Marvelon 21 Tablets

• This medicine is a combined oral contraceptive pill (‘the pill’).


• You take it to prevent pregnancy.


• This low-dose contraceptive contains two types of female sex hormones, oestrogen and progestogen.


• These hormones prevent an egg being released from your ovaries so you can’t get pregnant.


• It also makes the fluid (mucus) in your cervix thicker which makes it more difficult for sperm to enter the womb.


• This pill is a 21-day pill – you take one each day for 21 days, followed by 7 days when you take no pills.


 

The benefits of taking the pillinclude:

• It is one of the most reliable reversible methods of contraception if used correctly


• It doesn’t interrupt sex


• It usually makes your periods regular, lighter and less painful


• It may help with pre-menstrual symptoms.


• Desogestrel, ethinylestradiol will not protect you against sexually transmitted infections, such as chlamydia or hiv.


• Only condoms can help to do this.


• Desogestrel, ethinylestradiol needs to be taken as directed to prevent pregnancy.


 

What you need to know before you use desogestrel, ethinylestradiol:

Do not use desogestrel, ethinylestradiol:

Tell your doctor if you:

• 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


• 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 recently had asevere liver disease;


• If you have ever had aliver tumour;


• If you have or have had apancreatitis(an inflammation of the pancreas) associated with high levels of fatty substances in your blood;


• Known or suspectedpregnancy;


• If you have cancer affected by sex hormones – such as somecancers of the breast, womb lining or ovary;


• If you havevaginal bleedingthat has not been explained by your doctor;


• If you areallergic(hypersensitive) to any of the ingredients in desogestrel, ethinylestradiol.


• If you have hepatitis c and are taking medicinal products containing ombitasvir/ paritaprevir/ ritonavir and dasabuvir


 

Warnings and precautions:

You should let your doctor know:

• If you notice possible signs of a blood clot that may mean you are suffering from a blood clot in the leg (i.e.Deep vein thrombosis), a blood clot in the lung (i.e.Pulmonary embolism), a heart attack or a stroke .


• If you have ever had problems with yourheart, circulation or blood clotting.


• If you havediabetes.


• If you have ever hadkidney or liver problems.


• If you have ever hadsevere depression.


• If you have ever hadmigraines.


• If you have hadproblems while pregnant or while using the pill,like:


• Itching of the whole body (pruritus),


• Jaundice which was not caused by infection,


• Gall stones,


• Systemic lupus erythematosus (sle),


• A blister-like rash, calledherpes gestationis,


• A hearing problem calledotosclerosis,


• Other rare conditions calledporphyriaandhereditary angioedema.


• If you havebrown patches on your face or body(chloasma) – if so avoid too much exposure to the sun or ultraviolet light.


• 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 defence system).


• If you have haemolytic uraemic syndrome (hus - a disorder of blood clotting causing failure of the kidneys).


• If you have sickle cell anaemia (an inherited disease of the red blood cells).


• 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


• If you have just given birth you are at an increased risk of blood clots.


• If you have an inflammation in the veins under the skin (superficial thrombophlebitis).


• If you have varicose veins.


 

Other medicines and desogestrel, ethinylestradiol:

• Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.


• Some medicines may stop desogestrel, ethinylestradiol from working properly.


 

These include medicines used for the treatment of:

• Epilepsy(primidone, phenytoins, phenobarbital, carbamazepine, oxcarbazepine, topiramate, felbamate, modafinil);


• Tuberculosis(rifampicin);


• Hiv infection(ritonavir, nelfinavir, nevirapine, efavirenz);


• Hepatitis c virus infection(e.g., boceprevir, telaprevir);


• Other infectious disease(e.g., griseofulvin);


• High blood pressure in the blood vessels of the lungs(bosentan);


• Depressive moods(the herbal remedyst.John’s wort).


 

How to use desogestrel, ethinylestradiol:

• To prevent pregnancy, always take this medicine exactly as described in this leaflet or as your doctor, family planning nurse or pharmacist has told you.


• Check with your doctor, family planning nurse or pharmacist if you are not sure.


• Take desogestrel, ethinylestradiol every day for 21 days


• Desogestrel, ethinylestradiol comes in strips of 21 pills, each marked with a day of the week.


• Take your pill at the same time every day.


• Start by taking a pill marked with the correct day of the week.


• Follow the direction of the arrows on the strip.


• Take one pill each day, until you have finished all 21 pills.


• Swallow each pill whole, with water if necessary.


• Do not chew the pill.


• Then have seven pill-free days


• After you have taken all 21 pills in the strip, you have seven days when you take no pills.


• So if you take the last pill of one pack on a friday, you will take the first pill of your next pack on the saturday of the following week.


• Within a few days of taking the last pill from the strip, you should have a withdrawal bleed like a period.


• This bleed may not have finished when it is time to start your next strip of pills.


• You don’t need to use extra contraception during these seven pill-free days – as long as you have taken your pills correctly and start the next strip of pills on time.


• Then start your next strip


• Start taking your next strip of desogestrel, ethinylestradiol after the seven pill-free days – even if you are still bleeding.


• Always start the new strip on time.


• As long as you take desogestrel, ethinylestradiol correctly, you will always start each new strip on the same day of the week.


 

Possible side effects:

Stop using the product and seek immediate medical attention if you have noticed:

• Signs of deep vein thrombosis: swelling of one leg or along a vein in the leg or foot especially when accompanied by pain or tenderness in the leg which may be felt only when standing or walking; increased warmth in the affected leg; change in colour of the skin on the leg e.g.Turning pale, red or blue.


• Signs of a pulmonary embolism: sudden unexplained breathlessness or rapid breathing; sudden cough without an obvious cause, which may bring up blood; sharp chest pain which may increase with deep breathing; severe light headedness or dizziness; rapid or irregular heartbeat; severe pain in your stomach.


• Signs of retinal vein thrombosis (blood clot in the eye): symptoms most commonly occur in one eye: immediate loss of vision or painless blurring of vision which can progress to loss of vision.


• Signs of heart attack: chest pain, discomfort, pressure, heaviness; sensation of squeezing or fullness in the chest, arm or below the breastbone;


• Signs of a stroke: sudden weakness or numbness of the face, arm or leg, especially on one side of the body; sudden confusion, trouble speaking or understanding; sudden trouble seeing in one or both eyes; sudden trouble walking, dizziness, loss of balance or coordination; sudden, severe or prolonged headache with no known cause; loss of consciousness or fainting with or without seizure.


• Signs of blood clots blocking other blood vessels: swelling and slight blue discolouration of an extremity; severe pain in your stomach (acute abdomen).


• Signs of a severe allergic reaction: swelling of the face, lips, mouth, tongue or throat.


• Signs of breast cancer: dimpling of the skin; changes in the nipple; any lumps you can see or feel.


• Signs of cancer of the cervix: vaginal discharge that smells and contains blood; unusual vaginal bleeding; pelvic pain; painful sex.


• Signs of severe liver problems: severe pain in your upper abdomen; yellow skin or eyes (jaundice).


 

How to store desogestrel, ethinylestradiol:

• Keep this medicine out of the sight and reach of children.


• Do not use desogestrel, ethinylestradiol after the expiry date which is stated on the carton.


• The expiry date refers to the last day of that month.


• Store desogestrel, ethinylestradiol below 25°c but not in the fridge.


• Store it in the original package, in order to protect from light and moisture.


• 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.