2.
BEFORE YOU TAKE COPEGUS
Copegus is
not suitable for everyone.
Please take special note of the
advice regarding taking Copegus during pregnancy below.
Do not take Copegus if the answer to
any of the following questions is "YES". If you are not
sure, ask your doctor:
- Have
you ever had an allergic reaction to ribavirin or to
any of the other ingredients of Copegus?
- Are
you pregnant, or do you think you may be pregnant?
Women of childbearing age must have a negative
pregnancy test before starting to take Copegus, even
if they are using a reliable method of birth
control. It is also very important that pregnancy is
avoided for 6 months after finishing Copegus
treatment. More advice is given below.
Men and women who are to
take Copegus should read this carefully.
- Are
you breast-feeding? You can still take Copegus but
you must not breast-feed your baby while you are
taking the medicine.
- Do
you have a serious heart disorder, or have you had a
serious heart disorder in the previous 6 months?
- Do
you already have serious problems with your liver so
that it does not work properly? People who already
have badly damaged livers (due to hepatitis C or due
to other causes) are usually unsuitable for Copegus
plus interferon alfa-2a or peginterferon alfa-2a
treatment.
- Do
you have or have you ever been told that you have a
blood disorder caused by an unusual type of
haemoglobin (the red pigment in your blood). These
conditions include sickle cell anaemias and
thalassaemias and these often run in families.
Take special care with Copegus:
Copegus
may not be suitable for you if the answer to any of
the following questions is "YES". In some cases,
your doctor may decide not to give you Copegus. In
other cases, you may be given a lower dose of
Copegus. Your doctor will advise you if Copegus is
right for you.
-
Do you have any other sort of heart problem?
People with serious problems should not have
Copegus (see above) but those with less severe
problems may be given it sometimes. If so, your
doctor will monitor you carefully. Also, if you
have any history of disturbances with the rhythm
of your heart, your doctor will usually take an
ECG before you start treatment. If you get a new
heart problem or if your heart problem gets
worse while you are taking Copegus, this may be
because Copegus sometimes causes a drop in the
number of red blood cells so causing anaemia.
Your blood will be checked regularly while you
are taking Copegus. In addition, you should tell
your doctor if you notice that you are pale, or
start feeling weak or tired.
-
Do you have a problem with your kidneys or are
you on dialysis? Your doctor may decide Copegus
is not suitable and treatment may be stopped or
the dose may be reduced (see section 3 of this
leaflet).
-
Do you have or have you ever had gout? If you
have had gout and even if you are on treatment
for gout, taking Copegus can cause a flare up of
the problem. You can still start to take Copegus
but your doctor will monitor you closely during
treatment. If you notice symptoms of gout during
treatment, you should tell your doctor
immediately.
-
Do you have or have you had a severe nervous or
mental disorder? Your doctor will assess the
suitability of treatment of Copegus. If
prescribed your doctor will monitor you closely
during treatment.
-
Have you ever had depression or developed
symptoms associated with depression (eg feeling
of sadness, dejection etc) whilst taking Copegus?
If you notice symptoms of depression you should
tell your doctor immediately.
Other important information
before taking Copegus:
-
Copegus in combination with interferon alfa-2a
or peginterferon alfa-2a is not recommended to
be used in children or teenagers (anyone below
18 years of age) because studies to see how this
medicine works and its safe use in these
patients have not been done.
-
Before you start treatment, your doctor will
perform blood tests that will measure the
numbers of blood cells and the amounts of
different chemicals in your blood. These tests
will be repeated after 2 and 4 weeks of
treatment and after that as frequently as the
doctor thinks it is necessary.
Pregnancy
It is extremely important that
both men and women of child-bearing age who are
taking Copegus make sure that they and their sexual
partners use a total of two effective forms of birth
control simultaneously during treatment with Copegus
and for six months after stopping treatment.
If you need advice on contraception, ask your doctor
before you start to take Copegus.
Women
Copegus must not be given to
pregnant women because it is possible that this
could lead to the loss of the baby or to the birth
of a malformed baby or to problems in the baby after
birth. If you know that you are, or think
that you may be already pregnant before starting to
take Copegus, you must tell your doctor before you
start taking the tablets. Even if you do not think
you are pregnant and you are using a reliable method
of birth control, your doctor will make sure that
you have a negative pregnancy test before you start
the treatment. A pregnancy test must be performed
before therapy is started. Pregnancy tests will be
repeated every month while you are taking Copegus
and for six months after stopping treatment. If you
should accidentally become pregnant while you are
taking Copegus, your doctor will discuss the risks
with you and advise you.
Men
Ribavirin (the active ingredient in Copegus tablets)
can enter the sperm. It is important that sperm that
contains ribavirin is not allowed to start a
pregnancy and that ribavirin is not allowed to reach
an unborn child.
The
female partners of men who are taking Copegus must
have a negative pregnancy test before the man starts
to take Copegus and should have monthly pregnancy
tests while the man is taking Copegus and for six
months after stopping treatment.
