Skip to Content

VIOLITE 100/20 MICROGRAMS FILM-COATED TABLETS

Active substance(s): ETHINYLESTRADIOL / LEVONORGESTREL

View full screen / Print PDF » Download PDF ⇩
Transcript
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

VIOLITE

100/20 micrograms film-coated tablets
levonorgestrel/ethinylestradiol
Important things to know about combined hormonal contraceptives (CHCs).
• They are one of the most reliable reversible methods of contraception if used correctly
• They 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 (see section 2 “Blood clots”)
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the
same as yours.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.
See section 4.
What is in this leaflet
1. What Violite is and what it is used for
2. What you need to know before you take Violite
3. How to take Violite
4. Possible side effects
5. How to store Violite
6. Contents of the pack and other information
1. WHAT VIOLITE IS AND WHAT IT IS USED FOR
Violite is a combined oral contraceptive pill for the prevention 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 ethinylestradiol.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE VIOLITE
General notes
Before you start using Violite you should read the information on
blood clots in section 2. It is particularly important to read the
symptoms of a blood clot – see Section 2 “Blood clots”).
Before you can 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.
In this leaflet some situations are described where you should
stop using Violite or where the reliability of Violite may be
decreased and there is a higher risk of pregnancy. In such
situations you should either not have sex or you should take
extra non-hormonal contraceptive precautions (e.g. use a
condom or other barrier method). Do not use the rhythm or
temperature methods. These methods can become
unreliable because Violite alters the monthly changes in
body temperature and cervical mucus.
When you should not use Violite
You should not use Violite if you have any of the conditions listed
below. If you do have any of the conditions listed below, you must
tell your doctor. Your doctor will discuss with you what other
form of birth control would be more appropriate.
• 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 (see section ‘Blood clots’);
• if you have ever had a heart attack or a 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 ever had a severe liver disease, and you have been
told by your doctor that your liver function test results are not
yet back to normal
• if you have ever had liver tumours
• if you are pregnant or suspect you may be pregnant
• if you are allergic (hypersensitive) to any of the ingredients in
Violite
When to take special care with Violite
When should you contact your doctor?
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’ (thrombosis) section below.
For a description of the symptoms of these serious side effects
please go to “How to recognise a blood clot”.
Tell your doctor if any of the following conditions apply to you.
If the condition develops, or gets worse while you are using
Violite, you should also tell your doctor
• 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
(see in section 2 ‘Blood clots’);
• if you have just given birth you are at an increased risk of blood
clots. You should ask your doctor how soon after delivery you
can start taking Violite;
• if you have an inflammation in the veins under the skin
(superficial thrombophlebitis);
• if you have varicose veins;
• if you have constantly elevated blood pressure or a significant
increase in blood pressure which does not respond adequately
to your blood pressure medication.
• if you have diabetes;
• if you are overweight (obese);
• if you have a disease of the heart valves or heart rhythm
disorder (atrial fibrillation);
• if you or your close family have ever had problems with blood
clotting ;
• if you have the inherited disease called porphyria;
• if you have migraines;
• if you suffer from depression;
• if you have a loss of hearing due to a disorder known as
otosclerosis;
• if you suffer from a disease known as Sydenham’s Chorea. The
symptoms include irregular, sudden involuntary movements;
• if you have had during a pregnancy or when using another
contraceptive pill a skin condition which caused itching, red
patches and blisters (herpes gestationis);
• if you have had during a pregnancy temporary brown patches
on your skin (chloasma). The pill can make this recur so you
should avoid strong sunlight or sunbeds while taking Violite;
• if you experience any sudden unexplained changes in your
vision;
• if you have gallstones, gallbladder disease or have problems
caused by a blockage of the bile ducts (cholestasis) - this may
cause intense itching;
• if you have hereditary angioedema, products containing
oestrogens may cause or worsen the symptoms of angioedema.
You should see your doctor immediately if you experience
symptoms of angioedema such as swollen face, tongue and/or
pharynx and/or difficulty swallowing, or hives together with
difficulty in breathing.
BLOOD CLOTS
Using a combined hormonal contraceptive such as Violite
increases your risk of developing a blood clot compared with 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 a ‘venous thrombosis’, ‘venous
thromboembolism’ or VTE)
• in the arteries (referred to as an ‘arterial thrombosis’, ‘arterial
thromboembolism’ or ATE).
Recovery from blood clots is not always complete. Rarely, there
may be serious lasting effects or, very rarely, they may be fatal.
It is important to remember that the overall risk of a harmful
blood clot due to Violite is small.
HOW TO RECOGNISE A BLOOD CLOT
Seek urgent medical attention if you notice any of the following
signs or symptoms.

