UlceSep 20 mg gastro-resistant hard capsules

Package Leaflet: Information for the User

Introduction

Package Leaflet: Information for the User

Ulcesep 20 mg gastro-resistant hard capsules

Omeprazole

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you; do not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet Contents

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

1. What Ulcesep is and what it is used for

Ulcesep contains the active substance omeprazole. It belongs to a group of medicines known as "proton pump inhibitors". These medicines work by reducing the amount of acid produced by the stomach.

Ulcesep is used to treat the following conditions:

In adults:

• Gastroesophageal reflux disease (GERD). In this condition, stomach acid passes back into the esophagus (the tube connecting the throat to the stomach), causing pain, inflammation, and heartburn.
• Ulcers in the upper part of the intestine (duodenal ulcer) or in the stomach (gastric ulcer).
• Ulcers infected with a bacterium 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 a group of medicines called NSAIDs (non-steroidal anti-inflammatory drugs). Ulcesep may also be used to prevent ulcers from forming if you are taking NSAIDs.
• Excess stomach acid caused by a tumor in the pancreas (Zollinger-Ellison syndrome).

In children and adolescents:

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

• Gastroesophageal reflux disease. In this condition, stomach acid passes back into the esophagus (the tube connecting the throat to the stomach), causing pain, inflammation, and heartburn.

In children, symptoms of the disease may include regurgitation of stomach contents into the mouth, vomiting, and inadequate weight gain.

Children over 4 years of age and adolescents

• Ulcers infected with a bacterium called Helicobacter pylori. If your child has this condition, their doctor may also prescribe antibiotics to treat the infection and allow the ulcer to heal.

2. What you need to know before taking Ulcesep

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 containing proton pump inhibitors (e.g. pantoprazole, lansoprazol, rabeprazol, esomeprazole),
• if you are taking a medicine containing nelfinavir (used to treat Human Immunodeficiency Virus (HIV) infection).

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

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Ulcesep.

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

• You lose weight significantly without reason and have difficulty swallowing.
• You have stomach pain or indigestion.
• You start vomiting food or vomiting blood.
• Your bowel movements 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 ever had a skin reaction after treatment with a medicine similar to Ulcesep used to reduce stomach acidity.
• You are scheduled to have a specific blood test (chromogranin A).

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

When taking omeprazole, kidney inflammation 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. You should report these signs to your treating physician.

If you take Ulcesep for a long period (more than 1 year), your doctor will likely perform periodic check-ups. You should report any new or unusual symptoms or circumstances during each visit to your doctor.

Taking Ulcesep with other medicines

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

Do not take Ulcesep if you are taking a medicine containing nelfinavir (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 in 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 clots, 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 (used in 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)).

If your doctor has prescribed, in addition to Ulcesep, the antibiotics amoxicillin and clarithromycin to treat ulcers caused by Helicobacter pylori infection, it is very important that you inform them about any other medicines you are taking.

Taking Ulcesep with food and drinks

You may 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 are planning to become pregnant, consult your doctor before using this medicine. Your doctor will decide whether you can take Ulcesep during this time.

Your doctor will decide whether you can take Ulcesep while breastfeeding.

Driving and using machines

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

Ulcesep contains sucrose

This medicine contains sucrose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Ulcesep

Follow exactly the instructions for taking this medicine as given by your doctor. If in 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 your age.

The usual doses are indicated below.

Use in adults

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

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

Treatment of ulcers in the upper intestine (duodenal ulcer):

• The recommended dose is 20 mg once daily for 2 weeks. Your doctor may prescribe the same dose for another 2 weeks if the ulcer has not yet healed.
• If the ulcer has not completely healed, the dose may be increased to 40 mg (2 capsules of 20 mg) once daily for 4 weeks.

Treatment of stomach ulcers (gastric ulcer):

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

Prevention of recurrence of gastric and duodenal ulcers:

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

Treatment of gastric and duodenal ulcers caused by NSAIDs:

• The recommended dose is 20 mg once daily for 4–8 weeks.

Prevention of gastric and duodenal ulcers during NSAID treatment:

• The recommended dose is 20 mg once daily.

Treatment of ulcers caused by Helicobacter pylori infection and prevention of their recurrence:

• The recommended dose is 20 mg twice daily for one week.
• Your doctor will also instruct you to take two of the following antibiotics: amoxicillin, clarithromycin, and metronidazole.

Treatment of excess stomach acid caused by a pancreatic tumour (Zollinger-Ellison syndrome):

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

Use in children and adolescents

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

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

Treatment of ulcers caused by Helicobacter pylori infection and prevention of their recurrence:

• Children over 4 years of age may take Ulcesep. The dose for children is based on body weight, and the doctor will determine the correct dose.
• The 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 may 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 medicine from breaking down due to stomach acid. It is important not to damage the granules.

