Package leaflet: Information for the user

Remifemin
0.018 – 0.026 ml, tablets
Cimicifugae racemosae rhizomae extractum fluidum (0.78-1.14:1) isopropanolicum 40% (v/v)
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.
This medicine should always be taken as described in this patient leaflet or as directed by a
physician or pharmacist.

Keep this leaflet, so that you can read it again if necessary.
Speak to your pharmacist if you need advice or further information.
If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist.
If there is no improvement after 2–4 weeks, or if the patient feels worse, contact a doctor.

Contents of the leaflet:

What Remifemin is and what it is used for
Important information before taking Remifemin
How to take Remifemin
Possible side 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 medicine containing a liquid extract from the rhizome of black cohosh (Cimicifugae
racemosae rhizoma).
Remifemin is a herbal medicinal product used to relieve menopausal symptoms.
Remifemin is used to alleviate menopausal symptoms such as hot flushes and excessive sweating.
If there is no improvement after 2–4 weeks, or if the patient feels worse, consult a doctor.

2. Important information before taking Remifemin
When not to take Remifemin
Do not take Remifemin if you are allergic (hypersensitive) to the active substance or to any of the
other ingredients of this medicine (listed in section 6).

Warnings and precautions
Exercise particular caution and discuss with your doctor:

if you have been diagnosed with liver function disorders. In such cases, liver function tests should be performed.
if symptoms suggesting liver damage occur (such as fatigue, loss of appetite, yellowing of the skin or eyes, severe pain in the upper abdomen, nausea, vomiting, dark urine).

In such cases, stop taking Remifemin immediately and contact your doctor without delay.

if vaginal bleeding or other worrying symptoms occur. Consult your doctor to determine the cause.
if you are taking estrogens. The decision to use Remifemin together with estrogens can only be made by a doctor.
if you have previously been treated or are currently being treated for breast cancer or other hormone-dependent tumors.

If any of the above situations apply to you, consult your doctor before starting treatment with Remifemin.
This medicine is not intended for use in men.

Children and adolescents
This medicine is not intended for use in children and adolescents under 18 years of age.

Other medicines and Remifemin
Interactions with other medicines are not known.
Inform your doctor about all medicines you are currently taking or have recently taken.

Remifemin with food, drink and alcohol
Interactions are not known.

Pregnancy, breastfeeding and fertility
The safety of Remifemin during pregnancy and breastfeeding has not been established.
Do not take this medicine during pregnancy or breastfeeding.
The effect of the medicine on fertility is unknown. Women of childbearing potential should consider using effective contraception.
If you are pregnant or breastfeeding, suspect you may be pregnant, or are planning to have a baby, consult your doctor before taking this medicine.

Driving and using machines
Studies on the ability to drive and operate machinery have not been conducted.

This medicine contains lactose.
If you have previously been diagnosed with intolerance to certain sugars, consult your doctor before taking Remifemin.

3. How to take Remifemin

This medicine should always be taken as described in this patient leaflet or as directed by your doctor. If in doubt, consult your doctor or pharmacist.
The recommended dose for adult women is:
1 tablet twice daily (one tablet in the morning and one in the evening).
Tablets should be swallowed whole with an adequate amount of liquid.

Duration of treatment
The therapeutic effects of Remifemin do not appear immediately. The first beneficial effects are usually observed after two weeks of treatment. It is recommended to take Remifemin for several months; however, treatment longer than 6 months requires consultation with a doctor.

Taking more Remifemin than recommended
No cases of overdose with Remifemin have been reported. If you take more than the recommended dose, contact your doctor or pharmacist immediately.

If you miss a dose of Remifemin
Do not take a double dose to make up for a missed tablet. Continue taking the medicine at your usual times.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Possible adverse reactions of the medicine and their frequency of occurrence:
very common: (≥1/10)
common: (≥1/100 to <1/10)
uncommon: (≥1/1,000 to <1/100)
rare: (≥1/10,000 to <1/1,000)
very rare: (<1/10,000)
not known: (cannot be estimated from the available data)

The following may occur during treatment with the medicine:
Rare:
gastrointestinal disorders (dyspepsia, diarrhoea), skin allergic reactions (urticaria, pruritus, rash), facial swelling and peripheral oedema, weight gain.

Not known:
Cases of hepatotoxicity (including hepatitis, jaundice, abnormal liver function tests) have been reported with products containing black cohosh (Cimicifuga).

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
e-mail: [email protected]

Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Remifemin

No special storage instructions are required.
The medicine should be stored out of the reach and sight of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

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

What Remifemin looks like and contents of the pack
Round, light beige tablets.
The pack contains 30, 60, 100 or 200 tablets.

Marketing Authorisation Holder and Manufacturer:
Schaper & Brümmer GmbH & Co. KG
Bahnhofstraße 35
38259 Salzgitter, Germany

For further information, contact the representative of the Marketing Authorisation Holder:
Orkla Care S.A., ul. Fabryczna 5a, 00-446 Warsaw, tel. +48 22 358 13 00, e-mail:
[email protected]