TROXEVASIN DUO gel 45g
TROXEVAZINE DUO gel 45 g ACTAVIS
Leaflet: user information
Troxevasin Duo 30 mg/20 mg/g gel
Troxevasin Duo 30 mg/20 mg/g gel
indomethacin/troxerutin
(indomethacin/troxerutin)
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.
Keep this leaflet. You may need to read it again.
If you need further information or advice, ask your pharmacist.
If you get any side effects, tell your doctor or pharmacist. This also includes any possible side effects not described in this leaflet. See point 4.
If after 5-7 days you do not feel better or your condition worsens, you should seek medical help.
What this leaflet contains
1. What Troxevasin Duo gel is and what it is used for
2. What you need to know before you use Troxevasin
3. How to use Troxevasin Duo gel
4. Possible side effects
5. How to store Troxevasin Duo gel
6. Contents of the package and additional information
1. What Troxevasin Duo gel is and what it is used for
Troxevasin Duo is a combined medicinal product containing indomethacin and troxerutin. Indomethacin has pronounced anti-inflammatory, anti-rheumatic and anti-edematous properties. Troxerutin reduces the increased permeability of capillaries and strengthens the venous walls. After rubbing, the gel easily penetrates the skin and subcutaneous tissues, reducing inflammation and pain.
Troxevasin Duo gel is used for symptomatic treatment of:
• manifestations of chronic venous insufficiency (varicose veins) - edema, pain and heaviness in the legs;
• superficial thrombophlebitis, phlebitis; post-phlebitic conditions;
• in the complex treatment of hemorrhoidal disease;
• rheumatism of the soft tissues: tendovaginitis, bursitis, fibrositis, periatritis;
• post-operative swelling, contusions, strains, sprains.
If after 5-7 days you do not feel better or your condition worsens, you should seek medical help.
2. What you need to know before using Troxevasin Duo gel
Do not use Troxevasin Duo gel:
• if you are allergic to indomethacin, troxerutin or any of the other ingredients of
this medicine (listed in section 6).
• in case of allergy to NSAIDs (non-steroidal anti-inflammatory drugs).
• on open wounds, mucous membranes, around the oral cavity and eyes.
Warnings and precautions
It is not recommended to use the product in persons with a past or proven allergy to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs, bronchial asthma, allergic rhinitis or other allergic manifestations.
Long-term application of the product, especially on large skin areas, should be avoided in active ulcer disease, severe liver and kidney diseases, due to the risk of reaching high concentrations of the active substances in the blood.
If the duration of treatment exceeds 10 days, laboratory control of the blood count (number of leukocytes and platelets) is necessary.
Children and adolescents
It is not recommended for use in children under 14 years of age due to a lack of sufficient clinical experience.
Other drugs and Troxevasin Duo
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
Concomitant administration with corticosteroids is not recommended due to an increased tendency to develop ulcers in the gastrointestinal tract.
Troxevasin Duo gel with food, drink and alcohol
There is no indication of the need for a special diet or restrictions on certain types of food and drink during treatment with this product.
Pregnancy, lactation and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before using this medicine.
Due to insufficient data, its use in pregnant women and during breastfeeding is not recommended, except after a benefit/risk ratio assessment by the doctor.
Driving and using machines
It does not affect the ability to drive and operate machinery.
Troxevasin Duo gel contains sodium benzoate and dimethylsulfoxide
Sodium benzoate in the composition of the product is a moderate irritant for the skin, eyes and mucous membranes.
Dimethylsulfoxide as an excipient may cause skin irritation.
3. How to use Troxevasin Duo gel
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
The product is intended for external application on undamaged skin.
It is applied 3-4 times a day by gently rubbing a thin layer on the affected area. The amount sufficient for one treatment is about 4-5 cm of gel. The total daily amount should not exceed 20 cm.
The duration of treatment should not exceed 10 days.
Use in children and adolescents
This medicinal product is not recommended for children under 14 years of age. Their safety and effectiveness have not been proven.
If you have used more than the required dose of Troxevasin Duo gel
There are no data on cases of overdose with local application of the product.
In case of ingestion, burning in the oral cavity, salivation, nausea, vomiting may occur.
Measures in case of ingestion - rinsing the oral cavity and stomach, if necessary symptomatic treatment.
If it gets into the eyes, on mucous membranes or open wounds, local irritation is observed - tearing, redness, burning, pain.
Measures - abundant washing of the affected area with water or physiological solution until disappearance or reduction of complaints.
If you forget to use Troxevasin Duo gel
If you have missed one application, use the product at the time of the next regular intake without increasing the dose.
If you have any further questions related to the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The tolerability of the product is generally very good.
Local reactions (at the site of application)
Skin and subcutaneous tissue disorders - contact dermatitis, itching, redness, skin rashes, feeling of warmth and burning at the application site.
Systemic (general) reactions
In exceptional cases, with long-term application on large areas of the body, the appearance of systemic adverse drug reactions is possible:
Gastrointestinal disorders, nausea, heaviness and bloating after eating, abdominal pain, increase in liver enzymes.
Immune system disorders: hypersensitivity reactions (anaphylaxis, asthma attack, angioedema).
Reporting adverse reactions
If you get any side effects, tell your doctor or pharmacist. This includes all possible side effects not described in this leaflet. You can also report adverse reactions directly through the Medicines Executive Agency, 8 Damyan Gruev Street, 1303 Sofia, phone: 02 8903417, website: www.bda.bg. By reporting side effects, you can contribute to getting more information about the safety of this medicine.
5. How to store Troxevasin Duo gel
To be stored below 25°C.
Keep out of the reach of children.
Do not use Troxevasin Duo gel after the expiry date marked on the carton. The expiration date corresponds to the last day of the specified month.
Shelf life after first opening the package: 6 months
Do not dispose of medicines down the drain or in the household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.
6. Contents of the package and additional information
What Troxevasin Duo gel contains
The active substances are indomethacin and troxerutin. 1 g of gel contains 30 mg of indomethacin and 20 mg of troxerutin.
The other ingredients are: carbomer, disodium edetate, sodium benzoate (E 211), macrogol 400, isopropyl alcohol, dimethyl sulfoxide, aromatic composition (Fresco BM & GD R.08.0932.1), purified water.
What Troxevasin Duo gel looks like and what the package contains
Troxevasin Duo gel is a yellow or yellow-brown gel mass with a uniform consistency. Each 45 g gel in a membrane aluminum tube. 1 tube in a cardboard box together with a leaflet.
License holder
Actavis EAD
29 Atanas Dukov St
1407 Sofia, Bulgaria
Manufacturer
Balkanpharma-Troyan AD, "Krayrechna" St. No. 1 5600 Troyan, Bulgaria
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