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RIBAVIRIN 200 MG CAPSULES HARD

Active substance(s): RIBAVIRIN

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Ribavirin 200 mg capsules
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 Ribavirin is and what it is used for
2. What you need to know before you take Ribavirin
3. How to take Ribavirin
4. Possible side effects
5. How to store Ribavirin
6. Contents of the pack and other information
1. What Ribavirin is and what it is used for
Ribavirin contain the active ingredient ribavirin. Ribavirin stops the
multiplication of many types of viruses, including hepatitis C virus. Ribavirin
must not be used without interferon alfa-2b, i.e. Ribavirin must not be used
alone.
Previously untreated patients:
The combination of Ribavirin with interferon alfa-2b is used to treat patients
3 years of age and older who have chronic hepatitis C (HCV) infection. For
children and adolescents weighing less than 47 kg a solution formulation is
available.
Previously treated adult patients:
The combination of Ribavirin with interferon alfa-2b is used to treat adult
patients with chronic hepatitis C, who have previously responded to treatment
with an alfa interferon alone, but whose condition has recurred.
There is no safety or efficacy information on the use of Ribavirin with
pegylated or other forms of interferon (i.e., not alfa-2b).
2. What you need to know before you take Ribavirin
Ribavirin is not recommended for use in patients under the age of 3 years.
DO NOT take Ribavirin
If any of the following apply to you or your child you are caring for, do not
take this medicine, and tell your doctor if you:
are allergic to ribavirin or any of the other ingredients of this medicine
(listed in section 6.).
are pregnant or planning to become pregnant. (see section
“pregnancy and breast-feeding).
are breast-feeding.
have had any previous severe heart problem, or have had any problems
with the heart in the last 6 months
have any severe medical conditions that leave you very weak, including
severe kidney disease.
have severe kidney disease and/or are on haemodialysis
have had severe liver problems, which are not related to hepatitis C.
have suffered from any blood disorder, for example anaemia (low blood
count), thalassemia or sickle-cell anaemia.
Have suffered from autoimmune disease in the past, or suffer from
autoimmune hepatitis or are taking other medicine that suppress your
immune system (that protects you against infection and some diseases).
Children and adolescents must not take combination therapy with Ribavirin
and alpha interferon when there is existence or history of serious nervous or
mental problems, such as severe depression, suicidal thoughts or attempted
suicide.
You should tell your doctor if you have suffered from any other serious illness
in the past.
-

Reminder: Please read the “Do not use” section of the package leaflet for
interferon alfa-2b before you begin combination treatment with Ribavirin.

Warnings and precautions Seek medical advice immediately if you develop
symptoms of a severe allergic reaction (such as difficulty in breathing,
wheezing or hives) while taking this treatment.
Children and adolescents weighing less than 47 kg:
The use of Ribavirin is not recommended.
Talk to your doctor if you or the child you are caring for:

are an adult who has or had a severe nervous or mental disorder,
confusion, unconsciousness, or have had thoughts of suicide or have
attempted suicide, or have a history of substance abuse (e.g. alcohol
or drugs)

have ever had depression or develop symptoms associated with
depression (e.g. feeling of sadness, dejection, etc.) while on treatment
with Ribavirin.

are a woman of childbearing age (see section “Pregnancy and breastfeeding”)

are a male and your female partner is of childbearing age (see section
“Pregnancy and breastfeeding”)

had a previous serious heart condition or have cardiac disease

are older than 65 years or if you have problems with your kidneys

have or have had any serious illness

have thyroid problems
During treatment with Ribavirin in combination therapy with an alfa interferon,
dental and gum disorders, which may lead to loss of teeth, have been
reported. In addition, dry mouth that could have a damaging effect on teeth
and membranes of the mouth has been reported during longterm treatment
with ribavirin in combination therapy with an alpha interferon. 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.
During treatment with Ribavirin in combination therapy with an alpha
interferon, patients may experience eye problems, or loss of vision in rare
instances. If you receive ribavirin in combination with an alpha interferon, you
should have a baseline eye examination. Any patient complaining of decrease
or loss of vision must have a prompt and complete eye examination. Patients
with preexisting eye disorders (e.g. diabetic or hypertensive retinopathy)
should receive periodic eye exams during combination therapy with ribavirin
and an alpha interferon. Combination therapy with ribavirin and an alpha
interferon should be discontinued in patients who develop new or worsening
eye disorders.
-

Reminder: Please read the “Take special care” section of the Package
Leaflet for interferon alfa-2b before you begin combination treatment.

