OMEPRAZOL DAVUR 10 mg HARD GASTRO-RESISTANT CAPSULES

2. What you need to know before you take Omeprazole Davur 10 mg

Do not take Omeprazole Davur

• if you are allergic to omeprazole or any of the other ingredients of this medicine (listed in section 6).
• if you are allergic to medicines containing proton pump inhibitors (e.g. pantoprazole, lansoprazole, rabeprazole, esomeprazole).
• if you are taking a medicine containing nelfinavir (used to treat HIV infection).

If you are not sure, talk to your doctor or pharmacist before taking omeprazole.

Warnings and precautions

Talk to your doctor or pharmacist before taking omeprazole.

Omeprazole may hide the symptoms of other diseases. Therefore, if you get any of the following symptoms, or if they get worse, you should see your doctor:

• Unintentional weight loss and difficulty swallowing.
• Stomach pain or indigestion.
• Vomiting blood or food.
• Black stools (blood-stained faeces).
• If you have severe or persistent diarrhoea, as omeprazole has been associated with a slightly increased risk of infectious diarrhoea.
• Severe liver problems.
• If you have ever had a skin reaction after treatment with a medicine similar to omeprazole to reduce stomach acid.
• If you get a rash on your skin, especially in areas exposed to the sun, you should contact your doctor as soon as possible, as you may need to stop your treatment with omeprazole. Also remember to mention any other symptoms that you may notice, such as joint pain.
• You are due to have a specific blood test (Chromogranin A)

Kidney inflammation can occur when taking omeprazole. The signs and symptoms may include decreased urine output or blood in the urine and/or hypersensitivity reactions such as fever, rash and joint pain. You should inform your doctor of these signs.

If you take omeprazole for a long period of time (more than 1 year), your doctor will probably keep you under regular surveillance. You should inform your doctor of any new or unusual symptoms, whenever you see your doctor.

If you are taking proton pump inhibitors like omeprazole, especially over a period of more than one year, you may have a slightly increased risk of hip, wrist and spine fractures. Inform your doctor if you have osteoporosis or if you are taking corticosteroids (which can increase the risk of osteoporosis).

Omeprazole may interfere with some diagnostic tests (Chromogranin A). To avoid these interference, treatment with omeprazole should be stopped at least 5 days before the measurement.

This medicine may affect the way your body absorbs vitamin B12. If you have to take omeprazole for a long time, contact your doctor if you get any of the following symptoms, which could be a sign of vitamin B12 deficiency:

• Extreme tiredness or lack of energy
• Numbness or tingling
• Pain in the tongue or mouth, mouth ulcers
• Muscle weakness
• Altered vision
• Memory problems, confusion, depression

Taking Omeprazole Davur with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Omeprazole may affect how these medicines work and these medicines may affect how omeprazole works.

Do not take omeprazole if you are taking a medicine containing nelfinavir (used to treat HIV infection).

Tell your doctor or pharmacist if you are taking any of the following medicines:

• Ketoconazole, itraconazole, posaconazole or voriconazole (used to treat fungal infections)
• Digoxin (used for heart problems)
• Diazepam (used to treat anxiety, relax muscles or in epilepsy)
• Phenytoin (used in epilepsy). If you are taking phenytoin, your doctor will need to monitor you when you start or stop taking omeprazole
• Medicines used to prevent blood clots, such as warfarin or other vitamin K antagonists. Your doctor will need to monitor you when you start or stop taking omeprazole
• Rifampicin (used to treat tuberculosis)
• Atazanavir (used to treat HIV infection)
• Tacrolimus (in cases of organ transplantation)
• St John’s Wort (Hypericum perforatum) (used to treat mild depression)
• Cilostazol (used to treat intermittent claudication)
• Saquinavir (used to treat HIV infection)
• Clopidogrel (used to prevent blood clots (thrombi))
• Erlotinib (used to treat cancer)
• Methotrexate (a chemotherapy medicine used in high doses to treat cancer). If you are taking high doses of methotrexate, your doctor may need to temporarily stop your treatment with omeprazole.

If your doctor has also prescribed the antibiotics amoxicillin and clarithromycin to treat ulcers caused by Helicobacter pyloriinfection, it is very important that you tell your doctor about any other medicines you are taking.

Taking Omeprazole Davur with food and drink

You can take your capsules with food or on an empty stomach.

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. Your doctor will decide whether you can take omeprazole during this time.

Omeprazole passes into breast milk but it is unlikely to affect the baby at doses used to treat acid-related diseases. Your doctor will decide whether you can take omeprazole if you are breast-feeding.

Driving and using machines

Omeprazole is unlikely to affect your ability to drive or use any tools or machines. Side effects such as dizziness and visual disturbances (see section 4) may occur. If affected, you should not drive or operate machinery.

Omeprazole Davur contains sucrose and sodium

This medicine contains 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.

This medicine contains less than 1 mmol sodium (23 mg) per capsule, i.e. it is essentially “sodium-free”.

