Violite Tablets

In such situations you should either not have sex 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 Microlite alters the monthly changes of body temperature and of cervical mucous.

When taken correctly combined oral contraceptives, have a failure rate of approximately 1% per year. The failure rate may increase when pills are missed or taken incorrectly, if you have a stomach upset or when you take certain other medicines or herbal remedies.

Violite, like other hormonal contraceptives, does not protect against HIV infection (AIDS) or any other sexually transmitted disease.

When not to take Violite

Do NOT take Violite:

• if you have ever had a blood clot in a blood vessel of the leg (thrombosis), of the lung (embolus) or other organs
• if you have ever had a heart attack or stroke
• if you have ever had a disease that can be an indicator of a heart attack in the future or of a stroke
• if you have a disease that may increase the risk of a clot in the arteries 
• if you have diabetes with damaged blood vessels
• if you have ever had a certain form of migraine
• if you have ever had severe liver disease and your liver function is still not normal.
• if you have ever had a tumour in the liver
• if you have ever had or suspect you have breast cancer or cancer of the genital organs
• if you have any unexplained bleeding from the vagina
• if you know or suspect that you are pregnant
• if you have an allergy (hypersensitivity) to ethinylestradiol, levonorgestrel, or to any of the other ingredients of Microlite. This may cause itching, rash or swelling.
• If any of these conditions start while you are using Violite, stop taking the pills immediately and talk to your doctor.

When to take special care with Violite

In some situations you need to take special care while using Violite or any other combined pill, and it may be necessary that you are regularly checked by your doctor. If any of the following conditions applies to you, you must inform your doctor before starting to use Violite. Also, if any of the following conditions develops or worsens while you are using Violite you must consult your doctor:

• a close relative has had breast cancer you have liver or gallbladder disease you have diabetes
• you have depression
• you have Crohn's disease or inflammatory bowel disease (ulcerative colitis)
• you have a blood disease called HUS (haemolytic uraemic syndrome) that causes kidney damage you have epilepsy (see “Microlite and using other medicines”)
• you have a disease of the immune system called SLE (systemic lupus erythematosus), an illness causing generalised skin disorders
• you have a disease that first appeared during pregnancy or with earlier use of sex hormones (for example, hearing loss, a blood disease called porphyria, skin rash with blisters during pregnancy (gestational herpes), or a nerve disease causing sudden movements of the body (Sydenham's chorea)
• you have ever had golden brown pigment patches (chloasma), so called “pregnancy patches”, especially on the face. If this is the case, avoid direct exposure to sunlight or ultraviolet light.
• you have an intolerance to lactose or are on a lactose-free diet
• you have hereditary angioedema (rapid swelling of the skin, mucosal tissues, internal organs or brain); products containing oestrogens may cause or worsen the symptoms. If you experience symptoms of angioedema such as swollen face, tongue, throat/neck area, difficulty swallowing or hives together with difficulty in breathing, you should see your doctor immediately.
• you have sickle cell disease
• you have a high level of fat in your blood (cholesterol or triglycerides) or someone in your family has had this
• you have high blood pressure. Your doctor may decide to stop Microlite until your blood pressure is lower.
• you have any disturbance of blood clotting (for example, protein C deficiency)

Violite and venous and arterial blood clots

The use of any combined pill, including Violite, increases a woman‟s risk of developing a blood clot in a vein (venous thrombosis) compared with women who do not take any contraceptive pill.
The use of combined pills has also been connected with an increase of the risk of a blood clot in an artery (arterial thrombosis), for example, in the blood vessels of the heart (heart attack) or the brain (stroke). Blood clots may also occur in the liver, gut, kidney or eye but this is very rare.

