Fortiven Gel

Package Leaflet: Information for the Patient

Fortiven Gel

1000 IU/g, gel
Sodium Heparin

Read the package 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 package leaflet for the patient or as directed by a doctor, pharmacist, or nurse.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist. If you experience any side effects, including any possible side effects not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4. If you do not feel better or feel worse after a few days, contact your doctor.

Table of Contents of the Leaflet:

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

1. What is Fortiven Gel and what is it used for

Fortiven Gel contains heparin, which has anticoagulant, anti-inflammatory, and anti-edema properties.
The medicine is intended for topical use on the skin.
Fortiven Gel is indicated for:

• treatment of superficial vein diseases: ∙phlebitis, ∙thrombophlebitis, ∙varicose veins of the lower limbs,
• edema, bruises, subcutaneous hematomas.

2. Important information before using Fortiven Gel

When not to use Fortiven Gel

• on open, bleeding, and oozing wounds, mucous membranes, and eye areas, skin lesions of unknown origin, infected skin,
• due to the presence of methylparaben and propylparaben, the medicine should not be used in people with paraben allergy,
• in patients with confirmed bleeding tendency.

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Warnings and precautions

Before starting to use Fortiven Gel, discuss it with your doctor, pharmacist, or nurse.
Prolonged use of the medicine may cause skin hypersensitivity reactions in some patients.
If skin changes occur (redness, rash, itching, burning, erythema), the medicine should be discontinued.
During treatment with the medicine, monitor the appearance of the skin.

Fortiven Gel and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to use.
Heparin used topically in the form of a gel is only slightly absorbed into the bloodstream. Due to the low concentration of heparin in plasma, interactions with other medicines are negligible.
Only in patients with bleeding tendency and in patients taking anticoagulant medicines, prolonged use of the medicine on large surfaces may enhance the anticoagulant effect, increasing the risk of bleeding. In such cases, it is recommended to monitor blood coagulation parameters.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before using this medicine.
Pregnancy
Heparin does not cross the placenta, however, during pregnancy, the medicine should be used with caution and only when necessary.
Breastfeeding
Heparin does not pass into breast milk, however, during breastfeeding, the medicine should be used with caution and only when necessary.

Driving and using machines

There are no data on the effect of the medicine on the ability to drive and use machines.

Fortiven Gel contains propylene glycol

The medicine may cause skin irritation.

Fortiven Gel contains methylparaben and propylparaben

The medicine may cause allergic reactions (possible late reactions).

How to use Fortiven Gel

This medicine should always be used exactly as described in the package leaflet for the patient or as directed by a doctor, pharmacist, or nurse. If you have any doubts, consult your doctor, pharmacist, or nurse.
The medicine is intended for topical use on the skin.
It is recommended to apply a thin layer of the gel (a strip of 3 cm to 10 cm) to the affected area, 2 to 3 times a day.
After using the medicine, wash your hands thoroughly.

Use in children

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The medicine should not be used in children due to the lack of clinical trials on the efficacy and safety of use in this patient group.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
During prolonged use of the medicine, skin allergic reactions may occur: redness, itching, rash, burning, erythema, skin inflammation.

Reporting side effects

If you experience any side effects, including any possible side effects not listed in this leaflet, tell your 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:
Aleje Jerozolimskie 181C, 02-222 Warsaw
tel.: +48 22 49 21 301, fax: +48 22 49 21 309
e-mail: ndl@urpl.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

How to store Fortiven Gel

Store in a closed, original package, at a temperature below 25°C.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the package. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Fortiven Gel contains

• The active substance of the medicine is sodium heparin. One gram of gel contains 1000 IU of sodium heparin.
• The other ingredients (excipients) are: carbomer 5984, sodium hydroxide 30%, propylene glycol, methylparaben, propylparaben, disodium edetate, polysorbate 20, rose aroma AR 0287, purified water.

What Fortiven Gel looks like and contents of the pack

The medicine is a colorless gel with a rose aroma.
The pack consists of an aluminum tube with a polyethylene cap, containing 35 g, 50 g, 100 g of gel, in a cardboard box.
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Marketing authorization holder and manufacturer

"HASCO-LEK" S.A.
51-131 Wrocław, ul. Żmigrodzka 242 E
Medicine Information
tel. (22) 742 00 22
e-mail: informacjaoleku@hasco-lek.pl

Date of last revision of the leaflet:

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