Triphasil

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NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia.

Levonorgestrel and Ethinylestradiol Tablets

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common questions about Triphasil. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you taking Triphasil against the benefits this medicine is expected to have for you.

If you have any questions about taking this medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine.

You may need to read it again.

What Triphasil is used for

Triphasil is an oral contraceptive, commonly known as a "birth control pill" or "the Pill". Triphasil tablets contain two hormones (levonorgestrel and ethinylestradiol), which prevent you from becoming pregnant if taken correctly. They are similar to the hormones that your body normally produces.

Triphasil prevents pregnancy in several ways:

It inhibits the egg release by stopping it maturing

It changes the cervical mucus consistency making it difficult for the sperm to reach the egg

It changes the lining of the uterus making it less suitable for implantation.

Ask your doctor if you have any questions about why Triphasil has been prescribed for you.

Your doctor may have prescribed Triphasil for another reason.

This medicine is available only with a doctor's prescription.

Triphasil is not habit-forming.

This medicine is not expected to affect your ability to drive a car or operate machinery.

Before you take Triphasil

When you must not take Triphasil

Do not take Triphasil if you have an allergy to:

Any medicine containing ethinylestradiol or levonorgestrel

Any of the ingredients listed at the end of this leaflet

Any other similar medicines (such as other oral contraceptives).

Some of the symptoms of an allergic reaction may include:

shortness of breath

wheezing or difficulty breathing

swelling of the face, lips, tongue or other parts of the body

rash, itching or hives on the skin.

Do not take Triphasil if you have or have had any of the following medical conditions:

Venous thromboembolism (VTE) and are on medicines called anticoagulants which are used to "thin the blood"

Blood clots or a history of blood clots in the:

Legs (thrombophlebitis or deep vein thrombosis (DVT)),

Lungs (pulmonary embolism)

Eyes.

Hereditary or an acquired disposition for venous thromboembolism

Multiple risk factors VTE including obesity, age above 35 years, smoking, high cholesterol

Major surgery and have been confined to bed for long periods of time

Arterial thromboembolism (ATE) or a past history of these that include:

Stroke

Angina

Transient ischaemic attack or "mini stroke".

Hereditary or an acquired disposition for ATE

History of migraine, accompanied by blurred vision, difficulty in speaking, muscle weakness, or increased sensitivity to light, sound, or noise

Multiple risk factors for ATE or a serious risk factor for ATE that include:

Uncontrolled high blood pressure

Diabetes with blood vessel damage

Severe lipid disease

Sickle cell anaemia.

Disease in any blood vessel(s)

Inflammation of the pancreas, which is associated with very high blood levels of triglycerides (fatty substances)

Breast cancer or cancer of the lining of the womb, cervix or vagina, or you think you have these conditions

Unexplained vaginal bleeding

Liver tumour or liver disease

Yellowing of the whites of the eyes or the skin (jaundice) during pregnancy or during previous use of an oral contraceptive

Vaginal bleeding, the cause of which is unknown

Cancer or suspected cancer of the breast or sex organs (e.g. cervix, vagina, ovaries, endometrium, womb) and known or suspected oestrogen-dependent tumours.

If you are not certain whether these may apply to you, or you are worried by anything in this list, tell your doctor.

Do not take this medicine if you are pregnant or you think you are pregnant.

Pregnancy must be excluded before you start taking Triphasil.

Do not take this medicine if you are taking anti-viral hepatitis C virus (HCV) medicinal products such as those containing glecaprevir, pibrentasvir, ombitasvir, paritaprevir, ritonavir and dasabuvir with or without ribavirin.

If you are not sure about your anti-HCV medication, tell your doctor.

Do not give this medicine to a child.

Do not take this medicine if you have already experienced menopause.

Do not take this medicine after the expiry date (EXP) printed on the pack or if the packaging is torn or shows signs of tampering.

If it is expired or damaged, return it to your pharmacist for disposal.

Before you start to take Triphasil

You must have a thorough medical check-up, including a Pap smear, breast check, blood pressure check and urine test.

You must tell your doctor if you or anyone in your immediate family has, or has had blood clots in the legs or lungs.

Blood clots are a rare occurrence when taking an oral contraceptive.

