FABROVEN 150 mg/150 mg/100 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the User

Fabroven 150 mg/150 mg/100 mg Hard Capsules

Dry extract of ruscus, hesperidin methyl chalcone, ascorbic acid

Read the entire package leaflet carefully before starting to take this medicine, as it contains important information for you.

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

Contents of the Package Leaflet

1. What is Fabroven and what is it used for
2. What you need to know before taking Fabroven
3. How to take Fabroven
4. Possible side effects
5. Storage of Fabroven
6. Contents of the pack and further information

1. What is Fabroven and what is it used for

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

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

This medicine is a venotonic agent and a vascular protective agent (increases venous tone and capillary resistance, and decreases vascular permeability).

This medicine is indicated in adults for:

Short-term relief (for 2-3 months) of edema and symptoms related to chronic venous insufficiency.

2. What you need to know before taking Fabroven

Do not take Fabroven

• if you are allergic to the active ingredients (ruscus extract, hesperidin methyl chalcone, and/or ascorbic acid (vitamin C)) or any of the other components of this medicine (listed in section 6),
• if you have iron storage disorders (thalassemia, hemochromatosis, sideroblastic anemia) due to the presence of ascorbic acid (vitamin C) in the composition of the medicine.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Fabroven.

• in case of diarrhea, stop treatment and inform your doctor (see section 4. Possible side effects),
• venous circulatory disorders: if you feel uncomfortable and/or vascular fragility has not improved after 2 weeks of treatment, consult your doctor.

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

Children and adolescents

This medicine is not indicated in children and adolescents.

Other medicines and Fabroven

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Fabroven contains ascorbic acid and may be used with caution with deferoxamine and deferiprone (in particular, medicines 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 plan to become pregnant, consult your doctor or pharmacist before using this medicine.

As a precaution, it is recommended to avoid using Fabroven during pregnancy and it should not be used during breastfeeding.

Driving and using machines

Not applicable.

Fabroven contains Yellow Orange FCF (E-110).

May cause allergic reactions.

3. How to take Fabroven

Follow exactly the administration instructions of this medicine indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Adults:

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

The duration of treatment is 2 to 3 months.

This medicine is administered orally.

The hard capsules should 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 (reduction of red blood cells) in patients with G6PD deficiency (glucose-6-phosphate dehydrogenase).

May cause oxalate kidney stones (kidney stones due to calcium oxalate crystals) from more than 1 g daily of ascorbic acid.

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

If you forget to take Fabroven

Do not take a double dose to make up for forgotten doses.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The side effects that may occur are:

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

Diarrhea, sometimes severe, rapidly reversible when treatment is discontinued (see section 2. Warnings and precautions)

Abdominal pain

• Uncommon (may affect up to 1 in 100 people):

Insomnia (difficulty sleeping)

Dyspepsia (functional digestive disorder)

Nausea

Erythema (redness of the skin)

Pruritus (itching)

Muscle spasms

Pain in the limbs (in hands and/or feet)

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

Nervousness

Dizziness

Peripheral cooling (coldness in hands and/or feet)

Pain in the veins (sensitive veins)

Gastrointestinal disorders

Aphthous stomatitis (inflammation of the oral cavity with vesicles)

Increased alanine aminotransferase (increased liver parameter)

• Not known (frequency cannot be estimated from the available data):

Gastric pain.

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

Colitis (inflammation of the colon) reversible after treatment discontinuation.

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 side effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this package leaflet. You can also report them directly through the Spanish Medicines and Health Products Agency's website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Fabroven

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

Do not store above 25°C.

Store in the original packaging to protect from moisture.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicines in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Contents of the pack and further information

Composition of Fabroven

• The active ingredients are: 150 mg of ruscus aculeatus extract valued in steroidal heterosides, 150 mg of hesperidin methylchalcone, and 100 mg of ascorbic acid in a hard capsule.
• The other ingredients 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 and packaging of the product

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

Format of 60 hard capsules. PVC/Polyethylene/Polyvinylidene Chloride/Aluminum blister pack.

Marketing authorization holder

PIERRE FABRE IBÉRICA, S.A.

C/ Ramón Trias Fargas, 7-11

08005 Barcelona (Spain)

Manufacturer

PIERRE FABRE MÉDICAMENT PRODUCTION

Site PROGIPHARM

Rue du Lycée

45500 GIEN (France)

Date of the last revision of this package leaflet: November 2023

"Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) https://www.aemps.gob.es"