Remifemin plus 60 tablets

Remifemin® plus dragees are herbal medicinal products for relieving menopausal symptoms (such as hot flashes, sweating), especially with pronounced symptoms such as moodiness, nervousness, irritability and lack of concentration.

If you do not feel better or if you feel worse after 6 weeks, contact your doctor.

Contraindications

Remifemin® plus dragees must not be taken,

• if you are allergic to black cohosh, St. John's wort or any of the other ingredients of Remifemin® plus coated tablets mentioned in section 6.
• if you are being treated with any of the following medicines at the same time:

- ciclosporin (suppresses the immune system)

- Oral tacrolimus (suppresses the immune system after transplantation)

- amprenavir, indinavir and other proteinase inhibitors (used to treat HIV infection or AIDS)

- Irinotecan (cytostatic used to treat cancer)

- Warfarin (inhibits blood clotting).

interactions

No interactions have been reported for medicinal products containing black cohosh.

Remifemin® plus dragees must not be taken at the same time as the following medicines, as they can reduce their effect (see also the section “Remifemin® plus dragees must not be taken”): ciclosporin, tacrolimus for oral use, amprenavir, indinavir, other proteinase inhibitors, irinotecan, warfarin.

The simultaneous use of certain medicines for the treatment of depression or anxiety (serotonin reuptake inhibitors such as sertraline, paroxetine, nefazodone), the medicine buspirone (for severe pain) or some medicines for migraine (triptans) can increase their undesirable effects.

Medicines that contain ingredients from St. John's wort (Hypericum), such as Remifemin® plus dragees, can reduce the effectiveness of other medicines, such as amitriptyline, fexofenadine, benzodiazepines, methadone, simvastatin, digoxin. Please ask your doctor or pharmacist if you are taking any of these medications.

If you are receiving concomitant hormone replacement therapy, medical supervision is required.

Remifemin® plus coated tablets can affect the effectiveness of contraceptive medicines (“birth control pills”). Increased bleeding between periods is possible. Additional contraceptive measures should be used to avoid unwanted pregnancies.

Before a planned operation, you must inform the treating physicians that you are taking Remifemin® plus dragees.

Taking Remifemin® plus dragees with food, drink and alcohol
No special precautions are necessary.

Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Since there is insufficient data, taking Remifemin® plus dragees during pregnancy and breastfeeding cannot be recommended.

Women of childbearing potential should consider effective non-hormonal contraceptive methods while taking this drug.

application

The recommended dose for women going through the menopause is:
1 Remifemin® plus dragee twice a day (morning and evening), if necessary 2 Remifemin® plus dragees twice a day.

Use in children and adolescents:
There is no area of ​​application for Remifemin® plus coated tablets in children and adolescents under the age of 18 or in men.

Method of application:
To be taken orally, whole with sufficient liquid.

Duration of use:
Remifemin® plus dragees do not work immediately, the onset of effect becomes apparent after 2 weeks of treatment.

If your symptoms worsen or do not improve after 6 weeks of use, you must consult a doctor.

In order not to overlook other diseases, a doctor should be consulted at least every 6 months.

side effects

Cases of liver damage (including hepatitis, yellowing of the skin, changes in liver function blood tests) have been reported with the use of medicines containing black cohosh. In this case, taking Remifemin®plus Dragees must be stopped immediately.

Skin reactions (such as hives, itching, rash), swelling of the face, swelling of the legs, weight gain, gastrointestinal disorders (such as indigestion, diarrhoea), tiredness and restlessness may occur.

Light-skinned people can react to intense exposure to the sun with symptoms similar to sunburn.

The frequency with which side effects occur is not known.

composition

• The active ingredients are:
  1 coated tablet contains dry extract of Cimicifuga rootstock (6 - 11 : 1) 2.5 - 5 mg corresponding to 1 mg triterpene glycosides, calculated as 27-deoxyactein extractant 2-propanol 40% (V/V)

Dry extract of St. John's wort (3.5 - 6 : 1) 58.0 - 85.0 mg equivalent to 0.25 mg total hypericin,
calculated as hypericin
extractant ethanol 60% (v/v)

• The other ingredients are:
  microcrystalline cellulose, lactose monohydrate, potato starch hypromellose, glycerol dibehenate, colloidal anhydrous silica, macrogol 6000, indigotine E 132, talc, iron oxide E 172, magnesium stearate, glycerol alconate