Troxerutin chema

Package leaflet: Information for the patient

TROXERUTIN CHEMA 20 mg/g, gel
(Troxerutinum)
Please read all of this leaflet carefully before using the medicine, because it contains
important information for the patient.
This medicine should always be used exactly as described in the patient leaflet or as
advised by the 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 your symptoms do not improve or if you feel worse, consult your doctor.

Contents of the leaflet:

1. What Troxerutin Chema is and what it is used for
2. Important information before using Troxerutin Chema
3. How to use Troxerutin Chema
4. Possible side effects
5. How to store Troxerutin Chema
6. Contents of the pack and other information

1. What Troxerutin Chema is and what it is used for

Troxerutin Chema is a gel formulation.
It is intended for topical use only.
The active substance in Troxerutin Chema gel is troxerutin, which belongs to the group of bioflavonoids.
Indications
Troxerutin Chema is indicated for topical application to the skin in painful and swollen legs caused by chronic venous insufficiency and its symptoms such as: sensation of "heavy legs" and lower limb pain, lower limb swelling, varicose veins of the calf.

2. Important information before using Troxerutin Chema

When not to use Troxerutin Chema:

• if the patient is allergic to troxerutin or to any of the other ingredients of this medicine (listed in section 6);
• on mucous membranes and open wounds.

Warnings and precautions
Do not apply to mucous membranes and open wounds.
This medicine should not be used in children.
Troxerutin Chema 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 use.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she might be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.
Troxerutin Chema should not be used during the first trimester of pregnancy unless, in the opinion of the doctor, the benefits outweigh the possible risk to the fetus.
Driving and operating machinery
Troxerutin Chema has no effect on the ability to drive or operate machinery.

3. How to use Troxerutin Chema

Troxerutin Chema is intended for topical use on the skin.
This medicine should always be used exactly as described in the patient information leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Unless otherwise advised by a physician, apply a thin layer of the gel twice daily to the affected area of skin and gently massage in until completely absorbed.
After applying the medicine, wash your hands.
Use of a higher than recommended dose of Troxerutin Chema
Symptoms of overdose are not known when the medicine is used according to the instructions and recommended method of use.
Missed application of Troxerutin Chema
If a dose is missed, continue treatment as usual by applying the gel to the skin in the same amount as before.
Do not apply a double amount to make up for a missed dose.
Stopping use of Troxerutin Chema
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 medicine can cause adverse reactions, although not everybody will experience them.
When troxerutin is applied topically, adverse reactions occur very rarely. Skin redness and urticaria may occur.
Reporting of adverse reactions
If any adverse symptoms occur, including any adverse effects not listed in the leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
{current address, telephone and fax numbers of the above Department}
e-mail: [email protected]
Reporting adverse reactions enables further information on the safety of the medicine to be collected.

5. How to store Troxerutin Chema

Store below 25°C. Do not freeze.
Keep the medicine out of sight and reach of children.
Pay attention to the expiry date of the medicine.
Do not use this medicine after the expiry date stated on the tube. The expiry date refers to the last day of the stated month.
Medicines must 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 Troxerutin Chema contains

• The active substance is troxerutin. 1 g of gel contains 20 mg of troxerutin.
• Other components: macrogol glycerol ricinoleate, carbomer, tromethamine, glycerol, disodium edetate, ethanol 96%, purified water.

What Troxerutin Chema looks like and contents of the pack
Troxerutin Chema is a yellow, yellow-orange or yellow-green translucent gel.
The gel is packed in a lacquered aluminium tube with a PE or PP cap, together with the patient leaflet, placed in a cardboard box containing 30 g of gel.

Marketing Authorisation Holder and Manufacturer
CHEMA-ELEKTROMET
Labour Cooperative
Przemysłowa 9 Street
35-105 Rzeszów
Phone: +48 17 862 05 90
E-mail: [email protected]