newChoice IZZI-FEM

1. Indication: Avoid pregnancy.
2. Dosage and Usage:
   – Take one tablet as soon as possible, preferrably within 12 hours and no later than 72 hours after you have had unprotected intercouse.
   Do not delay taking the tablet. The tablet works best the sooner you take it after having unprotected sex (for example, it is better to take it within 12 hours rather than delay until the third day). It can only prevent you becoming pregnant if you take it within 72 hours of unprotected sex. – If vomitting occurs within 3 hours of taking the tablet, another tablet should be taken immediately. The patient should then seek advice from her doctor, family planning clinic or pharmacist.
   – newChoice EC Izzi can be used at any time during your menstrual cycle assuming you are not already pregnant or think you may be pregnant.
3. Contraindications
   – Hypersensitivity to the active substance or to any content of drug.
   – Women who are pregnant or think that they may already be pregnant.
   – Young women under 16 years of age or use before the first menstrual bleeding (menarche).
   – Patients with current severe hepatic dysfunction, or history of one but their liver function tests have not returned to normal.
   – Existing or previous liver tumors (benign or malignant).
   – Patients with current or history of thrombosis or at high risk of thrombosis (e.g. myocardial infarction, stroke, etc.).
   – Known or suspected sex hormone-dependent malignant tumors (e.g. of the genital organs or the chest).
   – Patients at risk of ectopic pregnancy (previous history of ectopic pregnancy or of salpingitis, i.e. inflammation of the Fallopian tubes).
   – Vaginal bleeding that has not been diagnosed.
   – Diabetes mellitus with vascular damage.
4. Undesirable effects
   The most commonly reported undesirable effect was nausea. Frequency of adverse reactions:
   – Very common (≥10): Headache, nausea, abdominal pain lower, bleeding not related to menses*, fatigue…
   – Common (≥1/100 to <1/10): Dizziness, diarrhoea, vomiting, delay of menses more than 7 days**, menstruation irregular, breast tenderness…

*Bleeding patterns may be temporarily disturbed, but most women will have their next menstrual period within 5-7 days of the expected time.
**If the next menstrual period is more than 5 days overdue, pregnancy should be excluded.
– Very rare (<1/10,000): Abdominal pain, rash, urticaria, pruritus, pelvic pain, dysmenorrhoea, face oedema.

5. Interaction with other medicaments
   – The metabolism of levonorgestrel is enhanced by concomitant use of liver enzyme inducers, mainly CYP3A4 enzyme inducers.
   – Drugs suspected of having similar capacity to reduce the plasma levels of levonorgestrel include barbiturates (including primidone), phenytoin, carbamazepine, herbal medicines containing Hypericum perforatum (St. John’s Wort), rifampicin, ritonavir, rifabutin, and griseofulvin.
   – For women who have used enzyme-inducing drugs in the past 4 weeks and need emergency contraception, the use of non-hormonal emergency contraception should be considered. Taking a double dose of levonorgestrel is an option.
   – Medicines containing levonorgestrel may increase the risk of ciclosporin toxicity due to possible inhibition of ciclosporin metabolism.

6. Precaution
   newChoice EC Izzi is not as effective as a regular method of contraception and is suitable only as an emergency measure.
7. Pregnancy and lactation: No
8. Effects on ability to drive and use machines:
   newChoice EC Izzi tablet is unlikely to affect your ability to drive a car or use machines.