VIVOTIF

Active substance: BACILLUS SALMONELLA TYPHI TY21A ATTENUATED

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Vivotif® Oral Typhoid Vaccine
(Live, oral, strain Salmonella enterica serovar Typhi Ty21a)
Your medicine is known by the above name, but will be referred to as
Vivotif throughout this:
Patient Information Leaflet
Read all of this leaflet carefully before you start taking this
medicine.
• Keep this leaflet. You may need to read it again.
• If you have further questions, please ask your doctor or pharmacist.
• This vaccine has been prescribed for you. Do not pass it on to
others. It may harm them.
• If any of the side effects gets serious, or if you notice side effects
not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1) What Vivotif is and what it is used for
2) Before you take Vivotif
3) How to take Vivotif
4) Possible side effects
5) How to store Vivotif
6) Further information

1) What Vivotif is and what it is used for
What Vivotif is
Vivotif is a vaccine that protects you against typhoid fever.
• Typhoid fever is an infection caused by a type of Salmonella bacteria –
called “Salmonella typhi”.
• You can catch typhoid fever from food or water that contains these
bacteria.
• Typhoid fever can kill you, unless you get special antibiotic treatment.
Vivotif is for adults and children who are at least 6 years old:
• travelling to countries where there is a risk of catching typhoid fever.
• living in countries where there is a risk of catching typhoid fever.
How Vivotif works
The bacteria in Vivotif have been altered so that they cannot cause typhoid
fever. However, they can still stimulate the body’s natural defence system
(immune system). This means that it may protect you against the bacteria
that cause typhoid fever. Unlike most vaccines, Vivotif is a course of
capsules you take by mouth.
Other types of Salmonella illness
There are many other types of Salmonella bacteria. Most of these cause
illnesses with diarrhoea that are quite different to typhoid fever. They are
also less serious. Vivotif cannot protect you against infections due to these
other types of Salmonella bacteria.
Do I still need to take care after having Vivotif?
It is important that you still take care not to have food or water that may
contain the bacteria that cause typhoid. This is because not everyone
having a full course of Vivotif will be fully protected against typhoid fever.
Also, the protection only lasts for at most three years.

2) Before you take Vivotif
Do not take Vivotif if:
• you are allergic (hypersensitive) to lactose or sucrose or any of the
ingredients contained in Vivotif (listed in Section 6).



you have a poor immune system for any reason. For example, if you
have had poor immunity to infections since birth. You may also have
poor immunity due to treatments that depress the immune system –
such as high dose corticosteroids, cancer drugs or radiotherapy.
• you have an infection with a high temperature or an illness affecting
your gut (such as diarrhoea) at the moment – do not have Vivotif until
you have recovered.
Do not take Vivotif if any of the above apply to you. If you are not sure, talk
to your doctor or pharmacist before taking Vivotif.
Taking other medicines and having other vaccines
Please tell your doctor or pharmacist if you are taking or have recently
taken any other medicines. This includes medicines obtained without a
prescription, including herbal medicines, or have recently received any
other vaccine. This is because Vivotif can affect the way some other
medicines work. Also, some other medicines can affect the way Vivotif
works.
In particular tell your doctor or pharmacist if you are taking:
• antibiotics – Vivotif may not work if it is taken while you are also taking
antibiotics. Take Vivotif at least 3 days after the last dose of an
antibiotic. Also, if possible, do not take antibiotics until 3 days after the
last dose of Vivotif.
• medicines to prevent malaria – do not start these until 3 days after the
last dose of Vivotif. However, tablets that contain atovaquone plus
proguanil can be taken on the same days as Vivotif. Also, mefloquine
can be taken on the same days as Vivotif – but leave at least 12 hours
between doses of mefloquine and of Vivotif.
If any of the above apply to you, talk to your doctor or pharmacist before
taking Vivotif.
If you need to have the yellow fever vaccine or oral polio vaccine before
you travel, these can be given while you are taking Vivotif.
Pregnancy and breast-feeding
Vivotif should only be given to pregnant women if it is clearly necessary. If
you are or think you may be pregnant, discuss this with your doctor or
pharmacist before taking Vivotif.
It is not known if the bacteria or any other ingredients of Vivotif can pass
into breast milk. If you are breast-feeding, discuss this with your doctor or
pharmacist before taking Vivotif.
Driving and using machines
Vivotif is not known to affect your ability to drive or use machines.
Important information about some of the ingredients of Vivotif
Vivotif contains lactose and sucrose. If you have been told by your doctor that you
have intolerance to some sugars, contact your doctor before taking this medicine.

