Dukoral

Package leaflet: Information for the user

DUKORAL, oral suspension and effervescent powder for oral suspension

Inactivated oral cholera vaccine.
Please read all of this leaflet carefully before you start using this vaccine, because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This vaccine has been prescribed for you only. Do not give it to other people.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.
• Make sure you mix the vaccine with the buffer solution as described in this leaflet. See section 3.

Contents of this leaflet:

1. What Dukoral is and what it is used for
2. What you need to know before you use Dukoral
3. How to use Dukoral
4. Possible side effects
5. How to store Dukoral
6. Contents of the pack and other information

1. What Dukoral is and what it is used for

Dukoral is an oral cholera vaccine that stimulates the immune defenses in the intestine. The vaccine
protects against cholera in adults and children from 2 years of age onwards.
Dukoral induces the body to develop protection against cholera. After receiving the
vaccine, the body will produce substances called antibodies, which fight the toxin and the cholera bacteria responsible for diarrhea.

2. What you need to know before using Dukoral

Do not use Dukoral:

• if you are allergic to any of the vaccine components (listed in section 6) or to formaldehyde
• if you have an acute gastrointestinal disorder or an infection with fever (vaccination should be postponed)

Warnings and precautions
Talk to your doctor before using Dukoral:

• if you are taking a medicine that affects the immune system
• if you have an immune system disease (including HIV infection). In your case, the vaccine may provide a lower level of protection than in people with a healthy immune system.

The vaccine does not provide complete protection, and it is important to follow dietary and hygiene advice to prevent diarrhoeal diseases.
Children
Do not give this vaccine to children under 2 years of age, as protection has not been studied in this age group.
Other medicines and Dukoral
Tell your doctor if you are taking, have recently taken, or might take any other medicines.
Do not take other medicines from 1 hour before up to 1 hour after taking the vaccine.
Dukoral with food and drinks
Avoid food and drinks from 1 hour before up to 1 hour after vaccination.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or are breastfeeding, consult your doctor before taking the vaccine.
Driving and using machines
There are no reasons to suspect that Dukoral may affect the ability to drive or operate machinery.
Dukoral contains sodium
Dukoral contains approximately 1.1 g of sodium per dose. This should be taken into consideration in individuals on a low-sodium diet.

3. How to use Dukoral

Use this medicine exactly as described in this leaflet or as directed by your doctor. If you are in doubt, consult your doctor.

Adults and children from 6 years of age
The primary vaccination course consists of 2 doses taken orally (by mouth), administered at least 1 week (up to 6 weeks) apart.

• Take the 1st dose no later than 2 weeks before travel.
• Take the 2nd dose at least 1 week after the 1st dose and at least 1 week before travel.
  The last dose takes about 1 week to start providing protective effect.
  For continued protection, revaccination is recommended within 2 years.
  If less than 2 years have passed since the last vaccination, a single dose is sufficient to renew protection.
  If more than 2 years have passed since the last vaccine dose, the primary vaccination course must be repeated (2 doses).

Children from 2 years up to but not including 6 years of age
The primary vaccination course consists of 3 doses taken orally (by mouth), administered at least 1 week (up to 6 weeks) apart. For mixing with the vaccine, only half of the sodium bicarbonate solution should be used.

• Give the child the 1st dose no later than 3 weeks before travel.
• Give the child the 2nd dose at least 1 week after the 1st dose.
• Give the child the 3rd dose at least 1 week after the 2nd dose and at least 1 week before travel.

The last dose takes about 1 week to start providing protective effect.
For continued protection, revaccination is recommended within 6 months.
If less than 6 months have passed since the last vaccination, a single dose is sufficient to renew protection.
If more than 6 months have passed since the last vaccination, the primary vaccination course must be repeated (3 doses).

The suspension supplied in a single-dose glass vial is a whitish suspension. Each vial is accompanied by a sachet containing a white effervescent powder of sodium bicarbonate. The effervescent powder must be dissolved in a glass of cool water, and the resulting sodium bicarbonate solution must be mixed with the suspension. It is important to use the sodium bicarbonate solution because it protects the vaccine from gastric acidity.
Drink the entire mixture within 2 hours after mixing with the sodium bicarbonate solution.

