VIVOTIF Hard Gastro-Resistant Capsules

Introduction

Package Leaflet: Information for the User

Vivotif Hard Gastric-Resistant Capsules

SalmonellaTyphi Ty21a

Read all of this leaflet carefully before you start taking 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, pharmacist, or nurse.
• This vaccine has been prescribed for you only, do not pass it on to others.
• If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. See section 4.

Contents of the Package Leaflet

1. What is Vivotif and what is it used for
2. What you need to know before you start taking Vivotif
3. How to take Vivotif
4. Possible side effects
5. Storage of Vivotif
6. Contents of the pack and further information

1. What is Vivotif and what is it used for

Vivotif is an oral vaccine that stimulates the immune response against a type of bacteria called SalmonellaTyphi, which causes typhoid fever. It is used for protection against typhoid fever in adults and children from 5 years of age.

How Vivotif works

The bacteria contained in Vivotif have been modified so that they cannot cause typhoid fever, but still stimulate the body's natural defense system (the immune system) to fight the bacteria that cause typhoid fever.

Other types of diseases caused by Salmonella

There are many other types of Salmonellabacteria. Most of them cause diseases with diarrhea, which are very different from typhoid fever and are less severe. Vivotif cannot protect against infections caused by these other types of Salmonella.

2. What you need to know before you start taking Vivotif

Do not take Vivotif:

• if you are allergic (hypersensitive) to SalmonellaTyphi Ty21 or to any of the other components of this vaccine (listed in section 6).
• if you have had allergic reactions before when taking Vivotif.
• if your immune system is weakened for any reason; for example, if you have had low immunity to infections since birth. You may also have low immunity due to certain infections or treatments that depress the immune system, such as high-dose corticosteroids, cancer medicines, or radiation therapy.
• if you currently have a high fever (over 38.5°C) or an intestinal disease (such as diarrhea), do not take Vivotif until you have recovered.

Warnings and precautions

Not all people who take a complete cycle of Vivotif will be fully protected against typhoid fever. It is important to follow hygiene advice and be careful with food and water consumed in areas affected by typhoid fever.

Children

Do not give this vaccine to children under 5 years of age, as the capsule is not suitable for this age group.

Using Vivotif with other medicines

Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicine or vaccine. This includes medicines available without a prescription and herbal medicines. This is because Vivotif may affect the way other medicines and vaccines work.

In particular, tell your doctor, pharmacist, or nurse if you are taking:

• antibiotics – Vivotif may not work if taken while also taking antibiotics. Do not take Vivotif until at least 3 days after the last dose of antibiotic.
• medicines to prevent malaria – do not start taking these medicines until 3 days after the last dose of Vivotif, unless your doctor, pharmacist, or nurse tells you otherwise.

If any of the above applies to you, tell your doctor, pharmacist, or nurse before taking Vivotif.

Using Vivotif with food and drinks

Vivotif is taken on an empty stomach, and at least one hour before the next meal.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, 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

Vivotif has not been observed to affect the ability to drive and use machines. However, do not drive or use machines if you do not feel well.

Vivotif contains lactose and sucrose

If your doctor has told you that you have an intolerance to some sugars, consult your doctor before taking this medicine.

3. How to take Vivotif

Follow exactly the administration instructions of this vaccine given by your doctor, pharmacist, or nurse. If in doubt, consult your doctor, pharmacist, or nurse again.

The blister containing the vaccine capsules should be inspected to check that the aluminum foil and capsules are intact.

How much and when to take

The recommended dose is three capsules. One capsule is taken every other day.

• Take the first capsule on a selected day. This is day 1.
• Take the second capsule on day 3.
• Take the third capsule on day 5.

How to take the capsules

• Take the capsules on an empty stomach, and at least one hour before the next meal.
• Do not crush or chew the capsules.
• Swallow the capsules with cold or lukewarm water (not more than 37°C).
• Swallow them as quickly as possible after putting them in your mouth.

Protection against typhoid fever begins between 7 and 10 days after taking the cycle of three capsules. Your doctor, pharmacist, or nurse will tell you how far in advance of your trip you should take the Vivotif cycle.

After three years, you may need to take Vivotif again if you continue to visit areas where typhoid fever is present. In this case, consult your doctor, pharmacist, or nurse.

If you take more Vivotif than you should

If you accidentally take all three doses at once, tell your doctor, pharmacist, or nurse. It is unlikely that you will become ill, but you may not be well protected against typhoid fever.

If you forget to take Vivotif

If you miss 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 medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all vaccines, this vaccine can cause side effects, although not everybody gets them.

Contact your doctor immediately if you experience the following serious side effects:

• severe allergic reactions that cause swelling of the face or throat and shortness of breath, and/or a drop in blood pressure and fainting.

Other side effects:

Common side effects (may affect up to 1 in 10 people)

• stomach pain,
• feeling or being sick,
• diarrhea,
• fever,
• headache,
• redness of the skin.

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

• skin irritation, rash, red or prominent eruptions, and itching,
• weakness,
• general malaise,
• chills,
• feeling of tiredness,
• tingling,
• feeling of pins and needles,
• dizziness,
• muscle or joint pain,
• back pain,
• decreased appetite, abdominal gases, inflammation,
• flu-like symptoms.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Agency's website: www.notificaRAM.es.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Vivotif

Keep this vaccine out of the sight and reach of children.

Do not use Vivotif after the expiry date stated on the label. The expiry date is the last day of the month stated.

Store in a refrigerator (between 2°C and 8°C).

Keep the blister in the outer packaging to protect it from light.

Do not use this vaccine if you notice that the blister or capsules are not intact.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and further information

Composition of Vivotif

• Each capsule contains at least 2 x 10^9 viable cells of SalmonellaTyphi Ty21a.
• The other ingredients are anhydrous lactose, sucrose, acid hydrolysate of casein, ascorbic acid (E300), magnesium stearate (E470), inactivated SalmonellaTyphi Ty21a cells. Capsule shell: gelatin, titanium dioxide (E171), erythrosine (E127), yellow iron oxide (E172), and red iron oxide (E172). Capsule coating: hydroxypropylmethylcellulose phthalate, ethylene glycol, and diethyl phthalate.

Appearance of the product and contents of the pack

The pack contains a blister pack with three enteric-coated capsules of Vivotif. The capsules are bicolored white and salmon.

Marketing authorization holder

Bavarian Nordic A/S,

Philip Heymans Alle 3,

DK-2900 Hellerup,

Denmark

Manufacturer

IL-CSM GmbH

Marie-Curie-Strasse 8

D-79539 Lörrach

Germany

You can obtain further information on this medicine by contacting the local representative of the marketing authorization holder:

Bavarian Nordic Spain, S.L.U.

This medicine 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, Poland, Portugal, Slovakia, Sweden, United Kingdom (Northern Ireland): Vivotif

Germany: Typhoral L

Date of last revision of this leaflet: December 2021

Other sources of information

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS)

http://www.aemps.es/