Herbal medicinal product

What is Prefemin and when is it used?

Prefemin contains a dry extract from the fruits of chaste tree (Vitex agnus-castus) as an active ingredient. .

The fruits of chasteberry relieve symptoms before menstruation (premenstrual syndrome, PMS). Prefemin is therefore used for symptoms that begin up to two weeks before menstruation and disappear again when bleeding begins. The complaints include physical and mental ailments that make everyday work difficult. These are complaints such as headaches, skin problems, a slight feeling of tension in the breasts, abdominal pain and mood swings, irritability, nervous tension, moodiness, tiredness and sleep problems. In addition, Prefemin is also traditionally used for menstrual cycle disorders (too frequent or too infrequent menstrual periods).

Prefemin can also be taken by women who are taking a preparation for hormonal contraception ("the pill") and have symptoms prior to bleeding

What should be considered?

A doctor should be consulted if there is tension and swelling in the breasts or if there are problems with the menstrual period.

This medicinal product contains approximately 40 mg of digestible carbohydrates per single dose (1 film-coated tablet). The drug is suitable for diabetics.

When should Prefemin not be taken/used or only with caution?

The film-coated tablets may be used in the event of hypersensitivity to one of the ingredients (see «What does Prefemin contain?»). not be taken.

Tell your doctor, pharmacist or druggist if you

• suffer from other diseases,
• have allergies or
• take other medicines (including those you bought yourself!)!

Prefemin contains lactose. Please only take Prefemin after consulting your doctor if you know that you suffer from a sugar intolerance.

Please only take Prefemin after consulting your doctor,

• if you have or have had an estrogen-sensitive malignancy.
• if you have or have had a disease of the pituitary gland (pituitary gland)
• if you use dopamine agonists, dopamine antagonists, estrogens or anti-estrogens

A mutual weakening of the effect cannot be ruled out when dopamine antagonists are administered (certain drugs used to treat psychotic disorders , e.g. haloperidol, sulpiride; or to promote gastric emptying and motility in the gastrointestinal tract, e.g. metoclopramide, domperidone) and anti-oestrogens (certain medicines used to treat breast cancer, e.g. tamoxifen, anastrozole). A mutual strengthening of the effect cannot be ruled out when dopamine agonists (medicines for the therapy of Parkinson's disease, e.g. cabergoline, pramipexole) and estrogens (e.g. with hormonal contraceptives) are administered.

Can Prefemin be taken during pregnancy or while breastfeeding?

There is no need to take Prefemin during pregnancy, as menstruation naturally does not occur.

You should not take the medicine or ask your doctor for advice if you are breast-feeding.

Based on previous experience, there is no known risk for the child when used as intended. However, systematic scientific investigations have never been carried out. As a precaution, you should avoid taking medicines during pregnancy and breastfeeding or ask your doctor, pharmacist or druggist for advice.

How do you use Prefemin?

Take 1 film-coated tablet of Prefemin every day. A minimum of 3 months of therapy is recommended as efficacy is built up during this period. The film-coated tablet is taken with a little water, preferably at the same time each day, e.g. after getting up or before going to bed, regardless of meals.

Follow the dosage given in the package leaflet or as prescribed by your doctor. If you think the medicine is too weak or too strong, talk to your doctor, pharmacist or druggist.

The use and safety of Prefemin in children and adolescents has not yet been tested.

What side effects can Prefemin have?

The following side effects have been observed for Prefemin:

Rashes and itchy skin. In this case, the therapy should be discontinued and, if necessary, a doctor should be consulted.

Changes in frequency or intensity of menstrual bleeding.

No information is available on the frequency of occurrence.

In the event of menstrual disorders in connection with treatment with Prefemin, a doctor should be consulted (see "What should be considered?").

In a few cases, individual symptoms of the premenstrual syndrome can occur more frequently at the beginning of treatment with Prefemin.

If there is no improvement or if the symptoms or menstrual disorders worsen further, a doctor should be consulted.

If you get any side effects, talk to your doctor, pharmacist or druggist. This also applies in particular to side effects that are not listed in this leaflet.

What else needs to be considered?

The medicinal product may only be used up to the date marked «EXP» on the container.

Storage Instructions

Store at room temperature (15 - 25 °C) in the original packaging.

Keep out of the reach of children.

Further information

Your doctor, pharmacist or druggist can provide you with further information.

What does Prefemin contain?

Active ingredients

1 film-coated tablet contains 20 mg dry extract of chasteberry fruits ( Vitex agnus-castus L., fructus), drug-extract ratio 6 – 12: 1, extractant ethanol 67.7% (V/V).

Excipients

Microcrystalline cellulose, lactose monohydrate (40 mg), colloidal silicon dioxide, hypromellose, titanium dioxide (E 171), magnesium stearate, macrogol 400, propylene glycol (E 1520) , macrogol 20'000.

Approval number

55037 (Swissmedic)

Where can you get Prefemin? What packs are available?

In pharmacies and drugstores, without a doctor's prescription.

Blisters of 30 and 90 film-coated tablets.

Authorization holder

Max Zeller Söhne AG, CH-8590 Romanshorn

This leaflet was last checked by the Medicines Agency (Swissmedic) in June 2021.