Package leaflet: Information for the user

HEMOVASAL 1% Cream

(sodium heparan sulfate salt)
Please read this leaflet carefully before using this medicine because it contains important information for you.
Use this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you.

Keep this leaflet. You may need to read it again.
If you need further information or advice, consult your pharmacist.
If you experience any of the side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Contact your doctor if you do not notice improvement or if you notice worsening of symptoms after a short period of treatment.

Contents of this leaflet:

What HEMOVASAL is and what it is used for
What you need to know before using HEMOVASAL
How to use HEMOVASAL
Possible side effects
How to store HEMOVASAL
Package contents and other information

1. What HEMOVASAL is and what it is used for

Hemovasal 1% cream is a topical vasoprotective medicinal product (protects blood vessels).
Hemovasal 1% cream is used to treat symptoms due to venous insufficiency (poor blood return towards the heart), in conditions of capillary fragility, in minor trauma (e.g. sprains, contusions), and for the treatment of haematomas (bruises).
Consult your doctor if you do not feel better or if you feel worse after a short period of treatment.

2. What you need to know before using HEMOVASAL

Do not use HEMOVASAL

If you are allergic to heparan sulfate or to any of the other ingredients of this medicine (listed in section 6).
Hypersensitivity to substances similar to heparan sulfate.
Hemovasal 1% cream must not be applied to open skin lesions (wounds), mucous membranes, or sites of infection in case of suppurative processes (pus formation).

Warnings and precautions
The use of Hemovasal 1% cream during haemorrhagic events (significant bleeding),
even if occurring at sites different from the application area, should be carefully evaluated.
Prolonged or extensive use may lead to local irritative or sensitization phenomena; in such cases,
discontinue treatment and consult your doctor.
Use Hemovasal only after consulting your doctor if you have had allergic reactions to substances similar
to heparan sulfate, even if such events occurred in the past.
Talk to your doctor or pharmacist before using HEMOVASAL.
Children and adolescents
Do not use Hemovasal in children and adolescents.
Other medicines and HEMOVASAL
No interactions with other medicines have been reported.
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicines.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or are breastfeeding,
consult your doctor or pharmacist before using this medicine.
During pregnancy, use Hemovasal 1% cream only when strictly necessary and under medical supervision.
Driving and using machines
Hemovasal 1% cream does not affect the ability to drive or operate machinery.
HEMOVASAL contains parahydroxybenzoates and cetyl stearyl alcohol
Hemovasal 1% cream contains parahydroxybenzoates which may cause allergic reactions (including delayed reactions).
It also contains cetyl stearyl alcohol, which may cause local skin reactions (e.g. contact dermatitis).

3. How to use HEMOVASAL

Use this medicine exactly as stated in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is 2–3 applications per day.
Hemovasal 1% cream can be applied at any time of day.
Warning: Use Hemovasal 1% cream only for short treatment periods.
Hemovasal 1% cream should be applied in sufficient quantity to cover the entire affected area.
If you use more HEMOVASAL than you should
In case of accidental ingestion/overdose of Hemovasal 1% cream, contact your doctor immediately or go to the nearest hospital.
If you forget to use HEMOVASAL
Do not use a double dose to make up for the missed dose.
If you stop using HEMOVASAL
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
A case of urticarial reaction (itchy skin swellings) probably related to the drug has been reported, which rapidly improved upon discontinuation of treatment.
Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the website http://agenziafarmaco.gov.it/it/responsabili.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store HEMOVASAL

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of that month.
The expiry date applies to the product if it is stored unopened and correctly preserved.
It is important to always keep the information about the medicine available; therefore, keep both the packaging and the leaflet.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What HEMOVASAL contains

The active substance is heparan sulfate sodium salt. 100 grams of cream contain 1 gram of heparan sulfate sodium salt.
The other ingredients are glyceryl monostearate, decyl oleate, cetylstearyl alcohol, polyethylene glycol ether of fatty alcohols, methyl p-hydroxybenzoate (E 218), propyl p-hydroxybenzoate (E 216), neroli essence, purified water.

Description of the appearance of HEMOVASAL and package contents
Hemovasal 1% cream is a cream for cutaneous use.
The package contains one 30 g tube of cream.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder: FAR.G.IM. S.p.A., Via Cervignano, 29 - 95129 Catania.
Manufacturer: Doppel Farmaceutici S.r.l., Via Martiri delle Foibe, 1 – 29016 Cortemaggiore (Piacenza).