Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Vivotif, gastro-resistant capsules
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Salmonella typhi strain ty 21a may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
for
Vivotif is an oral vaccine that stimulates an immune response against a type of bacteria called Salmonella Typhi that causes typhoid fever. It is used for protection from typhoid fever in adults and children 5 years and older. How Vivotif works The vaccine bacteria in Vivotif have been altered so that they cannot cause typhoid fever but still stimulate the body's natural defence system (immune system) to fight typhoid-causing bacteria. 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. 2.
What you need to know before you take it
e Vivotif
Do not take Vivotif:
- if you are allergic (hypersensitive) to Salmonella Typhi Ty21a or any of the other ingredients of this vaccine (listed in section 6).
- if you experienced allergic reactions when you previously took Vivotif.
- if 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 certain infections or treatments that depress the immune system – such as high dose corticosteroids, cancer drugs or radiotherapy.
- if you have a high fever (above 38.5oC) or an illness affecting your gut (such as diarrhoea) at the moment – do not take Vivotif until you have recovered. Warnings and precautions Not everyone taking a full course of Vivotif will be fully protected against typhoid fever. It is important to continue to adhere to hygiene advice and exercise caution regarding food and water consumed in typhoid-affected areas.
Children Do not give this vaccine to children younger than 5 years old since the capsule is not suitable for this age group. Other medicines and Vivotif Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines or vaccines. This includes medicines obtained without a prescription, including herbal medicines. This is because Vivotif can affect the way some other medicines and vaccines work. In particular tell your doctor, pharmacist or nurse if you are taking:
- antibiotics – Vivotif may not work if it is taken while you are also taking antibiotics. Take Vivotif no earlier than 3 days after the last dose of an antibiotic.
- medicines to prevent malaria – do not start these until 3 days after the last dose of Vivotif unless otherwise directed by your doctor, pharmacist or nurse. If any of the above apply to you, talk to your doctor, pharmacist or nurse before taking Vivotif. Vivotif with food and drink Vivotif is taken on an empty stomach and at least one hour before the next meal. Pregnancy, breast-feeding and fertility If you are pregnant or breast-feeding, 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 is not known to affect your ability to drive or use machines. However, do not drive or use any machines if you are feeling unwell. Vivotif contains lactose and sucrose If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. 3. How to take Vivotif Always take this vaccine exactly as your doctor, pharmacist or nurse has told you. Check with your doctor, pharmacist or nurse if you are not sure. The blister pack containing the vaccine capsules should be inspected to ensure that the foil seal 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 chosen day. This is Day 1.
- Take the second capsule on Day 3.
- Take the third capsule on Day 5.
How to take it
your 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 (temperature not more than 37°C).
- Swallow the capsules as quickly as possible after placing in your mouth.
Protection against typhoid fever starts at about seven to ten days after taking the course of three capsules. Your doctor, pharmacist or nurse will advise you how soon before travelling to have your course of Vivotif. After three years, you may need to receive Vivotif again if you continue to visit areas where typhoid fever occurs. In this case, consult with your doctor, pharmacist or nurse. If you take more Vivotif than you should If you take all three doses at once by accident, tell your doctor, pharmacist or nurse. 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, pharmacist or nurse.
Possible side effects
Like all vaccines, this vaccine can cause side effects, although not everybody gets them. Contact a doctor immediately if you experience the following serious side effects:
- serious allergic reactions causing swelling of the face or throat and breathlessness and/or a drop in blood pressure and fainting. Other side effects: Common side effects (may affect up to 1 in 10 people)
- stomach pains,
- feeling or being sick,
- diarrhoea,
- fever,
- headache,
- skin redness. Other side effects (frequency cannot be estimated from the available data):
- 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.
