Venosmil 200mg 20 Capsules

1. What is Venosmil and what is it 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 occurs:

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

Consult your doctor or pharmacist before taking Venosmil.

Venosmil should not be used for treating oedema caused by cardiac, renal or liver insufficiency. In this case treatment should be targeted at the main cause.

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 have recently taken other drugs, including ones purchased without a doctor’s prescription. No incompatibility with other drugs has been observed.

Children and adolescents

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 until the third month of pregnancy unless the benefit outweighs the risk.

Driving and operating machines

No studies were done on the effects on the ability to drive and operate machines. Hidrosmin is very unlikely to have an effect on your ability to drive or operate machines.

3. How to take Venosmil

Always take this drug exactly as recommended by your doctor or pharmacist. Talk to your doctor or pharmacist should you have any questions.

Adults:

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 have been done on these groups and the dosage relies upon your doctor’s discretion.

Use

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 in excessive amounts

Only take Venosmil the way it has been prescribed for you. There are signs of overdose and/or intoxication. If you take a higher Venosmil dose by accident, immediately consult your doctor or pharmacist.

If you skip a dose of Venosmil

Do not take a double dose to make up for the dose you skipped. If you skipped the daily dose, take the next one the way it has been 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 of the digestive system (stomach ache, nausea, or on skin (rash, itching), or related to the nervous system (nausea, headache). If you observe any side effects that differ from the abovementioned, consult your doctor or pharmacist.

Reporting side effects

Should you experience any side effects, tell your doctor or pharmacist. These include ones not described in this leaflet. You could also notify us for side effects directly via the national information system.

In the case of informing about side effects, you could contribute to gathering 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 stated on the cardboard package and the blister after “Exp.”. The expiry date refers to 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 dispose of drugs you no longer need. These measures will contribute to the environmental protection. Store below 30 °C.

6. Package contents and additional information 

The active ingredient is Hidrosmin; each capsule contains 200 mg hidrosmin.

The other ingredients are:

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.

The medicinal product is offered in blisters of OPA/A1/PVC-foil and AL-foil, 10 capsules in each blister; two or six blisters in a box.

Not all packages can be marketed.

Marketing Authorisation Holder and Manufacturer

FAES FARMA S.A.