SALVIATHYMOL

SALVIATHYMOL N Madaus Drops

Important notes (mandatory information)

Salviathymol N Madaus liquid. Areas of application: mild-acting medicine for minor inflammations of the gums and oral mucosa. Warning: Contains 31% alcohol by volume!

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

Salviathymol N Madaus liquid
Active ingredients: sage oil, eucalyptus oil, peppermint oil, cinnamon oil, clove oil, fennel oil, star anise oil, levomenthol, thymol
Traditional medicine

Read the entire package leaflet carefully before you start taking this medicine, as it contains important information. Always take 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 experience any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. See section 4.
• If you do not feel better or even worse after 7 days, contact your doctor.

What this package leaflet contains

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

1. WHAT IS SALVIATHYMOL N MADAUS AND WHAT IS IT USED FOR?

Salviathymol N Madaus is a traditional medicine. Area of application: Traditionally used as a mild-acting medicine for minor inflammations of the gums and oral mucosa. If symptoms of inflammation of the gums and oral mucosa persist for more than 1 week, a doctor should be consulted.

2. WHAT SHOULD YOU CONSIDER BEFORE USING SALVIATHYMOL N MADAUS?

Salviathymol N Madaus must not be used:

• if you are allergic to anethole, anise, cinnamon or Peruvian balsam, fennel or other umbellifers (e.g. celery) or any of the other ingredients of this medicine listed in section 6.
• in infants and toddlers and in pregnant women.

Warnings and precautions

Please talk to your doctor or pharmacist before using Salviathymol N Madaus.

Children and adolescents

There are no adequate studies on the use of Salviathymol N Madaus in children. Salviathymol N Madaus should therefore not be used in children under 12 years of age.

Use of Salviathymol N Madaus with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken or intend to take 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. Salviathymol N Madaus should not be used during pregnancy and breast-feeding due to insufficient studies.

Driving and using machines

No special precautions are required.

Important information about certain other ingredients of Salviathymol N Madaus

This medicine contains 31% alcohol by volume. Due to the content of propylene glycol, irritation of the mucous membranes may occur when using this medicine.

3. HOW TO USE SALVIATHYMOL N MADAUS?

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: Adults and children over 12 years of age use up to 3 times daily 20 drops (corresponding to 1 g) of liquid diluted in a glass (approx. 100 ml) of lukewarm water.

Type of application

The dilution described above is sufficient for 3 - 4 rinses, i.e. for a total rinsing time of approx. 2 minutes. Also draw the liquid through the spaces between the teeth. Do not swallow the liquid and do not rinse with water afterwards. As an additive in oral irrigators for daily oral hygiene, a few drops or more of Salviathymol N Madaus are added to the container of the device previously filled with water. Rinse the device briefly with clear water after use.

Duration of use

The duration of use depends on the course of the symptoms. If the symptoms persist for more than 1 week, a doctor should be consulted. If you have any further questions on the use of 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.

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.

As with all essential oils, irritation of the skin and mucous membranes may be increased after use of the product, coughing and bronchospasm may be triggered or increased. The occurrence of hypersensitivity reactions of the skin, respiratory tract or gastrointestinal tract is possible. Due to the content of propylene glycol, irritation of the mucous membranes may occur when using this medicine. If side effects occur, discontinue use of Salviathymol N Madaus and consult a doctor.

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 TO STORE SALVIATHYMOL N MADAUS?

Keep this medicine out of the reach of children. Do not use the medicine after the expiry date which is stated on the container and carton after "Use by". The expiry date refers to the last day of the month indicated. Storage conditions: No special storage conditions are required for this medicine. Note on shelf life after opening the container: 12 months.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Salviathymol N Madaus contains

The active ingredients are: 1 g of liquid (equivalent to 1 ml) contains: sage oil 2 mg, eucalyptus oil 2 mg, peppermint oil 23 mg, cinnamon oil 2 mg, clove oil 5 mg, fennel oil 10 mg, star anise oil 5 mg, levomenthol 20 mg, thymol 1 mg. The other ingredients are: ethanol 96%, propylene glycol, sodium dodecyl sulfate, polysorbate 80, saccharin sodium, chlorophyll-copper complex (E 141), purified water.

What Salviathymol N Madaus looks like and contents of the pack

Dark green liquid in packs of 20 ml (N1), 50 ml (N2) and 100 ml (N3).

Pharmaceutical entrepreneur
MEDA Pharma GmbH & Co. KG
Benzstraße 1
61352 Bad Homburg
Tel.: (06172) 888-01
Fax: (06172) 888-27 40
E-mail: medinfo@medapharma.de

Manufacturer

Madaus GmbH
51101 Cologne

This leaflet was last revised in December 2015.

Source: Information from the package leaflet
Status: 12/2017
Areas of application: mild-acting medicine for minor inflammations of the gums and oral mucosa. Warning: Contains 31% alcohol by volume!