Are you experiencing any of
these signs?

What are you possibly
suffering from?

• 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
• 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;
If you are unsure, talk to a doctor as
some of these symptoms such as
coughing or being short of breath may
be mistaken for a milder condition
such as a respiratory tract infection
(e.g. a ‘common cold’).
Symptoms most commonly occur in
one eye:
• immediate loss of vision or
• painless blurring of vision which can
progress to loss of vision
• chest pain, discomfort, pressure,
heaviness
• sensation of squeezing or fullness
in the chest, arm or below the
breastbone;
• fullness, indigestion or choking
feeling;
• upper body discomfort radiating
to the back, jaw, throat, arm and
stomach;
• sweating, nausea, vomiting or
dizziness;
• extreme weakness, anxiety, or
shortness of breath;
• rapid or irregular heartbeats
• 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.
Sometimes the symptoms of stroke
can be brief with an almost immediate
and full recovery, but you should still
seek urgent medical attention as you
may be at risk of another stroke.
• swelling and slight blue
discolouration of an extremity;
• severe pain in your stomach
(acute abdomen).

Deep vein thrombosis

Pulmonary embolism

Retinal vein thrombosis
(blood clot in the eye)

Heart attack

Stroke

Blood clots blocking
other blood vessels

BLOOD CLOTS IN A VEIN
What can happen if a blood clot forms in a vein?
• The use of combined hormonal contraceptives has been
connected with an increase in the risk of blood clots in the vein
(venous thrombosis). However, these side effects are rare. Most
frequently, they occur in the first year of use of a combined
hormonal contraceptive.
• If a blood clot forms in a vein in the leg or foot it can cause a
deep vein thrombosis (DVT).
• If a blood clot travels from the leg and lodges in the lung it can
cause a pulmonary embolism.
• Very rarely a clot may form in a vein in another organ such as
the eye (retinal vein thrombosis).
When is the risk of developing a blood clot in a vein highest?
The risk of developing a blood clot in a vein is highest during the
first year of taking a combined hormonal contraceptive for the
first time. The risk may also be higher if you restart taking a
combined hormonal contraceptive (the same product or a
different product) after a break of 4 weeks or more.
After the first year, the risk gets smaller but is always slightly
higher than if you were not using a combined hormonal
contraceptive.
When you stop Violite your risk of a blood clot returns to normal
within a few weeks.
What is the risk of developing a blood clot?
The risk depends on your natural risk of VTE and the type of
combined hormonal contraceptive you are taking.
The overall risk of a blood clot in the leg or lung (DVT or PE) with
Violite is small.
• Out of 10,000 women who are not using any combined
hormonal contraceptive and are not pregnant, about 2 will
develop a blood clot in a year.
• Out of 10,000 women who are using a combined hormonal
contraceptive that contains levonorgestrel such as Violite,
about 5-7 will develop a blood clot in a year.
• The risk of having a blood clot will vary according to your
personal medical history (see “Factors that increase your risk of
a blood clot” below).
Risk of developing a
blood clot in a year
Women who are not using a
combined hormonal pill/patch/
ring and are not pregnant
Women using a combined
hormonal contraceptive pill
containing levonorgestrel,
norethisterone or
norgestimate
Women using Violite

