Package leaflet: Information for the user

Venolan, 300 mg, hard capsules
Troxerutinum
Please read all of this leaflet carefully before taking this medicine because it contains
important information for you.
This medicine should always be used exactly as described in this patient leaflet or as directed
by your doctor or pharmacist.

Keep this leaflet so that you can read it again if necessary.
If you need advice or further information, please consult your pharmacist.
If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement or if you feel worse, contact your doctor.

Leaflet contents

What Venolan is and what it is used for
Important information before taking Venolan
How to take Venolan
Possible side effects
How to store Venolan
Contents of the pack and other information

1. What Venolan is and what it is used for
Troxerutin, the active substance in Venolan, has a protective effect on blood vessels.
Venolan is used for the treatment of the following disorders and conditions:

disorders of venous and lymphatic circulation;
post-thrombotic syndromes;
phlebitis of the lower limbs;
varicose veins of the lower limbs;
venous edema;
leg ulcers;
increased capillary permeability;
tendency to petechiae and hemorrhages.

2. Important information before taking Venolan

When not to take Venolan
Do not take this medicine if you are allergic to troxerutin or to any of the other ingredients of this medicine (listed in section 6). Allergic reactions may include rash, itching, swelling of the face, lips, tongue, or shortness of breath (if such symptoms occur, contact your doctor immediately).
Warnings and precautions
This medicine should not be used in children.
Patients who have ankle swelling due to heart, liver, or kidney disease should not use Venolan, as the expected therapeutic effect may not occur.
Venolan with other medicines
Tell your doctor or pharmacist if you are currently taking, have recently taken, or plan to take any other medicines.
No adverse interactions of Venolan with other medicines have been reported.
Venolan with food and drink
It is best to take this medicine after a meal.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, you should consult your doctor before using this medicine.
Venolan is not recommended during pregnancy.
It is not known whether Venolan passes into breast milk. Women who are breastfeeding should not use Venolan.
Driving and using machines
There is no data available on the adverse effects of Venolan on the ability to drive or operate machinery. If in doubt, consult your doctor or pharmacist.

3. How to use Venolan

This medicine should always be taken exactly as described in this patient information leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

The usual dose is one capsule (300 mg) two or three times daily, taken after meals.
The maintenance dose is one capsule (300 mg) daily, taken after a meal.

Venolan is for oral use. The capsule should be swallowed whole with water.

If you feel the effect of this medicine is too strong or too weak, consult your doctor.

Taking more Venolan than you should
In case of overdose, seek medical advice immediately. Show the doctor the packaging of the capsules.

If you forget to take Venolan
Take the next dose at your regular scheduled time.
Do not take a double dose to make up for a missed dose.

Stopping Venolan treatment
Treatment of disorders and diseases for which Venolan is used is long-term. Do not stop treatment without consulting your doctor, even if you feel better.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicinal product can cause adverse reactions, although not everybody will experience them.
Venolan is generally a well-tolerated medicine. Adverse reactions, if they occur, are mild and transient.
Rarely observed (less frequently than in 1 out of 1,000 treated patients):
Nausea – subsides if the medicine is taken during a meal; abdominal distension, abdominal pain, urticaria, facial flushing, photosensitivity, headache.
If any of the above symptoms occur, discontinue the medicine and consult a physician.

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse reactions not listed in this leaflet, inform a physician or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl

Adverse reactions may also be reported to the Marketing Authorisation Holder.
Reporting adverse reactions enables better assessment of the safety profile of the medicine.

5. How to store Venolan

Store below 25°C.
Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "EXP".
The expiry date refers to the last day of the stated month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Venolan contains

The active substance is troxerutin. Each hard capsule contains 300 mg of troxerutin.
The other ingredients are: povidone K-25, talc, magnesium stearate, titanium dioxide (E 171), red iron oxide (E 172), yellow iron oxide (E 172), gelatin.

What Venolan looks like and contents of the pack
Hard, elongated pink-brown capsules. The granulate inside the capsule is yellow.
Venolan is packed into blisters made of Aluminium/PVC/PE-PVDC foil, placed in a
cardboard box. Each box contains 25 or 50 capsules.

Marketing Authorisation Holder and Manufacturer
GEDEON RICHTER POLSKA Sp. z o.o.
ul. Ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki
Poland
Tel.: (22) 755 50 81

For further information about this medicine, please contact:
GEDEON RICHTER POLSKA Sp. z o.o.
Medical Department
ul. Ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki
Tel. +48 (22) 755 96 48
[email protected]

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