Description
Капки Кармолис
Капките Кармолис са създадени по старинна рецепта от 10 алпийски билки. Продуктът притежава способността благоприятно да повлиява функцията на дихателната система, помагат при главоболие и метеоризъм, мускулни болки, ревматоиден артрит, стомашни оплаквания (гадене, загуба на апетит). Подобряват общото самочувствие.
Summary
CARMOLIS Drops
Active ingredients : menthol, thyme oil, anise oil, cassia oil, clove oil, lemon oil, lavender oil, spike lavender oil, citronella oil, sage oil, nutmeg oil, spirit of balm.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
100 g of CARMOLIS Drops contain 1720 mg menthol, 860 mg essential oils (thyme, anise, cassia, clove, lemon, lavender, spike, citronella, sage, nutmeg), 172 mg spirit of balm-mint.
Contains 65 vol% alcohol
3. PHARMACEUTICAL FORM
Solution
4. CLINICAL PARTICULARS
4.1. Therapeutic Indications
For inhalation in case of
• diseases of the respiratory tract and common colds
For ingestion in case of
• gastrointestinal disorders, nausea, indigestion such as flatulence, fullness, loss of appetite
• nervousness, restlessness, irritation, sleeping disturbances, meteorosensitivity, nervous disorders during climacterium, traveller's disorders
For embrocation in case of
• pain of the muscles and limbs
• rheumatism, lumbago, ischialgia
• headache
• itching of the skin, insect bites
4.2. Posology and Method of Administration
10-20 drops of CARMOLIS are taken on a piece of sugar, in a cup of tea or a glass of water up to 5 times a day.
For external use the aching parts of the body should be rubbed several times a day with CARMOLIS.
For inhalation 20 drops of CARMOLIS are put into boiling water or tea and the steams are inhaled.
POSOLOGY FOR SPECIAL INDICATIONS
Flatulence, fullness, indigestion : 10-20 drops of CARMOLIS are taken on a piece of sugar, in a cup of tea or in a glass of water.
Nervous sleeping disturbances : Before going to bed 10-20 drops of CARMOLIS are taken in a cup of tea or in hot sugar water.
Traveller's disorders : In case of nausea a view drops of CARMOLIS taken on a piece of sugar or in a glass of water exert sedative and relaxing effects.
Nervousness : 10-20 drops of CARMOLIS are taken on a piece of sugar or in a cup of tea 3 times a day.
Common cold : 10-20 drops of CARMOLIS are taken on a piece of sugar or in a cup of tea up to 5 times a day.
Headache : In addition to the oral ingestion the forehead, temple and neck may be rubbed with CARMOLIS.
Pain of the limbs : The aching parts should be daily rubbed with CARMOLIS and should be kept warm.
Respiratory diseases : 20 drops of CARMOLIS are put into boiling tea and the steams are inhaled. Afterwards the tea may be drunken. Rubbing the chest and the back with CARMOLIS before going to bed facilitates respiration.
Itching of the skin, insect bites : The concerned regions are swabbed with CARMOLIS, but should not be rubbed.
4.3. Contraindications
In case of severe diseases of the internal organs (obstructions of the bile ducts, cholecystitis, hepatic disorders, gastrointestinal ulcers) oral administration of CARMOLIS Drops is contraindicated.
CARMOLIS Drops should not be administered to children.
Due to the content of alcohol (65 vol%) CARMOLIS Drops should not be administered to patients suffering from hepatic diseases, alcoholics, epileptics, patients suffering from cerebral damages as well as to pregnant and lactating women.
4.4. Special Warnings and Special Precautions for Use
Eye-contact has to be absolutely avoided.
4.5. Interaction with Other Products and Other Forms of Interactions
Not known.
4.6. Pregnancy and Lactation
CARMOLIS Drops should not be administered to pregnant and lactating women.
4.7. Effects on Ability to Drive and Use Machines
CARMOLIS Drops contain 65 vol% alcohol. Following the recommended dose up to 0,54 g alcohol are ingested with each single dose.
