Skip to Content

HAVRIX MONODOSE VACCINE

Active substance(s): VIRUS HEPATITIS A

PDF options:  View Fullscreen   Download PDF

PDF Transcript

GSK-BEL-Wavre-BEWAV
United Kingdom-GBR
Havrix
N/A
BIO_DRW202

Read all of this leaflet carefully before you receive this vaccine because it
contains important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, nurse or pharmacist.
• This vaccine has been prescribed for you. Do not pass it on to others. It may
harm them.
• If you get any side effects talk to your doctor, nurse or pharmacist. This includes
any possible side effects not listed in this leaflet.
What is in this leaflet:
1 What Havrix Monodose is and what it is used for
2 What you need to know before you receive Havrix Monodose
3 How Havrix Monodose is given
4 Possible side effects
5 How to store Havrix Monodose
6 Contents of the pack and other information
1 What Havrix Monodose is and what it is used for

N/A
N/A
1
K

0

0

9.0pt
10.0pt
90%
9.0pt
No

Biologicals
Additional Information Panel
Unfolded dimensions: 210x422mm
Folded dimensions: 210x25mm
2D Pharmacode value: N/A

Havrix Monodose is a vaccine containing hepatitis A virus. It is used to boost the body’s
immune system to help protect against hepatitis A infection in adults and adolescents
(16 years of age and above).
How Havrix Monodose works
• The virus is not alive so this vaccine cannot cause hepatitis A infection.
• When you are given Havrix Monodose vaccine your body will make antibodies (the
body’s natural defence system) against the hepatitis A virus.
• After 2 to 4 weeks, these antibodies will have been produced and will protect you
against hepatitis A infection.
• To ensure long term protection, you should receive a second (booster) vaccination
6 to 12 months after your first dose. As long as you receive the booster within
5 years, you should still be fully protected. Once you have had your booster
vaccination, you are not expected to need an additional dose of Havrix.
• Having this vaccine will only protect against hepatitis A and not against any other
type of hepatitis virus or any other illness that can cause hepatitis (inflammation of
the liver).
Some general information on hepatitis A infection is given at the end of this leaflet.
2 What you need to know before you receive Havrix Monodose
Havrix Monodose should not be given if:
• you are allergic (hypersensitive) to any of the ingredients of Havrix (listed in
section 6)
• you are allergic (hypersensitive) to any other hepatitis A injection or neomycin, an
antibiotic that may be present in very small amounts
• you are between ages 1-15 years, as another product, Havrix Junior Monodose is
recommended for this age group
• you have a high temperature (fever). The presence of a minor infection such as a cold
should not be a problem. Talk to your doctor first.
Do not have Havrix if any of the above apply to you. If you are not sure, talk to your
doctor, nurse or pharmacist.
Warnings and precautions
Check with your doctor, nurse or pharmacist before Havrix Monodose is given if:
• you are on dialysis for a kidney problem
• you already have the hepatitis A virus or are living with someone who has caught the
hepatitis A virus recently
• you have any problem with the way your body fights disease (immunosuppression).
If any of the above apply to you Havrix Monodose can still be given, but you may not
develop enough antibody after a single injection to protect you against infection.
In these cases, the doctor or nurse may decide that extra doses of Havrix Monodose
should be given and may take a blood test to measure the antibody levels in the blood
before or after the vaccine is given.
Sometimes, an injection of antibody will be needed to try to protect you until the vaccine
starts to work. This can be given at the same time as the vaccine but will be injected into
the opposite arm.
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.
Other medicines or vaccines and Havrix Monodose
Tell your doctor or nurse if you are taking, about to take or have recently taken, any
other medicine. Other vaccines can be given at the same time as Havrix Monodose.
These vaccines will be given at different injection sites.
Pregnancy and breast-feeding
• Women who are pregnant may sometimes be vaccinated.
• Talk to your doctor or nurse if you think you are, or might be pregnant.
• Talk to your doctor or nurse if you are breast-feeding. It is sometimes possible
to have the vaccine when you are breast-feeding.
Driving and using machines
Havrix Monodose should not affect your ability to drive or operate machinery.
However, some of the effects mentioned under Section 4 “Possible side effects”
may temporarily affect the ability to drive or use machines.
Important information about some of the ingredients of Havrix
Monodose
Please tell your doctor if you have had an allergic reaction to neomycin
(antibiotic).
3 How Havrix Monodose is given
• H
 avrix Monodose is for use in adults and adolescents 16 years of age and
above.
• Children (1 to 15 years of age) should be given Havrix Junior Monodose.
• Havrix Monodose (1 ml) is injected into the muscle in the upper arm.
• The first dose of vaccine should protect you from infection with hepatitis A
virus within 2 to 4 weeks after the injection. Protection should last for at least
1 year.
• The best way to ensure that protection continues for at least 40 years is to
receive a second (booster) dose of the vaccine. This should be given 6 to
12 months after the first injection.
• If a second dose is not given within 5 years of the first dose, the doctor may
decide that vaccination should start again, with 2 doses of vaccine within
1 year.
4 Possible side effects
Like all medicines, this vaccine can have side effects, although not everybody gets them.
Allergic reactions (these may occur with up to 1 in 10,000 doses of the vaccine)
See your doctor straight away, if you have an allergic reaction. The signs may include:
• local or widespread rashes that may be itchy or blistering
• swelling of the eyes and face
• difficulty in breathing or swallowing
• a sudden drop in blood pressure
• a very fast heart beat
• 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.