Other medicines and Ribavirin
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines
are receiving azathioprine in combination with ribavirin and pegylated
alpha interferons and, therefore may be at an increased risk of developing
severe blood disorders.
are infected with both Human Immunodeficiency Virus (HIV-positive)
and Hepatitis C Virus (HCV) and are being treated with an anti-HIV
medicinal product(s) – [nucleoside reverse transcriptase inhibitor (NRTI),
and/or highly active anti-retroviral therapy (HAART)]:
- Taking Ribavirin in combination with an alpha interferon and an antiHIV medicinal product(s) may increase the risk of lactic acidosis, liver
failure, and blood abnormalities development (reduction in number of
red blood cells which carry oxygen, certain white blood cells that fight
infection, and blood clotting cells called platelets).
- With zidovudine or stavudine, it is not certain if ribavirin will change
the way these medicines work. Therefore, your blood will be checked
regularly to be sure that the HIV infection is not getting worse. If it gets
worse, your doctor will decide whether or not your Ribavirin treatment
needs to be changed. Additionally, patients receiving zidovudine with
ribavirin in combination with alpha interferons could be at increased
risk of developing anaemia (low number of red blood cells). Therefore
the use of zidovudine and ribavirin in combination with alpha
interferons is not recommended.
- Due to the risk of lactic acidosis (a build-up of lactic acid in the body)
and pancreatitis, the use of ribavirin and didanosine is not
recommended and the use of ribavirin and stavudine should be
avoided.
- Co-infected patients with advanced liver disease receiving (HAART)
may be at increased risk of worsening liver function. Adding treatment
with alfa interferons alone or in combination with ribavirin may
increase the risk in this patient subset.

Black

P150

P150

Ribavirin 200 mg
capsules

Package leaflet: Information for the user

-

Ribavirin 200 mg
capsules

Pharmacode position may change as per Supplier's m/c requirement &additional
small pharma code may appear on the front / back panel

Reminder: Please read the “Taking other medicines” section of the Package
Leaflet for interferon alfa-2b before you begin combination treatment.
Ribavirin with food and drink and alcohol
Ribavirin must be taken with food.
Pregnancy and breast-feeding and fertility
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.
If you are pregnant you must not take Ribavirin. Ribavirin can be very
damaging to your unborn baby (embryo).
Both female and male patients must take special precautions in their sexual
activity if there is any possibility for pregnancy to occur:

Girl or woman of childbearing age:
You must have a negative pregnancy test before treatment, each month
during treatment, and for the 4 months after treatment is stopped. This should
be discussed with your doctor.

Men:
Do not have sex with a pregnant woman unless you use a condom. This will
lessen the possibility 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 7 months after
treatment has stopped. You and your female partner must use an effective
contraceptive during the time you are taking Ribavirin and for 7 months after
stopping the treatment. This should be discussed with your doctor (see
section “Do not take Ribavirin”).
If you are a woman who is breast-feeding, you must not take Ribavirin.
Discontinue breastfeeding before starting to take Ribavirin.
Driving and using machines
Ribavirin has no effect on your ability to drive or use machines. However,
interferon alfa-2b may cause sleepiness, tiredness or confusion.
Do not drive or use any tools or machines if you feel tired or sleepy, or are
confused from this treatment.
Ribavirin contains lactose Each Ribavirin capsule contains a small amount
of lactose. If you have been told by your doctor that you have an intolerance
to some sugars, discuss with your doctor before taking this medicinal
product.
3. How to take Ribavirin
General information about taking this medicine
If the child you are caring for is under the age of 3 years, do not administer.
Always take this medicine exactly as your doctor has told you. Check with
your doctor or pharmacist, if you are not sure.
Do not take more than the recommended dosage and take the medicine for as
long as prescribed. Your doctor has determined the correct dose of Ribavirin
based on how much you or the child you are caring for weighs.
Standard blood tests will be taken to check your blood, kidney and liver
function.
Blood tests will be done regularly to help your doctor to know if this
treatment is working.
Depending upon the results of these tests, your doctor may change/adjust
the number of hard capsules you or the child you are caring for take,
prescribe a different pack size of Ribavirin, and/or change the length of
time to take this treatment.
If you have or develop severe kidney or liver problems, this treatment will
be stopped.
The recommended dose, according to how much the patient weighs, is shown
in the table below:
1. Look for the line that shows how much the adult or child/adolescent
weighs.
Reminder: If the child is under the age of 3 years, do not administer.
2. Read across on the same line to see how many hard capsules to take.
Reminder: If your doctor’s instructions are different from the amounts
in the below table, follow your doctor’s instructions.
3. If you have any questions about the dose, ask your doctor.
If the adult
weighs (kg)
< 65

