CIMIFEMIN 2.5 MG Coated tablet

Зміст інструкції

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

Cimifemin

tablets
Dry extract ofCimicifuga racemosa(L.) Nutt., rhizome
Read this leaflet carefully before using this medicine as 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.
• If you want more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better or if your symptoms worsen after 4-6 weeks.

Contents of this leaflet:

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

1. What is Cimifemin and what is it used for

Cimifemin is a medicine of plant origin to relieve menopausal disorders, such as hot flashes
and excessive sweating.

2. What you need to know before using Cimifemin

Do not take Cimifemin
if you are allergic to Cimicifuga racemosaor 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 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 indicative of liver damage (fatigue, loss of appetite, yellowing of the skin and eyes, or severe pain in the upper abdomen with nausea and vomiting, or dark urine) immediately stop taking Cimifemin and consult your doctor.
• if you experience menstrual problems or if your periods return.
• also, if unclear symptoms persist or new symptoms appear, consult your doctor. This is because they may be evidence of diseases that require investigation by a doctor.
• if your symptoms worsen during treatment with Cimifemin, you should consult your doctor.

Other medicines and Cimifemin
Interaction studies have not been conducted.
No known interactions with other medicines or food have been reported.
Tell your doctor or pharmacist if you are taking, have recently taken, or might take
any other medicine.

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

Driving and using machines
Studies on the effects on the ability to drive and operate machines have not been conducted.

Cimifemin contains lactose
If your doctor has diagnosed you with intolerance to some sugars, contact them before taking
this medicine.

3. How to use Cimifemin

Take this medicine following exactly the instructions in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.

The recommended dose is
1 tablet twice a day– one in the morning and one in the evening – without particular regard to
meals.
Swallow the tablet whole with a sufficient amount of liquid. Do not suck or chew the
tablet.
The score line is not designed for breaking the tablet.
Based on the therapeutic indications, use by children, adolescents and men is not foreseen.
No data are available for specific dosage recommendations in case of impaired
renal/hepatic function.

Duration of treatment
If symptoms persist during use of the medicine, consult a doctor or pharmacist.
Cimifemin does not produce its effect immediately. The first therapeutic effects may be
observed after two weeks of treatment at the earliest.
It is advisable to take Cimifemin for several months, but for no more than 6 months without medical
advice.

If you take more Cimifemin than you should
No cases of overdose have been reported. The listed side effects may be more severe.
You should therefore stop taking the medicine and consult a doctor.
If none of these undesirable effects occur, continue taking the usual dose at the
usual time.

If you forget to use Cimifemin
Do not take a double dose to make up for a missed tablet.
Continue taking it at the usual time.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

Possible side effects:
The following side effects may occur with the use of this medicine:

Not known (frequency cannot be estimated based on available data)

• facial swelling and peripheral edema
• allergic skin reactions (urticaria, itching, rash)
• gastrointestinal disorders (dyspepsia (digestive problems), diarrhea)
• cases of hepatic toxicity have been reported with products containing Cimicifuga (hepatitis, jaundice, abnormal liver function tests).

In these cases, stop taking the medicine and consult a doctor urgently.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through 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 box to protect the medicine from light.
Do not use this medicine after the expiry date which is stated on the pack after Exp.
The expiry date refers to the last day of that month.
This medicine does not require special storage conditions.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how
to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

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

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

Manufacturer and authorisation holder
Schaper & Brümmer GmbH & Co. KG
Bahnhofstr. 35
38259 Salzgitter
Germany

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