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COPEGUS 400MG FILM COATED TABLETS

Active substance(s): RIBAVIRIN

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Package leaflet: Information for the patient

Copegus® 400 mg
film-coated tablets
Ribavirin
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 or pharmacist.
- 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 or pharmacist. This includes any
possible side effects not listed in this leaflet.
See section 4.
What is in this leaflet:
1. What Copegus is and what it is used for
2. What you need to know before you take
Copegus
3. How to take Copegus
4. Possible side effects
5. How to store Copegus
6. Contents of the pack and other information

1. What Copegus is and what it is
used for
Ribavirin, which is the antiviral active substance
of Copegus, inhibits the multiplication of
many types of viruses, including the hepatitis
C viruses (which can cause an infection of the
liver called hepatitis C).
Copegus is used in combination with other
medicines to treat certain chronic forms of
hepatitis C.
Copegus should only be used in combination
with other medicines to treat hepatitis C.
It should not be taken alone.
Refer also to the package leaflets of the other
medicines that are used in combination with
Copegus.

2. What you need to know before
you take Copegus
Do not take Copegus:
- if you are allergic to ribavirin or to any of
the other ingredients of this medicine (listed
in section 6).
- if you are pregnant or breast-feeding (see
section “Pregnancy and breast-feeding”).
- if you have had a heart attack or have
suffered from any other severe heart disease
in the previous six months.
- if you have a blood disorder such as sickle
cell anaemia or thalassaemia (weakening
and destruction of red blood cells).
Refer also to the package leaflets of the other
medicines that are used in combination with
Copegus.
Do not take Copegus in combination with
medicines called interferons or pegylated
interferons if you have advanced liver disease
(e.g. your skin has become yellow and you
have excess fluid in your abdomen).
Warnings and precautions
Talk to your doctor before taking Copegus
● if you are a woman of
child-bearing age (see
section “Pregnancy and
breast-feeding”).
● if you are a man and
your female partner is
of childbearing age (see
section “Pregnancy and
breast-feeding”).
● if you have a heart problem. In this case you
will need to be monitored carefully. A heart
recording (ECG or electrocardiogram) is
recommended prior to and during treatment.
● if you develop a heart problem along with
intense fatigue. This may be due to anaemia
caused by Copegus.
● if you have ever had anaemia (the risk of
developing anaemia is higher in women
compared to men, in general).
● if you have a problem with your kidneys.
Copegus treatment may need to be decreased.
● if you have had an organ transplant (such as
liver or kidney) or have one planned in the
near future.
● if you develop symptoms of an allergic reaction
such as difficulty in breathing, wheezing,
sudden swelling of the skin and mucous
membranes, itching or rashes. Copegus
treatment must be stopped immediately and
you should seek medical help immediately.
● if you have ever had depression or develop
symptoms associated with depression (e.g.
feelings of sadness, dejection, etc) while on
treatment with Copegus (see section 4).
● if you are an adult who has or had a history
of substance abuse (e.g. alcohol or drugs).
● if you are under the age of 18.. The efficacy
and safety of Copegus in combination with
peginterferon alfa-2a or interferon alfa-2a
have not been sufficiently evaluated in
patients under the age of 18 years.
● if you are co-infected with HIV and are being
treated with any anti HIV medicinal products.
● if you have been withdrawn from previous
therapy for hepatitis C because of anaemia
or low blood count.
Before treatment with Copegus, kidney
function must be tested in all patients. Your
doctor must also test your blood before
starting treatment with Copegus. The blood
tests should be repeated after 2 and 4 weeks of
treatment, and thereafter as frequently as your
doctor thinks is necessary.
If you are a woman of childbearing age, you must
have a pregnancy test before starting treatment
with Copegus, every month during treatment
and during the 4 months after treatment (see
section “Pregnancy and breast-feeding”).
