Marvelon/Marvelon 28

Marvelon/Marvelon 28

desogestrel + ethinylestradiol

Manufacturer:

MSD

Distributor:

Zuellig Pharma
Full Prescribing Info
Contents
Desogestrel, ethinylestradiol.
Description
Marvelon: The active substances are ethinylestradiol (0.030 mg) and desogestrel (0.150 mg).
Marvelon 28: The active substances are: in the large tablets: ethinylestradiol (0.030 mg) and desogestrel (0.150 mg); in the smaller tablets: no active ingredients.
Excipients/Inactive Ingredients: The other ingredients are: silica colloidal anhydrous; lactose monohydrate; potato starch; povidone; stearic acid; all-rac-alpha-tocopherol.
In the smaller tablets (Marvelon 28 only): lactose monohydrate; potato starch, magnesium stearate.
Action
Marvelon/Marvelon 28 is a combined oral contraceptive ('the combined Pill'). Each tablet (Marvelon only) or large tablet (Marvelon 28 only) contains a small amount of two different female hormones. These are desogestrel (a progestogen) and ethinylestradiol (an estrogen). The small tablets do not contain hormones and are called placebo tablets (Marvelon 28 only). Because of the small amounts of hormones, Marvelon/Marvelon 28 is considered a low-dose oral contraceptive. As all tablets in the pack combine the same hormones in the same dose, it is considered a monophasic combined oral contraceptive.
The combined Pill may also have non-contraceptive health benefits.
The period may be lighter and shorter. As a result, the risk of anaemia may be lower. The period pains may become less severe or may completely disappear.
In addition, some serious disorders have been reported to occur less frequently in users of Pills containing 50 μg of ethinylestradiol ('high-dose Pills'). These are benign breast disease, ovarian cysts, pelvic infections (pelvic inflammatory disease or PID), ectopic pregnancy (pregnancy in which the embryo implants outside of the uterus) and cancer of the endometrium (lining of the womb) and ovaries. This may also be the case for low-dose Pills but this has not been confirmed.
Indications/Uses
Marvelon/Marvelon 28 is used to prevent pregnancy.
When taken correctly (without missing tablets), the chance of becoming pregnant is very low.
Dosage/Direction for Use
When and how to take the tablets: Marvelon: The Marvelon pack contains 21 tablets. On the pack, each tablet is marked with the day of the week on which it is to be taken. Take the tablet at about the same time each day, with some liquid if necessary. Follow the direction of the arrows until all 21 tablets have been taken. During the next 7 days take no tablets. A period should begin during these 7 days (the withdrawal bleed). Usually it will start on day 2-3 after the last Marvelon tablet. Start taking the next pack on the 8th day even if the period continues. This means that the patient will always start new packs on the same day of the week, and also that the patient has the withdrawal bleed on about the same days, each month.
Marvelon 28: The Marvelon 28 pack contains 28 white tablets: 21 large tablets with the active substances (number 1-21) and 7 small tablets without active substances (number 22-28). Take the tablet at about the same time each day, with some liquid if necessary. Start with the number 1 tablet in the left-hand top corner (marked 'start'). Follow the direction of the arrows until all 28 tablets have been taken. Doing this, use all the large tablets first, and then continue with the smaller placebo tablets. A period should begin during the 7 days that the patient uses the placebo tablets (the withdrawal bleed). Usually it will start on day 2-3 after the last large tablet. Start taking the next pack immediately after the last placebo tablet, even if the period continues. This means that the patient will always start new packs on the same day of the week, and also that the patient has the withdrawal bleed on about the same days, each month.
Starting the first pack of Marvelon/Marvelon 28: When no hormonal contraceptive has been used in the past month: Start taking Marvelon/Marvelon 28 on the first day of the cycle, i.e. the first day of menstrual bleeding.
Marvelon: Take a tablet marked with that day of the week. For example, if the period starts on a Friday, take a tablet marked Friday. Then follow the days in order.
Marvelon/Marvelon 28 will work immediately, it is not necessary to use an additional contraceptive method.
The patient may also start on days 2-5 of the cycle, but if she does, make sure to also use an additional contraceptive method (barrier method) for the first 7 days of tablet-taking in the first cycle.
When changing from another combined hormonal contraceptive (combined oral contraceptive pill (COC), vaginal ring, or transdermal patch): The patient can start taking Marvelon/Marvelon 28 the day after taking the last tablet from the present Pill pack (this means no tablet-free break). If the present Pill pack also contains inactive tablets the patient can start Marvelon/Marvelon 28 on the day after taking the last active tablet (if not sure which this is, ask the doctor or pharmacist). The patient can also start later, but never later than the day following the tablet-free break of the present Pill (or the day after the last inactive tablet of the present Pill). In case the patient uses a vaginal ring or transdermal patch, it is best to start using Marvelon/Marvelon 28 on the day the ring or patch is removed. The patient can also start, at the latest, on the day the patient would have started using the next ring or patch.
If the patient has used the Pill, patch or ring consistently and correctly and if sure that the patient is not pregnant, the patient can also stop taking the Pill or remove the ring or patch on any day and start using Marvelon/Marvelon 28 immediately.
If the patient follows these instructions, it is not necessary to use an additional contraceptive method.
When changing from a progestogen-only pill (minipill): The patient can stop taking the minipill any day and start taking Marvelon/Marvelon 28 the next day, at the same time. But if having intercourse, make sure to also use an additional contraceptive method (a barrier method) for the first 7 days that the patient is taking Marvelon/Marvelon 28.
When changing from a progestogen-only injectable, implant or a progestogen releasing intrauterine device (IUD): Start using Marvelon/Marvelon 28 when the next injection is due or on the day that the implant or IUD is removed. But if having intercourse, make sure she also uses an additional contraceptive method (a barrier method) for the first 7 days that she is taking Marvelon/Marvelon 28.
After having a baby: If the patient has just had a baby, the doctor may tell to wait until after the first normal period before starting taking Marvelon/Marvelon 28. Sometimes it is possible to start sooner. The doctor will advise the patient. If the patient is breast-feeding and wants to take Marvelon/Marvelon 28, talk to the doctor first.
After a miscarriage or an abortion: The doctor will advise the patient.
If the patient forgets tablets: If the patient is less than 12 hours late in taking a tablet, the reliability of the Pill is maintained. Take the tablet as soon as remembered and take the next tablets at the usual times.
If the patient is more than 12 hours late in taking any tablet, the reliability of the Pill may be reduced. The more consecutive tablets missed, the higher the risk that the contraceptive efficacy is decreased.
Marvelon: There is a particularly high risk of becoming pregnant if the patient misses tablets at the beginning or at the end of the pack.
Marvelon 28: There is a particularly high risk of becoming pregnant if the patient misses large (active) tablets at the beginning of the pack or in the third week (the week before she starts taking the small tablets).
Therefore the patient should follow the rules given as follows.
More than one tablet forgotten in a pack: Ask the doctor for advice.
1 tablet missed in week 1: Take the missed tablet as soon as remembered (even if this 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.
If the patient had sexual intercourse in the week before missing the tablets, it's possible that she could be pregnant. Tell the doctor immediately.
1 tablet missed in week 2: Take the missed tablet as soon as remembered (even if this means taking two tablets at the same time) and take the next tablets at the usual time. The reliability of the Pill is maintained. The patient needs not use extra contraceptive precautions.
1 tablet missed in week 3: The patient may choose either of the following options, without the need for extra contraceptive precautions.
Take the missed tablet as soon as remembered (even if this means taking two tablets at the same time) and take the next tablets at the usual time.
Marvelon: Start the next pack as soon as the current pack is finished so that no gap is left between packs. The patient may not have a withdrawal bleed until the end of the second pack but may have spotting or breakthrough bleeding on tablet-taking days, or; Stop taking tablets from the current pack, have a tablet-free break of 7 days or less (including the day the patient missed the tablet) and then start the next pack. If the patient does this, she can always start the next pack on the same day of the week as she usually does.
If the patient has forgotten tablets in a pack and does not have period in the first normal tablet-free break, the patient may be pregnant. Tell the doctor before starting with the next pack.
Marvelon 28: Start the next pack as soon as the large (active) tablets in the current pack are finished, so skip the smaller placebo tablets. The patient may not have a withdrawal bleed until she takes the placebo tablets at the end of the second pack but may have spotting or breakthrough bleeding on active tablet-taking days, or; Stop taking the large (active) tablets from the current pack and immediately continue with the smaller placebo tablets (a maximum of 6 days, the total number of placebo plus missed tablets may not be more than 7). Then continue with the next pack. If the patient does this, she can always start the next pack on the same day of the week as she usually does.
1 tablet missed in week 4 (Marvelon 28 only): The reliability of the Pill is maintained. Take the tablet as soon as remembered and take the next tablets at the usual times.
If the patient has forgotten tablets in a pack and does not have the expected period in the first normal tablet-free break (Marvelon) or placebo tablet interval (Marvelon 28), she may be pregnant. Consult the doctor before starting with the next pack.
If the patient suffers from gastro-intestinal disturbances (e.g., vomiting, severe diarrhoea): If the patient vomits, or has severe diarrhoea, the active ingredients of the Marvelon/Marvelon 28 tablet may not have been completely absorbed. If the patient vomits within 3 to 4 hours after taking the tablet, this is like missing a tablet. The patient must follow the advice for missed tablets. If the patient has severe diarrhoea, please tell the doctor.
If the patient wants to delay the period: Marvelon: The patient can delay the period if she starts with the next pack of Marvelon immediately after finishing the current pack. The patient can continue with this pack for as long as she wishes, until this pack is empty. When the patient wishes the period to begin, just stop tablet-taking. While using the second pack the patient may have some breakthrough bleeding or spotting on tablet-taking days. Start with the next pack after the usual 7-day tablet-free break.
Marvelon 28: The patient can delay the period if she continues with the large (active) tablets in the next pack of Marvelon 28 immediately after finishing the large tablets in the current pack. The patient can continue with this pack for as long as she wishes, until this pack is empty. When the patient wishes the period to begin, just stop tablet-taking. While using the second pack the patient may have some breakthrough bleeding or spotting on active tablet-taking days. Start with the next pack after the usual 7-day placebo tablet interval.
If the patient wants to change the starting day of the period: If the patient takes the tablets correctly, she will have the period on about the same day every 4 weeks. If the patient wants to change this day, just shorten, (never lengthen) the next tablet-free break (Marvelon) or placebo tablet interval (Marvelon 28). For example, if the period usually starts on a Friday and in future the patient wants it to start on Tuesday (3 days earlier) start the next pack 3 days sooner than she usually does. If the patient makes the tablet-free break (Marvelon) or placebo tablet interval (Marvelon 28) very short (e.g. 3 days or less), she may not have a bleeding during the break/interval. The patient may have some breakthrough bleeding or spotting while using the next pack (Marvelon) during the use of the large tablets in the next pack (Marvelon 28).
If the patient has unexpected bleeding: With all Pills, for the first few months, the patient can have irregular vaginal bleeding (spotting or breakthrough bleeding) between the periods. The patient may need to use sanitary protection, but keep taking the tablets as usual. Irregular vaginal bleeding usually stops once the body has adjusted to the Pill (usually after about 3 months). If bleeding continues, becomes heavy or starts again, tell the doctor.
If the patient has missed a period: If the patient has taken all of the tablets at the right time, and she has not vomited, or used other medicines then she is very unlikely to be pregnant. Keep taking Marvelon/Marvelon 28 as usual.
If the patient misses the period twice in a row, she may be pregnant. Tell the doctor immediately. Do not start the next pack of Marvelon/Marvelon 28 until the doctor has checked the patient is not pregnant.
If the patient wants to stop taking Marvelon/Marvelon 28: The patient can stop taking Marvelon/Marvelon 28 at any time she wants. If the patient does not want to become pregnant, ask the doctor about other methods of birth control.
If the patient stops taking Marvelon/Marvelon 28 because she wants to get pregnant, wait until she has had a natural period before trying to conceive. This helps the patient to work out when the baby will be due.
Overdosage
There have been no reports of serious harmful effects from taking too many Marvelon/Marvelon 28 tablets at one time. If taken several tablets at a time, the patient may have nausea, vomiting or vaginal bleeding. If it is discovered that a child has taken Marvelon/Marvelon 28, ask the doctor for advice.
Contraindications
Do not use the Marvelon/Marvelon 28 if the patient has any of the conditions listed as follows. If anything on this list applies to the patient, tell the doctor before starting to use Marvelon/Marvelon 28. The doctor may advise to use a different type of Pill or an entirely different (non-hormonal) method of birth control: If the patient has, or has had in the past a blood clot (thrombosis) in a blood vessel of the leg, lung (embolus) or other organs.
If the patient has or has had in the past a heart attack or stroke.
If the patient has or has 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 the patient has a disturbance of blood clotting (for example, protein C deficiency).
If the patient has major surgery (e.g., an operation) and the ability to move around is limited for a long period of time (see The Pill and Thrombosis under Precautions).
If the patient has (had) a type of migraine called 'migraine with aura'.
If the patient has diabetes mellitus with blood vessel damage.
If the patient has a serious risk factor, or several risk factors for developing thrombosis, this may also be a reason why Marvelon/Marvelon 28 cannot be used (see also The Pill and Thrombosis under Precautions).
If the patient has or has had a pancreatitis (an inflammation of the pancreas) associated with high levels of fatty substances in the blood.
If the patient has jaundice (yellowing of the skin) or have (had) severe liver disease and the liver is not yet working normally.
If the patient has or has had a cancer that may grow under the influence of sex hormones (e.g. of the breast or the genital organs).
If the patient has or has had a liver tumour.
If the patient has any unexplained vaginal bleeding.
If the patient is pregnant or thinks she might be pregnant.
If the patient is allergic to any of the ingredients of Marvelon/Marvelon 28.
If any of these conditions appear for the first time while using the Pill, stop taking it at once and tell the doctor. In the meantime, use a non-hormonal contraceptive. See also Precautions.
Do not use Marvelon/Marvelon 28 if the patient has Hepatitis C and is taking the combination drug regimen ombitasvir/paritaprevir/ritonavir, with or without dasabuvir (see Interactions).
Warnings
In this monograph, several situations are described where the patient should stop taking the Pill, or where the reliability of the Pill may be decreased. In such situations the patient should not have sexual intercourse or 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.
Contraindicated in patients who have blood clot in blood vessel and liver disease.
Should not use in women who have risk of blood clot in blood vessel e.g. have history of angiitis, obesity, diabetes and hypertension.
Not recommended in patients with liver tumours or patients who have history of liver tumours and patients or suspected patients who have sex hormone related cancer such as breast cancer or reproductive organ cancer.
Use with caution in smoking women especially women older than 35 years should consult doctor before use.
Seek medical consultation in case of use other than for contraception.
Consult doctor if the patient notices disorder symptom.
Special Precautions
Marvelon/Marvelon 28, like all contraceptive Pills, does not protect against HIV infection (AIDS) or any other sexually transmitted disease.
Marvelon/Marvelon 28 has been prescribed for the patient personally. Do not share it with others.
If the combined Pill is used in the presence of any of the conditions listed as follows the patient may need to be kept under close observation. The doctor can explain this to the patient. Therefore, if any of these applies to the patient, tell the doctor before starting to use Marvelon/Marvelon 28.
The patient smokes; has diabetes; is overweight; has high blood pressure; has a heart valve disorder or a certain heart rhythm disorder; has an inflammation of the veins (superficial phlebitis); has varicose veins; anyone in the immediate family has had a thrombosis, a heart attack or a stroke; suffers from migraine; suffers from epilepsy; the patient or someone in the immediate family has or has had high cholesterol or triglycerides (fats in the blood); anyone in the immediate family has had breast cancer; has liver or gallbladder disease; has Crohn's disease or ulcerative colitis (chronic inflammatory bowel disease); has systemic lupus erythematosus (SLE; a chronic connective tissue disease affecting the skin all over the body); has haemolytic uraemic syndrome (HUS; a disorder of blood clotting causing failure of the kidneys); has sickle cell disease (a rare blood disease); has an operation, or if the ability to move around is limited for a long period of time (see The Pill and Thrombosis as follows); if the patient has recently given birth she is at an increased risk of blood clots. The patient should ask the doctor how soon after delivery she can start using Marvelon/Marvelon 28 (see The Pill and Thrombosis as follows); has a condition that occurred for the first time or got worse during pregnancy or previous use of sex hormones (e.g., hearing loss, a disease called porphyria, a skin disease called herpes gestationis, a disease called Sydenham's chorea); has or has had chloasma (yellowish-brown pigmentation patches on the skin, particularly of the face); if so, avoid too much exposure to the sun or ultraviolet light.
If any of the previously mentioned conditions appear for the first time, comes back or gets worse while using the Pill, contact the 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 the Pill is taken. The risk is higher in Pill-users than in non-users. The chance of getting a thrombosis is highest during the first year after starting using the Pill for the very first time. The risk is also higher if the patient restarts using the Pill (the same product or a different product) after a break of 4 weeks or more.