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

If you or your child have difficulty 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 still water, acidic fruit juice (e.g. apple, orange or pineapple juice), or apple puree.
• Always shake the mixture well just before drinking it (the mixture will not be clear). Then drink the mixture immediately or within 30 minutes.
• To ensure that all the medicine is taken, fill the glass halfway with water, swirl it well, and drink the water. Do not chew or crush the solid parts of the medicine.

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 may also call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine 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 it is almost time for the next dose, skip the missed dose. Do not take a double dose to make up for missed doses.

If you stop taking Ulcesep

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

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

• Sudden wheezing, swelling of the lips, tongue or throat, or body swelling, skin rash, fainting, or difficulty swallowing (severe allergic reaction).
• Skin redness with blistering or peeling. Severe blisters and bleeding in the lips, eyes, mouth, nose, and genitals may also occur. This could be Stevens-Johnson syndrome or toxic epidermal necrolysis.
• Yellowing of the skin, dark urine, and fatigue, which may be symptoms of liver problems.

Adverse effects may occur at certain frequencies, defined as follows:

Other adverse effects are:

Common adverse effects

• Headache.
• Stomach or intestinal problems: diarrhoea, stomach pain, constipation, and gas (flatulence).
• Nausea or vomiting.
• Benign polyps in the stomach.

Uncommon adverse effects

• Swelling of the feet and ankles.
• Sleep disorders (insomnia).
• Dizziness, tingling sensation, drowsiness.
• Sensation of spinning (vertigo).
• Abnormal blood test results used to assess liver function.
• Skin rash, hives, and itching.
• General malaise and lack of energy.
• Fractures of the hip, wrist, and spine.

Rare adverse effects

• Blood problems, such as reduced white blood cells or platelets. This may cause weakness, bruising, and increased risk of infections.
• Allergic reactions, sometimes severe, including swelling of the lips, tongue, and throat, fever, and wheezing.
• Low sodium levels in the blood. This may cause weakness, vomiting, and cramps.
• Restlessness, confusion, or depression.
• Taste disturbances.
• Vision problems, such as blurred vision.
• Sudden sensation of difficulty breathing (bronchospasm).
• Dry mouth.
• Inflammation inside the mouth.
• Fungal infection called "candidiasis" that may affect the intestine.
• Liver problems, such as jaundice, which may cause yellowing of the skin, dark urine, and fatigue.
• Hair loss (alopecia).
• Skin rash upon exposure to sunlight.
• Joint pain (arthralgia) or muscle pain (myalgia).
• Severe kidney problems (interstitial nephritis).
• Increased sweating.

Very rare adverse effects

• Blood count abnormalities, such as agranulocytosis (low white blood cell count) or pancytopenia (low red blood cell, white blood cell, and platelet counts).
• Aggressiveness.
• Seeing, feeling, or hearing things that are not real (hallucinations).
• Severe liver problems leading to liver failure and brain inflammation.
• Sudden onset of severe rash, blistering, or skin peeling. This may be accompanied by high fever and joint pain (erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Muscle weakness.
• Breast enlargement in males.

Frequency not known

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

If you are taking Ulcesep for more than three months, your blood magnesium levels may decrease. Low magnesium levels may cause fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, and increased heart rate. If you experience any of these symptoms, contact your doctor immediately. Low magnesium levels may also lead to decreased levels of potassium and calcium in the blood. Your doctor may decide to perform periodic blood tests to monitor your magnesium levels.

In very rare cases, Ulcesep may affect the white blood cells and cause immunodeficiency. If you develop an infection with symptoms such as fever accompanied by a severely deteriorated general condition, or fever with signs of localized infection such as neck, throat, or mouth pain, or difficulty urinating, you should consult your doctor as soon as possible for a blood test to rule out a deficiency in white blood cells (agranulocytosis). It is important that you inform your doctor about any medication you are taking at that time.

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

Do not be alarmed by this list of possible adverse effects. You may not experience any of them.

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Ulcesep

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

No special storage conditions are required.

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

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at a SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ulcesep 20 mg gastro-resistant hard capsules

• The active substance is omeprazole. Each capsule contains 20 mg of omeprazole.

• The other components (excipients) are:

• Pellets: sucrose/corn starch, sodium lauryl sulfate, disodium phosphate, mannitol (E-421), hypromellose (hydroxypropylmethylcellulose), purified water q.s.

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

• Capsule components: indigotine (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 pack contents

Ulcesep 20 mg gastro-resistant hard capsules are presented as hard capsules containing spherical gastro-resistant microgranules of omeprazole, in packs of 14, 28 and 56 gastro-resistant hard capsules.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Especialidades Farmacéuticas Centrum, S.A.

C/ Sagitario, 14

03006 Alicante

Spain

Date of the most recent revision of this leaflet: March 2023.

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)