Prospect: information for the user

Vivotif hard gastro-resistant capsules

SalmonellaTyphi Ty21a

Read this prospect carefully before starting to take this vaccine, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This vaccine has been prescribed only for you, and you must not give it to other people.
• If you experience adverse effects, consult your doctor, pharmacist, or nurse, even if they do not appear in this prospect. See section 4.

1. What isVivotifand for what it is used

2. What you need to know before starting to takeVivotif

3. How to takeVivotif

4. Possible adverse effects

5. Storage ofVivotif

6. Contents of the package and additional information

Vivotif is an oral vaccine that stimulates the immunological response against a type of bacteria

calledSalmonellaTyphi, which causes typhoid fever. It is used for protection against typhoid fever in adults and children aged 5 years and older.

How Vivotif works

The bacteria contained in Vivotif have been modified in such a way that although they cannot

cause typhoid fever, they still stimulate the body's natural defense system (the immune system) to fight against the bacteria that cause typhoid fever.

Other types of diseases caused bySalmonella

There are many other types of bacteria in theSalmonellagroup. Most of them cause

diarrheal diseases, which are very different from typhoid fever. They are also less severe. Vivotif cannot protect you against infections caused by these other types ofSalmonella.

Do not take Vivotif:

• if you are allergic (hypersensitive) toSalmonellaTyphi Ty21 or to any of the other components of this vaccine (listed in section 6).
• if you have had allergic reactions previously while 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 suppress the immune system, such as high doses of corticosteroids, oncological medications, or radiation therapy.
• if you currently have a high fever (above 38.5°C) or an intestinal illness (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 essential to follow hygiene advice and take care when consuming food and water in areas affected by typhoid fever.

Children

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

Use of Vivotif with other medications

Inform your doctor, pharmacist, or nurse if you are taking, have recently taken, or may need to take any other medication or vaccine. This includes over-the-counter medications and herbal medications. This is because Vivotif may affect how other medications and vaccines work.

Particularly, inform 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.
• medications to prevent malaria–do not start taking these medications until at least 3 days after the last dose of Vivotif, unless your doctor, pharmacist, or nurse advises otherwise.

If any of the above circumstances affect you, inform your doctor, pharmacist, or nurse before taking Vivotif.

Use of Vivotif with food and beverages

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 plan to become pregnant, consult your doctor or pharmacist before using this medication.

Driving and operating machinery

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

Vivotif contains lactose and saccharose

If your doctor has informed you that you have intolerance to certain sugars, consult with your doctor before taking this medication.

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

Inspect the blister pack containing the vaccine capsules to verify that the aluminum foil and capsules are intact.

How much and when to take

The recommended dose is three capsules. Take one capsule 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 placing them in your mouth.

Protection against typhoid fever begins between seven and ten days after taking the three-capsule cycle. Your doctor, pharmacist, or nurse will inform you how far in advance of your trip to administer the Vivotif cycle.

After three years, you may need to receive Vivotif again if you continue to visit areas where typhoid fever is present. Consult with your doctor, pharmacist, or nurse.

If you take more Vivotif than you should

If you accidentally take all three doses at once, inform 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 forget a dose, take it as soon as you remember. Then take the next dose around 48 hours later.

If you have any other questions about the use of this medication, ask your doctor, pharmacist, or nurse.

Like all vaccines, this vaccine may produce adverse effects, although not all people will experience them.

Notify your doctor immediately if you experience the following severe adverse effects:

• Severe allergic reactions that cause swelling of the face or throat and difficulty breathing, and/or a drop in blood pressure and fainting.

Other adverse effects:

Frequent adverse effects (may affect up to 1 in 10 people)

• Abdominal pain,
• Feeling or being nauseous,
• Diarrhea,
• Fever,
• Headache,
• Redness of the skin.

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

• Skin irritation, rash, red or prominent eruptions, and itching,
• Weakness,
• General discomfort,
• Chills,
• Sensation of fatigue,
• Tickling,
• Sensation of pins and needles,
• Dizziness,
• Muscle or joint pain,
• Back pain,
• Decreased appetite, abdominal gas, inflammation,
• Symptoms similar to the flu.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es.

By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep this vaccine out of sight and reach of children.

Do not use Vivotif after the expiration date shown on the label. The expiration date is the last day of the month indicated.

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

Store the blister pack in the outer packaging to protect it from light.

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

Medicines should not be disposed of through the drains. Ask your pharmacist how to dispose of the containers and medicines that you no longer need. By doing so, you will help protect the environment.

Composition of Vivotif

• Each capsule contains a minimum of 2 x 10 9 live viable cells of Salmonella Typhi Ty21a.
• The other components are anhydrous lactose, sucrose, casein acid hydrolysate, ascorbic acid (E300), magnesium stearate (E470), inactivated cells of Salmonella Typhi Ty21a. Capsule exterior: gelatin, titanium dioxide (E171), erythrosine (E127), yellow iron oxide (E172), and red iron oxide (E172). Capsule coating: phthalate of hydroxypropylmethylcellulose, ethylene glycol, and diethyl phthalate.

Appearance of the product and contents of the packaging

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

Holder of the marketing authorization

Bavarian Nordic A/S,

Philip Heymans Alle 3,

DK-2900 Hellerup,

Denmark

Responsible for manufacturing

IL-CSM GmbH

Marie-Curie-Strasse 8

D-79539 Lörrach

Germany

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Bavarian Nordic Spain, S.L.U.

This medication is authorized in the member states of the European Economic Area and in the United Kingdom (Northern Ireland) with 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

Last review date of this leaflet: December 2021

Other sources of information

The detailed information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.es/