Vivotif gastro-resistant hard capsules
SpainTable of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Vivotif gastro-resistant hard capsules
Salmonella Typhi Ty21a
Read the entire leaflet carefully before you start taking this vaccine, because it contains important information for you.
- Keep this leaflet, as you may need to read it again.
- If you have any questions, consult your doctor, pharmacist or nurse.
- This vaccine has been prescribed for you only, and you should not give it to other people.
- If you experience any adverse reactions, consult your doctor, pharmacist or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.
Contents of the leaflet
- What Vivotif is and what it is used for
- What you need to know before taking Vivotif
- How to take Vivotif
- Possible side effects
- How to store Vivotif
- Contents of the pack and other information
1. What Vivotif is and what it is used for
Vivotif is an oral vaccine that stimulates the immune response against a type of bacterium called Salmonella Typhi, 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 so that, although they cannot cause typhoid fever, they can still stimulate the body's natural defense system (the immune system) to fight the bacteria that cause typhoid fever.
Other diseases caused by Salmonella
There are many other types of bacteria in the Salmonella group. Most of them cause illnesses with diarrhea, which are very different from typhoid fever and are also less severe. Vivotif cannot protect you against infections caused by these other types of Salmonella.
2. What you need to know before taking Vivotif
Do not take Vivotif:
- if you are allergic (hypersensitive) to Salmonella Typhi Ty21a or to any of the other components of this vaccine (listed in section 6).
- if you have previously had allergic reactions after taking Vivotif.
- if your immune system is weakened for any reason; for example, if you were born with low immunity to infections. You may also have low immunity due to certain infections or treatments that suppress the immune system, such as high-dose corticosteroids, cancer medications, or radiotherapy.
- if you currently have a high fever (over 38.5°C) or an intestinal illness (e.g. diarrhoea), do not take Vivotif until you have recovered.
Warnings and precautions
Not everyone who completes a full course of Vivotif will be fully protected against typhoid fever. It is important to follow hygiene advice and to be cautious about the food and water consumed in areas affected by typhoid fever.
Children
Do not administer this vaccine to children under 5 years of age, as the capsule formulation is not suitable for this age group.
Use of Vivotif with other medicines
Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might need to take any other medicines or vaccines. This includes medicines available without a prescription and herbal remedies. This is because Vivotif may affect how other medicines or vaccines work.
In particular, inform your doctor, pharmacist, or nurse if you are taking:
- antibiotics – Vivotif may not work if taken while you are 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 at least 3 days after the last dose of Vivotif, unless your doctor, pharmacist, or nurse advises otherwise.
If any of the above apply to you, inform your doctor, pharmacist, or nurse before taking Vivotif.
Use of Vivotif with food and drink
Vivotif should be 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 become pregnant, consult your doctor or pharmacist before using this medicine.
Driving and using machines
Vivotif has not been shown to affect the ability to drive or operate machinery. However, do not drive or use machinery if you do not feel well.
Vivotif contains lactose and sucrose
If your doctor has informed you that you have an intolerance to certain sugars, consult your doctor before taking this medicine.
3. How to take Vivotif
Follow exactly the administration instructions for 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 verify that the aluminum foil and the 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 (no hotter 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 completing the three-capsule course. Your doctor, pharmacist, or nurse will advise you how long in advance of travel the Vivotif course should be administered.
After three years, you may need to receive Vivotif again if you continue to visit areas where typhoid fever occurs. 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, inform your doctor, pharmacist, or nurse. It is unlikely that you will become ill, but you may not be adequately 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 approximately 48 hours after.
If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.
4. Possible adverse effects
Like all vaccines, this vaccine may cause adverse effects, although not everyone will experience them.
Contact your doctor immediately if you experience the following serious adverse effects:
- severe allergic reactions causing swelling of the face or throat, 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)
- stomach pain,
- feeling unwell or nausea,
- diarrhoea,
- fever,
- headache,
- skin redness.
Other adverse effects (frequency cannot be estimated from the available data):
- skin irritation, rash, red or raised rash, and itching,
- weakness,
- general malaise,
- chills,
- feeling tired,
- tingling,
- prickling sensation,
- dizziness,
- muscle or joint pain,
- back pain,
- loss of appetite, abdominal gas, swelling,
- flu-like symptoms.
Reporting of adverse effects
If you experience any adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es.
By reporting adverse 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 indicated.
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 the capsules are not intact.
Medicines should not be disposed of via wastewater. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Vivotif
- Each capsule contains at least 2 x 109 viable cells of Salmonella Typhi Ty21a.
- The other components are anhydrous lactose, sucrose, acid hydrolysate of casein, ascorbic acid (E300), magnesium stearate (E470), inactivated cells of Salmonella Typhi Ty21a. 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.
Nature and contents of the container
The pack contains a blister 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
Further information on this medicinal product is available from the local representative of the Marketing Authorization Holder:
Bavarian Nordic Spain, S.L.U.
This medicinal product is authorized in the European Economic Area member states 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 the latest revision of this leaflet: December 2021
Other sources of information
Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.es/