Brand Name Choices
No generic medication is available for Gedarel (Desogestrel/Ethinyl Estradiol)
What Gedarel is and what it is used for
Gedarel is a COC, also called the pill. It contains two types of female hormones: a progestogen, desogestrel, and an oestrogen, ethinylestradiol in a low dose. These help to stop you from getting pregnant, just as your natural hormones would stop you conceiving again when you are already pregnant. The COC 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 alters the monthly changes of body temperature and of cervical mucus. Remember, COC pills like Gedarel will not protect you against sexually-transmitted diseases (such as AIDS). Only condoms can help to do this.
How to take Gedarel
Always take this medicine exactly as your doctor has told you. Check with your doctor if you are not sure. Each pack of Gedarel contains 1 calendar strip of 21 coated tablets or 3, 6, 13 calendar strips of 21 coated tablets. The calendar strip has been designed to help you remember to take your tablets. The strip is marked with the day of the week on which each tablet should be taken. Following the direction of the arrow printed on the strip you should take one tablet each day for 21 days until the strip is empty. Then you have 7 days when you do not take a tablet. During the 7 tablet-free days, on day 2 or 3, you will have menstruationlike withdrawal bleeding, i.e. your “monthly period”. Start your next strip on the 8th day (following the 7 tablet-free days) – even if the bleeding has not yet ended. As long as you take Gedarel correctly, you will always start each new strip on the same day of the week, and you will always have your monthly period on the same day of the week in each month (in every 28 days). 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 no oral contraception has been used during the preceding cycle 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 a tablet marked for that day of the week (for example, if it is Tuesday when your period starts, take the tablet marked Tuesday 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 from another COC, or combined contraceptive vaginal ring or patch You should start taking Gedarel preferably on the day after the last active tablet (the last tablet containing the active substance) of your previous COC, but at the latest on the day following the usual tablet-free interval or following the last placebo tablet of your previous COC. In case a vaginal ring or a transdermal patch has been used, the woman should start using Gedarel preferably on the day of removal, but at the latest when the next application would have been due. Changing to Gedarel 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 Follow the advice of your doctor. After having a baby After having a baby, you can start Gedarel 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 use. If, after having a baby, you have had intercourse before starting Gedarel (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 (again) after having a baby. Read the section on “Pregnancy and breast-feeding”. If you take more Gedarel than you should There are no reports of serious harmful results of taking too many Gedarel tablets. 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 tablets, or you discover that a child has taken some, ask your doctor or pharmacist for advice. If you forget to take Gedarel
• 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 tablet-free 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. 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 tablet-free period go straight on to the next strip. Most likely, you will have a period (withdrawal bleed) at the end of the second strip but you may also have spotting or breakthrough bleeding during the second strip. 2. You can also stop the strip and go directly to the tablet-free period of 7 days (record the day on which you forgot your tablet). If you want to start a new strip on your fixed start day, make the tablet-free 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 first tablet-free period, this may mean that you are pregnant. You must contact your doctor before you go on to the next strip.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. If you get any side effect, particularly if severe and persistent, or have any change to your health that you think may be due to Gedarel, please talk to your doctor. An increased risk of blood clots in your veins (venous thromboembolism (VTE)) or blood clots in your arteries (arterial thromboembolism (ATE)) is present for all women taking combined hormonal contraceptives. For more detailed information on the different risks from taking combined hormonal contraceptives please see section 2 “What you need to know before you take Gedarel”.
Very common (may affect more than 1 in 10 people): irregular bleeding.
Common (may affect up to 1 in 10 people): depression, mood altered, nervousness, headache, dizziness, nausea, abdominal pain, acne, tender breasts, breast pain, absence of menstruation, painful menstruation, pre-menstrual syndrome (physical and emotional problems before the start of menstruation), weight gain.
Uncommon (may affect up to 1 in 100 people): fluid retention, decreased sexual desire, migraine, impaired hearing (otosclerosis), high blood pressure, diarrhoea, vomiting, rash, nettle-rash (urticaria), breast enlargement.
Rare (may affect up to 1 in 1,000 people): hypersensitivity, increased sexual desire, eye irritation due to contact lens, 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), chloasma (discolouration of the skin, so called “pregnancy patches”,) vaginal discharge, breast discharge and weight loss. Harmful blood clots in a vein or artery for example:
• in a leg or foot (i.e. DVT)
• in a lung (i.e. PE)
• heart attack
• mini-stroke or temporary stroke-like symptoms, known as a transient ischaemic attack (TIA)
• blood clots in the liver, stomach/intestine, kidneys or eye. The chance of having a blood clot may be higher if you have any other conditions that increase this risk (see section 2 for more information on the conditions that increase risk for blood clots and the symptoms of a blood clot).
How to Store Gedarel
Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date (EXP.) which is stated on the package. The expiry date refers to the last day of that month. Store below 30 ºC. Store in the original package. 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.
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