The risk of a blood clot is highest during the first year of taking an oral contraceptive for the first time or if you are re-starting the "pill" after a break of 4 weeks or more.

The risk of having a blood clot is higher in oral contraceptive users than in non-users, but is not as high as during pregnancy.

Tell your doctor about any of the following conditions as these are risk factors for developing blood clots:

Cancer

Systemic lupus erythematosus (SLE)

Haemolytic uraemic syndrome (HUS) - a disorder of blood coagulation causing failure of the kidneys)

Crohn's disease or ulcerative colitis (chronic inflammatory bowel disease)

Sickle cell disease

Smoking particularly if you are heavy smoker (15 or more cigarettes per day) and are aged over 35 years

Have had any recent surgery or trauma

Recently had a baby

Lost a baby in the second trimester

Are pregnant

Had major surgery and have been confined to bed for long periods of time

Also tell your doctor if you are planning a long haul plane flight (greater than 4 hours).

You must tell your doctor if you or anyone in your immediate family has, or has had a stroke or heart attack.

Taking oral contraceptives is linked with an increased risk of having a heart attack, angina, stroke or a "mini stroke".

Tell your doctor if you have any of the following conditions:

Heart disease including heart valve disorders or certain heart rhythm disorders

High blood pressure, a history of high blood pressure, or high blood pressure during pregnancy

High cholesterol

Hepatitis C

Diabetes

Migraine or other headaches

Hyperhomocysteinemia.

Tell your doctor if over 35 years of age or are overweight.

If you are not certain whether any of the above may apply to you, check with your doctor.

Tell your doctor if you have any other health problems, especially:

Breast lumps, abnormal breast X-ray or mammogram

Epilepsy

Depression

Gallbladder disease

Fluid retention or kidney disease

Asthma

Fibroids

Yellowing of the whites of the eyes or skin (jaundice) during pregnancy or during previous oral contraceptive use

Hereditary angioedema (swelling of the face, lips, mouth, tongue or throat).

If you have any of these conditions you should have regular check-ups with your doctor to make sure that taking Triphasil is not making the conditions worse.

Tell your doctor if you plan to become pregnant or are breast feeding.

Your doctor can discuss the risks and benefits involved with you.

If you have not told your doctor about any of the above, tell him/her before you start taking Triphasil.

Triphasil contains lactose.

If you know that you are intolerant to some sugars, or your doctor has told you so, speak to your doctor before taking it.

Tell your doctor if you are allergic to any foods, dyes, preservatives or any other medicines.

Taking other medicines

Tell your doctor if you are taking any other medicines, including:

All prescription medicines

All medicines, vitamins, herbal supplements or natural therapies you buy without a prescription from a pharmacy, supermarket, naturopath or health food shop.

Some medicines may be affected by Triphasil or may affect how well it works. You may need different amounts of your medicines, or you may need to take different medicines. Your doctor will advise you.

Tell your doctor or pharmacist if you are taking any of the following:

Anti-viral hepatitis C virus (HCV) medicines such as glecaprevir, pibrentasvir, ombitasvir, paritaprevir, ritonavir and dasabuvir

Rifampicin and rifabutin for the treatment of tuberculosis

Antibiotics such as ampicillin, other penicillins and tetracyclines

Anti-fungal agents such as griseofulvin

Barbiturates (certain types of medicines prescribed for epilepsy, such as phenobarbitone)

Medicines for epilepsy (such as phenytoin, primidone, carbamazepine and topiramate)

Ritonavir for the treatment of HIV infection

Modafinil used to treat excessive daytime sleepiness

St. John's wort, an ingredient in many medicines you can buy without a prescription from a pharmacy, health food shop or supermarket

Corticosteroids such as dexamethasone.

While you are taking any of these medicines, and for the next 7 days after stopping them, you must use an additional non-hormonal method of contraception (such as condoms or a diaphragm, but not the rhythm or temperature methods). If you come to the end of the yellow tablets during this time, start the next pack straight away. Skip the 7 red tablets.

If you take rifampicin and some other medicines, you may need to use additional non-hormonal contraception for four weeks after finishing the course of treatment.

