<!DOCTYPE DOCUMENT SYSTEM "icon.dtd" []>

<DOCUMENT author="perl program" datec=020199 title="leaflet" book="ABPI" edition="1996-97" section="company">
<PB n=1>
<CB n=1>
<DIV type=0>

<HEAD weight="bold" >
Patient Information Leaflet
</HEAD>

<DIV type=1>

<HEAD weight="bold" >
Viraferon Injection
</HEAD>


</DIV>
<DIV type=1>

<HEAD weight="bold" >
What is Viraferon?
</HEAD>


<BLOCK>
Viraferon contains a substance known as alfa interferon. Alfa interferons are proteins which are normally produced by the body to help defend itself against viruses.
</BLOCK>


</DIV>
<DIV type=1>

<HEAD weight="bold" >
What type of medicine is it?
</HEAD>


<BLOCK>
Viraferon is an alfa interferon used to treat some viral infections. It cannot be taken by mouth since it would be broken down by enzymes in the gut. It must therefore be administered by injection. The dose is measured in International Units (IU)
</BLOCK>


</DIV>
<DIV type=1>

<HEAD weight="bold" >
What do vials of Viraferon contain?
</HEAD>


<BLOCK>
Viraferon is available as a solution. Solutions contain either 10 million IU or 25 million IU of interferon alfa-2b(rbe) per vial. They also contain the following inactive ingredients: glycine, sodium phosphate dibasic, sodium phosphate monobasic, methyl and propyl parabens, human albumin and water for injections.
</BLOCK>


<BLOCK>
Product Licence Holder: Schering-Plough Ltd, Welwyn Garden City, Hertfordshire AL? 1TW.
</BLOCK>


<BLOCK>
Manufactured by: Schering-Plough (Brinny) Co., Innishannon, County Cork, Ireland.
</BLOCK>


</DIV>
<DIV type=1>

<HEAD weight="bold" >
When is Viraferon used?
</HEAD>


<BLOCK>
Viraferon is used to treat Hepatitis B and Hepatitis C/ Non-A, Non-B, which are viral infections of the liver.
</BLOCK>

<DIV type=2>

<HEAD slant="italic" >
What is Hepatitis?
</HEAD>


<BLOCK>
Hepatitis simply means inflammation of the liver. It is often caused by infection with a virus. The four most important types of viral Hepatitis are known by the letters A, B, C and D.
</BLOCK>


<BLOCK>
Hepatitis A is the commonest type, and patients normally recover completely. Hepatitis B and Hepatitis C are a greater threat to health because they can develop into chronic disease (see below). Hepatitis D virus can only infect someone who has already contracted the Hepatitis B virus.
</BLOCK>


</DIV>
<DIV type=2>

<HEAD slant="italic" >
What is Hepatitis B?
</HEAD>


<BLOCK>
The virus which causes Hepatitis B is carried by millions of people throughout the world. The virus is transferred from person to person by contact with body fluids such as blood, saliva and urine. It is most commonly spread by sexual contact or by sharing contaminated needles. The virus can also be transmitted from mother to child during (or soon after) birth.
</BLOCK>


<BLOCK>
The initial symptoms of Hepatitis B include fever, tiredness, loss of appetite and flu-like symptoms, followed by jaundice (the skin and the white of the eyes turn yellow). However, in some people the symptoms are very mild. The majority of people recover completely but a proportion will become chronic carriers. Hepatitis is considered to be chronic when the virus is still present in the body six months or more after the initial illness. This indicates that the body has not succeeded in overcoming the infection.
</BLOCK>


<BLOCK>
A minority of people with chronic Hepatitis B go on to develop cirrhosis (permanent scarring of the liver) or liver cancer, both of which can be fatal. Fortunately, effective treatment is now available for chronic Hepatitis B.
</BLOCK>


</DIV>
<DIV type=2>

<HEAD slant="italic" >
What is Hepatitis C?
</HEAD>


<BLOCK>
Hepatitis C is caused by a different kind of virus to Hepatitis B, and it is more difficult to screen for in the blood. Hepatitis C is most often spread through blood transfusions, but it is also associated with drug abuse and sexual activity. Some patients will have initial symptoms similar to those in Hepatitis A or B, but these are generally less severe in Hepatitis C.
</BLOCK>


<BLOCK>
About half of the people infected with the Hepatitis C virus go on to develop the chronic disease (a higher incidence than that seen with Hepatitis B). There is <CB n=2> also a higher chance that these people will subsequently develop cirrhosis of the liver.
</BLOCK>


<BLOCK>
Your doctor will explain to you which of these conditions you have.
</BLOCK>


</DIV>

</DIV>
<DIV type=1>

<HEAD weight="bold" >
Are there any people who should not be treated with Viraferon?
</HEAD>


<BLOCK>
You should not be treated if you:
</BLOCK>


<LIST type="bulleted">

<ITEM>

<BLOCK>
are allergic to any of the ingredients in Viraferon
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
have a severe heart complaint
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
have severe kidney disease
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
have epilepsy, or other nervous system problems
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
have thyroid disease (unless you are taking treatment for it)
</BLOCK>

