Fabroven 150 mg/150 mg/100 mg hard capsules

Spain
Brand name Fabroven 150 mg/150 mg/100 mg hard capsules
Form capsules, hard
Active substance / Dosage
Prescription type Prescription Only Medicine
Registration number 59471
Fabroven 150 mg/150 mg/100 mg hard capsules capsules, hard

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Fabroven 150 mg/150 mg/100 mg hard capsules

Dry extract of ruscus, methylhesperidin chalcone, ascorbic acid

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

  • Keep this leaflet as 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, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
  • If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Fabroven is and what it is used for

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

Fabroven belongs to a group of medicines called capillary protectants (cardiovascular system).

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

This medicine is indicated in adults for:

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

2. What you need to know before starting to take Fabroven

Do not take Fabroven

  • if you are allergic to the active substances (ruscus extract, methylhesperidin chalcone, and/or ascorbic acid (vitamin C)) or any of the other ingredients 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.

  • if diarrhea occurs, discontinue 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 two weeks of treatment, consult your doctor.

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

Children and adolescents

This medicine is not indicated for use in children and adolescents.

Other medicines and Fabroven

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

Fabroven contains ascorbic acid and should be used with caution when taking deferoxamine and deferiprone (in particular, medicines used in diseases caused by excess iron or aluminum) to prevent any occurrence of heart problems.

Taking Fabroven with food, drinks and alcohol

No specific studies have been conducted.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you might be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

As a precautionary measure, it is preferable to avoid using Fabroven during pregnancy and it should not be used during breastfeeding.

Driving and using machines

It is unknown whether Fabroven affects your ability to drive or use machines, as no specific studies have been conducted.

Fabroven contains sunset yellow FCF (E110).

It may cause allergic reactions.

3. How to take Fabroven

Follow exactly the instructions for use of this medicine given by your doctor. If in doubt, consult your doctor or pharmacist again.

Adults:

The recommended dose 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, the active substance in Fabroven) may lead to hemolytic anemia (reduction in the number of red blood cells) in patients with G6PD (glucose-6-phosphate dehydrogenase) deficiency.

Oxalate kidney stones (oxalate renal lithiasis) may occur with daily intakes exceeding 1 g of ascorbic acid.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 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 missed doses.

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

4. Possible adverse effects

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

The possible adverse effects are:

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

Diarrhoea, occasionally severe (associated with a risk of weight loss and fluid and electrolyte imbalance in the blood or other body fluids if treatment is continued), 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 (indigestion)

Nausea

Erythema (redness of the skin)

Pruritus (itching)

Muscle spasms

Pain in extremities (in hands and/or feet)

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

Nervousness

Dizziness

Peripheral coldness (coldness in hands and/or feet)

Pain in veins (tender veins)

Gastrointestinal disorders

Aphthous stomatitis (inflammation of the mouth with presence of vesicles)

Increased alanine aminotransferase (elevated liver function parameter)

•Frequency not known (frequency cannot be estimated from available data):

Gastric pain.

Maculopapular rash (skin redness) and urticaria (swelling of red, itchy patches).

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

Interference with laboratory tests due to ascorbic acid.

Other adverse effects in children and adolescents

Not applicable.

Reporting of adverse effects:

If you experience any type of adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse 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 it 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. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of Fabroven

  • The active substances are: 150 mg of Ruscus aculeatus extract standardised to steroidal saponosides, 150 mg of methylhesperidin chalcone, and 100 mg of ascorbic acid per hard capsule.
  • Other components are: talc, macrogol 6000, colloidal anhydrous silica, magnesium stearate, quinoline yellow (E104), sunset yellow FCF (E110)*, titanium dioxide (E171) and gelatin.

*(see section 2: Fabroven contains sunset yellow FCF (E110)).

Nature of the product and contents of the pack

This medicine is presented as yellow and orange hard capsules.

Pack size: 60 hard capsules. PVC/polyethylene/polyvinylidene chloride/aluminium blister packs.

Marketing Authorisation 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 most recent revision of this leaflet: February 2026

“Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) https://www.aemps.gob.es”