481624

Package Leaflet:
Information for the User

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
• Fatigue
Common (these may occur with up to 1 in 10 doses of the vaccine):
• Loss of appetite
• Stomach upset e.g. diarrhoea and nausea
• Swelling or hard lump at the injection site
• Generally feeling unwell
• Fever
Uncommon (these may occur with up to 1 in 100 doses of the vaccine):
• Upper respiratory tract infection, runny or blocked nose
• Dizziness
• Vomiting
• Aching muscles, muscular stiffness not caused by exercise
• Flu-like symptoms, such as high temperature, sore throat, runny nose, cough and
chills
Rare (these may occur with up to 1 in 1000 doses of the vaccine):
• Abnormal sensation such as of burning, prickling, tickling or tingling, pins and
needles, loss of feeling or numbness
• Itching
• Chills
Not known: frequency cannot be estimated from the available data
• Fits or seizures
• Inflammation of the blood vessels, often with skin rash
• Hives, red, often itchy spots which starts on the limbs and sometimes on the face
and the rest of the body.
• Joint pain
Occasionally tests for liver function can become abnormal for a short time. Extremely
rarely there may be reactions involving the nerves. You should tell your doctor
immediately if you have problems moving your arms or legs or difficulty with walking
and moving about.
If any of the side effects gets serious or if you notice any side effects not mentioned in
this leaflet, please tell your doctor or nurse
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any
possible side effects not listed in this leaflet. You can also report side effects directly via
the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the safety of this
medicine.

MINIATURE PHARMA CODE N° 1389

481624

MINIATURE PHARMA CODE N° 1389

1

Havrix® Monodose® Vaccine
Suspension for injection in a pre-filled syringe
Hepatitis A (inactivated) vaccine (adsorbed)

5 How to store Havrix Monodose







Keep out of the sight and reach of children.
Store between 2°C and 8°C in a refrigerator.
Do not freeze.
Store in the original package with this leaflet in order to protect from light.
Do not use after the expiry date which is stated on the label and carton.
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 Havrix Monodose contains
• The active ingredient is inactivated hepatitis A virus. Each 1 ml dose of the vaccine
contains 1440 ELISA units of hepatitis A viral protein, adsorbed on aluminium
hydroxide, hydrated.
• The other ingredients are polysorbate 20, amino acids for injection, disodium
phosphate, monopotassium phosphate, sodium chloride, potassium chloride and,
water for injections.
What Havrix Monodose looks like and contents of the pack
Havrix Monodose is a cloudy white injectable liquid vaccine in a pre-filled syringe that
contains a single 1 ml dose.
The vaccine is available in packs of 1 or 10 pre-filled syringes.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation holder:
SmithKline Beecham Ltd,
Stockley Park West, Uxbridge,
Middlesex, UB11 1BT
Manufacturer:
GlaxoSmithKline Biologicals s.a., Rixensart, Belgium.
Other formats:
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
Havrix Monodose Vaccine
Reference number
10592/0037
This is a service provided by the Royal National Institute of Blind People.
This leaflet was last revised in April 2016
Havrix and Monodose are registered trade marks of the GSK group of companies
© 2016 GSK group of companies. All rights reserved.
General information on hepatitis A
Hepatitis A virus causes an infection of the liver. You can catch the virus by
eating or drinking contaminated food or water. The virus is present in the bowel
movement (motion) of infected people, even when they may have no signs of the
infection. You can catch hepatitis A infection in any country but the risk is highest in
places and countries where sanitation and food and water hygiene are poor.
After catching the virus, it can be up to 6 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 sickness, yellowing of the skin and eyes (jaundice),
fever and headache. 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 weeks or months, but a few people
may take up to a year to make a full recovery. While 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 hospital care is needed until the infection
gets better.
There are many other types of virus that can cause hepatitis. The signs may be the same
as in hepatitis A infection but the viruses are not always caught through food and drink.

