Elvinette

This applies to the following diseases:

• diabetes with damaged blood vessels
• very high blood pressure
• a very high level of fat in the blood (cholesterol or triglycerides)
• if you have a disturbance of blood clotting (for example, protein C deficiency)
• if you have (or have ever had) a certain form of migraine (with so-called focal neurological symptoms)
• if you have (or have ever had) a liver disease and your liver function is still not normal
• if your kidneys are not working well (renal failure)
• if you have (or have ever had) a tumour in the liver
• if you have (or have ever had) or if you are suspected of having breast cancer or cancer of the genital organs
• if you have any unexplained bleeding from the vagina
• if you are allergic to ethinylestradiol or drospirenone, or any of the other ingredients of Elvinette. This may cause itching, rash or swelling.

When to take special care with Elvinette:

In some situations you need to take special care while using Elvinette or any other combination pill, and your doctor may need to examine you regularly. If any of the following conditions applies to you, tell your doctor before starting to use Elvinette.

Also, if any of the following applies or if any of the conditions develops or worsens while you are using Elvinette consult your doctor:

• if a close relative has or has ever had breast cancer if you have a disease of the liver or the gallbladder if you have diabetes
• if you have depression
• if you have Crohn's disease or inflammatory bowel disease (ulcerative colitis)
• if you have a blood disease called HUS (haemolytic uraemic syndrome) which causes kidney damage
• if you have a blood disease called sickle cell anaemia
• if you have epilepsy (see page 5 “Yasminelle and using other medicines”)
• if you have a disease of the immune system called SLE (systemic lupus erythematosus)
• if you have a disease that first appeared during pregnancy or earlier use of sex hormones (for example, hearing loss, a blood disease called porphyria, skin rash with blisters during pregnancy (gestational herpes), a nerve disease causing sudden movements of the body (Sydenham's chorea))
• if you have or have ever had chloasma (a discoloration of the skin especially of the face or neck known as “pregnancy patches”). If so, avoid direct sunlight or ultraviolet light.
• if you have hereditary angioedema, products containing oestrogens may cause or worsen symptoms. You should see your doctor immediately if you experience symptoms of angioedema such as swollen face, tongue and/or throat and/or difficulty swallowing or hives together with difficulty breathing.
• Yasminelle and venous and arterial blood clots

The use of any combination pill, including Elvinette, increases a woman‟s risk of developing a venous blood clot (venous thrombosis) compared with women who do not take any contraceptive pill.

The risk of venous blood clots in users of combination pills increases:

• with increasing age
• if you are overweight
• if one of your close relatives ever had a blood clot in the leg, lung (pulmonary embolism), or other organ at a young age
• if you have to have surgery, if you have had a serious accident or if you are immobilized for a long time. It is important to tell your doctor that you are using Yasminelle as you may have to stop taking it. Your doctor will tell you when to start again. This is usually about two weeks after you are back on your feet.

Bleeding between periods

During the first few months that you are taking Yasminelle you may have unexpected bleeding (bleeding outside the gap week). If this bleeding occurs for more than a few months, or if it begins after some months, your doctor must find out what is wrong.

What to do if no bleeding occurs during the gap week

If you have taken all the tablets correctly, have not had vomiting or severe diarrhoea and you have not taken any other medicines, it is highly unlikely that you are pregnant.
If the expected bleeding does not happen twice in succession, you may be pregnant. Contact your doctor immediately. Do not start the next strip until you are sure that you are not pregnant.
Interactions

Some medicines can make Elvinette less effective in preventing pregnancy, or can cause unexpected bleeding. These include:

• medicines used for the treatment of
• epilepsy (e.g. primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine)
• tuberculosis (e.g. rifampicin)
• HIV infections (ritonavir, nevirapine) or other infections (antibiotics such as griseofulvin, penicillin, tetracycline)
• high blood pressure in the blood vessels in the lungs (bosentan)
• the herbal remedy St. John's wort

Elvinette may influence the effect of other medicines, e.g.

• medicines containing ciclosporin
• the anti-epileptic lamotrigine (this could lead to an increased frequency of seizures)
• Ask your doctor or pharmacist for advice before taking any medicine.

Taking Elvinette with food and drink

• Elvinette may be taken with or without food, if necessary with a small amount of water.

Pregnancy

• If you are pregnant, do not take Elvinette. If you become pregnant while taking Yasminelle stop immediately and contact your doctor. If you want to become pregnant, you can stop taking Elvinette at any time.
• Ask your doctor or pharmacist for advice before taking any medicine.