- back pain
- decreased appetite, abdominal gas, bloating
- flu-like illness 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 Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
How to store it
Vivotif
Keep this vaccine out of the sight and reach of children. Do not use Vivotif after the expiry date which is stated on the label. The expiry date refers to the last day of that month. Store in a refrigerator (2°C – 8°C). Keep the blister pack in the outer carton in order to protect from light. Do not use this vaccine if you notice that the blister pack or the capsules are not intact. Do not throw away any medicines via wastewater. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
Contents of the pack and other information
What Vivotif contains
- Each capsule contains at least 2×109 viable cells of Salmonella Typhi Ty21a.
- The other ingredients are lactose anhydrous, sucrose, casein acid hydrolysate, ascorbic acid (E300), magnesium stearate (E470), non-viable cells of Salmonella Typhi Ty21a. Capsule shell: gelatin, titanium dioxide (E171), erythrosine (E127), iron oxide yellow (E172), and iron oxide red (E172). Capsule coating: hydroxypropylmethylcellulose phthalate, ethylene glycol, and diethyl phthalate. What Vivotif looks like and contents of the pack The pack contains a blister pack with three enteric-coated capsules of Vivotif. The capsules are bicoloured white and salmon. Marketing Authorisation Holder Bavarian Nordic A/S, Philip Heymans Alle 3, DK-2900 Hellerup, Denmark Manufacturer Smiro Qualitas Limited 4 Flatford Road Haverhill, CB9 7WWW United Kingdom This medicinal product is authorised in the Member States of the EEA under the following names: Austria, Belgium, Czech Republic, Denmark, Finland, France, Italy, Luxembourg, Netherlands, Norway, Poland, Portugal, Slovakia, Spain, Sweden: Vivotif Germany: Typhoral L This leaflet was last revised in June 2024 Other sources of information Detailed information on this medicine is available on the MHRA website: http://www.mhra.gov.uk.
Frequently asked questions about Vivotif, gastro-resistant capsules
How do I take Vivotif, gastro-resistant capsules?
Vivotif, gastro-resistant capsules comes as capsule. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Vivotif, gastro-resistant capsules?
The active substance in Vivotif, gastro-resistant capsules is salmonella typhi strain ty 21a.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Vivotif, gastro-resistant capsules, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Vivotif, gastro-resistant capsules without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: salmonella typhi strain ty 21a
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
Vivotif is indicated for active oral immunisation against typhoid fever, caused by Salmonella enterica serovar Typhi, (S. Typhi), in adults and children aged five years and older.
This vaccine should be used in accordance with official recommendations.
4.2. Posology and method of administration
Posology
One capsule of Vivotif is taken on each of Days 1, 3 and 5.
Complete vaccination comprises the ingestion of three capsules as described above. The optimal immune response may not be achieved unless the entire vaccination schedule is completed.
Protection against typhoid fever commences approximately seven to ten days after ingesting the third dose of vaccine. The entire vaccination schedule should be completed at least one week prior to travel to an endemic area.
Revaccination
Revaccination is recommended at three years following the most recent vaccination for all individuals.
Revaccination comprises the ingestion of three capsules on Days 1, 3, and 5, as for the original vaccination schedule.
Paediatric Population
The posology in children is the same as in adults. Safety and efficacy in children under five years of age have not been established.
Method of administration
One capsule of Vivotif is taken with cold or lukewarm water (temperature not more than 37ºC) on an empty stomach and at least one hour before the next meal. The vaccine capsule should not be chewed and should be swallowed as soon as possible after placing in the mouth.
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Allergic reaction to previous ingestion of the product.
Congenital or acquired immune deficiency (including patients receiving immunosuppressive or antimitotic drugs).
Acute febrile illness or acute gastrointestinal illness. Vaccination should be postponed until after recovery.
4.4. Special warnings and precautions for use
Vivotif does not provide 100% protection against typhoid fever. Vaccinees should adhere to hygiene advice and exercise caution regarding food and water consumed in typhoid-affected areas.
The capsules contain lactose and sucrose. Patients with rare hereditary problems of galactose intolerance, congenital lactase deficiency, glucose-galactose malabsorption, fructose intolerance, or sucrose-isomaltase insufficiency should not take this vaccine.
