Package leaflet: Information for the patient

Rutoven 20 mg/g gel
Troxerutin (Troxerutinum)
Please read all of this leaflet carefully before using this medicine, because it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by the
doctor, pharmacist, or nurse.

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, pharmacist, or nurse. See section 4.
If your symptoms do not improve or if you feel worse, you should contact your doctor.

Contents of the leaflet:

What Rutoven is and what it is used for
Important information before using Rutoven
How to use Rutoven
Possible side effects
How to store Rutoven
Contents of the pack and other information

1. What Rutoven is and what it is used for

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

2. Important information before using Rutoven

When not to use Rutoven

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

Warnings and precautions
Before starting to use Rutoven, consult your doctor, pharmacist, or nurse.
Do not apply to damaged skin.
Children
The safety of use in children has not been established. Consult a doctor before using this medicine in children.
Rutoven and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
There is no data available regarding interactions with other medicines.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult a doctor or pharmacist before using this medicine.
Due to lack of data confirming safety of use, Rutoven is not recommended during pregnancy and breastfeeding.
Driving and operating machinery
Rutoven has no effect on the ability to drive and operate machinery.
Rutoven contains ethyl parahydroxybenzoate and bronopol
This medicine contains ethyl parahydroxybenzoate and may therefore cause allergic reactions (including delayed-type reactions). The medicine also contains bronopol, which may cause local skin irritation (contact dermatitis) in sensitive individuals.

3. How to use Rutoven

Apply the medicine to the skin.
Apply a thin layer of the gel to the affected skin areas suffering from symptoms related to
venous insufficiency, such as swelling, heaviness, and tingling sensations. Gently massage until
completely absorbed. Use 3 times daily for a period of 2–3 weeks.
If you feel the effect of the medicine is too strong or too weak, consult your doctor.
Using more Rutoven than recommended
There is no information available regarding overdose of this medicine.
If you forget to use Rutoven
Do not apply a double dose to make up for the missed application.
Continue treatment according to the previously established schedule.
Stopping the use of Rutoven
If you have any further questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
In sensitive individuals, skin redness or urticaria may occur.
Other adverse reactions may occur in some people during treatment with Rutoven.
Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed
in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions
can be reported directly to the Department of Monitoring of Adverse Reactions of 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 adverse reactions, additional information on the safety of the medicine can be collected.

5. How to store Rutoven

Do not store above 25°C.
Keep the medicine in a place invisible and inaccessible to children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month.
Do not use the medicine more than six months after opening the tube.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. Such measures help protect the environment.

6. Contents of the packaging and other information

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

What Rutoven looks like and contents of the pack
Rutoven is a gel.
Available pack: an aluminium tube containing 30 g of gel, in a cardboard box.

Marketing Authorisation Holder and Manufacturer
Poznańskie Zakłady Zielarskie „Herbapol” S.A.
Towarowa 47/51, 61-896 Poznań, Poland
tel. + 48 61 886 18 00, fax + 48 61 853 60 58