Men who
are taking Copegus and whose partners are already
pregnant MUST use a condom while taking Copegus so
as to prevent ribavirin from reaching the unborn
baby. Men should continue to use condoms for up to 6
months after treatment has finished if their partner
is still pregnant.
Breast-feeding
Copegus
must not be used if you are breast-feeding. The
active ingredient, ribavirin, may pass into the milk
and harm your baby.
Driving and using machines:
Copegus
does not affect your ability to drive or use
machines. However interferon alfa-2a or
peginterferon alfa-2a can cause sleepiness,
tiredness and confusion. Do not drive or operate any
tools or machines if you develop any of these
symptoms.
Taking other medicines:
Please
inform your doctor or pharmacist if you are taking
or have recently taken any other medicines, even
those not prescribed.
If you
take zidovudine or stavudine, because you are HIV
positive or suffering from AIDS, it is possible that
Copegus will decrease the effect of these medicines.
Therefore your blood will be checked regularly to be
sure the HIV infection is not getting worse. If it
gets worse your doctor may decide to discontinue
your treatment with Copegus.
Co-administration of Copegus and didanosine is not
recommended. If you do take Copegus together with
didanosine certain side effects of didanosine may
occur more often (such as changes in sensation or in
ability to move and inflammation of the pancreas;
reports of liver failure leading to death have been
reported). It is also possible that people who are
taking a number of different medicines (whether or
not these include didanosine) for HIV infection
could be at higher risk of these side effects, and
also at higher risk of developing a serious
condition called lactic acidosis, while taking
Copegus.
3. HOW
TO TAKE COPEGUS
Your doctor
will instruct you on how many tablets per day you should
take and at what time of the day. The dose that you are
asked to take may be changed during your course of
treatment depending on the results of the blood tests
that will be done (see below).
It is very important that you follow
these instructions exactly at all times. If you are not
sure about anything, always ask your doctor.
The usual
dose of Copegus for HCV patients is 800, 1000 or
1200mg/day:
-
Patients taking 800mg/day: 2 tablets in the morning
and 2 tablets in the evening
-
Patients taking 1000mg/day: 2 tablets in the morning
and 3 tablets in the evening
-
Patients taking 1200mg/day: 3 tablets in the morning
and 3 tablets in the evening
Treatment is
usually given for at least six months and may be
continued for one year. How long your treatment lasts
can depend on whether you have been treated with
interferon or peginterferon before for hepatitis C
infection, the type of hepatitis C virus that you have,
and other things like your age, sex and the condition of
your liver before you start the treatment. Your doctor
will advise you on how long your treatment should last.
The
recommended dosage of Copegus in HIV/HCV co-infected
patients is 800mg once a day for 48 weeks.
The dose is
the same for people over 65 years unless they have very
poor kidneys.
Copegus is
not suitable for people less than 18 years old because
it is not known what dose is safe and effective.
The tablets
should be taken together with food and should be
swallowed whole.
The tablets
should be handled with care and
should not be broken or crushed. If you have been
accidentally in touch with damaged tablets, wash all
areas that have been in contact with the content of the
tablet thoroughly with soap and water. If any powder
from the tablets gets in your eyes, rinse your eyes
thoroughly with sterile water, or plain water if sterile
water is not available.
If you
experience side effects during treatment, your doctor
will give you a lower daily dose of Copegus or may tell
you to stop taking Copegus for a while or permanently
stop the treatment. Most changes in dose are because of
low numbers of red blood cells.
A lower
daily dose is also necessary for people who have poor
kidneys before they start taking Copegus or whose
kidneys do not work so well as usual during treatment.
Sometimes Copegus has to be stopped because of poor
kidneys. People with very poor kidneys or who need
dialysis treatments are not usually given Copegus
because it is not known what dose is safe and effective.
The dose of
Copegus may be lowered or Copegus may have to be stopped
if your liver stops working as well as usual while you
are taking the treatment.
If
you take more Copegus than you should:
If you
have or think you may have taken too many tablets,
you should seek medical help immediately. Your
doctor will treat you if necessary.
If
you forget to take Copegus:
If you
miss a dose, take it as soon as you remember and
take the next dose at the normal time. Do not take a
double dose of Copegus to make up for forgotten
doses.
If someone else
takes your Copegus tablets by mistake ,
they should get urgent medical attention and advice.
Make sure that they take the bottle with them to the
doctor or hospital so that it is clear what they have
taken.
4.
POSSIBLE SIDE EFFECTS
Like all
medicines, Copegus can have side effects.
The most common side effects
(more than 10% of patients) that have been reported
during treatment with Copegus in combination with
interferon alfa-2a or peginterferon alfa-2a are:
A decrease
in the number of red blood cells (anaemia).
Loss of
appetite, insomnia (sleeplessness), irritability,
depression, dizziness, loss of concentration, headache.
