Package leaflet: Information for the patient

Prefemin PMS, 20 mg, coated tablets
( Agni casti fructus extractum siccum )
Please read all of this leaflet carefully before taking this medicine, because
it contains important information for the patient.
This medicine should always be taken exactly as described in this patient information leaflet or as directed by the pharmacist.

Keep this leaflet, so that you can read it again if necessary.
If you need advice or further information, consult your pharmacist.
If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement after 3 months of treatment, or if you feel worse, consult your doctor.

Contents of the leaflet:

What Prefemin PMS is and what it is used for
Important information before taking Prefemin PMS
How to take Prefemin PMS
Possible side effects
How to store Prefemin PMS
Contents of the pack and other information

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

Prefemin PMS coated tablets contain an extract from the fruit of the chaste tree ( Vitex agnus-castus L. fructus ), which reduces the severity of premenstrual symptoms (so-called premenstrual syndrome) in women.
Premenstrual symptoms most commonly include: headache, skin changes, breast tension and swelling, gastrointestinal discomfort, mood changes, irritability, and nervous tension. These symptoms typically occur during the one- to two-week period before menstruation.
Indications
Prefemin PMS is a herbal medicinal product for the treatment of premenstrual syndrome.

2. Information before using Prefemin PMS

When not to use Prefemin PMS

if the patient has hypersensitivity (allergy) to the fruit of the common chaste tree ( Vitex agnus-castus L. fructus ) or to any of the excipients of the medicine (listed in section 6).

Warnings and precautions
Please consult a doctor

if the patient suffers or has suffered from estrogen-dependent malignant tumours;
if the patient is taking medicines belonging to the following groups: 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), or antiestrogens (e.g. some medicines used in breast cancer treatment);
if symptoms worsen during use of the medicinal product;
if the patient has a history of pituitary gland disorders;
if the patient has prolactin-secreting pituitary tumours, because consumption of the fruit of common chaste tree ( Vitex agnus-castus L., fructus ) may mask symptoms of the tumour.

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

Prefemin PMS and other medicines
Interactions between the extract of the fruit of common chaste tree ( Vitex agnus-castus L., fructus ) and 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 antiestrogens (e.g. some medicines used in breast cancer treatment) cannot be ruled out.
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient intends to take.

Pregnancy and breastfeeding
There is no indication for use in pregnant patients.
Reproduction studies indicate that extracts of the fruit of common chaste tree may affect lactation. Use during breastfeeding is not recommended.
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.

Driving and operating machinery
No studies on the effects on the ability to drive and operate machinery have been conducted.

Prefemin PMS contains lactose
If the patient has been diagnosed by a doctor as having an intolerance to certain sugars, she should consult a doctor before using the medicinal product.

3. How to use Prefemin PMS

This medicine should always be taken exactly as described in this leaflet or
as directed by your doctor or pharmacist. If in doubt, consult your 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, with or without food, preferably at the same time each day, e.g. after waking up or before going to bed.
Duration of therapy:
To achieve optimal treatment effect, it is recommended to continue taking the medicine for 3 months (including during menstruation). If symptoms persist after continuous use for more than three months, consult your doctor or a qualified healthcare professional.
Children and adolescents:
There is no appropriate indication for use in children before puberty. Use in children and adolescents under 18 years of age is not recommended due to insufficient data (see section "Warnings and precautions").
Use of a higher than recommended dose of Prefemin PMS
Cases of overdose are not known. A patient who has taken more than the recommended dose should inform her doctor. The doctor will decide on appropriate measures.
Missed dose of Prefemin PMS
If a dose is missed, take the next dose at the usual time according to the dosing schedule. Do not take a double dose to make up for the missed dose.

4. Possible adverse effects

Like all medicines, Prefemin PMS may cause adverse effects, although not
everyone will experience them.
Severe allergic reactions with facial swelling, shortness of breath, and difficulty
swallowing have been reported. Skin (allergic) reactions (e.g. rash, urticaria),
headache, dizziness, gastrointestinal disorders (such as nausea, abdominal pain),
acne, and menstrual disturbances may occur. Frequency is unknown.
In isolated cases, individual symptoms of premenstrual tension syndrome may
worsen at the beginning of treatment with Prefemin PMS.
After the first signs of hypersensitivity/allergic reaction, Prefemin PMS must not be
re-administered.
If any adverse effects not listed above occur, consult a physician or pharmacist.

Reporting of adverse effects
If any adverse symptoms occur, including any adverse effects not listed in this leaflet,
inform your doctor, pharmacist, or nurse. Adverse effects can be reported directly to the
Department of Monitoring Adverse Drug Reactions of the Office for Registration of
Medicinal Products, Medical Devices and Biocidal Products: Al. Jerozolimskie 181C,
02-222 Warsaw, phone: 22 49-21-301, fax: 22 49-21-309, website:
https://smz.ezdrowie.gov.pl.
Adverse effects may also be reported to the marketing authorization holder.
Reporting adverse effects helps to gather further information on the safety of the medicine.

5. How to store Prefemin PMS

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

6. Contents of the pack and other information

What Prefemin PMS contains
The active substances in the medicine are: Agni casti fructus extractum siccum
Other ingredients in 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 contents of the pack
Prefemin PMS is available in packs containing 30 or 90 tablets. One blister made of PVC/PVDC/Al foil contains 30 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder:
Sirowa Poland Sp. z o.o.
Poselska 11 Street
03-931 Warsaw
Poland

Importer:
PHOENIX Pharma Polska Sp. z o.o.
Rajdowa 9, Konotopa
05-850 Ożarów Mazowiecki
Poland

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