3. How to take Omeprazole Davur 10 mg

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Your doctor will tell you how many capsules to take and for how long.

The usual doses are as follows.

Use in adults:

Treatment of symptoms of GORD, such as heartburn and acid regurgitation:

• If your doctor finds that you have mild oesophageal damage, the usual dose is 20 mg once a day for 4-8 weeks. Your doctor may tell you to take a dose of 40 mg once a day for a further 8 weeks if the oesophagus has not yet fully healed.
• The usual dose once the oesophagus has healed is 10 mg once a day.
• If your oesophagus has not been damaged, the usual dose is 10 mg once a day.

Treatment of duodenal ulcers:

• The usual dose is 20 mg once a day for 2 weeks. Your doctor may tell you to take a dose of 20 mg once a day for a further 2 weeks if the ulcer has not yet fully healed.
• If the ulcer does not fully heal, the dose can be increased to 40 mg once a day for 4 weeks.

Treatment of gastric ulcers:

• The usual dose is 20 mg once a day for 4 weeks. Your doctor may tell you to take a dose of 20 mg once a day for a further 4 weeks if the ulcer has not yet fully healed.
• If the ulcer does not fully heal, the dose can be increased to 40 mg once a day for 8 weeks.

Preventionof duodenal and stomach ulcers:

• The usual dose is 10 mg or 20 mg once a day. Your doctor may increase the dose to 40 mg once a day.

Treatment of ulcers caused by NSAIDs:

• The usual dose is 20 mg once a day for 4-8 weeks.

Prevention of ulcers caused by NSAIDs:

• The usual dose is 20 mg once a day.

Treatment of ulcers caused byHelicobacter pyloriinfection and prevention of relapse:

• The usual dose is 20 mg omeprazole twice a day for one week. Your doctor will also tell you to take two antibiotics among amoxicillin, clarithromycin and metronidazole.

Treatment of excess acid in the stomach caused by atumour in the pancreas (Zollinger-Ellison syndrome):

• The usual dose is 60 mg a day.
• Your doctor will adjust the dose depending on your needs and will also decide how long you need to take the medicine for.

Use in children and adolescents:

Treatment of symptoms of GORD, such as heartburn and acid regurgitation:

• Children over 1 year of age and = 10 kg can take omeprazole. The dose for children is based on the child’s weight and your doctor will decide the correct dose.

Treatment of ulcers caused byHelicobacter pyloriinfection and prevention of relapse:

• Children over 4 years of age can take omeprazole. The dose for children is based on the child’s weight and your doctor will decide the correct dose.
• Your doctor will also prescribe two antibiotics for your child, amoxicillin and clarithromycin.

How to take this medicine

• It is recommended to take the capsules in the morning.
• You can take your capsules with food or on an empty stomach.
• Swallow the capsules whole with half a glass of water. Do not chew or crush the capsules, as they contain coated granules which stop the medicine from being broken down by the acid in the stomach. It is important not to damage the granules.

What to do if you or your child have trouble swallowing the capsules

• If you or your child have trouble swallowing the capsules:
• • Open the capsules and swallow the contents directly with half a glass of water or put the contents into a glass of water (non-fizzy), fruit juice (e.g. apple, orange or grapefruit) or a teaspoon of soft food (e.g. yoghurt or honey), and swallow it immediately. Always stir the mixture just before drinking it (the mixture will not be clear). You must drink the mixture within 30 minutes.
  • To make sure that you have taken all the medicine, rinse the glass with half a glass of water, swirl it around and drink it.

If you take more Omeprazole Davur than you should

If you have taken more Omeprazole Davur than you should, talk to a doctor or pharmacist immediately. You can also contact the national poison centre, phone 91 562 04 20, quoting the medicine and the amount taken.

If you forget to take Omeprazole Davur

If you forget to take a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and continue as usual. Do not take a double dose to make up for a forgotten dose.

If you stop taking Omeprazole Davur

Do not stop taking omeprazole without first talking to your doctor or pharmacist.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

If you experience any of the following adverse effects, contact your doctor or go to the hospital immediately:

• Sudden whistling when breathing (sudden wheezing), swelling of the lips, tongue, and throat or body, skin rash, fainting or difficulty swallowing (severe allergic reaction). (rare)
• Redness of the skin with blistering or peeling. Intense blisters and bleeding may also appear on the lips, eyes, mouth, nose, and genitals. This could be "Stevens-Johnson syndrome" or "toxic epidermal necrolysis". (very rare)
• Widespread rash, high body temperature, and inflammation of the lymph nodes (DRESS syndrome or drug hypersensitivity syndrome). (rare)
• A red, scaly, and widespread rash with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the start of treatment (acute generalized exanthematous pustulosis). (rare)
• Yellowing of the skin, dark urine, and fatigue, which can be symptoms of liver problems. (rare)

Other adverse effects are:

Frequent Adverse Effects (may affect up to 1 in 10 people)

• Headache.
• Effects on the stomach or intestine: diarrhea, stomach pain, constipation, and gas (flatulence).
• Nausea or vomiting.
• Benign polyps in the stomach.

