PREFEMIN TBL 20MG N90

ATC code: G02CX 

Active substances: Agni Casti Fructus Extractum Siccum

Vendor, principal: Nycomed Sefa As. 
No prescription needed/Patient care products, dressings, gloves, medical devices,...

PREFEMIN 20MG N90

Package leaflet: Information for the user

Prefemin, 20 mg film-coated tablets

Dry chasteberry fruit extract

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.
-   Keep this leaflet. You may need to read it again.
-   Ask your pharmacist if you need more information or advice.
-   If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
-   You must talk to a doctor if you do not feel better or if you feel worse after one month.

What is in this leaflet

1.   What Prefemin is and what it is used for
2.   What you need to know before you use Prefemin
3.   How to use Prefemin
4.   Possible side effects
5.   How to store Prefemin
6.   Contents of the pack and other information

1. What Prefemin is and what it is used for

Prefemin is used to treat complaints associated with the premenstrual syndrome, which begin up to two weeks before menstruation and disappear as menstruation begins.
The premenstrual syndrome may include different physical and psychological complaints and symptoms, such as headache, skin problems, breast tenderness, discomfort in the abdomen, mood swings, irritability, nervousness, depressiveness, fatigue and insomnia.

2. What you need to know before you use Prefemin Do not use Prefemin:

-   if you are allergic to chasteberry fruits or any of the other ingredients of this medicine (listed in section 6);
-   if you are pregnant or breast-feeding;
-   if you are a girl or an adolescent under the age of 18.

Warnings and precautions

Talk to your doctor or pharmacist before using Prefemin.
Patients who have or have had oestrogen-dependent tumours should talk to a doctor before using Prefemin.
Patients who use dopamine agonists, dopamine antagonists, oestrogens and antioestrogens, should talk to a doctor before using Prefemin (see section “Other medicines and Prefemin”).
Limited adequate data is available on the use in girls and adolescents under the age of 18.
If symptoms worsen during the use of Prefemin, talk to a doctor or pharmacist.
Patients with a pituitary disorder should ask a doctor for advice before taking this medicine.
In the case of prolactin-secreting pituitary tumours, the use of chasteberry fruits may mask the symptoms of a tumour.

Other medicines and Prefemin

Mutual decrease in effect cannot be excluded if the tablets are concomitantly used with dopamine agonists, dopamine antagonists, oestrogens and antioestrogens.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Pregnancy, breast-feeding and fertility

During pregnancy, the use of Prefemin is not necessary.
Do not use Prefemin during breast-feeding, as it may reduce breast milk production.
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.

Driving and using machines

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

Prefemin contains lactose monohydrate

Prefemin contains lactose monohydrate as an excipient. If you have been told by your doctor that you have intolerance to some sugars, talk to your doctor before taking this medicine.

3. How to use Prefemin

Adult women
The usual dose is one tablet a day (including on days without complaints). The treatment should last for at least 3 months.
It is advisable to take the tablet with a small amount of water and at the same time every day (for example, in the morning after waking up or in the evening before bedtime), irrespective of meal times.

If you forget to take Prefemin

Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Severe allergic reactions, including swelling of the face, dyspnoea and swallowing difficulties. The following side effects have been reported (incidence is unknown):
(Allergic) skin reactions (rash and urticaria), headache, dizziness, gastrointestinal disorders
(e.g. nausea, stomach pain), acne, menstrual cycle disorders.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the website of the State Agency of Medicines: www.ravimiamet.ee. By reporting side effects you can help provide more information on the safety of this medicine.

5.   How to store Prefemin

Keep this medicine out of the sight and reach of children.
Do not store at a temperature higher than 25 °C. Store in the original package, protected from moisture.
Do not use this medicine after the expiry date which is stated on the carton after “Use by” and on the blister after “EXP”. The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6.   Contents of the pack and other information

What Prefemin contains

One film-coated tablet contains:
The active substance is 20 mg of dry chasteberry fruit extract (Agni casti fructus extractum siccum) (6-12:1), which equals 120-240 mg of natural chasteberry fruits (Vitex agnus castus). Other ingredients:
Tablet content: colloidal anhydrous silica, microcrystalline cellulose, lactose monohydrate, magnesium stearate;
Tablet coating: macrogol 400 and 20000, hypromellose, propylene glycol and titanium dioxide (E171).
Extract: ethanol 60% (m/m).

What Prefemin looks like and contents of the pack

White, round, coated tablet.
30 or 90 tablets in a blister package and outer carton. Not all pack sizes may be marketed.

Marketing Authorisation Holder

UAB “Sirowa Vilnius”
Eisiskiq pl. 8A,
LT - 02184 Vilnius Lithuania

Manufacturer

UAB Entafarma Klonenq vs. 1, LT-19156 Širvintp r. sav.,
Lithuania
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Sirowa Tallinn AS Salve 2c 11612 Tallinn Estonia
Telephone: +372 6 830 700

This leaflet was last revised in March 2014

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