onsumer Medicine Information
This leaflet has been written to provide you with some background information on LOGYNON ED tablets and how you should take this medicine. Your doctor and pharmacist have detailed information on LOGYNON ED tablets; they are trained to help you to understand why you are taking this medicine.
Read this information carefully before you start taking LOGYNON ED tablets. Keep this leaflet in a handy place; you may wish to refer to it again before you have finished taking these tablets. Please contact either your doctor, clinic or pharmacist if you have any questions about your treatment with LOGYNON ED tablets or if you have any problems or difficulties before, during or after taking LOGYNON ED tablets.
It is important to remember that LOGYNON ED tablets is a PRESCRIPTION ONLY MEDICINE - you should only use LOGYNON ED tablets as directed by your doctor.
LOGYNON ED is the brand name for 28 active tablets; 6 light brown coated tablets each containing 50ìg levonorgestrel and 30ìg ethinylestradiol, 5 white coated tablets each containing 75ìg levonorgestrel and 40ìg ethinylestradiol, 10 ochreous coated tablets each containing 125ìg levonorgestrel and 30ìg ethinylestradiol and 7 large white placebo tablets.
The AUST R number for LOGYNON ED is 40192. As well as its active ingredients, LOGYNON ED contains lactose, maize starch, povidone, talc-purified, magnesium stearate, sucrose, macrogol 6000, calcium carbonate, glycerol, titanium dioxide, iron oxide yellow Cl77492, iron oxide red Cl77491 and glycol montanate.
LOGYNON ED is presented in PVC/Aluminium backed blister platforms of 28 tablets with each tablet allocated to a day of the week. It is sold in boxes containing 4 blister platforms.
WHAT IS LOGYNON ED USED FOR AND HOW DOES IT WORK?
LOGYNON ED is an oral contraceptive, commonly known as a "Birth Control Pill" or "The Pill" that has been prescribed to prevent you from getting pregnant. LOGYNON ED prevents pregnancy in several ways:
inhibiting the egg release by stopping it maturing;
changing the cervical mucus consistency making it difficult for the sperm to reach the egg;
changing the lining of the uterus making it less suitable for implantation.
When taken as directed LOGYNON ED is very effective at preventing pregnancy. Oral contraceptives such as LOGYNON ED may have the following theoretical benefits:
a decrease in the amount of blood you lose each month during your period;
a decrease in iron deficiency (called anaemia);
a decrease in period pain;
a decrease in pelvic inflammatory disease;
a decrease in developing ovarian cysts;
an improvement in acne;
a reduced risk of tubal (ectopic) pregnancy;
a reduced risk of benign breast disease (breast lumpiness);
a reduced risk of getting cancer of the uterus (womb) lining and ovaries.
CHECKLIST BEFORE USING LOGYNON ED
Before being prescribed LOGYNON ED your doctor should perform a thorough medical and gynaecological examination (including the breasts). Your doctor will also note your family medical history.
The use of Oral Contraceptives such as LOGYNON ED by cigarette smokers may increase the risk of cardiovascular disease. This risk increases with heavy smoking and advancing age and is quite marked in women over the age of 35 years. You should therefore stop smoking if you want to use an oral contraceptive such as LOGYNON ED.
Do not use LOGYNON ED if you have any of the conditions listed below. If any of these apply to you, tell your doctor before starting to use LOGYNON ED. Your doctor may advise you to use a different type of Pill or an entirely different (non-hormonal) method of birth control.
If you have, or have ever had a disorder affecting the blood circulation: in particular, those conditions relating to thrombosis (the formation of a blood clot) in the blood vessels of the legs (deep vein thrombosis), the lungs (pulmonary embolism), the heart (heart attack), or other parts of the body (see also the section later in this leaflet called "The Pill and thrombosis").
If you have or have had a stroke (caused by a blood clot or a rupture of a blood vessel in the brain).
If you have or have ever had a condition that may be a first sign of a heart attack (such as angina pectoris or chest pain) or stroke (such as transient ischaemic attack or small reversible stroke).
If you have a history of migraine accompanied by e.g. visual symptoms, speech disability, or weakness or numbness in any part of your body.
If you have diabetes mellitus with blood vessel damage.
If you have or have had a pancreatitis (an inflammation of the pancreas) associated with high levels of fatty substances in your blood.
If you have jaundice (yellowing of the skin) or severe liver disease.
If you have or have had a cancer that may grow under the influence of sex hormones (e.g. of the breast or the genital organs).
If you have or have had a benign or malignant liver tumor.
If you have any unexplained vaginal bleeding.
If you are pregnant or think you might be pregnant.
If you are hypersensitive (allergic) to ethinyloestradiol or levonorgestrel or any of the other ingredients of LOGYNON ED.