Page 1 of 1

481628

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.

1
481628

Havrix® Monodose® Vaccine

GSK-BEL-Wavre-BEWAV

Suspension for injection in a pre-filled syringe
Hepatitis A (inactivated) vaccine (adsorbed)

United Kingdom-GBR
Package Leaflet: Information for the User
Read all of this leaflet carefully before you receive this vaccine
because it contains important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, nurse or
pharmacist.
• This vaccine has been prescribed for you. Do not pass it on to
others. It may harm them.
• If you get any side effects talk to your doctor, nurse or
pharmacist. This includes any possible side effects not listed in
this leaflet.

Havrix
N/A
BIO_DRW183

N/A
N/A
1
K

What is in this leaflet:
1 What Havrix Monodose is and what it is used for
2 What you need to know before you receive Havrix Monodose
3 How Havrix Monodose is given
4 Possible side effects
5 How to store Havrix Monodose
6 Contents of the pack and other information

Other medicines or vaccines and Havrix Monodose
Tell your doctor or nurse if you are taking, about to take or have recently taken, any
other medicine. Other vaccines can be given at the same time as Havrix Monodose.
These vaccines will be given at different injection sites.
Pregnancy and breast-feeding
• Women who are pregnant may sometimes be vaccinated.
• Talk to your doctor or nurse if you think you are, or might be pregnant.
• Talk to your doctor or nurse if you are breast-feeding. It is sometimes possible to
have the vaccine when you are breast-feeding.
Driving and using machines
Havrix Monodose should not affect your ability to drive or operate machinery.
However, some of the effects mentioned under Section 4 “Possible side effects” may
temporarily affect the ability to drive or use machines.
Important information about some of the ingredients of Havrix Monodose
Please tell your doctor if you have had an allergic reaction to neomycin (antibiotic).

3 How Havrix Monodose is given





Havrix Monodose is for use in adults and adolescents 16 years of age and above.
Children (1 to 15 years of age) should be given Havrix Junior Monodose.
Havrix Monodose (1 ml) is injected into the muscle in the upper arm.
The first dose of vaccine should protect you from infection with hepatitis A virus
within 2 to 4 weeks after the injection. Protection should last for at least 1 year.
• The best way to ensure that protection continues for at least 40 years is to receive
a second (booster) dose of the vaccine. This should be given 6 to 12 months after
the first injection.
• If a second dose is not given within 5 years of the first dose, the doctor may decide
that vaccination should start again, with 2 doses of vaccine within 1 year.

4 Possible side effects
1 What Havrix Monodose is and what it is used for
0

0

Havrix Monodose is a vaccine containing hepatitis A virus. It is used to boost the
body’s immune system to help protect against hepatitis A infection in adults and
adolescents (16 years of age and above).
How Havrix Monodose works
• The virus is not alive so this vaccine cannot cause hepatitis A infection.
• When you are given Havrix Monodose vaccine your body will make antibodies
(the body’s natural defence system) against the hepatitis A virus.
• After 2 to 4 weeks, these antibodies will have been produced and will protect
you against hepatitis A infection.
• To ensure long term protection, you should receive a second (booster) vaccination
6 to 12 months after your first dose. As long as you receive the booster within
5 years, you should still be fully protected. Once you have had your booster
vaccination, you are not expected to need an additional dose of Havrix.
• Having this vaccine will only protect against hepatitis A and not against
any other type of hepatitis virus or any other illness that can cause hepatitis
(inflammation of the liver).
Some general information on hepatitis A infection is given at the end of this
leaflet.

