Ribavirin Aurobindo

Package leaflet: Information for the user

Ribavirin Aurobindo 200 mg hard capsules

Equivalent medicine
Please read all of this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, because it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Ribavirin Aurobindo is and what it is used for

2. What you need to know before taking Ribavirin Aurobindo

3. How to take Ribavirin Aurobindo

4. Possible side effects

5. How to store Ribavirin Aurobindo

6. Contents of the pack and other information

7. What Ribavirin Aurobindo is and what it is used for

Ribavirin Aurobindo contains the active substance ribavirin. This medicine inhibits the
replication of the hepatitis C virus. Ribavirin Aurobindo must not be used alone.
Depending on the genotype of the hepatitis C virus you have, your doctor may choose to treat
you with a combination of this medicine and other antiviral drugs. Additional limitations
on treatment may apply depending on whether or not you have previously been treated for
chronic hepatitis C infection. Your doctor will recommend the most appropriate therapy.
The combination of Ribavirin Aurobindo with other medicines is used to treat adult
patients with chronic hepatitis C (HCV).
Ribavirin Aurobindo may be used in paediatric patients (children from 3 years of age and
adolescents) who have not been previously treated and who do not have severe liver disease.
For paediatric patients (children and adolescents) weighing less than 47 kg, an oral solution formulation is available.
If you have further questions about the use of this medicine, ask your doctor or pharmacist.

2. What you need to know before taking Ribavirina Aurobindo

DO NOT take Ribavirina Aurobindo
Do not take Ribavirina Aurobindo if any of the following apply to you or to the child you are caring for.
If you have any doubts, consult your doctor or pharmacist before taking Ribavirina Aurobindo.

• You are allergic to ribavirin or to any of the excipients of this medicine (listed in section 6).
• You are pregnant or planning a pregnancy (see section “Pregnancy, breastfeeding and fertility”)
• You are breastfeeding
• You have had a serious heart condition in the past 6 months
• You have any blood disorder, such as anemia (low blood count), thalassemia, or Mediterranean anemia

Children and adolescents must not receive combination therapy with Ribavirina Aurobindo and interferon alfa if they have current or past severe psychiatric or mental disorders such as severe depression, suicidal thoughts, or suicide attempts.
You must inform your doctor if you have previously suffered from any other serious illness.

• Reminder: Read the “Do not take” section of the package leaflet of any other medicines used in combination with this medicine.

Warnings and Precautions
Combination therapy with ribavirin and (peg)interferon alfa is associated with various serious adverse reactions. These include:

• Psychiatric and central nervous system effects (such as depression, suicidal thoughts, suicide attempts, and aggressive behavior, etc.). Seek medical help immediately if you notice the onset of depression, suicidal thoughts, or changes in your behavior. You may consider asking a family member or friend to help monitor you for signs of depression or behavioral changes.
• Serious eye disorders.
• Dental and periodontal disorders: Dental and gum problems have been reported in patients treated with Ribavirina Aurobindo in combination with (peg)interferon alfa-2b. It is necessary to thoroughly brush teeth twice daily and undergo regular dental check-ups. Additionally, some patients may experience episodes of vomiting. If this occurs, rinse your mouth thoroughly immediately afterwards.
• Failure to achieve full adult height may occur in some children and adolescents.
• Increased levels of thyroid-stimulating hormone (TSH) in children and adolescents.

Paediatric population
If you are caring for a child and the doctor decides not to delay combination treatment with peginterferon alfa-2b or interferon alfa-2b until adulthood, it is important to be aware that this combination therapy may cause growth inhibition, which in some patients may be irreversible.
In addition, the following events have occurred in patients taking Ribavirina Aurobindo:
Hemolysis: Ribavirina Aurobindo may cause breakdown of red blood cells, leading to anemia, which may compromise heart function or worsen symptoms of heart disease.
Pancytopenia: Ribavirina Aurobindo may cause a decrease in platelets and in the number of red and white blood cells when used in combination with peginterferon.
Standard blood tests will be performed to monitor your blood and the function of your kidneys and liver.