The risk of having a blood clot in a vein or in an artery increases:

• with increasing age
• if you smoke. You are strongly advised to stop smoking when you use Microlite, especially if you are older than 35 years.
• if you are overweight
• if one of your close relatives had a blood clot in the leg, lung (pulmonary embolism), or other organ at a young age
• if you have major surgery, any surgery to the legs, a serious accident or if you are immobilised for a long time. It is important to tell your doctor in advance that you are using Violite as the treatment may have to be stopped. Your doctor will tell you when to start Violite again. This is usually about two weeks after you are back on your feet
• if you have high levels of blood cholesterol or triglycerides
• if you have high blood pressure
• if you suffer from migraine
• if you have a problem with your heart (valve disorder, a disturbance of the cardiac rhythm)

Stop taking Violite and contact your doctor immediately if you notice possible signs of a blood clot, such as:

• severe pain, warmth and/or swelling in one of your legs
• pain or tenderness in the leg which may be felt only when standing or walking
• red or discolored skin on the leg
• sudden severe pain in the chest which may reach the left arm or may increase with deep breathing rapid or irregular heartbeat
• sudden breathlessness or rapid breathing
• sudden cough which may bring up blood, without an obvious cause
• any unusual, severe or long-lasting headache, first occurrence or worsening of migraine
• partial or complete blindness or double vision
• sudden confusion
• difficulty in speaking or understanding or inability to speak
• dizziness, lightheadedness or fainting
• weakness, strange feeling, or numbness in any part of the body
• difficulty controlling your movements or balance
• difficulty walking
• sudden severe stomach ache
• pain, discomfort, pressure, heaviness, sensation of squeezing or fullness in the chest, arm, or below the breastbone;
• discomfort which spreads to the back, jaw, throat, arm, stomach;
• fullness, indigestion or choking feeling;
• sweating, nausea, vomiting, anxiety
• seizure or loss of consciousness.

Very occasionally thrombosis may cause serious permanent disabilities and may even be fatal.
The risk of having a clot is also higher if you have had a baby recently.

Violite and cancer

• Cervical cancer in long-term users has been reported, but the effect of sexual behaviour or other factors such as human papilloma virus (HPV) is not clear.
• Breast cancer has been observed slightly more often in women using combined pills, but it is not known whether this is caused by the treatment. For example it may be that more tumours are detected in women on combined pills because they are examined by their doctor more often. The occurrence of breast tumours becomes gradually less after stopping the combined hormonal contraceptives. It is important to regularly check your breasts and you should contact your doctor if you feel any lump.
• Benign liver tumours (non-cancerous) are rare, and malignant liver tumours (cancerous) are even more rarely reported in combined pill users. Contact your doctor if you have unusually severe stomach pain.

Bleeding between periods

• During the first few months when you are taking Microlite, you may have unexpected bleeding (bleeding outside the pill-free days). If this bleeding occurs for more than three 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 tablet-free days
• 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 this is not the case or if the expected bleeding does not happen twice in succession, you may be pregnant. Contact your doctor immediately as pregnancy must be ruled out before the pill is continued. Only start the next strip if you are sure that you are not pregnant.

Violite and using other medicines

Some medicines can make Microlite 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)
• tuberculosis (e.g. rifampicin)
• HIV infections (ritonavir or nevirapine) or other infections (antibiotics such as penicillin, tetracycline)
• the herbal remedy St. John's wort

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

• medicines containing cyclosporine
• the anti-epileptic lamotrigine (this could lead to an increased frequency of seizures).

Taking Violite with food and drink

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

Pregnancy

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

Breast-feeding

• Taking Violite is not advisable during breast-feeding unless advised to by your doctor. 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 Violite affects driving or using machines.

How to take Violite

• Each blister strip contains 21 tablets. Each tablet is marked with the weekday when the tablet should be taken. For example, if you start to take the tablets on a Tuesday, press the tablet through the aluminium foil, at a blister marked "TUE". Take the tablets every day in the order shown by the arrows.
• Take one tablet of Violite every day for 21 days, with water if necessary. You may take the tablets with or without food, but you should take the tablets every day around the same time.
• Once you have finished all 21 tablets, you will not take any tablets during the next 7 days. Your period (withdrawal bleed) will start during these 7 days, usually 2–3 days after taking the last Violite tablet.
• Start the next blister pack on the 8th day even if your period continues. This way you will always start a new pack on the same day of the week, and the withdrawal bleed will occur roughly at the same time each month.