About 2 out of
10,000 women
About 5-7 out of
10,000 women

About 5-7 out of
10,000 women

Factors that increase your risk of a blood clot in a vein
The risk of a blood clot with Violite is small but some conditions
will increase the risk. Your risk is higher:
• if you are very overweight (body mass index or BMI over
30kg/m2);
• if one of your immediate family has had a blood clot in the leg,
lung or other organ at a young age (e.g. below the age of about
50). In this case you could have a hereditary blood clotting
disorder;
• if you need to have an operation, or if you are off your feet for a
long time because of an injury or illness, or you have your leg in
a cast. The use of Violite may need to be stopped several weeks
before surgery or while you are less mobile. If you need to stop
Violite ask your doctor when you can start using it again;
• as you get older (particularly above about 35 years);
• if you gave birth less than a few weeks ago.
The risk of developing a blood clot increases the more conditions
you have.
Air travel (>4 hours) may temporarily increase your risk of a blood
clot, particularly if you have some of the other factors listed.
It is important to tell your doctor if any of these conditions apply
to you, even if you are unsure. Your doctor may decide that
Violite needs to be stopped.
If any of the above conditions change while you are using Violite,
for example a close family member experiences a thrombosis for
no known reason; or you gain a lot of weight, tell your doctor.
BLOOD CLOTS IN AN ARTERY
What can happen if a blood clot forms in an artery?
Like a blood clot in a vein, a clot in an artery can cause serious
problems. For example, it can cause a heart attack or a stroke.

