Contraceptive tablets for women
21 yellow tablets, each containing the active ingredients cyproterone acetate and ethinyloestradiol (2 mg/35 microgram (µg))
7 white placebo tablets
Consumer Medicine Information
What is in this leaflet
This leaflet answers some common questions about LAILA-35 ED. It does not contain all of the available information. It does not take the place of talking to your doctor or pharmacist.
All medicines have benefits and risks. Your doctor has weighed the risks of you taking LAILA-35 ED against the benefits they expect it will have for you.
If you have any concerns about taking this medicine, talk to your doctor or pharmacist.
Keep this leaflet with your medicine. You may need to read it again.
What LAILA-35 ED is used for
LAILA-35 ED is a hormonal preparation used to treat the following androgen-dependent conditions in women:
- severe acne when other treatments have failed
- mild to moderate increased growth of facial or body hair (hirsutism).
Androgens are male sex hormones, produced by women in small amounts. If a woman's body produces too much of these hormones or is overly sensitive, then androgen-dependent conditions occur. LAILA-35 ED works by blocking the action of these hormones.
LAILA-35 ED is also an effective oral contraceptive, commonly known as the "Pill" or "birth control pill".
As a contraceptive, LAILA-35 ED prevents pregnancy by:
- preventing ovulation
- thickening the cervical mucus to act as a barrier to sperm
- making the lining of the uterus less suitable for implantation of the fertilised egg.
Oral contraceptives such as LAILA-35 ED may have the following theoretical benefits:
- a decrease in the amount of blood you lose each cycle during your period
- a decrease in anaemia
- a decrease in period pain
- a reduced risk of pelvic inflammatory disease
- a reduced risk of developing ovarian cysts
- an improvement in acne
- a reduced risk of tubal (ectopic) pregnancy
- a reduced risk of benign breast disease (breast lumpiness)
- a reduced risk of getting cancer of the uterus (womb) lining and ovaries.
Ask your doctor if you have any questions about why LAILA-35 ED has been prescribed for you. Your doctor may have prescribed this medicine for another reason.
LAILA-35 ED is not for use in men.
LAILA-35 ED does not protect against HIV infections (AIDS) or other sexually transmitted diseases (STDs). A barrier form of contraception such as a condom or diaphragm is needed.
LAILA-35 ED is available only with a doctor's prescription.
Before you take it
When you must not take it
Do not take LAILA-35 ED if you are allergic to:
- any other medicines containing cyproterone or ethinyloestradiol
- any other oral contraceptive
- any other medicine known as a progestagen or oestrogen, including injections and implants
- any of the ingredients listed at the end of this leaflet.
Some of the symptoms of an allergic reaction may include skin rash, itching or hives; swelling of the face, lips or tongue which may cause difficulty in swallowing or breathing; wheezing or shortness of breath.
Do not take LAILA-35 ED if you have or have had:
- any condition affecting blood circulation, in particular those conditions relating to thrombosis, (formation of blood clots in the legs, lungs or other parts of the body)
- a heart attack, stroke or angina (chest pain)
- a migraine accompanied by visual symptoms, speech disability or weakness or numbness in any part of the body
- diabetes mellitus with blood vessel complications
- inflammation of the pancreas associated with high triglyceride (blood fats) levels in the blood
- jaundice (yellowing of the skin)