Dukoral oral suspension and effervescent granules for oral suspension
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
DUKORAL suspension and effervescent granules for oral suspension
Cholera vaccine (inactivated, oral)
Read all of this leaflet carefully before you start using 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, ask 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.
- Make sure to mix the vaccine with the buffer solution exactly as described in this leaflet. See section 3.
Contents of this leaflet
- What Dukoral is and what it is used for
- What you need to know before using Dukoral
- How to use Dukoral
- Possible side effects
- How to store Dukoral
- 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 of the intestine. The vaccine protects adults and children from the age of 2 years against cholera.
Dukoral causes the body to produce its own protection against cholera. After receiving the vaccine, your body will produce substances called antibodies, which fight the toxin and the cholera bacteria that cause 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 accompanied by fever (vaccination should be postponed).
Warnings and precautions
Consult your doctor before starting 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 in individuals with a normal immune system.
The vaccine does not confer complete protection, and it is important to follow dietary and hygiene recommendations to avoid contracting diarrhoeal diseases.
Children
Do not administer this vaccine to children under 2 years of age, as protection has not been studied in this age group.
Use of Dukoral with other medicines
Inform your doctor if you are taking, have recently taken, or might need to take any other medicines.
Do not take any other medication from one hour before until one hour after administration of the vaccine.
Use of Dukoral with food and drink
Avoid eating and drinking from one hour before until one hour after administration of the vaccine.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before taking this vaccine.
Driving and using machines
There are no reasons to suspect that Dukoral has effects on the ability to drive and use machines.
Dukoral contains sodium
Dukoral contains approximately 1.1 g of sodium per dose, which should be taken into account in patients on low-sodium diets.
3. How to use Dukoral
Follow exactly the instructions for administering this medicine as provided in this leaflet or as directed by your doctor. If in doubt, consult your doctor again.
Adults and children aged 6 years and older: The primary vaccination consists of two oral (by mouth) doses given at least one week apart (up to six weeks).
- Take the first dose no later than 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 maintain continued protection, revaccination is recommended within two years. If less than two years have passed since your last vaccine dose, a single dose will renew your protection. If more than two years have passed since your last vaccine dose, the primary vaccination should be repeated (2 doses).
Children aged 2 to under 6 years: The primary vaccination consists of three oral (by mouth) doses given at least one week apart (up to six weeks). Only half of the buffer solution should be mixed with the vaccine.
- Administer the first dose to the child no later than three weeks before starting the trip.
- Administer the second 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 maintain continued protection, revaccination is recommended within six months. If less than six months have passed since the last vaccine dose, a single dose will renew protection. If more than six months have passed since the last vaccination, the primary vaccination should be repeated (3 doses).
The suspension is a whitish suspension supplied in a single-dose glass vial. Each vial comes with a sachet containing a white effervescent granulate of sodium bicarbonate. The effervescent granulate must be dissolved in a glass of cold water, and the resulting buffer solution must be mixed with the suspension. It is important to use the buffer solution, as it protects the vaccine from gastric acid.
Drink the entire mixture within 2 hours after mixing it with the buffer solution.
Instructions for use:
- To prepare the buffer solution, dissolve the effervescent granulate in a glass of cold water (approx. 150 ml) by gently stirring.
Do not use any other liquid.
For children aged 2 to under 6 years: discard half of the buffer solution.
-
Shake the Dukoral® suspension vial (1 vial = 1 dose).
-
Pour the contents of the Dukoral® suspension vial into the glass of buffer solution (see 1). Mix gently.
-
Drink the entire mixture within 2 hours. Avoid eating or drinking for one hour before and one hour after consuming the mixture.
If you take more Dukoral than you should
If you take the doses with less than one week between them, contact your doctor, pharmacist, or nurse.
Since each Dukoral vial contains only one dose, overdose is unlikely.
If you have taken more than one dose at once, contact your doctor, pharmacist, or nurse.
If you forget to take Dukoral
You may 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 further questions about the use of this vaccine, ask your doctor, pharmacist, or nurse.
4. Possible adverse effects
Like all medicines, Dukoral can cause adverse effects, although not everyone will experience them.
Contact a doctor immediately if you experience the following serious adverse effects:
- Severe diarrhoea with loss of body fluids
- Severe allergic reactions causing swelling of the face or throat and difficulty breathing
Other adverse effects:
Uncommon adverse effects (may affect up to 1 in 100 people)
- Diarrhoea, stomach pain, gastric cramps, gastric gurgling, gastric distension, gas in the stomach, and general gastric discomfort
- Headache
Rare adverse effects (may affect up to 1 in 1,000 people)
- Fever
- General malaise, dizziness
- Nausea, vomiting, loss or decreased appetite
- Swelling, nasal inflammation, and cough
Very rare adverse effects (may affect up to 1 in 10,000 people)
- Rash
- Sore throat, reduced sense of taste
- Fatigue/tiredness
- Sweating, shivering
- Joint pain
- Inability to sleep
Other adverse effects (frequency cannot be estimated from available data)
- Flu-like symptoms, respiratory symptoms, chills, generalised pain, weakness
- Urticaria, itching
- Swelling of the lymph nodes
- Numbness or tingling
- Hypertension
Reporting of adverse effects
If you experience any type of adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the national reporting system detailed in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of 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 the month indicated.
Store in a refrigerator (between 2°C and 8°C). Do not freeze.
The product in the vial and the unopened sachet, stored in the outer carton, 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 must not be disposed of via wastewater or household waste. 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 Dukoral
- The active substances are: 31.25x10⁹ bacteria* from the following strains of V. cholerae O1: classical Inaba (heat-inactivated), El Tor Inaba (formalin-inactivated), classical Ogawa (heat-inactivated), classical Ogawa (formalin-inactivated). Recombinant cholera toxin B subunit (rCTB), 1 mg.
*bacterial content prior to inactivation
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The other components of the vaccine suspension are: sodium dihydrogen phosphate, disodium hydrogen phosphate, sodium chloride, and water for injections.
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The effervescent granules contain: sodium bicarbonate, citric acid, sodium carbonate, sodium saccharin, sodium citrate, and raspberry flavouring.
Nature of the product and contents of the container
Dukoral is presented as a suspension and effervescent granules for oral suspension. The suspension is a whitish suspension supplied in a vial. The effervescent granules are white with a raspberry flavour and are supplied in a sachet.
Dukoral is available in packs of 1, 2 and 20 doses. Only certain pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Valneva Sweden AB, 105 21 Stockholm, Sweden.
Date of the most recent review of this 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 can be found on the European Medicines Agency website in all languages of the European Union/European Economic Area.