</ITEM>

</LIST>



<BLOCK>
Children are not normally treated with Viraferon unless the doctor thinks that it is essential.
</BLOCK>


<BLOCK>
You should not take Viraferon if you have certain types of long-term liver disease e.g. cirrhosis (check with your doctor if you are not sure).
</BLOCK>


</DIV>
<DIV type=1>

<HEAD weight="bold" >
It may be necessary to carry out tests during treatment
</HEAD>


<BLOCK>
At intervals whilst receiving Viraferon therapy and prior to starting treatment your blood will be tested. In addition, if you are being treated for Hepatitis B you may also need a special liver test (a liver biopsy).
</BLOCK>


</DIV>
<DIV type=1>

<HEAD weight="bold" >
Are there any other reasons why Viraferon should not be used?
</HEAD>


<BLOCK>
If you are pregnant or breast-feeding a baby you should only be treated with Viraferon if you have discussed with your doctor whether the benefits of the medicine for you, the mother, outweigh any possible risks to the child. If you are of child-bearing age, you should use contraceptives during treatment.
</BLOCK>


</DIV>
<DIV type=1>

<HEAD weight="bold" >
What would happen if you were allergic to Viraferon?
</HEAD>


<BLOCK>
Very rarely, some patients have allergic reactions following their first injection. This could be in the form of a severe, red or itchy rash, difficulty in breathing, or shock. Your doctor will then stop your treatment.
</BLOCK>


</DIV>
<DIV type=1>

<HEAD weight="bold" >
Should Viraferon be stopped for any other reason?
</HEAD>


<BLOCK>
If you have any of the following illnesses before treatment, or develop them whilst on treatment, your doctor may need to reduce your dose of Viraferon, or you may need extra treatment to control them. Your doctor will decide by watching the signs and symptoms carefully, doing tests if necessary. In some cases it may be necessary to stop Viraferon altogether:
</BLOCK>


<LIST type="bulleted">

<ITEM>

<BLOCK>
chest problems or pneumonia
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
diabetes
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
problems with blood clotting ,
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
liver conditions
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
low blood pressure
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
a heart attack or irregular heart beat
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
depression, confusion, unconsciousness
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
thyroid problems
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
psoriasis
</BLOCK>

</ITEM>

</LIST>



<BLOCK>
If you notice any changes in your eyesight whilst you are taking Viraferon, you should tell your doctor as he may wish to perform an eye examination.
</BLOCK>


</DIV>
<DIV type=1>

<HEAD weight="bold" >
Are there any medicines which should not be given at the same time as Viraferon?
</HEAD>


<BLOCK>
Sleeping tablets, medicines taken for anxiety (sedatives) and strong pain killers should not be taken during treatment unless you have checked with your doctor first. You can take 1-2 paracetamol 500 mg tablets 30 minutes before injection if you need to but remember not to exceed 8 tablets in any 24 hours.
</BLOCK>


<BLOCK>
Certain asthma drugs, called theophylline or aminophylline, may need a change in dosage during Viraferon treatment.
</BLOCK>


</DIV>
<DIV type=1>

<HEAD weight="bold" >
What is the dose?
</HEAD>


<BLOCK>
The dose you are given depends on how big you are. It varies with your body surface area. Technically, this is measured in square metres (m2), but actually it is worked out from your weight and height.
</BLOCK>


<BLOCK>
There are also different doses according to the disease being treated. Sometimes doctors prescribe different doses to those shown below. If this applies <PB n=2> <CB n=1> to you, you can discuss it with your doctor, if you have not already done so.
</BLOCK>


</DIV>
<DIV type=1>

<HEAD weight="bold" >
How is Viraferon given?
</HEAD>


<BLOCK>
Usually by subcutaneous injection. This means Viraferon is injected with a short needle into the fatty tissue just under the skin. It is usually given three times a week on every other day, for example, on Mondays, Wednesdays and Fridays.
</BLOCK>


<BLOCK>

<EMPH slant = "italic">
Disease treated
</EMPH>

<EMPH slant = "italic">
Dose
</EMPH>
 Hepatitis B:Usually 2.5 to 5 million lU/m2 3 times a week for 4 to 6 months by subcutaneous injection.
</BLOCK>


<BLOCK>
Chronic Hepatitis C/Usually 3 million IU 3 times a Non-A, Non-B:week for up to 18 months, by subcutaneous injection.
</BLOCK>


</DIV>
<DIV type=1>

<HEAD weight="bold" >
What to do in case of overdose
</HEAD>


<BLOCK>
Contact your doctor as soon as possible.
</BLOCK>


</DIV>
<DIV type=1>

<HEAD weight="bold" >
Many patients give injections themselves at home
</HEAD>


<BLOCK>
As Viraferon is usually given 3 times a week, it is usually more convenient to have injections at home. You can give subcutaneous injections yourself. These injections are simple to do and you will be shown how to do them. Sometimes a relative, friend or community nurse could do them for you.
</BLOCK>