The following severe side effects are associated
in particular with Copegus use in combination
with interferon alfa-2a or peginterferon
alfa-2a, please refer to the package leaflet of
these medicinal products for more detailed
information on these safety issues:
● Psychiatric and central nervous system
effects (such as depression, suicidal
thoughts, attempted suicide and aggressive
behavior, etc.). 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 changes in your behaviour
● Severe ocular disorder
● Dental and periodontal disorders: Dental
and gum disorders have been reported in
patients receiving Copegus and peginterferon
alfa-2a combination therapy. You should
brush your teeth thoroughly twice daily and
have regular dental examinations. In
addition some patients may experience
vomiting. If you have this reaction, be sure
to rinse your mouth thoroughly afterwards
● Growth inhibition in children and adolescents
that may be irreversible in some patients
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Other medicines and Copegus
Tell your doctor or pharmacist if you are
taking, have recently taken or might take any
other medicines.
Patients who also have HIV infection: Tell
your doctor if you are being treated for HIV.
Lactic acidosis (a build up of lactic acid in the
body, leading to the blood becoming acidic) and
worsening liver function are side effects associated
with HAART (Highly Active Anti-Retroviral
Therapy), an HIV treatment regimen. If you
are receiving HAART, the addition of Copegus
to peginterferon alfa-2a or interferon alfa-2a
may increase your risk of lactic acidosis or
liver failure. Your doctor will monitor you for
signs and symptoms of these conditions.
If you take zidovudine or stavudine, because
you are HIV positive or suffering from AIDS it
is possible that Copegus can decrease the
effect of these medicines. Therefore your
blood will be checked regularly to make sure
the HIV infection is not getting worse. If it
does get worse, your doctor may decide to stop
your treatment with Copegus. In addition,
patients receiving zidovudine in combination
with Copegus and alfa interferons are at
increased risk of developing anaemia.
Co-administration of Copegus and didanosine,
(which is a treatment for HIV) is not
recommended. Certain side effects of
didanosine (e.g. liver problems, tingling and
painful arms and /or feet, pancreatitis) may
occur more frequently.
Patients receiving azathioprine in combination
with Copegus and peginterferon are at increased
risk of developing severe blood disorders.
Refer also to the package leaflets of the other
medicines that are used in combination with
Copegus.
Ribavirin may remain in your body for up to
2 months, therefore you should check with
your doctor or pharmacist before starting
treatment with any of the other medicines
mentioned in this leaflet.
Copegus with food and drink
Copegus film-coated tablets are normally
taken at two times in the day with food
(morning and evening) and should be
swallowed whole.
Pregnancy and breast-feeding
If you are pregnant or breast feeding, think
you may be pregnant or are planning to have a
baby, ask your doctor or pharmacist for advice
before taking this medicine.
Copegus can be very harmful to the unborn
child; it may cause birth defects. Therefore,
if you are a female patient, it is very
important to avoid becoming pregnant during
treatment and during the 4 months after
treatment. Copegus can damage the sperm and
so harm the embryo (unborn child). Therefore,
if you are a male patient, it is very important
for your female partner to avoid becoming
pregnant during your treatment and during the
7 months after treatment.
If you are a woman of childbearing age who is
taking Copegus, you must have a negative
pregnancy test before treatment, each month
during therapy and for the
4 months after treatment is
stopped. You must use an
effective contraceptive
during the time you are
taking the treatment and
for 4 months after stopping treatment. This can
be discussed with your doctor. If your male
partner is being treated with Copegus, please
see the section “If you are a man”.
If you are a man who is taking Copegus,
do not have sex with a pregnant woman unless
you use a condom. This will lessen the chance
for ribavirin to be left in the woman’s body.
If your female partner is not pregnant now but
is of childbearing age, she must be tested for
pregnancy each month during treatment and
for the 7 months after treatment has stopped.
You or your partner must use an effective
contraceptive during the time you are taking
the treatment and for 7 months after stopping
treatment. This can be discussed with your
doctor. Please see “if you are a woman” if
your female partner is treated with Copegus
If you are pregnant or breast feeding, think
you may be pregnant or are planning to have a
baby, ask your doctor or pharmacist for advice
before taking this medicine.
It is not known whether Copegus is excreted in
human milk. Women should not breast-feed
while taking Copegus as this may harm the
baby. If treatment with Copegus is necessary,
breast-feeding should be stopped.
Refer also to the package leaflets of the other
medicines that are used in combination with
Copegus for the treatment of hepatitis C.
