Remifemin tablets
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
REMIFEMIN ® tablets
Extract of Cimicifuga racemosa L.
Read the entire leaflet carefully before you start taking this medicine because it contains important information for you.
Follow exactly the instructions for use of this medicine as described in this leaflet, or those provided by your doctor or pharmacist.
- 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 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 30 days.
PACKAGE LEAFLET CONTENTS:
- What Remifemin is and what it is used for.
- What you need to know before taking Remifemin.
- How to take Remifemin.
- Possible adverse effects.
- How to store Remifemin.
- Contents of the pack and other information.
1. What REMIFEMIN is and what it is used for
Remifemin is a herbal medicinal product for the relief of symptoms associated with menopause.
Remifemin is indicated for the treatment of menopausal symptoms such as hot flushes and excessive 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 STARTING TO TAKE REMIFEMIN
Do not take Remifemin:
If you are hypersensitive (allergic) to the rhizome of Cimicifuga racemosa L. 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 medicine:
- If you have had liver damage. In that case, you should only take Remifemin after consulting your doctor.
- If you notice signs and symptoms that could suggest liver damage (tiredness, loss of appetite, yellowing of the skin or eyes, severe pain in the upper stomach area with nausea and vomiting, or dark urine). In such case, you must immediately stop treatment and consult your doctor.
- If vaginal bleeding or other symptoms occur, consult your doctor.
- If you have been treated or are currently being treated with estrogen for the treatment of breast cancer or other hormone-dependent tumors. You must consult your doctor before starting treatment with Remifemin.
- If symptoms persist or worsen after 8 weeks of treatment, consult your doctor or pharmacist.
Use of Remifemin with other medicines:
No interactions have been reported.
Inform your doctor or pharmacist if you are taking/using, have recently taken/used, or might need to take/use any other medicinal product.
Pregnancy and breastfeeding:
This medicine is not indicated for pregnant or breastfeeding women. The safety of this medicine during pregnancy and breastfeeding has not been established.
If you are pregnant or breastfeeding, think you might be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
Use of a contraceptive method is recommended if there is a possibility of becoming pregnant during treatment.
Driving and use of machinery:
No special precautions are required.
Remifemin contains lactose: If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.
3. HOW TO TAKE REMIFEMIN
Follow exactly the instructions for use provided in this leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
The recommended dose for adult women is: 1 tablet twice daily (morning and afternoon).
The tablets should be swallowed whole, without chewing (do not suck), with sufficient water (preferably with a glass of water).
The tablets may be taken independently of meals.
Duration of treatment
The effects of Remifemin are not immediate and may begin to appear after two weeks of treatment. As long as symptoms improve, a treatment duration of up to six months is recommended. After this period, do not continue taking the medicine without consulting your doctor to assess whether treatment should be continued.
If you take more Remifemin than you should:
In case of accidental ingestion of large quantities, go immediately to a medical center or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the name of the medicine and the amount ingested.
If you forget to take Remifemin:
Do not take a double dose to make up for the missed dose. Continue taking Remifemin at your next scheduled dose.
If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.
4. Possible adverse effects
Like all medicines, Remifemin can cause adverse effects, although not everyone will experience them.
Cases of liver injury (including hepatitis, jaundice, abnormalities in liver function tests) have been reported in association with the use of medicines containing the root of Cimicifuga racemosa L.
Gastrointestinal disorders (dyspepsia, diarrhea), cutaneous allergic reactions (urticaria, pruritus, skin rash), facial edema and peripheral edema, and weight gain have been described. The frequency of occurrence of these cases is unknown. If you experience any of these effects, do not continue treatment and consult your doctor.
Reporting of 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 leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. REMIFEMIN Storage
Keep this medicine out of the sight and reach of children.
Do not store above 30°C.
Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.
Medicines must not be disposed of via wastewater drains or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.
6. PACKAGE CONTENTS AND ADDITIONAL INFORMATION
Composition of Remifemin:
- The active substance is 0.018 – 0.026 ml of liquid extract from the rhizome of Cimicifuga racemosa L., corresponding to 20 mg of the plant (extraction agent: 40% v/v propan-2-ol).
- The other components are: powdered cellulose, potato starch, lactose monohydrate, magnesium stearate, peppermint flavor.
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 patient information leaflet was approved in June 2014.
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.es/