Ask your doctor or pharmacist about how long you need to use additional non-hormonal contraception.

Tell your doctor or pharmacist if you are taking any of the following:

Atorvastatin used to treat high cholesterol

Indinavir for the treatment of HIV infection

Anti-fungal agents such as itraconazole and fluconazole

Paracetamol

Ascorbic acid (Vitamin C)

Ciclosporin used to prevent organ rejection

Theophyllines used for asthma and other breathing difficulties

Corticosteroids

Lamotrigine for seizures.

If you have not told your doctor or pharmacist about any of the above, tell them before you start taking Triphasil.

How to take Triphasil

Follow all directions given to you by your doctor or pharmacist carefully.

They may differ from the information contained in this leaflet.

Each blister pack of Triphasil contains 21 active tablets: 6 tablets are brown, 5 tablets are white and 10 tablets are yellow in colour; and 7 inactive tablets which are red. Each blister strip of Triphasil provides a month of tablets. It is important that you take the tablets in the correct order. Following the arrows on the blister strip will assist you.

When to take Triphasil

You must take Triphasil every day, regardless of how often you have sex.

Triphasil will work best if you do not miss any tablets and take it at the same time each day. Taking your Triphasil at the same time each day will also help you remember when to take the tablets.

It does not matter if you take Triphasil before or after food.

If you are concerned about this, please speak to your doctor or pharmacist.

How to take it

Swallow Triphasil with a full glass of water.

Starting a hormonal contraceptive for the first time

To start taking Triphasil follow these steps:

1. On the first day of your menstrual period, take a tablet that matches the day of the week from the shaded section of the blister pack. If your period starts between Monday and Friday your first tablet is red. If your period starts on a Saturday or Sunday your first tablet is brown.

You must also use an additional non-hormonal method of contraception (such as condoms or a diaphragm, but not the rhythm or temperature methods) until you have taken a brown or white tablet in the correct order every day for 7 days without a break.

2. Then take one tablet each day, following the arrows so that you are taking the correct tablet for the day of the week until all tablets have gone.

3. You will have a 'withdrawal' bleed, similar to having a period, during the week of the red tablets.

If you do not have a period while you are taking the red tablets, and there is any chance that you have not followed all the instructions in this leaflet, contact your doctor to check if you are pregnant.

Going on to further blister packs

1. On the day after the last tablet in your previous blister pack, begin the next pack by taking a tablet from the shaded section of the blister pack. If the day of the week when you start your new pack is between Monday and Friday, your first tablet is red. If it is Saturday or Sunday, your first tablet is brown. Do this even if you are still bleeding.

2. Each new pack is started with a red or brown tablet on the same day as the first pack, so that you have 6 days on brown tablets, 5 days on white tablets, 10 days on yellow tablets and 7 days on red tablets. There is no break between packs.

If you start taking your new pack late, you must also use an additional non-hormonal method of contraception (such as condoms or a diaphragm, but not the rhythm or temperature methods) until you have taken a brown or white tablet in the correct order every day for 7 days without a break.

Switching from a different combined oral contraceptive

Follow these steps if your current oral contraceptive contains an oestrogen and a progestogen:

1. Stop taking your current oral contraceptive after you have taken the last active tablet. If your current oral contraceptive pack also contains inactive, or reminder tablets, do not take them.

2. The next day, take the first tablet from the shaded section that matches the day of the week. If the day of the week is between Monday and Friday your first tablet is red. If it is Saturday or Sunday your first tablet is brown.

3. Then take one tablet each day; following the arrows so that you are taking the correct tablet for the day of the week until all of the tablets have gone.

4. You will have a 'withdrawal' bleed, similar to having a period, during the week of red tablets.

If you do not have a period while you are taking the red tablets, and there is any chance that you have not followed all the advice in this leaflet, contact your doctor to check if you are pregnant.

Switching from a progestogen-only contraceptive

You can stop taking a progestogen-only contraceptive tablet any day and start taking Triphasil the next day, at the same time.

If you have been using a progestogen-only implant, start taking Triphasil on the day the implant is removed.

If you have been using a progestogen-only injection, start taking Triphasil on the day the next injection would be due.

In all cases start Triphasil by taking a red or brown tablet from the shaded section that matches the day of the week.

