Package leaflet: Information for the patient

PROVENAL 250 ULS soft capsules

Sulodexide
Equivalent medicine
Please read this leaflet carefully before taking this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it could be harmful.
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Provenal is and what it is used for
What you need to know before taking Provenal
How to take Provenal
Possible side effects
How to store Provenal
Contents of the pack and other information

1. What Provenal is and what it is used for

The active substance in Provenal is Sulodexide, which belongs to the therapeutic category of antithrombotic agents, heparinics; this substance prevents the formation of blood clots in blood vessels (both in arteries and veins).
Provenal is used to treat chronic venous ulcers.

2. What you should know before taking Provenal

Do not take Provenal

if you are allergic to sulodexide, heparin, or heparinoids (medicines used to slow down or stop blood clotting), or to any of the other ingredients of this medicine (listed in section 6);
if you have haemorrhagic diseases (conditions involving bleeding);
if you have a tendency to bleed (haemorrhagic diathesis).

Warnings and precautions
Talk to your doctor or pharmacist before taking Provenal.
Inform your doctor if you are being treated with other anticoagulants (medicines that make the blood thinner), as they may excessively increase the effects of this medicine. In such cases, your doctor may consider it necessary to periodically monitor blood clotting parameters.
If you are pregnant, inform your doctor, as the use of Provenal is not recommended (see section “Pregnancy and breastfeeding”).
Other medicines and Provenal
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Taking multiple medicines that thin the blood at the same time, such as heparin or oral anticoagulants, may excessively increase the effects of Provenal.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
As a precautionary measure, you should not take this medicine during pregnancy, even though studies on its fetal toxicity have not shown any risks.
Driving and using machines
This medicine does not affect the ability to drive or operate machinery.
Provenal contains sodium p-hydroxybenzoate in the soft capsule shell.
These may cause allergic reactions (including delayed reactions).
Provenal contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e. essentially ‘sodium-free’.

3. How to take Provenal

Take this medicine exactly as your doctor or pharmacist has told you.
If you are in any doubt, consult your doctor or pharmacist.
The recommended dose is 2 capsules daily, taken orally, preferably before meals.

If you take more Provenal than you should
If you take more capsules of Provenal than prescribed by your doctor, you may have an increased risk of bleeding. In such a case, inform your doctor immediately or go to the nearest emergency room without delay.

If you forget to take Provenal
Do not take a double dose to make up for the missed dose.

If you stop taking Provenal
Take Provenal exactly as prescribed by your doctor. Do not stop taking this medicine without consulting your doctor first.

If you have any doubts about how to use 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.
Rarely, you may experience allergic reactions (sensitization) which may manifest as skin rashes in different parts of the body; however, these symptoms quickly disappear when treatment is discontinued. If necessary, your doctor will start an appropriate therapy.
Occasionally, when taking the capsules, you may experience stomach and intestinal disturbances.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the website: www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Provenal

This medicine does not require any special storage conditions.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack.
The expiry date refers to the last day of that month.
The expiry date applies to the product in its original, unopened packaging, correctly stored.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Provenal contains

The active substance is Sulodexide. One soft capsule contains 250 ULS of Sulodexide.
The other components are Sodium lauryl sulfate; Vegetable oil; Precipitated silica. Composition of the capsule shell: Gelatin; Glycerol; Ethyl p-hydroxybenzoate sodium (E 215); Propyl p-hydroxybenzoate sodium (E 217); Brown iron oxide (E 172); Yellow iron oxide (E 172).

Description of the appearance of Provenal and package contents
Soft capsules for oral use.
Pack containing 50 soft capsules in blisters.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Konpharma S.r.l.
Via Pietro della Valle 1
00193 - Rome
Manufacturer
Catalent Italy S.p.A.
Via Nettunense km 20,100 – 04011 Aprilia (LT).