4.5. Interaction with other medicinal products and other forms of interaction
Vaccination with Vivotif should be postponed during and for at least three days before and after antibiotic or antibacterial sulfonamide treatment, due to possible inhibition of the growth of the vaccine organisms and potential attenuation of the immune response. A longer interval should be considered for long-acting antibiotics (e.g., azithromycin).
Combination with malaria prophylaxis
If malaria prophylaxis is needed, it is recommended to complete the vaccination with Vivotif prior to malaria prophylaxis. In this case, an interval of at least three days should be kept between the last dose of Vivotif and the start of malaria prophylaxis.
Vivotif may be administered concomitantly with yellow fever vaccine, CVD 103-HgR cholera vaccine and oral polio vaccine. No data are available regarding interaction between Vivotif and other live attenuated vaccines.
4.6. Fertility, pregnancy and lactation
Pregnancy
Animal reproduction studies have not been conducted with Vivotif. It is not known whether Vivotif causes foetal harm when administered to pregnant women or can affect reproduction capacity. Vivotif should not be administered during pregnancy unless clearly needed, like in cases of increased risk of infection.
Breast-feeding
There are no data regarding administration of Vivotif to nursing mothers. S. Typhi Ty21a is not absorbed systemically, therefore is it not expected to be excreted in human milk. Vivotif should not be administered during breast-feeding unless clearly needed, like in cases of increased risk of infection.
Fertility
It is not known whether Vivotif can affect reproductive capacity.
4.7. Effects on ability to drive and use machines
No studies on the effects on the ability to drive or use machines have been performed. However, some of the undesirable effects mentioned under section 4.8 may temporarily affect the ability to drive or operate machinery.
4.8. Undesirable effects
Summary of safety profile
During clinical trials over 1.4 million capsules of Vivotif were administered. Since initial registration the number of doses distributed exceeds 100 million. The most frequent adverse reactions have been abdominal pain, nausea, headache, fever, diarrhoea, vomiting, and skin rash. Most adverse reactions have been mild. One isolated, non-fatal anaphylactic shock considered to be an allergic reaction to the vaccine was reported.
The adverse reaction frequency classification used is as follows: Very common (≥ 1/10); common (≥ 1/100 to <1/10); uncommon (≥ 1/1,000 to <1/100); rare (≥ 1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data).
Tabulated summary of adverse reactions
Adverse reactions occurring in clinical trials were as follows:
Adverse Reactions
Frequency
Nervous system disorders
Headache
Common
Gastrointestinal disorders
Abdominal pain, nausea, vomiting, diarrhoea
Common
Skin and subcutaneous tissue disorders
Rash
Common
General disorders and administration site conditions
Pyrexia
Common
Adverse reactions reported during post-marketing surveillance are as follows:
Adverse Reactions*
Immune system disorders
Hypersensitivity, anaphylactic reaction, including shock
Metabolism and nutrition disorders
Decreased appetite
Nervous system disorders
Paraesthesia, dizziness
Gastrointestinal disorders
Flatulence, abdominal distension
Skin and subcutaneous tissue disorders
Dermatitis, pruritus, urticaria
Musculoskeletal and connective tissue disorders
Arthralgia, myalgia, back pain
General disorders and administration site conditions
Asthenia, malaise, fatigue, chills, influenza-like illness
*Because these reactions are reported spontaneously during post-marketing from a population of unknown size, it is not possible to establish their frequency. Therefore, the frequency of these reactions is not known.
Paediatric Population
Frequency, type and severity of adverse reactions in children are expected to be the same as in adults.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store
4.9. Overdose
Occasional reports of overdose have been received, i.e. consumption of two or more capsules at the same time. The symptoms reported were not different from those at the recommended dosage.
💬 Ask about this leaflet
Ask anything about Vivotif, gastro-resistant capsules. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.