CLIMEN Tablet Ref.[50748] Active ingredients: Cyproterone Estradiol

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 (at Least once per year) your doctor will discuss with you the benefits and risks associated with hormone replacement therapy.

Your doctor will perform regular clinical breast examinations, particularly if you have a history of breast cancer in your family, or if you presently have breast cysts or nodules. Your doctor may also ask you to have a mammogram. Contact you doctor if you notice changes in your breasts during treatment.

Women on hormone replacement therapy have an increased risk of developing thromboembolic disease, cancer of the breast or uterus, cardiovascular accident or cerebro-vascular stroke.

Inform your doctor of any illnesses you may have during treatment. Menopause therapy is not contraindicated for the following conditions, but does require special monitoring: arterial hypertension, diabetes, endometriosis (ailment characterised by the presence of uterine mucous outside of the uterus), uterine fibroma, hepatic or biliary disorders, epilepsy, migraine or severe headache, renal or cardiac insufficiency, asthma, lupus, (severe disease affecting the skin in particular), otospongiosis (ear ailment resulting in hearing deterioration).

Inform your doctor immediately if any of the following symptoms appear:

• allergic reactions (difficulty in breathing, thoracic oppression, generalised hives-type rash, itching);
• jaundice (of eyes and skin);
• significant increase in arterial pressure;
• unusual leg pain, weakness in extremities;
• chest pain, irregular pulse, sudden shortness of breath;
• loss of consciousness, confusion, unusual severe headaches, dizziness, impaired vision, slowed speech or voice loss;
• pregnancy;
• lump in breast area.

Inform your doctor if you need to be confined to bed or undergo surgery.

Contact your doctor if, despite treatment, oestrogen deficiency symptoms associated with menopause continue to persist.

Consult your doctor if you experience profuse bleeding. Because this medication contains lactose, it should not be used by women with galactosemia, malabsorption syndrome involving glucose and galactose or lactase deficiency (rare metabolic diseases).

This medication contains sucrose, which should be taken into account in women with fructose intolerance, malabsorption syndrome involving glucose and galactose or sucrase-isomaltase deficiency (rare metabolic diseases).

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, oxcarbazepine, phenobarbital, phenytoin, rifabutin, rifampicin, ritonavir, nelfinavir, nevirapine, efavirenz or herbal preparations containing millepertuis (Hypericum perforatum); this also applies for any non-prescription medications you may be taking.

Interaction with foods and beverages

Not applicable.

Interaction with other phytotherapeutic products or alternative therapies

Not applicable.

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 exposure to this medication in the course of pregnancy does not constitute grounds for terminating a pregnancy.

Not applicable.

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 of menopause:

• breast tension,
• genital bleeding,
• abdominal pain and swelling,
• nausea,
• headache,
• painful menstruation,
• vaginal discharge.

Rarely observed:

• vomiting,
• disturbed hepatic function (liver), icterus Uaundice), biliary vesicle disorder,
• disturbances in libido,
• skin disorders.

Inform your doctor or pharmacist if you notice any side effects that are not mentioned in this leaflet, or if any of the side effects become severe.