When can you start with the first strip?

If you have not used a contraceptive with hormones in the previous month

• Begin taking Violite on the first day of the cycle (that is, the first day of your period). If you start Microlite on this day you are immediately protected against pregnancy. You may also begin on day 2-5 of your cycle, but you must use extra protective measures (for example, a condom) for the first 7 days.

Changing from another combined hormonal contraceptive, or vaginal ring or patch

• Start taking Violite on the day after the last active tablet of your previous pill or, at the latest, on the day following the usual tablet-free break or the last placebo tablet of the previous hormonal contraceptive. In the case of a vaginal ring or patch, start taking Violite on the day of removal or, at the latest, when the next application would have been due.

Changing from a progestogen-only-method (oral pill, injection, implant or an intrauterine system IUS).

• You may change to Violite tablets on any day from a progestogen-only pill (from an implant or an IUS on the day of its removal, from an injectable when the next injection would be due) but in all of these cases you must use extra protective measures (for example, a condom) for the first 7 days of tablet-taking.

After first trimester miscarriage or abortion

• Follow the advice of your doctor.

After having a baby or second trimester miscarriage or abortion

• Start Microlite between 21 and 28 days after delivery or second trimester miscarriage or abortion. If you start later than day 28, you must use an additional barrier method (for example, a condom) during the first 7 days of Violite use.
• If, after having a baby, you have had sex before starting Microlite (again), you must first be sure that you are not pregnant or you must wait until your next period before taking Violite.

Use in children and adolescents

• You should not take Violite before you have started to have a monthly period.

Use in older patients

• You should not take Violite after the menopause.

Use in patients with liver problems

• You should not take Violite if you have severe liver problems.

Use in patients with kidney problems

• You should talk to your doctor before taking Violite if you have kidney problems.

If you take more Violite than you should

• There are no reports of serious harmful results from taking too many Violite tablets.
• If you take several tablets at once then you may have symptoms of nausea or vomiting. Young girls may have bleeding from the vagina.
• If you have taken too many Violite tablets, or you discover that a child has taken some, ask your doctor or pharmacist for advice.

If you forget to take Violite

• 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 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.

Therefore, you should keep to the following rules:

• tablet-taking must never be discontinued for longer than 7 days.
• the effectiveness of Violite depends on 7 days of uninterrupted tablet-taking.

If you are more than 12 hours late during days 1-7:

• Take the last missed tablet as soon as you remember, even if this means taking two tablets at the same time. Then continue to take the next tablets at the usual time. In addition, a barrier method such as a condom should be used for the next 7 days. If you have had sex in the 7 days before missing the tablet, the possibility of a pregnancy must be considered. The more tablets have been missed and the closer they are to the regular tablet-free break, the higher the risk of pregnancy. See your doctor if this has happened to you.

If you are more than 12 hours late during days 8-14:

• Take the last missed tablet as soon as you remember, even if this means taking two tablets at the same time. Then continue to take the next tablets at the usual time. Provided you have taken the tablets correctly in the 7 days preceding the first missed tablet, there is no need to use extra contraceptive precautions. If you have not taken the tablets correctly or have missed more than one tablet, you should use extra contraceptive precautions for the next 7 days.

If you are more than 12 hours late during days 15-21:

• The risk of pregnancy increases the nearer you are to the tablet-free break of 7 days. However, pregnancy can still be prevented by adjusting the dosage.
• If you use the following advice, there is no need to use extra contraceptive precautions, provided that all the tablets have been taken correctly in the 7 days before the first missed tablet. If this is not the case, you should follow the first of these two options and use extra contraceptive precautions for the next 7 days as well.

1. Take the forgotten tablet as soon as you remember, even if that means taking two tablets at the same time. Then take the rest of the tablets at the usual time. Instead of having a 7 day tablet – free break, continue immediately with the next pack of 21 tablets. There will probably be no withdrawal bleed until the end of the second pack, but you may experience spotting or breakthrough bleeding on tablet-taking days.
2. You can stop taking the tablets from the current pack and have a tablet-free break of 7 days, including the days you missed tablets, and then continue with the next pack.
If you miss several tablets and have no withdrawal bleed during the first normal tablet-free break, the possibility of a pregnancy must be considered.