3) How to take Vivotif
Always take Vivotif exactly as your doctor has told you. You should check
with your doctor or pharmacist if you are not sure.
How much and when to take
The usual dose is 3 capsules. These are taken every other day.
• Take the first capsule on a chosen day. This is Day 1.
• Take the second capsule on Day 3.
• Take the third capsule on Day 5.

How to take your capsules
• Do not crush or chew the capsules.
• Swallow the capsules with cold or lukewarm water.
• Swallow the capsules as quickly as possible after placing in your
mouth.
• Take about one hour before a meal.
How long Vivotif works for
Protection against typhoid fever starts at about 7–10 days after taking the
course of 3 capsules. Your doctor or pharmacist will advise you how soon
before travelling to have your course of Vivotif.
If you are living in a place where you are likely to be exposed to the
bacteria that cause typhoid fever, you may be protected for up to 3 years
after vaccination.




If any of the side effects gets serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist.
Reporting of side effects. 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 Vivotif



If you travel from time to time to areas where you are at particular risk of
catching typhoid fever, have a repeat course of three capsules of Vivotif
every year.



If you take more Vivotif than you should
If you take all three doses at once by accident, tell your doctor or
pharmacist. It is unlikely to make you ill but you may not be well protected
against typhoid fever.



If you forget to take Vivotif
If you forget a dose, take it as soon as you remember. Then take the next
dose about 48 hours later.
If you have any further questions on the use of this product, ask your
doctor or pharamcist.

4) Possible side effects
Like all vaccines, Vivotif can cause side effects, although not everybody
gets them.
The following side effects may happen with this vaccine:
Allergic reactions (affects less than 1 in 10,000 people).
If you have an allergic reaction, see a doctor straight away. The signs may
include:
• a drop in blood pressure and fainting.
See a doctor straight away if you experience these symptoms.
Common (affects less than 1 in 10 people)
• stomach pains,
• feeling or being sick,
• diarrhoea,
• fever,
• flu-like illness,
• headache,
• skin redness.
Very rare (affects less than 1 in 10,000 people)
• skin irritation rashes, red or lumpy raised rashes and itching,
• weakness,
• generally feeling unwell,
• shivering,
• feeling tired,
• pins and needles,

feeling dizzy,
pain in your joints or muscles.



Keep all medicines out of the sight and reach of children.
Do not use Vivotif after the expiry date which is stated on the carton
and blister label, after ‘Exp’ The expiry date refers to the last day of the
month.
Store in a refrigerator (2°C to 8°C), as the vaccine is not stable at
normal room temperatures. It is essential to put the capsules back in
the refrigerator between doses. Store in a dry place in its original
packaging. Protect from light.
If your capsules become discoloured or show any other signs of
deterioration, consult your doctor or pharmacist who will tell you what
to do.
Medicines should not be disposed of via wastewater or household
waste. Ask your pharmacist how to dispose of medicines no longer
required. These measures will help to protect the environment.

6) Further information
What Vivotif contains:
• The active substance is a live bacteria called Salmonella enterica
serovar Typhi (abbr. S. typhi) (strain Ty21a). The bacteria have been
freeze-dried and enclosed in a capsule. The enteric coating of the
capsules protects the bacteria in the capsules from the stomach acids
that could kill them. Each enteric-coated capsule contains not less than
9
2 x 10 viable Salmonella enterica serovar typhi. One capsule is one
dose.


The other ingredients are sucrose, lactose, amino acid-peptide mixture
(Hy-Case SF), ascorbic acid (E300), magnesium stearate (E470),
inactivated S. typhi (strain Ty21a). ”Capsule”: gelatin, titanium dioxide
(E171), erythrosine (E127), yellow iron oxide (E172) and red iron oxide
(E172).

What Vivotif looks like and contents of the pack
The blister pack contains three enteric-coated capsules. The capsules
have a white body and a salmon coloured cap.
PL 10383/2072

POM

Who makes and repackages your medicine?
Your medicine is manufactured by Crucell Switzerland S.A.,
Rehhagstrasse 79, CH-3018 Berne, Switzerland. Procured from within the
EU and repackaged by Product Licence Holder: Primecrown Ltd, 4/5
Northolt Trading Estate, Belvue Road, Northolt, Middlesex, UB5 5QS.
Leaflet date: 10.12.2013
Vivotif is a registered trademark of Crucell Switzerland A.G.

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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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