Package Insert: Information for the User

Ulcesep 20 mg Hard Gastrorresistant Capsules

Omeprazole

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

1. What is Ulcesep and for what it is used

2. What you need to know before starting to take Ulcesep

3. How to take Ulcesep

4. Possible adverse effects

5. Storage of Ulcesep

6. Contents of the package and additional information

Ulcesep 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.

Ulcesep is used to treat the following diseases:

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 calledHelicobacter 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). Ulcesep may 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).

Children and adolescents:

Children over 1 year of age and ≥ 10 kg of weight

• Gastroesophageal reflux disease. 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, symptoms of the disease may include the return of stomach contents to the mouth (regurgitation), vomiting, and insufficient weight gain.

Children over 4 years of age and adolescents

• Ulcers infected by a bacteria calledHelicobacter 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 Ulcesep:

• 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 that contain proton pump inhibitors (e.g. pantoprazole, lansoprazole, rabeprazole, esomeprazole),
• if you are taking a medicine that contains nelfinavir (used to treat Human Immunodeficiency Virus (HIV) infection).

If you are unsure, speak to your doctor or pharmacist before taking Ulcesep.

Warnings and precautions

Consult your doctor or pharmacist before startingtotake Ulcesep.

Ulcesep may mask the symptoms of other diseases. Therefore, if you experience any of the following symptoms before starting to take Ulcesep 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 blood.
• Your stools are black (blood-stained stools).
• 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 had a skin reaction after treatment with a similar medicine to Ulcesep for reducing stomach acid.
• You are scheduled to have a specific blood test (chromogranin A).

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

When taking omeprazole, it may cause kidney inflammation. Symptoms and signs may include decreased urine volume or blood in the urine and/or hypersensitivity reactions such as fever, skin rash, and joint stiffness. You should inform your doctor of these signs.

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

Use of Ulcesep with other medicines

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medicine, including those purchased without a prescription. Ulcesep may affect the mechanism of action of some medicines and some medicines may affect Ulcesep.

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

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

• 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 Ulcesep.
• Medicines 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 Ulcesep.
• 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 medicines you are taking.

Taking Ulcesep with food and drinks

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine. Your doctor will decide if you can take Ulcesep during this time.

Your doctor will decide if you can take Ulcesep if you are breastfeeding.

Driving and operating machinery

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

Ulcesep contains saccharose

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

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

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.

Use in adults

Treatment of symptoms of GERD, such asheartburn and acid regurgitation:

• If your doctor checks that you have mild damage to the esophagus, the recommended dose is 20 mg once a day for 4-8 weeks. Your doctor may prescribe a dose of 40 mg (2 capsules of 20 mg) once a day for another 8 weeks if the esophagus has not yet healed.
• The recommended dose once the esophagus has healed is 10 mg once a day.
• If you do not have damage to the esophagus, the recommended dose is 10 mg once a day.

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

• The recommended dose is 20 mg 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 heal completely, the dose may be increased to 40 mg (2 capsules of 20 mg) once a day for 4 weeks.

Treatment ofstomach ulcers(gastric ulcer):

• The recommended dose is 20 mg 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 heal completely, the dose may be increased to 40 mg (2 capsules of 20 mg) once a day for 8 weeks.

Preventionof the recurrence ofstomach and duodenal ulcers:

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

Treatment ofstomach and duodenal ulcerscaused byNSAIDs:

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

Preventionofstomach and duodenal ulcersduring the administration ofNSAIDs:

• The recommended dose is 20 mg once a day

Treatment ofulcers causedby the infectionbyHelicobacter pyloriandprevention of its recurrence:

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

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

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

Use in children and adolescents

Treatment of symptoms of GERD, such asheartburn and acid regurgitation:

• Children over one year of age who weigh more than 10 kg may take Ulcesep. The dose for children is based on body weight, and your doctor will decide the correct dose.

Treatment ofulcers causedby the infectionbyHelicobacter pyloriand prevention of its recurrence:

• Children over 4 years old may take Ulcesep. 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 contain coated granules that prevent the medication from breaking down in the stomach acid. It is essential 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 without gas, a sour fruit juice (e.g. apple, orange, or pineapple) or a cooked apple sauce.
• 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. Do not chew or crush the solid parts of the medication.

If you take more Ulcesep than you should

If you have taken more Ulcesep than prescribed by your doctor, consult your doctor or pharmacist immediately. You can also call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount taken.

If you forget to take Ulcesep

If you forget to take a dose, take it as soon as you remember. However, if there is little time left for the next dose, skip the missed dose. Do not take a double dose to compensate for the missed doses.

If you interrupt the treatment with Ulcesep

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

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

• Sudden hissing sounds while breathing (sudden sibilance), 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 intensely and bleeding may occur in the lips, eyes, mouth, nose, and genitals. This may be 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 disorders (insomnia).
• Dizziness, tingling, 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.
• Fracture of the hip, wrist, and spine.

Rare side effects

• Blood disorders, such as a decrease in white blood cells or platelets. This may cause weakness or bruising and increase the risk of infections.
• Allergic reactions, sometimes very intense, including swelling of the lips, tongue, and throat, fever, and sibilance.
• Low sodium levels in the blood. This may cause weakness, vomiting, and cramps.
• Agitation, confusion, or depression.
• Changes in taste.
• Visual problems, such as blurred vision.
• Sudden sensation of difficult 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 may 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 side effects

• Blood count abnormalities, such as agranulocytosis (low white blood cell count) or pancytopenia (low red blood cell, white blood cell, and platelet count).
• Aggression.
• To see, feel, or hear things that do not exist (hallucinations).
• Severe liver problems that cause liver failure and brain inflammation.
• Sudden appearance 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.

Frequency not known

• Skin rash, possibly with joint pain.
• Low magnesium levels in the blood.

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

In very rare cases, Ulcesep may affect white blood cells in the blood and cause immunodeficiency. If you experience an infection with symptoms such as fever with a very deteriorated general condition or fever with symptoms of local infection, 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.

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

Do not worry about this list of possible side effects. You may not experience any of them.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Vigilance of Medicines for Human Use:https://www.notificaRAM.es. By reporting side effects, you can contribute to providing more information about the safety of this medicine.

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

No special storage conditions are required.

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

Do not use this medication after the expiration date shown on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or trash. Dispose of the packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Ulcesep 20 mg hard-gastrorresistant capsules

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

• Pellet : sucrose/cornstarch, sodium lauryl sulfate, disodium phosphate, mannitol (E-421), hydroxypropylmethylcellulose (hypromellose), purified water c.s.

Capsule coating agents : polyethylene glycol 6000 (Macrogol 6000), talc, polysorbate 80, titanium dioxide (E-171), Eudragit L30D, and purified water.

• Capsule components : indigotin (E-132), quinoline yellow (E-104), titanium dioxide (E-171), and gelatin (cap) and titanium dioxide (E-171) and gelatin (body).

Appearance of the product and contents of the packaging

Ulcesep 20 mg hard-gastrorresistant capsules are presented in the form of hard-gastrorresistant capsules containing spherical microgranules of omeprazole, in packaging of 14, 28, and 56 hard-gastrorresistant capsules.

Only some packaging sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Especialidades Farmacéuticas Centrum, S.A.

C/ Sagitario, 14

03006 Alicante

Spain

Last review date of this leaflet: March 2023.

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)