Prefemin Pms

PATIENT INFORMATION LEAFLET

Leaflet attached to the packaging: patient information

Prefemin PMS, 20 mg, coated tablets
( Agni casti fructus extractum siccum)

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in the patient leaflet or according to the pharmacist's instructions.

• Keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor or pharmacist. See section 4.
• If after 3 months there is no improvement or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet:

• 1. What is Prefemin PMS and what is it used for
• 2. Important information before taking Prefemin PMS
• 3. How to take Prefemin PMS
• 4. Possible side effects
• 5. How to store Prefemin PMS
• 6. Package contents and other information

1. What is Prefemin PMS and what is it used for

Prefemin PMS, coated tablets, contain an extract of chasteberry ( Vitex agnus-castus L. fructus), which reduces the severity of premenstrual symptoms (so-called premenstrual syndrome) in women.
Symptoms of premenstrual syndrome most often occur in the form of: headache, skin changes, feeling of tension and swelling in the breasts, gastrointestinal disorders, mood changes, irritability, and nervous tension. These symptoms appear in the period up to two weeks before menstruation.

Indications

Prefemin PMS is a herbal medicine for the treatment of premenstrual syndrome.

2. Important information before taking Prefemin PMS

When not to take Prefemin PMS

• if the patient is hypersensitive (allergic) to chasteberry ( Vitex agnus-castus L. fructus) or to any of the excipients of the medicine (listed in section 6).

Warnings and precautions

Consult a doctor

• if the patient has or has had an estrogen-dependent malignant tumor;
• if the patient is taking dopamine agonists (e.g., some medicines used in Parkinson's disease), dopamine antagonists (some medicines used in schizophrenia, bipolar affective disorders, nausea, or vomiting), estrogens (e.g., used in hormone replacement therapy), and anti-estrogens (e.g., some medicines used in breast cancer treatment);
• if symptoms worsen during the use of the medicinal product;
• if the patient has a history of pituitary disorders;
• if the patient has prolactin-secreting pituitary tumors, as the consumption of chasteberry ( Vitex agnus-castusL., fructus) may mask the symptoms of the tumor.

Children and adolescents

The safety of the medicinal product in children and adolescents under 18 years of age has not been established due to the lack of appropriate data.

Prefemin PMS and other medicines

It cannot be ruled out that the extract of chasteberry ( Vitex agnus-castusL., fructus) interacts with dopamine agonists (e.g., some medicines used in Parkinson's disease), dopamine antagonists (some medicines used in schizophrenia, bipolar affective disorders, nausea, or vomiting), estrogens (e.g., used in hormone replacement therapy), and anti-estrogens (e.g., some medicines used in breast cancer treatment).
Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.

Pregnancy and breastfeeding

There are no indications for use in pregnant women.
Based on reproductive studies, extracts of chasteberry may affect lactation. It is not recommended to use during breastfeeding.
If you are pregnant, breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine.

Driving and using machines

No studies have been conducted on the effects on the ability to drive and use machines.

Prefemin PMS contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, consult your doctor before taking this medicinal product.

3. How to take Prefemin PMS

This medicine should always be taken exactly as described in this leaflet or according to the doctor's or pharmacist's instructions. In case of doubt, consult a doctor or pharmacist.
Recommended dose:
Adult women: 1 coated tablet per day.
Method of administration:
For oral use. The coated tablet should be swallowed with water, regardless of meals, preferably at the same time, e.g., after waking up or before going to bed.
Duration of therapy:
To achieve the optimal treatment effect, it is recommended to continue taking the medicine for 3 months (also during menstruation). If symptoms persist after uninterrupted use for more than three months, consult a doctor or qualified healthcare professional.
Children and adolescents:
There is no appropriate indication for use in children before puberty.
It is not recommended to use in children and adolescents under 18 years of age due to the lack of sufficient data (see "Warnings and precautions").

Taking a higher dose of Prefemin PMS than recommended

There are no known cases of overdose. A patient who has taken a higher dose of the medicine than recommended should inform their doctor. The doctor will decide on the necessary measures.

Missing a dose of Prefemin PMS

In case of a missed dose, the next dose should be taken at the usual time, according to the dosing schedule. Do not take a double dose to make up for the missed dose.

4. Possible side effects

Like all medicines, Prefemin PMS can cause side effects, although not everybody gets them.
Severe allergic reactions with facial swelling, shortness of breath, and difficulty swallowing have been reported. Skin reactions (allergic) (e.g., rash, hives), headaches, dizziness, gastrointestinal disorders (such as nausea, abdominal pain), acne, and menstrual disorders may occur. The frequency is not known.
In individual cases, the symptoms of premenstrual syndrome may worsen at the beginning of Prefemin PMS treatment.
After the first signs of hypersensitivity/allergic reaction appear, do not take Prefemin PMS again.
If other side effects not mentioned above occur, consult a doctor or pharmacist.
Reporting side effects
If you experience any side effects, including any side effects not listed in the leaflet, tell your doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309, website: https://smz.ezdrowie.gov.pl.
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of the medicine.

5. How to store Prefemin PMS

Keep out of the reach and sight of children.
Store in a temperature not exceeding 25°C, in a dry place.
Do not use the medicine after the expiry date stated on the packaging.

6. Package contents and other information

What Prefemin PMS contains

The active substances of the medicine are: Agni casti fructus extractum siccum
Other ingredients of the medicine are: microcrystalline cellulose, lactose monohydrate, magnesium stearate, colloidal silicon dioxide.
Coating composition: Macrogol 400, Macrogol 20 000, propylene glycol; white coating suspension: hypromellose, titanium dioxide (E 171), Macrogol 400.

What Prefemin PMS looks like and what the pack contains

Prefemin PMS is available in packs of 30 or 90. One blister pack of PVC/PVDC/Al contains 30 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder:

Sirowa Poland Sp. z o.o.
ul. Poselska 11
03-931 Warsaw
Poland
Importer:
PHOENIX Pharma Polska Sp. z o.o.
ul. Rajdowa 9, Konotopa
05-850 Ożarów Mazowiecki
Poland

Date of last revision of the leaflet: 09.2022