RIGEVIDON

Active substance: LEVONORGESTREL

View full screen / Print PDF » Download PDF ⇩

Transcript
PACKAGE LEAFLET: INFORMATION FOR THE USER

RIGEVIDON®

150 micrograms/30 micrograms coated tablets
levonorgestrel and ethinylestradiol
Read all of this leaflet carefully before you start taking this medicine.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Rigevidon is and what it is used for
2. Before you take Rigevidon
3. How to take Rigevidon
4. Possible side effects
5. How to store Rigevidon
6. Further information

1. WHAT RIGEVIDON IS AND WHAT IT IS USED FOR
Rigevidon is a combined oral contraceptive, also called ‘the Pill’.
You take it to stop you getting pregnant. It contains two types of
female hormones: an oestrogen, ethinylestradiol, and a progestogen,
levonorgestrel in a low dose.
The combined contraceptive pill protects you against pregnancy in
three ways. These hormones:
1. stop the ovary from releasing an egg each month (ovulation)
2. thicken the fluid in your cervix (at the neck of the womb) making
it more difficult for the sperm to reach the egg
3. alter the lining of the womb to make it less likely to accept a
fertilised egg.
General information
If taken correctly, the pill is an effective reversible form of
contraception. However, in certain circumstances the effectiveness
of the pill may reduce or you may have to stop taking the pill (see
later). In these cases either do not have sex, or use extra nonhormonal contraceptive precautions (such as condoms or another
barrier method) during intercourse to ensure effective
contraception.
Remember, combined oral contraceptive pills like Rigevidon will not
protect you against sexually-transmitted diseases (such as AIDS).
Only condoms can help to do this.

2. BEFORE YOU TAKE RIGEVIDON
Take SPECIAL CARE with Rigevidon
Before you can begin taking Rigevidon, your doctor will ask you
some questions about your personal health history and that of your
close relatives. The doctor will also measure your blood pressure,
and depending upon your personal situation, may also carry out
some other tests.
Regular check-ups
Once you have started taking Rigevidon, your doctor will see you
again for regular check-ups yearly, or if you have any problem you
can see your doctor at any time.
Do NOT take Rigevidon if you
• are allergic (hypersensitive) to ethinylestradiol, levonorgestrel or
any of the other ingredients of Rigevidon, which are listed in
Section 6 of this leaflet
• have or have ever had a blood clot (thrombosis) in a blood vessel
of the leg, lung (embolus) or other organs
• have had a heart attack or stroke
• have any medical condition which increases your risk of suffering
a heart attack (for example, angina pectoris, which causes severe
pain in the chest) or a stroke (for example, a momentary slight
stroke with no lasting effects)
• have heart disease or fluctuations in heart rhythm
• if you have or have ever had migraine with visual disturbances,
abnormal touch sensation, or movement
• have very high blood pressure
• have diabetes affecting your blood vessels
• have or have ever had eye disorders (e.g. a disease of the retina
called retinopathy)
• have or have ever had liver tumours or liver disease
• have breast cancer or another cancer, for example ovarian cancer,
cervical cancer, or cancer of the uterus (womb)
• have unexplained bleeding from your vagina
• are pregnant or think you might be.
If you have any of the following diseases/conditions, you should
only take Rigevidon under strict medical supervision, since these
conditions may get worse while you are taking the pill.
Tell your doctor before starting to take Rigevidon if you
• have a disorder of blood-fat (lipid) metabolism, or other very
rare blood disorders
• have high blood pressure
• have varicose veins or inflammation of a vein (usually in the legs)
(thrombophlebitis)
• have migraines
• have diabetes
• have Crohn’s disease or ulcerative colitis (chronic inflammatory
bowel diseases)
• have the inherited form of deafness known as otosclerosis
• have depression
• have the movement disorder called Sydenham’s chorea
• have liver and/or gall bladder disease (yellowing of the skin,
gallstones)
• have the inherited disease called porphyria
• have sickle cell anaemia
• have a blood disorder called haemolytic uraemic syndrome
- HUS (a disorder where blood clots cause the kidneys to fail)
• have systemic lupus erythematosus - SLE (an inflammatory
disease which can affect many parts of the body, including the
skin, joints and internal organs)
• have itching (pruritus)
• have the rash known as herpes gestationis
• have brown patches on your face and body (chloasma), which
you can reduce by staying out of the sun and not using sunbeds
or sunlamps.

