Patient leaflet - Femiloges gastro-resistant tablets
1. What Femiloges is and what it is used for
This medicine contains a dry extract of Rhapon-
tic rhubarb root. It is a traditional herbal medicinal
product used for the relief of symptoms of the me-
nopause, such as hot flushes/sweats, sleep distur-
bances, slightly low mood and mild anxiety, based
on traditional use only. As there is evidence that
Rhapontic rhubarb may have hormone-like actions,
it should only be used by women of childbearing age
if contraception is used.
2. What you need to know before you take Femiloges
Do not take Femiloges if:
you are allergic to Rhapontic rhubarb root
or any of the other ingredients of this medicine
(listed in section 6)
you are pregnant, think you may be pregnant
or are breast-feeding
you are of childbearing age and not using con-
traception
you are under 18 years old
you have unexplained vaginal bleeding
you are or have been treated for breast cancer or
other hormone-dependent tumours
you are taking oestrogen-containing medicines
(e.g hormonal contraceptives, hormone replace-
ment therapy) unless your doctor advises that it
is safe to do so
Warnings and precautions
If you have a peristant history of menstrual disorders, consult your doctor before taking this medicine.
If unexpected bleeding occurs or you notice any re-appearance or changes in menstrual bleeding, consult your doctor. It may be signs of conditions that require medical examina-tions by a doctor.
This medicine is intended for relief of meno-pausal symptoms including slightly low mood and mild anxiety. Patients with signs and sym-ptoms of depression should consult a doctor for appropriate treatment.
Children and adolescents
This medicine is not to be used in children and adolescents under 18 years old.
Other medicines and Femiloges
Tell your doctor, pharmacist or qualified healthcare practitioner if you are taking, have recently taken or might take any other medicines.
Do not take this medicine together with oestrogen-containing medicines (e.g. hormonal contracep-tives, hormone replacement therapy) unless your doctor advises it is safe to do so.
If Femiloges is taken at the same time as medicines that are known as antacids, the gastro-resistant film-coating of Femiloges may be dissolved prematurely. Therefore, Femiloges and antacids should be taken at least 1 hour apart.
Pregnancy and breast-feeding
Femiloges should not be used during pregnancy and breast-feeding. For women of child bearing age, Femiloges should not be used without contraception. Driving and using machines
This medicine has no known influence on the ability to drive and use machines.
Femiloges contains lactose, sucrose and sodium
Femiloges contains lactose and sucrose. If you have been told by your doctor that you have an intoleran-Femiloges gastro-resistant tablets is referred to as “Femiloges” throughout this package leaflet.
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ce to some sugars, contact your doctor before taking this medicine. This medicine contains less than 1 mmol sodium (23 mg) per gastro-resistant tablet, that is to say essentially ‘sodium-free’.
3. How to take Femiloges
Always take this medicine exactly as described in this leaflet or as your doctor, pharmacist or qualified healthcare practitioner has told you. Check with your doctor, pharmacist or qualified healthcare practitioner if you are not sure.
Adult women experiencing menopausal symptoms
The recommended dose is 1 gastro-resistant tablet of Femiloges once daily. Do not take more than the label/leaflet tells you to take.
This medicine is not for use in children or adolescents under 18 years old.
Method of administration
Do not crush or chew the tablets. Femiloges should be swallowed whole with a sufficient amount of liquid (e.g. a glass of water), ideally at the same time each day. Take it at least half an hour before breakfast or 1 - 2 hours before a meal. Duration of administration
You must talk to a doctor, pharmacist or qualified healthcare practitioner if you feel worse, or do not feel better after 3 months. You must not take Femiloges for more than 6 months without medical advice. If you take more Femiloges than you should
No cases of overdose have been reported. How-ever if you take more than the recommended dose and you feel unwell, speak to your doctor, pharma-cist or qualified healthcare practitioner and take this leaflet with you.
If you forget to take Femiloges
If you forget to take Femiloges and it is within 12 hours of your usual dose, take the forgotten dose as soon as you remember. If you remember the for-gotten dose after more than 12 hours, you should not take the missed dose. Wait until your next usual dose is due and take it then. Do not take a double dose to make up for a forgotten tablet.
If you stop taking Femiloges
You do not have to take any special measures. If the symptoms mentioned in section 2, “Warnings and precautions” occur, you should consult your doctor, pharmacist or qualified healthcare practiti-oner. If you have any further questions on the use of this medicine, ask your doctor, pharmacist or qualified healthcare practitioner.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects may occur:
Gastrointestinal symptoms such as
nausea
stomach ache
flatulence
diarrhoea
Headache
Allergic (hypersensitivity) reactions such as
reddening of the skin
Femiloges
gastro-resistant tablets
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skin rash
swelling of the skin (also in the face) itching
The frequency that these effects may occur is not known.
Reporting of side effects
If you get any side effects, talk to your doctor, phar-macist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard, or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this me-dicine.
5. How to store Femiloges
Keep this medicine out of the sight and reach of children. Do not store this medicine above 30 °C. Store in the original packaging.
Do not use this medicine after the expiry date which is stated on the blister and carton 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 Femiloges contains
Each gastro-resistant tablet contains 4 mg of extract (as dry extract) from Rhapontic rhubarb root (Rheum rhaponticum L., radix) (DER 16-26:1)
Extraction solvent: aqueous solution of calcium oxide (calcium oxide: water ratio 1:38 (m/m)).
The other ingredients are calcium carbonate, carnauba wax, beeswax white, lactose monohydrate, macrogol (6 000), macrogol (35 000), magnesium stearate, methacrylic acid – methyl methacrylate copolymer (1:1), microcrystalline cellulose, sodium laurilsulfate, povidone K25, povidone K90, sucrose, talc, triethyl citrate.
What Femiloges looks like and contents of the pack
White, round, biconvex gastro resistant tablet. Femiloges is available in packs of 30, 50, 60, 90 and 100 tablets.
Not all pack sizes may be marketed.
Traditional Herbal Registration
Holder and Manufacturer
Dr. Loges + Co. GmbH
Schützenstraße 5
21423 Winsen (Luhe)
Germany