CLIMEN Tablet (2009)

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1. Name of the medicinal product

Climen, coated tablet.

2. Qualitative and quantitative composition

The active substances are: Micronised estradiol valerate: 2.000 mg Contained in each white coated tablet. Micronised estradiol valerate: 2.000 mg Micronised cyproterone acetate: 1.000 mg Contained in each ...

3. Pharmaceutical form

Coated tablet. This medication contains a combination of an oestrogen and a progestin (micronised cyproterone acetate). This medication is indicated for the treatment of disorders resulting from oestrogen ...

4.1. Therapeutic indications

CLIMEN coated tablet is indicated for the prevention of menopause-related osteoporosis in women with increased risk of fracture and who do not tolerate, or who are contraindicated for other treatments ...

4.2. Posology and method of administration

Mode of administration Taken orally. Dosage This treatment consists of 1 tablet per day for 21 days, to be taken without interruption in the following order: take 1 white tablet each day for 11 days, then ...

4.3. Contraindications

You should never take CLIMEN coated tablet if you have any of the following conditions: previous or present venous or arterial thromboembolic disease (phlebitis, pulmonary embolism, chest angina, myocardial ...

4.4. Special warnings and precautions for use

A medical examination needs to be conducted before starting treatment, as well as periodically during treatment. In order to determine whether or not your treatment should be continued, at regular intervals ...

4.5. Interaction with other medicinal products and other forms of interaction

If you are using other medications: Inform your doctor or pharmacist if you have taken any other medication recently, particularly anti-convulsivants, antituberculins, or treatment for AIDS such as: carbamazepine, ...

4.6. Pregnancy and lactation

This medication is not indicated for use during pregnancy or breast feeding. If while taking this medication you find out that you are pregnant, you must stop the treatment and contact your doctor. Accidental ...

4.7. Effects on ability to drive and use machines

Not applicable.

4.8. Undesirable effects

Description of possible side effects As with all medications, CLIMEN coated tablet may also cause side effects, although not all patients experience them. Frequently observed during hormonal treatment ...

4.9. Overdose

Signs of overdose generally include a sensation of pain in the breast area, swollen stomach, flatulence, nausea, vomiting, irritability, bleeding. No specific treatment is necessary in such cases. Ask ...

6.1. List of excipients

Lactose, corn starch, povidone, talc, magnesium stearate, sucrose, macrogol 6000, calcium carbonate, wax E, glycerol, titanium dioxide, iron oxide yellow, iron oxide red pigment.

6.3. Shelf life

Do not use CLIMEN coated tablets after the expiration date printed on the box.

6.4. Special precautions for storage

Store below +30°C. Keep away from, and out of sight of children.

6.5. Nature and contents of container

This medication is available as a coated tablet. Each box contains 21 tablets.

6.6. Special precautions for disposal and other handling

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

7. Marketing authorization holder

Bayer Pharma AG Germany.

10. Date of revision of the text

August, 2009