ENGERIX B 20 MICROGRAMS / 1ML SUSPENSION FOR INJECTION - patient leaflet, side effects, dosage

1 What Engerix B is and what it is used for

Engerix B is a vaccine used to prevent hepatitis B infection. It can also help to prevent hepatitis D infection.

This vaccine can be given to new born babies, children and adolescents up to and including 15 years of age.

Hepatitis B is an infectious illness of the liver caused by a virus. Some people have the hepatitis B virus in their body but cannot get rid of it. They can still infect other people and are known as carriers. The disease is spread by the virus entering the body following contact with body fluids, most often blood, from an infected person.

If the mother is a carrier of the virus she can pass the virus to her baby at birth. It is also possible to catch the virus from a carrier through, for example, unprotected sex, shared injection needles or treatment with medical equipment which has not been properly sterilised.

The main signs of the illness include headache, fever, sickness and jaundice (yellowing of the skin and eyes) but in about three out of 10 patients there are no signs of illness.

In those infected with hepatitis B one out of 10 adults and up to nine out of 10 babies will become carriers of the virus and are likely to go on to develop serious liver damage and in some cases cancer of the liver.

How Engerix B works

Engerix B contains a small amount of the ‘outer coating’ of the hepatitis B virus. This ‘outer coating’ is not infectious and cannot make you ill.

• When you are given the vaccine it will trigger the body’s immune system to prepare itself to protect against these viruses in the future
• Engerix B will not protect you if you have already caught the hepatitis B virus

Engerix B can only help to protect you against infection with hepatitis B virus

2 What you need to know before you receive Engerix B

Engerix B should not be given:

• If you are allergic (hypersensitive) to Engerix B or any of the other ingredients of this vaccine (listed in section 6)
• If you have a high temperature (fever)

Engerix B should not be given if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before receiving Engerix B. Please tell your doctor or pharmacist if you have any allergies or if you have ever had any health problems after being given a vaccine.

Warnings and precautions

Talk to your doctor or pharmacist before you receive Engerix B if you:

• Are on dialysis for a kidney problem or have an illness which may affect your/his/her immune system.

People who have dialysis, long term liver problems, carry hepatitis C or are HIV positive may still be given Engerix B by their doctor. This is because hepatitis B infections can be severe in these patients. More information about kidney problems and dialysis is in section 3

If you are not sure if any of the above apply to you, talk to your doctor before having Engerix B.

Fainting can occur (mostly in adolescents) following, or even before, any needle injection. Therefore tell the doctor or nurse if you fainted with a previous injection.

Like other vaccines, Engerix B may not be totally effective in protecting you against hepatitis B. A number of factors, such as older age, gender, being overweight, smoking and some long term problems reduce your immune response to the vaccine. If any of these apply to you, your doctor may decide to give you a blood test or give you an additional dose of Engerix B to make sure you are protected.

Other medicines and Engerix B

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Engerix B can be given at the same time as most other routine vaccines. Your doctor will ensure that the vaccines are injected separately and into different parts of the body.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Engerix B is unlikely to affect your ability to drive or use machines. However, do not drive or use machines if you are feeling unwell.

Engerix B contains sodium

This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium free’.

3 How Engerix B is given

How your vaccine is given

The doctor will give the recommended dose of Engerix B to you.

Engerix B will be given:

• as an injection into the muscle of the upper arm in children and adolescents
• as an injection into the thigh muscle for babies and young children
• as an injection under the skin if you bruise easily or have a bleeding problem

How much is given

You will be given a series of injections of Engerix B. Once you have completed the course of injections you can expect long term protection against hepatitis B.

• New born babies, children and adolescents up to and including 15 years of age and under are usually given the 10 micrograms/0­.5 ml vaccine

There are several ways in which you can be given Engerix B. Your doctor will choose the most appropriate course for you:

Schedule 1 – for new born babies, children and adolescents up to and including 15

• – now

• – 1 month after first injection

• – 6 months after first injection

Schedule 2 – for new born babies, children and adolescents up to and including 15

• – now

• – 1 month after first injection

• – 2 months after first injection

• – 12 months after first injection

• In new born babies, schedule 2 will allow Engerix B to be given at the same time as other routine childhood vaccines
• This schedule can also be used if you are being vaccinated due to recent exposure to hepatitis B, as it will give protection more quickly

It is very important for you to return for your injections at the recommended times. If you have any questions about the amount of vaccine you are being given, please speak to your doctor.

