FAVE DE FUCA COATED TABLETS

2. What you need to know before taking FAVE DE FUCA

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 abdominal or stomach pain of unknown origin
• 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.

Do not administer to children under 12 years of age.

Warnings and precautions:

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

Pharmacological treatment of constipation is only an aid to hygienic-dietary treatment, which is based mainly on the following:

-A diet rich in fiber and liquids,

-Practicing physical exercise,

-Reeducating bowel habits.

All of these facilitate and stimulate evacuation, contributing to relieving constipation.

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

Children and adolescents

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

Using FAVE DE FUCA with other medications:

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

In general, the use of laxatives can interfere with the proper functioning of medications you are already taking.

Do not take this medication without consulting your doctor first if you are being treated with medications used to normalize heart rhythm (antiarrhythmics), such as quinidine, or with astemizole and terfenadine (antihistamines), intravenous erythromycin, halofantrine, and pentamidine (for infection treatment), 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 corticoids, or with diuretics (used to increase urine elimination).

• Digitalis or cardiac glycosides (used for the heart), as potassium decrease can increase the effects of these medications.
• Oral antidiabetics or insulin, as it can increase the effect of these medications and produce hypoglycemia.

Taking FAVE DE FUCA with food and drinks

Avoid taking licorice when taking this medication, as it can intensify potassium loss.

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 any 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 could pose a risk of toxicity.

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 on the infant due to the passage of substances with this activity into breast milk.

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

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

Driving and using machines

No effects of this medication have been described that affect your ability to drive and use 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 told you that you have an intolerance to certain sugars, consult with them 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 per tablet.

This medication contains 0.01 mg of propylene glycol per tablet.

The FAVE DE FUCA coated tablets have a characteristic odor, more or less intense and variable, depending on the collection time of one of its essential components (the seaweed Fucus vesiculosus), which does not affect the action and good tolerance of the preparation.

3. How to take FAVE DE FUCA

Follow the administration instructions for the medication contained in this prospectus or as 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 of age, and the elderly, it is recommended to take one tablet after dinner. 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 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 Toxicology 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 massive diarrhea with water and electrolyte loss. If the electrolyte imbalance is severe, it can cause confusion, cardiac arrhythmia, cramps, fatigue, or weakness, which may be more pronounced in the elderly.

If you forget to take FAVE DE FUCA

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

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

4. Possible adverse effects

Like all medications, this medication can 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. The urine may turn a yellow-brown color, although this has no clinical significance. All these symptoms disappear when treatment is discontinued.

If you consider that any of the adverse effects you are experiencing are serious 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 Pharmacovigilance System for Human Use Medications: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Storage of FAVE DE FUCA

Keep in the original packaging.

Do not store at a temperature above 30°C.

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

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

Medications should not be thrown down the drain or into the trash. Deposit the packaging and medications you no longer need in the point at the pharmacy. 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 FAVE DE FUCA

• The active ingredients per tablet are:

56.56-80,808 mg of Rhamnus frangulaL (frangula) bark extract, which corresponds to 13.33 mg of glucofrangulin calculated as Glucofrangulin A. Extraction solvent: Ethanol 60% V/V

103-58.9 mg of Rhamnus purshianusD.C (cascara sagrada) bark extract, corresponding to 15.31 mg of hydroxyanthracene heterosides expressed as Cascaroside A, Extraction solvent: Ethanol 60% V/V;

61.36 mg of Fucus vesiculosusL, seaweed extract (1.5-3:1), which contains 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, methylparaben (E 218), propylparaben (E 216), propylene glycol (E 1520), ethylparaben (E 214), sodium hydroxide.

Appearance of the product and package contents

FAVE DE FUCA are oval, dark brown coated tablets, presented in blister packs of plastic and aluminum, in boxes of 10, 20, 30, or 40 units.

Only some package sizes may be marketed.

Marketing authorization holder

URIACH CONSUMER HEALTHCARE, S.L.

Av. Generalitat 163-167

08174 Sant Cugat del Vallès

(Barcelona-Spain)

Manufacturers:

Date of the last revision of this prospectus: November 2017

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.es/