Driving and using machines
Copegus has very little effect on your ability
to drive or use machines.
However, the other medicines you take with
Copegus may have an effect. Check the
package leaflets of the other medicines you are
using in combination with Copegus.

3. How to take Copegus
Always take this medicine exactly as your
doctor has told you. Check with your doctor or
pharmacist if you are not sure. Your doctor
will decide the correct dose for you depending
on your body weight, type of virus, and the
medicine you take in combination with Copegus.
The recommended dose ranges between
800mg to 1400 mg/day depending on the other
medicines you are using in combination with
Copegus.
- 800 mg/day: Take 1 Copegus 400 mg tablet
in the morning and 1 tablet in the evening
- 1000 mg/day: Patients are advised to take
Copegus 200 mg tablets
- 1200 mg/day: Patients are advised to take
Copegus 200 mg tablets
- 1400 mg/day: Patients are advised to take
Copegus 200 mg tablets
In the case of combination therapy with other
medicines, please follow the dosing regimen
recommended by your doctor and refer also to
the package leaflets of the other medicines.
Swallow the tablets whole and take the tablets
with food.
As ribavirin is teratogenic (may cause
abnormalities in the unborn child), the tablets
should be handled with care and should not
be broken or crushed. If you accidentally
touch damaged tablets, wash thoroughly with
soap and water any part of your body which
came in contact with the contents of the tablet.
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.
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The amount of time you have to continue
taking Copegus film-coated tablets varies,
depending on, the type of virus you are
infected with, which other medicine you are
being treated with, on treatment response and
whether you have been treated before. Please
check with your doctor and follow the
recommended duration of treatment.
If you are over the age of 65 you should
consult your doctor before using Copegus.
If you have the impression that the effect of
Copegus is too strong or too weak, talk to your
doctor or pharmacist.
If side-effects occur during treatment, your
doctor may adapt the dose or stop treatment.
Refer also to the package leaflets of the other
medicines that are used in combination with
Copegus.
If you take more Copegus than you should
Contact your doctor or pharmacist as soon as
possible.
If you forget to take Copegus
Do not take a double dose to make up for a
forgotten dose.
If you miss a dose, take it as soon as you remember
and take the next dose at the normal time.
If you stop taking Copegus
Only your doctor can decide when your treatment
should be discontinued. Never stop the treatment
yourself because the disease, for which you
are being treated, can come back or get worse.
If you have any further questions on the use of
this medicine, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, this medicine can cause
side effects, although not everybody gets them.
Reporting of side effects
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 effects directly (see below). By
reporting side effects you can help provide
more information on the safety of this medicine.
United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
During treatment, your doctor will take blood
samples regularly to check for changes in your
white blood cells (cells that fight infection),
red blood cells (cells that carry oxygen),
platelets (blood clotting cells), liver function
or changes in other laboratory values.
Refer also to the package leaflets of the other
medicines that are used in combination with
Copegus for information on the side effects for
those products.
The side effects listed in this section were
observed primarily when Copegus was used in
combination with interferon alfa-2a or
peginterferon alfa-2a.
Tell your doctor immediately if you notice any
of the following side effects occur: severe
chest pain; persistent cough; irregular
heartbeat; trouble breathing; confusion;
depression; severe stomach pain; blood in
stools (or black, tarry stools); severe
nosebleed; fever or chills; problems with your
eyesight. These side effects can be serious and
you may need urgent medical attention.