Factors that increase your risk of a blood clot in an artery
It is important to note that the risk of a heart attack or stroke
from using Violite is very small but can increase:
• with increasing age (beyond about 35 years);
• if you smoke. When using a combined hormonal contraceptive
like Violite you are advised to stop smoking. If you are unable to
stop smoking and are older than 35 your doctor may advise you
to use a different type of contraceptive;
• if you are overweight;
• if you have high blood pressure;
• if a member of your immediate family has had a heart attack or
stroke at a young age (less than about 50). In this case you
could also have a higher risk of having a heart attack or stroke;
• if you, or someone in your immediate family, have a high level
of fat in the blood (cholesterol or triglycerides);
• if you get migraines, especially migraines with aura;
• if you have a problem with your heart (valve disorder,
disturbance of the rhythm called atrial fibrillation);
• if you have diabetes.
If you have more than one of these conditions or if any of them
are particularly severe the risk of developing a blood clot may be
increased even more.
If any of the above conditions change while you are using Violite,
for example you start smoking, a close family member
experiences a thrombosis for no known reason; or you gain a lot
of weight, tell your doctor.
Violite and cancer
• Cervical cancer in long-term users has been reported, but the
effect of sexual behavior 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 that you are taking Violite, you may
have unexpected bleeding (bleeding or spotting outside the
tablet free week). If this bleeding lasts longer than a few months,
or if it begins after some months, your doctor must investigate
the cause.
What to do if no bleeding occurs in the tablet free 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 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. Do not start the next blister pack until you are sure
that you are not pregnant.
Other medicines and Violite
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.
Pregnancy
Do not take Violite if you are pregnant. If you think you may have
become pregnant while using Violite tell your doctor
immediately.
Breastfeeding
It is not recommended that you take the combined pill while you
are breastfeeding as the hormones can affect your milk. If you
wish to breastfeed, your doctor will be able to advise you on
suitable alternative methods of contraception.
Always ask your doctor, nurse, or healthcare professional for
advice before taking any medicine.
Driving and using machines
The effect of Violite on the ability to drive or operate machinery
has not been studied. Dizziness has been reported as a side effect.
If you experience dizziness do not drive or operate machinery
until it has resolved.
Violite contains lactose
If you suffer from intolerance to certain sugars you should
consult your doctor before taking Violite.
3. HOW TO USE VIOLITE
Always take this medicine exactly as your doctor or pharmacist
has told you. Check with your doctor or pharmacist if you are not
sure.
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.
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.
If you 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.
If you have vomiting or 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
How to delay a period
You can delay your period by starting another pack of Violite
without any tablet-free week. You may have some spotting or
bleeding while taking the second pack, this is nothing to worry
about.
You should have a normal bleed after finishing the second course
of tablets.
If you take more Violite than you should
If you accidentally take more Violite than you should, you may
have symptoms including gastrointestinal problems (e.g. nausea,
vomiting, abdominal pain), breast tenderness, dizziness,
drowsiness/fatigue and vaginal bleeding. These symptoms will
reduce naturally as your body deals with the excess hormones.
If you are worried ask your doctor for advice.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can 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”.
If you experience any of the following serious side effects, seek
medical help immediately:
Rare side effects (may affect up to 1 in 1,000 people)
• harmful blood clots in a vein or artery for example:
– in a leg or foot (i.e. DVT)
– in a lung (i.e. PE)
– heart attack
– stroke
– mini-stroke or temporary stroke-like symptoms, known
as a transient ischaemic attack (TIA)
– blood clots in the liver, stomach/intestine, kidneys or eye.
The chance of having a blood clot may be higher if you have any
other conditions that increase this risk (see section 2 for more
information on the conditions that increase risk for blood clots
and the symptoms of a blood clot)
• A serious allergic reaction – Rare side effect (may affect up to
1 in 1,000 people)
Symptoms include sudden wheeziness, difficulty in breathing
or dizziness, swelling of the eyelids, face, lips or throat, skin rash,
hives
• A blood clot in the eye - it is not known how frequently this
occurs
Symptoms include loss of vision, pain and swelling of the eye
especially if sudden.
• Haemolytic uremic syndrome (a condition which affects your
blood and kidneys) – it is not known how frequently this
occurs
Symptoms include vomiting, diarrhoea (which may be bloody),
fever, feeling weak, passing less urine than usual.
• Pancreatitis - it is not known how frequently this occurs
Symptoms include severe upper abdominal pain which may
spread to your back.
• Erythema multiforme - Rare side effect (may affect up to 1 in
1,000 people)
Symptoms include a skin rash with pink-red blotches especially
on palms of hands or soles of feet which may blister. You may
also have ulcers in the mouth, eyes or genitals and have a fever.
Other side effects include:
Common (may affect up to 1 in 10 people)
• Mood swings, depression
• Headache, dizziness
• Nausea, abdominal pain
• Breast pain or tenderness
• Weight increase
Uncommon (may affect up to 1 in 100 people)
• Decreased interest in sex
• skin rash
• migraine
• vomiting diarrhoea
• itching or raised bumps on the skin
• swollen breasts
• fluid retention
Rare (may affect up to 1 in 1,000 people)
• Contact lens intolerance
• allergic reactions
• increased interest in sex
• breast or vaginal discharge
• red skin lesions or nodules
• skin redness or blotchiness
• weight decrease
If you are at all worried about any new symptoms or other
aspects of your health while taking Violite, please tell your doctor.
Reporting of side effects – United Kingdom
If you get any side effects talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet. You can
also report side effect directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard.
By reporting side effects, you can help provide more information
on the safety of this medicine.
Reporting of side effects - Ireland
If you get any side effects, talk to your doctor, pharmacist or
nurse. This includes any possible side effects not listed in this
leaflet. You can also report side effects directly via HPRA
Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2;
Tel: +353 1 6764971; Fax: +353 1 6762517.
Website: www.hpra.ie; E-mail: medsafety@hpra.ie.
By reporting side effects, you can help provide more information
on the safety of this medicine.
5. HOW TO STORE VIOLITE
• Keep this medicine out of the sight and reach of children.
• Do not store above 25° C
• Do not use this medicine after the expiry date stated on the
blister pack and the carton after EXP. The expiry date refers to
the last day of that month.
If you stop taking Violite: 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.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Violite contains
The active substances are ethinylestradiol and levonorgestrel.
• Each coated tablet contains 20 microgram ethinylestradiol and
100 microgram levonorgestrel.
The other ingredients are:
Tablet core: Lactose monohydrate, Polacrilin potassium,
Microcrystalline cellulose, Magnesium stearate.
Tablet coating: Opadry II pink, consisting of: Macrogol 3350,
Titanium dioxide (E171), Polyvinyl alcohol, Talc (E553b),
Iron oxide red (E172), Iron oxide yellow (E172).
What Violite looks like and contents of the pack
Pink, cylindrical, biconvex, film coated tablet of 6 mm
approximately.
Violite is packed in PVC/PVDC/Aluminium blister packs of 21
tablets.
Each pack may contain either:
1 x 21 film-coated tablets or
3 x 21 film-coated tablets
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Consilient Health Limited
5th Floor, Beaux Lane House,
Mercer Street Lower, Dublin 2, Ireland
Manufacturer
Cyndea Pharma, S.L.
Polígono Industrial Emiliano Revilla Sanz
Av. de Ágreda 31, 42110 Ólvega (Soria), Spain
This leaflet was last revised in March 2016
P0361

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide