Prospect: information for the patient

REMIFEMIN®tablets

Extract of Cimicifuga racemosa L.

Read this prospect carefully before starting to take this medication, because it contains important information for you

Follow exactly the medication administration instructions contained in this prospect, or those indicated by your doctor or pharmacist

• Keep this prospect, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.
• You should consult a doctor if you worsen or do not improve after 30 days

CONTENTS OF THE PROSPECT:

1. What it is and what Remifemin is used for.
2. What you need to know before starting to take Remifemin.
3. How to take Remifemin
4. Possible adverse effects
5. Storage of Remifemin
6. Contents of the package and additional information

Remifemin is a plant-based medication 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 symptoms worsen or do not improve after 30 days of treatment.

Do not take Remifemin:

If you have hypersensitivity (allergy) to the rhizome ofCimicifuga 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 that case, you should only take Remifemin after consulting your doctor.
• If you observe signs and symptoms that may suggest liver damage (fatigue, loss of appetite, yellow skin and eyes, severe upper stomach pain with nausea and vomiting, or dark urine). In that case, you should stop treatment immediately and consult your doctor
• If you experience vaginal bleeding or other symptoms, 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 Remifemin treatment
• If symptoms continue or worsen after 8 weeks of treatment, you should consult your doctor or pharmacist

Use of Remifemin with other medications:

No interactions have been described.

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

Pregnancy and breastfeeding:

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

If you are pregnant or breastfeeding, believe you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medication.

It is recommended to use some form of contraception if there is a possibility of becoming pregnant during treatment.

Driving and operating 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.

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor or pharmacist. In case of 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 (do not suck), with sufficient water (preferably with a glass of water).

The tablets can be taken independently of meals.

Treatment duration

The effects of Remifemin are not immediate, they may begin to manifest after two weeks of treatment. Whenever there is an improvement in symptoms, a treatment of up to six months in duration is recommended. From this point on, the medication should not be continued without consulting a doctor to evaluate 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 Toxicological Information Service at tel.: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Remifemin:

Do not take a double dose to compensate for the missed doses, but continue taking Remifemin at the usual time.

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

Like all medications, Remifemin may cause adverse effects, although not everyone will experience them.

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

Gastrointestinal disturbances (dyspepsia, diarrhea), skin allergic reactions (urticaria, pruritus, cutaneous rash), facial edema, peripheral edema, and weight gain have been described. The frequency of these cases is unknown. If you experience these types of effects, do not continue treatment and consult your doctor.

Reporting Adverse Effects

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

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

Do not store at a temperature 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 drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. In this way, you will help protect the environment.

Composition of Remifemin:

• The active ingredient is 0.018 – 0.026 ml of liquid extract of Cimicifuga racemosa L. rhizome, corresponding 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 content of the container

Round tablets, with a slightly beige color.

Each container contains 60 tablets.

Manufacturer and responsible party

The manufacturer and responsible party 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 prospectus was approved in June 2014

The detailed and updated information on this medication is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.es/