• Blood tests will be carried out regularly to help your doctor assess whether the treatment is effective.
• Depending on the results of these tests, your doctor may modify/adjust the number of hard capsules you or the child you are caring for should take, prescribe a different pack size of this medicine, and/or modify the duration of treatment.
• If you have or develop severe kidney or liver problems, this treatment will be discontinued.

Seek immediate medical attention if you develop symptoms of a severe allergic reaction (such as difficulty breathing, shortness of breath, or hives) while taking this medicine.
Inform your doctor if you or the child you are caring for:

• Is a woman of childbearing potential (see section “Pregnancy, breastfeeding and fertility”)
• Is a man and your partner is of childbearing potential (see section “Pregnancy, breastfeeding and fertility”)
• Has had a previous serious heart condition or has a heart disease
• Has another liver condition in addition to hepatitis C infection
• Has kidney problems
• Has HIV (human immunodeficiency virus) or has ever had other immune system disorders

Refer to the package leaflet of (peg)interferon alfa for more detailed information on these safety-related factors.

• Reminder: Read the “Warnings and precautions” section of the package leaflet for any other medicines used in combination with Ribavirina Aurobindo before starting combination therapy.

Use in children and adolescents
If the child weighs less than 47 kg or is unable to swallow, an oral solution of ribavirin is available.
Other medicines and Ribavirina Aurobindo Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

• Azathioprine, a medicine that suppresses the immune system: using this medicine in combination with Ribavirina Aurobindo may increase the risk of developing serious blood disorders.
• Medicines for Human Immunodeficiency Virus (HIV) - [nucleoside reverse transcriptase inhibitors ( NRTIs )] and/or combination antiretroviral therapy ( cART )]:
• Taking this medicine in combination with interferon alfa and an HIV medicine may increase the risk of lactic acidosis, liver failure, and development of blood abnormalities (reduction in the number of red blood cells carrying oxygen, certain white blood cells fighting infections, and blood-clotting cells called platelets).
• With zidovudine or stavudine, it is uncertain whether this medicine alters how these medicines work. Therefore, regular blood monitoring is necessary to ensure that the HIV infection does not worsen. If it does, your doctor will decide whether treatment with Ribavirina Aurobindo needs to be modified. In addition, patients taking zidovudine with ribavirin in combination with interferon alfa may be at increased risk of developing anemia (low red blood cell count). Therefore, the use of zidovudine and ribavirin in combination with interferon alfa is not recommended.
• Due to the risk of lactic acidosis (accumulation of lactic acid in the body) and pancreatitis, the use of ribavirin and didanosine is not recommended, and the use of ribavirin and stavudine must be avoided.
• Patients with concurrent infection and advanced liver disease treated with HAART may be at increased risk of worsening liver function. Adding interferon alfa monotherapy or in combination with ribavirin may increase this risk in this subgroup of patients.

Reminder: Read the “Other medicines” section of the package leaflet for any other medicines used in combination with Ribavirina Aurobindo before starting combination therapy with this medicine.
Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
If you are pregnant, you must not take this medicine. This medicine can be very harmful to your unborn baby (embryo).
Both men and women must take special precautions regarding sexual activity if there is any possibility of pregnancy:

• Girl or woman of childbearing potential: A negative pregnancy test must be obtained before treatment, every month during treatment, and for 4 months after stopping treatment. Discuss this with your doctor.
• Men: You must not have sexual intercourse with a pregnant woman unless you use a condom. This will reduce the possibility of transferring ribavirin to the woman’s body. If your partner is not currently pregnant but is of childbearing potential, she must take a pregnancy test every month during your treatment and for 7 months after stopping treatment.
  You and your partner must use effective contraception during the time you are taking Ribavirina Aurobindo and for 7 months after stopping treatment. Discuss this with your doctor (see section “Do not take Ribavirina Aurobindo”).
  If you are a woman who is breastfeeding, you must not take this medicine.
  Stop breastfeeding before starting this medicine.

Driving and using machines
This medicine does not affect your ability to drive or use machinery; however, other medicines used in combination with Ribavirina Aurobindo may impair your ability to drive or use machinery. Therefore, do not drive or operate machinery if your treatment causes fatigue, drowsiness, or confusion.

Ribavirina Aurobindo contains
Each capsule of Ribavirina Aurobindo contains a small amount of lactose. If your doctor has informed you that you have an intolerance to certain sugars, contact your doctor before taking this medicine.

3. How to take Ribavirina Aurobindo

General information on taking Ribavirina Aurobindo
Always take Ribavirina Aurobindo exactly as directed by your doctor. If you have
any doubts, consult your doctor or pharmacist.
Do not take a higher dose than recommended and take the medicine for the entire
duration prescribed by your doctor.
Your doctor has determined the correct dose of this medicine based on your weight or
the weight of the child you are caring for.
Adults
The recommended dose and duration of treatment with Ribavirina Aurobindo depend on
the patient's weight and the medicines used in combination.
Use in children and adolescents
The dose for children over 3 years of age and adolescents depends on the person's
weight and the medicines used in combination. The recommended dose of Ribavirina
Aurobindo in combination with interferon alfa-2b is shown in the following table.

Take the prescribed dose orally with water and during a meal. Do not chew the hard capsules.
For children and adolescents who cannot swallow a hard capsule, an oral solution of this medicine is available.
Reminder: this medicine is used in combination with other medicines for hepatitis C virus infection. For complete information, make sure to read the "How to take" section of the package leaflet of the other medicines used in combination with Ribavirina Aurobindo.
If you take more Ribavirina Aurobindo than you should
Inform your doctor or pharmacist as soon as possible.
If you forget to take Ribavirina Aurobindo
Take/administer the missed dose as soon as possible on the same day. If a full day has passed, consult your doctor. Do not take a double dose to make up for the missed dose.

4. Possible side effects

Read the section “Possible side effects” in the package leaflet of the other medicines used in combination with Ribavirina Aurobindo.
Like all medicines, this medicine used in combination with other medicines may cause side effects, although not everyone experiences them. Although not all of these side effects may occur, if they do occur they may require medical treatment.
Contact your doctor immediately if you experience any of the following side effects during combination treatment with other medicines:

• chest pain or persistent cough; changes in heartbeat, fainting,
• confusion, feeling depressed; suicidal thoughts or aggressive behaviour, suicide attempt, thoughts of threatening the lives of others,
• numbness or tingling sensation,
• difficulty sleeping, thinking or concentrating,
• severe stomach pain, black or tarry stools, blood in stools or urine, pain in the lower or side back,
• pain or difficulty urinating,
• severe nosebleeds,
• fever or chills after several weeks of treatment,
• vision or hearing problems,
• severe skin rashes or redness.

The following side effects have been reported with the combination of ribavirin and an interferon alfa in adults:

Very commonly reported side effects (may affect more than 1 in 10 people):

• reduction in red blood cell count (which may cause fatigue, shortness of breath, dizziness), reduction in neutrophils (which makes you more susceptible to infections)
• difficulty concentrating, feeling anxious or nervous, mood swings, feeling depressed or irritable, feeling tired, trouble falling asleep or staying asleep
• cough, dry mouth, pharyngitis (sore throat)
• diarrhoea, dizziness, fever, flu-like symptoms, headache, nausea, chills, viral infection, vomiting, weakness
• loss of appetite, weight loss, stomach ache
• dry skin, irritation, hair loss, itching, muscle pain, joint and muscle pain, rash.

