Fave de Fuca coated tablets

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

FAVE DE FUCA coated tablets

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

Follow exactly the instructions for administration of the medicine contained in this leaflet or those indicated 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 adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

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

Contents of the leaflet:

1. What FAVE DE FUCA is and what it is used for
2. What you need to know before taking FAVE DE FUCA
3. How to take FAVE DE FUCA
4. Possible adverse effects
5. Storage of FAVE DE FUCA
6. Contents of the pack and other information

1. What FAVE DE FUCA is and what it is used for

FAVE DE FUCA is a combination of plant extracts with laxative properties, meaning they stimulate intestinal activity and promote bowel movements.

FAVE DE FUCA relieves occasional constipation.

You should consult a doctor if your condition worsens or does not improve within 4 days.

2. What you need to know before starting to take FAVE DE FUCA

Do not take FAVE DE FUCA:

• If you are allergic to the active substances or to any of the other components of this medicine (listed in section 6).

• In case of appendicitis or abdominal or stomach pain of unknown origin.

• If you suffer from inflammatory bowel diseases (e.g., Crohn's disease, ulcerative colitis).

• If you have a thyroid gland disorder (hyperthyroidism).

• If you have liver or kidney problems.

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 measures, which are mainly based on the following:

• A diet rich in fiber and fluids,
• Physical exercise,
• Re-education of bowel habits.

All of these promote and stimulate evacuation, helping to relieve constipation.

If these measures are not sufficient to relieve constipation, you may take FAVE DE FUCA for up to 6 days. If after 4 days of treatment you have not achieved the desired effect and still require the medicine, consult your doctor.

Long-term use of laxatives should be avoided, as it may cause adverse effects (see section 4. POSSIBLE ADVERSE EFFECTS).

Children and adolescents

This medicine must not be given to children under 12 years of age.

Use of FAVE DE FUCA with other medicines:

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

In general, the use of laxatives may interfere with the effectiveness of other medicines you are taking.

Do not take this medicine without first consulting your doctor if you are being treated with medicines used to regulate heart rhythm (antiarrhythmics), such as quinidine, or with astemizole and terfenadine (antihistamines), intravenous erythromycin, halofantrine and pentamidine (for treating infections), bepridil (for myocardial infarction), sultopride (a tranquilizer), or vincamine (a peripheral vasodilator).

Observe the recommended treatment duration for this medicine, especially if you are taking any of the following medicines:

• Tetracosactide or other corticosteroids, or diuretics (used to increase urine elimination).

• Digitalis or cardiac glycosides (used for heart conditions), as decreased potassium levels may enhance the effects of these medicines.
• Oral antidiabetics or insulin, as this may increase the effect of these medicines and cause hypoglycemia.

Taking FAVE DE FUCA with food and drink

Avoid consuming liquorice while taking this medicine, as it may intensify potassium loss.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using any medicine.

The use of this medicine during pregnancy is not recommended. Although no problems related to pregnancy or the fetus have been reported at recommended doses, animal studies indicate that some of the components of this medicine could pose a risk of toxicity.

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

Breastfeeding women should not take this medicine, to avoid a possible laxative effect in the infant due to transfer of active substances 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 medicine. Consult your doctor or pharmacist before using this medicine, and if you consider any adverse effect you experience to be severe, or if you notice any adverse effect not mentioned in this leaflet.

Extra care should be taken when changing diapers in patients who are incontinent, to avoid contact with feces.

Driving and use of machines

No effects of this medicine on the ability to drive or operate machinery have been reported.

FAVE DE FUCA contains glucose, sucrose and lactose, methyl parahydroxybenzoate, ethyl parahydroxybenzoate, propyl parahydroxybenzoate, sodium benzoate and propylene glycol.

This medicine contains glucose, sucrose and lactose. If your doctor has informed you of an intolerance to certain sugars, consult him before taking this medicine.

It may cause allergic reactions (possibly delayed) because it contains methyl, ethyl and propyl parahydroxybenzoate.

This medicine contains 0.06 mg of sodium benzoate per tablet.

This medicine contains 0.01 mg of propylene glycol per tablet.

The coated tablets of FAVE DE FUCA have a characteristic odor, varying in intensity depending on the harvesting period of one of its essential components (the seaweed Fucus vesiculosus), which does not affect in any way the efficacy or good tolerability of the preparation.

3. How to take FAVE DE FUCA

Follow exactly the instructions for use provided in this leaflet or those given by your doctor or pharmacist. If in doubt, consult 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 elderly patients, it is recommended to take one tablet after dinner. The laxative effect occurs between 6 and 12 hours after administration.

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

The maximum recommended duration of treatment is 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 at telephone number: 91 562 04 20, indicating the medicine 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 loss of water and electrolytes. 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 forget to take FAVE DE FUCA

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

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

4. Possible adverse effects

Like all medicines, this medicine may produce adverse effects, although not everyone will experience them.

Occasionally, abdominal pain and spasms, flatulence (gas in the abdomen), nausea, mucous stools and/or diarrhoea, skin rashes, and allergic reactions may occur. A yellowish-red to brownish discoloration of the urine may appear; however, this has no clinical significance. All these symptoms disappear when treatment is discontinued.

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not mentioned in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. FAVE DE FUCA STORAGE

Store in the original packaging.

Do not store above 30°C.

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

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at a pharmacy’s SIGRE collection point. If you are unsure, ask your pharmacist how to properly dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of FAVE DE FUCA

• The active substances per tablet are:

56.56 – 80.808 mg of extract from the bark of Rhamnus frangula L. (frangula), corresponding to 13.33 mg of glucofrangulin calculated as Glucofrangulin A. Extraction solvent: Ethanol 60% V/V

103–58.9 mg of extract from the bark of Rhamnus purshianus D.C. (cascara sagrada), corresponding to 15.31 mg of hydroxyanthracene glycosides expressed as Cascharoside A. Extraction solvent: Ethanol 60% V/V;

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

• Other components are: Talc, monohydrate glucose, monohydrate lactose, sodium stearate, sucrose, arabic gum, 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 pack contents

FAVE DE FUCA are coated oval tablets of dark brown color, packed in plastic/aluminum blister packs, in cardboard boxes containing 10, 20, 30 or 40 units.

Only certain pack 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 most recent review of this leaflet: November 2017

Detailed and up-to-date information on this medication is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.es/"