Very common side effects with the combination
of pegylated alfa interferon and ribavirin (may
affect more than 1 in 10 people) are:
Blood disorders: Anaemia
(low red cell count),
neutropenia (low white
blood cell count)
Metabolic disorders: Loss
of appetite
Psychiatric disorders:
Feeling depressed (feeling
low, feeling bad about yourself or feeling
hopeless), inability to sleep
Nervous system disorders: Headache,
difficulty concentrating and dizziness
Respiratory disorders: Cough, shortness of breath
Gastrointestinal disorders: Diarrhoea, nausea,
abdominal pain
Skin disorders: Loss of hair, and skin reactions
(including itching, dermatitis and dry skin)
Musculoskeletal disorders: Pain in joints and
muscles
General disorders: Fever, weakness, tiredness,
shaking, chills, pain, and irritability (getting
easily upset)
Common side effects with the combination of
pegylated alfa interferon and ribavirin (may
affect up to 1 in 10 people):
Infections: Upper respiratory infection,
bronchitis, fungal infection of the mouth and
herpes (a common recurring viral infection
affecting the lips, mouth)
Blood disorders: Low platelet count (affecting
the clotting ability) and enlarged lymph glands
Endocrine disorders: Overactive and
underactive thyroid gland
Psychiatric disorders: Mood /emotion changes,
anxiety, aggression, nervousness, decreased
sexual desire
Nervous system disorders: Poor memory,
fainting, decreased muscle strength, migraine,
numbness, tingling, burning sensation, tremor,
changes in the sense of taste, nightmares,
sleepiness
Eye Disorders: Blurry vision, eye pain, eye
inflammation and dry eyes
Ear disorders: Sensation of room spinning, ear
pain, ringing in ears
Cardiac disorders: Rapid heart rate, pulsation
of the heart beats, swelling in the extremities
Vascular disorders: Flushing, low blood pressure
Respiratory disorders: Shortness of breath with
activity, nose bleeds, nose and throat
inflammation, infections of the nose and
sinuses (air-filled spaces found in the bones of
the head and face), runny nose, sore throat
Gastrointestinal disorders: Vomiting,
indigestion, difficulty swallowing, mouth
ulceration, bleeding gums, inflammation of
tongue and mouth, flatulence (excess amount
of air or gases), constipation, dry mouth
Skin disorders: Rash, increased sweating,
psoriasis, hives, eczema, sensitivity to
sunlight, night sweats
Musculoskeletal disorders: Back pain, joint
inflammation, muscle weakness, bone pain,
neck pain, muscle pain, muscle cramps
Reproductive system disorders: Impotence
(inability to maintain an erection)
General disorders: Chest pain, flu-like illness,
malaise (not feeling well), lethargy, hot
flushes, thirst, weight decreased
Uncommon side effects with the combination
of pegylated alfa interferon and ribavirin (may
affect up to 1 in 100 people):
Infections: Lower respiratory tract infections,
urinary tract infection, skin infections
Immune disorders: Sarcoidosis (areas of
inflamed tissue occurring throughout the
body), inflammation of the thyroid
Endocrine disorders: Diabetes (high blood sugar)
Metabolic disorders: Dehydration
Psychiatric disorders: Thoughts of suicide,
hallucinations (abnormal perceptions), anger
Nervous system disorder: Peripheral
neuropathy (disorder of the nerves affecting
the extremities)
Eye disorder: Bleeding in the retina (back of
the eye)
Ear and labyrinth disorders: Hearing loss
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Vascular disorder: High blood pressure
Respiratory disorder: Wheezing
Gastrointestinal disorders: Gastrointestinal
bleeding, inflammation of the lips,
inflammation of the gums
Liver disorders: Poor functioning of the liver
Rare side effects with the combination of
pegylated alfa interferon and ribavirin (may
affect up to 1 in 1000 people):
Infections: Infection of the heart, infection of
the external ear
Blood disorders: Severe reduction in red blood
cells, white blood cells and platelets
Immune system disorders: Severe allergic
reaction, systemic lupus erythematosus (an
illness where the body attacks its own cells),
rheumatoid arthritis (an autoimmune disease)
Psychiatric disorders: Suicide, psychotic
disorders (severe problems with personality
and deterioration in normal social functioning)
Nervous system disorders: Coma (a deep
prolonged unconsciousness), seizures, facial palsy
Eye disorders: Inflammation and swelling of
the optic nerve, inflammation of the retina,
ulceration of the cornea
Cardiac disorders: Heart attack, heart failure,
heart pain, rapid heart rhythm, rhythm disorders
