Favilax capsules
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
PACKAGE LEAFLET: INFORMATION FOR THE USER
FAVILAX capsules.
Extracts of Rhamnus purshiana D.C., Fucus vesiculosus L., Rhamnus frangula L.,
Read this entire leaflet carefully before you start taking this medicine, because it contains important information for you.
Follow exactly the instructions for use provided in this leaflet or those given by your doctor or pharmacist.
This medicine is available without a prescription. However, to achieve the best results, it must be used correctly.
- Keep this leaflet, as you may need to read it again.
- If you need advice or further information, consult your pharmacist.
- If you experience any adverse effects, consult your doctor or pharmacist, even if these are effects not listed in this leaflet. You should consult your doctor if your condition worsens or if you do not improve after 4 days.
Leaflet contents:
- What Favilax is and what it is used for
- What you need to know before taking Favilax
- How to take Favilax
- Possible adverse effects
- How to store Favilax
- Contents of the pack and other information
1. What Favilax is and what it is used for
FAVILAX is a herbal medicine for adults and children over 12 years of age, composed of a combination of plant extracts with laxative properties, meaning they stimulate intestinal activity and promote bowel movement.
FAVILAX relieves occasional constipation.
2. What you need to know before starting to take Favilax
Do not take Favilax:
- If you are allergic (hypersensitive) to the active substances or to any of the other components of Favilax.
- If you suffer from 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 of age.
If measures to relieve constipation such as a diet rich in fiber and fluids, physical exercise, or retraining of bowel habits are not sufficient, you may take Favilax for a maximum of 6 days. In general, taking it two or three times per week of treatment is sufficient. 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).
Inform your doctor or pharmacist if you are using, have recently used, or might need to take any other medicines, including those obtained without a prescription.
The use of laxatives may interfere with the proper functioning of other medicines you are already taking.
Warnings and precautions
Consult your doctor or pharmacist before starting to take FAVILAX if you are being treated with:
- Medicines used to normalize heart rhythm (antiarrhythmics) such as quinidine.
- Astemizole and terfenadine (antihistamines).
- Intravenous erythromycin.
- Halofantrine and pentamidine for infections.
- Bepridil for myocardial infarction.
- Sultopride (tranquilizer).
- Vincamine (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 their effect may be increased and lead to hypoglycemia.
Use with other medicines
Inform your doctor or pharmacist if you are using, have recently used, or might need to take any other medicine.
Use in elderly patients
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 if you experience any adverse effects not mentioned in this leaflet or if you suffer a serious adverse effect.
When using this medicine in incontinent patients, extra care should be taken when changing diapers to avoid contact with feces.
Pregnancy and breastfeeding
Consult your doctor or pharmacist before using any medicine.
If you are pregnant, breastfeeding, think you might be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medicine.
The use of this medicine during pregnancy is not recommended, because although no problems related to pregnancy or the fetus have been reported at the recommended doses, experimental animal studies indicate that one of the components of this medicine could pose a risk of toxicity.
Breastfeeding women should not use this medicine to avoid a possible laxative effect in the infant due to passage of active substances into breast milk.
Driving and use of machines
No effects of this medicine affecting your ability to drive or operate machinery have been reported.
3. How to take Favilax
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.
The normal recommended dose for individuals over 12 years of age is one capsule after dinner, taken with a glass of water. 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 4 days of treatment, consult your doctor or pharmacist.
Use in children
This medicine must not be given to children under 12 years of age.
If you take more Favilax than you should
If you have taken more Favilax than you should, contact your doctor or pharmacist immediately. You may experience abdominal pain, spasms, and severe 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 elderly patients.
In case of overdose or accidental ingestion, call the Toxicology Information Service at telephone number 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 missed doses.
If you stop taking Favilax
If you have any further questions about the use of this product, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, Favilax 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. 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.
5. Storage of Favilax
Keep in the original packaging.
Do not store above 30°C.
Store in a cool and dry place.
Keep out of sight and reach of children.
Do not use this medicine after the expiry date stated on the container “after EXP”. The expiry date is the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to properly dispose of unused medicines and their containers. This will help protect the environment.
6. Contents of the pack and other information
Composition of Favilax
The active ingredients per capsule are:
- 170 mg of dried ethanolic extract of bark from Rhamnus purshiana (Cascara sagrada), equivalent to 14.28 mg of hydroxyanthracene glycosides; 126 mg of dried aqueous extract of Fucus vesiculosus (Fucus), containing 11.97 - 39.69 micrograms of iodine; 86.8 mg of dried ethanolic extract of Rhamnus frangula (Frangula), equivalent to 13.67 mg of glucofrangulins.
- Other components: Microcrystalline cellulose, magnesium stearate and anhydrous colloidal silica.
The capsule shell consists of gelatin, titanium dioxide (E171), Indigotine (E132), quinoline yellow (E104).
Appearance of the product and pack contents
Favilax is dark green capsules.
Pack containing 45 capsules in three blisters (aluminum/PVC) with 15 capsules each.
Marketing Authorization Holder and Manufacturer
Marketing Authorization 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 patient information leaflet was approved in:
May 2012
Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/