2 What you need to know before you receive Havrix Monodose

TEXT SIZE CONTAINED IN THIS ARTWORK
Body text size: 9pt
Leading: 10pt
Horizontal Scale: 100%
Smallest text size: 9pt
Microtext: No

Biologicals
Additional Information Panel
Unfolded dimensions: 385x325mm
Folded dimensions: 130x55mm
2D Pharmacode value: 481628CVY

Havrix Monodose should not be given if:
• you are allergic (hypersensitive) to any of the ingredients of Havrix (listed in
section 6)
• you are allergic (hypersensitive) to any other hepatitis A injection or neomycin,
an antibiotic that may be present in very small amounts
• you are between ages 1-15 years, as another product, Havrix Junior Monodose
is recommended for this age group
• you have a high temperature (fever). The presence of a minor infection such as
a cold should not be a problem. Talk to your doctor first.
Do not have Havrix if any of the above apply to you. If you are not sure, talk to
your doctor, nurse or pharmacist.
Warnings and precautions
Check with your doctor, nurse or pharmacist before Havrix Monodose is given if:
• you are on dialysis for a kidney problem
• you already have the hepatitis A virus or are living with someone who has
caught the hepatitis A virus recently
• you have any problem with the way your body fights disease
(immunosuppression).
If any of the above apply to you Havrix Monodose can still be given, but you
may not develop enough antibody after a single injection to protect you against
infection.
In these cases, the doctor or nurse may decide that extra doses of Havrix
Monodose should be given and may take a blood test to measure the antibody
levels in the blood before or after the vaccine is given.
Sometimes, an injection of antibody will be needed to try to protect you until the
vaccine starts to work. This can be given at the same time as the vaccine but will
be injected into the opposite arm.

Like all medicines, this vaccine can have side effects, although not everybody gets
them.
Allergic reactions (these may occur with up to 1 in 10,000 doses of the vaccine)
See your doctor straight away, if you have an allergic reaction. The signs may
include:
• local or widespread rashes that may be itchy or blistering
• swelling of the eyes and face
• difficulty in breathing or swallowing
• a sudden drop in blood pressure
• a very fast heart beat
• 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
• Fatigue
Common (these may occur with up to 1 in 10 doses of the vaccine):
• Loss of appetite
• Stomach upset e.g. diarrhoea and nausea
• Swelling or hard lump at the injection site
• Generally feeling unwell
• Fever
Uncommon (these may occur with up to 1 in 100 doses of the vaccine):
• Upper respiratory tract infection, runny or blocked nose
• Dizziness
• Vomiting
• Aching muscles, muscular stiffness not caused by exercise
• Flu-like symptoms, such as high temperature, sore throat, runny nose, cough and
chills
Rare (these may occur with up to 1 in 1000 doses of the vaccine):
• Abnormal sensation such as of burning, prickling, tickling or tingling, pins and
needles, loss of feeling or numbness
• Itching
• Chills
Not known: frequency cannot be estimated from the available data
• Fits or seizures
• Inflammation of the blood vessels, often with skin rash
• Hives, red, often itchy spots which starts on the limbs and sometimes on the face
and the rest of the body.
• Joint pain
Occasionally tests for liver function can become abnormal for a short time. Extremely
rarely there may be reactions involving the nerves. You should tell your doctor
immediately if you have problems moving your arms or legs or difficulty with
walking and moving about.
If any of the side effects gets serious or if you notice any side effects not mentioned
in this leaflet, please tell your doctor or nurse.

If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side effects not listed in this leaflet.
You can also report side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the safety
of this medicine.

