VIOLITE® – a cost effective equivalent to Microlite®1


VIOLITE® contains the same active ingredients as Microlite®1

What is VIOLITE® & what is it used for?

  • VIOLITE ® is a combined oral contraceptive pill for the preventation of pregnancy.
  • It contains two different female hormones, levonorgestrel and ethinylestradiol.
  • Each of the 21 round pink tablets contains 100 micrograms of levonorgestrel and 20 micrograms of ethinlestradiol.

What you need to know before you take VIOLITE®

  • Before you start to use VIOLITE® you should read the information on bloodclots in the Patient Information Leaflet contain inside your VIOLITE® pill packet. It is particularly important to read the symptoms of a  blood clots – see section 2 in the leaflet “Blood Clots”.
  • Before you start taking VIOLITE® your doctor will ask you some questions around your personal health history and that of your close relatives. Your doctor will also measure your blood pressure and may also carry out some other tests.

How to take VIOLITE®

  • Each blister strip of Violite® contains 21 tablets.
  • Take your first tablet from the blister showing the correct day of the week.
  • You must take one tablet every day, with water if necessary, at the same time each day until the pack is finished.
  • You will then have a tablet free-week before you start your next pack of tablets.
  • You will always start your next pack on the same day of the week.
  • During the tablet free week you will have bleeding similar to a period. This bleeding will usually start after two or three days, and may not finish before you start the next pack of tablets.

How to start taking VIOLITE®

If this is the first time you are starting the pill or you have not used a hormonal contraceptive for the past month

  • Take the first tablet on the first day of your period.
  • Starting later than the first day of bleeding (from days 2-5 of the cycle) will mean you will have to use additional barrier contraception for the first 7 days.

If you are changing from another combined contraceptive pill, vaginal ring, or transdermal patch

Changing from pills containing 21 tablets in each pack:

  • Finish the pack of the current pill before starting Violite ® the next day without a break.

Changing from ‘every day’ pills containing 28 tablets in each pack

  • If your current pill contains any inactive tablets (placebo tablets), do not take these, and start Violite ® straight away the next day without leaving any tablet-free break.

Changing from vaginal ring or transdermal patch

  • You should start to take the pill preferably on the day the last ring or patch of a cycle pack is removed, or, at the latest, when the next application is due.

If you are changing from a progestogen-only method (oral pill, injection, implant or an intrauterine system (IUS))

  • You may change to Violite® 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.

If you are starting Violite ® after a termination that occurred during the first trimester (three months) of pregnancy

  • You can start taking Violite® immediately but should follow the advice of your doctor before doing so. No additional barrier contraception is needed.

If you are starting Violite® after giving birth or after a termination of pregnancy that occurred during the second Trimester

  • As with any other contraceptive pill, Violite ® should not be started less than 28 days after giving birth or after termination of a second trimester pregnancy because you are at an increased risk of blood clots.
  • If you start later, you are advised to use a barrier contraceptive method during the first 7 days of taking the pill.
  • If you have had sex before starting Violite ® be sure you are not pregnant or wait until your next period. Always ask your doctor for advice if you are not sure.

What if I forget to take VIOLITE®

  • If you forget to take a tablet there is a risk you could become pregnant
  • If you realise you have missed a tablet within 12 hours of the time you normally take your tablet, take the missed tablet immediately and continue as normal, taking the next tablet at the usual time until the end of the blister pack.
  • If you realise you have missed a tablet more than 12 hours after you normally take it, there is a risk you could become pregnant. In this case: Take the last missed tablet immediately, even if this means taking 2 tablets on the same day. Continue taking the tablets until the end of the blister pack. In addition, use a barrier method of contraception (e.g. condom) for the next 7 days. If this 7-day period extends beyond the last tablet in the pack, start the next blister pack straight away without a tablet free break. You may have some spotting or bleeding while taking the second pack, this is nothing to worry about. If you have forgotten one or more tablets in a blister pack and you do not have any bleeding in the tablet-free week, you may be pregnant and you should ask your doctor for advice.

For step by step guidance on what to do if you forget to take your tablets, please click on the button below:

Missed Pill Guidance button

What if I vomit of have severe diarrhoea after taking VIOLITE®

  • 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.

For step by step guidance on what to do if you vomit or have severe diarrhoea, please click on the button below:

Missed Pill Guidance button

Frequently asked questions about VIOLITE®

I was previously on Microlite® and have now been changed to VIOLITE® – what is the difference?

There is very little difference between these pills as they both contain exactly the same active ingredients in the same quantities, but they are made by different manufacturers and therefore have different names.

What if I miss a dose of VIOLITE®?

