Fortiven gel
Poland
Table of Contents
Patient Information Leaflet
Fortiven Gel
1000 IU/g, gel
Heparinum natricum
Please read all of this leaflet carefully before using this medicine, because 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, pharmacist, or nurse.
- 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, pharmacist, or nurse. See section 4. If there is no improvement after a few days, or if you feel worse, contact your doctor.
Contents of the leaflet:
- 1. What Fortiven Gel is and what it is used for
- 2. Important information before using Fortiven Gel
- 3. How to use Fortiven Gel
- Possible side effects
- 5. How to store Fortiven Gel
- Contents of the pack and other information
1. What Fortiven Gel is and what it is used for
Fortiven Gel contains heparin, which has anticoagulant, anti-inflammatory, and anti-edematous properties.
The medicine is intended for topical application to the skin.
Fortiven Gel is indicated for:
- supportive treatment of superficial venous disorders:
∙ phlebitis,
∙ thrombophlebitis,
∙ varicose veins of the lower limbs, - oedema, contusions, subcutaneous haematomas.
2. Important information before using Fortiven Gel
When not to use Fortiven Gel
- if the patient is allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6),
- on open, bleeding, or oozing wounds, mucous membranes, and around the eyes; for skin lesions of unknown origin or infected skin,
- due to the presence of methyl and propyl parahydroxybenzoate, this medicine should not be used in individuals with known allergy to parabens,
- in patients diagnosed with bleeding disorders.
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Warnings and precautions
Before starting to use Fortiven Gel, consult 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), discontinue use of the medicine.
During treatment, monitor the appearance of the skin.
Fortiven Gel and other medicines
Inform your doctor or pharmacist about all medicines currently used, recently taken, or planned to be used.
Topically applied heparin in gel form is only minimally absorbed into the bloodstream. Due to low plasma heparin concentrations, interactions with other medicines are negligible.
However, in patients with bleeding disorders or those taking anticoagulant medicines, prolonged application over large skin areas may enhance anticoagulant effects, increasing the risk of bleeding. In such cases, blood coagulation parameters should be monitored.
Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.
Pregnancy
Heparin does not cross the placenta; however, during pregnancy, the medicine should be used cautiously and only when clearly necessary.
Breastfeeding
Heparin does not pass into breast milk; however, during breastfeeding, the medicine should be used cautiously and only when clearly necessary.
Driving and operating machinery
There are no data available regarding the effect of the medicine on the ability to drive or operate machinery.
Fortiven Gel contains propylene glycol
The medicine may cause skin irritation.
Fortiven Gel contains methyl parahydroxybenzoate and propyl parahydroxybenzoate
The medicine may cause allergic reactions (including delayed-type reactions).
How to use Fortiven Gel
This medicine should always be used exactly as described in the patient leaflet or as directed by a doctor, pharmacist, or nurse. If in doubt, consult a doctor, pharmacist, or nurse.
This medicine is intended for topical application to the skin.
It is recommended to apply a thin layer of gel (a strip 3 to 10 cm long) evenly to the affected area, 2 to 3 times daily.
After application, hands should be washed thoroughly.
Use in children
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Fortiven Gel should not be used in children due to lack of clinical data on efficacy and safety in this patient group.
4. Possible adverse reactions
Like any medicine, this product may cause adverse reactions, although not everyone experiences them.
During prolonged use of the medicine, skin allergic reactions may occur: redness,
itching, rash, burning sensation, erythema, inflammatory skin conditions.
Reporting adverse reactions
If any adverse symptoms occur, including any possible 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:
Aleje Jerozolimskie 181C, 02 - 222 Warsaw
tel.: + 48 22 49 21 301, fax: + 48 22 49 21 309
e-mail: [email protected]
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to gather further information on the safety of the medicine.
How to store Fortiven Gel
Store in a closed, original container, at a temperature below 25°C.
Keep the medicine out of 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 will help protect the environment.
6. Contents of the packaging and other information
What Fortiven Gel contains
- The active substance 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, methyl parahydroxybenzoate, propyl parahydroxybenzoate, disodium edetate, polysorbate 20, rose aroma AR 0287, purified water.
What Fortiven Gel looks like and contents of the pack
The medicine is a colourless gel with a rose scent.
The medicine is packed in an aluminium tube with a polyethylene cap, containing 35 g, 50 g, or 100 g of gel, placed in a cardboard box.
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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
email: [email protected]
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