The FDA Center for Drug Evaluation and Research (CDER) has published a warning about the use of medicinal products containing omeprazole associated with the risk of allergic reactions.
Section “Warnings and precautions”
Section “Warnings”
Warning about the occurrence of allergic reactions
Additions and/or changes are underlined:
- do not use if you are allergic to omeprazole.
- omeprazole may cause serious skin reactions. Symptoms may include:
- redness of the skin;
- blisters;
- rash
If an allergic reaction occurs, stop use and seek medical attention immediately.
Section “Other information”
- read the instructions for medical use before use;
- keep the box. It contains important information.
- store at a temperature of 20-25°C; protect from high temperatures and moisture;
- take the tablet immediately after opening the individual blister. Do not store the tablet outside the blister for later use.
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