Desimar Film-Coated Tablets

DESIMAR is a combined oral contraceptive (“the combined Pill”) used to prevent pregnancy.

Do not take DESIMAR :

• if you are allergic (hypersensitive) to desogestrel and ethinylestradiol or any of the other ingredients of DESIMAR (listed in section 6).
• 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 a heart attack or stroke in the past.
• if you have or have 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 you have a disturbance of blood clotting (e.g. protein C deficiency).
• if you have (had) a type of migraine called 'migraine with aura'.
• if you have diabetes mellitus with blood vessel damage.
• if you have a serious risk factor, or several risk factors for developing thrombosis, this may also be a reason why you cannot use DESIMAR (see also "The Pill and Thrombosis").
• if you have or have had 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 liver tumour.
• if you have any unexplained vaginal bleeding.
• if you are pregnant or think you might be pregnant.

General notes: In this leaflet, several situations are described where you should stop taking DESIMAR, or where the reliability of DESIMAR 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 the rhythm or temperature methods. These methods can be unreliable because DESIMAR alters the usual changes in temperature and cervical mucus that occur during the menstrual cycle.

Women should be advised that DESIMAR like all contraceptive Pills does not protect against HIV infections (AIDS) and other sexually transmitted diseases (STDs). Women should be advised that additional barrier contraceptive measures are needed to prevent transmission of STDs and HIV infection.

Warnings and precautions

Talk to your pharmacist, doctor or other healthcare provider before taking this medicine. If used in the presence of any of the conditions listed below; you may need to be kept under close observation. Your doctor can explain this to you. Therefore, before starting to use DESIMAR, 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 of your veins (superficial phlebitis)
• 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 or someone in your immediate family has or has had high blood levels of cholesterol or triglycerides (fatty substances)
• 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 chronic connective tissue disease affecting the skin all over the body)
• if you have haemolytic uraemic syndrome (HUS, a disorder of blood coagulation causing failure of the kidneys)
• if you have sickle cell disease (for example, sickle cell anaemia, or other sickle cell conditions)
• 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 neurological 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 radiation

If any of the above conditions appear for the first time, recur or worsen while using DESIMAR, you should contact your doctor.

Oestrogen and/or progesterone/progestogen containing medicines including DESIMAR, may cause mood changes and depression, which may be severe. Severe depression is associated with a higher risk of suicidal thoughts/behaviour (e.g. talking about suicide, withdrawing from social contact, having mood swings, being preoccupied with death or violence, feeling hopeless about a situation, increasing use of alcohol/drugs, doing self-destructive things, personality changes) and suicide. If you experience mood changes and depression, contact your doctor for advice.

The efficacy of DESIMAR may be reduced in the event of missed tablets, vomiting or concomitant medication.

Do not share medicines prescribed for you with any other person. Always take DESIMAR exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

When and how to take the tablets: The DESIMAR pack contains 28 tablets (21 white active tablets and 7 green inactive tablets). Take your tablet at about the same time each day, with some liquid if necessary. The first tablet should be taken from the silver section of the calendar pack by selecting the tablet corresponding to the day of the week (e.g. “MO’ for Monday). Thereafter one tablet must be taken daily for 28 days following the direction shown by the arrows, until the pack is finished. A period should begin during the 7 days that you use the inactive tablets (the withdrawal bleed). Usually, it starts on day 2 or 3 after starting the inactive tablets and may not have finished before the next pack is started. Each subsequent pack is started in the silver section the day after the last tablet of the current pack. This means that you will always start new packs on the same day of the week, and also that you have your period on about the same days, each month.

Starting your first pack of DESIMAR: When no hormonal contraceptive has been used in the past month: Start taking DESIMAR on the first day of your cycle, i.e. the first day of menstrual bleeding. The first tablet should be taken from the silver section of the calendar pack by selecting the tablet corresponding to the day of the week (e.g. “MO’ for Monday). Then take 1 tablet every day following the directions shown by the arrows.

DESIMAR can have side effects. Not all side effects reported for DESIMAR are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking DESIMAR, please consult your healthcare provider for advice.

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following: If you notice possible signs of thrombosis, myocardial infarction or a stroke such as:

• 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 have speech disability
• 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

These are all serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following: Frequent side effects reported include the following:

• Depressive mood, altered mood, headache, migraine, nausea, vomiting, diarrhoea, abdominal pain, rash, hives, body weight changes, fluid retention.

Other less frequent side effects reported include the following:

• Changes in interest in sex, contact lens intolerance, breast discharge, vaginal discharge, inflammation of the skin, hypersensitivity reactions.

Frequency unknown:

• Suicidal thoughts/behaviour and suicide.

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Store all medicines out of reach of children. Store at or below 25 °C in the original package in order to protect from light. Excursions above 25 °C are not permitted. Do not use after the expiry date stated on the carton. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).