1. What is Venosmil and what it is used for
Hidrosmin is a drug that belongs to the group of flavonoids and acts on the consequences of venous hyperaemia of the lower limb veins (known as venous stasis), usually due to varicose veins or previous venous thrombosis. Venosmil is used for short-term alleviation (two-three months) of oedema and symptoms related to chronic venous hyperaemia (pain, heavy legs, oedema etc.).
2. What you need to know before taking Venosmil
Please consult your doctor if any of the following happens:
Do not take Venosmil
Should you observe any hypersensitivity reactions to the active ingredient or some of the drug compounds enlisted in point 6.
Warnings and precautions
In the case you do not observe any patient symptoms improvement, consult your doctor.
Administration of other drugs
Please inform your doctor or pharmacist if you take or recently took other drugs, including the ones purchased without doctor’s prescrip- tion. No incompatibility with other drugs was observed.
Children and youth
Drug use by children is not recommended.
Pregnancy, breastfeeding and fertility
Pregnancy and breastfeeding
Inform your doctor if you think you are pregnant or if you believe you could be pregnant. Consult your doctor before taking this drug. Even though the studies which have been done on animals did not show any teratogenic effects (foetus malformations), no additional studies were presented about the use during pregnancy and breastfeeding. The use of Venosmil during pregnancy is not recommended especially till the third month of pregnancy unless the benefit outweighs the risk.
Driving and machine operating
No studies were done of the effects on the ability to drive and operate machines. Hidrosmin is very unlikely to have effect on your ability to drive or operate machines.
3. How to take Venosmil
Always take this drug exactly in the way it is recommended by your doctor or pharmacist. Talk to your doctor or pharmacist should you have any questions.
The usual Venosmil daily dose is one capsule of 200 mg, three times daily while eating.
Elderly patients, patients of renal or liver injury
No studies were done on these groups and the prescribed drug is upon your doctor’s discretion.
After taking it out of the blister, the capsule should be immediately taken with a glass of water or another liquid to facilitate swallowing.
If you have taken Venosmil overdose
Take Venosmil only the way it was prescribed for you. There are signs of overdose and/or intoxication. If you take higher Venosmil dose by accident, immediately consult your doctor or pharmacist.
If you skip Venosmil use
Do not take double dose to make up for the dose you skipped. If you skipped the daily dose, take the next one the way it was prescribed by your doctor. Should you have any additional questions about the use of this drug, please ask your doctor or pharmacist.
4. Possible side effects
Just like all other drugs, this drug could cause side effects although not everybody gets them. This drug is usually well tolerated. The most frequently observed side effects are either on the digestive system (stomach ache, nausea, or on skin (rash, itching), or related to the nervous system (nausea, headache). If you observe whatever side effects that differ from the abovementioned, consult your doctor or pharmacist.
Notification of side effects
Should you get any side effects, tell your doctor or pharmacist. These include those not described in this leaflet. You could also notify us for side effects directly via the national information system.
Bulgarian Drug Agency “Damyan Gruev” Str. Nº 8 1303 Sofia
Tel.: +359 2 8903417
In the case of informing about side effects, you could contribute for getting more information about the safety of this drug.
5. How to store Venosmil
Store this drug away from the reach of children. Do not use Venosmil after the expiry date on the cardboard package and the blister after “Exp.”. The expiry date is the last day of the month in question. Do not throw away drugs in the sewage or in the municipal waste container. Ask your pharmacist for the way to destroy the drugs you no longer need. These measures will contribute for the environmental protection. Store below 30 °C.
6. Package contents and additional information Venosmil composition
Of the capsule composition – magnesium stearate.
Of the gelatine capsules: gelatine, erythrosine (E127), quinoline ye- llow (E104), titanium dioxide (E171) and purified water.
Appearance of Venosmil 200 mg and package contents
Venosmil 200 mg solid capsules are orange and they contain fine yellow powder.
Not all packages could be marketed.
Marketing Authorisation Holder and Manufacturer
FAES FARMA S.A.,
Maximo Aguirre 14,
48 940 Leioa (Vizcaya), Spain
Should you need additional information about this drug, please contact the local representative of the use permit holder.