Trigestrel 0,05 mg/0,03 mg/0,075 mg/0,04 mg/0,125 mg Tablets

• TRIGESTREL is used for prevention of pregnancy.

• If you use it as instructed you are very unlikely to become pregnant.

• Oral contraceptives are also used for control of painful menstrual bleeding, and / or to control abnormal uterine bleeding.

• It also benefits those who want to use oral contraceptive and have coincidental acne.

• In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do.

• If you are using oral contraceptives for contraception you should understand how their benefits and risks compare to those of other birth control methods.

• This is a decision you, your sexual partner, and your doctor will make.

• Before you start taking TRIGESTREL your pelvic organs, breasts and blood pressure should be checked by your doctor and these checks should be repeated regularly.

Do not take TRIGESTREL:

• If you have depression, which is not well controlled with treatment.
• If you have had depression with previous use of hormonal contraceptives.

Before you take TRIGESTREL tell your doctor if you have any of these:

• If you have blood clots in any part of the body or ever had these before.
• If you ever had a heart attack or heart related disease.
• Cancer of the breast or womb or have ever had either of these conditions or have family history for either of these conditions.
• If you have (or history of) tumours in uterus.
• Abnormal bleeding from vagina.
• If you are pregnant or think you are pregnant.
• If you had liver related disease or liver tumours.
• If you suffer from migraine or frequent severe headache.
• If you are allergic to any of the ingredients of TRIGESTREL.

If you are taking medicines on a regular basis, concomitant use of the medicine may cause undesirable interactions. Please consult your doctor, pharmacist or other health care professional for advice. If you are pregnant or breastfeeding your baby while taking this medicine, please consult your doctor, pharmacist or other health care professional for advice.

Do not share medicines prescribed for you with any other person. Always take TRIGESTREL exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

This memo pack has been specially designed to help you to remember to take your tablets. Each tablet is placed in its own bubble. If you are new to the tablet treatment or are starting the tablets again after a break, take your first TRIGESTREL tablet on the first day of bleeding of your next period. For other users, follow instructions for “changing from another type of oral contraceptive”, “Starting TRIGESTREL after having a baby “or as directed by a physician.

Always take TRIGESTREL exactly as you doctor has instructed you. You should check with your doctor or pharmacist if you are unsure of how to use TRIGESTREL. The usual dose is one tablet every day at the same time, preferably after the evening meal or at bedtime.

During the first cycle of administration, take the first tablet from the red area of the pack marked with the appropriate day of the week. Thereafter, take one tablet daily following the arrows marked on the package until all the tablets have been taken. You may have withdrawal bleeding within 2 to 4 days after the last yellow tablet is taken. You should use an additional method of protection until 14 tablets have been taken.

TAKING YOUR FIRST PACK OF TRIGESTREL

• You must start by taking tablet from the red area of the pack marked with the appropriate day of the week. It is important to realise that all tablets are not same and that they must therefore be taken in the right order, starting from the red area. Take the tablet from the red area having the day mentioned same as the day you are starting the tablet.
• After taking your first tablet take one tablet each day, following the direction of the arrows, until you have finished all tablets in pack.
• You should try to take tablet at the same time everyday.
• Swallow each tablet whole, with water if necessary.
• By starting in this way, you will have contraceptive protection.

TAKING YOUR NEXT PACK OF TRIGESTREL

• Start taking your next pack of TRIGESTREL the day after you have finished the current pack.

If you take more TRIGESTREL than you should If you have taken more than one tablet you may experience nausea and you may have withdrawal bleeding you should consult your doctor who will be able to advise you what action, if any, is necessary. 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 TRIGESTREL

• You should take the missed tablet as soon as you remember.
• If you forget to take tablets for two consecutive days, then you should take both the tablets as soon as you remember.
• In either case, you should take the next tablet at its usual time.
• Each time you miss one or two consecutive tablets, you or your partner must use another method of contraception (such as condom) until you have taken tablets for next 14 consecutive days.
• If you miss one or more inert tablets, you will be still protected against pregnancy, provided you start the tablets on the proper day.
• If you miss three consecutive tablets discontinue the remainder of the package and discard it, start a new package on the eighth day after you have taken the last tablet.
• You or your partner must use another method of contraception (such as condom), until you have taken tablets for next 14 consecutive days.
• If you do not have withdrawal bleeding and you have taken TRIGESTREL as per directions, it is unlikely that you have conceived.
• You must begin a second course of TRIGESTREL on the usual day.
• If you do not get bleeding at the end of your second cycle, you should stop taking TRIGESTREL immediately and consult your doctor.
• If you are taking the tablet for the treatment of painful menstrual bleeding or abnormal uterine bleeding, take the tablet in the same way as mentioned prevention of pregnancy.

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

Tell your doctor if you notice any of the following:

Frequent side effects:

• Nausea and/or vomiting, bloating, abdominal cramps
• Water retention
• Breast tenderness and menstrual irregularities such as spotting, breakthrough bleeding or complete stopping of menstrual bleeding
• Acne

Less frequent side effects:

• High blood pressure
• Intolerance to contact lenses has been reported and vision may deteriorate in some patients
• Headache, weight gain
• Impaired liver function
• Reduced glucose tolerance and changes in lipid metabolism
• Increased risk of cervical cancer, breast cancer, and liver tumours
• Rapid, involuntary movements
• Depression and other mental changes
• Changes in libido, vaginal infections.
• Spots or patches on the skin, and other skin or hair changes, skin rashes, increased facial hair.

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.

• In order to protect from light and moisture do not store in a bathroom.

• Do not use after the expiry date stated on the carton. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage system (e.g. toilet).

• Store all medicines out of reach of children.