VENOSMIL® capsules

 (FAES  SPAİN)

Hidrosmin

COMPOSITION
Each capsule contains 200 mg of hidrosmin as the active ingredient.
The other components are: magnesium stearate excipient.
The gelatine capsule contains: Gelatine, erythrosine (E127), orange yellow S (E110), quinoline yellow (E104) and titanium dioxide (E171).

PHARMACOLOGICAL ACTION
Hidrosmin is a drug pertaining to the flavonoid family that combats the consequences of pooling of blood in the veins in the inferior extremities (also known as venous insufficiency) in those cases where difficulties in normal functioning are observed, a condition which is generally a result of varicose veins or old thrombosis.

INDICATIONS
Venosmil is used to provide short term relief (two-three months) of edemas and symptoms related with chronic venous insufficiency (pain, heavy legs, swelling, etc.).

INTERACTION WITH OTHER DRUGS AND FOODS
Inform your doctor or chemist if you are taking or have recently taken any other drugs, including those unprescribed by your doctor.
No interactions with food substances or other drugs have been observed, however, no other drugs should be taken, unless they have been prescribed by your doctor.

CONTRAINDICATIONS, PRECAUTIONS AND INCOMPATIBILITIES
Venosmil should be taken with extreme caution, therefore please consult your doctor should any of the following situations arise:
• If you observe any hypersensitive reactions to this drug or any of its components.
• It you have suffered asthma or are allergic to aspirin.
Pregnancy
If you think you are pregnant or believe you might be, consult your doctor prior to taking this drug.
Taking into account that there is no appropriate evidence-based information on the safety of Venosmil during pregnancy, its use should be avoided during the same.
Lactation
No decisive data is available on the elimination of hidrosmin in maternal milk and as such should not be used during the lactation period.

ADVERSE EFFECTS
This drug is generally well-tolerated.
The most frequent adverse reactions observed are either of a digestive (gastric pain, nausea) or dermatological nature (eruptions, itching), or related with the nervous system (sickness, headaches).
Should you observe any adverse reactions other than those described previously, consult your doctor or chemist.

WARNING ON EXCIPIENTS
This drug contains the orange yellow S (E110) excipient which could cause allergic reactions, including asthma, especially in patients allergic to acetylsalicylic acid.

DOSE AND METHOD OF ADMINISTRATION
Follow your doctor's recommendations on when and how to take this drug.
Oral use.
Adults:
The normal dose of Venosmil is one 200 mg capsule, three times a day, generally coinciding with meals.
Once removed from the blister, the capsule should be taken immediately, either with water or any other liquid to ease deglutition.

TREATMENT IN CASE OF INTOXICATION OR OVERDOSE
In this case consult the Toxicological Information service or consult your doctor.

PRESENTATION
Packages containing 20 and 60 capsules.

OTHER PRESENTATIONS
VENOSMIL gel, 60 g tube.

STORAGE OF VENOSMIL
Protect from heat and humidity. Store below 25 C.
Expiry
This drug should not be used after the expiry date on the package.
KEEP VENOSMIL OUT OF THE SIGHT AND REACH OF CHILDREN
Prescription drug.

Manufacturer and licence holder
FAES FARMA, S.A.
C/ Máximo Aguirre, 14
48940 Leioa (España-Espagne-Spain)