Gedarel Ed 20 Micrograms/150 Micrograms -28 Film-Coated Tablet
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Gedarel ED 20 micrograms/150 micrograms -28 film-coated tablets ethinylestradiol / desogestrel
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you..
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
- If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
The name of your medicine is 'Gedarel ED 20 micrograms/150 micrograms -28 film-coated tablets’, but will be referred to as 'Gedarel ED -28’ throughout the remainder of this leaflet.
1. What Gedarel ED -28is and what it is used for
2. What you need to know before you take Gedarel ED -28
3. How to take Gedarel ED -28
4. Possible side effects
5. How to store Gedarel ED -28
6. Contents of the pack and other information
1. What Gedarel ED -28 is and what is used for
Gedarel ED -28 is a contraceptive pill and is used to prevent pregnancy.
Each slightly yellow film-coated tablet contains a small amount of two different female hormones, namely desogestrel and ethinylestradiol. The green film-coated tablets contain no active substances and are also called placebo tablets.
Contraceptive pills that contain two hormones are called “combination” pills.
The combined contraceptive pill protects you against getting pregnant in three ways. These hormones
1. stop the ovary from releasing an egg each month (ovulation).
2. also thicken the fluid (at the neck of the womb making it more difficult for the sperm to reach the egg.
3. alter the lining of the womb to make it less likely to accept a fertilised egg.
General information
If taken correctly, the pill is an effective reversible form of contraception. However, in certain circumstances the effectiveness of the pill may reduce or you should stop taking the pill (see later). In these cases either do not have sex, or use extra contraceptive precautions (such as condoms or spermicides) during intercourse to ensure effective contraception.
Do not use rhythm or temperature methods. These methods can be unreliable because Gedarel ED -28 alters the monthly changes of body temperature and of cervical mucus.
Remember, combined oral contraceptive pills like Gedarel ED -28 will not protect you against sexually-transmitted diseases (such as AIDS). Only condoms can help to do this.
2. What you need to know before you take Gedarel ED -28
Before you can begin taking Gedarel ED -28, your doctor will ask you some questions about your personal health history and that of your close relatives. The doctor will also measure your blood pressure, and depending upon your personal situation, may also carry out some other tests.
Do not take Gedarel ED -28
- if you have (or have had in the past) a blood clot (thrombosis) in a blood vessel of the leg, lung (embolus) or other organs,
- if you have (or have had in the past) a heart attack or stroke
- if you have (or have had in the past) a disease that can be a predictor of a heart attack (for
example, angina pectoris, which causes severe pain in the chest) or of a stroke (for example, a transient slight stroke with no residual effects).
- if you have a disease that may increase the risk of a thrombosis. This applies to the following diseases:
o- diabetes with damaged blood vessels o- very high blood pressure
o- a very high level of fat in the blood (cholesterol or triglycerides)
- if you have a disturbance of blood clotting (for example, protein C deficiency)
- if you have (had) a certain form of migraine (with so-called focal neurological symptoms).
- if you have (had) an inflammation of the pancreas (pancreatitis)
- if you have or have had in the past a liver disease and your liver function is still not normal.
- if you have or have had a tumour in the liver.
- if you have (had) or if you are suspected of having breast cancer or cancer of the genital organs.
- if you have any unexplained bleeding from the vagina.
- if you have endometrial hyperplasia (excessive proliferation of the cells of the inner lining of the womb).
- if you are pregnant or think you might be.
- if you are allergic to ethinylestradiol or desogestrel, or any of the other ingredients of this medicine (listed in section 6). This can be recognised by itching, rash or swelling.
Warnings and precautions
Talk to your doctor or pharmacist before taking Gedarel ED -28.