After having a baby

If you have just had a baby, talk to your doctor before you start taking Triphasil.

After a miscarriage or abortion

Your doctor will advise you how to take Triphasil after a miscarriage or abortion.

How long to take Triphasil

Continue taking your medicine for as long as your doctor tells you.

Your doctor may prescribe Triphasil for long periods, until you no longer need or want contraception.

If you are not sure how long you should be taking Triphasil, ask your doctor.

If you forget to take your tablets

If you forget to take Triphasil every day it may not work as well in protecting you from becoming pregnant.

Do not try to make up for missed doses by taking more than one tablet at a time.

Forgetting one or more active tablets

If you forget to take one active tablet (brown, white or yellow tablet) but it is less than 12 hours late, take the missed tablet immediately. Take the next tablet at your usual time, even if this means taking two active tablets in one day.

If you do not take the missed tablet within 12 hours, Triphasil may not work as well in protecting you from becoming pregnant.

If you forget to take one active tablet (brown, white or yellow tablet), and you remember more than 12 hours late, take the last missed tablet as soon as you remember and the next tablet at the usual time.

Continue to take tablets at your usual time but you must also use an additional non-hormonal method of contraception (such as condoms or a diaphragm but not the rhythm or temperature methods) until you have taken an active tablet every day for 7 days in the correct order without a break. If you come to the end of the yellow tablets during this time, start the next pack straight away. Skip the 7 red tablets.

Forgetting two active tablets

If you forget two active tablets (brown, white or yellow tablets), take the last missed tablet as soon as you remember, and the next tablet at the usual time.

Continue to take your tablets at the usual time but you must also use an additional non-hormonal method of contraception (such as condoms or a diaphragm but not the rhythm or temperature methods) until you have taken an active tablet every day for 7 days in the correct order without a break. If you come to the end of the yellow tablets during this time, start the next pack straight away. Skip the 7 red tablets.

You may not have a withdrawal bleed until the end of the new pack, but you may have spotting or breakthrough bleeding when taking the active tablets. If you don't have a withdrawal bleed at the end of the new pack, contact your doctor, who must make sure that you are not pregnant before you start the next pack.

Forgetting three or more active tablets

Contact your doctor for advice on what to do.

Forgetting a red tablet

If you miss one or more inactive, red tablets, leave them in the pack and do not worry.

However, if you miss red tablets and then forget to start the next pack on time, start as soon as you remember by taking a brown tablet that matches the day of the week. You must also use an additional non-hormonal method of contraception (such as condoms or a diaphragm but not the rhythm or temperature methods) until you have taken a brown or white tablet in the correct order every day for 7 days without a break.

If you are not sure what to do, ask your doctor or pharmacist.

If you are having trouble remembering to take Triphasil, ask your pharmacist for some hints.

If you vomit or have diarrhoea after taking Triphasil

If you have vomiting or diarrhoea within 4 hours of taking an active tablet (brown, white or yellow tablet), you must use an additional non-hormonal method of contraception (such as condoms or a diaphragm, but not the rhythm or temperature methods) until you have taken an active tablet every day for 7 days in the correct order without a break. If you come to the end of the yellow tablets during this time, start the next pack straight away. Skip the 7 red tablets.

The tablet may not have time to be absorbed properly and may not protect you from becoming pregnant.

If you have vomiting or diarrhoea after taking a red tablet, do not worry.

If you take too much (overdose)

Immediately telephone your doctor or the Poisons Information Centre (telephone 13 11 26) for advice, or go to Accident and Emergency at your nearest hospital if you think you or anyone else may have taken too much Triphasil.

Do this even if there are no signs of discomfort or poisoning.

You may need urgent medical attention.

Symptoms of an overdose may have include:

Feeling sick or vomiting

Dizziness

Feeling sleepy or tired

Women may also experience menstrual bleeding.

While you are taking Triphasil

Things you must do

Tell any other doctors, dentists and pharmacists who are treating you that you are taking Triphasil.

If you are about to start taking any new medicines, tell the doctor or pharmacist that you are taking Triphasil.

If you become pregnant while taking Triphasil, see your doctor immediately.