Infrequent Adverse Effects (may affect up to 1 in 100 people)

• Swelling of the feet and ankles.
• Sleep disorders (insomnia).
• Dizziness, tingling sensation, drowsiness.
• Feeling that everything is spinning (vertigo).
• Alterations in blood tests that check liver function.
• Skin rash, hives, and itching.
• Feeling of general discomfort and lack of energy.
• Fracture of the wrist, hip, or spine.

Rare Adverse Effects (may affect up to 1 in 1,000 people)

• Blood problems, such as a decrease in white blood cells or platelets. This can cause weakness or bruising and increase the likelihood of infections.
• Allergic reactions, sometimes very intense, including swelling of the lips, tongue, and throat, fever, and wheezing.
• Low sodium levels in the blood. This can cause weakness, vomiting, and muscle cramps.
• Agitation, confusion, or depression.
• Taste disorders.
• Visual problems, such as blurred vision.
• Sudden feeling of difficult breathing (bronchospasm).
• Dry mouth.
• Inflammation of the mouth.
• Infection called "candidiasis" that can affect the intestine and is caused by a fungus.
• Liver problems, such as jaundice, which can cause yellowing of the skin, dark urine, and fatigue.
• Hair loss (alopecia).
• Skin rash with exposure to sunlight.
• Joint pain (arthralgias) or muscle pain (myalgias).
• Severe kidney problems (interstitial nephritis).
• Increased sweating.

Very Rare Adverse Effects (may affect up to 1 in 10,000 people)

• Blood count alterations, such as agranulocytosis (lack of white blood cells). Aggressiveness.
• Seeing, feeling, or hearing things that do not exist (hallucinations).
• Severe liver problems that cause liver failure and brain inflammation.
• Erythema multiforme.
• Muscle weakness.
• Increased breast size in males.

In very rare cases, omeprazole may affect the white blood cells in the blood and cause immunodeficiency. If you have an infection with symptoms such as fever with a severely deteriorated general condition or fever with symptoms of local infection, such as neck, throat, or mouth pain, or difficulty urinating, you should consult your doctor as soon as possible to perform a blood test and rule out a lack of white blood cells (agranulocytosis). It is essential that you provide information about the medication you are taking at that time.

Unknown Frequency (cannot be determined from available data)

• Inflammation in the intestine (which causes diarrhea).

• If you are taking omeprazole for more than three months, it is possible that magnesium levels in the blood may decrease. Low magnesium levels can cause fatigue, muscle contractions, disorientation, convulsions, dizziness, and increased heart rate. If you have any of these symptoms, go to the doctor immediately. Low magnesium levels can also cause a decrease in potassium and calcium levels in the blood. Your doctor may decide to perform periodic blood tests to monitor magnesium levels.
• Skin rash, possibly with joint pain.

Reporting Adverse Effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is an adverse effect that is not listed in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: http://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Conservation of Omeprazol Davur 10 mg

Keep this medicine out of sight and reach of children.

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

Store below 30°C.

Keep the bottle perfectly closed to protect it from moisture.

Keep the blister pack in the original packaging to protect it from moisture.

Medicines should not be thrown down the drain or into the trash. Deposit the packaging and medicines you no longer need at the SIGRE point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Omeprazol Davur 20 mg Hard Gastric-Resistant Capsules EFG

• The active ingredient is omeprazole. Each capsule contains 20 mg of omeprazole.
• The other components (excipients) are: sugar spheres (sucrose and cornstarch), sodium carboxymethyl starch type A (derived from potato), sodium lauryl sulfate, povidone, disodium phosphate dodecahydrate, hypromellose, copolymer of methacrylic acid and ethyl acrylate (1:1), triethyl citrate, titanium dioxide (E171), talc, sodium hydroxide.

The capsule is composed of: erythrosine (E127), carmine indigo (E132), titanium dioxide (E171), gelatin, quinoline yellow (E104).

Printing ink:Shellac, propylene glycol (E1520), sodium hydroxide, polyvinylpyrrolidone, titanium dioxide (E171).

Product Appearance and Package Contents

Omeprazol Davur 20 mg capsules are formed by an orange body marked with a "20" and a blue cap marked with "O", containing white-beige omeprazole microgranules.

Package sizes:

HDPE bottles with 14, 28, and 56 capsules.

Blisters of 14, 28, and 56 capsules.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Teva Pharma, S.L.U.

Anabel Segura 11, Edificio Albatros B, 1st floor,

Alcobendas, 28108 Madrid (Spain)

Manufacturer

Teva Pharma, S.L.U.

Malpica Industrial Estate, Calle C nº 4.

50016 Zaragoza, Spain

Date of the Last Revision of this Prospectus:December 2023

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es