If any of these conditions appear for the first time while using the Pill, stop taking it at once and consult your doctor. In the meantime, use non-hormonal contraceptive measures.
In this leaflet, several situations are described where you should stop taking the Pill, or where the reliability of the Pill may be decreased. In such situations you should not have sex or you should take extra non-hormonal contraceptive precautions, e.g., use a condom or another barrier method. Do not use rhythm or temperature methods. These methods can be unreliable because the Pill alters the usual changes in temperature and cervical mucus that occur during the menstrual cycle.
LOGYNON ED, like all contraceptive Pills, does not protect against HIV infection (AIDS) or any other sexually transmitted disease.
BEFORE YOU START TO USE LOGYNON ED
If the combined Pill is used in the presence of any of the conditions listed below you may need to be kept under close observation. Your doctor can explain this to you. Therefore, if any of these apply to you, tell your doctor before starting to use LOGYNON ED:
you have diabetes;
you are overweight;
you have high blood pressure;
you have a heart valve disorder or a certain heart rhythm disorder;
you have an inflammation of your veins (superficial phlebitis);
you have varicose veins;
anyone in your immediate family has had a thrombosis, a heart attack or a stroke;
you suffer from migraine;
you suffer from epilepsy;
you or someone in your immediate family has or has had high blood levels of cholesterol or triglycerides (fatty substances);
anyone in your immediate family has had breast cancer;
you have liver or gallbladder disease;
you have Crohn's disease or ulcerative colitis (chronic inflammatory bowel disease);
you have systemic lupus erythematosus (SLE; a disease affecting the skin all over the body);
you have hemolytic uremic syndrome (HUS; a disorder of blood coagulation causing failure of the kidneys);
you have sickle cell disease;
you have a condition that occurred for the first time or worsened during pregnancy or previous use of sex hormones (e.g. pruritus related to cholestasis, jaundice, gallstone formation, otosclerosis related hearing loss, a metabolic disease called porphyria, a skin disease called herpes gestationis, a neurological disease called Sydenham's chorea);
you have or have had chloasma (yellowish-brown pigmentation patches on the skin, particularly of the face); if so, avoid too much exposure to the sun or ultraviolet radiation.
If any of the above conditions appear for the first time, recur or worsen while using the Pill, you should contact your doctor.
The Pill and thrombosis
A thrombosis is the formation of a blood clot, which may block a blood vessel.
A thrombosis sometimes occurs in the deep veins of the legs (deep venous thrombosis). If this blood clot breaks away from the veins where it is formed, it may reach and block the arteries of the lungs, causing a so-called "pulmonary embolism". Deep venous thrombosis is a rare occurrence. It can develop whether or not you are taking the Pill. It can also happen if you become pregnant. The risk is higher in Pill users than in non-users but not as high as the risk during pregnancy.
Blood clots can also occur very rarely in the blood vessels of the heart (causing a heart attack) or the brain (causing a stroke). Extremely rarely blood clots can occur in the liver, gut, kidney or eye.
Very occasionally thrombosis may cause serious permanent disabilities or may even be fatal.
Biochemical factors (hereditary or acquired) that may indicate a possible predisposition for blood clot formation include having Activated Protein C (APC) resistance, hyperhomocysteinemia, antithrombin-III deficiency, protein C deficiency, protein S deficiency and antiphospholipid antibodies.
The risk of having a heart attack or stroke increases as you get older. It also increases the more you smoke. When using the Pill you should stop smoking, especially if you are older than about 35 years of age.
If you develop high blood pressure while using the Pill, you may be told to stop using it.
The risk of having deep venous thrombosis is temporarily increased as a result of an operation or immobilisation (for example, when you have your leg or legs in plaster or splints). In women who use the Pill the risk may be yet higher. Tell your doctor you are using the Pill well in advance of any expected hospitalisation or surgery. Your doctor may tell you to stop taking the Pill several weeks before surgery or at the time of immobilisation. Your doctor will also tell you when you can start taking the Pill again after you are back on your feet.
If you notice possible signs of a thrombosis, stop taking the Pill and consult your doctor immediately (See also "When should you contact your doctor?").
The Pill and cancer
Breast cancer has been diagnosed slightly more often in women who use the Pill than in women of the same age who do not use the Pill. This slight increase in the numbers of breast cancer diagnoses gradually disappears during the course of the 10 years after stopping use of the Pill. It is not known whether the difference is caused by the Pill. It may be that the women were examined more often, so that the breast cancer was noticed earlier.
In rare cases benign liver tumors and even more rarely, malignant liver tumors have been reported in users of the Pill. These tumors may lead to internal bleeding. Contact your doctor immediately if you have severe pain in your abdomen.
Cervical cancer has been reported to occur more often in women using the Pill for a long time. This finding may not be caused by the Pill but may be related to sexual behavior and other factors.