Commonly reported side effects (may affect up to 1 in 10 people):

• reduction in blood clotting cells called platelets, which may cause easier bruising and spontaneous bleeding; reduction in certain white blood cells called lymphocytes that help fight infections; reduced activity of the thyroid gland (which may make you feel tired, depressed, increase cold sensitivity and other symptoms); excess sugar or uric acid (as in gout) in the blood, low calcium levels in the blood, severe anaemia
• bacterial or fungal infections, crying, agitation, amnesia, impaired memory, nervousness, abnormal behaviour, aggressive behaviour, rage, feeling confused, lack of interest, mental disorder, mood changes, unusual dreams, desire to harm yourself, feeling drowsy, trouble sleeping, loss of sexual interest or inability to perform sexually, vertigo (sensation of spinning)
• blurred or abnormal vision, eye irritation or pain or eye infection, dry or watery eyes, changes in hearing or voice, ringing in the ears, ear infection, earache, cold sores (herpes simplex), altered taste, loss of taste, bleeding gums or mouth ulcers, burning sensation on the tongue, tongue pain, inflamed gums, dental problems, migraine, respiratory tract infections, sinusitis, nosebleeds, non-productive cough, difficulty or rapid breathing, stuffy or runny nose, thirst, dental disorder
• heart murmur (abnormal heart sounds), chest pain or discomfort, feeling faint, feeling unwell, hot flushes, increased sweating, heat intolerance and excessive sweating, low or high blood pressure, palpitations (pounding heartbeat), increased heart rate
• swelling, constipation, gas from indigestion (flatulence), increased appetite, irritated bowel, irritation of the prostate gland, jaundice (yellow skin), loose stools, pain on the right side of the ribs, enlarged liver, stomach discomfort, frequent need to urinate, passing more urine than usual, urinary tract infection, abnormal urine
• painful, irregular or absent menstrual cycle, unusually heavy and prolonged menstrual periods, painful menstruation, ovarian or vaginal disorder, breast pain, erectile problems
• abnormal hair structure, acne, arthritis, bruising, eczema (inflamed, red, itchy and dry skin with possible widespread lesions), hives, increased or reduced sensitivity to touch, nail disorders, muscle spasms, numbness or tingling sensation, limb pain, joint pain, trembling hands, psoriasis, swollen hands or ankles, sensitivity to sunlight, skin rash with patchy lesions and thickening, redness of the skin and skin disorder, swollen face, swollen glands (swollen lymph nodes), tense muscles, tumour (not specified), instability when walking, fluid retention.

Uncommonly reported side effects (may affect up to 1 in 100 people):

• seeing or hearing things that are not present
• heart attack, panic attack
• hypersensitivity reaction to the medicine
• pancreatitis, bone pain, diabetes mellitus
• muscle weakness

Rarely reported side effects (may affect up to 1 in 1,000 people):

• epileptic seizures (fits)
• pneumonia
• rheumatoid arthritis, kidney problems
• dark or bloody stools, severe 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 (may affect up to 1 in 10,000 people):

• suicide
• stroke (cerebrovascular event)

Side effects not known (frequency cannot be estimated from available data):

• thoughts of threatening the lives of others
• mania (excessive or irrational enthusiasm)
• pericarditis (inflammation of the lining of the heart), pericardial effusion [a build-up of fluid between the pericardium (the lining of the heart) and the heart itself]
• changes in tongue colour

Side effects in children and adolescents
The following side effects have been reported with the combination of this medicine and interferon alfa-2b in children and adolescents:

Very commonly reported side effects (may affect more than 1 in 10 people):

• reduction in red blood cell count (which may cause fatigue, shortness of breath, dizziness), reduction in neutrophils (which makes you more susceptible to infections)
• reduced thyroid activity (which may make you feel tired, depressed, increase cold sensitivity and other symptoms)
• feeling depressed or irritable, stomach upset, feeling unwell, mood swings, feeling tired, trouble falling asleep or staying asleep, viral infection, weakness
• diarrhoea, dizziness, fever, flu-like symptoms, headache, loss or increase in appetite, weight loss, reduced growth rate (height and weight), pain on the right side of the ribs, pharyngitis (sore throat), chills, stomach ache, vomiting
• dry skin, hair loss, irritation, itching, muscle pain, joint and muscle pain, skin rash.

