FAVILAX CAPSULES

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

FAVILAXcapsules.

Extracts of Rhamnus purshianaD.C., Fucus vesiculosusL., Rhamnus frangulaL.,

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

Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor or pharmacist.

This medication can be obtained without a prescription. Nevertheless, to achieve the best results, it should be used properly.

• Keep this package leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience adverse effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You should consult your doctor if your condition worsens or does not improve after 4 days.

Contents of the package leaflet:

1. What Favilaxis and what it is used for
2. What you need to know before taking Favilax
3. How to take Favilax
4. Possible adverse effects
5. Storage of Favilax
6. Package contents and additional information

1. What is Favilax and what is it used for

FAVILAX is a plant-based medication for adults and children over 12 years old, composed of an association of vegetable laxative extracts, which stimulate intestinal activity and facilitate the evacuation of feces.

FAVILAX relieves occasional constipation.

2. What you need to know before taking Favilax

Do not take Favilax:

• If you are allergic (hypersensitive) to the active ingredients or any of the other components of Favilax.
• If you have inflammatory bowel diseases (e.g., Crohn's disease, ulcerative colitis).
• If you have any thyroid gland disorder (hyperthyroidism).
• If you have any liver or kidney disorder.
• In case of appendicitis or abdominal or stomach pain of unknown origin.
• Do not administer to children under 12 years old.

If measures to relieve constipation, such as a high-fiber diet and fluids, physical exercise, or re-education of the bowel habit, are not sufficient, you can take Favilaxfor a maximum of 6 days. In general, it is sufficient to take it two or three times a week during treatment. If after 4 days of treatment you have not achieved the desired effect and continue to need the medication, consult your doctor.

Prolonged use of laxatives should be avoided, as they can cause adverse effects. (See section 4. POSSIBLE ADVERSE EFFECTS).

Inform your doctor or pharmacist if you are using or have recently used other medications, including those obtained without a prescription.

The use of laxatives can interfere with the proper functioning of medications you are already taking.

Warnings and precautions

Consult your doctor or pharmacist before starting to take FAVILAX if you are being treated with:

• Medications used to normalize heart rhythm (antiarrhythmics) such as quinidine.
• Astemizole and terfenadine (antihistamines).
• Erythromycin administered intravenously.
• Halofantrine and pentamidine in infections.
• Bepridil for myocardial infarction.
• Sultopride (tranquilizer).
• Vincamine (peripheral vasodilator).

Respect the recommended treatment duration for this medication, especially if you are being treated with any of the following medications:

• Tetracosactide or other corticosteroids or diuretics used to increase urine elimination.
• Digitalis or cardiac glycosides (used for the heart), as potassium reduction can increase the effects of these medications.
• Oral antidiabetics or insulin, as it can increase the effect of these medications and cause hypoglycemia.

Use of other medications

Inform your doctor or pharmacist if you are using or have recently used or may need to take any other medication.

Use in the elderly

Due to your age and depending on your physical condition, you may be more sensitive to the effects of the medication. Consult your doctor or pharmacist before using this medication if you notice any adverse effect not mentioned in this package leaflet or if you experience a severe adverse effect.

When using this medication in incontinent patients, greater care should be taken when changing diapers to avoid contact with feces.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medication.

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

The use of this medication is not recommended during pregnancy, as although no problems related to pregnancy or the fetus have been reported at the recommended doses, experimental studies in animals indicate that some components of this medication may pose a risk of toxicity.

Breastfeeding women should not use this medication to avoid a possible laxative effect in the infant due to the passage of active substances into breast milk.

Driving and using machines

No effects of this medication have been described that affect your ability to drive and use machines.

3. How to take Favilax

Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

The recommended dose for adults and children over 12 years old is one capsule after dinner with a glass of water. The laxative effect is achieved between 6 and 12 hours after administration.

Elderly patients are more sensitive to the effects of this medication.

The maximum recommended treatment duration will be 6 days; if symptoms persist after 4 days of treatment, consult your doctor or pharmacist.

Use in children

This medication should not be administered to children under 12 years old.

If you take more Favilax than you should

If you have taken more Favilaxthan you should, consult your doctor or pharmacist immediately. You may experience abdominal pain, spasms, and massive diarrhea with water and electrolyte loss. If the electrolyte imbalance is severe, it can cause confusion, cardiac arrhythmia, cramps, fatigue, or weakness, which can be more pronounced in the elderly.

In case of overdose or accidental ingestion, call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Favilax

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

If you interrupt treatment with Favilax

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

4. Possible adverse effects

Like all medications, Favilaxcan cause adverse effects, although not everyone will experience them.

Occasionally, abdominal pain and spasms, bloating (gas in the abdomen), nausea, mucous stools and/or diarrhea, skin rashes, and allergic reactions may occur. All these symptoms disappear when treatment is discontinued.

If you consider that any of the adverse effects you are experiencing is severe or if you notice any adverse effect not mentioned in this package leaflet, inform your doctor or pharmacist.

5. Storage of Favilax

Keep in the original packaging.

Do not store at a temperature above 30°C.

Keep in a cool and dry place.

Keep out of the sight and reach of children.

Do not use this medicationafter the expiration date shown on the packaging “after CAD”. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the pharmacy's collection point. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Favilax

The active ingredients per capsule are:

• 170 mg of dry ethanol extract of Rhamnus purshiana(Cascara sagrada) bark, corresponding to 14.28 mg of hydroxyanthracene heterosides; 126 mg of dry aqueous extract of Fucus vesiculosus(Fucus) containing 11.97 - 39.69 micrograms of iodine; 86.8 mg of dry ethanol extract of Rhamnus frangula(Frangula) corresponding to 13.67 mg of glucofrangulins.
• The other components are: Microcrystalline cellulose, magnesium stearate, and anhydrous colloidal silica.

The capsule is composed of gelatin, titanium dioxide (E171), indigotine (E132), and quinoline yellow (E104).

Appearance of the product and package contents

Favilaxare dark green capsules.

Box of 45 capsules in three blisters (aluminum/PVC) of 15 capsules each.

Marketing authorization holder and manufacturer

Holder

LABORATORIOS CINFA, S.A.

Olaz-Chipi, 10. Poligono Industrial Areta

31620 Huarte-Pamplona (Navarra)

Spain

Manufacturer

Industria Química y Farmacéutica VIR, S.A.

C/ Laguna, 66-68-70 Pol. Industrial Urtinsa II

28923 - Alcorcón

Madrid (SPAIN)

Or

SINCROFARM S.L.

MERCURIO, 10 POL. IND. ALMEDA

CORNELLA DE LLOBREGAT, BARCELONA

SPAIN

This package leaflet was approved in:

May 2012

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