FEMILOGES

FEMILOGES gastro-resistant tablets

Important notes (mandatory information)

femiLoges 4 mg gastro-resistant tablets. Active ingredient: Rhubarb root dry extract. Areas of application: for the improvement of psychological and neurovegetative symptoms caused by menopause, such as hot flushes/sweating, sleep disorders, depressive moods and anxiety. Warning: Contains lactose and sucrose.

For risks and side effects, read the package leaflet and consult your doctor or pharmacist.


PACKAGE LEAFLET: INFORMATION FOR USERS

femiLoges 4 mg gastro-resistant tablets for use in women
Active ingredient: Rhubarb root dry extract

Read the entire package leaflet carefully before you start taking this medicine, as it contains important information. Always take this medicine exactly as described in this package leaflet or exactly as directed by your doctor or pharmacist.

• Keep the package leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If you notice any side effects, contact your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. See section 4.
• If you do not feel better or even worse after 3 months, contact your doctor.

What this package leaflet contains

1. WHAT IS FEMILOGES AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE TAKING FEMILOGES?
3. HOW TO TAKE FEMILOGES?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE FEMILOGES?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT IS FEMILOGES AND WHAT IS IT USED FOR?

femiLoges is a herbal medicine made from rhubarb root dry extract for the treatment of menopausal symptoms. femiLoges is used to improve psychological and neurovegetative symptoms caused by menopause, such as hot flushes/sweating, sleep disorders, depressive moods and anxiety.

2. WHAT SHOULD YOU CONSIDER BEFORE TAKING FEMILOGES?

femiLoges must not be taken:

• if you are allergic to rhubarb root dry extract or any of the other ingredients of this medicine listed in section 6.
• if you are pregnant, suspect you are pregnant or are breastfeeding.
• if you have unexplained genital bleeding.
• if you are or have been under medical treatment for an estrogen-dependent tumor, as it is not known whether rhubarb root dry extract influences the growth of an estrogen-dependent tumor.

Warnings and precautions

In the event of menstrual irregularities or recurrence, as well as persistent, unclear or newly occurring symptoms, please consult your doctor, as these may be medical conditions that require clarification by a doctor. Do not take femiLoges without medical advice together with medicines containing estrogen.

Taking femiLoges with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken or intend to take any other medicines. No interactions with other medicines have been observed so far when taking femiLoges. No interaction studies have been performed. Since the gastro-resistant tablet coating of femiLoges may be prematurely dissolved when taken together with medicines that bind stomach acid (antacids), there should be an interval of at least one hour between taking femiLoges and the antacid.

Pregnancy and breastfeeding

Ask your doctor or pharmacist for advice before taking any medicine. femiLoges must not be taken during pregnancy and breastfeeding.

Driving and using machines

The effects of femiLoges on the ability to drive and use machines are not known.

femiLoges contains lactose and sucrose

Therefore, please only take femiLoges after consulting your doctor if you are known to suffer from an intolerance to certain sugars. Note for diabetics: 1 gastro-resistant tablet contains approx. 0.01 bread units (BE).

3. HOW TO TAKE FEMILOGES?

Always take this medicine exactly as described in this package leaflet or exactly as agreed with your doctor or pharmacist. Check with your doctor or pharmacist if you are not sure.

Unless otherwise prescribed by your doctor, the recommended dose is

1 gastro-resistant femiLoges tablet once a day.

Please take femiLoges unchewed with sufficient liquid (e.g. a glass of drinking water), preferably always at the same time of day. In the morning at least half an hour before breakfast or one to two hours before a meal. It is recommended to take femiLoges for several months. However, medical advice should also be sought for the treatment of menopausal symptoms. Therefore, do not take femiLoges for longer than 4 months without medical advice.

Please talk to your doctor or pharmacist if you have the impression that the effect of femiLoges is too strong or too weak.

If you have taken more femiLoges than you should

Accidental ingestion of 1 - 2 gastro-resistant tablets more than prescribed usually has no adverse effects. If you take a larger amount of femiLoges, please inform your doctor.

If you forget to take femiLoges

If this was not more than 12 hours ago, please take the missed dose as soon as you notice. If you do not notice the missed dose until more than 12 hours after the usual time of administration, please do not take the missed dose and take the gastro-resistant tablet at the next time of administration, as described in this leaflet.

If you stop taking femiLoges

No special measures are required. If any of the symptoms mentioned under 2. ("Special care must be taken when taking femiLoges") occur, your doctor should be consulted.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following frequency information is used to evaluate side effects:
Very common:	more than 1 in 10 treated persons
Common:	1 to 10 in 100 treated persons
Uncommon:	1 to 10 in 1,000 treated persons
Rare:	1 to 10 in 10,000 treated persons
Very rare:	less than 1 in 10,000 treated persons
Not known:	frequency cannot be estimated from the available data.

Hypersensitivity reactions, such as skin redness, rash, swelling of the skin (including the face), itching, may occur when using femiLoges. The frequency of these side effects cannot be estimated from the available data. Please contact your doctor so that they can clarify whether there is a connection with taking femiLoges or whether the symptoms are due to another cause.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Dept. of Pharmacovigilance, Kurt-Georg-Kiesinger-Allee 3, D-53175 Bonn, website: www.bfarm.de. By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE FEMILOGES?

Keep this medicine out of the reach of children. Do not use this medicine after the expiry date which is stated on the blister and carton after "Use by". The expiry date refers to the last day of the month indicated. Never dispose of medicines via wastewater (e.g. not via the toilet or sink). Ask your pharmacist how to dispose of the medicine when you no longer use it. You help to protect the environment. Further information can be found at www.bfarm.de/arzneimittelentsorgung.

Storage conditions

Do not store above 25°C.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What femiLoges contains

1 gastro-resistant tablet contains the active ingredient 4 mg dry extract of rhubarb root (16-26:1); Extraction solvent: aqueous calcium oxide solution (calcium oxide: Purified water in a ratio of 1:38 (m/m)). The other ingredients are: Calcium carbonate (E 170), carnauba wax, bleached wax, lactose monohydrate, macrogol 6000, macrogol 35000, magnesium stearate (Ph. Eur.) [vegetable], methacrylic acid-methyl methacrylate copolymer (1:1) (Ph. Eur.), microcrystalline cellulose, sodium dodecyl sulfate, povidone K 25, povidone K 90, sucrose (saccharose), talc, triethyl citrate.

What femiLoges looks like and contents of the pack

Original packs of 30, 50, 60, 90 and 100 white gastro-resistant tablets. Not all pack sizes may be marketed.

Pharmaceutical entrepreneur and manufacturer

Dr. Loges + Co. GmbH
Schützenstraße 5
21423 Winsen (Luhe)
Phone: 04171 707-0
Fax: 04171 707-125
E-mail: info@loges.de

This leaflet was last revised in June 2022.

Source: Information from the package leaflet
Status: 02/2023
Active ingredient: Rhubarb root dry extract. Areas of application: for the improvement of psychological and neurovegetative symptoms caused by menopause, such as hot flushes/sweating, sleep disorders, depressive moods and anxiety. Warning: Contains lactose and sucrose.