Remifemin

1. What is Remifemin and what is it used for

Remifemin is a medicine containing a liquid extract of black cohosh root ( Cimicifugae
racemosae rhizoma).
Remifemin is a herbal medicine that alleviates symptoms during menopause.
Remifemin is taken as a remedy to alleviate menopausal symptoms such as hot flashes and excessive sweating.
If after 2 - 4 weeks there is no improvement or the patient feels worse, you should consult a doctor.

2. Important information before taking Remifemin

When not to take Remifemin

If the patient is allergic (hypersensitive) to the active substance or any of the other ingredients of this medicine (listed in section 6.)

Warnings and precautions

You should exercise special caution and discuss with your doctor:

• if the patient has liver function disorders. In such cases, liver function tests should be performed.
• if symptoms suggesting liver damage appear (fatigue, loss of appetite, yellowing of the skin and eyes, severe pain in the upper abdomen, nausea, vomiting, dark urine color).

In such cases, you should stop taking Remifemin and immediately consult a doctor.

• if genital bleeding or other disturbing symptoms occur. You should consult a doctor to clarify their cause.
• if the patient is taking estrogens. The use of Remifemin together with estrogens can only be decided by a doctor.
• if the patient has been or is being treated for breast cancer or other hormone-dependent tumors.

If any of the above cases apply to the patient, you should consult a doctor before starting to take Remifemin.
The medicine is not intended for men.

Children and adolescents

The medicine is not intended for children and adolescents under 18 years of age.

Other medicines and Remifemin

Interactions with other medicines are not known.
You should inform your doctor about all medicines you are currently taking or have recently taken.

Remifemin with food, drink, and alcohol

No interactions are known

Pregnancy, breastfeeding, and fertility

The safety of using Remifemin during pregnancy and breastfeeding has not been established.
You should not take the medicine during pregnancy and breastfeeding.
The effect of the medicine on fertility is not known. Women of childbearing age should consider using effective contraception.
If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult a doctor before taking this medicine.

Driving and using machines

Studies on the effect on the ability to drive and use machines have not been conducted.

The medicine contains lactose.

If you have previously been diagnosed with intolerance to some sugars, you should consult a doctor before taking Remifemin.

3. How to take Remifemin

This medicine should always be taken as described in the patient leaflet or as directed by a doctor or pharmacist. In case of doubt, you should consult a doctor or pharmacist.
The recommended dose for adult women is:
2 times a day, 1 tablet each time (1 tablet in the morning and 1 tablet in the evening).
Tablets should be swallowed whole with a sufficient amount of liquid.

Duration of treatment

The effects of Remifemin do not appear immediately. The first therapeutic effects appear after two weeks of taking the medicine. It is recommended to take Remifemin for several months, but taking the medicine for more than 6 months requires consultation with a doctor.

Taking a higher dose of Remifemin than recommended

No cases of Remifemin overdose have been reported. In case of taking a higher dose than recommended, you should immediately consult a doctor or pharmacist.

Missing a dose of Remifemin

You should not take a double dose to make up for a missed tablet, but continue taking the medicine at the usual time.
In case of any further doubts related to the use of this medicine, you should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Possible side effects of the medicine and their frequency:
very common: (≥1/10)
common: (≥1/100 to <1>uncommon: (≥1/1,000 to <1>rare: (≥1/10,000 to <1>very rare: (<1>not known: (cannot be estimated from the available data)
During the use of the medicine, the following may occur:
Rarely:
gastrointestinal disorders (indigestion, diarrhea), skin allergic reactions (hives, itching, rash), facial edema and peripheral edema, weight gain.
Not known:
Cases of hepatotoxicity (including hepatitis, jaundice, abnormal liver test results) of products containing black cohosh ( Cimicifuga) have been reported.

Reporting side effects

If you experience any side effects, including any possible side effects not listed in the leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
e-mail: ndl@urpl.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help gather more information on the safety of the medicine.

5. How to store Remifemin

There are no special storage instructions.
The medicine should be stored in a place inaccessible and invisible to children.
Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of the given month.
Medicines should not be disposed of via wastewater or household waste containers. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Remifemin contains

The active substance is an extract of black cohosh root - Cimicifugae racemosae rhizomae extractum fluidum (0.78 – 1.14:1) isopropanolicum 40% (V/V).
1 tablet contains 0.018-0.026 ml of this extract.
The other ingredients are:
cellulose (powdered cellulose and lactose monohydrate), potato starch, magnesium stearate, peppermint oil.

What Remifemin looks like and contents of the pack

Round, light beige tablets.
The packaging contains 30, 60, 100, and 200 tablets.

Marketing authorization holder and manufacturer:

Schaper & Brümmer GmbH & Co. KG
Bahnhofstraße 35
38259 Salzgitter, Germany

To obtain more detailed information, you should contact the representative

of the marketing authorization holder::
Orkla Care S.A., ul. Fabryczna 5a, 00-446 Warsaw, phone: +48 22 358 13 00, e-mail:
office@orklacare.pl
Date of the last update of the leaflet: