Marviol is a combined oral contraceptive (‘the combined Pill’). Each tablet contains a small amount of two different female hormones. These are desogestrel (a progestogen) and ethinylestradiol (an estrogen).
What is Marviol?
- Marviol is a combined oral contraceptive (‘the combined Pill’). Each tablet contains a small amount of two different female hormones. These are desogestrel (a progestogen) and ethinylestradiol (an oestrogen).
- Because of the small amounts of hormone, Marviol 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.
Why use Marviol?
Marviol is used to prevent pregnancy. When taken correctly (without missing tablets), the chance of becoming pregnant is very low.
What you need to know before you take Marviol
- Before you start using Marviol you should read the information on blood clots in section 2. It is particularly important to read the symptoms of a blood clot - see section 2 “Blood clots”.
- 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 sexual intercourse 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.
- Marviol, like all contraceptive Pills, does not protect against HIV infection (AIDS) or any other sexually transmitted disease.
- Marviol has been prescribed for you personally. Do not share it with others.
- Marviol should normally not be used to delay a period. However, if in exceptional cases you need to delay a period, contact your doctor.
When you should not use Marviol
You should not use Marviol if you have any of the conditions listed below. If you do have any of the conditions listed below, you must tell your doctor. Your doctor will discuss with you what other form of birth control would be more appropriate.
- if you have (or have ever had) a blood clot in a blood vessel of your legs (deep vein thrombosis, DVT), your lungs (pulmonary embolus, PE) or other organs;
- if you know you have a disorder affecting your blood clotting – for instance, protein C deficiency, protein S deficiency, antithrombin-III deficiency, Factor V Leiden or antiphospholipid antibodies;
- if you need an operation or if you are off your feet for a long time (see section ‘Blood clots’);
- if you have ever had a heart attack or stroke;
- if you have (or have ever had) angina pectoris (a condition that causes severe chest pain and may be a first sign of a heart attack) or transient ischaemic attack [TIA -temporary stroke symptoms]).
If you have any of the following diseases that may increase your risk of a clot in the arteries:
- severe diabetes with blood vessel damage
- very high blood pressure
- a very high level of fat in the blood (cholesterol or triglycerides)
- a condition known as hyperhomocysteinaemia
- if you have (or have ever had) a type of migraine called ‘migraine with aura’;
- 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 tumour.
- if you have any unexplained vaginal bleeding.
- if you have endometrial hyperplasia (abnormal growth of the lining of the womb)
- if you are pregnant or think you might be pregnant.
- if you are allergic (hypersensitive) to desogestrel or ethinylestradiol, or any of the other ingredients of this medicine
When to take special care with Marviol
Before you can begin taking Marviol, 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.
Tell your doctor if any of the following conditions apply to you.
If the condition develops, or gets worse while you are using Marviol you should also tell your doctor.
- if you smoke;
- if you have diabetes;
- if you are overweight;
- if you have high blood pressure;
- if you have a heart valve disorder or a certain heart rhythm disorder;
- if you have an inflammation in the veins under the skin (superficial thrombophlebitis);
- if you have varicose veins;
- if anyone in your immediate family has had a thrombosis, a heart attack or a stroke;
- if you suffer from migraine;
- if you suffer from epilepsy;
- if you have elevated levels of fat in the blood (hypertriglyceridaemia) or a positive family history for this condition. Hypertriglyceridaemia has been associated with an increased risk of developing pancreatitis (inflammation of the pancreas);
- if you need an operation, or you are off your feet for a long time (see in section 2 ‘Blood clots’);
- if you have just given birth you are at an increased risk of blood clots. You should ask your doctor how soon after delivery you can start taking Marviol;
- if anyone in your immediate family has had breast cancer;
- if you have liver or gallbladder disease;
- if you have Crohn’s disease or ulcerative colitis (chronic inflammatory bowel disease);
- if you have systemic lupus erythematosus (SLE; a disease affecting your natural defense system);
- if you have haemolytic uraemic syndrome (HUS- a disorder of blood coagulation causing failure of the kidneys);
- if you have sickle cell anaemia (an inherited disease of the red blood cells);
- if you suffer from asthma
- if you suffer from an endogenous depression (a depression which is not caused by external factors)
- if you have a condition that occurred for the first time or worsened during pregnancy or previous use of sex hormones (e.g., hearing loss, a metabolic disease called porphyria, a skin disease called herpes gestationis, a disease called Sydenham’s chorea);
- if 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 light.
- If any of the above conditions appear for the first time, come back or get worse while using the Pill, you should contact your doctor.
The Pill and Thrombosis
Using a combined hormonal contraceptive such as Marviol, increases your risk of developing a blood clot compared with not using one. In rare cases a blood clot can block blood vessels and cause serious problems.
Blood clots can develop
- in veins (referred to as a ‘venous thrombosis’, ‘venous thromboembolism’ or VTE)
- in the arteries (referred to as an ‘arterial thrombosis’, ‘arterial thromboembolism’ or ATE). Recovery from blood clots is not always complete. Rarely, there may be serious lasting effects or, very rarely, they may be fatal.
- It is important to remember that the overall risk of a harmful blood clot due to Marviol is small.
The Pill and using Other Medicines
Some medicines may stop the Pill from working properly. These include medicines used for the treatment of epilepsy and narcolepsy (e.g. primidone, hydantoin, barbiturates, carbamazepine, oxcarbazepine, topiramate, felbamate, modafinil); tuberculosis (e.g. rifampicin) and HIV infections (e.g. ritonavir, nelfinavir, nevirapine, efavirenz); antibiotics (e.g. penicillins, tetracyclines, griseofulvin, rifabutin) for some other infectious diseases; high blood pressure in the blood vessels in the lungs (bosentan) and the herbal remedy St. John’s wort (Hypericum Perforatum primarily used for the treatment of depressive moods). The Pill may also interfere with how other medicines work (for instance cyclosporine and lamotrigine).
Please inform your doctor or pharmacist if you are taking or have recently taken any other medications or herbal products, even those not prescribed. Also tell any other doctor or dentist who prescribes another medicine (or your pharmacist) that you use Marviol. They can tell you if you need to take additional contraceptive precautions and if so, for how long.
The Pill and Pregnancy
- Marviol 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 Marviol, you should consult your doctor as soon as possible.
The Pill and Breastfeeding
- Marviol is generally not recommended for use during breastfeeding. If you wish to take the Pill while breastfeeding, please ask your doctor.
The Pill and Driving and Using machines
- There are no observed effects.
When and how to take the tablets?
The Marviol 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 your tablet at about the same time each day, with some water if necessary. Follow the direction of the arrows until all 21 tablets have been taken. During the next 7 days you 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 Marviol tablet. Start taking your next pack on the 8th day 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.
Starting your first pack of Marviol
When no hormonal contraceptive has been used in the past month.
- Start taking Marviol on the first day of your cycle, i.e. the first day of menstrual bleeding. Take a tablet marked with that day of the week. For example, if your period starts on a Friday, take a tablet marked Friday. Then follow the days in order. Marviol will work immediately, it is not necessary to use an additional contraceptive method.
- You may also start on days 2-5 of your cycle, but in that case make sure you 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).
- You can start taking Marviol the day after you take the last tablet from your present Pill pack (this means no tablet-free break). If your present Pill pack also contains inactive tablets you can start Marviol on the day after taking the last active tablet (if you are not sure which this is, ask your doctor or pharmacist). You can also start later, but never later than the day following the tablet-free break of your present Pill (or the day after the last inactive tablet of your present Pill). In case you use a vaginal ring or transdermal patch, it is best that you start using Marviol on the day you remove the ring or patch. You can also start at the latest, on the day you would have started using the next ring or patch.
- If you follow these instructions, it is not necessary to use an additional contraceptive method.
When changing from a progestogen-only pill (minipill).
- You can stop taking the minipill any day and start taking Marviol the next day, at the same time. But make sure you also use an additional contraceptive method (a barrier method) for the first 7 days that you are taking Marviol.
- When changing from an injectable, an implant or a progestogen-releasing intrauterine device (IUD).
- Start using Marviol 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 7 days that you are taking Marviol.
After having a baby.
- You can start Marviol between 21 and 28 days after having a baby. If you start later than day 28, you must use a so-called barrier method (for example, a condom) during the first 7 days of Marviol use. If, after having a baby, you have had sexual intercourse before starting Marviol (again), you must first be sure that you are not pregnant or you must wait until your next period.
- If you are breast-feeding and want to take Marviol, read section on “The Pill and Breastfeeding”.
- Ask your doctor what to do if you are not sure when to start.
After a miscarriage.
- Follow the advice of your doctor.
Like all medicines, Marviol 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 Marviol, 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 use Marviol”.
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.
Common (occurring in more than one per 100 women):
- depressed mood, mood changes;
- nausea, abdominal pain;
- increase in body weight;
- breast pain, breast tenderness;
Uncommon (occurring in more than one per 1000 women but not more than one per 100 women):
- fluid retention
- decreased sexual drive
- vomiting, diarrhoea rash, hives
- breast enlargement
Rare (occurring in less than one per 1000 or more women):
harmful blood clots in a vein or artery for example:
- in a leg or foot (i.e. DVT) o in a lung (i.e. PE)
- heart attack
- mini-stroke or temporary stroke-like symptoms, known as a transient ischaemic attack (TIA) o 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.
- hypersensitivity reactions;
- increased sexual drive;
- contact lens intolerance;
- erythema nodosum, erythema multiforme (these are skin conditions).
- breast secretion; vaginal secretion
- decrease in body weight;
If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.
How to store Marviol
Keep your tablets out of reach and sight of children
- Do not use Marviol Tablets after the Use By date which is stated on the carton, blister and sachet. The Use By date refers to the last day of the month. Store Tablets below 25°C. Keep your tablets in the original package in order to protect from light.
- Do not use the product if you notice, for example, colour change in the tablet, crumbling of the tablet or any other visible signs of deterioration.
- Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.