Epaxal
Hepatitis A Vaccine
inactivated, virosome
Read all of this leaflet carefully before this vaccine is given.
- Keep this leaflet. You may need to read it again.
- If you have further questions, please ask your doctor or your pharmacist.
In this leaflet:
- 1. What Epaxal is and what it is used for
- 2. Before having Epaxal
- 3. How Epaxal is given
- 4. Possible side effects
- 5. Storing Epaxal
- 6. Further information
The full name of the vaccine is Epaxal, emulsion for injection in pre-filled syringe, Hepatitis A vaccine (inactivated, virosome)
- The active substance in Epaxal is 24 international units of inactivated (killed) hepatitis A virus (strain RG-SB) that has been grown in human diploid cells. The viruses have been adsorbed on to particles called virosomes that are made from parts of the outer coat of a type of influenza virus and phospholipids called lecithin and cephalin.
- The other ingredients are sodium chloride and water for injections.
The Product License Holder is
Epaxal is manufactured by
What Epaxal is and what it is used for
Epaxal is provided as a clear, colourless liquid in a pre-filled syringe that contains a single 0.5 ml dose. The vaccine is available in packs of one or 10 pre-filled syringes.
Epaxal is a vaccine which contains killed hepatitis A virus. It works by causing your body to produce antibodies (your body’s natural defence system) against the hepatitis A virus. These antibodies will protect you against hepatitis A infection from about 2 to 4 weeks after the injection. Epaxal can be used in children from 1 year of age and adults.
Some general information about hepatitis A is given at the end of this leaflet.
Epaxal will only protect you against hepatitis A and not against any other type of hepatitis virus or any other illness that can cause hepatitis (inflammation of the liver).
Before having Epaxal
You should not have Epaxal if the answer to any of the following questions is “YES”. If you are unsure of anything or have questions, please talk to your doctor, nurse or pharmacist before the vaccine is given.
- Are you allergic to eggs or to products made from chicken?
- Are you allergic to formaldehyde?
- Are you allergic to any of the ingredients of the vaccine?
Also, vaccination may have to be delayed if the answer to the following question is “YES”:
- Do you have an infection with a fever at the moment?
Take special care with Epaxal
If the answer to the following question is “YES”, please tell your doctor, nurse or pharmacist before the vaccine is administered.
- Do you have a poor immune system (poor resistance to infections)? You may still be able to have Epaxal, but you may not develop enough antibodies after a single injection to protect you against infection. See section 3 about the need
for an early booster dose.
Also, please note the following:
- Is the person to be vaccinated less than one year old? Epaxal is not recommended below the age of one year.
- Are you more than 60 years old? You can still have Epaxal but information on protection in people over 60 is limited.
Please take note that if you normally have a flu vaccine, you will still need to have it. Although there are small amounts of influenza virus protein in Epaxal, the vaccine will not protect you against catching flu.
Pregnancy and breast-feeding
Epaxal should only be given to pregnant women if it is clearly necessary. If you are or think that you might be pregnant, discuss this with your doctor or nurse before having Epaxal.
It is not known if the vaccine passes into the breast milk. Talk to your doctor or nurse if you are breast-feeding.
Driving and using machines
Having this vaccine occasionally gives people dizziness or headaches that might affect your ability to drive or use machines.
Taking/using other medicines and having other vaccines
Please inform your doctor or nurse if you are taking or have recently taken any other medicines, even those not prescribed.
You can take tablets for the prevention of malaria on the same days as having doses of Epaxal. There is no need to stop the medicine.
Epaxal can be given at the same time as vaccines against yellow fever, typhoid fever, poliomyelitis, diphtheria, tetanus, meningococci A + C and influenza.
Vaccines given at the same time as Epaxal will be given using a separate syringe and at different injection sites.
You can also receive a dose of human gamma globulin (antibody) if it is necessary to protect you immediately against hepataitis A infection. The gammaglobulin should be given at a different injection site.
How Epaxal is given
Your doctor or nurse will inject the vaccine into the muscle, usually in your upper arm. In people who have conditions that make them bleed easily or whose blood does not clot normally, Epaxal can be given just below the skin.
The dose for all ages from one year upwards is 0.5 ml.
Protection against hepatitis A following the first vaccine dose should last for at least one year. To make sure that protection against hepatitis A is continued, a second dose of 0.5 ml should be given. It is best if this is given between 6 and 12 months after the first dose but it is known that a very good immune response to the booster occurs when the second dose is given up to 4 years later. Even if more than 4 years have gone by, you can still have a second dose of Epaxal
to boost your immunity.
People who have poor immunity to infections for any reason, should have a second dose earlier than other people, usually between 1 and 6 months after the first dose.
If you received your first vaccine dose with another hepatitis A vaccine, you can still be given Epaxal for the booster vaccination. Also, people who received Epaxal for the first dose can be boosted with another hepatitis A vaccine if necessary.
Epaxal Side Effects
Like all medicines, Epaxal can have side effects.
Serious allergic reactions are always a possibility after receiving a vaccine.
These reactions (reported by less than 1 in 10,000 people) 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.
Very common side effects (reported by more than 1 in 10 people) are pain at the injection site, tiredness and headaches.
Common side effects (reported by less than 1 in 10 but more than 1 in a 100 people) are:
- feeling sick
- diarrhoea
- loss of appetite
- redness, swelling or lumpiness at the site of injection
- generally feeling unwell
- fever (high temperature)
Uncommon side effects (reported by less than 1 in a 100 but more than 1 in a 1000 people) are:
- itchiness of the skin
- a rash
- dizziness
- being sick
- joint pain
Very rarely there may be reactions involving the nerves. You should tell your doctor immediately if you notice any of the following: pins and needles, loss of feeling or numbness and problems moving your arms or legs. Also, blood tests that measure how the liver is working sometimes show some slight changes for a brief period after vaccination.
If you notice any other effects after the vaccination that are not mentioned here, tell your doctor, nurse or pharmacist.
Storing Epaxal
Epaxal should be stored at 2–8 °C (in a refrigerator) and protected from light. It must not be frozen. The vaccine must not be used after the expiry date.
Keep Epaxal out of the reach and sight of children.
Further Information
Epaxal is distributed in the UK by:
This leaflet was last revised in March 2006
Disease information on hepatitis A
Hepatitis A is a liver disease caused by the hepatitis A virus. You can catch the virus by eating or drinking contaminated food or water. The virus is present in the stools of infected people, even if they show no signs of the disease. You can catch hepatitis A infection in any country but the risk is highest in countries where sanitation and food and water hygiene are poor.
After catching the virus, it can be up to six weeks before signs of illness are seen. Some people have the virus and never get ill but they can still infect other people during this time.
The main signs of the illness include a headache, fever, sickness and jaundice (yellowing of the skin and eyes). These signs are all due to an inflammation of the liver while it is infected with the virus. Most patients get better usually after a couple of months, but a few people may take up to a year to make a full recovery. Whilst recovering, people affected with hepatitis A may be unable to work, they may not be able to drink alcohol and may need to avoid certain foods according
to their doctors’ advice. Severe complications are very rare but sometimes the liver stops working and very special hospital care is needed until the infection gets better. The severity of the disease increases with age, and adults above
the age of 40–50 years are at an increased risk to suffer from complications, which can sometimes be fatal.
There are many other types of virus that can cause hepatitis. The signs may be the same as in hepatitis A infection but the other viruses are not always caught through food and drink. Epaxal can help to protect you against infection with
the hepatitis A virus only.
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