REMIFEMIN

REMIFEMIN tablets

Important notes (mandatory information)

Remifemin Tablets. Active ingredient: Dry extract from Cimicifuga rhizome. Areas of application: for the improvement of psychological and neurovegetative symptoms caused by menopause, such as hot flashes, sweating and sleep disorders.

For risks and side effects, read the package leaflet and ask your doctor or pharmacist.


PACKAGE LEAFLET: INFORMATION FOR THE USER

Remifemin Tablets for use in women during menopause
Active ingredient: Dry extract from Cimicifuga rhizome
Herbal medicinal product

Read the entire package leaflet carefully because it contains important information for you. This medicine is available without a prescription. However, Remifemin must be used as directed in order to achieve the best possible treatment results.

• Keep the package leaflet. You may want to read it again later
• Ask your pharmacist if you need more information or advice.
• If your symptoms worsen or do not improve after 4 to 6 weeks, you must consult a doctor.
• If any of the side effects listed here affect you significantly or if you notice any side effects not listed in this package leaflet, please inform your doctor or pharmacist.

This package leaflet contains

1. WHAT IS REMIFEMIN AND WHAT IS IT USED FOR?
2. WHAT DO YOU NEED TO KNOW BEFORE TAKING REMIFEMIN?
3. HOW TO TAKE REMIFEMIN?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE REMIFEMIN?
6. FURTHER INFORMATION

1. WHAT IS REMIFEMIN AND WHAT IS IT USED FOR?

Remifemin is a herbal medicinal product for the improvement of menopausal symptoms. Remifemin is used for the improvement of psychological and neurovegetative symptoms caused by menopause, such as hot flashes, sweating and sleep disorders.

2. WHAT DO YOU NEED TO KNOW BEFORE TAKING REMIFEMIN?

Remifemin must not be taken if you are hypersensitive (allergic) to Cimicifuga rhizome (rhizome of the black cohosh) or any of the other ingredients of Remifemin.

Special care must be taken when taking Remifemin:

• if your menstrual period is disturbed or occurs again. Even if you have persistent unclear symptoms or other symptoms appear again, you should consult a doctor. In these cases, it may be a medical condition that needs to be clarified by a doctor.
• if you are taking oestrogens at the same time, this should only be done under medical supervision. Remifemin can enhance the effect of oestrogens. Talk to your doctor.
• if your liver is damaged. In this case, you should only take Remifemin after consulting your doctor.
• if signs of liver damage occur (yellowing of the skin or eyes, dark urine, pain in the upper abdomen, nausea, loss of appetite, fatigue). In this case, you should stop taking Remifemin immediately and consult a doctor.
• if you are being treated or have been treated for breast cancer or other hormone-dependent tumours, you should not take Cimicifuga preparations without medical advice.
• if the symptoms worsen during treatment with Remifemin, you should consult a doctor or pharmacist.

When taking Remifemin with other medicines

No interactions are known. However, please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, even if they are non-prescription medicines.

Pregnancy and breast-feeding

There are no sufficient data on the use of Remifemin during pregnancy and breast-feeding. Remifemin should therefore not be taken during pregnancy and breast-feeding.

Driving and using machines

No special precautions are required.

Important information about certain other ingredients of Remifemin

This medicine contains lactose (milk sugar). Therefore, please only take Remifemin after consulting your doctor if you know that you suffer from an intolerance to certain sugars.

3. HOW TO TAKE REMIFEMIN?

Always take Remifemin exactly as described in this package leaflet. Please ask your doctor or pharmacist if you are not sure. Unless otherwise prescribed by your doctor, the usual dose is: Take 1 tablet twice a day (morning and evening) unchewed with some liquid (do not suck). You can take the tablets independently of meals.

Duration of use

The effect of Remifemin does not occur immediately. First therapeutic effects become apparent after 2 weeks of treatment. It is recommended to take Remifemin for several months, but not for longer than 6 months without medical advice. Please refer to the information under section 2 "What do you need to know before taking Remifemin?" Please talk to your doctor or pharmacist if you have the impression that the effect of Remifemin is too strong or too weak.

If you have taken more Remifemin than you should

In case of overdose of Remifemin, the side effects listed may occur more frequently. You should then stop taking the medicine and consult a doctor.

If you forget to take Remifemin

Do not take a double dose if you have forgotten to take the previous dose.

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

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, Remifemin can have side effects, although not everybody gets them.

The following frequency information is used to evaluate side effects:
Very common:	more than 1 in 10 treated persons
Common:	1 to 10 in 100 treated persons
Uncommon:	1 to 10 in 1,000 treated persons
Rare:	1 to 10 in 10,000 treated persons
Very rare:	less than 1 in 10,000 treated persons
Not known:	frequency cannot be estimated from the available data.

Rare (less than 1 in 1,000 but more than 1 in 10,000 treated persons):

• Gastrointestinal complaints (upper abdominal complaints, diarrhoea),
• allergic skin reactions (hives, itching, rash),
• swelling of the face or limbs,
• increase in liver values (transaminases),
• weight gain.

Very rare (less than 1 in 10,000 treated persons or unknown):

• Liver damage when using medicines with Cimicifuga rhizome. A safe causal relationship with these medicines has not yet been proven.

In these cases, you should stop taking the medicine and consult your doctor.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Dept. of Pharmacovigilance, Kurt-Georg-Kiesinger Allee 3, D-53175 Bonn, website: www.bfarm.de. By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE REMIFEMIN?

Keep out of reach of children. Do not use the medicine after the expiry date which is stated on the side flap of this pack. The expiry date refers to the last day of the month. This medicine does not require any special storage conditions.

6. FURTHER INFORMATION

What Remifemin contains

The active ingredient is: 1 tablet contains 2.5 mg dry extract from Cimicifuga rhizome (6 - 11 : 1) Extraction solvent: Propan-2-ol (40% V/V). The other ingredients are: Cellulose powder, lactose monohydrate, potato starch, magnesium stearate.

What Remifemin looks like and contents of the pack

Round, light beige tablets Remifemin is available in packs of 60 (N2), 100 (N3) and 200 tablets (hospital pack with 1000 tablets (10 times 100 pcs.).

Pharmaceutical entrepreneur and manufacturer

Schaper & Brümmer GmbH & Co. KG
Bahnhofstraße 35
38259 Salzgitter
Tel.: (0 53 41) 3 07-0
Fax: (0 53 41) 3 07-124
info@schaper-bruemmer.de
http://www.schaper-bruemmer.de

This package leaflet was last revised in November 2014.

Source: Information from the package leaflet
Status: 10/2017
Active ingredient: Dry extract from Cimicifuga rhizome. Areas of application: for the improvement of psychological and neurovegetative symptoms caused by menopause, such as hot flashes, sweating and sleep disorders.