Ribavirin for oral use - dose based on body weight
Usual daily Ribavirin dose
Number of 200 mg capsules
800 mg

65 - 80

1,000 mg

81 - 105

1,200 mg

> 105

1,400 mg

If the
child/
adolescent
weighs (kg)

Usual daily Ribavirin dose

47 – 49

600 mg

50 - 65
> 65

2 capsules in the morning and
2 capsules in the evening
2 capsules in the morning and
3 capsules in the evening
3 capsules in the morning and
3 capsules in the evening
3 capsules in the morning and
4 capsules in the evening
Number of 200 mg capsules

1 capsule in the morning and
2 capsules in the evening
800 mg
2 capsules in the morning and
2 capsules in the evening
see adult dose and corresponding number of hard
capsules

Take your prescribed dose by mouth with water and during your meal. Do not
chew the hard capsules. For children or adolescents who cannot swallow a
hard capsule, an oral solution of ribavirin is available.
Reminder: Ribavirin is only to be used in combination with interferon alfa-2b or
hepatitis C virus infection. For complete information be sure to read the “How
to use” section of the Package Leaflet for interferon alfa-2b.
Interferon medicine that is used in combination with Ribavirin may cause
unusual tiredness; if you are injecting this medicine yourself or giving it to a
child, use it at bedtime.
If you take more Ribavirin than you should
Tell your doctor or pharmacist as soon as possible.
If you forget to take Ribavirin
If you are self-administering treatment, or if you are the caregiver of a child
taking Ribavirin in combination with interferon alfa-2b, take/administer the
missed dose as soon as possible during the same day. If an entire day has
gone by, check with your doctor. Do not take a double dose to make up for a
forgotten dose.
4. Possible Side Effects
Please read the “Possible side effects” section of the Package Leaflet for
interferon alfa-2b.
Like all medicines, this medicine used in combination with an alpha interferon
product can cause side effects.although not everybody gets them.
Psychiatric and Central Nervous System:
Some people get depressed when taking ribavirin in combination treatment
with an interferon, and in some cases people had thoughts about threatening
the life of others, suicidal thoughts or aggressive behaviour (sometimes
directed against others). 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 changes in your behaviour.
Children and adolescents are particularly prone to develop depression when
being treated with ribavirin and interferon alpha. Immediately contact the
doctor or seek emergency treatment if they display any unusual behavioural
symptoms, feel depressed, or feel they want to harm themselves or others.
Growth and development (children and adolescents):
During the one year of treatment with ribavirin, in combination with interferon
alfa-2b, some children and adolescentsdid not grow or gain weight as much
as expected. Some children did not reach their projected height within
1-5 years after completing treatment.

Contact your doctor immediately if any of the following side effects
occur during treatment with Ribavirin in combination with an alpha
interferon product:

