Leaflet: information for the user

Fabroven 150 mg/150 mg/100 mg hard capsules

Dried extract of ruscus, hesperidin methyl chalcone, ascorbic acid

Read this leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What isFabrovenand what it is used for

2. What you need to know before starting to takeFabroven

3. How to takeFabroven

4. Possible side effects

5. Storage ofFabroven

6. Contents of the pack and additional information

Fabroven is a combination of 3 components:Ruscus extract, hesperidin methyl chalcone and ascorbic acid (vitamin C).

Fabroven belongs to the group of medications called capillary protectors (cardiovascular system).

This medication is a venotonic agent and a vascular protector agent (increases venous tonicity and capillary resistance, and decreases vascular permeability).

This medication is indicated in adults for:

Short-term relief (during two – three months) of edema and symptoms related to chronic venous insufficiency.

Do not take Fabroven

• if you are allergic to the active ingredients(extract of ruscus,hesperidin methyl chalconeand/or ascorbic acid(vitamin C)),
• if you have iron storage disorders (thalassemia, hemochromatosis, sideroblastic anemia) due to the presence of ascorbic acid(vitamin C)in the composition of the medication.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Fabroven.

• in case of diarrhea, discontinue treatment and inform your doctor (see section 4. Possible adverse effects),
• venous circulatory disorders: if you feel uncomfortable and/or vascular fragility has not improved after two weeks of treatment, consult your doctor.

Ascorbic acid (vitamin C) may affect the results of laboratory tests, such as blood glucose determination, bilirubin, transaminase activity, lactate, and others.

Children and adolescents

This medication is not indicated for children and adolescents.

Other medications and Fabroven

Inform your doctor or pharmacist if you are taking, have taken recently, or may take any other medication.

Fabroven contains ascorbic acid and may be used with caution with deferoxamine and deferiprone (particularly, medications used in diseases caused by excess iron or aluminum).

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medication.

As a precaution, it is preferable to avoid the use of Fabroven during pregnancy and it should not be used during breastfeeding.

Driving and operating machines

No information available.

Fabroven contains yellow-orange FCF (E-110).

It may cause allergic reactions.

Follow exactly the administration instructions for this medication as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

Adults:

The recommended dosage is 2 to 3 hard capsules per day.

The treatment duration is 2 to 3 months.

This medication is administered orally.

The hard capsules will be taken whole with a glass of water.

If you take more Fabroven than you should

Consult your doctor or pharmacist immediately

High doses of ascorbic acid (vitamin C, active ingredient of Fabroven) may lead to hemolytic anemia (decrease in the number of red blood cells) in patients with G6PD deficiency (glucose-6-phosphate dehydrogenase).

Lithiasis oxalica (kidney stones due to calcium oxalate crystals) may occur from more than 1 g per day of ascorbic acid.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20 indicating the medication and the amount ingested.

If you forgot to take Fabroven

Do not take a double dose to compensate for the missed doses.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

The side effects that can occur are:

•Frequent (can affect up to 1 in 10 people):

Diarrhea, sometimes severe, rapidly reversible when treatment is stopped (see section 2. Precautions and warnings)

Abdominal pain

•Less frequent (can affect up to 1 in 100 people):

Insomnia (difficulty sleeping)

Dispepsia (functional gastrointestinal disorder)

Nausea

Erythema (skin redness)

Pruritus (itching)

Muscle spasms

Pain in the extremities (hands and/or feet)

•Rare (can affect up to 1 in 1,000 people):

Nervousness

Dizziness

Peripheral cooling (cold hands and/or feet)

Pain in the veins (sensitive veins)

Gastrointestinal disorders

Herpes simplex (inflammation of the oral cavity with vesicles)

Increased alanine aminotransferase (elevated liver parameter)

•Unknown (frequency cannot be estimated from available data):

Gastric pain.

Maculopapular rash (skin redness) and urticaria (hives with itching).

Reversible colitis (inflammation of the colon) after treatment interruption.

Interference with laboratory tests due to ascorbic acid

Other side effects in children and adolescents

Not applicable.

Reporting of side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet.You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not store at a temperature above 25°C.

Store in the original packaging to protect it from moisture.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash.Deposit the packaging and medications you no longer need at the SIGRE collection pointat the pharmacy.If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. In this way, you will help protect the environment.

Composition of Fabroven

- The active principles are: 150 mg of Ruscus aculeatus extract valued in sterolic heterosides, 150 mg of hesperidin methylchalcone and 100 mg of ascorbic acid in a hard capsule.

- The other components are: talc, macrogol 6000, hydrophobic colloidal silica, magnesium stearate, quinoline yellow (E104), yellow orange FCF S (E110)*, titanium dioxide (E171) and gelatin.

*(see section 2: Fabroven contains yellow orange FCF (E-110).

Appearance of the product and content of the container

This medicine is presented in the form of hard yellow and orange capsules.

Format of 60 hard capsules. PVC/ Polyethylene/ Polyvinyl chloride/ Aluminum blister.

Holder of the marketing authorization

PIERRE FABRE IBÉRICA, S.A.

C/ Ramón Trias Fargas, 7-11

08005 Barcelona (Spain)

Responsible for manufacturing

PIERRE FABRE MÉDICAMENT PRODUCTION

Site PROGIPHARM

Rue du Lycée

45500 GIEN(France)

Last review date of this leaflet: November 2023

“Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) https://www.aemps.gob.es”