In some situations you need to take special care while using Gedarel ED -28 or any other combined hormonal contraceptive, and it may be necessary that you are regularly checked by your doctor. If any of the following conditions applies to you, you must inform your doctor before starting to use Gedarel ED -28. Also if any of the following conditions develops or worsens during the use of Gedarel ED -28 you must consult your doctor:
- if a close relative has or has had breast cancer
- if you have a disease of the liver or the gallbladder
- if you have diabetes
- if you have depression
- if you have Crohn’s disease or ulcerative colitis (inflammatory bowel disease)
- if you have HUS (haemolytic uraemic syndrome; a blood disease that causes kidney damage)
- if you have sickle cell anaemia (an inherited disease of the red blood cells)
- if you have epilepsy (see “Other medicines and Gedarel ED -28”)
- if you have SLE (systemic lupus erythematosus; a disease of the immune system)
- if you have a disease that first appeared during pregnancy or earlier use of sex hormones (for example, hearing loss, porphyria (a disease of the blood), gestational herpes (skin rash with vesicles during pregnancy), Sydenham’s chorea (a disease of the nerves in which sudden movements of the body occur)
- if you have or have ever had chloasma (golden brown pigment patches, so called “pregnancy patches”, especially on the face). If this is the case, avoid direct exposure to sunlight or ultraviolet light.
- If you have hereditary angioedema, products containing estrogens may induce or worsen symptoms of angioedema. You should see your doctor immediately if you experience symptoms of angioedema such as swollen face, tongue and/or pharynx and/or difficulty swallowing or hives together with difficulty breathing.
The Pill and blood clots (thrombosis)
Venous thrombosis
The use of any combination pill, including Gedarel ED -28, increases a woman’s risk of developing a venous thrombosis (formation of a blood clot in vessels) compared with a woman who does not take any (contraceptive) pill.
The risk of venous thrombosis in users of combined pills increases:
- with increasing age
- if you are overweight,
- if one of your close relatives has had a blood clot (thrombosis) in the leg, lung, or other organ at a young age,
- if you must have an operation (surgery) , any prolonged period of immobilization, or if you have had an serious accident. It is important to tell your doctor in advance that you are using Gedarel ED -28 as the treatment may have to be stopped. Your doctor will tell you when to start Gedarel ED -28 again. This is usually about two weeks after you are back on your feet.
- and possibly also with superficial thrombophlebitis (inflammation of a vein due to a blood clot in a vein located just below the skin's surface) and varicose veins (swollen and dilated veins, usually visible on the legs).
Very rarely, blood clots can also form in the blood vessels of the heart (causing a heart attack). In healthy young women the chance of having a heart attack is extremely small.
Arterial thrombosis
The use of combination pills has been connected with an increase of the risk of arterial thrombosis (obstruction of an artery), for example, in the blood vessels of the heart (heart attack) or the brain (stroke).
The risk of arterial thrombosis in users of combined pills increases:
- If you smoke (with heavier smoking and increasing age the risk further increases, especially in women over 35 years of age). You are strongly advised to stop smoking when you use Gedarel ED -28, especially if you are older than 35 years.
- with increasing age
- if you are overweight
- if one of your close relatives has had a heart attack or stroke at a young age
- if you have an increased fat content in your blood (cholesterol or triglycerides)
- if you have high blood pressure
- if you have migraine
- if you have a problem with your heart (valve disorder, a disturbance of the heart rhythm)
Stop taking Gedarel ED -28 and contact your doctor immediately if you notice possible signs of a blood clot (thrombosis), such as:
- severe pain and/or swelling in one of your legs
- sudden severe pain in the chest which may reach the left arm
- sudden breathlessness
- sudden cough without an obvious cause
- any unusual, severe or long-lasting headache or worsening of migraine
- partial or complete blindness or double vision
- difficulty in speaking or inability to speak
- giddiness or fainting
- weakness, strange feeling, or numbness in any part of the body The pill and cancer
An increased risk of cervical carcinoma in long-term users of oral contraceptives has been reported in some epidemiological studies, but there is controversy about the extent to which this finding is attributable to the confounding effects of sexual behaviour and other factors such as human papilloma virus (HPV).