chest pain or persistent cough

blood in stool or urine

changes in the way your heart

severe bleeding from your
beats
nose

fainting

fever or chills beginning

confusion,
after a few weeks of treatment

feeling depressed

lower back or side pain

suicidal thoughts or aggressive
p
painful or difficult urination
behaviour,

problems with your eyesight or

attempt suicide,
hearing,

thoughts about threatening the

severe skin rash or redness
life of others,

feelings of numbness or tingling

trouble sleeping, thinking or
concentrating

severe stomach pain

black or tar-like stools
The frequency of possible side effects listed below is defined using the
following convention:
Very common (affects more than 1 user in 10)
Common (affects 1 to 10 users in 100)
Uncommon (affects 1 to 10 users in 1,000)
Rare (affects 1 to 10 users in 10,000)
Very rare (affects less than 1 user in 10,000)
Not known (frequency cannot be estimated from the available data).
The following side effects have been reported with the combination of ribavirin
and an alpha interferon product in adults:
Very commonly reported side effects:
decreases in the number of red blood cells (that may cause fatigue,
shortness of breath, dizziness), decrease in neutrophils (that make you
more susceptible to different infections).
difficulty concentrating, feeling anxious or nervous, mood swings, feeling
depressed or irritable, tired feeling, trouble falling asleep or staying
asleep,
cough, dry mouth, pharyngitis (sore throat)
diarrhoea, dizziness, fever, flu-like symptoms, headache, nausea, shaking
chills, virus infection, vomiting, weakness,
loss of appetite, loss of weight, stomach pain,
dry skin, irritation, pain or redness at the site of injection, hair loss, itching,
muscle pain, muscle aches, pain in joints and muscles, rash.
Commonly reported side effects:
decrease in blood clotting cells called platelets that may result in easy
bruising and spontaneous bleeding, decrease in certain white blood cells
called lymphocytes that help fight infection, decrease in thyroid gland
activity (which may make you feel tired, depressed, increase your
sensitivity to cold and other symptoms) excess of sugar or uric acid (as in
gout) in the blood, low calcium level in the blood, severe anaemia
fungal or bacterial infections, crying, agitation, amnesia, memory
impaired, nervousness, abnormal behaviour, aggressive behaviour,
anger, feeling confused, lack of interest, mental disorder, mood changes,
unusual dreams, wanting to harm yourself, feeling sleepy, trouble
sleeping, lack of interest in sex or inability to perform, vertigo (spinning
feeling)
blurred or abnormal vision, eye irritation or pain or infection, dry or teary
eyes, changes in your hearing or voice, ringing in ears, ear infection,
earache, cold sores (herpes simplex), change in taste, taste loss,
bleeding gums or sores in mouth, burning sensation on tongue, sore
tongue, inflamed gums, tooth problem, migraine, respiratory infections,
sinusitis, nose bleed, nonproductive cough, rapid or difficult breathing,
stuffy or runny nose, thirst, tooth disorder,
cardiac murmur (abnormal heart beat sounds), chest pain or discomfort,
feeling faint, feeling unwell, flushing, increased sweating, heat intolerance
and excessive sweating, low or high blood pressure, palpitations
(pounding heart beat), rapid heart rate.
bloating, constipation, indigestion intestinal gas (flatus), increased
appetite, irritated colon, irritation of prostate gland, jaundice (yellow skin),
loose stools, pain on the right side around your ribs, enlarged liver,
stomach upset, frequent need to urinate, passing more urine than usual,
urinary tract infection, abnormal urine,
difficult, irregular, or no menstrual period, abnormally heavy and
prolonged menstrual periods, painful menstruation, disorder of ovary or
vagina, breast pain, erectile problem,
abnormal hair texture, acne, arthritis, bruising, eczema (inflamed, red,
