OMEPRAZOL AUROVITAS SPAIN 40 mg HARD GASTRO-RESISTANT CAPSULES

Introduction

Patient Information Leaflet

Omeprazole Aurovitas Spain 40 mg gastro-resistant hard capsules

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What Omeprazole Aurovitas Spain is and what it is used for
2. What you need to know before you take Omeprazole Aurovitas Spain
3. How to take Omeprazole Aurovitas Spain
4. Possible side effects
5. Storage of Omeprazole Aurovitas Spain
6. Contents of the pack and other information

1. What Omeprazole Aurovitas Spain is and what it is used for

Omeprazole Aurovitas Spain contains the active substance omeprazole. It belongs to a group of medicines called ‘proton pump inhibitors’. These medicines work by reducing the amount of acid produced by the stomach.

Omeprazole is used to treat the following conditions:

In adults:

• “Gastro-oesophageal reflux disease” (GORD). In this condition, acid from the stomach escapes into the gullet (the tube which connects the throat to the stomach), causing pain, inflammation, and heartburn.
• Ulcers in the upper part of the intestine (duodenal ulcer) or stomach (gastric ulcer).
• Ulcers which are infected with bacteria called Helicobacter pylori. If you have this condition, your doctor may also prescribe antibiotics to treat the infection and allow the ulcer to heal.
• Ulcers caused by medicines called non-steroidal anti-inflammatory drugs (NSAIDs). Omeprazole may also be used to prevent ulcers if you are taking NSAIDs.
• Too much acid in the stomach caused by a tumour in the pancreas (Zollinger-Ellison syndrome).

In children:

Children over 1 year of age and ≥ 10 kg

• “Gastro-oesophageal reflux disease” (GORD). In this condition, acid from the stomach escapes into the gullet (the tube which connects the throat to the stomach), causing pain, inflammation, and heartburn. In children, the symptoms of the disease can include the return of stomach contents into the mouth (regurgitation), vomiting, and poor weight gain.

Children over 4 years of age and adolescents

• Ulcers caused by bacteria called Helicobacter pylori. If your child has this condition, your doctor may also prescribe antibiotics to treat the infection and allow the ulcer to heal.

2. What you need to know before you take Omeprazole Aurovitas Spain

Do not take Omeprazole Aurovitas Spain

• 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).

Do not take omeprazole if any of the above apply to you. 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 Aurovitas Spain.

Serious skin reactions such as Stevens-Johnson syndrome, toxic epidermal necrolysis, drug rash with eosinophilia and systemic symptoms (DRESS) and acute generalized exanthematous pustulosis (AGEP) have been reported in association with omeprazole treatment. Stop taking Omeprazole Aurovitas Spain and contact your doctor immediately if you experience any of these symptoms.

Omeprazole may hide the symptoms of other diseases. Therefore, if you experience any of the following before or while taking omeprazole, consult your doctor immediately:

• Unintentional weight loss and difficulty swallowing.
• Stomach pain or indigestion.
• Vomiting food or blood.
• Black stools (blood-stained faeces).
• Severe or persistent diarrhea, as omeprazole has been associated with a slight increase in infectious diarrhea.
• 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 are due to have a specific blood test (Chromogranin A).

If you take omeprazole for a long period (over 1 year), your doctor will regularly check you for any changes.

Taking a proton pump inhibitor like omeprazole, especially over a period of more than one year, may slightly increase your risk of fracture of the hip, wrist, or spine. Tell your doctor if you have osteoporosis or if you are taking corticosteroids (which can increase the risk of osteoporosis).

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 you notice, such as joint pain.

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

This medicine may affect how your body absorbs vitamin B12. If you have to take omeprazole for a long time, talk to your doctor, as you may need to have your vitamin B12 levels checked. Contact your doctor if you notice any of the following symptoms, which could indicate low vitamin B12 levels:

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

Children

Some children with long-term illnesses may require long-term treatment, although this is not recommended. Do not give this medicine to children under 1 year of age or weighing less than 10 kg.

Other medicines and Omeprazole Aurovitas Spain

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This includes medicines that you can buy without a prescription.

Omeprazole may affect how other medicines work and some 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 for 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).
• Erlotinib (used to treat cancer).
• Methotrexate (a chemotherapy medicine used in high doses to treat cancer) - if you are taking high-dose methotrexate, your doctor may need to temporarily stop your treatment with omeprazole.

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

Taking Omeprazole Aurovitas Spain with food and drink

See section 3 “How to take Omeprazole Aurovitas Spain”.

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.

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 Aurovitas Spain contains sucrose

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.

Omeprazole Aurovitas Spain contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per capsule, which is essentially ‘sodium-free’.

3. How to take Omeprazole Aurovitas Spain

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 recommended doses are as follows.