Commonly reported side effects (may affect up to 1 in 10 people):

• reduction in blood clotting cells called platelets, which may cause easier bruising and spontaneous bleeding
• excess triglycerides in the blood, excess uric acid (as in gout) in the blood, increased activity of the thyroid gland (which may cause nervousness, heat intolerance and excessive sweating, weight loss, palpitations, tremors)
• agitation, rage, aggressive behaviour, behavioural disorder, difficulty concentrating, emotional instability, fainting, feeling anxious or nervous, feeling cold, feeling confused, restlessness, feeling drowsy, lack of interest or attention, mood changes, pain, poor quality of sleep, sleepwalking, suicide attempt, trouble sleeping, unusual dreams, desire to harm yourself
• bacterial infections, common cold, fungal infections, abnormal vision, dry or watery eyes, ear infection, eye irritation or pain or eye infection, altered taste, changes in voice, herpes, cough, inflamed gums, nosebleeds, nasal irritation, oral pain, pharyngitis (sore throat), rapid breathing, respiratory tract infections, chapped lips and cracked mouth corners, shortness of breath, sinusitis, sneezing, mouth ulcers, tongue sores, stuffy or runny nose, sore throat, toothache, dental abscess, dental disorder, vertigo (sensation of spinning), weakness
• chest pain, hot flushes, palpitations (pounding heartbeat), increased heart rate
• abnormal liver function
• acid reflux, back pain, enuresis, constipation, gastro-oesophageal or rectal disorder, incontinence, increased appetite, inflammation of the stomach and intestinal lining, stomach discomfort, loose stools
• difficulty urinating, urinary tract infection
• painful, irregular or absent menstrual cycle, unusually heavy and prolonged menstrual periods, vaginal disorder, inflamed vagina, testicular pain, development of male characteristics
• acne, bruising, eczema (inflamed, red, itchy and dry skin with possible widespread lesions), increased or reduced sensitivity to touch, increased sweating, increased muscle movement, tense muscles, injection site irritation or itching, limb pain, nail disorders, numbness or tingling sensation, pale skin, skin rash with patchy lesions and thickening, trembling hands, redness of the skin or skin disorder, skin discolouration, sun-sensitive skin, swelling due to excess fluid accumulation, swollen glands (swollen lymph nodes), tremor, tumour (not specified)

Uncommonly reported side effects (may affect up to 1 in 100 people):

• abnormal behaviour, emotional disorder, fear, nightmares
• bleeding of the mucous membrane lining the inner surface of the eyelids, blurred vision, drowsiness, light sensitivity, itchy eyes, facial pain, inflamed gums
• chest discomfort, difficulty breathing, lung infection, nasal discomfort, pneumonia, sneezing
• low blood pressure
• enlarged liver
• painful menstruation
• anal itching (pinworms and roundworms), blistering skin rash (herpes), reduced sensitivity to touch, muscle spasm, skin pain, pallor, skin peeling, redness, swelling

In adults, children and adolescents, attempts to harm oneself have been reported.
This medicine in combination with interferon alfa may also cause:

• aplastic anaemia, pure red cell aplasia (a condition in which the body has stopped or reduced red blood cell production); this causes severe anaemia, whose symptoms include unusual tiredness and lack of energy
• delirium
• upper and lower respiratory tract infections
• pancreatitis
• severe rashes which may be associated with blisters in the mouth, nose, eyes and other mucous membranes (erythema multiforme, Stevens-Johnson syndrome), toxic epidermal necrolysis (blisters and peeling of the top layer of skin)

