Rutoven

Leaflet attached to the packaging: patient information

Rutoven 20 mg/g gel

Troxerutin ( Troxerutinum)

Please read the contents of the leaflet carefully before using the medicine, as it contains important information for the patient.

This medicine should always be used exactly as described in the patient leaflet or as directed by a doctor, pharmacist, or nurse.

• Please keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, you should consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor, pharmacist, or nurse. 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 Rutoven and what is it used for
• 2. Important information before using Rutoven
• 3. How to use Rutoven
• 4. Possible side effects
• 5. How to store Rutoven
• 6. Package contents and other information

1. What is Rutoven and what is it used for

Rutoven contains troxerutin, which has a protective effect on blood vessels by maintaining their elasticity and reducing their permeability. Rutoven is used to treat chronic venous insufficiency and its symptoms, such as swelling of the legs, feeling of heaviness, tingling, etc.

2. Important information before using Rutoven

When not to use Rutoven

• -if the patient is allergic to the active substance or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before starting to use Rutoven, the patient should discuss it with their doctor, pharmacist, or nurse. Do not use on damaged skin.

Children

The safety of using Rutoven in children has not been established. Before using the medicine in children, the patient should consult a doctor.

Rutoven and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. There is no data on interactions with other medicines.

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 or pharmacist before using this medicine. Due to the lack of data confirming safety, the use of the medicine during pregnancy and breastfeeding is not recommended.

Driving and using machines

Rutoven does not affect the ability to drive or use machines.

Rutoven contains ethyl parahydroxybenzoate and bronopol

The medicine contains ethyl parahydroxybenzoate and may therefore cause allergic reactions (possible late-type reactions). The medicine also contains bronopol, which may cause local skin irritation (contact dermatitis) in sensitive individuals.

3. How to use Rutoven

The medicine should be applied to the skin. A thin layer of gel should be applied to the skin in areas affected by venous insufficiency, swelling, feeling of heaviness, tingling, etc. Massage gently until fully absorbed. Use 3 times a day for 2-3 weeks. If the patient feels that the effect of the medicine is too strong or too weak, they should consult their doctor.

Using a higher dose of Rutoven than recommended

There is no information on overdose.

Missing a dose of Rutoven

The patient should not use a double dose to make up for a missed dose. They should continue treatment according to the previously adopted schedule.

Stopping the use of Rutoven

If the patient has any further doubts about using this medicine, they should consult their doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Rutoven can cause side effects, although not everybody gets them. In sensitive individuals, skin redness, hives may occur. In some individuals, other side effects may occur during the use of Rutoven.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel. 48 22 49 21 301, fax 48 22 49 21 309, e-mail: [email protected]. By reporting side effects, more information can be gathered on the safety of the medicine.

5. How to store Rutoven

Do not store above 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. The expiry date refers to the last day of the given month. The medicine should not be used 6 months after opening the tube. Medicines should not be disposed of via wastewater or household waste containers. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Rutoven contains

The active substance of the medicine is troxerutin ( Troxerutinum) – 20 mg/g. The other ingredients (excipients) are: carbomer, sodium hydroxide, ethyl parahydroxybenzoate, bronopol, purified water.

What Rutoven looks like and what the package contains

Rutoven is a gel. The available packaging is an aluminum tube containing 30 g of gel, in a cardboard box.

Responsible entity and manufacturer

Poznańskie Zakłady Zielarskie „Herbapol” S.A. ul. Towarowa 47/51, 61-896 Poznań, Poland tel. + 48 61 886 18 00, fax + 48 61 853 60 58 Date of last update of the leaflet: