PATIENT INFORMATION LEAFLET
AULCER 20 mg hard gastro-resistant capsules

(Omeprazole)

Read this leaflet carefully before you start taking this medicine.

• Keep this leaflet, as you may need to read it again.

• If you have any doubts, consult your doctor or pharmacist.

• This medicine has been prescribed for you and should not be given to others, even if they have the same symptoms, as it may harm them.

• If you consider any of the side effects you are experiencing to be serious or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

AULCER contains the active ingredient omeprazole. It belongs to a group of medications known as “proton pump inhibitors”. These medications act by reducing the amount of acid produced by the stomach.

AULCER is used to treat the following diseases:

In adults:

• “Gastroesophageal reflux disease” (GERD). In this disorder, stomach acid passes into the esophagus (the tube that connects the throat to the stomach), causing pain, inflammation, and burning.
• Ulcers in the upper part of the small intestine (duodenal ulcer) or in the stomach (gastric ulcer).
• Ulcers infected by a bacteria called “Helicobacter pylori”. If you have this disease, it is possible that your doctor will prescribe antibiotics to treat the infection and allow the ulcer to heal.
• Ulcers caused by certain medications known as NSAIDs (nonsteroidal anti-inflammatory drugs). AULCER can also be used to prevent the formation of ulcers if you are taking NSAIDs.
• Excess acid in the stomach caused by a tumor in the pancreas (Zollinger-Ellison syndrome).

In children:

Children over 1 year of age and=10 kg

• “Gastroesophageal reflux disease” (GERD). In this disorder, stomach acid passes into the esophagus (the tube that connects the throat to the stomach), causing pain, inflammation, and burning.
  In children, the symptoms of the disease may include the return of stomach contents to the mouth (regurgitation), vomiting, and inadequate weight gain.

Children over 4 years of age and adolescents

• Ulcers infected by a bacteria called “Helicobacter pylori”. If your child has this disease, it is possible that your doctor will prescribe antibiotics to treat the infection and allow the ulcer to heal.

Do not take AULCER

• if you are allergic (hypersensitive) to omeprazole or any of the other components of AULCER.
• if you are allergic to medications that contain proton pump inhibitors (e.g. pantoprazole, lansoprazole, rabeprazole, esomeprazole).
• if you are taking a medication that contains nelfinavir (used for HIV infection).

If you are unsure, speak with your doctor or pharmacist before taking AULCER.

Warnings and precautions

Before taking this medication, inform your doctor if:

AULCER may mask the symptoms of other diseases.Therefore, if you experience any of the following symptoms before starting to take AULCER or during treatment, consult your doctor immediately:

• You lose weight significantly without apparent reason and have trouble swallowing.
• You have stomach pain or indigestion.
• You start vomiting food or vomiting blood.
• Your stools are black (stained with blood).
• You have severe or persistent diarrhea, as omeprazole has been associated with a slight increase in infectious diarrhea.
• You have severe liver problems.
• You have ever had a skin reaction after treatment with a similar medication to AULCER for reducing stomach acid.
• You are scheduled to have a specific blood test (Cromogranina A).

If you experience a skin rash, especially in sun-exposed areas, consult your doctor as soon as possible, as it may be necessary to interrupt treatment with AULCER. Remember to mention any other symptoms you may notice, such as joint pain.

When taking omeprazole, inflammation of the kidneys may occur. Signs and symptoms may include decreased urine volume or blood in the urine and/or hypersensitivity reactions such as fever, skin rash, and joint stiffness. Inform your doctor of these signs.

If you take AULCER for a long period (more than 1 year), your doctor will likely perform regular check-ups. Inform your doctor of any new or unusual symptoms and circumstances whenever you visit.

Use of other medications

Inform your doctor or pharmacist if you are using or have recently used other medications, including those purchased without a prescription. AULCER may affect the mechanism of action of some medications, and some medications may affect AULCER.

Do not take AULCER if you are taking a medication that containsnelfinavir(used to treat HIV infection).

Inform your doctor or pharmacist if you are taking any of the following medications:

• Ketoconazole, itraconazole, or voriconazole (used to treat fungal infections)
• Digoxin (used to treat heart problems)
• Diazepam (used to treat anxiety, relax muscles, or epilepsy)
• Phenytoin (used in epilepsy). If you are taking phenytoin, your doctor will need to monitor you when starting or stopping treatment with AULCER
• Medications used to prevent blood clotting, such as warfarin or other vitamin K antagonists. Your doctor will need to monitor you when starting or stopping treatment with AULCER
• 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)

If your doctor has prescribed you the antibiotics amoxicillin and clarithromycin to treat ulcers caused byHelicobacter pyloriinfection, it is very important to inform your doctor of any other medications you are taking.

Taking AULCER with food and drinks

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

Pregnancy and breastfeeding

Before taking AULCER, inform your doctor if you are pregnant or trying to become pregnant. Your doctor will decide if you can take AULCER during this time.

Your doctor will decide if you can take AULCER while breastfeeding.

Driving and operating machinery

AULCER is unlikely to affect your ability to drive or use tools or machines. However, side effects such as dizziness and visual disturbances (see section 4) may occur. If they do, you should not drive or operate machinery.

Important information about some components of AULCER 20 mg

This medication contains saccharose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

Follow exactly the administration instructions for AULCER indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

Your doctor will tell you how many capsules to take and for how long. This will depend on your condition and age.

The usual doses are indicated below.

Adults:

Treatment of symptoms ofGERD, such asheartburn and acid regurgitation:

• If your doctor checks that you have mild damage to the esophagus, the usual dose is 20mg once a day for 4‑8 weeks. Your doctor may prescribe a dose of 40mg (2 capsules of 20mg) for another 8 weeks if the esophagus has not yet healed.

• The usual dose once the esophagus has healed is 10mg once a day.
• If you do not have damage to the esophagus, the usual dose is 10mg once a day.

Treatment ofulcers of the upper part of the intestine(duodenal ulcer):

• The usual dose is 20mg once a day for 2 weeks. Your doctor may prescribe the same dose for another 2 weeks if the ulcer has not yet healed.
• If the ulcer does not fully heal, the dose may be increased to 40mg (2 capsules of 20mg) once a day for 4 weeks.

Treatment ofstomach ulcers(gastric ulcer):

• The usual dose is 20mg once a day for 4 weeks. Your doctor may prescribe the same dose for another 4 weeks if the ulcer has not yet healed.
• If the ulcer does not fully heal, the dose may be increased to 40mg (2 capsules of 20mg) once a day for 8 weeks.

Preventionof the recurrenceofstomach and duodenal ulcers:

• The usual dose is 10mg or 20mg once a day. Your doctor may increase the dose to 40mg (2 capsules of 20mg) once a day.

Treatment of stomach and duodenal ulcers caused by NSAIDs(nonsteroidal anti-inflammatory drugs):

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

Prevention of stomach and duodenal ulcersduring the administration ofNSAIDs:

• The usual dose is 20mg once a day

Treatment ofulcers causedby the infectionbyHelicobacter pyloriandprevention of their recurrence:

• The usual dose is 20mg of AULCER twice a day for a week.

• Your doctor will also prescribe two antibiotics, amoxicillin, clarithromycin, and metronidazole.

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

• The usual dose is 60mg (3 capsules of 20mg) per day.
• Your doctor will adjust the dose according to your needs and will also decide how long you should take the medication.

Children:

Treatment of symptoms ofGERD, such asheartburn and acid regurgitation

• Children over one year of age who weigh more than10 kgcan take AULCER. The dose for children is based on body weight, and your doctor will decide the correct dose.

Treatment ofulcerscausedby the infectionbyHelicobacter pyloriand prevention of their recurrence:

• Children over 4 years old can take AULCER. The dose for children is based on 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 medication

• 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 containcoated granulesthat prevent the medication from breaking down in the stomach acid. It is essential not to damage thegranules.

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 without gas, a sour fruit juice (e.g., apple, orange, or pineapple), or a cooked apple puree.
  • Always shake the mixture just before drinking it (the mixture will not be transparent). Then, drink the mixture immediately or within 30 minutes.
  • To ensure that all the medication has been taken, fill the glass of water to half, rinse it well, and drink the water. The solid parts contain the medication; do not chew or crush them.

If you take more AULCER than you should

If you have taken more AULCER than prescribed by your doctor, consult your doctor or pharmacist immediately. You can also call the Toxicological Information Service, phone91 562 04 20, indicating the medication and the amount taken.

If you forget to take AULCER 20 mg

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

If you experience any of the following rare but serious side effects, stop taking AULCER and consult your doctor immediately:

• Sudden hissing sounds while breathing (sudden onset of bronchospasm), swelling of the lips, tongue, and throat or body, skin rash, fainting, or difficulty swallowing (severe allergic reaction).
• Redness of the skin with blistering or peeling. Blisters may also appear on the lips, eyes, mouth, nose, and genitals. This could be a case of “Stevens-Johnson syndrome” or “toxic epidermal necrolysis.”
• Yellowing of the skin, dark urine, and fatigue, which may be symptoms of liver problems.

Side effects may occur with certain frequencies, which are defined as follows:

Other side effects are:

Common side effects

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

Uncommon side effects

• Swelling of the feet and ankles.
• Sleep disturbances (insomnia).
• Dizziness, tingling sensation, drowsiness.
• Sensation of spinning (vertigo).
• Abnormal blood test results that check liver function.
• Skin rash, hives, and itching.
• General feeling of discomfort and lack of energy.

Rare side effects

• Blood disorders, such as a decrease in white blood cells or platelets. This can cause weakness or bruising and increase the risk of infections.
• Allergic reactions, sometimes very severe, including swelling of the lips, tongue, and throat, fever, and bronchospasm.
• Low sodium levels in the blood. This can cause weakness, vomiting, and muscle cramps.
• Agitation, confusion, or depression.
• Changes in taste.
• Visual problems, such as blurred vision.
• Sudden sensation of difficulty breathing (bronchospasm).
• Dry mouth.
• Inflammation of the inside of the mouth.
• Infection called “candidiasis” that can affect the intestines 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 (arthritis) or muscle pain (myalgia).
• Severe kidney problems (interstitial nephritis).
• Increased sweating.

Very rare side effects

• 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 inflammation of the brain.
• Sudden onset of a severe rash, blistering, or peeling of the skin. This may be accompanied by high fever and joint pain (erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Muscle weakness.
• Enlargement of the breasts in men.
• Low magnesium levels in the blood.

Frequency “unknown”:

• Skin rash, possibly with joint pain

In rare cases, AULCER may affect white blood cells in the blood and cause immunodeficiency. If you experience an infection with symptoms such as fever with a general state of deterioration or fever with local infection symptoms, such as neck pain, throat pain, 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 to provide information about the medication you are taking at that time.

Unknown frequency

If you are taking AULCER for more than three months, it is possible that magnesium levels in the blood may decrease. Low magnesium levels can cause fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, and increased heart rate. If you experience any of these symptoms, see your 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.

If you are taking proton pump inhibitors such as AULCER, especially for a period of more than one year, it may slightly increase the risk of hip, wrist, and spinal fractures. Inform your doctor if you have osteoporosis or are taking corticosteroids (which can increase the risk of osteoporosis).

Do not worry about this list of possible side effects. You may not experience any of them. If you consider any of the side effects you are experiencing to be severe or if you notice any side effects not mentioned in this leaflet, inform your doctor or pharmacist.

Store in the original packaging.

Keep out of the reach and sight of children.

No special storage conditions are required..

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

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

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medicines that you no longer need. This will help protect the environment.

Composition of AULCER

• The active ingredient is omeprazole. Each capsule contains 20 mg of omeprazole.
• The other components (excipients) are:

• Core: sucrose/cornstarch, sodium lauryl sulfate, disodium phosphate, mannitol, hydroxypropylmethylcellulose (hypromellose), purified water cs.Capsule coating agents: polyethylene glycol 6000 (Macrogol 6000), talc, polysorbate 80, titanium dioxide, Eudragit L30D, and purified water.
• Capsule components: indigotin, quinoline yellow, titanium dioxide, and gelatin (cap) and titanium dioxide and gelatin (body).

Appearance of the product and contents of the package

AULCER 20 mg is presented in the form of hard capsules, containing gastric-resistant, spherical microgranules of omeprazole, in packages of 14 and 28 gastric-resistant capsules.

Holder of the marketing authorization and responsible for manufacturing:

Holder of the marketing authorization

ESPECIALIDADES FARMACÉUTICAS CENTRUM, S.A.

Sagitario 14

03006 Alicante

Spain

Responsible for manufacturing

Especialidades Farmacéuticas Centrum SA (Laboratorios Centrum SA)

C/Sagitario 14

03006 Alicante

Last review date of this leaflet:March 2023.