will tell you when to start Rigevidon again. This is usually about
two weeks after you are back on your feet.
Arterial thrombosis
The use of combined pills has been connected with an increase in
the risk of arterial thrombosis (blocking of an artery), for example, in
the blood vessels of the heart (heart attack) or the brain (stroke).
The risk of arterial thrombosis in users of combined pills increases:
• if you smoke. You are strongly advised to stop smoking when you
use Rigevidon, especially if you are older than 35 years
• if you have an increased amount of fat in your blood (cholesterol
or triglycerides)
• if you have high blood pressure
• if you have migraines
• if you have a problem with your heart (valve disorder or a
disturbance of the heart rhythm).
The pill and cancer
Breast cancer has been found slightly more often in women who
take the pill than in women of the same age who do not take the
pill. The risk goes up the longer you are on the pill, but returns to
normal within about 10 years of stopping it. It is not certain
whether the pill causes the increased risk of breast cancer. It may be
that women taking the pill are examined more often, so that breast
cancer is noticed earlier.
Because breast cancer is rare in women under the age of 40, the
extra cases of breast cancer in current and recent Pill users is small.
For example:
• Of 10,000 women who have never taken the Pill, about 16 will
have breast cancer by the time they are 35 years old
• Of 10,000 women who take the Pill for 5 years in their early
twenties, about 17-18 will have breast cancer by the time they are
35 years old
• Of 10,000 women who have never taken the Pill, about 100 will
have breast cancer by the time they are 45 years old
• Of 10,000 women who take the Pill for 5 years in their early
thirties, about 110 will have breast cancer by the time they are 45
years old.
Your risk of breast cancer is higher:
• if you have a close relative (mother, sister or grandmother) who
has had breast cancer
• if you are seriously overweight.
See a doctor as soon as possible if you notice any changes in your
breasts, such as dimpling of the skin, changes in the nipple or any
lumps you can see or feel.
In women using the pill, malignant and benign liver tumours have
been reported. Liver tumours may lead to life-threatening
intra-abdominal haemorrhage (bleeding in the stomach). So, if you
have pain in your upper stomach that does not clear up soon, tell
your doctor.
An increased risk of cervical cancer in long-term users of the pill has
been reported in some studies. It is uncertain whether this increased
risk is caused by the pill as it could be due to the effects of sexual
behaviour and other factors.
Taking other medicines
Please tell your doctor, your dentist or pharmacist if you are taking
or have recently taken any other medicines, including medicines
obtained without a prescription.
Some medicines may stop Rigevidon from working properly.
These medicines are for example:
• primidone, carbamazepine, oxcarbazepine, topiramate,
phenytoin, hydantoins, barbiturates (to treat epilepsy and other
illnesses)
• rifampicin (to treat tuberculosis)
• ritonavir (to treat HIV infections)
• griseofulvin (to treat fungal infections).
If you are taking these medicines for a short term (up to one
week) you should use an additional method of contraception
(such as a condom, diaphragm or foam) whilst you are taking the
other medicinal product and for 28 days afterwards.
• antibiotics (such as ampicillin, tetracycline).
If you are taking any of these antibiotics for a short term (up to
one week), you will also need to use an extra method of
contraception (condoms, diaphragm or foam) while you are
taking the other medicine and for 7 days after you stop taking it.
If these extra precautions overrun the end of the pack, start the next
pack the next day without a break. This means taking a pill every
day during your normal seven pill-free days. If you run two packs
together you may not have a period until the end of two packs. If
you don’t have a period after the second pack, you must talk to
your doctor before you start the next pack.
• herbal remedy commonly known as St John’s wort (hypericum
perforatum).
If you already take or if you want to take St John’s wort
preparation ask your doctor for advice as Rigevidon may not be
suitable for you.
Rigevidon may affect the following medicines:
• medicines used for suppression of tissue rejection following
transplant surgery (e.g. ciclosporin)
• lamotrigine (to treat epilepsy).
Before you have any blood or urine tests, tell your doctor or the
laboratory staff that you are taking the pill, because oral
contraceptives can affect the results of some tests.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any
medicine.

