DENTINOX

DENTINOX Gel N teething aid

Important notes (mandatory information)

Dentinox-Gel N teething aid. Areas of application: as a mild acting medicine for the short-term relief of discomfort during the first teething.

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


INFORMATION FOR USE: INFORMATION FOR THE USER

Dentinox-Gel N teething aid, gel for use in the oral cavity for teething children
Active ingredients: tincture of camomile flowers 150.0 mg/g, lidocaine hydrochloride 1 H2O 3.4 mg/g, macrogol lauryl ether 3.2 mg/g
Traditional medicine

Read the entire package leaflet carefully before you start using this medicine, as 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.
• 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 the teething child does not feel better or worse after one week, contact your doctor.

What is in this package leaflet

1. WHAT IS DENTINOX-GEL N TEETHING AID AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE USING DENTINOX-GEL N TEETHING AID?
3. HOW IS DENTINOX-GEL N TEETHING AID USED?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD DENTINOX-GEL N TEETHING AID BE STORED?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT IS DENTINOX-GEL N TEETHING AID AND WHAT IS IT USED FOR?

Dentinox-Gel N teething aid is a traditional medicine. Area of application: Dentinox-Gel N teething aid is used in the oral cavity: Traditionally used as a mild acting medicine for the short-term relief of discomfort during the first teething. If more severe reddening and swelling of the gums or pronounced accompanying symptoms occur, a doctor should be consulted.

2. WHAT SHOULD YOU CONSIDER BEFORE USING DENTINOX-GEL N TEETHING AID?

Dentinox-Gel N teething aid must not be used if the teething child is allergic to camomile, other composite flowers, lidocaine or related local anaesthetics (local anaesthetics of the amide type) or any of the other ingredients of this medicine listed in section 6. This medicine is not suitable for patients with the rare hereditary fructose intolerance due to the content of sorbitol.

Warnings and precautions

Please talk to your doctor or pharmacist before using Dentinox-Gel N teething aid if more severe reddening and swelling of the gums or pronounced accompanying symptoms occur. See under "Area of application:". Avoid contact of Dentinox-Gel N teething aid with the eyes. See under "

Type of use

".

Use of Dentinox-Gel N teething aid together with other medicines

Tell your doctor or pharmacist if you are using, have recently used or intend to use any other medicines.

Pregnancy and breast-feeding

Since this preparation is a medicine that is used exclusively in childhood to relieve discomfort during the first teething, information on pregnancy and breast-feeding is not applicable.

Driving and using machines

No special precautions are required.

Dentinox-Gel N teething aid contains sorbitol and propylene glycol

This medicine contains sorbitol. Please only use Dentinox-Gel N teething aid after consulting your doctor if you know that the teething child suffers from an intolerance to certain sugars. 10 g of gel contain 1 g of sorbitol (equivalent to 0.25 g of fructose), corresponding to less than 0.1 bread units. The calorific value is 2.6 kcal/g of sorbitol. Propylene glycol can cause skin irritation.

3. HOW IS DENTINOX-GEL N TEETHING AID 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. Unless otherwise prescribed by your doctor, the recommended dose is: In case of teething problems, a pea-sized piece of gel is applied to the affected area of the gums and gently massaged in. The application should be repeated 2 to 3 times a day. 1 g contains 100 mg of sorbitol, 25 mg of fructose corresponding. The calorific value is 2.6 kcal/g of sorbitol.

Type of use

Apply Dentinox-Gel N teething aid to the affected area of the gums with a clean finger or a clean cotton swab and gently massage it in, especially after meals and before going to sleep. Avoid contact of Dentinox-Gel N teething aid with the eyes.

Duration of use

Dentinox-Gel N teething aid is used as needed. It can be continued until all milk teeth, including the later molars, have erupted. Please note the information under "Area of application:". Please talk to your doctor or pharmacist if you have the impression that the effect of Dentinox-Gel N teething aid is too strong or too weak.

If you have used more Dentinox-Gel N teething aid than you should

The side effects may be increased (see side effects). If this is the case, please discontinue use of Dentinox-Gel N teething aid and consult a doctor.

If you forget to use Dentinox-Gel N teething aid

Do not use twice the amount to make up for the forgotten application.

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.

Important side effects or signs to watch out for, and measures to take if you are affected

Allergic reactions may occur, especially due to the lidocaine content. If hypersensitivity reactions occur on the skin or mucous membranes, the use of Dentinox-Gel N teething aid must be discontinued and a doctor consulted if necessary.

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 provide more information on the safety of this medicine.

5. HOW SHOULD DENTINOX-GEL N TEETHING AID BE STORED?

Keep this medicine out of the reach of children. Do not use the medicine after the expiry date which is stated on the tube and carton after "Use by:" or "Use by:". The expiry date refers to the last day of the month indicated. Storage conditions: Please keep Dentinox-Gel N teething aid tightly closed and do not store above 25°C. Note on shelf life after opening: The shelf life after opening the tube is 12 months.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Dentinox-Gel N teething aid contains

10 g of gel contain as active ingredients: tincture of camomile flowers (1:5), extraction agent: ethanol 70% (V/V) 1500 mg, lidocaine hydrochloride 1 H2O 34 mg, macrogol lauryl ether 32 mg. The other ingredients are: sorbitol solution 70% (non-crystallising) (Ph.Eur.), xylitol, propylene glycol, carbomer 974 P, sodium hydroxide solution (10%), polysorbate 20, sodium edetate (Ph.Eur.), saccharin sodium, purified water.

10 g of gel contain 1 g of sorbitol (equivalent to 0.25 g of fructose), corresponding to less than 0.1 bread units. The calorific value is 2.6 kcal/g of sorbitol.

What Dentinox-Gel N teething aid looks like and contents of the pack

Dentinox-Gel N teething aid is a gel for use in the oral cavity. Due to the herbal active ingredient (tincture of camomile flowers), it has a light brown colour. Dentinox-Gel N teething aid is available in packs of 10 g of gel.

Pharmaceutical entrepreneur and manufacturer

Dentinox Gesellschaft für pharmazeutische Präparate Lenk & Schuppan KG
Nunsdorfer Ring 19
12277 Berlin
Tel.: (030) 7200340
Fax: (030) 7211038
E-mail: dentinox@dentinox.de

This information for use was last revised in September 2014.

Source: Information from the package leaflet
Status: 02/2018
Areas of application: as a mild acting medicine for the short-term relief of discomfort during the first teething.