5 How to store Havrix Monodose







Keep out of the sight and reach of children.
Store between 2°C and 8°C in a refrigerator.
Do not freeze.
Store in the original package with this leaflet in order to protect from light.
Do not use after the expiry date which is stated on the label and carton.
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 Havrix Monodose contains
• The active ingredient is inactivated hepatitis A virus. Each 1 ml dose of the
vaccine contains 1440 ELISA units of hepatitis A viral protein, adsorbed on
aluminium hydroxide, hydrated.
• The other ingredients are polysorbate 20, amino acids for injection, disodium
phosphate, monopotassium phosphate, sodium chloride, potassium chloride
and water for injections.
What Havrix Monodose looks like and contents of the pack
Havrix Monodose is a cloudy white injectable liquid vaccine in a pre-filled
syringe that contains a single 1 ml dose.
The vaccine is available in packs of 1 or 10 pre-filled syringes.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation holder:
SmithKline Beecham Ltd,
Stockley Park West, Uxbridge,
Middlesex, UB11 1BT
Manufacturer:
GlaxoSmithKline Biologicals s.a., Rixensart, Belgium.
Other formats:
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
Havrix Monodose Vaccine
Reference number 10592/0037
This is a service provided by the Royal National Institute of Blind People.
This leaflet was last revised in April 2016
Havrix and Monodose are registered trade marks of the GSK group of companies
© 2016 GSK group of companies. All rights reserved.
General information on hepatitis A
Hepatitis A virus causes an infection of the liver. You can catch the virus by
eating or drinking contaminated food or water. The virus is present in the
bowel movement (motion) of infected people, even when they may have no
signs of the infection. You can catch hepatitis A infection in any country but
the risk is highest in places and countries where sanitation and food and water
hygiene are poor.
After catching the virus, it can be up to 6 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 sickness, yellowing of the skin and eyes
(jaundice), fever and headache. 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 weeks or months, but a few
people may take up to a year to make a full recovery. While 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 hospital care is needed until the infection gets better.
There are many other types of virus that can cause hepatitis. The signs may
be the same as in hepatitis A infection but the viruses are not always caught
through food and drink.

Page 1 of 1

MINIATURE PHARMA CODE N° 152
MINIATURE PHARMA CODE N° 152

481664
GSK-BEL-Wavre-BEWAV

481664

Havrix®
Monodose® Vaccine

1

United Kingdom-GBR
Havrix
N/A

Package Leaflet:
Information for the User

BIO_DRW204

Havrix® Monodose® Vaccine
Suspension for injection
Hepatitis A (inactivated) vaccine (adsorbed)

N/A
N/A
1
K

0

0

Read all of this leaflet carefully before you
receive this vaccine because it contains
important information for you.
• K
 eep this leaflet. You may need to read it
again.
• If you have any further questions, ask your
doctor, nurse or pharmacist.
• This vaccine has been prescribed for you.
Do not pass it on to others. It may harm
them.
• If you get any side effects talk to your
doctor, nurse or pharmacist. This includes
any possible side effects not listed in this
leaflet.
What is in this leaflet:
1 W
 hat Havrix Monodose is and what it is
used for
2 What you need to know before you
receive Havrix Monodose
3 How Havrix Monodose is given
4 Possible side effects
5 How to store Havrix Monodose
6 Contents of the pack and other information
1 
What Havrix Monodose is and what it is
used for

TEXT SIZE CONTAINED IN THIS ARTWORK
Body text size: 10pt
Leading: 13pt
Horizontal Scale: 100%
Smallest text size: 10pt
Microtext: No

Biologicals
Additional Information Panel
Unfolded dimensions: 498x162mm
Folded dimensions: 27x56mm
2D Pharmacode value: N/A

