Azulan®
oral fluid, OTC drugAzulan® is a fluid for application to skin and mucosa, of dark brown color and specific, styptic, slightly bitter taste and aromatic, chamomile smell. The product is intended for traditional use in the above mentioned indications and its efficiency is based exclusively on long term use and experience. The preparation demonstrates anti-inflammatory effects and, while used internally has relaxing influence on smooth muscles of alimentary tract (it acts carminatively).
Indications for application
Externally:
Traditionally in case of inflammatory states of skin and mucosa, for rinsing in inflammatory states of mouth and throat and in case of gum inflammation.
Internally:
In case of alimentary tract cramps as an auxiliary relaxing and carminative agent as well as an auxiliary agent in case of alimentary tract inflammations.
How to apply Azulan®
Externally:
Adults and youths over 12 years of age : 10 % water solution for rinsing and compresses ( 1 part of Azulan® + 9 parts of boiled, cooled water )
Internally:
Adults and youths over 12 years of age, orally 5 ml (1 tea spoon) in 1/2 glass of water 3 times a day before meal.
In case of taking higher than recommended dose of Azulan®
No cases of overdose have been described concerning internal or external application.
Immediately consult a physician or a pharmacist in case of taking higher than recommended dose of the drug.
In case of skipping the dose of Azulan®
Take the next dose.
Do not apply a double dose in order to supplement the omitted one.
Before you apply Azulan®
Do not apply the preparation if allergy to chamomile flowers or other plants of Compositae (Asteraceae) family exists.
Special warnings and precautions:
The drug contains 60 – 68 % v/v of ethanol. A single dose = 5 ml contains about 2.58 g of ethanol.
Because of ethanol content, the drug may be harmful for individuals with alcohol illness as well as in case of liver diseases or epilepsy.
Application of Azulan® to children
Because of ethanol content it is not recommended to apply the preparation to children younger than 12 years of age.
Pregnancy
No controlled clinical trials have been conducted in pregnant women.
Because of ethanol content in the preparation it is not recommended to apply the drug during this period.
Breast feeding
No controlled clinical trials have been conducted in breast feeding women.
Because of ethanol content in the preparation it is not recommended to apply the drug during this period.
Driving of vehicles and operation of moving mechanisms
The preparation contains 60 – 68 % v/v of ethanol.
1 dose (5 ml) contains about 2.58 g of ethanol.
Internal application of the product may cause impairment of psychophysical competence.
It is not recommended to take the drug before journey because alcohol contained by the preparation may be detected by devices for measuring alcohol level in the exhaled air.
Use of other drugs
Inform the doctor about all the recently applied drugs, even those sold over the counter and without prescription.
Possible undesired effects
Hypersensitivity reaction to chamomile (for example, contact allergy) may occur in some individuals during application of Azulan®.
In case of individuals allergic to plants of Compositae family, e.g. sagebrush, wormwood, cross reaction may occur. Sporadic cases of acute allergic reaction (anaphylactic shock, asthma) have been reported.
Discontinue application of the drug and contact a physician in case of allergy symptoms appearance (rash, urticaria, edema and increased sensitivity to sunlight).
Other undesired effects may occur in some individuals during application of Azulan®. In case of other undesired effects, not mentioned here, inform your doctor about them.
Storage of Azulan®
Store at the temperature not exceeding 25° C.
Store the drug out of reach and sight of children.
Do not use the drug after expiry period.
Composition
100g of the product contain:
Active substance:
Fluid ethanol extract of chamomile baskets (Chamomillae anthodii extractum fluidum), (1: 2), extractant – ethanol 70% [v/v] 100g
The preparation contains 60 – 68 % v/v of ethanol and 0.15 – 0.35 % of volatile oil.
Unit packaging consists of color glass bottle with polyethylene screw cap, containing 30 g or 90 g of the product.