The risk is not as high as the risk of developing a thrombosis during pregnancy.
The risk of getting a deep venous thrombosis for women using Pills with desogestrel may be slightly higher than for women using Pills with levonorgestrel. The absolute numbers remain very small. If 10,000 women use a Pill with levonorgestrel for one year, 2 women would get a thrombosis. If 10,000 women use a Pill with desogestrel for a year approximately 3 to 4 women would get a thrombosis. For comparison, if 10,000 women get pregnant, approximately 5-20 would get a thrombosis. These findings are based on the results of some studies. Other studies did not find a higher risk for Pills with desogestrel.
Blood clots can also occur very rarely in an artery (arterial thrombosis); for example 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.
The risk of venous thrombosis in users of combined pills increases: with increasing age; if the patient is overweight; if one of the close relatives has had a blood clot (thrombosis) in the leg, lung, or other organ at a young age; if the patient must have an operation; if the ability to move around is limited for long period of time, or if the patient has had a serious accident. It is important to tell the doctor in advance that Marvelon/Marvelon 28 is used as the treatment may have to be stopped. The doctor will tell when to start Marvelon/Marvelon 28 again. This is usually about two weeks after the patient is able to move around. See also Contraindications; if the patient gave birth less than a few weeks ago.
The risk of arterial thrombosis in users of combined pills increases: if the patient smokes. The patient is strongly advised to stop smoking when using Marvelon/Marvelon 28, especially if older than 35 years; has an increased fat content in the blood (cholesterol or triglycerides); has high blood pressure; has migraine; has a problem with the heart (valve disorder, a disturbance of the heart rhythm).
If the patient notices possible signs of a thrombosis, stop taking the Pill and consult the doctor immediately (see also Patient Counselling Information).
The Pill and Cancer: The information given as follows was obtained from studies of women who used combined oral hormonal contraceptives, such as the combined pill, and from an additional study that included both oral and non-oral hormonal contraceptive-users.
In studies with the combined pill, 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 the additional study that included both oral and non-oral hormonal contraceptive-users, the occurrence of breast cancer was reported to increase the longer the women used the contraceptive. The difference in the reported risk of breast cancer between women who had never used the contraceptive and those who had used the contraceptive was small: 13 additional cases of breast cancer per 100,000 women-years.
In rare cases benign liver tumours and even more rarely, malignant liver tumours have been reported in users of the Pill. These tumours may lead to internal bleeding. Contact the doctor immediately if the patient has severe pain in the abdomen.
Cervical cancer is caused by an infection with the human papilloma virus. It has been reported to occur more often in women using the Pill for a long time. It is unknown if this finding is due to the use of hormonal contraceptives or to sexual behaviour and other factors (such as better cervical screening).
Important Information about some of the ingredients of Marvelon/Marvelon 28: If the patient has been told by the doctor that she has an intolerance to some sugars, contact the doctor before starting with Marvelon/Marvelon 28.
The Pill and Driving and Using machines: There are no observed effects.
Use in Pregnancy: Marvelon/Marvelon 28 must not be used by women who are pregnant, or who think they may be pregnant. If the patient suspects that she is pregnant while already using Marvelon/Marvelon 28, tell the doctor as soon as possible.
Use in Lactation: Marvelon/Marvelon 28 is not usually recommended for use during breast-feeding. If the patient wishes to take the Pill while breast-feeding, ask the doctor.
Use In Pregnancy & Lactation
The Pill and Pregnancy: Marvelon/Marvelon 28 must not be used by women who are pregnant, or who think they may be pregnant. If the patient suspects that she is pregnant while already using Marvelon/Marvelon 28, tell the doctor as soon as possible.
The Pill and Breast-feeding: Marvelon/Marvelon 28 is not usually recommended for use during breast-feeding. If the patient wishes to take the Pill while breast-feeding, ask the doctor.
Side Effects
Like all medicines, Marvelon/Marvelon 28 can have side effects, although not everybody gets them.
Tell the doctor if the patient notices any unwanted effect, especially if severe or persistent, or if there is a change in the health that she thinks might be caused by the Pill.
Serious reactions seen with the Pill, as well as the related symptoms, are described in The Pill and Thrombosis and The Pill and Cancer under Precautions.
