JHP® Rödler Japanese Mint Oil, Essential Oil
For internal use: adults and adolescents from 12 years of age.
For external use: adults and children over 5 years.
Active ingredient: mint oil

Read the entire package leaflet carefully before taking this medicine because it contains important information.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.
Keep the package leaflet. You might want 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 also applies to side effects that are not listed in this leaflet. See section 4
If you do not feel better or worse after 7 days, if your condition worsens or if your symptoms still persist after 7 days, contact your doctor.

What is in this leaflet
What JHP Rödler is and what it is used for?
What you should know before taking/using JHP Rödler?
How should JHP Rödler be taken/used?
What are the side effects?
How to store JHP Rödler?
Contents of the pack and other information.

1. What JHP Rödler is and what it is used for?
Mint oil is a herbal medicine.
For adults and children from 5 years of age for inhalation:
• Catarrhs of the upper respiratory tract.
For adults and children from 5 years of age by rubbing into the skin:
• Muscle pain and nerve pain-like symptoms.
For adults and adolescents from 12 years of age to take with:
• catarrh of the upper respiratory tract,
• flatulence,
• bowel and stomach functional disorders.
If you do not feel better or worse after 7 days, if your condition worsens or if your symptoms persist after 7 days, contact your doctor.

2. What you should know before taking/using JHP Rödler?JHP JHP Rödler must not be taken/used,
if you are allergic to mint oil or menthol (the main component of mint oil),
in case of a lack of gastric juice (achlorhydria),
if there is an obstruction or inflammation of the bile ducts,
in case of inflammation of the gallbladder,
in the case of gallstones or other bile diseases,
in case of severe liver damage,
in the case of asthma or hypersensitivity of the airways,
by infants and children under 30 months (risk of laryngeal spasm),
by children with seizure disorders (with and without fever),
for inhalation in children up to 5 years of age, since breathing difficulties similar to those of asthma can occur.

Warnings and Precautions
Please talk to your doctor or pharmacist before taking/using JHP Rödler.
In the case of colds, you should see a doctor if shortness of breath, fever, or purulent or bloody sputum occurs.

When used internally, patients who are already suffering from heartburn or a diaphragmatic hernia, may in some cases experience aggravation of the symptoms. These patients should stop immediately the intake of JHP Rödler. In the case of inflammation or ulcers in the gastrointestinal area, mint oil should be used with caution.

Wash your hands thoroughly after external use of JHP Rödler. Therefore accidental contact of mint oil with sensitive parts of your body, such as mucous membranes and open wounds, or with the eyes can be avoided.

Children and adolescents
JHP Rödler must not be used for inhalation by children up to 5 years of age (please see the information under "JHP Rödler must not be used")
There are no adequate studies on the use of JHP Rödler for children and adolescents up to 12 years of age. For this reason, JHP Rödler should not be taken by children and adolescents up to the age of 12.

Taking/using JHP Rödler together with other medicines
Tell your doctor or the pharmacist if you are taking/using, have recently taken/used or might take/use any other medicines.
So far no interactions are known. Studies with JHP Rödler on interactions with other drugs have not been performed.

Pregnancy and brest-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 using this medicine.
The widespread use of mint oil as a medicine or food has not yet resulted in any indications of risks. However, there are no adequate studies on the use of mint oil during pregnancy and breastfeeding. Therefore the use of JHP Rödler is not recommended. There is also no data on the effects of mint oil on fertility.

Ability to drive and use machines
JHP Rödler has no influence on the ability to drive and use machines.
JHP Rödler contains menthol.

3. How should JHP Rödler be taken/used?
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Consult with your doctor or pharmacist if you are not sure.

The recommended dosage is:
For adults and children from 5 years:
• For inhalation, add 3-4 drops of JHP Rödler to hot water.
• For external use, a few drops of JHP Rödler are rubbed into the affected areas of the skin. Avoid eye contact.

For adults and children aged 12 and over:
• For oral use, take 2 drops of JHP Rödler, 1-3 times a day on sugar or in a glass of warm water.

Ingestion / application for children and adolescents
JHP Rödler should not be used topically or by inhalation for children under 5 years of age (see sections "Do not use JHP Rödler" and "Children and adolescents").

There are insufficient studies on the use of this medicine in children and adolescents under 12 years of age. Therefore, it should not be taken by children and adolescents under the age of 12.

Use in hepatic and renal insufficiency
There is insufficient data for specific dosage recommendations in the case of impaired kidney or liver function.
Type of application
For inhalation, topical on the skin and oral use.

Duration of ingestion
The duration of the application is not limited. In the case of acute symptoms that last longer than a week or recur periodically, we recommend consulting with a doctor.

Please, talk to your doctor or the pharmacist if you have the impression that the effect of JHP Rödler is too strong or too weak.

Overdose
If symptoms occur, call a doctor immediately!

If you forget to take/use JHP Rödler
Do not take/use a double amount if you have forgotten the previous dose/application. Continue treatment as usual.

If you stop taking/using JHP Rödler
Interrupting or prematurely ending treatment is usually harmless.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. What are the side effects?
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The frequency of side effects is based on the following categories:
Rare: may affect up to 1 in 1,000 people
Not known: Frequency cannot be estimated from the available data

Possible side effects
In rare cases, mint oil can cause an allergic skin reaction. When used externally, burning and redness of the skin may occur. The frequency is not known. In these cases, stop treatment and consult a doctor.

Too intensive application in the immediate vicinity of the eye can lead to a short-term slight stimulation of the tear flow.

Menthol (a component of mint oil) can cause laryngeal spasms in infants and children up to 30 months of age, leading to severe breathing difficulties.

Sensitive people may experience stomach problems after ingestion. The frequency is not known.

Sensitive (sensitized) patients may experience hypersensitivity reactions (including shortness of breath) caused by mint oil.

5. How to store JHP Rödler?
Keep this medicine out of the sight and reach of children.

You should not use this medicine after the expiry date printed on the container. The expiry date refers to the last day of the month.

This medicinal product does not require special storage conditions. JHP Rödler can attack plastics (e.g. acrylic). Therefore, please do not put or pour into plastic containers.

6. Contents of the pack and other information
What JHP Rödler contains:
The active substance is: mint oil. Contains menthol.
10 ml Essential Oil contains: 10 ml Mint Oil.

What JHP Rödler looks like and contents of the pack
Volatile oil.
JHP Rödler is available in glass bottles of 10ml and 30ml.
Not all pack sizes may be marketed.

Pharmaceutical license holder and manufacturer
License holder:
Recordati Pharma GmbH
Eberhard-Finckh-Str. 55
89075 Ulm
Telephone: (0731) 7047-0
Fax: (0731) 7047-297

Manufacturer:
Haupt Pharma Wolfratshausen GmbH
Pfaffenrieder Strasse 5
82515 Wolfratshausen