CLIMOFEMIN TBL 6.5MG N30

ATC code: G02CX01 

Active substances: Cimicifuga Racemosa

Vendor, principal: Nycomed Sefa As. 
No prescription needed/Patient care products, dressings, gloves, medical devices,...

CLIMOFEMIN 6.5MG N30

Package leaflet: Information for the user

Climofemin 6.5 mg tablets

Cimicifuga rhizome dry extract

Read all of this leaflet carefully before you start using this medicine because 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.
-   Ask your pharmacist if you need more information or advice.
-   Talk to your doctor or pharmacist if you get any side effects. This includes any possible side effects not listed in this leaflet. See section 4.
-   You must talk to a doctor if you do not feel better or if you feel worse after 3 months of treatment.

What is in this leaflet

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

1. What Climofemin is and what it is used for

Climofemin contains the dry extract of cimicifuga rhizome (Cimicifuga racemosa).
Climofemin is used for the relief of climacteric (menopause) complaints (such as hot flashes and excessive sweating) in women.

2. What you need to know before you use Climofemin Do not use Climofemin:

-   if you are allergic to cimicifuga rhizome dry extract or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Do not take Climofemin in the following cases:
-   if you have had liver disease. Patients with hepatic impairment should not take this medicinal product without consulting a doctor.
-   if you develop symptoms of hepatic impairment (fatigue, loss of appetite, yellowing of the skin or the whites of your eyes, stomach pain, nausea and/or vomiting, dark urine).
-   if there is a bleeding from the vagina or another new symptom;
-   if you are being treated or have treated with breast cancer or another hormone-dependent tumor;
-   if you are using oestrogens.

Other medicines and Climofemin

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Climofemin with food and drink

Climofemin can be taken with food or independent of meals.

Pregnancy, breast-feeding and fertility

Climofemin is used for the treatment of climacteric complains in women going through menopause. It is not used during pregnancy and breast-feeding. Since pregnancy may occur during the menopause period, effective contraception should be used during treatment.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

Driving and using machines

There is no information on Climofemin affecting the ability to drive or work with machines.

Climofemin contains lactose monohydrate

If you have been told by your doctor that you have intolerance to some sugars, talk to your doctor before taking this medicine.

3. How to use Climofemin

Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
The usual dose is one tablet per day, taken with a small amount of liquids. The tablet should not be chewed. It is recommended to take the tablet at the same time every day (in the morning or evening). The tablet can be taken independent of meals.
Climofemin will not relieve your complaints overnight. Ordinarily, you will start to feel better after 24 weeks of treatment; at least 6 weeks of treatment is recommended. If the symptoms persist even after 3 months of treatment, ask your doctor for advice in order to consider other treatment options for climacteric complaints.
Do not take this medicine for longer than 6 months without first talking to your doctor. The doctor will check your liver function if necessary and tell you whether you can continue using Climofemin.

Use in children and adolescents

Children and adolescents should not take this medicine.

If you use more Climofemin than you should

No cases of overdose of medicines containing cimicifuga rhizome dry extract have been reported to date. Talk to your doctor and go to the nearest hospital if you have taken too many Climofemin tablets by accident.

If you forget to use Climofemin

If you have forgotten to take Climofemin, take the next tablet at the prescribed time. Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

If you stop using Climofemin

It is safe to stop using Climofemin.
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.
The following undesirable effects have been reported with the use of preparations containing cimicifuga, the incidence of which is unknown:
-   hepatic impairment (including hepatitis, jaundice, changes in liver function tests);
-   allergic skin reactions (hives, itching, rash);
-   edema on the face, arms, legs;
-   gastrointestinal disorders (indigestion, diarrhoea).

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via www.ravimiamet.ee. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Climofemin

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date which is stated on the blister and external package. 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 Climofemin contains

-   The active substance is the dry extract of cimicifuga rhizome (Cimicifuga racemosa). One tablet contains 6.5 mg of cimicifuga (Cimicifuga racemosa) rhizome dry extract, corresponding to 29.25-55.25 mg of cimicifuga rhizome (extraction solvent: 60% ethanol).
-   Other ingredients are microcrystalline cellulose, lactose monohydrate, magnesium stearate, anhydrous colloidal silica, and croscarmellose sodium.

What Climofemin looks like and contents of the pack

Climofemin tablets are round biconvex yellowish-beige tablets.
Package: 30 tablets in a blister package and external carton.

Marketing Authorisation Holder and Manufacturer:

Marketing
Authorisation
Holder
UAB “Sirowa Vilnius”
Eišiškip pl. 8A,
LT - 02184 Vilnius Lithuania
Manufacturer UAB Entafarma Klonenq vs. 1 LT-19156 Širvintq r. sav.,
Lithuania
Phone: +370 382 33001
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Sirowa Tallinn AS Salve 2c 11612 Tallinn Estonia
Phone: +372 6 830 700

This leaflet was last revised in May 2018.

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