Instructions for use:

1. To prepare the sodium bicarbonate solution, dissolve the effervescent powder in a glass of cool water (approximately 150 ml), stirring gently. Do not use other liquids. For children aged 2 to below 6 years: discard half of the sodium bicarbonate solution.
2. Shake the bottle containing the Dukoral® suspension (1 bottle = 1 dose).
3. Pour the contents of the bottle containing the Dukoral® suspension into the glass with the sodium bicarbonate solution (see step 1). Mix gently.
4. Drink the entire mixture within 2 hours. Avoid food and drink from 1 hour before until 1 hour after taking the mixture.

If you take more Dukoral than you should
If doses are taken less than one week apart, consult your doctor, pharmacist, or nurse.
Cases of overdose are unlikely because each Dukoral vial contains only one dose.
If you take more than one dose at a time, consult your doctor, pharmacist, or nurse.
If you forget to take Dukoral
The second dose of Dukoral may be taken up to 6 weeks after the first dose (children aged 2 to below 6 years must receive 3 doses). If more than 6 weeks have passed, consult your doctor, pharmacist, or nurse.
If you have any doubts about using this vaccine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Dukoral can cause side effects, although not everybody gets them.
Contact your doctor immediately if you experience the following serious side effects:

• severe diarrhoea with loss of body water
• severe allergic reactions causing swelling of the face or throat and shortness of breath

Other side effects
Uncommon side effects (may affect up to 1 in 100 people)

• Diarrhoea, stomach pain, stomach cramps, stomach rumbling, bloated stomach, gas in the stomach, and general stomach discomfort
• Headache

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

• Fever
• Feeling unwell, dizziness
• Nausea (feeling sick), vomiting, loss of appetite or poor appetite
• Swelling, irritation of nasal mucosa, and cough

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

• Rash
• Sore throat, reduced sense of taste
• Weakness/fatigue
• Sweating, chills
• Joint pain
• Difficulty sleeping

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

• Influenza-like symptoms, respiratory symptoms, chills, generalised pain, weakness
• Urticaria, itching sensation
• Swollen lymph nodes
• Numbness or tingling
• High blood pressure

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Dukoral

Keep this medicine out of the sight and reach of children.
Do not use Dukoral after the expiry date stated on the packaging after "Exp". The expiry date refers to the last day of that month.
Store in a refrigerator (2°C – 8°C). Do not freeze.
The product, within the unopened vial and sachet and kept in the outer packaging, is stable at temperatures up to 25°C for a period of 14 days. After this period, the product must be used or discarded.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Dukoral contains

• The active substances are: 31.25x10 bacteria* for each of the following V. cholerae O1 strains: classical Inaba (heat-inactivated), El Tor Inaba (formalin-inactivated), classical Ogawa (heat-inactivated), classical Ogawa (formalin-inactivated). Recombinant B subunit of cholera toxin (rCTB) 1 mg. *bacterial content before inactivation.
• The excipients in the vaccine suspension are monosodium phosphate, disodium phosphate, sodium chloride, and water for injections.
• The effervescent powder contains sodium bicarbonate, citric acid, sodium carbonate, sodium saccharin, sodium citrate, and raspberry flavouring.

Description of the appearance of Dukoral and contents of the package
Dukoral is a suspension and effervescent powder for oral suspension. The suspension is a whitish
suspension supplied in a vial. The effervescent powder is white with a raspberry flavour and is supplied
in a sachet.
Dukoral is available in packages containing 1, 2 or 20 doses. Not all pack sizes may be marketed.

Marketing Authorisation Holder
Valneva Sweden AB
105 21 Stockholm
Sweden
[email protected]

Manufacturer
Valneva Sweden AB
Gunnar Asplunds allé 16
SE-171 69 Solna
Sweden

Other sources of information
More detailed information on this medicinal product 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.