Package leaflet: Information for the user

Cimifemin

tablets
Dry extract of Cimicifuga racemosa (L.) Nutt., rhizoma
Please read all of this leaflet carefully before you start using this medicine because it contains important information for you.
Use this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you.

Keep this leaflet. You may need to read it again.
If you need more information or advice, consult your pharmacist.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
Consult your doctor if you do not notice any improvement or if you experience worsening of symptoms after 4–6 weeks.

Contents of this leaflet:

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

1. What Cimifemin is and what it is used for

Cimifemin is a herbal medicinal product used to relieve menopausal symptoms, such as hot flushes and excessive sweating.

2. What you need to know before taking Cimifemin

Do not take Cimifemin
if you are allergic to Cimicifuga racemosa or to any of the other ingredients of this medicine
(listed in section 6).

Warnings and precautions
Talk to your doctor before taking Cimifemin:

if you have had or currently have liver damage.
if you are taking estrogens at the same time.
if you have been treated or are being treated for breast cancer or other hormone-dependent tumors.

Consult your doctor

if you experience signs and symptoms indicating liver damage (tiredness, loss of appetite, yellowing of the skin or eyes, severe pain in the upper stomach area with nausea and vomiting, or dark urine), stop taking Cimifemin immediately and consult your doctor.
if you experience menstrual disorders or if menstruation returns.
furthermore, if unclear symptoms persist or new symptoms appear, consult your doctor. This is because they may indicate diseases requiring medical investigation.
if your symptoms worsen during treatment with Cimifemin, you must consult your doctor.

Other medicines and Cimifemin
No interaction studies have been conducted.
No known interactions with other medicines or food have been reported.
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Pregnancy and breastfeeding
There are no adequate data on the use of Cimifemin during pregnancy and breastfeeding. Therefore, the use of Cimifemin is not recommended during pregnancy and breastfeeding.
Women of childbearing age should consider using an effective contraceptive method during treatment.

Driving and using machines
No studies have been carried out on the effects on the ability to drive vehicles and use machinery.

Cimifemin contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.

3. How to use Cimifemin

Take this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is
1 tablet twice daily – one in the morning and one in the evening – without regard to meals.
Swallow the tablet whole with sufficient liquid. Do not suck or chew the tablet.
The break line is not intended for splitting the tablet.
Based on the therapeutic indications, use in children, adolescents, and men is not envisaged.
There are no available data to recommend specific dosage adjustments in cases of impaired renal or hepatic function.
Duration of treatment
If symptoms persist during treatment, consult a doctor or pharmacist.
Cimifemin does not produce an immediate effect. The first therapeutic effects may be observed no sooner than after two weeks of treatment.
It is advisable to take Cimifemin for several months, but not for longer than 6 months without medical advice.
If you take more Cimifemin than you should
Cases of overdose have not been reported. The listed side effects may become more severe.
Therefore, stop taking the medicine and consult a doctor.
If none of these adverse effects occur, continue taking the usual dose at the usual time.
If you forget to take Cimifemin
Do not take a double dose to make up for the forgotten tablet.
Continue taking the medicine at the usual time.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Possible side effects:
The following side effects may occur with the use of this medicine:
Not known (frequency cannot be established based on available data)

swelling of the face and peripheral swelling
allergic skin reactions (urticaria, pruritus, rash)
gastrointestinal disorders (dyspepsia (digestive problems), diarrhoea)
cases of hepatotoxicity have been reported with products containing Cimicifuga (hepatitis, jaundice, abnormal liver function tests).

In such cases, stop taking the medicine and consult a doctor urgently.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Cimifemin

Keep this medicine out of the sight and reach of children.
Keep the blister in the outer carton to protect the medicine from light.
Do not use this medicine after the expiry date stated on the carton after "Exp".
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Cimifemin contains
The active substance is dried extract of Cimicifuga racemosa (L.) Nutt., rhizoma.
Each tablet contains 2.5 mg of Cimicifuga racemosa (L.) Nutt., rhizoma extract (6-11:1).
Extraction solvent: isopropyl alcohol (40% v/v).
The other components are: co-processed excipient consisting of cellulose powder and lactose monohydrate, potato starch, magnesium stearate (vegetable).

Description of the appearance of Cimifemin and the contents of the pack
Tablets are white to beige, round, slightly biconvex, with a score line on one side.
The score line is not intended to divide the tablet into equal doses.
Cimifemin is available in packs containing 20, 60 and 100 tablets.
Not all pack sizes may be marketed.

Manufacturer and Marketing Authorization Holder
Schaper & Brümmer GmbH & Co. KG
Bahnhofstr. 35
38259 Salzgitter
Germany

Distributor
PharmExtracta S.p.A.
Via G. Natta n. 28
29010 Pontenure (PC)