Havrix Monodose is a vaccine containing
hepatitis A virus. It is used to boost the
body’s immune system to help protect
against hepatitis A infection in adults and
adolescents (16 years of age and above).
How Havrix Monodose works
• T
 he virus is not alive so this vaccine cannot
cause hepatitis A infection.
• When you are given Havrix Monodose
vaccine your body will make antibodies
(the body’s natural defence system)
against the hepatitis A virus.
• After 2 to 4 weeks, these antibodies will
have been produced and will protect you
against hepatitis A infection.
• To ensure long term protection, you
should receive a second (booster)
vaccination 6 to 12 months after your
first dose. As long as you receive the
booster within 5 years, you should still be
fully protected. Once you have had your
booster vaccination, you are not expected
to need an additional dose of Havrix.
• Having this vaccine will only protect
against hepatitis A and not against
any other type of hepatitis virus or any
other illness that can cause hepatitis
(inflammation of the liver).
Some general information on hepatitis A
infection is given at the end of this leaflet.
2 
What you need to know before you
receive Havrix Monodose
Havrix Monodose should not be given if:
• y ou are allergic (hypersensitive) to any
of the ingredients of Havrix (listed in
section 6)
• you are allergic (hypersensitive) to any
other hepatitis A injection or neomycin,
an antibiotic that may be present in very
small amounts
• you are between ages 1-15 years, as
another product, Havrix Junior Monodose
is recommended for this age group
• you have a high temperature (fever). The
presence of a minor infection such as a
cold should not be a problem. Talk to your
doctor first.
Do not have Havrix if any of the above apply
to you. If you are not sure, talk to your
doctor, nurse or pharmacist.

Warnings and precautions
Check with your doctor, nurse or pharmacist
before Havrix Monodose is given if:
• you are on dialysis for a kidney problem
• you already have the hepatitis A virus or
are living with someone who has caught
the hepatitis A virus recently
• you have any problem with the way your
body fights disease (immunosuppression).
If any of the above apply to you Havrix
Monodose can still be given, but you may
not develop enough antibody after a single
injection to protect you against infection.
In these cases, the doctor or nurse may
decide that extra doses of Havrix Monodose
should be given and may take a blood test
to measure the antibody levels in the blood
before or after the vaccine is given.
Sometimes, an injection of antibody will be
needed to try to protect you until the vaccine
starts to work. This can be given at the same
time as the vaccine but will be injected into
the opposite arm.
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.
Other medicines or vaccines and Havrix
Monodose
Tell your doctor or nurse if you are taking,
about to take or have recently taken, any
other medicine. Other vaccines can be given
at the same time as Havrix Monodose.
These vaccines will be given at different
injection sites.
Pregnancy and breast-feeding
• W
 omen who are pregnant may sometimes
be vaccinated.
• Talk to your doctor or nurse if you think
you are, or might be pregnant.
• Talk to your doctor or nurse if you are
breast-feeding. It is sometimes possible
to have the vaccine when you are
breast-feeding.
Driving and using machines
Havrix Monodose should not affect your
ability to drive or operate machinery.
However, some of the effects mentioned
under Section 4 “Possible side effects” may
temporarily affect the ability to drive or use
machines.
Important information about some of the
ingredients of Havrix Monodose
Please tell your doctor if you have had an
allergic reaction to neomycin (antibiotic).
3 
How Havrix Monodose is given
• H
 avrix Monodose is for use in adults and
adolescents 16 years of age and above.
• Children (1 to 15 years of age) should be
given Havrix Junior Monodose.
• Havrix Monodose (1 ml) is injected into the
muscle in the upper arm.
• The first dose of vaccine should protect
you from infection with hepatitis A virus
within 2 to 4 weeks after the injection.
Protection should last for at least 1 year.
• The best way to ensure that protection
continues for at least 40 years is to receive
a second (booster) dose of the vaccine.
This should be given 6 to 12 months after
the first injection.
• If a second dose is not given within 5 years
of the first dose, the doctor may decide
that vaccination should start again, with
2 doses of vaccine within 1 year.

Page 1 of 2

1

4 
Possible side effects
Like all medicines, this vaccine can have side
effects, although not everybody gets them.

481664
GSK-BEL-Wavre-BEWAV
United Kingdom-GBR
Havrix
N/A
BIO_DRW204

N/A
N/A
1
K

Allergic reactions (these may occur with up
to 1 in 10,000 doses of the vaccine)
See your doctor
straight away, if
you have an allergic
reaction. The signs
may include:
• local or widespread
rashes that may be itchy or blistering
• swelling of the eyes and face
• difficulty in breathing or swallowing
• a sudden drop in blood pressure
• a very fast heart beat
• 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:

