Fortiven Activ Gel

Package Leaflet: Information for the Patient

FORTIVEN ACTIV GEL, 2400 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 or pharmacist.

• This leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement or the patient feels worse after a few days, they should contact their doctor.

Table of Contents of the Leaflet

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

1. What is FORTIVEN ACTIV GEL and what is it used for

FORTIVEN ACTIV GEL contains heparin, which has anti-coagulant, anti-inflammatory, and anti-edema properties.
The medicine is intended for topical use on the skin.
FORTIVEN ACTIV GEL is indicated for supportive local treatment of:

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

2. Important information before using FORTIVEN ACTIV GEL

When not to use FORTIVEN ACTIV GEL:

• if the patient is allergic to heparin or any of the other ingredients of this medicine (listed in section 6),
• on open, bleeding, and oozing wounds, mucous membranes, and eye areas, skin lesions of unknown origin, infected skin.

Warnings and precautions

Before starting to use FORTIVEN ACTIV GEL, the patient should discuss it with their doctor or pharmacist.
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Care should be taken in patients with a known bleeding tendency (predisposition to bleeding).
Prolonged use of the medicine may cause skin hypersensitivity reactions in some patients.
If skin changes (redness, rash, itching, burning, erythema) occur, the medicine should be discontinued.
The appearance of the skin should be monitored during the use of the medicine.

Children

FORTIVEN ACTIV GEL should not be used in children due to the lack of clinical trials regarding the efficacy and safety of use in this patient group.

FORTIVEN ACTIV GEL and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Heparin used topically in the form of a gel is only slightly absorbed into the bloodstream. Due to the low concentration of heparin in the serum, interactions with other medicines are negligible.
Only in patients with a 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, breastfeeding, and fertility

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.
Heparin does not cross the placenta and is not excreted into breast milk; however, during pregnancy and breastfeeding, the medicine should be used with caution and only in cases of clear necessity.

Driving and using machines

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

FORTIVEN ACTIV GEL contains 200 mg of propylene glycol in 1 g of gel.

Propylene glycol may cause skin irritation.

3. How to use FORTIVEN ACTIV GEL

This medicine should always be used exactly as described in the package leaflet for the patient or as directed by a doctor or pharmacist. In case of doubts, the patient should consult their doctor or pharmacist.
The medicine is intended for topical use on the skin.

Treatment duration

Depending on the disappearance of disease symptoms, the treatment period is up to 14 days.
Adults and children over 12 years of age: apply a thin layer of gel to the affected area. Use 1 to 3 times a day.
After applying the medicine, wash your hands thoroughly.

Use in children

The medicine should not be used in children due to the lack of clinical trials regarding the efficacy and safety of use in this patient group.
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Using a higher dose of FORTIVEN ACTIV GEL than recommended

In the case of topical use of heparin-containing medicines, there are no known cases of overdose.
If a higher dose of the medicine is used than recommended, the patient should immediately contact their doctor.

Missing a dose of FORTIVEN ACTIV GEL

A double dose should not be used to make up for a missed dose.
In case of any further doubts about the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

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

Reporting side effects

If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their 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, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be gathered on the safety of the medicine.

5. How to store FORTIVEN ACTIV GEL

Store in a closed, original package, at a temperature below 25°C.
The shelf life after first opening the tube is 6 months.
The medicine should be stored out of 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 stated.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What FORTIVEN ACTIV GEL contains

• The active substance of the medicine is sodium heparin. One gram of gel contains 2400 IU of sodium heparin.

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• The other ingredients (excipients) are: carbomer 5984 EP, sodium hydroxide 30%, disodium edetate, propylene glycol, polysorbate 20, Alodora Vera fragrance composition, purified water.

What FORTIVEN ACTIV GEL looks like and contents of the pack

FORTIVEN ACTIV GEL is a colorless (allowable opalescence) gel with a characteristic fragrance of the Alodora Vera fragrance composition.
The package consists of an aluminum tube with a membrane closed with a polyethylene cap, containing 30 g, 50 g, or 100 g of gel, in a cardboard box.

Marketing authorization holder and manufacturer

“PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK” S.A.
51-131 Wrocław, ul. Żmigrodzka 242 E
Information about the medicine
phone: (22) 742 00 22
e-mail: [email protected]

Date of the last update of the leaflet:

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