Prospect: information for the user

DUKORAL suspension and effervescent granule for oral suspension

Cholera vaccine (inactivated, oral)

Read this prospect carefully before starting to use this vaccine,because 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 any adverse effects, consult your doctor, pharmacist, or nurse, even if they do not appear in this prospect. See section 4.
• Make sure to mix the vaccine with the diluent as described in this prospect.See section 3.

Content of the prospect

1.What Dukoral is and for what it is used

2.What you need to know before starting to use Dukoral

3.How to use Dukoral

4.Possible adverse effects

5.Storage of Dukoral

6.Contents of the package and additional information

Dukoral is an oral vaccine against cholera that stimulates the intestinal immune defenses. The vaccine protects adults and children aged 2 years and older against cholera.

Dukoral causes the body to produce its own protection against cholera. After receiving the vaccine, the body will create substances called antibodies, which fight the cholera toxin and bacteria that cause diarrhea.

Do not use Dukoral

?if you are allergic to any of the components of the vaccine (listed in section 6) or formaldehyde.

?if you have an acute gastrointestinal disorder or an infection accompanied by fever (vaccination should be postponed).

Warnings and precautions

Consult your doctor before starting to take Dukoral

?if you are receiving treatment that affects your immune system

?if you have any immune system disorder (including HIV infection).

The vaccine may provide you with a lower level of protection than that occurring in people without immune system alteration.

The vaccine does not provide complete protection and it is essential to follow dietary and hygiene recommendations to avoid contracting diseases that cause diarrhea.

Children

Do not administer this vaccine to children under 2 years of age since protection has not been studied in this group.

Use ofDukoral withother medications

Inform your doctor if you are taking, have taken recently, or may need to take any other medication.

Do not take any other medication from one hour before until one hour after the administration of the vaccine.

Use of Dukoral with food and drinks

Avoid the intake of food and drinks from one hour before until one hour after the administration of the vaccine.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or intend to become pregnant, consult your doctor before taking the vaccine.

Driving and operating machinery

There is no reason to suspect that Dukoralproduces effects on the ability to drive and use machines.

Dukoralcontains sodium

Dukoral contains approximately 1.1 g of sodium per dose, which should be taken into account in patients with low-sodium diets.

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor. In case of doubt, consult your doctor again.

Adults and children aged 6 years and older:The primary vaccination consists of two dosesgiven orally (by mouth) separated by a minimum interval of one week (up to six weeks).

• Take the first dose at most two weeks before starting your trip.
• Take the second dose at least one week after the first dose and at least one week before your trip.

It takes approximately one week for protection to begin after the last dose.

To achieve continued protection, it is recommended to revaccinatein a periodof two years. If less than two years have passed sinceyour last dose of the vaccine, a single dose will renew your protection. If more than two years have passed sinceyour last dose of the vaccine, the primary vaccination should be repeated (2 doses).

Children aged 2 to under 6 years:The primary vaccination consists of three dosesgiven orally (by mouth) separated by a minimum interval of one week (up to six weeks). The vaccine should only be mixed with the buffer solution.

• Administer the first dose to the child at most three weeks before starting your trip.
• Administer thesecond dose to the child at least one week after the first dose.
• Administer the third dose to the child at least one week after the second dose and at least one week before your trip.

It takes approximately one week for protection to begin after the last dose.To achieve continued protection, it is recommended to revaccinate in a period of six months. If less than six months have passed since the lastdose of the vaccine, a single dose will renew the protection. If more than six months have passed since the last vaccination, the primary vaccination should be repeated (3 doses).

The suspension is a white suspension that is supplied in a glass vial for a single dose. Each vial comes with a package that contains aeffervescent granule, white in color, of sodium bicarbonate. Theeffervescent granulemust be dissolved in a glass of cold water, and the resulting buffer solution must be mixed with the suspension. It is essential to use the buffer solution, as it protects the vaccine from stomach acid.

Drink the entire mixture within 2 hours after mixing it with the buffer solution.

