Vivotif

B. PATIENT INFORMATION LEAFLET

Leaflet accompanying the packaging: information for the user

Vivotif

SalmonellaTyphi Ty21a

It is essential to carefully read the contents of this leaflet before taking this vaccine, as it contains important information for the patient.

• This leaflet should be kept, so it can be re-read if necessary.
• In case of any doubts, the doctor, pharmacist, or nurse should be consulted.
• This vaccine has been prescribed for a specific person. It should not be given to others.
• If any side effects occur, including any side effects not listed in the leaflet, the doctor, pharmacist, or nurse should be informed. See section 4.

Table of contents of the leaflet

• 1. What is Vivotif vaccine and what is it used for
• 2. Important information before taking Vivotif vaccine
• 3. How to take Vivotif vaccine
• 4. Possible side effects
• 5. How to store Vivotif vaccine
• 6. Package contents and other information

1. What is Vivotif vaccine and what is it used for

Vivotif is an oral vaccine that stimulates an immune response against the bacterium SalmonellaTyphi, which causes typhoid fever. It is used to provide protection against typhoid fever in adults and children aged 5 years and above.

How Vivotif vaccine works

The bacterium contained in the Vivotif vaccine has been modified so that it cannot cause typhoid fever, but it can still stimulate the body's natural defense system (immune system) to fight against the bacterium that causes typhoid fever.
Other types of diseases caused by Salmonellabacteria
There are many other types of Salmonellabacteria. Most of them cause diseases characterized by diarrhea, which differ significantly from typhoid fever. These are less serious diseases. The Vivotif vaccine does not provide protection against infections caused by other types of Salmonellabacteria.

2. Important information before taking Vivotif vaccine

When not to take Vivotif vaccine:

• if the patient is allergic (hypersensitive) to SalmonellaTyphi Ty21a or any of the other ingredients of this vaccine (listed in section 6);
• if the patient has had an allergic reaction after taking Vivotif vaccine in the past;
• if the patient has a weakened immune system for any reason, e.g., if the patient is born with a low resistance to infections. The patient may also have a weakened immune system due to certain infections or treatments that reduce the immune system's function, such as high doses of glucocorticosteroids, anticancer drugs, or radiation therapy.
• if the patient currently has a high fever (above 38.5°C) or a disease affecting the intestines (e.g., diarrhea), the Vivotif vaccine should not be taken until the symptoms have resolved.

Warnings and precautions

Not everyone who takes the full course of Vivotif vaccine will be fully protected against typhoid fever. It is essential to continue following hygiene recommendations and taking precautions when consuming food and water in areas where typhoid fever is common.

Children

This vaccine should not be given to children under 5 years of age, as the capsule is not suitable for this age group.

Vivotif vaccine and other medicines

The doctor, pharmacist, or nurse should be informed about all medicines or vaccines currently being taken or recently taken by the patient, as well as any planned to be taken, including those bought without a prescription, including herbal medicines. This is because Vivotif vaccine may affect the action of some medicines and vaccines.
In particular, the doctor, pharmacist, or nurse should be informed if the patient is taking:

• antibiotics - it is possible that Vivotif vaccine will not work if taken while taking antibiotics. Vivotif vaccine should be taken no earlier than 3 days after the last dose of antibiotics.
• anti-malaria drugs - treatment with these drugs can be started 3 days after the last dose of Vivotif vaccine, unless the doctor, pharmacist, or nurse advises otherwise.

If the patient is taking any of the above medicines, the doctor, pharmacist, or nurse should be informed before taking Vivotif vaccine.

Taking Vivotif vaccine with food and drink

Vivotif vaccine should be taken on an empty stomach and at least one hour before the next meal.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this vaccine.

Driving and using machines

It is unlikely that Vivotif vaccine will affect the ability to drive or use machines, but if the patient feels unwell, they should not drive or use machines.

Vivotif vaccine contains lactose and sucrose

If the doctor has previously diagnosed the patient with intolerance to some sugars, they should consult their doctor before taking this vaccine.

3. How to take Vivotif vaccine

This vaccine should always be taken as directed by the doctor, pharmacist, or nurse. In case of doubts, the doctor, pharmacist, or nurse should be consulted.
The blister pack containing the vaccine capsules should be checked for damage to the protective foil and capsules.

Number of capsules taken and time of taking

The recommended dose consists of three capsules. One capsule should be taken every other day.