Shortness of
breath, cough.
Feeling
sick, diarrhoea, stomach ache.
Hair loss,
itching, inflammation of the skin, dry skin.
Joint pain,
muscle pain.
Tiredness,
fever, shaking with chills, weakness, pains, and
reactions at the interferon injection sites.
The other common side effects
(between 5% and 10% of patients) that have been reported
during treatment with Copegus in combination with
interferon alfa-2a or peginterferon alfa-2a are:
Weight loss.
Poor memory,
emotional disorders, mood changes, anxiety.
Being sick,
dry mouth, heart burn.
Rash,
increased sweating.
Back pain.
The less common side effects
(between 1% and 5% of patients) that have been reported
during treatment with Copegus in combination with
interferon alfa-2a or peginterferon alfa-2a are:
A flare up
of cold sores on the lips and face, nose and throat
infections, bronchitis, fungal infections in the mouth.
Swelling of
the glands, decreases in the number of blood cells
called platelets giving easy bruising or bleeding.
Increase or decrease in activity of the thyroid gland.
Taste
disturbance, tingling sensation, increased or diminished
sense of touch, tremor, aggression, reduced sex drive,
migraine, sleepiness, nightmares, light-headedness and
fainting.
Blurred
vision, dryness of the eyes, inflammation of the eyes
and eye pain.
Vertigo,
earache. Irregular or increased heart rhythm.
Generalised swelling (water retention).
Sore throat,
runny nose, inflammation of the nose and throat, blocked
nose or sinuses, shortness of breath on exercise, nose
bleeds.
Excessive
wind, mouth ulceration or inflammation, bleeding of the
gums, inflammation of the tongue, difficulty in
swallowing.
Skin
disorders, inflammation and itchiness of the skin that
may include blistering (eczema), itchy and/or flakey
skin (psoriasis), swelling of the skin and flesh under
the skin that may also affect the face and neck, unusual
skin reactions to sunlight, night sweats.
Bone pain,
neck pain, muscle cramps, arthritis, muscle weakness,
impotence.
Flu-like
illness, generally feeling unwell or listless, hot
flushes, thirst and chest pain.
The uncommon (less than 1% of
patients) and rare (less than 0.1% of patients) side
effects that have been reported include:
Lung
infections (including lower respiratory tract
infections), wheezing skin infections, infections of the
outer ear, inflammation of the lining of the heart and
heart valves, liver cancer, rheumatoid arthritis,
swelling of neck and face (angioedema), and anaphylaxis.
Sarcoidosis
(a disease that results from inflammation of tissues of
the body) has been rarely reported. Sarcoidosis can
affect almost any body organ, but most often starts in
the lungs or lymph nodes.
If you
experience an allergic reaction (skin redness, itching)
please stop your therapy immediately and contact your
doctor as soon as possible. You should tell your doctor
straight away if you become short of breath or get a
swollen face. These reactions are rare but need urgent
medical treatment.
A condition
known as systemic lupus erythematosus, may occur, the
first sign may be a rash or generalised inflammation but
it may also be noticed as fever, pain in the joints and
general ill health.
Inflammation
of the thyroid gland.
A decrease
in platelets often with a purple rash (purpura).
Suicide
attempts (including taking an overdose) and anger. In
some cases people had suicidal thoughts or aggressive
behaviour. Some patients have actually committed
suicide. Be sure to seek emergency care if you notice
that you are becoming depressed or have suicidal
thoughts or change in your behaviour. You may want to
consider asking a family member or close friend to help
you stay alert to signs of depression or change in your
behaviour.
Numbness or
weakness in some areas of the body, coma, eye
ulceration/irritation and vision loss.
Inflammation
of the coverings of the heart with chest pain, bleeding
in the brain, inflammation of the linings of the lungs,
blood clots in the lungs, stomach ulcer, bleeding from
the stomach or gut, disturbance of the pancreas,
diabetes, poor working of the liver and liver failure,
fat laid down in the liver, inflammation of the gall
bladder and bile tubes, inflammation of muscles, and
gout, increased heart rate, palpitations, raised blood
pressure, chest pain, heart attack and heart failure.
During
treatment, there may be changes in the results of some
laboratory tests (including those mentioned above) that
may or may not be severe enough to give you any
symptoms. Very rarely there have been reports of
reduction in some blood parameters (red blood cells,
white blood cells and platelets) when used in
combination with peginterferon alfa-2a. Your doctor will
monitor these changes to make sure that they do not get
worse and may advise you to change the dose of Copegus
for a while. Very occasionally, it is necessary to stop
treatment for a while or even permanently.
Tumours have
been found in animals that have been given ribavirin. It
is not known for sure if there is any risk in man at the
doses of ribavirin and with the length of treatment that
is necessary to treat hepatitis C infections.
If you notice any side effects not
mentioned in this leaflet, please inform your doctor or
pharmacist.
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