Ulceral 20 mg gastro-resistant hard capsules EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Ulceral 20 mg gastro-resistant hard capsules EFG

omeprazole

Read the entire leaflet carefully before you start taking this medicine, as 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 only, and you should not give it to other people, even if they have the same symptoms as you, because it may 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 Ulceral is and what it is used for
2. What you need to know before taking Ulceral
3. How to take Ulceral
4. Possible side effects
5. How to store Ulceral
6. Contents of the pack and other information

1. What Ulceral is and what it is used for

Ulceral 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.

Ulceral is used to treat the following conditions:

In adults:

• "Gastroesophageal reflux disease" (GERD). In this disorder, stomach acid passes 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 medicines called NSAIDs (non-steroidal anti-inflammatory drugs).
• Ulceral 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).

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 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, your doctor may also prescribe antibiotics to treat the infection and allow the ulcer to heal.

2. What you need to know before taking Ulceral

Do not take Ulceral:

• if you are allergic to omeprazole or to 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 for HIV infection).

Do not take Ulceral if any of the above apply to you. If you are unsure, talk to your doctor or pharmacist before taking Ulceral.

Warnings and precautions

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

Severe cutaneous adverse reactions have been reported with Ulceral treatment, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP). Stop taking Ulceral and contact your doctor immediately if you experience any of these symptoms related to severe skin reactions described in section 4.

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

• Unintentional weight loss and difficulty swallowing.
• Stomach pain or indigestion.
• Vomiting food or vomiting blood.
• Black stools (blood-stained faeces).
• Severe or persistent diarrhoea, as omeprazole has been associated with a slight increase in infectious diarrhoea.
• Severe liver problems.
• If you have ever had a skin reaction after treatment with a medicine similar to omeprazole used to reduce stomach acid.
• If you are scheduled to have a specific blood test (chromogranin A).

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

Taking a proton pump inhibitor such as omeprazole, especially for more than one year, may slightly increase the risk of fractures of the hip, wrist, or spine. Inform your doctor if you have osteoporosis or if you are taking corticosteroids (which may increase the risk of osteoporosis).

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 omeprazole. Remember to mention any other symptoms you may notice, such as joint pain.

Kidney inflammation may occur while taking omeprazole. 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.

Children

Some children with chronic conditions 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.

Taking Ulceral with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription. Omeprazole may affect how some medicines work, and some medicines may affect omeprazole.

Do not take omeprazole 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, posaconazole, itraconazole, or voriconazole (used to treat fungal infections)
• Digoxin (used to treat heart problems)
• Diazepam (used to treat anxiety, to 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 omeprazole treatment
• 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 omeprazole treatment
• 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))
• Erlotinib (used to treat cancer)
• Methotrexate (a chemotherapy medicine used in high doses to treat cancer) – if you are taking a high dose of methotrexate, your doctor may need to temporarily stop omeprazole treatment.

If your doctor has prescribed omeprazole along with 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 Ulceral with food and drink

See section 3.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before taking this medicine.

Omeprazole passes into breast milk, but is unlikely to affect the infant when therapeutic doses are used. Your doctor will decide whether you can take omeprazole while breastfeeding.

Driving and using machines

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

Ulceral contains sucrose

If your doctor has diagnosed you with an intolerance to certain sugars, consult with them before taking this medicine.

Ulceral contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per capsule; therefore, it is essentially "sodium-free".

3. How to take Ulceral

Follow exactly the instructions for use of 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 recommended dose is described below:

Use in adults

Treatment of symptoms of GERD (gastroesophageal reflux disease), such as heartburn and acid regurgitation:

• If your doctor determines that you have mild damage to the esophagus, the recommended dose is 20 mg once daily for 4–8 weeks. Your doctor may prescribe a dose of 40 mg for an additional 8 weeks if the esophagus has not yet healed.
• The recommended dose after healing of the esophagus is 10 mg once daily.
• If you do not have esophageal damage, the recommended dose is 10 mg once daily.

Treatment of ulcers in the upper part of the 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 does not fully heal, the dose may be increased to 40 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 does not fully heal, the dose may be increased to 40 mg once daily for 8 weeks.

Prevention of recurrence of stomach and duodenal ulcers:

• The recommended dose is 10 mg or 20 mg once daily. Your doctor may increase the dose to 40 mg once daily.

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

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

Prevention of stomach and duodenal ulcers during NSAID therapy:

• 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 of Ulceral twice daily for one week.
• Your doctor will also instruct you to take two antibiotics from the following: amoxicillin, clarithromycin, and metronidazole.

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

• The recommended dose is 60 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 Ulceral. 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 Ulceral. 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), or apple sauce.
  • Always shake the mixture well just before drinking (the mixture will not be clear). Then drink the mixture immediately or within 30 minutes.
  • To ensure that all the medicine is taken, refill the glass halfway with water, swirl it well, and drink the water. The solid particles contain the medicine; do not chew or crush them.