</DIV>
<DIV type=1>

<HEAD weight="bold" >
Injecting yourself
</HEAD>


<LIST type="bulleted">

<ITEM>

<BLOCK>
Wash your hands thoroughly and wipe the rubber stopper on the vial with an alcohol swab supplied.
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
Taking a hypodermic syringe, remove the cap from the needle and push the needle through the rubber stopper on the vial.
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
Holding the vial upside down, slowly withdraw the correct volume of solution into the syringe, replace the cap on the needle and place the syringe on a clean flat surface whilst you prepare the area to be injected.
</BLOCK>

</ITEM>

</LIST>



</DIV>
<DIV type=1>

<HEAD weight="bold" >
Choosing an injection site
</HEAD>


<LIST type="bulleted">

<ITEM>

<BLOCK>
The best sites are the thigh, the outer surface of the upper arm or the abdomen (not the navel or waistline). If you are thin, do not use the abdomen. You should use a different site for each injection.
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
Clean the injection site with an alcohol swab and let it dry. Remove the needle cap from the syringe, pinch a 2 inch fold of skin between your thumb and index finger and insert the needle into the skin fold at an angle of between 45° and 90°. Holding the syringe with one hand, pull back the plunger slightly and see if any blood is drawn up. If you see blood, do not inject; withdraw the needle and start again at a new site. If you do not see blood, slowly push the plunger to inject, withdraw the needle and gently hold an alcohol swab on the injection site. If it bleeds, apply an adhesive dressing. Replace the needle cap and safely discard the complete needle/syringe unit.
</BLOCK>

</ITEM>

</LIST>



</DIV>
<DIV type=1>

<HEAD weight="bold" >
What to do if you forget to inject Viraferon
</HEAD>


<BLOCK>
Inject your recommended dose as soon as you remember and then carry on as normal.
</BLOCK>


<BLOCK>

<EMPH weight="bold">
Are there any side-effects
</EMPH>
 Like all drugs, Viraferon has side effects. Although a lot of different side effects have been seen, you should <CB n=2> remember that most of them only rarely occur. Side effects are generally dose related and get better when treatment is stopped.
</BLOCK>


<BLOCK>
The most common side effects are "flu-like" symptoms, such as fever fatigue and headache. These symptoms are similar to those experienced when you catch flu and the body produces interferon naturally to fight off the virus. The feverish symptoms are most likely to occur 2 to 6 hours after the first few injections. After 2 weeks or so they are likely to disappear. Injecting Viraferon about 2 hours before bedtime and taking 1-2 paracetamol 500 mg tablets 30 minutes before the injection and again when you go to bed will help alleviate the symptoms. Remember not to ' take more than 8 tablets in any 24 hour period.
</BLOCK>


<BLOCK>
You may go on feeling tired after the first few weeks of Viraferon therapy. If this is the case, take plenty of rest and pace your activities. You may also suffer from nausea and lose your appetite.
</BLOCK>


<LIST type="bulleted">

<ITEM>

<BLOCK>
 pain and weakness, sleepiness, dizziness, dry mouth, hair loss, back pain, depression, increased sweating, taste alteration, irritability, difficulty sleeping, confusion, difficulty in concentrating and low blood pressure.
</BLOCK>

</ITEM>

</LIST>



<BLOCK>
The following side-effects only occur rarely in a few patients being treated with Viraferon: abdominal pain, rash, nervousness, problems at the site of injection e.g. inflammation or redness, Herpes simplex, e.g. cold sores, itching, eye pain, anxiety, nose bleeds, coughing, sore throat, chest problems, pneumonia, inflammation of the lungs, drowsiness, loss of weight, swelling of the face, difficulty in breathing, indigestion, irregular heart beat, high blood pressure, increased appetite, decreased sex drive, bleeding of the gums, problems with your eyesight. Viraferon may also have an effect on the thyroid gland and cause high blood sugar. If you are having laboratory tests performed on your blood and urine, Viraferon may cause abnormal results. Very rarely, a few people have had fits after having high doses of Viraferon.
</BLOCK>


<BLOCK>
If you think you are suffering from these or any: other side effects, you should tell your doctor.
</BLOCK>


</DIV>
<DIV type=1>

<HEAD weight="bold" >
How you should store your Viraferon
</HEAD>


<BLOCK>
Viraferon solution should be stored in a refrigerator at 2-8°C, but it can be stored at room temperature (below 25°C) for short periods e.g. when travelling long distances. Once you start using the vial, it should be kept in a refrigerator at 2-8°C. Do not continue using the solution after 28 days. You may wish to write the date when you first used the solution, on the vial.
</BLOCK>


<BLOCK>
Do not use Viraferon after the expiry date which is stamped on the label.
</BLOCK>


</DIV>
<DIV type=1>

<HEAD weight="bold" >
If there is anything you do not understand
</HEAD>


<BLOCK>
You will see from this leaflet that Viraferon is quite a complex medicine. If there is anything you do not understand, ask your doctor to explain it.
</BLOCK>


<BLOCK>
Date of Revision: October 1995
</BLOCK>

</DIV>

</DIV>

</DOCUMENT>