itchy and dryness of the skin with possible oozing lesions), hives,
increased or decreased sensitivity to touch, nail disorder, muscle spasms,
numbness or tingling feeling, limb pain, pain at the site of injection, pain in
joints, shaky hands, psoriasis, puffy or swollen hands and ankles,
sensitivity to sunlight, rash with raised spotted lesions, redness of skin or
skin disorder, swollen face, swollen glands (swollen lymph nodes), tense
muscles, tumour (unspecified), unsteady when walking, water impairment.
Uncommonly reported side effects:
hearing or seeing images that are not present,
heart attack, panic attack,
hypersensitivity reaction to the medication,
inflammation of pancreas, pain in bone, diabetes mellitus,
muscle weakness.
Rarely reported side effects:
seizure (convulsions)
pneumonia,
diabetes, rheumatoid arthritis, kidney problems,
dark or bloody stools, intense abdominal pain
sarcoidosis (a disease characterised by persistent fever, weight loss, joint
pain and swelling, skin lesions and swollen glands),
vasculitis.
Very rarely reported side effects:
suicide.
Not known side effects:
thoughts about threatening the life of others,
mania (excessive or unreasonable enthusiasm),
pericarditis (inflammation of the lining of the heart), pericardial effusion
[a fluid collection that develops between the pericardium (the lining of the
heart) and the heart itself.
change in colour of the tongue
The following side effects have been reported with children and adolescents
taking ribavirin and an interferon alfa-2b product:
Very commonly reported side effects:
decreases in the number of red blood cells (that may cause fatigue,
shortness of breath, dizziness) decrease in neutrophils (that make you
more susceptible to different infections),
decrease in thyroid gland activity (which may make you feel tired,
depressed, increase your sensitivity to cold and other symptoms),
feeling depressed or irritable, feeling sick to stomach, feeling unwell,
mood swings, tired feeling, trouble falling asleep or staying asleep, virus
infection, weakness,
diarrhoea, dizziness, fever, flu-like symptoms, headache, loss of or
increase in appetite, loss of weight, decrease in the rate of growth (height
and weight), pain on right side of ribs, pharyngitis (sore throat), shaking
chills, stomach pain, vomiting,
dry skin, hair loss, irritation, pain or redness at the site of injection, itching,
muscle pain, muscle aches, pain in joints and muscles, rash.
Commonly reported side effects:
decrease in blood clotting cells called platelets (that may result in easy
bruising and spontaneous bleeding),
excess of triglycerides in the blood, excess of uric acid (as in gout) in the
blood, increase in thyroid gland activity (which may cause nervousness,
heat intolerance and excessive sweating, weight loss, palpitation,
tremors),
agitation, anger, aggressive behaviour, behaviour disorder, difficulty
concentrating, emotional instability, fainting, feeling anxious or nervous,
feeling cold, feeling confused, feeling of restlessness, feeling sleepy, lack
of interest or attention, mood changes, pain, poor quality sleep,
sleepwalking, suicide attempt, trouble sleeping, unusual dreams, wanting
to harm yourself,
bacterial infections, common cold, fungal infections, abnormal vision, dry
or teary eyes, ear infection, eye irritation or pain or infection, change in
taste, changes in your voice, cold sores, coughing, inflamed gums, nose
bleed, nose irritation, oral pain, pharyngitis (sore throat), rapid breathing,
respiratory infections, scaling lips and clefts in the corners of the mouth,
shortness of breath, sinusitis, sneezing, sores in mouth, sore tongue,
stuffy or runny nose, throat pain, toothache, tooth abscess, tooth disorder,
vertigo (spinning feeling), weakness
chest pain, flushing, palpitations (pounding heart beat), rapid heart rate,
abnormal liver function,