The Pill and pregnancy
LOGYNON ED must not be used by women who are pregnant, or who think they may be pregnant. If you suspect that you are pregnant while you are already using LOGYNON ED, you should consult your doctor as soon as possible.
The Pill and breast-feeding
LOGYNON ED is generally not recommended for use during breastfeeding. If you wish to take the Pill while breastfeeding, please seek the advice of your doctor.
The Pill and other medicines
Some medicines may stop the Pill from working properly. These include medicines used for the treatment of epilepsy (e.g. primidone, barbiturates, carbamazepine, oxcarbazepine, topiramate, and felbamate); tuberculosis (e.g. rifampicin), antibiotics (e.g. ampicillins, tetracyclines and griseofulvin) for some other infectious diseases and herbal medicines containing St John's wort. The Pill may also interfere with the working of other medicines.
Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines or herbal products, even those not prescribed. Also tell any other doctor or dentist who prescribes another medicine (or the dispensing pharmacist) that you use LOGYNON ED. They can tell you if you need to take additional contraceptive precautions and if so, for how long.
WHEN SHOULD YOU CONTACT YOUR DOCTOR?
When you are using the Pill, your doctor will tell you to return for regular check-ups.
Contact your doctor as soon as possible if:
you notice any changes in your own health, especially involving any of the items mentioned in this leaflet (see also: "Checklist before using LOGYNON ED" and "Before you start to use LOGYNON ED"; do not forget about the items related to your immediate family);
you feel a lump in your breast;
you are going to use other medications (see also "The Pill and other medicines");
you are to be immobilized or are to have surgery (consult your doctor at least four weeks in advance);
you have unusual, heavy vaginal bleeding;
you forgot tablets from the first row of the pack and had intercourse in the seven days before;
you have severe diarrhoea;
you miss your period twice in a row or suspect you are pregnant (do not start the next pack until told to by your doctor).
Stop taking tablets and see your doctor immediately if you notice any possible signs of thrombosis, myocardial infarction or stroke such as the following:
an unusual cough;
severe pain in the chest which may reach the left arm;
any unusual, severe, or prolonged headache or migraine attack;
partial or complete loss of vision, or double vision;
slurring or speech disability;
sudden changes to your hearing, sense of smell, or taste;
dizziness or fainting;
weakness or numbness in any part of your body;
severe pain in your abdomen;
severe pain or swelling in either of your legs.
The situations and symptoms mentioned above are described and explained in more detail elsewhere in this leaflet.
HOW TO USE LOGYNON ED PROPERLY
The LOGYNON ED pack contains 28 tablets. On the pack each tablet is marked with the day of the week on which it is to be taken. Take your tablets in the order directed on the pack at about the same time each day, with some liquid as needed. Daily tablet taking should be continuous, starting with a tablet corresponding to that day of the week from the red section of the LOGYNON ED pack. If you start tablet taking on Monday, Tuesday, Wednesday, Thursday or Friday your first tablet is a large white placebo one, while if you start on Saturday or Sunday your first tablet will be a light brown active one. Thereafter, one tablet is taken daily, following the arrows marked on the pack, until all tablets have been taken. Usually a period will start on 2-3 days after the last ochreous active LOGYNON ED tablet. Do not leave a gap between packs; i.e. start taking your next pack on the day after you have finished the current one, even if your period continues. This means that you will always start new packs on the same day of the week, and also that you have your withdrawal bleed on about the same days, each month.
How to start LOGYNON ED
After a natural cycle
Start taking LOGYNON ED on the first day of your cycle, i.e. the first day of menstrual bleeding. Take a tablet from the red section marked with that day of the week. For example, if your period starts on a Friday, then take a tablet marked Friday. Then follow the days in order. Additional non- hormonal contraceptive methods must be used for the next 14 days.
When changing pills
Changing from another combined oral contraceptive (COC)
You can start taking LOGYNON ED the day after you take the last active tablet from your present pill pack. If your present pill pack contains inactive (placebo) tablets, you should throw away the placebo tablets and start LOGYNON ED on the day after taking the last active tablet from your present pack (if you are not sure which this is, ask your doctor or pharmacist). This means no tablet free break. If you follow these instructions, it is not necessary to use an additional contraceptive method. A withdrawal bleed may not occur until the end of the first pack of LOGYNON ED.
Changing from a progestogen-only-method (minipill)
You can stop taking the minipill any day and start taking LOGYNON ED the next day, at the same time. But make sure you also use an additional contraceptive method (a barrier method) for the first 14 days of tablet taking when having intercourse.
Changing from an injectable, an implant, or a progestogen-releasing intrauterine device (IUD)
Start using LOGYNON ED when your next injection is due or on the day that your implant or your IUD is removed. But make sure you also use an additional contraceptive method (a barrier method) for the first 14 days of tablet taking when having intercourse.