Adults:

Treatment of symptoms of gastro-oesophageal reflux disease, such as heartburn and acid regurgitation:

• If your doctor finds that you have mild inflammation of the oesophagus (erosive oesophagitis), the recommended dose is 20 mg once a day for 4-8 weeks. Your doctor may tell you to take a dose of 40 mg for a further 8 weeks if the oesophagus has not yet healed.
• The recommended dose once the oesophagus has healed is 10 mg once a day.
• If you do not have an inflamed oesophagus, the usual dose is 10 mg once a day.

Treatment of duodenal ulcers:

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

Treatment of gastric ulcers:

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

Prevention of duodenal and stomach ulcers:

• The recommended 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:

(non-steroidal anti-inflammatory drugs):

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

Prevention of ulcers caused by NSAIDs:

• The recommended dose is 20 mg once a day.

Treatment of ulcers caused by Helicobacter pylori infectionand prevention of their return:

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

Treatment of Zollinger-Ellison syndrome:

• The usual dose is 60 mg daily.
• Your doctor will adjust the dose according to your needs and decide how long you will need to take the medicine.

Use in children and adolescents:

Treatment of symptoms of gastro-oesophageal reflux disease, such as heartburn and acid regurgitation:

• Children over 1 year of age and weighing more than 10 kg can take omeprazole. The dose for children is based on their body weight and your doctor will decide the correct dose.

Treatment of ulcers caused by Helicobacter pylori infectionand prevention of their return:

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

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 pour the contents into a glass of water, non-fizzy fruit juice (e.g. apple, orange, or pineapple) or apple sauce.
  • Always stir the mixture just before drinking it (the mixture will not be clear). Drink the mixture immediately or within 30 minutes.
  • To make sure you have taken all the medicine, refill the glass with water, rinse the glass well and drink it.

If you take more Omeprazole Aurovitas Spain than you should

If you have taken more omeprazole than prescribed by your doctor, contact your doctor or pharmacist immediately. You can also contact the national poison centre, phone 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Omeprazole Aurovitas Spain

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. Do not take a double dose to make up for a forgotten dose.

If you stop taking Omeprazole Aurovitas Spain

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 notice any of the following rare adverse effects(may affect up to 1 in 1,000) or very rare (may affect up to 1 in 10,000 people)but serious, stop taking omeprazole and consult your doctor 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)
  • Generalized rash, elevated body temperature, and inflammation of the lymph nodes (DRESS syndrome or drug hypersensitivity syndrome). (rare)
  • A red, scaly, and generalized 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:

Common 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.

Uncommon 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).
• Abnormal liver function tests.
• Skin rash, hives, and itching.
• Feeling of general discomfort and lack of energy.

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

• Blood problems, such as decreased white blood cells or platelets. This can cause weakness or bruising and increase the risk of infection.
• 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 cramps.
• Agitation, confusion, or depression.
• Taste disturbances.
• 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.
• 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 abnormalities, such as agranulocytosis (lack of white blood cells).
• Aggression.
• 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.

Frequency not known (frequency cannot be estimated from available data)

• Inflammation of the intestine (causing diarrhea).
• If you are taking omeprazole for more than three months, it is possible that your blood magnesium levels may decrease. Low magnesium levels can cause fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, and increased heart rate. If you experience any of these symptoms, consult your doctor immediately. Low magnesium levels can also lead to decreased potassium or calcium levels in the blood. Your doctor may decide to perform periodic blood tests to monitor your magnesium levels.
• Skin rash, possibly with joint pain.

In very rare cases, omeprazole can affect the white blood cells 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.

Reporting adverse effects:

If you experience any adverse effect, consult 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 Spanish Pharmacovigilance System for Human Use Medicines: www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Omeprazole Aurovitas Spain

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiration date stated on the label, carton, and blister after CAD. The expiration date is the last day of the month indicated.

Blister:Do not store above 25°C.

Bottle:Do not store above 30°C.

Keep this blister in the original packaging or keep the bottle perfectly closed to protect it from moisture.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE collection point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Omeprazole Aurovitas Spain

• The active ingredient is omeprazole. Each capsule contains 40 mg of omeprazole.
• The other ingredients are sugar spheres (consisting of sucrose, cornstarch, water), methacrylic acid-ethyl acrylate copolymer dispersion (1:1), hypromellose, talc, mannitol, macrogol 6000, titanium dioxide (E171), polysorbate 80, disodium phosphate, sodium lauryl sulfate.

Capsule composition:gelatin, water, titanium dioxide (E171), carmine (E132).

Appearance of the Product and Package Contents

Omeprazole Aurovitas Spain 40 mg capsules are formed by a white body and a blue cap. The capsules contain spherical microgranules of a white (ivory) to light cream color.

Package sizes:

Blister: 7, 14, 15, 28, 30, 50, 56, 60, 90, 98, 100, 140, 280, and 500 capsules.

Bottle: 7, 14, 28, 30, 56, 60, 90, 100, and 500 capsules.

Not all package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Manufacturer

Laboratorios Liconsa, S.A.

Avda. Miralcampo, Nº 7. Polígono Industrial Miralcampo,

19200 Azuqueca de Henares (Guadalajara)

Spain

Date of the last revision of this leaflet: January 2024

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/).