Active ingredient
- ribavirin
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: EU/1/99/107/004.
Rebetol Oral Solution
Package leaflet: Information for the user
Rebetol® 40 mg/mL oral solution
ribavirin
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
What is in this leaflet
1. What Rebetol is and what it is used for
2. What you need to know before you use Rebetol
3. How to use Rebetol
4. Possible side effects
5. How to store Rebetol
6. Contents of the pack and other information
This Package Leaflet contains information for the paediatric patient (child or adolescent, 3 through 17 years of age), or for his or her parent or caregiver.
1. What Rebetol is and what it is used for
Rebetol contains the active substance ribavirin. This medicine stops the multiplication of hepatitis C virus. Rebetol must not be used alone.
The combination of Rebetol and other medicines is used to treat patients who have chronic hepatitis C (HCV).
Rebetol may be used in paediatric patients (children 3 years of age and older and adolescents), who are not previously treated and without severe liver disease.
2. What you need to know before you use Rebetol
Do not take Rebetol
Do not take Rebetol if any of the following apply to you or the child you are caring for.
If you are not sure, talk to your doctor or pharmacist before taking Rebetol.
Reminder: Please read the “Do not take” section of the Package Leaflet for the other medicines used in combination with this medicine.
Warnings and precautions
There are several serious adverse reactions associated with the combination therapy of ribavirin with (peg)interferon alfa. These include:
Paediatric population
If you are caring for a child and your doctor decides not to defer combination treatment with peginterferon alfa-2b or interferon alfa-2b until adulthood, it is important to understand that this combination therapy induces a growth inhibition that may be irreversible in some patients.
In addition these events have occurred in patients taking Rebetol:
Haemolysis: Rebetol can cause a break down in red blood cells causing anaemia which may impair your heart function or worsen symptoms of heart disease.
Pancytopenia: Rebetol can cause a decrease in your platelet and red and white blood cell count when used in combination with peginterferon.
Standard blood tests will be taken to check your blood, kidney and liver function.
Seek medical help immediately if you develop symptoms of a severe allergic reaction (such as difficulty in breathing, wheezing or hives) while taking this treatment.
Talk to your doctor if you or the child you are caring for:
Please refer to the Package Leaflet of (peg)interferon alfa for more detailed information on these safety issues.
Reminder: Please read the “Warnings and precautions” section of the Package Leaflet for the other medicines used in combination with Rebetol before you begin combination treatment.
Other medicines with Rebetol
Tell your doctor or pharmacist if you or the child you are caring for are taking, have recently taken or might take:
Reminder: Please read the “Other medicines” section of the Package Leaflet for the other medicines used in combination with Rebetol before you begin combination treatment with this medicine.
Pregnancy and breast-feeding
If you are pregnant, you must not take this medicine. This medicine 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:
If you are a woman who is breast-feeding, you must not take this medicine. Discontinue breast-feeding before starting to take this medicine.
Driving and using machines
This medicine does not affect your ability to drive or use machines; however, other medicines used in combination with Rebetol may affect your ability to drive or use machines. Therefore, do not drive or use machines if you become tired, sleepy, or confused from this treatment.
Rebetol contains benzyl alcohol (E 1519)
This medicine contains 0.5 mg of benzyl alcohol per mL.
Benzyl alcohol may cause allergic reactions.
Ask your doctor or pharmacist for advice if you have a liver or kidney disease. This is because large amounts of benzyl alcohol can build-up in your body and may cause side effects (called “metabolic acidosis”).
Rebetol contains propylene glycol (E 1520)
This medicine contains 100.3 mg propylene glycol in each mL.
Rebetol contains sodium
This medicine contains up to 23.8 mg sodium (main component of cooking / table salt) in each daily dose. This is equivalent to 1.19 % of the recommended maximum daily dietary intake of sodium for an adult.
Rebetol contains sodium benzoate (E 211)
This medicine contains 1 mg sodium benzoate per mL.
Rebetol contains sorbitol (E 420)
This medicine contains 142 mg sorbitol in each mL. Sorbitol is a source of fructose. If your doctor has told you that you (or your child) have an intolerance to some sugars or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which a person cannot break down fructose, talk to your doctor before you (or your child) take or receive this medicine.
Rebetol contains sucrose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine. Sucrose may be harmful to the teeth.
3. How to use Rebetol
General information about taking this medicine:
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 this medicine based on how much you or the child you are caring for weighs.
Use in children and adolescents
Dosing for children above 3 years of age and adolescents depends on how much the person weighs and the medicines that are used in combination. The recommended dose of Rebetol combined with interferon alfa-2b or peginterferon alfa-2b, is shown in the below table.