In case of overdose the ability to drive and use machines may be impaired.
4.8. Undesirable Effects
Following the recommended dose adverse effects have not been observed.
4.9. Overdose
Not known.
5. PHARMACOLOGICAL PROPERTIES
5.1. Pharmacodynamic Properties
The efficacy of CARMOLIS Drops in the treatment of diseases of the respiratory tract is based on the content of menthol, thyme oil, anise oil, clove oil and sage oil as all these components exert expectorating, spasmolytic and antiseptic effects. By inhalation the volatile essential oils reach the throat and bronchi and so they are able to exert their actions at these sites. But after peroral or percutaneous administration the essential oils are effective as well, as their components are absorbed and – at least partly – are eliminated with breath.
Menthol, thyme oil and anise oil enhance the removal of mucus and secretion from the bronchi and trachea. This effect is evoked partly by liquefaction of the secretion and partly by accelerating the transport of secretion. In addition, the bronchospasmolytic properties of menthol, thyme oil, anise oil and clove oil are of great value in the treatment of respiratory diseases.
The efficacy of CARMOLIS in treating gastrointestinal disorders is based on its carminative, spasmolytic, antiseptic and cholagogue actions. Digestive effects are evoked either by reflex or by a direct irritation of the mucosa. In that way the secretion of gastric juice and gastric motoricity are enhanced. Due to the antispasmodic actions as well as to the antiseptic effects and stimulating effects on bowel motility CARMOLIS promotes the exit of flatus and prevents its excessive formation. The antiseptic properties are of essential importance in case of inflammatory gastrointestinal diseases. By stimulating the bile production in hepatic cells and promoting the release of bile from the gallbladder menthol, lavender oil, spike oil and nutmeg oil exert cholagogue effects which are an important contribution to the efficacy of CARMOLIS in the treatment of gastrointestinal complaints.
The sedative and spasmolytic properties of lavender oil, spike oil, citronella oil and Spiritus Melissae are responsible for the applicability of CARMOLIS in case of nervousness.
Due to the cell irritating effects of menthol, thyme oil, cassia oil, lavender oil, spike oil, citronella oil and nutmeg oil CARMOLIS may also be used as rubefacient . After penetration into the skin the oils enhance the blood flow resulting in a feeling of warmth and a reddening of the skin. In that way pains of various genesis such as rheumatic pain, myalgia etc. can be relieved symptomatically.
5.2. Pharmacokinetic Properties
Essential oils are lipophilic substances which are well absorbed by the mucosa and the intact skin. One way of absorption is the absorption from gastric mucosa when the oils are administered by mouth. After inhalation the volatile ethereal oils are absorbed by the nasal mucosa. When CARMOLIS is used as a rubefacient the essential oils penetrate into the skin.
The active substances are eliminated by expiration, but to a much higher extent they are eliminated by the kidney or by biliary excretion in a conjugated form.
5.3. Preclinical Safety Data
Acute oral toxicity
The active substances contained in CARMOLIS can be regarded as non-toxic.
In rats and mice the LD50 value was determined to be 11,34 g/kg bodyweight. The reference preparation lacking the essential oils had the same toxic potential.
6. PHARMACEUTICAL PARTICULARS
6.1. List of Excipients
Ethanol, purified water.
6.2. Incompatibilities
Not known.
6.3. Shelf Life
60 months
6.4. Special Precautions for Storage
Do not store above room temperature (up to 25°C).
6.5. Nature and Contents of Container
Colourless glass bottles with a dropper and a screw cap.
Package sizes : 20, 40, 80, 160, 240 ml
6.6. Instructions for Use and Handling
None
7. MARKETING AUTHORISATION HOLDER
OMEGIN Dr. Schmidgall GmbH D-Gottmadingen
8. MARKETING AUTHORISATION NUMBER
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
10. DATE OF REVISION OF THE TEXT
March 2002