Common (occurring in more than one per 100 users): Depressed mood, mood changes; headache; nausea, abdominal pain; breast pain, breast tenderness; increase in body weight.
Uncommon (occurring in more than one per 1000 users but not more than one per 100 users): Fluid retention; decreased sexual drive; migraine; vomiting, diarrhoea; rash, hives; breast enlargement.
Rare (occurring in less than one per 1000 users): Hypersensitivity reactions; blood clot in a vein; blood clot in an artery; increased sexual drive; contact lens intolerance; erythema nodosum, erythema multiforme (these are skin conditions); breast secretion, vaginal secretion; decrease in body weight.
If the patient notices any side effects not mentioned, please inform the doctor or pharmacist.
Drug Interactions
Please inform the doctor or pharmacist if the patient is taking or has 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 pharmacist) that Marvelon/Marvelon 28 is used.
Some medicines may stop Marvelon/Marvelon 28 from working properly. These include medicines used for the treatment of: epilepsy (e.g., primidone, phenytoin, phenobarbital, carbamazepine, oxcarbazepine, topiramate, felbamate); tuberculosis (e.g., rifampicin); HIV infections (e.g., ritonavir, nelfinavir, nevirapine, efavirenz); Hepatitis C virus infection (e.g., boceprevir, telaprevir); other infectious diseases (e.g., griseofulvin); high blood pressure in the blood vessels of the lungs (bosentan); depressive moods (the herbal remedy St. John's wort).
If the patient is taking medicines or herbal products that might make Marvelon/Marvelon 28 less effective, a barrier contraceptive method should also be used. Since the effect of another medicine on Marvelon/Marvelon 28 may last up to 28 days after stopping the medicine, it is necessary to use the additional barrier contraceptive method for that long.
Marvelon/Marvelon 28 may also interfere with how other medicines work, causing either an increase in effect (e.g., ciclosporin) or a decrease in effect (e.g., lamotrigine).
Do not use Marvelon/Marvelon 28 if the patient has Hepatitis C and are taking the combination drug regimen ombitasvir/paritaprevir/ritonavir, with or without dasabuvir as this may cause increases in liver function blood test results (increase in ALT liver enzyme). Marvelon/Marvelon 28 can be restarted approximately 2 weeks after completion of treatment with the combination drug regimen. (See Contraindications.)
Laboratory tests: If the patient is having any blood or urinary test, tell the health care professional that the patient is using Marvelon/Marvelon 28 as it may affect the results of some tests.
Storage
Store the tablets below 30°C in the original package. Do not freeze.
Store protected from light and moisture.
Do not use the product if the patient notices, for example, colour change in the tablet, crumbling of the tablet or any other visible signs of deterioration.
Patient Counseling Information
When to Contact the Doctor: Regular check-ups: When you are using the Pill, your doctor will tell you to return for regular check-ups. You should usually have a check-up every year.
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 monograph (see also Contraindications and Precautions; do not forget about changes in the health of your immediate family); you feel a lump in your breast; you experience symptoms of angioedema such as swollen face, tongue and/or throat and/or difficulty swallowing or hives together with difficulty breathing; you are going to use other medicines (see also Interactions); your ability to move around is limited for a long period of time or you are to have surgery (tell your doctor at least four weeks in advance); you have unusual, heavy vaginal bleeding; you forgot tablets in the first week of the pack and had intercourse in the seven days before; you have severe diarrhea; you miss your period twice in a row or suspect you are pregnant (do not start the next pack until your doctor tells you).
Stop taking tablets and see your doctor immediately if you notice possible signs of thrombosis: an unusual cough; severe pain in the chest which may reach the left arm; breathlessness; 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.
For more information, see Precautions.
MIMS Class
ATC Classification
G03AA09 - desogestrel and ethinylestradiol ; Belongs to the class of progestogens and estrogens in fixed combinations. Used as systemic contraceptives.
Presentation/Packing
Marvelon tab (biconvex, round and 6 mm in diameter; marked TR above 5 on one side and Organon* on the reverse side) 21's. Marvelon 28 tab [biconvex, round and 6 mm (active tablets) or 4.5 mm (placebo tablets) in diameter; large active tablets are marked TR above 5 on one side and Organon* on the reverse side; smaller placebo tablets are marked KH above 2 on one side and with a small square on the other side] 28's.
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