorders

Uncommon: Mild burning may occur temporarily after application of the gel.

Immune system disorders

Very rare: Due to the content of lidocaine, cinnamon and chamomile, allergic reactions may occur (e.g. contact allergy), also in case of hypersensitivity to daisy family plants (e.g. mugwort) and Peruvian balsam (due to so-called cross-reactions).

If hypersensitivity reactions occur on the skin or mucous membranes, the use of Kamistad Gel must be discontinued and a doctor must be consulted.

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 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 provide more information on the safety of this medicine.

5. HOW TO STORE KAMISTAD GEL?

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 tube. The expiry date refers to the last day of the month indicated. The shelf life after opening is 12 months. Do not store above +30°C. Do not dispose of medicines in wastewater or household waste. Ask your pharmacist how to dispose of the medicine when you stop using it. In this way, you help to protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Kamistad Gel contains

The active ingredients are: lidocaine hydrochloride 1H2O and extract of chamomile flowers. 1 g gel contains 20 mg lidocaine hydrochloride 1H2O and 185 mg extract of chamomile flowers (1:4-5). Extraction agent: Ethanol 50% (V/V) with 1.37% trometamol (adjusted with formic acid 98% to pH 7.3). The other ingredients are benzalkonium chloride, ethanol 96%, formic acid, polyacrylic acid, saccharin sodium, trometamol, purified water, water and cinnamon oil.

What Kamistad Gel looks like and contents of the pack

Yellow-brown gel. Kamistad Gel is available in tubes with 10 g and 20 g gel for use in the oral cavity.

Pharmaceutical entrepreneur

Stada Consumer Health Deutschland GmbH
Stadastraße 2 - 18
61118 Bad Vilbel
Telephone: 06101 603-0
Telefax: 06101 603-259
Internet: www.stada.de

Manufacturer

Stada Arzneimittel AG
Stadastraße 2 - 18
61118 Bad Vilbel

This leaflet was last revised in September 2019.

Source: Package leaflet information
Status: 09/2020
Areas of application: for the treatment of mild inflammations of the gums and oral mucosa.