Special Warning : אזהרת שימוש

4.4   Special warnings and precautions for use

In prospective clinical trials involving more than 1200 patients, black cohosh was not associated with serum enzyme elevations during treatment and no cases of clinically apparent liver injury were reported. However, products labeled as black cohosh have been linked to more than fifty instances of clinically apparent liver injury that have ranged in severity from symptomatic elevations in serum enzymes without jaundice, to acute self-limited hepatitis, prolonged hepatitis with cholestasis, autoimmune hepatitis, and acute liver failure requiring liver transplantation or with a fatal outcome.
The latency to onset of liver injury ranged from 1 to 48 weeks but was usually within 2 to 12 weeks.

Patients should stop taking Menopret® Film-coated tablets and consult their doctor immediately if they develop signs and symptoms suggestive of liver injury (such as unusual tiredness, loss of appetite, weight loss, yellowing of skin and eyes or severe upper stomach pain with nausea and vomiting, diarrhoea or dark urine).

Liver function test should be performed according to clinical judgment.

If vaginal bleeding occurs or other symptoms occur, a doctor should be consulted.
Menopret® Film-coated tablets should not be used together with oestrogens unless advised by a doctor.

Patients who have been treated or who are undergoing treatment for breast cancer or other hormone-dependent tumours should not use Menopret® Film-coated tablets without medical advice. Please see section 5.3 ‘Preclinical Safety Data’.

If the symptoms worsen during the use of the medicinal product, a doctor or a pharmacist should be consulted.

Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take Menopret® Film-coated tablets.

Effects on Driving

4.7   Effects on ability to drive and use machines

No studies on the effects on the ability to drive and use machines have been performed.