ENGERIX B 20 MICROGRAMS/1ML SUSPENSION FOR INJECTION

Active substance: HEPATITIS B SURFACE ANTIGEN

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20 micrograms/1 ml suspension for injection
Hepatitis B (rDNA) vaccine (adsorbed) (HBV)
Package leaflet:
Information for the user
Read all of this leaflet carefully before you start receiving this
vaccine because it contains important information for you.
• Keep this leaflet. You may need to read it again.
• f you have any further questions, ask your doctor or pharmacist.
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• his vaccine has been prescribed for you only. Do not pass it on
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to others.
• f you get any side effects, talk to your doctor or pharmacist.
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This includes any possible side effects not listed in this leaflet.
What is in this leaflet:
1 What Engerix B is and what it is used for
2 What you need to know before receiving Engerix B
3 How Engerix B is given
4 Possible side effects
5 How to store Engerix B
6 Contents of the pack and other information

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 both adults and adolescents 16 years
of age and over. In exceptional circumstances it can also be given
to children and adolescents 11 to 15 years of age (see section 3).
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.

454139

ENGERIX B ®

20 micrograms/1 ml
suspension for injection
Hepatitis B (rDNA) vaccine
(adsorbed) (HBV)

ENGERIX B ®

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 and fertility
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 may affect your ability to drive or use machines. 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
• s an injection under the skin if you bruise easily or have a
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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.
• dults and adolescents 16 years and over will be given the 20
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microgram / 1 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 adults or adolescents 16 years and over
First injection

- now

Second injection - 1 month after first injection

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.

Third injection

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.

• his schedule can also be used if you are being vaccinated due
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to recent exposure to hepatitis B, as it will give protection more
quickly.

• hen you are given the vaccine it will trigger the body’s
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immune system to prepare itself to protect against these
viruses in the future.
• ngerix B will not protect you if you have already caught the
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hepatitis B virus.
• ngerix B can only help to protect you against infection with
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hepatitis B virus.

- 6 months after first injection

Schedule 2 – for adults or adolescents 16 years and over
First injection

- now

Second injection - 1 month after first injection
Third injection

- 2 months after first injection

Fourth injection

- 12 months after first injection

Schedule 3 – for adults (18 years and over) only
This schedule will only be given to you in exceptional
circumstances, for example if you have to travel to a high risk
area within one month of being vaccinated.
First injection

- now

Second injection - 1 week after first injection
- 3 weeks after first injection

Fourth injection

2 What you need to know before receiving
Engerix B

Third injection

- 12 months after first injection

• f you are allergic (hypersensitive) to Engerix B or any of the
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ingredients (listed in Section 6)

Schedule 4 – for children and adolescents 11 to 15 years of
age only
This schedule is only used if it is doubtful your child will receive
the third injection. During this schedule the 20 microgram/ 1 ml
vaccine is used. This will provide a higher level of protection than
2 doses of the 10 microgram/ 0.5ml vaccine.

• If you have a high temperature (fever).

First injection

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.

Second injection - 6 months after first injection

Engerix B should not be given:

Warnings and precautions
Talk to your doctor or pharmacist before you receive Engerix B if you:
• re on dialysis for a kidney problem or have an illness which
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may affect your immune system
eople who have dialysis, long term liver problems, carry
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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/your child fainted with a previous injection.

- now

• hen this schedule is used protection is not always achieved
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until after the second dose. This two-dose schedule is only
used when there is a relatively low risk of hepatitis B infection
during the vaccination course and when completion of this
course can be assured.
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.
Kidney problems and dialysis
• People aged 16 or over
f you have a kidney problem or are on dialysis, your doctor
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may decide to vaccinate you with four double doses (2 x 20
microgram/1 ml) of vaccine at 0, 1, 2 and 6 months. Your
doctor may also decide to do a blood test to make sure you are
protected against hepatitis B.

4 Possible side effects

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

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

The following information is intended for healthcare
professionals only

The entire contents of a mono-dose container must be withdrawn
and should be used immediately.

Upon storage, the content may present a fine white deposit with
a clear colourless supernatant. Once shaken the vaccine is slightly
opaque.

Any unused medicinal product or waste material should be
disposed of in accordance with local requirements.

The vaccine should be inspected visually for any foreign
particulate matter and/or coloration prior to administration.
Discard if the content appears otherwise.

Allergic reactions (may
occur with up to 1 in 10,000
doses of the vaccine)
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 1 in 10 doses or more of
the vaccine)
• ain and redness at the injection site
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• feeling tired
• irritability
Common (These may occur with up to 1 in 10 doses of the vaccine)
• headache
• drowsiness
• ausea (feeling sick) or
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vomiting (being sick)
• iarrhoea or abdominal pain
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• loss of appetite
• a high temperature (fever)
• feeling generally unwell
• welling at the injection site
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• 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

• he other ingredients are sodium chloride, disodium
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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.
• or vial:
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uspension for injection (20 micrograms/ml). Pack size
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of 1, 3, 10, 25 or 100.
• For pre-filled syringe:
uspension for injection (20 micrograms/ml). Pack size
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of 1, 10, or 25.
• Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation holder:
SmithKline Beecham plc, trading as GlaxoSmithKline UK,
Stockley Park West, Uxbridge, Middlesex, UB11 1BT
Manufacturer:
GlaxoSmithKline Biologicals s.a., Rue de l’Institut 89,
B-1330 Rixensart, Belgium
This medicinal product is authorised in the Member
States of the EEA under the following names:
Austria, Denmark, Finland, Iceland, Netherlands, Norway,
Spain, Sweden: Engerix-B
Belgium, Luxembourg, Portugal, United Kingdom: Engerix B
France, Ireland, Italy: Engerix B-20
Germany: Engerix-B Adult
Greece: Engerix
This leaflet was last revised in August 2012
Other sources of information
To listen to or request a copy of this leaflet in Braille, large print
or audio please call, free of charge:

0800 198 5000 (UK only).
Please be ready to give the following information:
Product name
Engerix B
Reference number
10592/0165

10592/0166
This is a service provided by the Royal National Institute of Blind
People.

• flu like symptoms

Detailed information on this medicine is available on the website
of: the Medicines and Healthcare products Regulatory Agency
(MHRA)

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

Engerix B is a registered trademark of the GlaxoSmithKline group
of companies.

• swollen glands

© 2012 GlaxoSmithKline group of companies. All rights reserved.

• muscle pain

• hives, rash and itchiness
• joint pain
• pins and needles
Very rare (These may occur with up to 1 in 10,000 doses of the
vaccine)
• ruising easily and not being able to stop bleeding if you cut
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yourself
• low blood pressure
• inflammation of your blood vessels
• udden swelling of your face around your mouth and throat
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area (angioneurotic oedema)
• being unable to move muscles (paralysis)
• nflammation of your nerves (neuritis) which may cause loss
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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-Barré 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
If you get any side effects, talk to your doctor or pharmacist. This
includes any side effects not listed in this leaflet.

5 How to store Engerix B
• Keep this medicine out of the sight and reach of children.
• o not use Engerix B after the expiry date which is stated on
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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.
• tore in the original package in order to protect from light.
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• o not throw away any medicines via wastewater or
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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
• he active substance is the ‘outer coating’ of the hepatitis
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B virus. Each dose contains 20 micrograms/ 1 ml of protein,
made up of this outer coat adsorbed on aluminium hydroxide
hydrated.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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