The above conditions may get worse while you are taking the pill;
therefore regular medical check-ups are necessary while you are
on the pill.

You must not use Rigevidon when you are pregnant. If you become
pregnant or you think you might be pregnant, stop taking
Rigevidon and talk to your doctor immediately.

Also tell your doctor before starting to take Rigevidon if you
• are smoking
• are severely overweight (obese)

Rigevidon should not be taken during breast-feeding. If you are
breast-feeding and want to take the pill, you should discuss this
with your doctor.

The pill and thrombosis
Your chances of having a blood clot are only increased slightly by
taking the Pill.
• Of 100,000 women who are not on the Pill and not pregnant,
about 5 will have a blood clot in a year.
• Of 100,000 women taking a Pill such as Rigevidon, about 15 will
have a blood clot in a year.
• Of 100,000 women who are pregnant, around 60 will have a
blood clot in a year.

Driving and using machines
You can drive or operate machinery while taking Rigevidon.

Venous thrombosis
The use of any combined pill, including Rigevidon, increases a
woman’s risk of developing a venous thrombosis (formation of a
blood clot in vessels) compared with a woman who does not take
any contraceptive pill.
The risk of developing a blood clot in users of a combined pill
increases:
• as you get older
• if you are overweight
• if one of your close relatives has had a blood clot (thrombosis)
in the leg, lung, or another organ at a young age
• if you must have an operation (surgery), any prolonged period
of immobilization, or if you have had an serious accident. It is
important to tell your doctor in advance that you are using
Rigevidon as the treatment may have to be stopped. Your doctor

Important information about some of the ingredients of Rigevidon
Rigevidon contains lactose. If you have been told by your doctor
that you have an intolerance to some sugars, contact your doctor
before taking this medicinal product.
If you have been told by your doctor that you have rare hereditary
problems of galactose intolerance, the Lapp lactase deficiency or
glucose-galactose malabsorption, you should not take this
medicinal product.

3. HOW TO TAKE Rigevidon
The daily dosage is one coated tablet.
• You should try to take your pill at about the same time each day.
You may find it easiest to take it either last thing at night or first
thing in the morning.
• Swallow each pill whole, with water if necessary.
Each pack of Rigevidon contains 1 memo strip of 21 coated tablets
or 3 memo strips of 21 coated tablets. The memo pack has been
designed to help you remember to take your pills.
• The pack is marked with the day of the week on which each pill
should be taken.

• Following the direction of the arrow printed on the pack, you
should take one pill each day for 21 days until the strip is empty.
• Then you have 7 days when you do not take a pill. During the 7
pill-free days, on day 2 or 3, you will have menstruation -like
withdrawal bleeding, i.e. your monthly period.
• Start your next strip on the 8th day (following the 7 pill-free
days) – even if the bleeding has not yet ended.
• As long as you take Rigevidon correctly, you will always start each
new strip on the same day of the week, and you will always have
your monthly period on the same day of the month.
Starting the first pack
If no oral contraception has been used during the preceding cycle
• Take the first pill on the first day of your period. This is the day
when bleeding starts. Take a pill marked for that day of the week
(for example, if it is Tuesday when your period starts, take the pill
marked Tuesday on the pack). Follow the direction of the arrow
and continue taking one pill each day until the strip is empty.
• If you start on day 2-5 of your period, you should use another
method of contraception as well, such as the condom, for the first
7 pill-taking days, but this is only for the first pack.
• You do not need to use any other form of contraception during
the 7 day break provided you have taken the 21 pills properly and
you start the next pack on time.
Changing to Rigevidon from another combined hormonal
contraceptive
Start taking Rigevidon on the next day after the end of the previous
contraceptive strip. Do not leave a gap between packs. If your
previous pill strip also contains dummy pills, you should start with
Rigevidon on the day after the last active pill, but no later than on
the day after the usual 7 day gap with your previous pill (or after
taking the last dummy pill of your previous pack). When changing
from a combined contraceptive vaginal ring or patch to the pill,
follow the advice of your doctor.