If you take more Ulceral than you should

If you have taken more Ulceral than prescribed by your doctor, contact your doctor or pharmacist immediately. You may also call the Toxicology Information Service at telephone number 91 562 04 20, stating the medicine and the amount taken.

If you forget to take Ulceral

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 forgotten doses.

If you stop taking Ulceral

Do not stop treatment with Ulceral without first talking to your doctor or pharmacist.

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 can cause adverse effects, although not everyone will experience them.

If you notice any of the following rare (may affect up to 1 in 1,000 people) or very rare (may affect up to 1 in 10,000 people) but serious side effects, stop taking omeprazole and consult your doctor immediately:

• Sudden wheezing, swelling of the lips, tongue or throat, skin rash, fainting or difficulty swallowing (severe allergic reaction). (rare)
• Reddening of the skin 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”. (very rare)
• Widespread rash, high body temperature and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome). (rare)
• A widespread red, scaly rash with bumps under the skin and blisters accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis). (rare)
• Yellowing of the skin, dark urine and tiredness, which may be signs of liver problems.

Other adverse effects include:

Common adverse effects (may affect up to 1 in 10 people)

• Headache.
• Stomach or intestinal effects: diarrhoea, 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 of spinning (vertigo).
• Abnormalities in blood tests used to monitor liver function.
• Skin rash, hives and itching.
• General feeling of malaise and lack of energy.

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 may cause weakness or bruising and increase the likelihood 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 feeling of difficulty breathing (bronchospasm).
• Dry mouth.
• Inflammation inside the mouth.
• Fungal infection called “candidiasis” which may affect the intestine.
• Hair loss (alopecia).
• Skin rash upon exposure to sunlight.
• Joint pain (arthralgia) or muscle pain (myalgia).
• Serious 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).
• Aggressiveness.
• Seeing, feeling or hearing things that are not there (hallucinations).
• Serious liver problems leading to liver failure and brain inflammation.
• Erythema multiforme.
• Muscle weakness.
• Enlargement of the breasts in males.

Frequency not known (cannot be estimated from available data)

• Inflammation of the intestine (causing diarrhoea).
• If you are being treated with omeprazole for more than three months, your blood magnesium levels may decrease. Low magnesium levels may present as fatigue, involuntary muscle contractions, disorientation, seizures, dizziness or increased heart rate. If you experience any of these symptoms, inform your doctor immediately. Low magnesium levels may also lead to reduced levels of potassium or calcium in the blood. Your doctor may decide to carry out periodic blood tests to monitor your magnesium levels.
• Skin rash, possibly with joint pain.

In very rare cases, omeprazole may affect white blood cells and cause immunodeficiency. If you develop an infection with symptoms such as fever with a very poor general condition or fever with signs of local 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.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, 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 Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Ulceral

• 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 refers to the last day of the month indicated.

• Al/Al blister:

Store below 30°C.
Keep in the original packaging to protect from moisture.

• PVC-PVDC/Al blister:

Store below 25°C.
Keep in the original packaging to protect from moisture.

• HDPE bottle:

No special storage conditions required.
Period of validity after first opening of the bottle: 100 days.
Keep the bottle tightly closed to protect from moisture.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE collection point in your pharmacy. If you have any doubts, please ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ulceral

• The active substance is omeprazole. Ulceral gastro-resistant hard capsules contain 20 mg of omeprazole.
• The other components are sugar spheres (sucrose and maize starch), hypromellose (E-464), talc (E-553b), titanium dioxide (E-171), disodium hydrogen phosphate dihydrate (E-339 ii), sodium lauryl sulfate, polysorbate 80, methacrylic acid-ethyl acrylate copolymer, triethyl citrate (E-1505). Capsule shell: gelatin, titanium dioxide (E-171), printing ink (black iron oxide (E-172), potassium hydroxide and shellac). See section 2: Ulceral contains sucrose.

Nature and contents of the container

Ulceral capsules are white opaque hard gelatin capsules marked with “OM 20”, containing spherical granules.

White HDPE bottle with cap and security ring, equipped with a desiccant: 14, 28 and 56 capsules.

Alu/Alu blister: 14 and 28 capsules.

PVC-PVDC/Al blister: 14, 28 and 56 capsules.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Meiji Pharma Spain, S.A.
Avda. de Madrid, 94
28802 Alcalá de Henares, Madrid (Spain)

Manufacturer

Towa Pharmaceutical Europe S.L.
C/ de Sant Martí, 75-97
08107 - Martorelles (Barcelona)
Spain

Date of the most recent revision of this leaflet: October 2023

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