Breast cancer has been observed slightly more often in women using combined pills, but it is not known whether this is caused by the treatment. For example it may be that more tumours are detected in women on combined pills because they are examined by their doctor more often. The occurrence of breast tumours becomes gradually less after stopping the combination hormonal contraceptives. It is important to regularly check your breasts and you should contact your doctor if you feel any lump.
In rare cases, benign liver tumours, and in even fewer cases malignant liver tumours have been reported in pill users. Contact your doctor if you have unusual severe abdominal pain.
Children and adolescents
The safety and efficacy of desogestrel in adolescents below 18 years has not yet been established. No data are available.
Other medicines and Gedarel ED -28
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Also tell any other doctor or dentist who prescribes another medicine (or the dispensing pharmacist) that you use Gedarel ED -28. They can tell you if you need to take additional contraceptive precautions (for example condoms) and if so, for how long.
Some medicines can make Gedarel ED -28 less effective in preventing pregnancy, or can cause unexpected bleeding. These include medicines used for the treatment of
- epilepsy (e.g. primidone, bosentan, phenytoin, barbiturates, carbamazepine, oxcarbazepine, topiramate, hydantoins, felbamat, modafinil, rifabutin)
- tuberculosis (e.g. rifampicin)
- HIV infections (ritonavir, nelfinavir, nevirapin, efavirenz) or other infectious diseases (griseofulvin, ampicillin, tetracycline)
- the herbal remedy St. John’s wort.
Gedarel ED -28 may influence the efficacy of other medicines, e.g.
- medicines containing cyclosporine
- the anti-epileptic lamotrigine (this could lead to an increased frequency of seizures). Before you have any blood tests
Tell your doctor or the laboratory staff that you are taking the pill, because oral contraceptives can affect the results of some tests.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
You must not use Gedarel ED -28 when you are pregnant. If you become pregnant or you think you might be pregnant, stop taking Gedarel ED -28 and talk to your doctor immediately.
Gedarel ED -28 should not be taken during breast-feeding. If you are breast feeding and want to take the pill, you should discuss this with your doctor.
Driving and using machines
You can drive or operate machinery while taking Gedarel ED -28.
Gedarel ED -28contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
The ingredient sunset yellow may cause allergic reactions.
3. How to take Gedarel ED -28
Always take this medicine exactly as your doctor has told you. Check with your doctor if you are not sure. If before you started Gedarel ED -28, you took another contraceptive pill, you know that most contraceptive pills contain 21 tablets. With these contraceptive pills, you take one tablet for 21 days and then have a gap (tablet-free) week of 7 days. The pattern when using Gedarel ED -28 is different. After the 21 slightly yellow, active tablets, you must continue right away with the 7 green placebo tablets; there is therefore no gap week but a “placebo” week. Gedarel ED -28 come in calendar blister strips of 28 tablets. The calendar strip has been designed to help you remember to take your tablets.
You must know on which day of the week you will take the first tablet (You can mark the first day on the pack).
Following the direction of the arrow printed on the strip you should take one tablet each day for 28 days until the strip is empty.
During the 7 days that you are taking the green placebo tablets (the placebo week), bleeding should begin (so-called withdrawal bleeding). This usually starts on the 2nd or 3rd day after the last slightly yellow active tablet of Gedarel ED -28. Once you have taken the last green tablet, you should start with the following strip, whether your bleeding has stopped or not. This means that you should start the following strip on the same day of the week, and that the withdrawal bleed should occur on the same days each month.
If you use Gedarel ED -28 in this manner, you are protected against pregnancy also during the 7 days that you are taking a placebo tablet.
You should try to take your tablet at 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.
Swallow each tablet whole, with water if necessary.
