Leaflet FEM 7 COMBI transdermal therapeutic system

Indicated for: hormone replacement therapy in menopause

Route of administration: transdermal

Substance: estradiol + levonorgestrel (estrogen and progestogen)

ATC: G03CA53 (Genito urinary system and sex hormones | Estrogens | Natural and semisynthetic estrogens, plain)

Precautions:
Major drug interactions
Major drug interactions

This medicine may have important interactions with other medicines.

Breastfeeding warning
Breastfeeding warning

Use during breastfeeding only on medical advice.

Pregnancy warning
Pregnancy warning

Use during pregnancy only on medical advice.

Estradiol + levonorgestrel is a hormone combination used in postmenopausal women for symptoms such as hot flushes, night sweats, sleep disturbance and, in some cases, prevention of bone loss. Estradiol partly replaces the estrogen that falls after menopause, while levonorgestrel protects the lining of the womb in women who still have a uterus.

Treatment may be given as a transdermal patch or another form chosen by the doctor. The lowest effective dose should be used for the shortest period suitable for the treatment goal. Patches are applied to clean, dry, intact skin according to the instructions, avoiding irritated areas. This treatment is not a contraceptive and should not be used without medical assessment.

Side effects may include breast tenderness, vaginal bleeding, headache, nausea, bloating, mood changes, application-site irritation or fluid retention. Hormone therapy can increase the risk of blood clots, stroke, gallbladder disease and certain cancers, depending on age, duration of use, medical history and personal risk factors. Benefits and risks should be reviewed regularly.

Contact a doctor urgently if chest pain, shortness of breath, painful swelling of one leg, sudden severe headache, visual disturbance, unusual vaginal bleeding or a breast lump occurs. Tell your doctor if you have had hormone-dependent cancer, thrombosis, liver disease, migraine with aura or unexplained bleeding. Regular follow-up and reassessment of benefit are essential.

General data about FEM 7 COMBI

  • Substance: estradiol + levonorgestrel
  • Date of latest medicines list: 01-07-2013
  • Product code: W41892001
  • Pharmaceutical form: transdermal therapeutic system
  • Quantity: 4
  • Product type: Original
  • Prescription status: P-6L - Medicines dispensed with a medical prescription that is not retained by the pharmacy and may be renewed; the prescription may be used for 6 months from the date of issue.