Description

Zoely is a contraceptive pill that is used to prevent pregnancy.

All 24 white film-coated tablets are active tablets that contain a small amount of two different female hormones. These are nomegestrol acetate (a progestogen) and estradiol (an oestrogen).
The 4 yellow tablets are inactive tablets that do not contain hormones and are called placebo tablets.
Contraceptive pills that contain two different hormones, like Zoely, are called ‘combined pills’.
Estradiol, the oestrogen in Zoely, is identical to the hormone produced by your ovaries during a menstrual cycle.
Nomegestrol acetate, the progestogen in Zoely, is derived from the hormone progesterone. Progesterone is produced by your ovaries during a menstrual cycle.

Uses / Instructions

Take one tablet each day at about the same time, with some water if necessary. Do not take a break.

Warnings

You must not use Zoely if you have any of the conditions listed below. If you do have any of the conditions listed below, you must tell your doctor. Your doctor will discuss with you what other form of birth control would be more appropriate.

if you have (or have ever had) a blood clot in a blood vessel of your legs (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 a 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 ischaemic 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 (had) inflammation of the pancreas (pancreatitis) associated with high levels of fat
in your blood;
if you have (had) severe liver disease and your liver is not yet working normally;
if you have (had) a benign or malignant tumour in the liver;
if you have (had), or if you may have, cancer of the breast or the genital organs;
in case of presence or history of meningioma (generally benign tumour of the tissue located
between the brain and the skull). In case of doubt, contact your doctor.
if you have any unexplained bleeding from the vagina;
if you are allergic to estradiol or nomegestrol acetate, or any of the other ingredients of this medicine

Side Effects

Very common (may affect more than 1 in 10 people):

acne
changes to menstrual periods (e.g. absence or irregularity)

Common (may affect up to 1 in 10 people):

decreased interest in sex; depression/depressed mood; mood changes
headache or migraine
feeling sick (nausea)
heavy menstrual periods; breast pain; pelvic pain
weight gain

Uncommon (may affect up to 1 in 100 people):

increased appetite; fluid retention (oedema)
hot flush
swollen abdomen
increased sweating; hair loss; itching; dry skin; oily skin
heaviness in limbs
regular but scanty periods; larger breasts; breast lump; milk production while not pregnant; premenstrual syndrome; pain during intercourse; dryness in the vagina or vulva; spasm of the uterus
irritability
increased liver enzymes

See patient information leaflet for more details.

Ingredients

The active substances are:

nomegestrol acetate and estradiol

White active film-coated tablets: Each tablet contains 2.5 mg nomegestrol acetate and 1.5 mg estradiol (as hemihydrate).

Yellow placebo film-coated tablets: The tablet does not contain active substances.

– The other ingredients are:

Tablet core (white active and yellow placebo film-coated tablets):

Lactose monohydrate (see section 2 ‘Zoely contains lactose’), microcrystalline cellulose (E460), crospovidone (E1201), talc (E553b), magnesium stearate (E572) and colloidal anhydrous silica

Tablet coat (white active film-coated tablets):

Poly(vinyl alcohol) (E1203), titanium dioxide (E171), macrogol 3350 and talc (E553b)
Tablet coat (yellow placebo film-coated tablets):

Poly(vinyl alcohol) (E1203), titanium dioxide (E171), macrogol 3350, talc (E553b), iron oxide yellow (E172) and iron oxide black (E172)