• Take the first capsule on the chosen day. This will be Day 1.
• Take the second capsule on Day 3.
• Take the third capsule on Day 5.

How to take the capsules

• Capsules should be taken on an empty stomach and at least one hour before the next meal.
• Capsules should not be crushed or chewed.
• Capsules should be swallowed with cold or lukewarm water (at a temperature not above 37°C).
• Capsules should be swallowed as soon as possible after being placed in the mouth.

Protection against typhoid fever begins approximately 7 to 10 days after taking the full course of three capsules. The doctor, pharmacist, or nurse will advise when the patient can travel after taking the Vivotif vaccine course.
After three years, the patient may need to take Vivotif vaccine again if they continue to travel to areas where typhoid fever is common. In this case, the doctor, pharmacist, or nurse should be consulted.

Taking more than the recommended dose of Vivotif vaccine

In case of accidental ingestion of all three doses of the vaccine at the same time, the doctor, pharmacist, or nurse should be consulted. It is unlikely to cause illness, but the patient may not be adequately protected against typhoid fever.

Missing a dose of Vivotif vaccine

In case of a missed dose, the vaccine should be taken as soon as possible. The next dose should be taken after approximately 48 hours.
In case of any further doubts about the use of this vaccine, the doctor, pharmacist, or nurse should be consulted.

4. Possible side effects

Like all vaccines, Vivotif vaccine can cause side effects, although not everybody gets them.
The doctor should be consulted immediately if the patient experiences any of the following serious side effects:

• severe allergic reactions causing swelling of the face or throat and difficulty breathing and (or) a drop in blood pressure and fainting.

Other side effects:
Frequently occurring side effects (may occur in less than 1 in 10 people):

• abdominal pain;
• nausea or vomiting;
• diarrhea;
• fever;
• headache;
• skin redness.

Other side effects (frequency cannot be estimated from the available data):

• skin irritation, rash, red rash or rash with raised bumps, and itching;
• weakness;
• general feeling of being unwell;
• chills;
• feeling of tiredness;
• tingling;
• dizziness;
• joint or muscle pain;
• back pain;
• decreased appetite, gas, bloating;
• flu-like illness.

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the doctor, pharmacist, or nurse should be informed. Side effects can be reported directly to
the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Jerozolimskie Avenue 181C
PL-02 222 Warsaw
Phone: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this vaccine.

5. How to store Vivotif vaccine

The vaccine should be stored out of sight and reach of children.
Vivotif vaccine should not be used after the expiry date stated on the label. The expiry date refers to the last day of the month stated.
Store in a refrigerator (2°C - 8°C).
Store the blister pack in the outer packaging to protect from light.
Do not use this vaccine if the blister or capsules are damaged.
Medicines should not be disposed of via wastewater. The pharmacist should be asked how to dispose of medicines that are no longer needed. This will help protect the environment.
EXP means expiry date
Batch means batch number

6. Package contents and other information

What Vivotif vaccine contains

• Each capsule contains not less than 2x10^9 live cells of SalmonellaTyphi Ty21a.
• Other ingredients are: anhydrous lactose, sucrose, casein hydrolysate, ascorbic acid (E300), magnesium stearate (E470), killed cells of SalmonellaTyphi Ty21a. Capsule shell: gelatin, titanium dioxide (E171), erythrosine (E127), yellow iron oxide (E172), and red iron oxide (E172). Coating: hydroxypropyl methylcellulose phthalate, ethylene glycol, and diethyl phthalate.

What Vivotif vaccine looks like and what the pack contains

The pack contains a blister pack with three enteric-coated capsules of Vivotif vaccine. The capsules are two-colored: white and salmon.

Marketing authorization holder

Emergent Netherlands B.V., Strawinskylaan 411, 1077XX Amsterdam, Netherlands

Importer

IL-CSM GmbH
Marie-Curie-Strasse 8
79539 Lörrach
Germany
To obtain information about this medicinal product, the local representative of the marketing authorization holder should be contacted:

This medicinal product is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Austria, Belgium, Czech Republic, Denmark, Finland, France, Italy, Luxembourg, Netherlands, Norway, Portugal, Slovakia, Spain, Sweden, United Kingdom (Northern Ireland): Vivotif
Germany: Typhoral L
Date of last revision of the leaflet.
04/2022

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