or inflammation of the lining of the heart
Vascular disorders: Bleeding in the brain,
vasculitis (inflammation of the blood vessels)
Respiratory disorders: Interstitial pneumonia
(inflammation of the lungs with fatal
outcome), blood clots in the lung
Gastrointestinal disorders: Stomach ulcer,
inflammation of the pancreas
Liver disorders: Liver failure, bile duct
inflammation, fatty liver
Musculoskeletal disorders: Inflammation of
the muscles
Injury or poisoning: Substance overdose
Very rare side effects with the combination of
pegylated alfa interferon and ribavirin (may
affect up to 1 in 10,000 people):
Blood disorders: Aplastic anaemia (failure of
the bone marrow to produce red blood cells,
white blood cells and platelets)
Immune System disorders: Idiopathic (or
thrombotic) thrombocytopenic purpura
(increased bruising, bleeding, decreased
platelets, anaemia and extreme weakness)
Eye disorders: Loss of vision
Nervous System Disorders: Stroke
Skin disorders: Toxic epidermal necrolysis/
Stevens Johnson Syndrome/ erythema
multiforme (a spectrum of rashes with varying
degrees of severity which may be associated
with blisters in the mouth, nose, eyes and other
mucosal membranes), angioedema (swelling in
the skin and mucosa)
Side effects with unknown frequency:
Blood disorders: Pure red cell aplasia (a severe
form of anaemia where red blood cell production
is decreased or stopped); it can result in symptoms
such as feeling very tired with no energy
Immune System disorders: liver and kidney
transplant rejections, Vogt Koyanagi Harada
Syndrome – a rare disease characterised by
loss of vision, hearing, and skin pigmentation
Psychiatric disorders: mania (episodes of
exaggerated elevation of mood) and bipolar
disorders (episodes of exaggerated elevation of
mood alternating with sadness or hopelessness)
Eye disorders: Rare form of retinal detachment
with fluid in the retina
Digestive system disorders: Ischemic colitis
(insufficient blood supply to the bowels),
ulcerative colitis (inflammation of the large
intestine that causes ulcers, resulting in
diarrhoea), change in colour of the tongue
Musculoskeletal disorders:
Serious muscle damage
and pain
Renal disorders: kidneys
stop functioning
adequately, other
complaints that suggest
kidney problems
If you are infected with both viruses, HCV and
HIV, and are receiving HAART (Highly Active
Anti-Retroviral Therapy), the addition of Copegus
to peginterferon alfa-2a or interferon alfa-2a
therapy may cause fatal liver failure, peripheral
neuropathy (numbness, tingling or pain in hands or
feet), pancreatitis (symptoms may include stomach
pain, nausea and vomiting), lactic acidosis (a build
up of lactic acid in the body, leading to the blood
becoming acidic), influenza, pneumonia, affect
lability (alterations in mood), apathy (lethargy),
pharyngolaryngeal pain (pain in the back of your
mouth and throat), cheilitis (dry and cracked lips),
acquired lipodystrophy (increased amount of fat in
upper back and neck) and chromaturia (change
in colour of your urine) as side effects.
If you get any side effects, talk to your doctor
or pharmacist. This includes any possible side
effects not listed in this leaflet.

5. How to store Copegus
Keep this medicine out of the sight and reach
of children.
Do not use this medicine after the expiry date
which is stated on the label. The expiry date
refers to the last day of that month.
This medicinal product does not require any
special storage conditions.
Do not use this medicine if you notice the
bottle or packaging is damaged.
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 Copegus contains
- Each film-coated tablet contains 400 mg of
ribavirin.
- The other ingredients are
Tablet core: pregelatinised maize starch,
sodium starch glycolate (type A),
microcrystalline cellulose, maize starch,
magnesium stearate
Film coating: hypromellose, talc, titanium
dioxide (E171) yellow iron oxide (E172),
red iron oxide (E172), triacetin.
What Copegus looks like and contents of
the pack
The tablets are reddish brown, flat oval-shaped
film-coated tablets (marked with RIB 400 on
one side and ROCHE on the opposite side).
Copegus 400 mg film-coated tablets are available
in bottles containing 14 and 56 tablets. Not all
sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer
Roche Products Limited
6 Falcon Way
Shire Park
Welwyn Garden City
AL7 1TW
United Kingdom
Manufacturer
Roche Pharma AG
Emil-Barell-Str.1
D-79639 Grenzach-Wyhlen
Germany
This leaflet was last revised in September 2017.
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