REMIFEMIN COMPRESSED TABLETS

Introduction

Patient Information Leaflet

REMIFEMIN® tablets

Extract of Cimicifuga racemosa L.

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

Follow the administration instructions for the medication contained in this leaflet, or as indicated by your doctor or pharmacist, 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 not listed in this leaflet. See section 4.
• You should consult a doctor if your symptoms worsen or do not improve after 30 days.

CONTENTS OF THE LEAFLET:

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

1. What REMIFEMIN is and what it is used for

Remifemin is a herbal medicine for the relief of symptoms associated with menopause.

Remifemin is indicated for the treatment of symptoms related to menopause, such as hot flashes and intense sweating.

You should consult a doctor if your symptoms worsen or do not improve after 30 days of treatment.

2. What you need to know before taking REMIFEMIN

Do not take Remifemin:

If you are hypersensitive (allergic) to the rhizome of Cimicifuga racemosaL. or to any other component of Remifemin (see section 6. Additional Information).

Warnings and precautions:

Consult your doctor, pharmacist, or nurse before starting to take this medication:

• If you have had liver damage. In this case, you should only take Remifemin after consulting your doctor.
• If you observe signs and symptoms that could suggest liver damage (fatigue, loss of appetite, yellow skin and eyes, severe pain in the upper abdomen with nausea and vomiting, or dark urine). In this case, you should stop treatment immediately and consult your doctor.
• If you experience vaginal bleeding or other symptoms, you should consult your doctor.
• If you have been treated or are being treated with estrogen for breast cancer or other hormone-dependent tumors. You should consult your doctor before starting treatment with Remifemin.
• If your symptoms continue or worsen after 8 weeks of treatment, you should consult your doctor or pharmacist.

Using Remifemin with other medications:

No interactions have been reported.

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medication.

Pregnancy and breastfeeding:

This medication is not indicated for pregnant or breastfeeding women. The safety of this medication during pregnancy and breastfeeding has not been established.

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

It is recommended to use a contraceptive method if there is a possibility of becoming pregnant during treatment.

Driving and using machinery:

No special precautions are necessary.

Remifemin contains lactose: If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

3. How to take REMIFEMIN

Follow the administration instructions for the medication contained in this leaflet or as indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

The recommended dose is for adult women: 1 tablet twice a day (morning and evening).

The tablets should be swallowed without chewing (not sucked), with enough water (preferably with a glass of water).

The tablets can be taken independently of meals.

Duration of treatment

The effects of Remifemin are not immediate; they may start to manifest after two weeks of treatment. As long as there is an improvement in symptoms, a treatment duration of up to six months is recommended. After this time, you should not continue taking the medication without consulting your doctor to assess the continuation of treatment.

If you take more Remifemin than you should:

In case of accidental ingestion of large quantities, go to a medical center or call the Toxicology Information Service at 91 562 0420, indicating the medication and the amount ingested.

If you forget to take Remifemin:

Do not take a double dose to make up for forgotten doses, but continue taking Remifemin at the usual time.

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

4. Possible side effects

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

Cases of liver damage (including hepatitis, jaundice, alterations in liver function tests) associated with the use of medications containing the root of Cimicifuga racemosa Lhave been reported.

Gastrointestinal disorders (dyspepsia, diarrhea), skin allergic reactions (urticaria, itching, skin rash), facial edema, and peripheral edema, as well as weight gain, have been described. The frequency of these cases is unknown. If you experience this type of effect, do not continue treatment and consult your doctor.

Reporting side effects

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

5. Storage of REMIFEMIN

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

Do not store above 30°C.

Do not use this medication after the expiration date indicated 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. Deposit the packaging and any unused medication at the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. PACKAGE CONTENTS AND ADDITIONAL INFORMATION

Composition of Remifemin:

• The active ingredient is 0.018-0.026 ml of liquid extract of the rhizome of Cimicifuga racemosa L., which corresponds to 20 mg of the plant (extraction agent: propa-2-nol at 40% v/v).
• The other components are: powdered cellulose, potato starch, lactose monohydrate, magnesium stearate, peppermint essence.

Appearance of the product and package contents

Round tablets, slightly beige in color.

Each package contains 60 tablets.

Marketing authorization holder and manufacturer

The marketing authorization holder and manufacturer is Schaper & Brümmer GmbH - Co. KG. Bahnhofstraße 35, D-38259 –Salzgitter (Ringelheim). Germany.

Local representative:

Aristo Pharma Iberia, S.L.

C/ Solana, 26

28850 Torrejón de Ardoz - Madrid

Spain

This leaflet was approved in June 2014.

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/