Epaxal vaccine emulsion for injection 0.5ml pre-filled syringes

Epaxal is a vaccine which is used to give people immunity to hepatitis A. Vaccines work by making the body produce ‘ antibodies’. Antibodies are chemicals which inactivate germs when they enter the body. When you are vaccinated against an illness caused by particular germs, your body can produce antibodies to those germs very quickly and so the illness does not get a chance to develop. Because of this, vaccination is a very good way of preventing some illnesses.

Your prescriber may give you a booster dose, usually 6-12 months after the first dose to give you long-term protection against hepatitis A.

Epaxal is given to you by a healthcare professional. The person responsible for giving you your medicine will make sure that you get the right dose.

If you feel unwell after having the medicine then talk to your prescriber or someone involved in your medical care.

The person with responsibility for giving you your medicine will make sure that you have your medicine at the correct time.

This medicine will be given to you as an injection. If you have any concerns about this medicine or how this will be given to you, talk to someone who is involved in your medical care.

Having extra doses of some medicines can be harmful. In some cases even one extra dose can cause you problems.

In the case of Epaxal, the person who is responsible for giving you your medicine will make sure that you are given the correct dose.

As Epaxal is a vaccination which is usually given as a single dose, considerations to stopping this medicine are not relevant.

The medical team will often be responsible for looking after this medicine. However, if you are responsible for looking after this medicine make sure that you store it properly and safely. Check the label and Patient Information leaflet for details or ask a member of your medical team.

In the case of Epaxal:

Do not use the medicine after the expiry date shown on the packaging. If you have any unused medicine, return it to your pharmacist who will dispose of it safely.

Epaxal is not suitable for everyone and some people should never use it. Other people should only use it with special care. It is important that the person prescribing this medicine knows your full medical history.

Your prescriber may only prescribe this medicine with special care or may not prescribe it at all if you:

Furthermore the prescriber may only prescribe this medicine with special care or may not prescribe it at all for a child under the age of one year.

A medicine is only made available to the public if the clinical trials have shown that the benefits of taking the medicine outweigh the risks.

Once a medicine has been licensed, information on the medicine's effects, both intended and unintended, is continuously recorded and updated.

Some side-effects may be serious while others may only be a mild inconvenience.

Everyone's reaction to a medicine is different. It is difficult to predict which side-effects you will have from taking a particular medicine, or whether you will have any side-effects at all. The important thing is to tell your prescriber or pharmacist if you are having problems with your medicine.

Very common: More than 1 in 10 people who have Epaxal:

• headaches
• pain at the injection site
• tiredness

Common: More than 1 in 100 people who have Epaxal:

• diarrhoea
• fever
• general feeling of being unwell
• injection site reactions such as redness, hardening of the skin or swelling
• loss of appetite
• nausea

Uncommon: More than 1 in 1000 people who have Epaxal:

• feeling dizzy
• itching
• joint pain
• skin rash or rashes
• vomiting

The frequency of these side-effects is unknown:

• abnormal laboratory test results
• anaphylactic shock
• inflammation of the nervous system including neurological problems such as paralysis and Guillain Barr syndrome

If you feel unwell or if you have concerns about a side-effect, you will need to seek advice. If you feel very ill, get medical help straight away. Contact your prescriber, pharmacist, nurse or call NHS Direct on 0845 46 47.

There are no known important interactions between Epaxal and other medicines. If you experience any unusual symptoms while having Epaxal and other medicines you should tell your prescriber.

Medicines can interact with complementary preparations and vitamins. In general, there is not much information available about interactions between medicines and complementary preparations or vitamins.

If you are planning to take or are already taking any complementary preparations and vitamins you should ask your prescriber whether there are any known interactions with Epaxal.

Your prescriber can advise whether it is appropriate for you to take combinations that are known to interact. They can also discuss with you the possible effect that the complementary preparations and vitamins may have on your condition.

If you experience any unusual effects while taking this medicine in combination with complementary preparations and vitamins, you should tell your prescriber.

When taking any medicine you should be aware that it might interfere with your ability to drive or operate machinery safely.

You should see how this medicine affects you before you judge whether you are safe to drive or operate machinery. If you are in any doubt about whether you should drive or operate machinery, talk to your prescriber.

Medicines can interact with certain foods. In some cases, this may be harmful and your prescriber may advise you to avoid certain foods.

In the case of Epaxal:

Alcohol can interact with certain medicines.

In the case of Epaxal:

Most medicines, in some way, can affect the development of a baby in the womb. The effect on the baby differs between medicines and also depends on the stage of pregnancy that you have reached when you take the medicine.

In the case of Epaxal:

You need to discuss your specific circumstances with your doctor to weigh up the overall risks and benefits of taking this medicine. You and your doctor can make a decision about whether you are going to take this medicine during pregnancy.

If the decision is that you should not have Epaxal, then you should discuss whether there is an alternative medicine that you could take during pregnancy.

Certain medicines can pass into breast milk and may reach your baby through breast-feeding.

In the case of Epaxal:

Before you have your baby you should discuss breast-feeding with your doctor or midwife. They will help you decide what is best for you and your baby based on the benefits and risks associated with this medicine. You should only breast-feed your baby while taking this medicine on the advice of your doctor or midwife.

Medicines contain active ingredients. They may also contain other, additional ingredients that help ensure the stability, safety and effectiveness of the medicine. Some may be used to prolong the life of the medicine.

Epaxal contains:

If you are not able to take any of the ingredients in your medicine, talk to your prescriber or pharmacist to see if they can suggest an alternative medicine. If you have reacted badly to Epaxal before, do not have Epaxal. Talk to your prescriber, pharmacist or nurse as soon as possible.