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COPEGUS 400MG FILM COATED TABLETS

Active substance(s): RIBAVIRIN

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21.01.15

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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.

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 AntiRetroviral 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.

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

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.

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).

Patients receiving azathioprine in combination
with Copegus and peginterferon are at increased
risk of developing severe blood disorders.

Copegus is used in combination with other
medicines to treat certain chronic forms of
hepatitis C.

Refer also to the package leaflets of the other
medicines that are used in combination with
Copegus.

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.

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.

2. What you need to know before you
take Copegus

Copegus film-coated tablets are normally taken
at two times in the day with food (morning and
evening) and should be swallowed whole.

Copegus with food and drink

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).

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.

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).

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”.

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.

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, breastfeeding 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.

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.

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

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
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.
10156360_NP9344.indd 1

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.
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.
Please turn over 
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10156360 GB-IE

21.01.2015 10:09:00

Pantone Black

Format:

148x594 mm

Folding Format:

148x297 mm

Type Size

9,5 pt

Drawing Norm

NP9344

make-up code

GB-IE

Good To Print

Version

Date

3

21.01.15

11.08.10

Signature

Printing Colour:

Date

10156360

97.4.3524

Checked and
approved

Genisys-No.

Signature

MMBFMM8W
MMBFMM8Z

If you are over the age of 65 you should consult
your doctor before using Copegus.

Respiratory disorder: Wheezing
Gastrointestinal disorders: Gastrointestinal
bleeding, inflammation of the lips, inflammation
of the gums
Liver disorders: Poor functioning of the liver

If you have the impression that the effect of
Copegus is too strong or too weak, talk to your
doctor or pharmacist.

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

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.

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)

Ireland
HPRA Pharmacovigilance
Earlsfort Terrace
IRL - Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.hpra.ie
e-mail: medsafety@hpra.ie
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.

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

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)

If you are infected with both
viruses, HCV and HIV, and
are receiving HAART
(Highly Active AntiRetroviral 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.

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
Vascular disorder: High blood pressure
10156360_NP9344.indd 2

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 January 2015.
2

10156360 GB-IE

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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.

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