Information on use

Dear Patient!Please read this information on use carefully,because it contains important information youshould be aware of when using this medicaldrug product. Please consult your physicianor pharmacist if you have any questionsconcerning this product.

Active substance

Peppermint oil

Composition

100.0 ml China-Oel contain the pharmacolo-gically active component 100.0 ml peppermintoil.

Form of administration and contents

Ethereal oil, 10, 25 and 100 ml.

Herbal drug for use in treatment ofdigestive problems, catarrhs of the upperrespiratory tract, and externally intreatment of muscle or nerve pain.

Pharmaceutical manufacturer:

BIO-DIT-BERLIN GmbHSelerweg 4345D-12169 Berlin, GermanyTel.: ++49-(0)30-25 32 60 20www.bio-diaet-berlin.de

Indications

For internal use in treatment of spasmodicsymptoms in the bile ducts and gastrointestinaltract, for internal use or inhalation in treatmentof colds affecting the upper respiratory tract,for external use in treatment of muscle pains(myalgias) and symptoms similar to neuralpain (neuralgiform) symptoms.

Consult a physician if symptoms persist forlonger than one week or recur periodically.

Counterindications

In what cases should China-Oel not beused?

Do not use China-Oel internally in case of bileduct occlusion, gallbladder inflammation orsevere liver damage.

In what cases should China-Oel be usedonly after consulting a physician?

Descriptions of cases follow in which China-Oel should only be used under certain condi-tions and accompanied by special precautions.Please consult your physician in such cases.This also applies if these symptoms or ailmentshave occurred sometime in the past.In persons suffering from gallstones, this

medical drug product should only be takenafter consulting a physician.

What should you watch out for duringpregnancy and the breastfeeding period?

On the basis of widespread use of peppermintoil as a flavouring substance and orientationalanimal model studies, no risks arising fromuse during pregnancy or the breastfeedingperiod are known to date.

What precautions are necessary regardinginfants and small children?

In infants and small children (preschoolchildren) peppermint oil should not be usedin the facial area, in particular around thenose, or for inhalation, since this may induceasthma-like conditions.

The study data on use of this medical drugproduct in children with digestive disorders isinsufficient, so that children under 12 yearsof age should not take it.

Precautionary measures related to use and warnings

What precautionary measures are requi-red?

In external applications, wash hands thoroughlyafter use. By this means, accidental contactof peppermint oil with sensitive places on thebody such as mucosa and open wounds, orwith the eyes, can be avoided.

What precautions are required in roadtraffic or when working with machinesor unsecured at dangerous heights?

China-Oel has no negative influence on reac-tions in traffic or when working with machinesor unsecured at dangerous heights

Interactions

Can other medications influence the effectof China-Oel or be influenced by it?

No interactions with other medications areknown.

Dosage and application

The following information applies unlessotherwise prescribed by your physician.Please comply with the instructions foruse, since otherwise China-Oel cannottake effect properly.

How much China-Oel should you take,and how often?

Internal use:Average daily dose 6 to 12 drops, i.e. 23times a day 3-4 drops.

For inhalation:34 drops in approx. 300 ml hot water, 23times a day.

External use:Rub several drops into the affected skin area.

When and how should you use China-Oel?

Colds affecting the upper respiratory tract:

3 drops in hot water, inhale vapours with eyesclosed and drink 23 drops in hot water insuccessive swallows. Rub small amounts intochest, neck and back of neck.

Spasmodic symptoms in the bile ductsand gastrointestinal tract:

Drink 34 drops in half a glass of warm wateron an empty stomach.

Muscle pains (myalgias):

Rub (massage) several drops into the painfulareas, then keep warm with cotton wool ora wool cloth.

Symptoms similar to neural pain(neuralgiform):

Symptoms similar to neural pain (neuralgiform):Rub several drops into the painful areasthoroughly. For neuralgiform symptoms in thehead area, thoroughly rub several drops intothe forehead, temples and back of the neck.Subsequent application of small amounts ofcold water increases the effect.

Application errors and overdose

China-Oel should not come into contact witheye mucosa.

What must be done in case China-Oel hasbeen used in excessive amounts (inten-tional or accidental overdose)?