0

0

Very common (these may occur with more
than 1 in 10 doses of the vaccine):
• Headache
• Pain and redness at the injection site
• Fatigue
Common (these may occur with up to 1 in
10 doses of the vaccine):
• Loss of appetite
• Stomach upset e.g. diarrhoea and nausea
• Swelling or hard lump at the injection site
• Generally feeling unwell
• Fever
Uncommon (these may occur with up to 1 in
100 doses of the vaccine):
• Upper respiratory tract infection, runny or
blocked nose
• Dizziness
• Vomiting
• Aching muscles, muscular stiffness not
caused by exercise
• Flu-like symptoms, such as high
temperature, sore throat, runny nose,
cough and chills

TEXT SIZE CONTAINED IN THIS ARTWORK
Body text size: 10pt
Leading: 13pt
Horizontal Scale: 100%
Smallest text size: 10pt

Rare (these may occur with up to 1 in
1000 doses of the vaccine):
• Abnormal sensation such as of burning,
prickling, tickling or tingling, pins and
needles, loss of feeling or numbness
• Itching
• Chills

Microtext: No

Not known: frequency cannot be estimated
from the available data
Biologicals
Additional Information Panel
Unfolded dimensions: 498x162mm
Folded dimensions: 27x56mm
2D Pharmacode value: N/A

• Fits or seizures
• Inflammation of the blood vessels, often
with skin rash
• Hives, red, often itchy spots which starts
on the limbs and sometimes on the face
and the rest of the body.
• Joint pain
Occasionally tests for liver function can
become abnormal for a short time. Extremely
rarely there may be reactions involving
the nerves. You should tell your doctor
immediately if you have problems moving
your arms or legs or difficulty with walking
and moving about.
If any of the side effects gets serious or if you
notice any side effects not mentioned in this
leaflet, please tell your doctor or nurse.
If you get any side effects, talk to your
doctor, pharmacist or nurse. This includes
any possible side effects not listed in this
leaflet. You can also report side effects
directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard.
By reporting side effects you can help
provide more information on the safety of
this medicine.
5 
How to store Havrix Monodose





Keep out of the sight and reach of children.
S tore between 2°C and 8°C in a refrigerator.
Do not freeze.
Store in the original package with this
leaflet in order to protect from light.
• Do not use after the expiry date which is
stated on the label and carton.
• 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 Havrix Monodose contains
• T
 he active ingredient is inactivated
hepatitis A virus. Each 1 ml dose of
the vaccine contains 1440 ELISA units
of hepatitis A viral protein, adsorbed
on aluminium hydroxide, hydrated.
• The other ingredients are
polysorbate 20, amino acids for
injection, disodium phosphate,
monopotassium phosphate, sodium
chloride, potassium chloride and
water for injections.
What Havrix Monodose looks like and
contents of the pack
Havrix Monodose is a cloudy white
injectable liquid vaccine in a vial that
contains a single 1 ml dose.
The vaccine is available in packs of 1 or
10 vials.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation holder:
SmithKline Beecham Ltd,
Stockley Park West, Uxbridge,
Middlesex, UB11 1BT
Manufacturer:
GlaxoSmithKline Biologicals s.a.,
Rixensart, Belgium.
Other formats:
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

Havrix Monodose
Vaccine
Reference number 10592/0037
This is a service provided by the Royal
National Institute of Blind People.
This leaflet was last revised in April 2016
Havrix and Monodose are registered
trade marks of the GSK group of
companies
© 2016 GSK group of companies.
All rights reserved.
General information on hepatitis A
Hepatitis A virus causes an infection
of the liver. You can catch the virus by
eating or drinking contaminated food
or water. The virus is present in the
bowel movement (motion) of infected
people, even when they may have no
signs of the infection. You can catch
hepatitis A infection in any country but
the risk is highest in places and countries
where sanitation and food and water
hygiene are poor.
After catching the virus, it can be up to
6 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
sickness, yellowing of the skin and eyes
(jaundice), fever and headache. 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 weeks or months, but a few
people may take up to a year to make a
full recovery. While 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 hospital care is needed until the
infection gets better.
There are many other types of virus
that can cause hepatitis. The signs may
be the same as in hepatitis A infection
but the viruses are not always caught
through food and drink.

481664

Page 2 of 2

+ Expand Transcript

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.

Hide