Favilax capsulas

PATIENT INFORMATION LEAFLET

FAVILAXcapsules.

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

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

Follow exactly the administration instructions contained in this leaflet or those given by your doctor or pharmacist

This medicine can be obtained without a prescription. Nevertheless, for the best results, it should be used properly.

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

Favilax is a plant-based medication for adults and children over 12 years old, composed of an association of plant extracts that stimulate intestinal activity, promoting the evacuation of feces.

Favilax relieves occasional constipation.

Do not takeFavilax.

• If you are allergic (hypersensitive) to the active ingredients or any of the other components ofFavilax.
• If you have inflammatory bowel disease (e.g. Crohn's disease, ulcerative colitis).
• If you have any thyroid 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 liquids, physical exercise, or bowel habit reeducation are not sufficient, you may takeFavilaxfor 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 obtained the desired effect and continue to need the medication, consult your doctor.

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

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

The use of laxatives may 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
• Astemizol and terfenadine (antihistamines)
• Erythromycin administered intravenously.
• Halofantrine and pentamidine in infections.
• Bepridil for myocardial infarction.
• Sultoprida (tranquilizer)
• Vincamina (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.
• Digitals or cardiac glycosides (used for the heart), as potassium depletion may increase the effects of these medications.
• Oral antidiabetics or insulin, as it may 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 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 leaflet or if you experience a severe adverse effect.

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

Pregnancy and lactation

Consult your doctor or pharmacist before using any medication.

If you are pregnant, or in the lactation period, believe you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medication.

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 one of the components of this medication may be a cause of toxicity risk.

Women in the lactation period should not use this medication to avoid a possible laxative effect in the infant due to the passage of active substances to breast milk.

Driving and operating machinery

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

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor or pharmacist. If you are unsure, ask your doctor or pharmacist.

The recommended normal dose for individuals 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 taking the medication.

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

In case of overdose or accidental ingestion, call the Toxicological 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 compensate for the missed doses.

If you interrupt treatment with Favilax

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

Like all medications,Favilaxmay cause adverse effects, although not all people will experience them.

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

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

Store in the original packaging.

Do not store at a temperature above 30°C.

Store in a cool and dry place.

Keep out of sight and reach of children.

Do not usethis medicationafter the expiration date appearing 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. Dispose of the packaging and medicines you no longer need at the designated point of the Pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Favilax

The active principles per capsule are:

• 170 mg of dry ethanol extract of Rhamnus purshiana (Sage Bark) bark corresponding to 14.28 mg of heterosides hydroxyanthracenic; 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), Indigotin (E132), and quinoline yellow (E104).

Appearance of the product and contents of the packaging

Favilaxare dark green capsules.

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

Holder of the marketing authorization and responsible for manufacturing

Holder

Laboratorios Cinfa, S.A.

Olaz-Chipi, 10. Industrial Park Areta

31620 Huarte-Pamplona (Navarra)

Spain

Responsible for manufacturing

Industria Química y Farmacéutica VIR, S.A.

C/ Laguna, 66-68-70 Industrial Park Urtinsa II

28923 - Alcorcón

Madrid (SPAIN)

O

Sincrofarm S.L.

MERCURIO, 10 POL. IND. ALMEDA

Cornella de Llobregat, Barcelona

Spain

This leaflet has been approved in:

May 2012

The detailed and updated information of this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/