If you want to delay your period, you should continue the next
pack of Rigevidon, after taking the last pill in the current pack,
without a pill-free interval. You can take as many pills from this
next pack as you want, until the end of the second blister pack.
When you use the second pack, you may have breakthrough
bleeding or spotting. Regular intake of Rigevidon is resumed after
the usual 7 day tablet-free interval.
If you want to shift your period to another day of the week
If you take Rigevidon correctly, you will always have your monthly
period on the same day of the month. If you want to shift your
period to another day of the week, rather than the one you are
used to with the present pill intake, you may shorten (but never
lengthen) the forthcoming pill-free interval by as many days as you
like. For example, if your monthly period usually starts on Friday and
you want it to start on Tuesday (i.e. three days earlier), you should
start the next pack of Rigevidon three days earlier. The shorter the
pill-free interval, the greater the possibility that you will not have a
withdrawal bleeding, and that you may have breakthrough bleeding
or spotting during the second pack.
If you have bleeding between periods
A small number of women may have a little breakthrough bleeding
or spotting while taking Rigevidon, especially during the first few
months. Normally, this bleeding is nothing to worry about, and will
stop in a day or two. Keep taking the pills as usual,
and the problem should disappear after the first few packs. If the
bleeding keeps on returning, is annoying or long-lasting, talk to
your doctor.
If you miss a period
If you have taken all your pills correctly, and you have not had a
stomach upset, or used other medicines, then you are very unlikely
to be pregnant. Continue to take Rigevidon as usual.
If you have missed your period twice in a row, then you might be
pregnant and you should see your doctor immediately. You are only
allowed to continue taking the pill after doing a pregnancy test and
on your doctor’s advice.

If you are unclear or have further questions, ask your doctor or
pharmacist.

If you have any further questions on the use of this product ask
your doctor.

Changing to Rigevidon from a progestogen-only pill (POP or
minipill)
You can stop taking pills only containing progestogen any time, and
start taking Rigevidon the next day at the usual time. But be sure to
use additional prevention (such as condoms) during intercourse in
the first 7 days, during which you take the pills.

4. POSSIBLE SIDE EFFECTS

Changing to Rigevidon from a contraceptive injection or implant
If you have had an injection or implant of the hormone
progestogen, you can start to take Rigevidon on the day that your
next injection is due, or on the day that your implant is removed.
However, you should use another method of contraception (such
as condoms) during intercourse in the first 7 days, during which
you take the pills.
Starting after childbirth, miscarriage or abortion
After a birth, abortion or miscarriage, your doctor should advise you
about taking the pill.
If you have had a miscarriage or an abortion during the first three
months of pregnancy, you can start taking Rigevidon straight away.
In this case you do not need extra contraceptive precautions.
If you have had a delivery or abortion during the second trimester
of pregnancy, your doctor will advise you about taking the pill.
If you take more Rigevidon than you should
It is unlikely that taking more Rigevidon than you should will do you
any harm, but you may have nausea, vomiting or vaginal bleeding.
If you have any of these symptoms, you should talk to your doctor.
If you forget to take Rigevidon
If you forget to take a pill please follow these instructions.
If one pill is 12 hours late or less
You are still protected against pregnancy if you take the late pill as
soon as you remember, and keep taking your next pills at the usual
time. This may mean taking two pills in one day.