If you are about to have any blood tests, tell your doctor you are taking Triphasil.

It may interfere with the results of some tests.

If you miss a period and you have taken your tablets correctly, continue taking your tablets as you would normally.

Sometimes you might not have a menstrual period while taking Triphasil.

If you miss a period and you have not taken your tablets correctly, keep taking your tablets and see your doctor immediately.

Not taking your tablets correctly includes missing one or more tablets or starting a new pack later than you should have.

If you miss two menstrual periods, stop taking your tablets and see your doctor, even if you have taken the tablets correctly. You must use a non-hormonal method of contraception, (such as condoms or a diaphragm) during this time.

Your doctor should make sure you are not pregnant before you start taking Triphasil again.

Have regular check-ups from your doctor, including a Pap smear.

Oral contraceptives should not be prescribed for longer than one year without your doctor carrying out a check-up. Your doctor will advise you how often you need a Pap smear. A Pap smear can detect abnormal cells lining the cervix. Sometimes abnormal cells can progress to cervical cancer. The most important risk factor for cervical cancer is persistent human papillomavirus (HPV) infection. However, cervical cancer has been reported to occur more often in women using an oral contraceptive for a long time. This finding may not be caused by the oral contraceptive, but may be related to sexual behaviour and other reasons.

Perform regular breast self-examination.

Risk factors for the development of breast cancer include increasing age, family history, obesity, never having had a baby, and late age for first full-term pregnancy. Breast cancer has also been found slightly more often in women who use oral contraceptives than in women of the same age who do not use them. This slight increase in the number of breast cancer cases gradually disappears during the course of the 10 years after stopping the use of oral contraceptives. It is not known whether the oral contraceptive causes the difference. It may be that the women were examined more often, so that the breast cancer was noticed earlier.

If you are concerned about contracting a sexually transmitted disease (STD), ask your partner to wear a condom when having sexual intercourse with you.

Triphasil will not protect you from HIV-AIDS or any other sexually transmitted diseases (STDs), such as chlamydia, genital herpes, genital warts, gonorrhoea, hepatitis B, human papilloma virus and syphilis. To help protect yourself from STDs, you need to use a barrier contraceptive such as a condom.

Tell your doctor you are taking Triphasil at least 4 weeks before any planned hospitalisation or surgery.

Your doctor may tell you to stop taking Triphasil several weeks before surgery or at the time of immobilisation. Your doctor will tell you when you can start taking Triphasil after you are back on your feet.

To avoid pregnancy during this time you must use a non-hormonal method of contraception such as condoms or a diaphragm.

Things you must not do

Do not take Triphasil to treat any other complaints unless your doctor tells you to.

Do not give your medicine to anyone else.

Do not stop taking Triphasil, or change the dosage, without checking with your doctor.

If you stop taking Triphasil or do not take a tablet every day, without using another form of contraception, you may become pregnant.

Side Effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while taking Triphasil.

All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical attention if you get certain side effects.

It can be difficult to tell whether side effects are the result of taking Triphasil or are side effects of another medicine you are taking.

Do not be alarmed by the list of side effects.

You may not experience any of them.

Ask your doctor or pharmacist to answer any questions you have.

Tell your doctor if...

Tell your doctor if you notice any of the following.

Changes in bleeding patterns, including breakthrough bleeding/spotting

Painful periods

Missed periods, but if you have not taken Triphasil as directed you should check whether you are pregnant

Changes in mucus from the vagina

Changes in the cervix

Vaginal thrush (candida)

Breast pain, tenderness, enlargement, possible milk secretion

Changes in sex drive.

Nausea or vomiting

Abdominal pain, cramps or bloating

Mood changes, including depression

Headache, including migraines

Nervousness

Dizziness

Contact lenses becoming uncomfortable to wear

Weight change (increase or decrease)

Changes in appetite

Swelling of the hands, ankles or feet

Acne

Rash

Darkening of the skin, which may persist after stopping Triphasil

Loss of scalp hair

Increase in body hair.

The above list includes the more common side effects of your medicine.

Tell your doctor as soon as possible if...

