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Kamistad 20mg/185mg oral mucosa gel 10g

Kamistad 20 mg/185 mg oral mucosa gel 10g

Patient information leaflet: Information for the user

Kamistad 20 mg/185 mg oral mucosa 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 one week.

What is in this leaflet:

1. What Kamistad 20 mg/185 mg oral mucosa gel (hereinafter referred to as Kamistad gel) is and what it is used for
2. What you need to know before you use Kamistad gel
3. How to use Kamistad gel
4. Possible side effects
5. How to store Kamistad gel
6. Contents of the pack and other information

1. What Kamistad gel is and what it is used for

The active substances of Kamistad gel are lidocaine hydrochloride and chamomile flower extract.

Kamistad gel is a traditional herbal medicinal product for the local treatment of mild inflammations of the gums and oral mucosa.

If the symptoms of inflammation do not improve after one week, or if new symptoms appear, consult a doctor.

2. What you need to know before you use Kamistad gel

Do not use Kamistad gel

- if you are allergic to lidocaine or other amide-type local anaesthetics, chamomile or other plants of the daisy family, cinnamon, Peruvian balsam or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Kamistad gel must not come into contact with the eyes or open wounds.

Wash hands thoroughly after using the gel.

Children

The product is not recommended for use in children under 12 years of age due to insufficient data on safety and efficacy.

Other medicines and Kamistad gel

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

There are no known drug interactions with the dosage recommended in the package 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.

Its safe use during pregnancy and breast-feeding has not been proven, so its use is not recommended.

Effects of this medicine on driving and using machines

The effects on the ability to drive and use machines have not been studied.

Kamistad gel contains benzalkonium chloride

Benzalkonium chloride is irritating and may cause skin reactions.

3. How to use Kamistad gel

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.

Recommended dosage of the product

Adults: Three times a day, a gel strip of about half a centimetre in length.

Use in children

Children aged 12 years and over: Three times a day, a gel strip of about half a centimetre in length.

Children under 12 years of age: The product is not recommended for use in children under 12 years of age.
Method and duration of administration

The product is intended for local treatment of the oral mucosa.

The gel should be applied to the inflamed areas and gently rubbed in.

If the symptoms of inflammation do not improve after one week, or if new symptoms appear, consult a doctor.

If you feel that the effect of the product is too strong or too weak, talk to your doctor.

If you use more Kamistad gel than you should

Overdosage of Kamistad has not been reported to date.

In case of overdose, consult a doctor so that they can decide on the treatment based on the symptoms.

If you forget to use Kamistad gel

Continue treatment as described.

Do not use a double dose to make up for a forgotten dose.

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

4. Possible side effects

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

Uncommon side effects (may affect up to 1 in 100 people):

- A mild, transient burning sensation may occur after application.

Very rare side effects (may affect up to 1 in 10,000 people):

- Since the product contains lidocaine, cinnamon oil and chamomile extract, allergic reactions may occur (e.g. contact allergy).

Such a reaction may also occur in people who are allergic to plants of the daisy family (e.g. mugwort) or to Peruvian balsam ("cross-allergy").

- Severe allergic reactions (anaphylactic shock, asthma, facial oedema and urticaria) have been reported following internal use of chamomile-containing products.

If a hypersensitivity reaction occurs on the skin or mucous membranes, discontinue use of the product and consult a doctor.

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 effects directly to the authority, details provided in the Appendix V.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Kamistad gel

Store below 30°C.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and the tube after "EXP". The expiry date refers to the last day of that month.

Shelf life after first opening: 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 informationWhat Kamistad gel contains

- The active substances are: 20 mg lidocaine hydrochloride and 185 mg liquid extract of chamomile flower (1:4-5) in 1 g of gel.

Extraction solvent: ethanol 50%V/V containing 1.37% trometamol.

- The other ingredients are: Ceylon cinnamon bark oil, sodium saccharin, benzalkonium chloride, carbomer, trometamol, purified water, ethanol 96%, formic acid.

What Kamistad gel looks like and contents of the pack

Yellowish-brown, homogeneous gel with a characteristic odour.

10 g gel in a white, opaque PE screw-cap tube with a protective coating, sealed with an aluminium tube.

1 tube in a box.

Marketing Authorisation Holder and Manufacturer

STADA Arzneimittel AG

Stadastrasse 2-18, D-61118 Bad Vilbel

Germany

Tel.: +49 6101 603 0

Fax: +49 6101 603 259

e-mail: info@stada.de

Date of last revision of the package leaflet: April 2015