-

acid reflux, back pain, bedwetting, constipation, gastroesophageal or
rectal disorder, incontinence, increased appetite, inflammation of the
membrane of the stomach and intestine, stomach upset, loose stools,
urination disorders, urinary tract infection,
difficult, irregular or no menstrual period, abnormally heavy and prolonged
menstrual periods, disorder of vagina, inflammation of the vagina, testis
pain, development of male body traits,
acne, bruising, eczema (inflamed, red, itchy and dryness of the skin with
possible oozing lesions), increased or decreased sensitivity to touch,
increased sweating, increase in muscle movement, tense muscle,
irritation or itching at the site of injection, limb pain, nail disorder,
numbness or tingling feeling, pale skin, rash with raised spotted lesions,
shaky hands, redness of skin or skin disorder, skin discolouration, skin
sensitive to sunlight, skin wound, swelling due to a build-up of excess
water, swollen glands (swollen lymph nodes), tremor, tumour
(unspecified).

Uncommonly reported side effects
abnormal behaviour, emotional disorder, fear, nightmare,
bleeding of the mucous membrane that lines the inner surface of the
eyelids, blurred vision, drowsiness, intolerance to light, itchy eyes, facial
pain, inflamed gums,
chest discomfort, difficult breathing, lung infection, nasal discomfort,
pneumonia, wheezing,
low blood pressure,
enlarged liver,
painful menstruation,
itchy anal area (pinworms or ascarids), blistering rash (shingles),
decreased sensitivity to touch, muscle twitching, pain in skin, paleness,
peeling of skin, redness, swelling.
The attempt to harm yourself has also been reported in adults, children, and
adolescents.
Ribavirin in combination with an alpha interferon product may also cause:
aplastic anaemia, pure red cell aplasia (a condition where the body
stopped or reduced the production of red blood cells); this causes severe
anaemia, symptoms of which would include unusual tiredness and a lack
of energy,
delusions
upper and lower respiratory tract infection,
inflammation of the pancreas,
severe rashes which may be associated with blisters in the mouth, nose,
eyes and other mucosal membranes (erythema multiforme, Stevens
Johnson syndrome), toxic epidermal necrolysis (blistering and peeling of
the top layer of skin),
The following other side effects have also been reported with the combination
of ribavirin and an alpha interferon product:
abnormal thoughts, hearing or seeing images that are not present, altered
mental status, disorientation,
angioedema (swelling of the hands, feet, ankles, face, lips, mouth, or
throat which may cause difficulty in swallowing or breathing), stroke
(cerebrovascular events)
Vogt-Koyanagi-Harada syndrome (an autoimmune inflammatory disorder
affecting the eyes, skin and the membranes of the ears, brain and spinal
cord)
bronchoconstriction and anaphylaxis (a severe, whole-body allergic
reaction), constant cough,
eye problems including damage to the retina, obstruction of the retinal
artery, inflammation of the optic nerve, swelling of the eye and cotton
wool spots (white deposits on the retina),
enlarged abdominal area, heartburn, trouble having bowel movement or
painful bowel movement,
acute hypersensitivity reactions including urticaria (hives), bruises,
intense pain in a limb, leg or thigh pain, loss of range of motion, stiffness,
sarcoidosis, (a disease characterised by persistent fever, weight loss,
joint pain and swelling, skin lesions and swollen glands)
Ribavirin in combination with peginterferon alfa-2b or interferon alfa-2b may
also cause:
dark, cloudy or abnormally coloured urine.
difficulty breathing, changes in the way your heart beats, chest pain, pain
down left arm, jaw pain,
loss of consciousness,
loss of use, drooping or loss of power of facial muscles, loss of feeling
sensation,
loss of vision,
You or your caregiver should call your doctor immediately if you have
any of these symptoms.
If you are a HCV/HIV co-infected adult patients receiving anti-HIV treatment,
the addition of Ribavirin in and peginterferon alfa- 2b may increase your risk of
worsening liver function highly active anti-retroviral therapy (HAART) and
increase your risk of lactic acidosis, liver failure and blood abnormalities
development (reduction in number of red blood cells which carry oxygen,
certain white blood cells that fight infection, and blood clotting cells called
platelets) (NRTI).
In HCV/HIV co-infected patients receiving HAART, the following other side
effects have occurred with the combination of ribavirin hard capsules and
peginterferon alfa-2b (not listed above in adults side effects):
appetite decreased ,
back pain,
CD4 lympocytes decreased,
Defective metabolism of fat,
Hepatitis,
Limb pain,
Oral candidiasis (oral thrush),
Various laboratory blood values abnormalities.
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 via the Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the safety
of this medicine.
5. How to store Ribavirin
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
carton/blister after EXP. The expiry date refers to the last date of that month.
This medicinal product does not require any special storage conditions.
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 Ribavirin contains
The active substance is ribavirin.
Each Ribavirin capsule contains 200 mg of ribavirin.
-

The other ingredients are cellulose, microcrystalline, lactose
monohydrate, povidone, magnesium stearate.
The capsule shell contains gelatine, titanium dioxide (E171) and sodium
lauryl sulphate.
The capsule shell imprint contains shellac, propylene glycol, potassium
hydroxide, black iron oxide (E 172).

What Ribavirin looks like and contents of the pack
Capsule, hard
White / White, size ‘1’ hard gelatin capsules filled with white to off-white
granular powder and imprinted with ‘E’ on white cap and ‘81’ on white body
with black ink.
Ribavirin is available in PVC/PE/PVDC/Aluminium blisters and HDPE
containers in the pack sizes of
PVC/PE/PVDC/aluminium blister: 84, 112, 140 and 168 capsules
HDPE bottle: 42 and 500 capsules
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Milpharm Limited
Ares, Odyssey Business Park
West End Road
South Ruislip HA4 6QD
United Kingdom
Manufacturer
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta
This leaflet was last revised in 06/2014.

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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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