Vaccination and child birth

If you have hepatitis B and just gave birth, schedule 1 or 2 can be used to vaccinate your baby.

Your doctor may also decide to give your baby hepatitis B immunoglobulins (human antibodies) at the time as the first injection. This will help protect your baby from hepatitis B. It will be given at a separate injection site.

Kidney problems and dialysis

If your child has a kidney problem or is on dialysis, your doctor may decide to do a blood test or give extra doses of vaccine to make sure that your child is protected.

4 Possible side effects

Like all vaccines, this vaccine can cause side effects although not everybody gets them. The following side effects may happen with this vaccine:

Allergic reactions If you have an allergic reaction, see your doctor straight away. The signs may include:

• your face swelling
• low blood pressure
• difficulty breathing
• your skin going blue
• loss of consciousness

These signs usually start very soon after the injection has been given to you. See a doctor straight away if they happen after leaving the clinic.

Other side effects include:

Very common (these may occur with more than 1 in 10 doses of the vaccine)

• headache
• pain and redness at the injection site
• feeling tired
• irritability

Common (these may occur with up to 1 in 10 doses of the vaccine)

• drowsiness
• nausea (feeling sick) or vomiting (being sick)
• diarrhoea or abdominal pain
• loss of appetite
• a high temperature (fever)
• feeling generally unwell
• swelling at the injection site
• reactions at the injection site such as a hard lump

Uncommon (these may occur with up to 1 in 100 doses of the vaccine)

• dizziness
• muscle pain
• flu like symptoms

Rare (these may occur with up to 1 in 1,000 doses of the vaccine)

• swollen glands
• hives, rash and itchiness
• joint pain
• pins and needles

Side effects that have been reported during marketed use of Engerix B include:

• bruising easily and not being able to stop bleeding if you cut yourself
• low blood pressure
• inflammation of your blood vessels
• sudden swelling of your face around your mouth and throat area (angioneurotic oedema)
• being unable to move muscles (paralysis)
• inflammation of your nerves (neuritis) which may cause loss of feeling or numbness, including a temporary inflammation of the nerves, causing pain, weakness and paralysis in the extremities and often progressing to the chest and face (Guillain-Barre syndrome), a disease of the nerves of the eye (optic neuritis) and multiple sclerosis
• problems moving your arms or legs (neuropathy)
• inflammation of your brain (encephalitis)
• degenerative disease of the brain (encephalopathy)
• infection around the brain (meningitis)
• fit (convulsions)
• loss of skin sensitivity to pain or touch (hypoaesthesia)
• purple or reddish-purple bumps on the skin (lichen planus)
• red or purple spots on your skin
• painful and stiff joints (arthritis)
• weakness of the muscles

In babies born very prematurely (at or before 28 weeks of gestation) longer gaps than normal between breaths may occur for 2–3 days after vaccination.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme, Website: or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

5 How to store Engerix B

• Keep this vaccine out of the sight and reach of children
• Do not use Engerix B after the expiry date which is stated on the label and carton after EXP. The expiry date refers to the last day of that month
• Store in a refrigerator between 2°C and 8°C
• Do not freeze
• Store in the original package
• 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 Engerix B contains

• The active substance is the ‘outer coating’ of the hepatitis B virus. Each dose contains 10 micrograms/0­.5 ml of protein, made up of this outer coat adsorbed on aluminium hydroxide hydrated
• The other ingredients are sodium chloride, disodium phosphate dihydrate, sodium dihydrogen phosphate and water for injections

What Engerix B looks like and contents of the pack

• Engerix B is a cloudy white injectable liquid.
• For vial:

Suspension for injection (10 microgram­s/0.5 ml). Pack size of 1, 10, 25 or 100.

• For pre-filled syringe:

Suspension for injection (10 microgams/0­.5 ml). Pack size of 1 or 10 with or without needles.

• Not all pack sizes may be marketed.