Triphasil Tablets

TRIPHASIL belongs to a group of medicines called combined oral contraceptives (COCs) and is one of a group of medicines often referred to as the Pill. TRIPHASIL contains two types of hormones: an oestrogen, ethinylestradiol, and a progestogen, levonorgestrel. It is a triphasic contraceptive. This means that there are three levels of hormones in each pack which reflect the changing levels in your normal menstrual cycle. These hormones stop the ovary from releasing an egg each month. They also thicken the mucus at the neck of the womb making it more difficult for the sperm to reach the egg and alter the lining of the womb to make it less likely to accept a fertilised egg. TRIPHASIL is used to prevent you from becoming pregnant, to control irregularities in the frequency and flow of your menstrual cycle, and to assist with cramps and pain that is normally associated with your menstrual cycle. Whilst using TRIPHASIL for contraception it may also benefit with acne that may occur.

Do not take TRIPHASIL:

• if you are hypersensitive (allergic) to ethinylestradiol or levonorgestrel or to any of the other ingredients of TRIPHASIL (listed in section 6).
• if you or your close family have ever had problems with blood clotting or if you have the inherited disease called porphyria.
• if you are taking ritonavir (a medicine used to treat HIV infections).
• 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 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 ischemic 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.
• high blood pressure.
• a 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 or have ever had breast cancer.
• if you have ever had a severe liver disease, and you have been told by your doctor that your liver function test results are not yet back to normal.
• if you have ever had liver tumours.
• if you become or think you may have become pregnant.
• if you have undiagnosed vaginal bleeding.
• if you have a condition called Dubin-Johnson or Rotor syndromes (condition that affects the liver).
• if you have depression, which is not well controlled with treatment.
• if you have had depression with previous use of hormonal contraceptives.

Tell your doctor or family planning nurse if you have any medical problems or illnesses.

Warnings and precautions

Take special care with TRIPHASIL:

• if you suffer from severe kidney impairment. You will need to consult with your healthcare professional.
• if you have a history of liver disease or consume large quantities of alcohol. Seek urgent medical attention if you notice possible signs of a blood clot (see ‘Blood clots’ section). This could mean that you are possibly suffering from a blood clot in the leg (i.e. deep vein thrombosis), a blood clot in the lung (i.e. pulmonary embolism) and a heart attack or stroke.

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

This pack is designed to help you remember to take your pills. Starting the first pack: Take the first pill on the first day of your period. This is day one of your cycle - the day when bleeding starts. If you start taking the pill on day 2 to 5 of your period, you should use another method of contraception as well, such as the condom, for the first seven pill-taking days, but this is only for the first pack. You can take your pill at any time, but you should take it about the same time each day. You may find it easiest to take it either last thing at night or first thing in the morning. Take a pill every day in the order shown until you finish all 21 active pills in the pack. Once you have taken all 21 active pills, there will be seven pill-free (placebo) days. You will probably start bleeding after about 2 to 3 days and for several of those 7 days. You do not need to use any other form of contraception during the seven-day break provided you have taken the 21 pills properly and you start the next pack on time. However, if you are unsure please consult with your healthcare provider on alternative method of contraception such as a condom to be used together with TRIPHASIL.

The next pack: After seven pill-free (placebo) days, start your next pack. Do this whether or not you are still bleeding. You will always start a new pack on the same day of the week.

TRIPHASIL can have side effects. Not all side effects reported for TRIPHASIL are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking TRIPHASIL, please consult your healthcare provider for advice. If any of the following happens, stop taking TRIPHASIL and tell your doctor immediately or go to the casualty department at your nearest hospital:

• Swelling of the hands, feet, ankles, face, lips, mouth or throat, which may cause difficulty in swallowing or breathing.
• Rash or itching. These are all very serious side effects. If you have them, you may have had a serious reaction to TRIPHASIL. You may need urgent medical attention or hospitalisation.

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• Also, do not take any more pills until you have spoken to your doctor. In the meantime, use another method of contraception such as a condom or cap plus spermicide.
• if you get a migraine for the first time or if you already have migraines but they get worse or happen more often than before.
• breast cancer (symptoms may include, a lump or mass, discharge from your nipple, breast rash, pain in your breast).
• liver tumour (benign or malignant, symptoms may include loss of appetite, stomach pain, vomiting, weakness).
• you develop symptoms of a blood-clot formation.
• a sudden loss of brain function caused by a blockage or rupture of a blood vessel to the brain (loss of muscular control).
• heart attack. The symptoms include:
• unusual pain or swelling in your legs,
• sudden sharp pains in your chest which may reach your left arm,
• sudden shortness of breath or difficulty in breathing,
• sudden coughing for no apparent reason,
• any unusual, severe or long-lasting headache,
• any sudden changes to your eyesight (such as loss of vision or blurred vision),
• slurred speech or any other difficulties affecting your speech.

Store all medicines out of reach of children. Store at or below 25 °C. Keep in original packaging until required for use.

• Do not store in a bathroom.
• Do not use after the expiry date stated on the label.
• Return all unused medicine to your pharmacist.
• Do not dispose of unused medicine in drains or sewage systems (e.g. toilets).