Fortiven activ gel
Poland
Table of Contents
Patient Information Leaflet
FORTIVEN ACTIV GEL, 2400 IU/g, gel
Sodium Heparin
Please read this leaflet carefully before using this medicine, as it contains important information for you.
This medicine should always be used exactly as described in this patient leaflet or as directed by your 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 side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.
- If there is no improvement after a few days, or if you feel worse, consult your doctor.
Leaflet Contents
- What FORTIVEN ACTIV GEL is and what it is used for
- Important information before using FORTIVEN ACTIV GEL
- How to use FORTIVEN ACTIV GEL
- Possible side effects
- How to store FORTIVEN ACTIV GEL
- Contents of the pack and other information
1. What FORTIVEN ACTIV GEL is and what it is used for
FORTIVEN ACTIV GEL contains heparin, which has antithrombotic, anti-inflammatory, and anti-edematous effects.
This medicine is intended for topical application to the skin.
FORTIVEN ACTIV GEL is indicated for local supportive treatment of:
- superficial venous disorders:
- thrombophlebitis,
- varicose veins of the lower limbs,
- edema, contusions, subcutaneous hematomas.
2. Information before using FORTIVEN ACTIV GEL
When not to use FORTIVEN ACTIV GEL:
- if the patient is allergic to heparin or to any of the other ingredients of this medicine (listed in section 6),
- on open, bleeding, or exuding wounds, mucous membranes, around the eyes, skin lesions of unknown origin, or infected skin.
Warnings and precautions
Before starting to use FORTIVEN ACTIV GEL, consult your doctor or pharmacist.
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Use with caution in patients with diagnosed hemorrhagic diathesis (tendency to bleed).
Prolonged use of the medicine may cause skin hypersensitivity reactions in some patients.
If skin changes occur (redness, rash, itching, burning, erythema), discontinue use of the medicine.
During treatment, monitor the appearance of the skin.
Children
FORTIVEN ACTIV GEL should not be used in children due to lack of clinical data on efficacy and safety in this patient group.
FORTIVEN ACTIV GEL and other medicines
Inform your doctor or pharmacist about all medicines currently used, recently used, or planned for use.
Heparin applied topically in gel form is only minimally absorbed into the bloodstream. Due to low plasma concentration, interactions with other medicines are negligible.
However, in patients with hemorrhagic diathesis or those taking anticoagulant medicines, prolonged use over large skin areas may enhance anticoagulant effects, increasing the risk of bleeding. In such cases, blood coagulation parameters should be monitored.
Pregnancy, breastfeeding, and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.
Heparin does not cross the placenta or pass into breast milk. Nevertheless, during pregnancy and breastfeeding, the medicine should be used cautiously and only when clearly necessary.
Driving and operating machinery
There is no data available on the effects of the medicine on the ability to drive or operate machinery.
FORTIVEN ACTIV GEL contains 200 mg of propylene glycol per 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 patient leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
This medicine is intended for topical application to the skin.
Duration of treatment
Depending on the persistence of symptoms, treatment may last up to 14 days.
Adults and children over 12 years of age: apply a thin, even layer of gel to the affected area. Apply 1 to 3 times daily.
After applying the medicine, hands should be washed thoroughly.
Use in children
This medicine should not be used in children due to lack of clinical data on efficacy and safety in this patient group.
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Use of more than the recommended dose of FORTIVEN ACTIV GEL
With topical medicines containing heparin, cases of overdose have not been reported.
If more medicine has been used than recommended, contact a doctor immediately.
Missed dose of FORTIVEN ACTIV GEL
Do not use a double dose to make up for a missed dose.
If you have any further doubts concerning the use of this medicine, consult your doctor or pharmacist.
4. Possible adverse reactions
Like all medicinal products, this medicine can cause adverse reactions, although not everybody experiences them.
During prolonged use of the medicine, skin allergic reactions may occur: redness,
itching, rash, burning, erythema, inflammatory skin conditions.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, inform your 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
Al. Jerozolimskie 181C, 02-222 Warsaw,
tel.: +48 22 49 21 301, fax: +48 22 49 21 309,
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions enables further information on the safety of the medicine to be collected.
5. How to store FORTIVEN ACTIV GEL
Keep in a tightly closed, original container, at a temperature below 25°C.
Shelf life after first opening of the tube – 6 months.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. 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 required. Such measures help protect the environment.
6. Contents of the pack and other information
What the medicine FORTIVEN ACTIV GEL contains
- The active substance 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 colourless gel (slight opalescence is acceptable) with a characteristic odour of Alodora Vera fragrance composition.
The medicine is packed in an aluminium tube with a membrane, closed with a polyethylene cap, containing 30 g, 50 g or 100 g of gel, placed in a cardboard box.
Marketing Authorisation Holder and Manufacturer
„PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK” S.A.
51-131 Wrocław, ul. Żmigrodzka 242 E
Medicine Information
tel.: (22) 742 00 22
e-mail: [email protected]
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