Patient Information Leaflet for Hepatyrix® Vaccine

(Combined inactivated hepatitis A and Vi polysaccharide typhoid vaccine)

1. WHAT HEPATYRIX IS AND WHAT IT IS USED FOR

Hepatyrix is presented as a white and milky suspension. It is provided in single dose (1 ml) glass prefilled syringes.

Hepatyrix is available in packs of 1 and 10, with or without needles.

Hepatyrix is a vaccine that can be given to adults and teenagers from 15 years of age and above. The vaccine is used to help prevent two infectious diseases: hepatitis A and typhoid fever. The vaccine works by causing the body to produce its own protection (antibodies) against these infectious diseases.

Hepatitis A is an infectious illness of the liver caused by a virus.

Typhoid fever is an infectious illness caused by a type of bacteria called Salmonella typhi. Both diseases are caught and spread by eating or drinking contaminated food or water.

Since the hepatitis A virus and typhoid bacterium are present in the stools, the diseases can occur in any country, but they more commonly occur in places or countries with poor standards of personal or public hygiene. The main signs of hepatitis A infection include a headache, fever, sickness and jaundice (yellowing of the skin and eyes). Most patients usually get better in a few weeks, but it may take some months to make a full recovery. Rarely, hepatitis A infection can also cause serious liver disease and very rarely death. Hepatyrix can only help to protect you against infections with hepatitis A virus. It cannot protect you against other infections that can affect the liver that can cause symptoms similar to those of hepatitis A infections.

The main signs of typhoid fever include headache, pains in the stomach, constipation or diarrhoea, fever and, in some people, a rash. Patients normally get better after about four weeks, but relapses can occur. If it is not treated properly, typhoid can also be fatal. Hepatyrix can only protect you against typhoid fever. It cannot protect you against paratyphoid fever or infections with other salmonella bacteria that can cause food poisoning.

Hepatyrix does not contain live viruses or live bacteria and it cannot cause hepatitis A or typhoid fever.

If you have already been infected with hepatitis A virus before you have Hepatyrix, but you are not yet feeling unwell, the vaccine may not be able to prevent you becoming ill. Remember that no vaccine can provide complete, life long protection in all people vaccinated.

2. BEFORE YOU RECEIVE HEPATYRIX

Hepatyrix is only suitable for people who are at least 15 years old.

Hepatyrix must not be given if the answer to any of the following questions for the person who is going to have Hepatyrix is "YES".

If you are not sure about anything, ask your doctor or nurse before Hepatyrix is given to you.

• Have you previously had any allergic reaction to Hepatyrix, or any ingredient contained in this vaccine? The active substances and other ingredients in Hepatyrix are listed at the beginning of the leaflet. Signs of an allergic reaction may include itchy skin rash, shortness of breath and swelling of the face or tongue.
• Are you known to be allergic to neomycin?
• Have you previously had an allergic reaction to any vaccine against hepatitis A or typhoid fever diseases?
• Do you have a severe infection with a high temperature? In these cases, the vaccination will be postponed until you have recovered. A minor infection such as a cold should not be a problem, but talk to your doctor first.

If, for you or the person who is having the vaccine, the answer to any of the following questions is yes, Hepatyrix may or may not be suitable. Your doctor or nurse will advise you.

• do you have a poor immune response because you have had, or are having a course of treatment such as corticosteroids, cytotoxic drugs or radiotherapy? Your doctor or nurse may want to wait until the course of treatment has finished.
• do you have problems with your immune system due to AIDS or have you had a positive test for human immunodeficiency virus (HIV)? You may be given Hepatyrix, but the vaccine may not protect you as well as it protects people with normal immune systems.

3. HOW HEPATYRIX IS GIVEN

The dose of Hepatyrix for people who are at least 15 years of age is one millilitre.

The doctor or nurse will give Hepatyrix as an injection into muscle, usually in your upper arm.

Your doctor or nurse will take care that Hepatyrix is not given into a blood vessel.

The vaccine would not usually be given deep into the skin because protection may be less.

Your doctor or nurse will give you instructions on when to receive Hepatyrix vaccine.

For travellers, the vaccine is usually given at least two weeks before departure to give the immune system time to respond and start to protect you against infection.

If you have not previously been vaccinated against hepatitis A, one injection of Hepatyrix will protect you from hepatitis A infection for at least one year. You will need a booster injection of an inactivated hepatitis A vaccine 6 to 12 months later to give you protection against hepatitis A for up to 10 years.

Hepatyrix can also be given to you to boost your immunity to hepatitis A if you have already received a first dose of inactivated hepatitis A vaccine 6 to 12 months ago, provided that you also require protection against typhoid fever.

One injection of Hepatyrix should protect you from typhoid fever for about three years. If, after 3 years, you carry on being at risk from catching typhoid fever, you should arrange to receive an injection of purified Vi polysaccharide typhoid vaccine.

4. POSSIBLE SIDE EFFECTS

Any vaccine can have some side effects.

Serious allergic reactions are a very rare possibility after receiving a vaccine. These happen in less than one in ten thousand people vaccinated. These reactions may include difficulty in breathing, blue discolouration of the tongue or lips, low blood pressure (causing dizziness) and collapse. When these signs or symptoms occur they usually develop very quickly after the injection is given and while the person affected is still in the clinic or doctor's surgery. If any of these symptoms occur after leaving the place where your injection was given, you must consult a doctor IMMEDIATELY.

Side effects that occurred during clinical trials with Hepatyrix were as follows:

Very common (more than 1 in ten people vaccinated):

• Discomfort at the injection site or pain or redness

Common (less than 1 in 10 but more than 1 in 100 people vaccinated):

• Swelling at the injection site
• Feeling generally unwell
• Headache
• General aches
• Fever
• Feeling sick
• Itching

Very rare (less than 1 in 100,000 people vaccinated)

• Fainting

Also, being sick and loss of appetite were reported during clinical trials with the individual hepatitis A vaccine so they may happen after having Hepatyrix.

Additional side effects that have been reported very rarely (less than one in 10,000 people vaccinated) in the days or weeks after vaccination with Hepatyrix or with the individual hepatitis A vaccine, include:

• Other allergic reactions. These may be local or widespread rashes that may be itchy or blistering, or swelling of the eyes and face.
• Joint or muscle pains
• Fits
• Problems with the normal working of the nerves that can cause symptoms such as odd sensations including pins and needles, loss of feeling or numbness, problems moving your arms or legs or difficulty with walking and moving about.

If these events continue or become severe, tell your doctor.

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

5. STORING HEPATYRIX

Your doctor or nurse will usually make sure that Hepatyrix is stored correctly at 2°C - 8°C (in a refrigerator) in the original package so that it is protected from light.

They will also make sure that the vaccine is not used after the expiry date on the label.

The vaccine must not be frozen since this destroys the vaccine.

Hepatyrix must always be kept out of the reach and sight of children.