Like all medicines, Rigevidon can cause side effects, although not
everybody gets them.
These side effects have been reported in women using the pill,
which can occur in the first few months after starting Rigevidon, but
they usually stop once your body has adjusted to the pill.
The following serious adverse events have been reported in women
using combined oral contraceptives, see Section 2 under “The pill
and thrombosis” and “The pill and cancer”.
• Venous thromboembolism (a blood clot in vessels)
• Arterial thromboembolic disorders (the blocking of an artery)
• Cervical cancer (cancer in the neck of the womb)
STOP taking Rigevidon immediately and tell your doctor if any of
the following symptoms of a blood-clot formation occurs:
• any unusual, severe or long-lasting headache or migraine
• any sudden changes to your eyesight (such as loss of vision,
blurred vision or double vision)
• slurred speech or any other difficulties affecting your speech
• dizziness, fainting or fits
• sudden shortness of breath or difficulty in breathing, sudden
coughing for no apparent reason, bloody spittle
• sudden sharp pains in your chest which may reach your left arm
• unusual pain or swelling in your legs
• sudden weakness or numbness in one side or part of your body
• difficulties in moving around (known as motor disturbances)
• severe pain in your abdomen (known as acute abdomen)
Tell your doctor if
• you can feel a lump in your breast.
The most commonly reported undesirable effects (affects more
than 1 in 10 women) are irregular bleeding, nausea, weight gain,
tender breasts and headache.

If you are more than 12 hours late in taking a pill
If you are more than 12 hours late in taking a pill, your protection
against pregnancy might be reduced so you must use extra
contraceptive precautions. The more pills you have missed, the
greater the risk that your contraceptive protection is reduced.

Common (affects up to 1 in 10 women): Depression, excitability,
acne, no or reduced bleeding, weight gain, fluid retention, changes
in the sexual desire (increased or decreased), nervousness, eye
irritation when wearing contact lenses, sight disturbances and
migraine.

If you have missed more than one pill, ask your doctor for advice.

Uncommon (affects up to 1 in 100 women) and rare (affects up to
1 in 1000 women): Vomiting, brown patches on your face and body
(chloasma), high blood pressure, breast cancer, cervical cancer,
blood clot, enhanced levels of blood fat, impaired hearing
(otosclerosis), gallstones, inflammation of the pancreas, skin
disorders, liver tumours, changes in vaginal secretions or vaginal
thrush, chorea (a movement disease), systemic lupus erythematosus
(SLE, a disease of the connective tissue).

What to do if you miss the pill on the first week
Take the most recently missed pill as soon as you remember, even if
this means that you have to take 2 tablets at the same time (or in
one day). Thereafter, you should continue taking the next pill at the
usual time of the day. You must also use a barrier method of
contraception, e.g. a condom, for the next 7 days. If intercourse has
taken place during the previous 7 days the possibility of pregnancy
must be considered. The more missed tablets and the closer to the
tablet-free interval that this happens, the greater the risk of
pregnancy.

Before you have any blood tests
Tell your doctor or the laboratory staff that you are taking the pill,
because oral contraceptives can affect the results of some tests.

What to do if you miss the pill on the second week
Take the most recently missed pill as soon as you remember, even if
this means that you have to take 2 tablets at the same time (or in
one day). Thereafter, you should continue taking the next pill at the
usual time of the day. Provided that the tablets have been taken in a
correct manner during the 7 days before the missed tablet, it is not
necessary to take further contraceptive measures.
However, if this is not the case, or if more than 1 tablet has been
missed, you should take extra contraceptive precautions for 7 days.

If any of the side effects gets serious, or if you notice any side effects
not listed in this leaflet, please tell your doctor or pharmacist.

