PATIENT INFORMATION LEAFLET

Fave de Fuca coated tablets

Read this leaflet carefully before you start taking this medicine because it contains important information for you

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

-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. See section 4.

-You should consult a doctor if your symptoms worsen or do not improve after 4 days.

FAVE DE FUCA is an association of plant extracts that are laxatives, meaning they stimulate intestinal activity and promote the evacuation of feces.

FAVE DE FUCA relieves occasional constipation.

You should consult a doctor if symptoms worsen or do not improve after 4 days.

Do not take FAVE DE FUCA:

• If you are allergic to the active ingredients or any of the other components of this medication (listed in section 6).
• In case of appendicitis or unknown origin stomach or abdominal pain.
• If you have inflammatory bowel diseases (e.g. Crohn's disease, ulcerative colitis).
• If you have any thyroid gland disorders (hyperthyroidism).

-If you have any liver or kidney disorders.

Do not administer to children under 12 years old.

Warnings and precautions:

Consult your doctor or pharmacist before starting to take FAVE DE FUCA.

Pharmacological treatment of constipation is only a help to the hygienic-dietetic treatment that is mainly based on the following sections:

-A diet rich in fibers and liquids,

-Practicing physical exercise,

-Reeducating bowel habits.

All of them favor and stimulate evacuation, contributing to alleviate constipation.

If these measures are not sufficient to alleviate constipation, you can take FAVE DE FUCA for a maximum of 6 days. 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).

Children and adolescents

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

Use of FAVE DE FUCA with other medications:

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

Generally, the use of laxatives may interfere with the proper functioning of medications you are already taking.

Do not take this medication without consulting your doctor if you are being treated with medications used to normalize heart rhythm (antiarrhythmics), such as: quinidine, or with astemizol and terfenadine (antihistamines), intravenous erythromycin, halofantrine, and pentamidine (for infections), bepridil (for myocardial infarction), sultopride (tranquilizer) or 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 with diuretics (used to increase urine elimination).

-digitalis or cardiac glycosides (used for the heart), as potassium depletion may increase the effects of these medications.

-oral antidiabetic medications or insulin, as it may increase the effect of these medications and cause hypoglycemia.

Taking FAVE DE FUCA with food and drinks

Avoid taking antacids when taking this medication, as it may intensify potassium loss.

Pregnancy, lactation, and fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using any medication.

This medication is not recommended during pregnancy, as although there have been no reports of problems related to pregnancy or the fetus at the recommended doses, there are experimental studies in animals that indicate that one of the components of this medication may be a cause of toxicity risk.

If you are pregnant, do not use this medication without consulting your doctor.

Women who are breastfeeding should not take this medication; to avoid a possible laxative effect in the infant due to the passage of substances with this activity to breast milk.

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 and if you consider that any of the adverse effects you are experiencing is severe or if you appreciate any adverse effect not mentioned in this prospectus.

When using this medication, incontinent patients should be more careful when changing diapers to avoid contact with feces.

Driving and operating machines

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

FAVE DE FUCAcontains glucose, sucrose, and lactose, methylparaben, ethylparaben, propylparaben, sodium benzoate, and propylene glycol.

This medication contains glucose, sucrose, and lactose. If your doctor has indicated that you have an intolerance to certain sugars, consult with him before taking this medication.

It may cause allergic reactions (possibly delayed) because it contains methylparaben, ethylparaben, and propylparaben.

This medication contains 0.06 mg of sodium benzoate in each tablet.

This medication contains 0.01 mg of propylene glycol in each tablet.

The coated tablets of FAVE DE FUCA have a characteristic odor that is more or less intense and variable, depending on the time of harvest of one of its essential components (the marine algaFucus vesiculosus) and which has no influence whatsoever on the action and good tolerance of the preparation.

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

FAVE DE FUCA is administered orally: swallow the tablets with a glass of water.

In adults, adolescents over 12 years old, and the elderly, it is recommended to take or administer one tablet after dinner. The laxative effect is achieved between 6 and 12 hours after taking.

The elderly are more sensitive to the effects of this medication.

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

If you take more FAVE DE FUCA than you should

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

If you forgot to take FAVE DE FUCA

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

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

Like all medications, this medication may produce adverse effects, although not all people will experience them.

Occasionally, it may cause abdominal pain and spasms, gas in the abdomen (meteorism), nausea, mucous stools, and/or diarrhea, skin rashes, allergic reactions. A yellow-brown urine discoloration may appear, although this has no clinical significance. All these symptoms will disappear when treatment is suspended.

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

Reporting Adverse Effects

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

Keep in the original packaging.

Do not store at a temperature above30ºC.

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

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. Dispose of packaging and medications you no longer need >at a pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of FAVE DE FUCA

-The active principles per tablet are:

56.56 – 80.808 mg of bark extract ofRhamnus frangulaL (frangula), corresponding to 13.33 mg of glucofrangulina calculated as Glucofrangulina A. Solvent of extraction: Ethanol 60% V/V

103-58.9 mg of bark extract ofRhamnus purshianusD.C (sacred bark), corresponding to 15.31 mg of hydroxyanthracenic heterosides expressed as Cascaroside A, Solvent of extraction: Ethanol 60% V/V;

61.36 mg of extract of Fucus vesiculosus L., algae, (1.5-3:1) containing between 6.1 and 36.8 micrograms of iodine.

- The other components are: Talc, glucose monohydrate, lactose monohydrate, sodium stearate, sucrose, gum arabic, iron oxide (E 172), liquid glucose, carnauba wax, sodium benzoate, methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), propylene glycol (E 1520), ethyl parahydroxybenzoate (E 214), sodium hydroxide.

Appearance of the product and content of the packaging

FAVE DE FUCA are brown, oval-shaped coated tablets that are presented packaged in plastic and aluminum blister strips, in boxes of 10, 20, 30 or 40 units.

Only some sizes of packaging may be commercially available.

Holder of the marketing authorization

URIACH CONSUMER HEALTHCARE, S.L.

Av. Generalitat 163-167

08174 Sant Cugat del Vallès

(Barcelona-Spain)

Manufacturers responsible:

Last review date of this leaflet: November 2017

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