Remifemin plus Johanniskraut Filmtabletten

remifemin® PLUS St. John's Wort Film-Coated Tablets are recommended for pronounced psychological and moderate to severe menopausal symptoms as well as an efficient start of treatment for the first symptoms. The combination of black cohosh and St. John's wort not only alleviates physical symptoms such as hot flashes and sweating, but also psychological symptoms such as mood swings, nervousness and increased irritability.

• With the unique isopropanolic special extract from the black cohosh rhizome (iCR) in the highest approved dosage
• Additionally contains St. John's wort, which also improves psychological menopausal symptoms such as mood swings, nervousness and increased irritability
• Effectiveness and safety of iCR proven in over 35 studies with more than 43,000 women¹
• Hormone-free, and free of phytoestrogens
• Safe for breast and uterine tissue²

 

Application

2 film-coated tablets 2 times a day.

Dose reduction possible:
From the 9th week 2x1 film-coated tablet daily

 

How is it used?

What are Remifemin® plus coated tablets and what are they used for?

Remifemin® plus coated tablets are a herbal medicinal product for the relief of menopausal symptoms (such as hot flashes, sweating), especially with pronounced symptoms such as low mood, nervousness, irritability and difficulty concentrating.

If you do not feel better or even worse after 6 weeks, consult your doctor.

Note

• Patients who are or have been treated for breast cancer or other hormone-dependent tumors should not take preparations made from Cimicifuga without medical advice.
• Contains: Lactose and 3-sn-phosphatidyl)choline (soybean)
• Read the package leaflet!

 

Ingredients

Active ingredients per 1 tablet:

• 70 mg St. John's wort extract
• 3.75 mg black cohosh dry extract

 

Other ingredients: microcrystalline cellulose, glyceryl dibehenate, highly dispersed silicon dioxide, lactose-1-water, poly(vinyl alcohol), lecithin (soybean), xanthan gum, talc, titanium dioxide, black iron(III) oxide hydrate, indigo carmine

 

What should you consider before taking it?

What should you consider before taking Remifemin® plus coated tablets?

Remifemin® plus coated tablets 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 listed in section 6.
• if you are taking any of the following medicines at the same time:
  • Ciclosporin (suppresses the immune system)
  • Tacrolimus for oral use (suppresses the immune system after transplants)
  • Amprenavir, indinavir and other protease inhibitors (for the treatment of HIV infections or AIDS)
  • Irinotecan (cytostatic for the treatment of cancer)
  • Warfarin (inhibits blood clotting).

Warnings and precautions
Please talk to your pharmacist before taking Remifemin® plus coated tablets for the first time.

If you have a history of liver disease, you should only use Remifemin® plus coated tablets with special caution.

If signs of liver damage occur (yellowing of the skin or eyes, dark urine, severe pain in the upper abdomen with nausea and vomiting, fatigue, loss of appetite), you must stop taking Remifemin® plus coated tablets immediately and consult a doctor.

In case of menstrual irregularities, or if these recur after at least twelve months of absence, or in case of persistent unclear or newly occurring other symptoms, a doctor should be consulted for diagnostic clarification.

If you are or have been under medical treatment for a tumor whose growth could be influenced by certain hormones (estrogens)
(e.g. breast cancer or other hormone-dependent cancers), you should only take Remifemin® plus coated tablets on medical advice.

The active ingredient St. John's wort makes you more sensitive to sunlight under certain circumstances. Therefore, you should avoid excessive sunbathing and the use of sunbeds, solariums or UV light therapy while taking Remifemin® plus coated tablets.

Children and adolescents
There is no indication for Remifemin® plus coated tablets in children and adolescents under 18 years of age and in men.

Taking Remifemin® plus coated tablets with other medicines Please inform your doctor or pharmacist if you are taking or have recently taken or intend to take any other medicines.

No interactions have been reported for black cohosh-containing medicines.

Remifemin® plus coated tablets must not be taken at the same time as the following medicines, as they may weaken their effect (see also section "Remifemin® plus coated tablets must not be taken"): Ciclosporin, Tacrolimus for oral use, Amprenavir, Indinavir, other protease inhibitors, Irinotecan, Warfarin.

If 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) are used at the same time, their undesirable effects may be increased.

Medicines that contain ingredients from St. John's wort (Hypericum), like Remifemin® plus coated tablets, can weaken 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 medicines.

If you are receiving hormone replacement therapy at the same time, medical supervision is required.

Remifemin® plus coated tablets can affect the effectiveness of medicines for contraception ("birth control pill"). Increased breakthrough bleeding is possible. To avoid unwanted pregnancies, additional contraceptive measures should be used.

Before a planned operation, be sure to inform the attending physicians that you are taking Remifemin® plus coated tablets.

Taking Remifemin® plus coated tablets with food, drinks and alcohol
No special precautions are necessary.

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, or if you suspect you may be pregnant or intend to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.

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

Women of childbearing potential should consider effective non-hormonal methods of contraception while taking this medicine.

Driving and using machines
No corresponding studies have been conducted on the effect on the ability to drive a vehicle or operate machinery.

Remifemin® plus coated tablets contain milk sugar (lactose).
Therefore, please only take Remifemin® plus coated tablets after consulting your doctor if you know that you suffer from an intolerance to certain sugars.

How should the medicine be taken?

How should Remifemin® plus coated tablets be taken?

Always take this medicine exactly as described in this leaflet or exactly as agreed with your doctor or pharmacist. Check with your doctor or pharmacist if you are not sure.

The recommended dose for women in menopause is
1 Remifemin® plus coated tablet 2 times a day (morning and evening),
if necessary 2 Remifemin® plus coated tablets 2 times a day.

Use in children and adolescents
There is no indication for Remifemin® plus coated tablets in children and adolescents under 18 years of age and in men.

Method of administration
For oral use, swallow whole with sufficient liquid.

Duration of use
Remifemin® plus coated tablets do not work immediately, an effect is noticeable from
2 weeks of treatment.

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

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

If you have taken more Remifemin® plus coated tablets than you should
No poisoning symptoms have been observed to date in cases of overdose of Remifemin® plus coated tablets. After taking a massive overdose (more than 40 coated tablets), sunlight and other UV sources must be avoided for a period of 1-2 weeks.

If you forget to take Remifemin® plus coated tablets:
Do not take a double dose if you have forgotten to take the previous dose.

If you have any further questions about taking this medicine, ask your doctor or pharmacist.

What side effects are possible?

How should Remifemin® plus coated tablets be stored?

Do not store above 30°C.

Keep this medicine out of the reach of children.

Do not use this 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.

Special storage instructions

How should Remifemin® plus coated tablets be stored?

Do not store above 30° C.

Keep this medicine out of the reach of children.

Do not use this 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.

Special notes on the content

Contents of the pack and further information

What Remifemin® plus coated tablets contain

The active ingredients are:
1 coated tablet contains
Dry extract of Cimicifuga rhizome (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
corresponding to 0.25 mg total hypericins,
calculated as hypericin
Extractant ethanol 60 % (V/V)

The other ingredients are:
Microcrystalline cellulose, lactose monohydrate, potato starch Hypromellose, glyceryl dibehenate, highly dispersed silicon dioxide, macrogol 6000, indigo carmine E 132, talc, iron oxide E 172, magnesium stearate, glycerol alkonate

How Remifemin® plus coated tablets look like and contents of the pack
green, shiny coated tablets in blister packs

60 coated tablets
100 coated tablets