What to do if you miss the pill on the third week
The risk of pregnancy is high because of the forthcoming tablet-free
interval. The reduced contraceptive protection may, however, be
prevented by adjusting the tablet intake. Therefore, by following
one of the following two alternatives, it is not necessary to take
further contraceptive precautions, provided that all tablets have
been taken correctly during the 7 days before the first missed tablet.
If you have not taken Rigevidon correctly during the 7 days before
the first missed tablet, you should follow the first of the two
alternatives. Additionally a barrier method (such as a condom)
should be used with the pill for the next 7 days.

Medicines should not be disposed of via wastewater or household
waste. Ask your pharmacist how to dispose of medicines no longer
required. This will help to protect the environment.

1. Take the most recently missed pill as soon as you remember, even
if it means that you have to take 2 tablets at the same time (or in
one day). Thereafter, you should continue taking the next pill at
the usual time of the day. You should then start the next pack
immediately, i.e. without a tablet-free interval between the packs.
Withdrawal bleeding is unlikely until the end of the second pack,
but there may be some spotting, or breakthrough bleeding, on
the days you are taking the pill.
2. You may also stop taking tablets from the current pack. In that
case, you should keep a period without tablets of up to 7 days,
including those days when you forgot to take your tablets, and
thereafter continue with the next pack.
If you have missed tablets and then do not get withdrawal bleeding
in the first normal tablet-free interval, the possibility of pregnancy
must be considered.
If you want to stop taking Rigevidon
You can stop taking Rigevidon at any time. If you stop taking
Rigevidon to have a baby, use another method of contraception
until you have had a proper period. In this case, it will be easier for
your doctor to tell you when your baby will be born.
What to do if you have a stomach upset
If you have been sick or had diarrhoea within 3-4 hours after taking
the pill, your body may not get its usual dose of hormones from
that pill. In this case the advice concerning missed pills, described
above should be followed. In case of vomiting or diarrhoea, use
extra contraceptive precautions, such as a condom, for any
intercourse during the stomach upset and for the next seven days.
What to do if you want to delay or to shift your period
If you want to delay or to shift your period, you should contact your
doctor for advice.

5. HOW TO STORE Rigevidon
Do not use Rigevidon after the expiry date which is stated on the
package. The expiry date refers to the last day of the month.
Store below 25°C.
Keep out of the reach and sight of children.

6. FURTHER INFORMATION
What Rigevidon contains
The active substances are ethinylestradiol and levonorgestrel.
One coated tablet contains 30 micrograms ethinylestradiol and
150 micrograms levonorgestrel.
The other ingredients are:
Colloidal anhydrous silica, magnesium stearate, talc, maize starch,
lactose monohydrate (33 mg), sucrose, calcium carbonate, titanium
dioxide (E171), copovidone, macrogol 6000 and povidone
carmellose sodium.
What Rigevidon looks like and contents of the pack
White, biconvex, circular coated tablets.
Each box contains 1, 3, 6 or 13 calendar pack(s) of 21 coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Gedeon Richter Plc., Gyömr� i út 19-21, 1103 Budapest, Hungary
o
Distributed by
Consilient Health (UK) Ltd., 500 Chiswick High Road, London,
W4 5RG
Manufacturer
Gedeon Richter Plc., Gyömr� i út 19-21, 1103 Budapest, Hungary
o
This medicinal product is authorised in the Member States of the
EEA under the following names:
Rigevidon coated tablet: Austria, Denmark, Ireland, Luxembourg,
Portugal, Spain and United Kingdom
Nora 30 coated tablet: Belgium
Laurenza 30 mikrogramm/150 mikrogramm überzogene tabletten:
Germany
Ethinylestradiol/levonorgestrel Richter 0.03 mg/0.15 mg, omhulde
tabletten: The Netherlands
Levodiol 30 mikrogram/150 mikrogram tabletter, drasjerte: Norway
This leaflet was last revised in December 2012.

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
(web5)