Starting the first pack
If you have not used a contraceptive with hormones in the previous month
Take the first tablet on the first day of your period. This is the first day of your cycle - the day when
bleeding starts. Take the first tablet and you can mark this day on the pack.
Follow the direction of the arrow and continue taking one tablet each day until the strip is empty.
If you start on day 2-5 of your period, you should use another method of contraception as well, such as the condom, for the first seven tablet-taking days, but this is only for the first pack.
Changing to Gedarel ED -28 from another combined hormonal contraceptive, or combined contraceptive vaginal ring or patch
Start taking Gedarel ED -28 on the day after the tablet-free period of your previous pill finishes (or after the last inactive tablet of your previous pill). If a vaginal ring or a transdermal patch has been used, you should start using Gedarel ED -28 preferably on the day of removal of the ring/patch, but at the latest when the next application/insertion would have been due.
Changing to Gedarel ED -28 from a progestogen-product (progestogen-only-pills, injection, implant or progestogen releasing IUD)
You may switch any day from the progestogen-only tablet (from an implant or the IUD on the day of its removal, from an injectable when the next injection would be due) but in all of these cases you must use extra protective measures (for example, a condom) for the first 7 days of tablet-taking.
After a miscarriage or abortion
Follow the advice of your doctor.
After having a baby
After having a baby, you can start Gedarel ED -28 between 21 and 28 days later. If you start later than day 28, you must use a so-called barrier method (for example, a condom) during the first seven days of Gedarel ED -28 use. If, after having a baby, you have had intercourse before starting Gedarel ED -28 (again), you must first be sure that you are not pregnant or you must wait until the next menstrual bleed.
Let your doctor advise you, in case you are not sure when to start.
If you are breast-feeding and want to start Gedarel ED -28 (again) after having a baby.
Read the section on “Pregnancy and breast-feeding”.
If you take more Gedarel ED -28 than you should
There are no reports of serious harmful results of taking too many Gedarel ED -28. If you take several tablets at once then you may have symptoms of nausea or vomiting. Young girls may have bleeding from the vagina. If you have taken too many Gedarel ED -28, or you discover that a child has taken some, ask your doctor or pharmacist for advice.
If you forget to take Gedarel ED -28
The green tablets of the strip are placebo tablets. If you forget one these tablets, this has no effect on the reliability of Gedarel ED -28. You should throw away the forgotten placebo tablet so that you do not make the placebo week longer. This might have a negative effect on the reliability of Gedarel ED -28.
If you miss a slightly yellow tablet, you must follow the following advice:
• If you are less than 12 hours late taking a tablet, the protection from pregnancy is not reduced. Take the tablet as soon as you remember and then take the following tablets again at the usual time.
• If you are more than 12 hours late taking a tablet, the protection from pregnancy may be reduced. The greater the number of tablets that you have forgotten, the greater is the risk that the protection from pregnancy is reduced.
The risk of incomplete protection against pregnancy is greatest if you forget a tablet at the beginning or the end of the strip. Therefore, you should adhere to the following rules (see also the diagram below):
More than one tablet forgotten in this strip
Contact your doctor.
One tablet forgotten in week 1
Take the forgotten tablet as soon as you remember, even if that means that you have to take two tablets at the same time. Take the tablets again at the usual time and use extra precautions for the next 7 days, for example, a condom. If you have had intercourse in the week before the oversight or you have forgotten to start a new strip after the placebo tablets period, you must realize that there is a risk of pregnancy. In that case, contact your doctor
One tablet forgotten in week 2
Take the forgotten tablet as soon as you remember, even if that means that you have to take two tablets at the same time. Take the tablets again at the usual time. Provided that the tablets have been taken correctly for the 7 days preceding the forgotten tablet, the protection from pregnancy is not reduced, and you do not need to take extra precautions.
One tablet forgotten in week 3
You can choose between two possibilities:
1. Take the forgotten tablet as soon as you remember, even if that means that you have to take two tablets at the same time. Take the tablets again at the usual time. Instead of the taking the green tablets (placebo tablets), go straight on to the next strip.
Most likely, you will have a period (withdrawal bleed) at the end of the second strip -during taking the green tablets- but you may also have spotting or breakthrough bleeding during the second strip.
2. You can also stop taking the slightly yellow tablets and go on directly on to the 7 green placebo tablets (record the day on which you forgot your tablet). If you want to start a new strip on your fixed start day, make the placebo period less than 7 days.
If you follow either of these two recommendations, you will remain protected against pregnancy.
If you have forgotten any of the tablets in a strip, and you do not have bleeding in the normal placebo week, this may mean that you are pregnant. You must contact your doctor before you go on to the next strip.
What to do in case of vomiting or severe diarrhoea
If you vomit within 3-4 hours of taking a tablet or you have severe diarrhoea, there is a risk that the active substances in the tablet are not fully absorbed into your body. The situation is similar to if you forget a tablet. After the vomiting or diarrhoea has stopped, you must take another tablet from a reserve strip as soon as possible. This should be done within 12 hours of when you normally take your tablet. If this is not possible and more than 12 hours have passed, you should follow the advice given under “If you forget to take Gedarel ED -28”.
Bleeding between periods
During the first few months that you are taking Gedarel ED -28, you may have unexpected bleeding (bleeding outside the placebo period). If this bleeding lasts longer than a few months, or if it begins after some months, your doctor must investigate the cause.
What you must do if no bleeding occurs in the placebo-tablet_week
If you have taken all the tablets correctly, have not had vomiting or severe diarrhoea and you have not taken any other medicines, it is highly unlikely that you are pregnant.
If the expected bleeding does not happen twice in succession, you may be pregnant. Contact your doctor immediately. Do not start the next strip until you are sure that you are not pregnant.
Ask your doctor for advice.
Delay of menstrual period: what you must know
Even if not recommended, delay of your menstrual period (withdrawal bleed) is possible by going straight on to a new strip of Gedarel ED -28 after the last slightly yellow active tablet instead of taking the green placebo tablets. You may experience spotting (drops or flecks of blood) or breakthrough bleeding while using this second strip. After the usual placebo-tablet period of 7 days, continue with the following strip.
You might ask your doctor for advice before deciding to delay your menstrual period.
Change of the first day of your menstrual period: what you must know
If you take the tablets according to the instructions, then your menstrual period/withdrawal bleed will begin whilst taking the placebo-tablets. If you have to change this day, you do this by making the placebo-tablet_period shorter (but never longer!). For example, if your placebo-tablet period begins on a Friday, and you want to change this to a Tuesday (3 days earlier) you must start a new strip 3 days earlier than usual. If you make the placebo-tablet period very short (for example, 3 days or less) then it may be that you do not have any bleeding during this placebo-tablet period. You may then experience spotting (droplets or flecks or blood) or breakthrough bleeding.
If you are not sure how to proceed, contact your doctor for advice.
If you stop taking Gedarel ED -28
You can stop taking Gedarel ED -28 whenever you want. If you do not want to become pregnant, ask your doctor for advice about other reliable methods of birth control.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
More serious reactions associated with combined hormonal contraceptive pills are detailed above in section 2 under “The pill and blood clots (thrombosis)” and “The pill and cancer”. Please read these subsections carefully, and if you have any questions, ask your doctor.
Like any medicine, hypersensitivity reactions (allergy to the ingredients of Gedarel ED -28) may develop. Therefore, if you experience any of the following symptoms, such as skin rash, itching, swelling of the face, painful joint or any unusual symptom (e.g. fever, sore throat, difficulty breathing, fainting), you should see your doctor immediately.