Instructions for use:

1. To prepare the buffer solution, dissolvetheeffervescent granulein a glass of cold water (approx. 150 ml) gently stirring.

Do not use any other liquid.

For children aged 2 to under 6 years:discard half of the buffer solution.

1. Shake the vial of suspensionDukoral(1 vial = 1 dose).

1. Pour the contents of the vial of suspensionDukoralinto the glass of buffer solution (see 1). Mix gently.
   
2. Drink the entire mixture within 2 hours. Avoid eating and drinking from one hour before to one hour after drinking the mixture.

If you take more Dukoral than you should

If you take the doses with an interval of time less than one week, contact your doctor, pharmacist, or nurse.

Since each vial of Dukoral contains only one dose, it is unlikely that an overdose will occur.

If you have taken more than one dose at a time, contact your doctor, pharmacist, or nurse.

If you forgot to take Dukoral.

You can take the second dose of Dukoral up to 6 weeks after the first dose (children aged 2 to under 6 years must take 3 doses). If more than 6 weeks have passed, contact your doctor, pharmacist, or nurse.

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

Like all medications, Dukoral can produce adverse effects, although not all people will experience them.

Seek immediate medical attention if you experience the following severe adverse effects:

• Intense diarrhea with loss of body fluids
• Severe allergic reactions that cause facial or throat swelling and difficulty breathing

Other adverse effects:

Less common adverse effects (may affect up to 1 in 100 people)

• Diarrhea, stomach pain, stomach cramps, belching, stomach bloating, gas in the stomach, and general stomach discomfort
• Headache

Rare adverse effects (may affect up to 1 in 1,000 people)

• Fever
• General feeling of illness, sensation of dizziness
• Nausea, vomiting, loss or decrease of appetite
• Swelling, inflammation inside the nose and throat

Very rare adverse effects (may affect up to 1 in 10,000 people)

• Rash
• Sore throat, decreased sense of taste
• Fatigue/feeling of tiredness
• Sweating, chills
• Joint pain
• Inability to fall asleep

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

• Flu-like symptoms, respiratory symptoms, chills, generalized pain, weakness
• Hives, itching
• Swelling of lymph nodes

• Numbness or tingling

• High blood pressure

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 national notification system included in theAppendix V.By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keepthis medication out of the sight and reach of children.

Do not use Dukoral after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Store in the refrigerator (between 2°C and 8°C). Do not freeze.

The product from the vial and the sachet, stored in the outer box, remains stable at temperatures not exceeding 25°C for a period of 14 days. At the end of this period, the product should be used or discarded.

Medicines should not be disposed of through drains or in the trash.Ask your pharmacist how to dispose ofthe packaging and the medications that you no longerneed. This will help protect the environment.

Composition of Dukoral

• The active principles are:
  31.25x109bacteria* of the following strains ofV. choleraeO1: classical biotype Inaba (heat-inactivated), biotype El Tor Inaba (formalin-inactivated), classical biotype Ogawa (heat-inactivated), classical biotype Ogawa (formalin-inactivated).
  Recombinant cholera toxin B subunit (TCBr), 1 mg.

*Bacterial content prior to inactivation

• The other components of the suspension containing the vaccine are sodium dihydrogen phosphate, disodium hydrogen phosphate, sodium chloride, and water for injection.

• The effervescent granule contains sodium bicarbonate, citric acid, sodium carbonate, sodium saccharin, sodium citrate, and raspberry flavor.

Appearance of the product and contents of the packaging

Dukoral is presentedintheformoforal suspensionandeffervescent granule.The suspension is a white suspension presented in an ampoule. The effervescent granule is white with raspberry flavor and is supplied in a sachet.

Dukoral is presented in packaging of 1, 2, and 20 doses. Only some packaging sizes may be commercially available.

Marketing authorization holder and manufacturer

Valneva Sweden AB, 105 21 Stockholm, Sweden.

[email protected]

Last review date ofthis leaflet:MM/YYYY

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency website:http://www.ema.europa.eu.

This leaflet is available in all languages of the European Union/European Economic Area on the European Medicines Agency website.