Breast-feeding

• Use of Elvinette is generally not advisable when a woman is breast-feeding. If you want to take the pill while you are breast-feeding you should contact your doctor.
• Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

• There is no information suggesting that use of Elvinette affects driving or use of machines.
• Important information about some of the ingredients of Elvinette
• Elvinette contains lactose.
• If you cannot tolerate certain sugars, contact your doctor before you take Elvinette.

How to take Elvinette

• Take one tablet of Elvinette every day, if necessary with a small amount of water. You may take the tablets with or without food, but you should take the tablets every day around the same time.
• The strip contains 21 tablets. Next to each tablet is printed the day of the week that it should be taken. If, for example you start on a Wednesday, take a tablet with “WED” next to it. Follow the direction of the arrow on the strip until all 21 tablets have been taken.
• Then take no tablets for 7 days. In the course of these 7 tablet-free days (otherwise called a stop or gap week) bleeding should begin. This so-called “withdrawal bleeding” usually starts on the 2nd or 3rd day of the gap week.
• On the 8th day after the last Yasminelle tablet (that is, after the 7-day gap week), you should start with the following strip, whether your bleeding has stopped or not. This means that you should start every strip on the same day of the week and that the withdrawal bleed should occur on the same days each month.
• If you use Elvinette in this manner, you are also protected against pregnancy also during the 7 days when you are not taking a tablet.

If you forget to take Elvinette

• If you are less than 12 hours late taking a tablet, the protection against 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 against pregnancy may be reduced. The greater the number of tablets that you have forgotten, the greater is the risk of becoming pregnant.
• The risk of incomplete protection against pregnancy is greatest if you forget a tablet at the beginning or at the end of the strip.
• What to do in the case of vomiting or severe diarrhoea
• If you vomit within 3-4 hours after taking a tablet or you have severe diarrhoea, there is a risk that the active substances in the pill will not be fully taken up by your body. The situation is almost the same as forgetting a tablet. After vomiting or diarrhoea, take another tablet from a reserve strip as soon as possible. If possible take it within 12 hours of when you normally take your pill.
• Delaying your period: what you need to know
• Even though it is not recommended, you can delay your period by going straight to a new strip of Yasminelle instead of the tablet-free period and finishing it. You may experience light or menstruation-like bleeding while using this second strip. After the usual tablet-free period of 7 days, start the next strip.

Side effects

Like all medicines, Elvinette can cause side effects although not everybody gets them. The following is a list of the side effects that have been linked with the use of Elvinette.

Common side effects (between 1 and 10 in every 100 users may be affected):

• mood swings
• headache
• abdominal pain (stomach ache)
• acne
• breast pain, breast enlargement, breast tenderness, painful or irregular periods
• weight gain

Uncommon side effects (between 1 and 10 in every 1,000 users may be affected):

• Candida (fungal infection)
• cold sores (herpes simplex)
• allergic reactions
• increased appetite
• depression, nervousness, sleep disorder feeling of "pins and needles‟, giddiness (vertigo)
• problems with vision irregular heart beat or unusually fast heart rate
• a blood clot (thrombosis) in a vessel of the leg or the lungs (pulmonary embolism), high blood pressure, low blood pressure, migraine, varicose veins
• sore throat
• nausea, vomiting, inflammation of stomach and/or intestine, diarrhoea, constipation
• sudden swelling of the skin and/or mucous membranes (e.g. tongue or throat), and/or
• difficulty swallowing or hives together with difficulty breathing (angioedema), hair loss (alopecia), eczema, itching, rashes, dry skin, oily skin disorders (seborrheic dermatitis)
• neck pain, limb pain, muscle cramps
• bladder infection
• breast lump (benign and cancer), milk production while not pregnant (galactorrhea), ovarian
• cysts, hot flushes, absence of periods, very heavy periods, vaginal discharge, vaginal dryness, lower abdominal (pelvic) pain, abnormal cervical smear (Papanicolaou or Pap smear), decreased interest in sex
• fluid retention, lack of energy, excessive thirst, increased sweating
• weight loss

How to store Elvinette

• Keep Elvinette out of the reach and sight of children.
• This medical product does not require any special storage conditions

References:

http://www.drugs.com/international/yasminelle.html

http://www.medicines.ie/medicine/11249/SPC/Yasminelle/

http://www.hpra.ie/img/uploaded/swedocuments/2126133.PA1410_024_001.75f7fbc4-9492-403b-b023-55ca41294abb.000001Product%20Leaflet%20Approved.130409.pdf

http://www.anticonceptivas.org/en/yasminelle/

http://patient.info/doctor/missed-contraceptive-pills