The following serious side effects/conditions have been reported to occur or worsen in women using the pill: Crohn's disease or ulcerative colitis (chronic inflammatory bowel diseases), systemic lupus erythematosus (SLE, a disease of the connective tissue), epilepsy, the rash known as herpes gestationis, a blood disorder called haemolytic uraemic syndrome - HUS (a disorder where blood clots cause the kidneys to fail), brown patches on the face and body (chloasma), movement disorder called Sydenham's chorea, yellowing of the skin, gynaecological disorders (endometriosis, uterine myoma).
The following side effects have been reported in women using the pill, which can occur in the first few months after starting Gedarel ED -28 21+7 , but they usually stop once your body has adjusted to the pill.
Very common (may affect 1 or more than 1 in 10 users): irregular bleeding and weight gain.
Common (may affect up to 1 in 10 people): none or reduced bleeding, tender breasts, breast pain, depression, mood altered, headache, nervousness, dizziness, nausea, abdominal pain, acne, bleeding from the uterus that is not due to menstruation.
Uncommon (may affect up to 1 in 100 people): decreased sexual desire, migraine, rash, fluid retention, impaired hearing (otosclerosis), high blood pressure, vomiting, diarrhoea, nettle-rash (urticaria), breast enlargement.
Rare (may affect up to 1 in 1,000 people): vaginal candidiasis (fungal infection), hypersensitivity, thromboembolism, increased sexual desire, eye irritation due to contact lens, loss of hair (alopecia), itching, skin disorders (erythema nodosum - a skin disease associated with joint pain, fever, hypersensitivity, or infection, and characterized by small, painful, pink to blue nodules under the skin and on the shins that tend to recur, erythema multiforme - a skin disease characterized by solid raised spots on the skin or fluid-filled blisters lesions and reddening or discoloration of the skin often in concentric zones about the lesions), vaginal discharge, breast discharge and weight loss.
Reporting of side effects
If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme. Website: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Gedarel ED -28
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date. The expiry date refers to the last day of the month. Store below 30°C, in the original packaging in order to protect from light.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information What Gedarel ED -28 contains
The active substances are ethinylestradiol and desogestrel in each slightly yellow tablet.
One slightly yellow film-coated tablet contains 20 micrograms ethinylestradiol and 150 micrograms desogestrel.
The green placebo (inactive) film-coated tablet does not contain active substances.
The other ingredients are:
Active film-coated tablets:
Tablet core: potato starch; stearic acid; all-rac-alpha-tocopherol; lactose monohydrate; magnesium stearate; silica colloidal anhydrous; povidone K 30, quinoline yellow (E104).
Tablet coating: hypromellose; macrogol 6000; propylene glycol.
Placebo film-coated tablets:
Tablet core: cellulose, microcrystalline; lactose anhydrous, maize starch, pregelatinised, magnesium stearate, silica, colloidal anhydrous
Tablet coating: polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, Indigo Carmine (E132), Quinoline Yellow (E104), iron oxide, black (E172), Sunset Yellow (E110)
What Gedarel ED -28 looks like and contents of the pack
The active film-coated tablet: slightly yellow, round shaped, biconvex film-coated tablets of about 6 mm diameter, with P9 sign on one side and RG sign on other side.
The placebo film-coated tablet is green, round, biconvex film-coated tablet, diameter about 6 mm, without engraving.
Gedarel ED 20 micrograms/150 micrograms -28 film-coated tablets are packed into the PVC/PVDC//Aluminium blisters. The blisters are packed into cardboard cartons.
Each box contains 1, 3, 6 or 13 calendar pack(s) of 21 active film-coated tablets+7 placebo film-coated tablet.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Gedeon Richter Plc.
H-1103 Budapest Gyomroi ut 19-21.
Hungary
This medicinal product is authorised in the Member States of the EEA under the following names:
Denmark: Myrzi 28 Belgium: Trendeso Luxembourg: Trendeso Norway: Hunogidon 28 Finland: Hunogidon (28)
Sweden: Hunogidon 28 United Kingdom: Gedarel ED-28
This leaflet was last revised in
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