Rebetol oral solution – Usual dosage to be used with interferon alfa-2b or peginterferon alfa-2b in children above 3 years of age and adolescents
If the patient weighs 10-12 kg
Measure and give this dose:
If the patient weighs 13-14 kg
Measure and give this dose:
If the patient weighs 15-17 kg
Measure and give this dose:
If the patient weighs 18-20 kg
Measure and give this dose:
If the patient weighs 21-22 kg
Measure and give this dose:
If the patient weighs 23-25 kg
Measure and give this dose:
If the patient weighs 26-28 kg
Measure and give this dose:
If the patient weighs 29-31 kg
Measure and give this dose:
If the patient weighs 32-33 kg
Measure and give this dose:
If the patient weighs 34-36 kg
Measure and give this dose:
If the patient weighs 37-39 kg
Measure and give this dose:
If the patient weighs 40-41 kg
Measure and give this dose:
If the patient weighs 42-44 kg
Measure and give this dose:
If the patient weighs 45-47 kg
Measure and give this dose:
1. Measure:
You can measure the dose with the oral dosing syringe provided.
The plastic oral dosing syringe consists of two parts, an opaque barrel, and a white plunger rod that fits into the barrel.
The rod is marked with 0.5 mL markings starting at 1.5 mL (at the very top of the rod) and ending at 10 mL.
A. Insert the assembled dosing syringe into the bottle of Rebetol oral solution.
B. While keeping the tip in the liquid, pull the rod out. As the solution fills the syringe, you will see the numbers on the rod go up, such as 1.5 mL, 2.0 mL, 2.5 mL, etc.
Reminder: Your doctor may have changed the amount based on recent test results.
C. Pull the rod out until you can read the correct number of mL for the dose you are measuring.
D. Take the oral syringe out of the bottle and check to see that the correct amount appears in the bottom of the syringe. If you have too much or too little, try again until you have the correct amount.
2. Deliver:
Try not to let the oral syringe touch the inside of the mouth.
Hold the syringe to your mouth and release the dose into your mouth (or the mouth of the patient you are caring for) by pushing in the rod.
Swallow the dose.
3. Rinse:
If the syringe has touched the inside of the mouth, rinse it with water before inserting it in the bottle again.
The syringe should be rinsed with water after each use to avoid stickiness.
4. Taking all your medicine:
Take or give the prescribed dose by mouth in the morning and evening, with a meal.
Reminder: This medicine is used in combination with other medicines for hepatitis C virus infection. For complete information be sure to read the “How to use” section of the Package Leaflet for the other medicines used in combination with Rebetol.
If you take more Rebetol than you should
Tell your doctor or pharmacist as soon as possible.
If you forget to take Rebetol
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 the other medicines used in combination with Rebetol.
Like all medicines, this medicine used in combination with other medicines can cause side effects, although not everybody gets them. Although not all of these unwanted effects may occur, they may need medical attention if they do occur.
Contact your doctor immediately if you notice any of the following side effects occurring during combination treatment with other medicines:
Children and adolescents
The following side effects have been reported with the combination of this medicine and an interferon alfa-2b product in children and adolescents:
Very commonly reported side effects (may affect more than 1 in 10 people):
Commonly reported side effects (may affect up to 1 in 10 people):
Uncommonly reported side effects (may affect up to 1 in 100 people):
Adults
The additional following side effects have occurred with the combination of this medicine and an alpha interferon product in adults but not in children:
Commonly reported side effects (may affect up to 1 in 10 people):
Uncommonly reported side effects (may affect up to 1 in 100 people):
Rarely reported side effects (may affect up to 1 in 1,000 people):
Very rarely reported side effects (may affect up to 1 in 10,000 people):
Not known side effects (frequency cannot be estimated from the available data):
The attempt to self-harm has also been reported in adults, children, and adolescents.
This medicine in combination with an alpha interferon product may also cause:
The following other side effects have also been reported with the combination of this medicine and an alpha interferon product:
This medicine in combination with peginterferon alfa-2b or interferon alfa-2b may also cause:
You or your caregiver should call your doctor immediately if you have any of these side effects.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store . By reporting side effects, you can also help provide more information on the safety of this medicine.
5. How to store Rebetol
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. Once the bottle has been opened, the oral solution can be used for 1 month.
Do not store above 30°C.
Do not use this medicine without advice of your doctor or pharmacist if you notice any change in the appearance of the solution.
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 Rebetol contains
What Rebetol looks like and contents of the pack
This solution is packaged in 118 mL size amber glass bottles containing 100 mL of oral solution.
A 10 mL oral dosing syringe is provided to measure the dose.
Marketing Authorisation Holder:
Manufacturer:
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
This leaflet was last revised in September 2020
Other sources of information
Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
© Merck Sharp & Dohme Limited 2020. All rights reserved.
PIL.RBO.20.UK.7322a.IB-088.RCN013327-email change
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