Patient Information Leaflet

Femimeno, 4 mg, enteric-coated tablets
Rhei rhapontici radicis extractum siccum raffinatum et quantificatum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.
This medicine should always be taken exactly as described in this patient leaflet or as directed by
your doctor or pharmacist.

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

Table of contents

What Femimeno is and what it is used for
What you need to know before taking Femimeno
How to take Femimeno
Possible side effects
How to store Femimeno
Contents of the pack and other information

1. What Femimeno is and what it is used for

This medicine contains a dried, refined and quantified extract of rhubarb root (Rheum rhaponticum L.).
It is a herbal medicinal product used to relieve menopausal symptoms in women, such as hot flushes.
Menopause is the time marking the end of menstrual cycles. Menopausal symptoms occur during the transitional period before and after menopause.

2. Important information before taking Femimeno

When not to take Femimeno

if the patient is allergic to the root of garden rhubarb ( Rheum rhaponticum L. ) or to any of the other ingredients of this medicine (listed in section 6).
if the patient is pregnant, suspects she may be pregnant, or is breastfeeding.
if the patient has unexplained vaginal bleeding.
if the patient has been treated or is being treated for diagnosed or suspected estrogen-dependent tumours, because it is unknown whether garden rhubarb root may influence their growth.

Warnings and precautions
In case of disorders or recurrent menstrual bleeding, as well as persistent, unexplained or newly occurring symptoms, consult a physician.
These may be signs of diseases requiring medical evaluation and diagnosis.
Do not take this medicine together with medicines containing estrogens (hormonal contraceptives or hormone replacement therapy).

Children and adolescents
Femimeno must not be used in children and adolescents.

Femimeno with other medicines
Inform your doctor or pharmacist about any medicines you are currently taking, have recently taken or plan to take.
No interactions have been observed to date when taking Femimeno with other medicines. However, interaction studies have not been conducted.
When Femimeno is taken concomitantly with acid-binding medicines (antacids), premature dissolution of the enteric coating of Femimeno tablets may occur. Therefore, Femimeno and antacids should be taken at least 1 hour apart.

Pregnancy and breastfeeding
Do not take this medicine if you are pregnant, suspect you may be pregnant, or are breastfeeding. Femimeno is intended for use only in postmenopausal women.
If pregnancy occurs, stop taking Femimeno and consult your doctor.
While taking Femimeno, use appropriate non-hormonal contraception (barrier methods such as condoms). Hormonal contraception (e.g. oral contraceptives) is not recommended.

Driving and operating machinery
This medicine has no effect or has a negligible effect on the ability to drive and operate machinery.

Femimeno contains lactose, sucrose and sodium
Femimeno contains lactose and suc游戏副本

3. How to take Femimeno

This medicine should always be taken exactly as described in this patient information leaflet or as directed by your doctor or pharmacist. Do not exceed the recommended dose. If in doubt, consult your doctor or pharmacist.

Dosing for adult women
The recommended dose is 1 Femimeno enteric-coated tablet once daily.

Method of administration
Femimeno tablets should be swallowed whole with sufficient liquid (e.g. a glass of water), preferably at the same time each day. Take at least half an hour before breakfast or 1–2 hours before other meals.

Duration of treatment
If there is no improvement after 3 months, or if the patient feels worse, consult a doctor.
Femimeno should not be taken for longer than 6 months without medical advice.

Use in children and adolescents
Femimeno should not be used in children and adolescents.

Overdose of Femimeno
No cases of overdose have been reported.

Missed dose of Femimeno
If a dose of Femimeno is missed and less than 12 hours have passed since the usual dosing time, the missed dose should be taken as soon as remembered. If more than 12 hours have passed, the missed dose should not be taken. Wait until the next scheduled dose and take the next tablet at the usual time. Do not take a double dose to make up for a missed tablet.

Stopping Femimeno
No special actions are required. If symptoms listed in section 2, "Warnings and precautions", occur, consult a doctor.

If you have any further doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Frequency unknown (frequency cannot be estimated from the available data)

Allergic reactions (hypersensitivity), such as:
- skin redness (rash)
- skin rash
- skin swelling (including face)
- itching

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions 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,
tel.: + 48 22 49 21 301,
fax: + 48 22 49 21 309,
website: https://smz.ezdrowie.gov.pl.
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Femimeno

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton after:
"Expiry date (EXP)". The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. This will help protect
the environment.
Do not store above 30 °C.

6. Contents of the packaging and other information

What Femimeno contains

The active substance is: Each enteric tablet contains 4 mg of extract (as a purified, dry extract) from Rheum rhaponticum L., radix (rhizome of rhapontic rhubarb) (DER 16-26:1), corresponding to 2.2-2.6 mg of raponticin and 1.0-1.5 mg of desoxyraponticin. Extraction solvent: aqueous solution of calcium oxide (calcium oxide : purified water 1:38 (m/m)).
Other ingredients are: calcium carbonate, carnauba wax, lactose monohydrate, macrogol, magnesium stearate, copolymer of methacrylic acid and methyl methacrylate (1:1), microcrystalline cellulose, sodium lauryl sulfate, povidone, sucrose, talc, triethyl citrate.

What Femimeno looks like and contents of the pack
Femimeno is a white, round, odourless tablet with a smooth, shiny surface.
The medicine is available in blisters made of PVC/PVDC/Aluminium foil containing 30, 50, 60, 90 or 100 enteric tablets, packed in a cardboard box with an instruction leaflet.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Loges + Co. GmbH
Schützenstraße 5
DE-21423 Winsen (Luhe), Germany
Tel.: +49 (0) 4171 707 – 0
Fax: +49 (0) 4171 707 – 100
E-mail: [email protected]

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Kamila Szczepankowska-Urbowicz
Puszczyka 1 m. 2, 05-515 Zgorzała, Poland
Telephone: +48 609447125
Email: [email protected]

This medicinal product is authorised in the member countries of the European Economic Area under the following names:
Austria: femiLoges magensaftresistente Tabletten
Belgium: Femiloges 4 mg comprimés gastrorésistants
Bulgaria: femiLoges 4 mg стомашно-устойчиви таблетки
Czech Republic: Femipause
Denmark: femiLoges
Finland: Femiloges
France: Femimeno 4 mg comprimés gastrorésistants
Greece: Femimeno
Hungary: femiLoges 4 mg gyomornedv-ellenálló tabletta
Italy: femiLoges
Croatia: Femimeno 4 mg želučanootporne tablete
Luxembourg: femiLoges
Netherlands: femiLoges
Norway: femiLoges
Poland: Femimeno
Portugal: femiLoges
Romania: FemiLoges 4 mg comprimate gastrorezistente
Sweden: Femimeno
Slovakia: femiLoges