The following additional side effects have also been observed with the combination of this medicine and interferon alfa:

• abnormal thoughts, seeing or hearing things that are not present, altered mental state, disorientation
• angioedema (swelling of the hands, feet, ankles, face, lips, mouth or throat which may cause difficulty swallowing or breathing)
• Vogt-Koyanagi-Harada syndrome (an autoimmune inflammatory disorder affecting the eyes, skin, and membranes of the ears, brain and spinal cord)
• bronchoconstriction and anaphylaxis (a severe allergic reaction throughout the body), persistent cough
• eye problems including retinal damage, retinal artery occlusion, optic neuritis, eye swelling and cotton-wool spots (white deposits on the retina)
• enlarged abdominal area, heartburn, difficulty having a bowel movement, painful bowel movement
• acute hypersensitivity reactions including hives, bruising, severe 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)

This medicine in combination with peginterferon alfa-2b or interferon alfa-2b may also cause:

• dark, cloudy or unusual-coloured urine
• difficulty breathing, changes in heart rhythm, chest pain, pain radiating down the left arm, jaw pain
• loss of consciousness
• loss of use, relaxation or loss of control of facial muscles, loss of sensation
• loss of vision

You or your caregiver should call your doctor immediately if you experience
any of these symptoms:
If you are an adult patient with concurrent HCV/HIV infection receiving HIV treatment, adding this medicine and peginterferon alfa may increase your risk of worsening liver function (with combination antiretroviral therapy (cART)) and increase the risk of lactic acidosis, liver failure and development of blood abnormalities (reduction in the number of red blood cells carrying oxygen, certain white blood cells fighting infections and blood clotting cells called platelets) (NRTI).
In patients with concurrent HCV/HIV infection treated with cART, the following side effects have been reported with the combination of ribavirin in hard capsules and peginterferon alfa-2b (not listed among the side effects in adults reported above):

• reduced appetite
• back pain
• reduction in CD4 lymphocytes
• defective fat metabolism
• hepatitis
• limb pain
• oral candidiasis (oral thrush)
• various abnormalities in blood test values

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ribavirina Aurobindo

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton/blister after
EXP. The expiry date refers to the last day of the month.
This medicine does not require any special storage conditions.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Ribavirina Aurobindo contains

• The active substance is ribavirin. Each capsule of Ribavirina Aurobindo contains 200 mg of ribavirin.
• The other ingredients are: microcrystalline cellulose, lactose monohydrate, povidone, magnesium stearate. The capsule shell contains: gelatin, titanium dioxide (E171), and sodium lauryl sulfate. The printing ink for the capsules contains: shellac, propylene glycol, potassium hydroxide, and black iron oxide (E172).

Description of the appearance of Ribavirina Aurobindo and pack contents
Hard capsules.
White/white hard gelatin capsules of size '1', filled with white to off-white granular powder, printed with 'E' on the white cap and '81' on the white body using black ink.
Ribavirina Aurobindo is available in PVC/PE/PVDC/Aluminum blisters and HDPE bottles in the following pack sizes:
PVC/PE/PVDC/Aluminum blisters: 84, 112, 140 and 168 capsules.
HDPE bottles: 42 and 500 capsules.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Aurobindo Pharma (Italia) S.r.l.
Via San Giuseppe 102
21047 Saronno (VA)
Italy

Manufacturer
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate,
Hal Far, Birzebbugia, BBG 3000
Malta

This medicinal product is authorised in the European Economic Area (EEA) under the following names:
Germany: Ribavirin Aurobindo 200 mg Hard capsules
Spain: Ribavirina Aurobindo 200 mg cápsulas duras EFG
France: Ribavirine Arrow 200 mg, gélule
Italy: Ribavirina Aurobindo
Portugal: Ribavirina Aurobindo
Romania: Ribavirin Aurobindo 200 mg capsules
United Kingdom: Ribavirin 200 mg capsules