After miscarriage or abortion
Your doctor will advise you.
After having a baby.
If you have just had a baby, your doctor may tell you to wait until after your first normal period before you start taking LOGYNON ED. Sometimes it is possible to start sooner. Your doctor will advise you. If you are breast-feeding and want to take LOGYNON ED, you should discuss this first with your doctor.
Additional contraceptive precautions
When additional contraceptive precautions are required you should either abstain from sex, or to use a barrier method of contraception, a cap (or diaphragm) plus spermicide, or a condom. Rhythm methods are not advised as the Pill disrupts the cyclical changes associated with the natural menstrual cycle e.g. changes in temperature and cervical mucus.
How to manage reduced reliability
When LOGYNON ED is taken according to the directions for use, the occurrence of pregnancy is highly unlikely. However, the reliability of oral contraceptives may be reduced under the following circumstances:
If you forgot to take the white placebo tablets (row 4 of your blister pack), you are still protected against pregnancy because they do not contain any active ingredients. However, to make sure that you do not change your pill taking rhythm, which is important for the contraceptive reliability of your pill, you should proceed with your next tablet at the normal time and discard the forgotten inactive tablets to avoid any confusion. If you forgot the last tablet from row 4 of your current pack it is important that you still take the first tablet from the next pack at the correct time.
The following advice refers to missing active tablets:
If you are less than 12 hours late in taking any tablet, contraceptive protection is not reduced. You should take the tablet as soon as you remember and take further tablets at the usual time.
If you are more than 12 hours late in taking any active tablet, contraceptive protection may be reduced. The more consecutive tablets you have missed the higher the risk that the contraceptive effect is decreased.
You should take the missed tablet as soon as you remember (even if it means taking two tablets at the same time) and take the next tablets at the usual time. Use extra contraceptive precautions (barrier method) for the next 7 days.
There is an increased risk of becoming pregnant if you have missed active tablets at the beginning or end of the pack. If you have missed tablets at these times and have had sexual intercourse in the week before missing the tablet, there is a possibility of becoming pregnant. So tell your doctor immediately.
If you miss a period
If you have taken all of your tablets at the right time, and you have not vomited, nor had severe diarrhoea while taking pills, or used other medicines then you are very unlikely to be pregnant. Continue to take LOGYNON ED as usual.
If you miss your period twice in a row, you may be pregnant. Tell your doctor immediately. Do not start the next pack of LOGYNON ED until your doctor has checked you are not pregnant.
If you have unexpected bleeding
With all pills, for the first few months, you can have irregular vaginal bleeding (spotting or breakthrough bleeding) between your periods. You may need to use sanitary protection, but continue to take the tablets as normal. Irregular vaginal bleeding usually stops once your body has adjusted to the pill (usually after about 3 tablet-taking cycles). If it continues, becomes heavy or starts again, tell your doctor.
Advice in case of vomiting
If you vomit, or have severe diarrhoea after taking the active tablets, the active ingredients may not have been completely absorbed. If you vomit within 3 to 4 hours after taking your tablet, this is like missing a tablet. Therefore follow the advice for missed tablets. If you have severe diarrhoea, please contact your doctor. Vomiting or diarrhoea while taking placebo tablets (row 4) does not have an influence on the contraceptive reliability.
Serious side effects
Serious reactions associated with the use of the Pill, as well as the related symptoms, are described in the following sections: "The Pill and thrombosis/The Pill and cancer". Please read these sections for additional information and consult your doctor at once where appropriate.
Other possible side effects
The following side effects have been reported by users of the Pill, although they need not be caused by the Pill. These side effects may occur in the first few months that you are using the Pill and usually lessen with time.
breast tenderness, pain and secretion;
changes in sexual drive; depressive mood/mood changes;
contact lens intolerance;
nausea, vomiting and other intestinal or stomach complaints;
changes in vaginal secretion;
various skin reactions;
changes in body weight;
Do not be alarmed by this list of possible side effects. You may not experience any of them.
If you notice any side effects not mentioned in this leaflet, please inform your doctor.
If too many LOGYNON ED tablets are taken (overdose)
There have been no reports of serious harmful effects from taking too many LOGYNON ED active tablets at one time. If you have taken several tablets at a time, you may have nausea, vomiting or vaginal bleeding. If you discover that a child has taken LOGYNON ED, ask your doctor for advice.
STORING LOGYNON ED
LOGYNON ED should be stored below 30 deg C. It should not be used after the expiry date printed on the blister platform and outer box.
WHERE TO GO FOR FURTHER INFORMATION
Should you have any questions on the use of LOGYNON ED you should discuss these with your doctor.
LOGYNON ED is distributed in Australia by Schering Pty Limited, 27-31 Doody Street, Alexandria NSW 2015.
DATE OF INFORMATION
This document was last revised in June 2004