Tell your doctor as soon as possible if you notice any worsening of conditions that you may already have such as:

Chorea (involuntary muscle spasm)

Porphyria

Systemic lupus erythematosus (Lupus)

Varicose veins

Gallbladder disease

Hereditary angioedema (swelling of the face lips, mouth, tongue or throat).

Go to hospital if...

Tell your doctor immediately, or go to accident and emergency at your nearest hospital if you notice any of the following:

Unexplained or persistent pains in the head, chest, arm or below the breastbone

Severe pain, swelling or discolouration in either of your legs

Shortness of breath

Rapid or irregular heartbeat

Blurred or double vision

Partial or complete loss of sight

Eye protrusion, swelling of the eye or eye lesions

Dizziness or fainting, sometimes with loss of balance

Sweating, nausea or vomiting

An unusual cough

Weakness or numbness in any part of your body

Discomfort radiating to the back, jaw, throat or stomach

Confusion, trouble speaking or understanding

Bloody diarrhoea

Abdominal pain

Fever

Feeling of indigestion or choking

Rectal bleeding

Feeling tired

Lose your appetite or lose weight

Breast lumps

Jaundice or a yellowing of the skin or eyeballs, often with fever, fatigue, loss of appetite, dark coloured urine or light coloured bowel movements. Taking oral contraceptives has been associated with an increased risk of having a benign liver tumour, and in very rare cases, liver cancer. The risk appears to increase the longer oral contraceptives are taken

Migraine headaches for the first time

More frequent migraines if you already suffer from them

Itchy rash

You are an epileptic and your fits become more frequent

Rise in blood pressure. You may experience headache, blurred vision or palpitations. Sometimes your blood pressure may rise without you experiencing any of these symptoms. It is important to keep your routine doctor's appointments so that your blood pressure can be checked

Swelling around the eyes or mouth.

Whilst these side effects are rare, they are serious. You may need urgent medical attention or hospitalisation.

Other side effects not listed above may also occur in some patients. Tell your doctor if you notice anything else that is making you feel unwell, even if it is not on this list.

After stopping Triphasil

If your periods do not return within 2 to 3 months of stopping Triphasil, tell your doctor.

Some women have short-term problems getting pregnant after stopping Triphasil, especially if they had irregular menstrual cycles before starting to use an oral contraceptive.

If you are planning to become pregnant after stopping Triphasil, use a non-hormonal method of contraception such as condoms or a diaphragm for 3 months before trying to get pregnant.

Ask your doctor or pharmacist for advice about taking folate if you plan to become pregnant.

After taking Triphasil

Storage

Keep your tablets in the blister pack until it is time to take them.

If you take the tablets out of the blister pack they may not keep well.

Keep your tablets in a cool, dry place where the temperature stays below 25°C and is away from light.

Do not store Triphasil or any other medicine in a bathroom or near a sink. Do not leave Triphasil in the car on hot days or on window sills.

Heat and dampness can destroy some medicines.

Keep it where children cannot reach it.

A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Disposal

If your doctor tells you to stop taking Triphasil, or the expiry date has passed, ask your pharmacist what to do with any left over.

Product description

What it looks like

Triphasil comes in a 16 week box containing 4 blister packs. Each blister pack contains 4 different tablets:

6 brown active tablets

5 white active tablets

10 yellow active tablets

7 red inactive tablets.

The blister pack is marked with days of the week next to each tablet to ensure they are taken in the correct order.

Ingredients

Each brown tablet contains 50 micrograms of levonorgestrel and 30 micrograms of ethinylestradiol as the active ingredients.

Each white tablet contains 75 micrograms of levonorgestrel and 40 micrograms of ethinylestradiol as the active ingredients.

Each yellow tablet contains 125 micrograms of levonorgestrel and 30 micrograms of ethinylestradiol as the active ingredients.

The red tablets contain no active ingredients.

The brown, white, yellow and red tablets also contain the following inactive ingredients:

Lactose monohydrate

Maize starch

Povidone

Purified talc

Magnesium stearate

Sucrose

Macrogol 6000

Calcium carbonate

Glycerol (brown and yellow tablets only)

Glycol montanate.

The brown tablets also contain the following colouring agents:

Iron Oxide Yellow

Iron Oxide Red

Titanium dioxide.

The yellow tablets also contain the colouring agents: