FLAVINIA 80 mg FILM-COATED TABLETS

Introduction

FLAVINIA 80 mg film-coated tablets

Extract ofGlycine max(Soy)

Read the entire leaflet carefully before starting to take thismedication, as it contains important information for you.

Follow the administration instructions for the medication contained in this leaflet or as indicated by your doctor, pharmacist, or nurse exactly.

• Keep this leaflet, as you may need to read it again.- If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this leaflet.
• You should consult a doctor if your condition worsens or does not improve after 8 weeks of treatment.

Contents of the leaflet

1. What FLAVINIA is and what it is used for
2. What you need to know before taking FLAVINIA
3. How to take FLAVINIA
4. Possible side effects
5. Storage of FLAVINIA
6. Package contents and additional information

1. What FLAVINIA is and what it is used for

FLAVINIA is a medication that acts by relieving hot flashes associated with menopause.

As a result of the reduction in the number and intensity of hot flashes, there is an improvement in other climacteric symptoms, such as insomnia and nervousness.

You should consult your doctor if your condition worsens or does not improve after 2 or 3 months of treatment.

2. What you need to know before taking FLAVINIA

Do not take FLAVINIA:

If you are allergic (hypersensitive) to the Extract of Glycine max(soy) or to any of the components of FLAVINIA.

Be particularly careful withFLAVINIA:

If you have been diagnosed with a hormone-dependent tumor, consult your doctor before taking this medication.

If you have a pre-existing deficiency in iodine absorption, as isoflavones may interfere with the absorption of thyroid hormone (T4 or thyroxine).

Warnings and precautions:

If you have been diagnosed with a hormone-dependent tumor, consult your doctor before taking this medication.

Children and adolescents:

FLAVINIA is a medication that is not intended for children and adolescents.

Using FLAVINIA with other medications:

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

Antibiotics may decrease the action of FLAVINIA 80 mg.

Using FLAVINIA with food or drinks:

No interactions between FLAVINIA and food or drinks have been described.

Pregnancy, breastfeeding, and fertility:

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

Do not take FLAVINIA during pregnancy and breastfeeding, as it is not intended for this population.

Driving and using machines:

Taking FLAVINIA does not affect the ability to drive and use machines.

Important information about some of the components of FLAVINIA:

FLAVINIA contains sodium carboxymethyl starch (type A) of potato as an excipient, which is gluten-free.

3. How to take FLAVINIA

Follow the administration instructions for FLAVINIA indicated in this leaflet or as indicated by your doctor, pharmacist, or nurse exactly. In case of doubt, ask your doctor, pharmacist, or nurse.

FLAVINIA is administered orally.

Adults:

The recommended dose is 1 tablet per day. Take the tablet with a glass of water.

The effects of FLAVINIA are not immediate; they may start to manifest from the first 2 weeks, with the best results obtained at 2-3 months. After 3 months of starting treatment, consult your doctor to continue.

If you think the action of FLAVINIA is too strong or too weak, inform your doctor or pharmacist.

If you take more FLAVINIA than you should:

No cases of overdose with FLAVINIA have been described. If you have taken more FLAVINIA than you should, inform your doctor or pharmacist.

If you forget to take FLAVINIA

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

If you interrupt treatment with FLAVINIA

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

4. Possible side effects

Like all medications, FLAVINIA can cause side effects, although not everyone will experience them.

At the recommended dose, no side effects have been observed.

If you consider that any of the side effects you are experiencing is serious or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

Reporting side effects

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

5. Storage of FLAVINIA

Keep out of 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 disposed of through wastewater or household waste. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

FLAVINIA does not require special storage conditions.

6. Additional information

Composition of FLAVINIA

• The active ingredient is the Extract of Glycine max (soy). Each film-coated tablet contains 200 mg of extract of Glycine max seeds with a content of 80 mg of total isoflavones.

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Core of the tablet:Destab (which contains calcium carbonate, sodium lauryl sulfate, acacia, and water), Microcrystalline cellulose, Silica colloidal hydrated, Sodium Carboxymethyl Starch (type A) of potato, Magnesium stearate.

Coating of the tablet: Opadry II purple which contains polyvinyl alcohol, talc, titanium dioxide (E-171), polyethylene glycol (macrogol), soy lecithin (E-322), colorants*.

*The colorants are: Aluminum lake red allura (E-129), Iron oxide black (E-172), Aluminum lake carmine indigo (E-132).

Appearance of the product and package contents

FLAVINIA are film-coated tablets, circular, biconvex, purple in color.

Each package contains 30 film-coated tablets in a blister pack (aluminum/PVC/PVDC)

Marketing authorization holder and manufacturer

ITALFARMACO, S.A.

C/ San Rafael, 3 – 28108 Alcobendas (Madrid)

Phone: 916572323

This leaflet was approved inFebruary 2012

Detailed and updated information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS), http://www.aemps.gob.es.