Hy – An 0,03 mg Tablets

• HY - AN is an oral contraceptive.

• The active ingredient is levonorgestrel, which is a type progesterone. It works by thickening the fluid (mucus) at the neck of the womb (cervix) making it very difficult for the sperm to reach the egg, and it also alters the lining of the womb to make it less likely to accept a fertilised egg.

If you are taking other medicines on a regular basis, including complementary or traditional medicines, the use of HY - AN with these medicines may cause undesirable interactions. Please consult your doctor, pharmacist or other healthcare professional, for advice. Ensure that you do not suffer from the conditions listed below or that the prescribing doctor is aware that you may have had any of the listed conditions.

• undiagnosed vaginal bleeding,
• possible pregnancy
• severe arterial disease
• hormone dependent neoplasm
• severe liver disease such as hepatic adenoma
• porphyria

They should not be used after the recent evacuation of a hydatidiform mole. Please inform the physician or dentist in charge that you are taking this medicine before any kind of surgery (including dental surgery) or emergency treatment. Your doctor will decide whether you should continue taking this medicine.

Do not share medicines prescribed for you with any other person. Always take HY - AN exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. HY - AN (levonorgestrel) must be taken exactly as directed and at intervals not exceeding 24 hours. Patients should be instructed to take the tablets at the same time every day, preferably after the evening meal or at bedtime. The patient begins HY - AN (Levonorgestrel) on day 1 of her menstrual cycle, i.e. the first day of bleeding. One tablet is taken every day at the same time, without interruption, as long as contraception is desired. Tablets should be taken on this continuous daily regimen whether or not bleeding occurs. A mechanical method of contraception should be used until the first fourteen tablets have been taken.

If you take more HY - AN than you should

In the event of overdosage, consult your doctor or pharmacist. If neither is available seek help at the nearest hospital or poison centre.

If you forget to take HY - AN

• The risk of pregnancy increases with each tablet missed.
• If the patient misses one tablet she should be instructed to take it as soon as she remembers and to also take her next tablet at the regular time.
• If she misses two tablets, she should take one of the missed tablets as soon as she remembers as well as taking her regular tablet for that day at the proper time.
• In either case, she should use a mechanical method of contraception for the next 7 days.
• If she has missed one or two tablets and does not have a period within 45 days of her last, she should discontinue HY - AN (levonorgestrel) and depend upon a mechanical method of contraception until the possibility of pregnancy has been excluded.
• If more than two tablets have been missed, HY - AN (levonorgestrel) should be discontinued immediately and a mechanical method of contraception should be used until menses has appeared or the possibility of pregnancy has been excluded.
• Alternatively, if the patient has taken the tablets correctly and if menses does not appear within 60 days from the last period, a mechanical method of contraception should be substituted until an appropriate diagnostic procedure is performed to exclude the possibility of pregnancy.
• The contraceptive effectiveness may be reduced during episodes of vomiting or diarrhoea & extra contraceptive measures may be necessary during and for 7 days after recovery.

HY - AN can have side effects. Not all side - effects reported for HY - AN are included in this leaflet. Should your general health worsen, or if you experience any untoward effects while taking [this medicine] HY - AN, please consult your health care provider for advice.

If any of the following happens, stop taking / using HY - AN and tell your doctor immediately or go to the casualty department at your nearest hospital:

• Sudden severe chest pain, sudden breathlessness, or severe pain /swelling in calf of one leg (possibly indicative of thromboembolic complications).
• Unusual, severe prolonged headache, sudden disturbances of vision or hearing or other perceptual disorders, collapse, marked numbness or weakness affecting one side of the body or other signs or symptoms suggestive of cerebrovascular accident.
• A first unexplained epileptic seizure.
• Hepatitis, jaundice, generalised itching, liver enlargement, severe upper abdominal pain.
• Significant rise in BP (above 160 mm Hg systolic or 100 mm/Hg diastolic).

These are all very serious side effects. If you have them, you may have had a serious reaction to HY - AN. You may need urgent medical attention or hospitalisation.

Tell your doctor if you notice any of the following:

Frequent side effects:

• Hyperglycaemia, weight gain
• Mood changes
• Headache, fatigue
• Fluid retention
• Abdominal pain or cramping, diarrhoea, nausea
• Amenorrhoea, breakthrough bleeding, menorrhagia, spotting

Less frequent side effects:

• Thromboembolism or thrombus formation
• Increases in hepatic enzyme levels, jaundice
• Melasma, acne, skin rash
• Breast pain or tenderness

Post marketing reported side effects:

• Suicidal thoughts/behaviour and suicide

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

• Store at or below 25 ˚C.
• Protect from light.
• Store all medicines out of reach of children.
• Do not store medicines in the bathroom in hot and moist conditions.
• Do not use the medicine after the expiry date on the container.
• Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage system (e.g. toilet).