BIONORICA

KLIMADYNON 60 COMPRIMATE FILMATE

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Klimadynon 2.8 mg film-coated tablets is a herbal medicine indicated for adult women for
the relief of menopausal symptoms, such as hot flashes and profuse sweating.

Ingredients:
- The active substance is:
1 film-coated tablet contains: 2.8 mg dry extract of cimicifuga rhizome (Cimicifuga racemosa (L.) Nutt., rhizoma) (5-10:1)
Extraction solvent: ethanol 58% (V/V)
- The other components are: Calcium hydrogen phosphate dihydrate; ammonium methacrylate copolymer, type A, 30% dispersion (Eudragit RL 30D); red iron oxide (E 172); yellow iron oxide (E 172); lactose monohydrate; macrogol 6000; magnesium stearate (vegetable); potato starch; sodium hydroxide; sorbic acid; talc; titanium dioxide (E171).

Warnings and precautions:
Talk to your doctor:
- if you have a history of liver conditions. Liver function tests should be performed;
- if signs of liver damage appear (fatigue, loss of appetite, yellowing of the skin and
whites of the eyes (jaundice) or severe pain in the upper abdomen, nausea, vomiting, dark
urine), stop taking Klimadynon and contact your doctor immediately;
- if vaginal bleeding or other new or unclear symptoms appear;
- if you are taking or have taken treatment for breast cancer or other hormone-dependent tumors;
- if you are taking estrogen treatment;
- if symptoms worsen during treatment with this medicine.
If any of the above conditions apply to you, do not take Klimadynon
without medical advice.

Method of administration:
- Always take this medicine exactly as described in this leaflet or as your
doctor or pharmacist has told you. Talk to your doctor or pharmacist if you are not
sure.
- The recommended dose is:
For adult menopausal women, the usual dose is one film-coated tablet twice a day,
morning and evening (the maximum dose is 2 film-coated tablets per day).
- For oral administration. The film-coated tablets should be taken with a sufficient amount of liquid. Do not
chew or suck.
- Duration of treatment:
If symptoms persist during treatment with the medicine, consult your doctor or
pharmacist.
Klimadynon should not be used for more than 6 months without medical advice.
- Use in children and adolescents
There is no relevant use of Klimadynon film-coated tablets in children and adolescents for
the given therapeutic indication.
- Special patient categories:
There is insufficient data regarding the recommended dose in patients with impaired kidney/liver function.
Patients with a history of liver diseases should not use Klimadynon without medical advice
(see section 2. "Warnings and precautions" and section 4. "Adverse reactions").