What drospirenone/ ethinylestradiol is used for:

• This medicine is a contraceptive pill and is used to prevent pregnancy.

Do not use drospirenone/ ethinylestradiol:

• If you have (or have ever had) a blood clot in a blood vessel of your leg (deep vein thrombosis, DVT), your lungs (pulmonary embolus, PE) or other organs;
• If you know you have a disorder affecting your blood clotting – for instance, protein C deficiency, protein S deficiency, antithrombin-III deficiency, Factor V Leiden or antiphospholipid antibodies;
• If you need an operation or if you are off your feet for a long time (see section ‘Blood clots’);
• If you have ever had a heart attack or stroke;
• If you have (or have ever had) angina pectoris (a condition that causes severe chest pain and may be a first sign of a heart attack) or transient ischemic attack (TIA – temporary stroke symptoms);
• If you have any of the following diseases that may increase your risk of a clot in the arteries:
• Severe diabetes with blood vessel damage
• Very high blood pressure
• A very high level of fat in the blood (cholesterol or triglycerides)
• A condition known as hyperhomocysteinaemia
• If you have (or have ever had) a type of migraine called ‘migraine with aura’;
• If you have (or have ever had) liver disease and your liver function is still not normal
• If your kidneys are not working well (renal failure)
• If you have (or have ever had) had a tumor in the liver
• If you have (or have ever had) or if you are suspected of having breast cancer or cancer of the genital organs.
• If you have any unexplained bleeding from the vagina
• If you are allergic to ethinylestradiol or drospirenone, or any of the other ingredients of this medicine

Warnings and precautions:

• Talk to your doctor before taking it, you should also tell your doctor:
• If a close relative has or has ever had breast cancer
• If you have a disease of the liver or the gallbladder
• If you have diabetes
• If you have depression
• If you have Crohn’s disease or ulcerative colitis (chronic inflammatory bowel disease);
• If you have hemolytic uremic syndrome
• If you have sickle cell anemia (an inherited disease of the red blood cells);
• If you have elevated levels of fat in the blood (hypertriglyceridemia) or a positive family history for this condition
• If you need an operation, or you are off your feet for a long time
• If you have just given birth you are at an increased risk of blood clots
• If you have an inflammation in the veins under the skin (superficial thrombophlebitis)
• If you have varicose veins
• If you have epilepsy
• If you have systemic lupus erythematosus
• If you have a disease that first appeared during pregnancy or earlier use of sex hormones (for example, hearing loss, a blood disease called porphyria, yellowing of the skin or eyes (jaundice), itching of the whole body (pruritis), skin rash with blisters during pregnancy (gestational herpes), a nerve disease causing sudden movements of the body (Sydenham’s chorea))
• If you have ever had a discoloration of the skin especially on the face or neck known as “pregnancy patches” (chloasma).
• If so, avoid direct sunlight or ultraviolet light.
• If you have hereditary angioedema, products containing estrogens may cause or worsen the symptoms.

Possible side effects:

• Stop using the product and seek immediate medical attention if you develop throat tightness or swelling of the eyes, face, lips or tongue, feel faint, or have difficulty breathing.
• Stop using the product if you develop hives or itching of the face or body.

Other medicines and drospirenone/ ethinylestradiol:

It will interact with medicine that:

• Can have an influence on the blood levels of it
• Can make it less effective in preventing pregnancy
• Can cause unexpected bleeding
• These include medicines used for the treatment of
• Epilepsy (e.g. Primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine)
• Tuberculosis (e.g.Rifampicin)
• HIV and Hepatitis C Virus infections (so-called protease inhibitors and non-nucleoside reverse transcriptase inhibitors, such as ritonavir, nevirapine, efavirenz
• Fungal infections (griseofulvin, ketoconazole)
• Arthritis, arthrosis (etoricoxib)
• High blood pressure in the blood vessels in the lungs (bosentan)
• The herbal remedy St.John’s wort
• This medicine may influence the effect of other medicines:
• Medicines containing ciclosporin
• The anti-epileptic lamotrigine (this could lead to an increased frequency of seizures)
• Theophylline (used to treat breathing problems)
• Tizanidine (used to treat muscle pain and/or muscle cramps).