If you miss a pill, follow the missed pill guidance or review the Patient Information Leaflet contained inside every pack of VIOLITE®. If you miss more than one pill ask your doctor, nurse or pharmacist for advice.

What happens if I have a stomach upset? If you have been sick within 3-4 hours after taking your pill or you have severe diarrhoea, your body may not get its usual dose of hormones from that pill. After vomiting or diarrhoea, take another pill from a reserve strip as soon as possible. If possible take it within 12 hours of when you normally take your pill. If that is not possible or 12 hours or more have passed, you should follow the advice given for missing a pill.

What side effects may I experience?

Like all medicines VIOLITE® may 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 Violite®, 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 Violite® ”of the patient information leaflet contained inside the Violite® packet. Depressed mood and depression are undesirable effects of hormonal contrceptives. Contact your physician in the case of mood changes and depressive symptoms.

Am I likely to develop a blood clot if I take VIOLITE®?

The use of any combined oral contraceptive pill increases your risk of developing a blood clot compared with women who do not take any contraceptive pill. Recovery from blood clots is not always complete. Rarely, there may be serious lasting effects or, very rarely, they may be fatal. Please read the patient information leaflet contained inside your pack of Violite® pills for further information on symptoms, risks, and factors that increase your risk of a blood clot in a vein. If you notice possible signs of a blood clot, stop taking your pill and contact your doctor immediately.

Are there any medicines I shouldn’t take whilst I am on oral contraceptives?

Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines. There are some medicines that may interact with Violite®. Medicines can sometimes interfere with each other. If you receive treatment from any other doctor, nurse or qualified healthcare professional make sure they are aware that you are using Violite® as a contraceptive. They can advise if it will be necessary to take any additional precautions (e.g. using a condom or other barrier contraceptive) while you are taking other medicines while you are taking Violite®. Some medicines can make Violite® less effective in preventing pregnancy, or can cause unexpected bleeding. These include medicines used for treatment of:

  • HIV infections (ritonavir, nevirapine)
  • Epilepsy (e.g. phenobarbital, phenytoin, primidone, felbamate, carbamazepine, oxcarbazepine or topiramate)
  • Infections (e.g. rifabutin, rifampicin, griseofulvin, ampicilline or other penicillins or tetracycline)
  • Sleep disorders (modafinil)
  • Gout (phenylbutazone)
  • The herbal remedy St. John’s Wort (Hypericum perforatum), which is used to treat certain types of depression

If you have been told to take additional contraceptive precautions while taking any of the above medicines follow your doctor’s instructions carefully. If you need to take the medicine beyond the end of your current tablet pack, miss your tablet-free week and start the next pack straight away. In some cases you may need to continue to use additional barrier contraception for several weeks after you have stopped taking the medicine.

Violite® may interfere with the following medicines:

  • Cyclosporine (to reduce the body’s immune response)
  • Lamotrigine (for epilepsy)

Taking an antibiotic medicine called troleandomycin may increase the risk for intrahepatic cholestasis (retention of bile in the liver) while taking the combined pill.

Am I at risk of developing 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.

Blood clots

  • Using a combined hhormonal contraceptive such as VIOLITE ® increases your risk of developing a blood clot compared to 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 veionous thrombosis or VTE) In the arteries (referred to as arterial thrombosis or ATE)
  • Recovery from blood clots is not always complete. Rarely, there may be serious lasting effects, or, very rarely they may be fatal
  • Please read the Patient Information Leaflet contained inside your packet of VIOLITE ® pills for further information on symptoms, risks, and factors that increase your risk of a blood clot in a vein
  • It is important to remember that your overall risk of a harmful blood clot due to VIOLITE® is small

VIOLITE® General Information

  • If taken correctly, VIOLITE® is reliable, reversible form of contraception if used correctly.
  • VIOLITE® will not protect you against sexually transmitted diseases. Only condoms can help to do this.
  • VIOLITE® slightly increase the risk of having a blood clot in the veins and arteries, especially in the first year or when restarting a combined hormonal contraceptive following a break of 4 or more weeks.
  • Please be alert and see your doctor if you think you may have symptoms of a blood clot, or suffer any side effects when taking VIOLITE®
  • Seek urgent medical attention 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 (see ‘Blood clot’ section in the patient information leaflet.

References:

  1. MIMS Ireland (August 2017) Contraception pp.322-325. MPI Media Ltd. Dublin
  2. Violite Patient Information Leaflet

Information placed on this digital platform is not intended as a substitute for consultation with your healthcare professional. Please consult your doctor or nurse for further information.

IE/OCS/0817/0057f(1) Date of preparation: March 2019


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