Venolan

Package Leaflet: Information for the Patient

Venolan, 300 mg, Hard Capsules

Troxerutin

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in this package leaflet for the patient or as directed by a doctor or pharmacist.

• Keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement or the patient feels worse, they should contact their doctor.

Table of Contents of the Leaflet

• 1. What is Venolan and what is it used for
• 2. Important information before taking Venolan
• 3. How to take Venolan
• 4. Possible side effects
• 5. How to store Venolan
• 6. Contents of the pack and other information

1. What is Venolan and what is it used for

Troxerutin, the active substance of Venolan, has a protective effect on blood vessels.

Venolan is used to treat the following diseases and conditions:

• venous and lymphatic circulation disorders;
• post-thrombotic syndrome;
• phlebitis of the lower limbs;
• varicose veins of the lower limbs;
• edema of venous origin;
• ulcers of the lower legs;
• increased permeability of capillaries;
• tendency to bruising and bleeding.

2. Important information before taking Venolan

When not to take Venolan

If the patient is allergic to troxerutin or any of the other ingredients of this medicine (listed in section 6). Allergy may manifest as a rash, itching, swelling of the face, lips, tongue, or difficulty breathing (if such symptoms occur, the patient should immediately contact their doctor).

Warnings and precautions

The medicine should not be taken by children.
Patients with edema in the ankle area caused by heart, liver, or kidney disease should not take Venolan, as the expected therapeutic effect may not occur.

Venolan and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
No adverse effects of Venolan have been found in combination with other medicines.

Venolan with food and drink

The medicine is best taken after a meal.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor before taking this medicine.
Venolan is not recommended during pregnancy.
It is not known whether Venolan passes into breast milk. Breastfeeding women should not take Venolan.

Driving and using machines

There is no data on the adverse effects of Venolan on the ability to drive and use machines. If necessary, the patient should consult their doctor or pharmacist.

3. How to take Venolan

This medicine should always be taken exactly as described in this package leaflet for the patient or as directed by a doctor or pharmacist. In case of doubt, the patient should consult their doctor or pharmacist.
Usually, the recommended dose is one capsule (300 mg) two or three times a day, after meals.
The maintenance dose is one capsule (300 mg) per day after a meal.
Venolan is taken orally. The capsule should be swallowed whole, with water.
If the patient feels that the effect of the medicine is too strong or too weak, they should consult their doctor.

Taking a higher dose of Venolan than recommended

In case of taking a higher dose of the medicine than recommended, the patient should immediately consult their doctor. They should show the doctor the package with the capsules.

Missing a dose of Venolan

The next dose should be taken at the scheduled time.
A double dose should not be taken to make up for a missed dose.

Stopping Venolan treatment

Treatment of disorders and diseases for which Venolan is used is long-term. The patient should not stop treatment without consulting their doctor, even if they feel better.
In case of any further doubts about taking this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Venolan can cause side effects, although not everybody gets them.
Venolan is generally well-tolerated. Side effects, if they occur, are mild and transient.
Rare side effects (less than 1 in 1,000 treated patients):
Nausea - transient if the medicine is taken during meals; bloating, abdominal pain, hives, facial flushing, hypersensitivity to light, headaches.
If the patient experiences any of these symptoms, they should stop taking the medicine and consult their doctor.

Reporting side effects

If the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of 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
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Venolan

Store in a temperature below 25°C.
The medicine should be stored 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 month stated.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Venolan contains

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

What Venolan looks like and contents of the pack

Hard capsules, elongated, pink-brown in color. The granulate in the capsule is yellow in color.
Venolan is packaged in blisters of aluminum/PVC/PE-PVDC foil placed in a cardboard box. The box contains 25 or 50 capsules.

Marketing authorization holder and manufacturer

GEDEON RICHTER POLSKA Sp. z o.o.
ul. Ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki
Poland
phone: (22) 755 50 81
To obtain more detailed information about this medicine, the patient should contact:
GEDEON RICHTER POLSKA Sp. z o.o.
Medical Department
ul. Ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki
Phone: +48 (22)755 96 48
[email protected]

Date of last revision of the leaflet:

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