Ingestion of large amounts of ethereal oilsmay lead to abdominal pain, nausea andvomiting. In severe cases, intoxication,numbness, cardiac disturbances or dyspnoeamay result.

The literature describes cases in which intakeof 8-9 g of menthol, the main component ofpeppermint oil (equivalent to about 18 mlpeppermint oil) caused only nausea and a coldsensation. Since, however, the literature alsodescribes intoxications in sensitive persons inparticular caused by only 2 g of menthol(equivalent to about 1 teaspoon of peppermintoil), a physician should be informed in everycase of possible intoxication with China-Oel.The physician will then take the propermeasures.

No specific antidotes are known; milk andalcoholic beverages are contraindicated, sincethey can increase the uptake of ethereal oils.Excessive inhalation may induce coughing,which then ceases immediately wheninhalation is discontinued.

Side effects

What side effects can occur when China-Oel is used?

Stomach malaise may occur in sensitive personsafter intake.

External application may induce a burningsensation and skin reddening, which symptomsabate when the oil is rinsed off thoroughlywith water.

In rare cases, peppermint oil may also induceallergic skin reactions. In such cases, treatment

with the oil must be discontinued and aphysician must be consulted.

If you observe side effects not listed in thispackage leaflet, please inform your physicianor pharmacist.

Information concerning the stability period (expiry date) of this medical drug product

The expiry date for this package is printed onthe label and on the folding carton. Do not

use the product in this package after the expirydate! China-Oel will keep for at least 20months after the bottle has been opened.

Store medicines out of reach of children.

Always keep the bottle in the outercarton, protected from exposure to light.

Status of information: 05.2004 V5155

Interesting informationabout China-OelChina-Oel pure peppermint oil fromBIO-DIT-BERLIN is the ethereal oilderived from the freshly harvested,blossoming above-ground parts ofMenthae x piperitae L. by means ofwater steam distillation.

BIO-DIT-BERLIN have defined internalcompany standards to ensure the

quality of China-Oel, which standardsare more stringent than required bylaw. This extra care guarantees thatthe product you buy is a herbalmedicine manufactured by BIO-DIT-BERLIN in harmony with nature.Application of method ensures thatyou get a herbal medicine that hasbeen proven over many decades, onethat is highly effective and welltolerated.

Because China-Oel is a natural herbalmedicine, variations in odour, taste andcolour may occur depending on theharvesting time, climatic conditionsand where the herb is grown. Thesenatural variations do not, however,indicate defective quality, but ratherdemonstrate the natural nature of thisproduct and have no effect on itsefficacy and tolerance.

Get well soon!

Important:

Insert the inhalator only about 1 cm into thenasal openings or mouth. Do not swallow it!Store out of reach of children!

Take precautions to make sure China-Oel doesnot get into the eyes when applying drops of

Interesting informationabout the China-Oel Inhalator

5. Treatment of the nasal cavity:Insert the blue side into each nostril and breathe through the nose vigorously.

6. Treatment of the throat: Insert the white side of the inhalator into the mouth and breathe deeply.

1.

2.1. Remove the blue upper section of the cap to

open the China-Oel Inhalator.2. Pull out the upper section of the cap together

with the absorbent fleece.

3.

4.

5. 6.

Instructions for use of the China-Oel Inhalator:

Medical device as per EECDirective 93/42/EEC

The China-Oel Inhalator is used for inhalationof China-Oel. Inhalation brings the China-Oelinto contact with the nasal and oral mucosaand deep inhalation introduces it into theupper respiratory tract, where it can thenunfold its pharmacological effect.

Care and cleaning of the China-OelInhalator:After using the China-Oel Inhalator, wipe offthe outside of the device with a clean clothand store it in the original package!

Travelling with the China-Oel Inhalator:The advantage of the China-Oel Inhalator isthat with it application of the China-Oel ispossible anywhere and anytime, e.g. at theoffice, in the theatre or car or while travelling.The inhalator is simple and easy to use andcan be refilled with 2-3 drops of China-Oel.

it to the fleece tube!

The inhalator is registered as a Federal GermanPatent under No. P 33 388.

3. Distribute 23 drops of China-Oel along the fleece tube.

4. Replace the upper section of the cap togetherwith the absorbent fleece in the lower sectionof the inhalator and close it.