What to do in the case of vomiting or severe diarrhoea

• Vomiting or diarrhoea may make Violite less effective in preventing pregnancy.
• If you vomit within 3-4 hours of taking a tablet or 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 as soon as possible. If possible, take it within 12 hours of when you normally take your pill. If this is not possible or 12 hours have passed, follow the advice given under “If you forget to take Violite - above”.
• If you do not want to change your normal tablet-taking routine, you can take the extra tablet from another pack.
• If the vomiting or diarrhoea continues, talk to your doctor. You will need to use extra contraceptive measures.

Delaying your period: what you need to know

• Although it is not recommended, you can delay your period by going straight to a new pack of Violite and finishing it. You may experience spotting (droplets or flecks of blood) or breakthrough bleeding while using this second pack. When the second pack is finished, you must have a 7-day tablet-free break.
• It is advisable to consult your doctor before deciding to delay your menstrual period.

Changing of the first day of your menstrual period: what you need to know

• If you want to change the starting day or have your period on another day of the week, you can shorten your next tablet-free break by as many days as you like. The shorter the break, the higher the risk that there will be no withdrawal bleed and that you will experience breakthrough bleeding and spotting during the second pack. Never lengthen your tablet-free break.
• If you are not sure what to do, talk to your doctor.

If you want to stop taking Violite

• You can stop taking Violite whenever you want. If you do not want to become pregnant, ask your doctor for advice about other reliable methods of birth control. If you want to become pregnant, stop taking Violite and wait for a menstrual period before trying to become pregnant. You will be able to calculate the expected delivery date more easily.
• If you have any further questions on the use of this product, ask your doctor or pharmacist.

Possible side effects

Like all medicines, Violite 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 Violite:

Common side effects: 

• mood swings, depression
• headache
• nausea, abdominal pain
• breast pain or tenderness weight increase

Uncommon side effects: 

• decreased interest in sex
• skin rash
• migraine
• vomiting, diarrhoea
• itching or raised bumps on the skin swollen breasts
• fluid retention

Rare side effects: 

• contact lens intolerance
• allergic reactions
• increased interest in sex
• breast or vaginal discharge red skin lesions or nodules skin redness or blotchiness weight decrease

The following serious adverse events have been reported slightly more often in women using contraceptive pills

• venous or arterial blood clots
• stroke
• high cholesterol
• changes in glucose tolerance
• golden brown pigment patches (chloasma), so called “pregnancy patches”,
• raised blood pressure
• liver tumours or breast cancer
• disturbances of liver function

The following conditions may occur or get worse with combined oral contraceptives:

• Crohn's disease, ulcerative colitis, migraine, cervical cancer, porphyria (metabolism disorder which causes abdominal pains and mental disorders), systemic lupus erythematosus (where the body attacks and injures its own organs and tissues), herpes in late pregnancy, Sydenham's chorea (rapid involuntary jerking or twitching movements), haemolytic uraemic syndrome (a condition which occurs after diarrhoea caused by E.coli), liver problems shown by jaundice, gall bladder disorders or gallstone formation, loss of hearing.
• In women with hereditary exogenous angioedema, the oestrogens in contraceptive pills may induce or exacerbate symptoms of angioedema.
• If any of the side effects gets serious or if you notice any side effects not listed in this leaflet or if you think that this may be the case, please tell your doctor or pharmacist.

How to store Violite

• Keep Violite out of the reach and sight of children.
• Do not store above 25

References:

https://www.dred.com/ie/microlite.html

http://www.medicines.ie/medicine/2379/SPC/Microlite+100+20+microgram+Tablets/

http://www.irishhealth.com/discussion/message.html?dis=4&topic=5121

http://www.hpra.ie/img/uploaded/swedocuments/2126004.PA1410_007_001.192e0a6f-fdf1-467b-9033-222b98b6015c.000001Product%20Leaflet%20Approved.130314.pdf

https://en.wikipedia.org/wiki/Microlite