Pro Ulco 15 mg gastro-resistant capsules

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Pro-Ulco 15 mg gastro-resistant capsules

Lansoprazole

Read the entire leaflet carefully before you start taking this medicine.

• 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 and should not be given to others, even if they have the same symptoms, as it may harm them.
• If you think any of the side effects you experience is severe or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

Leaflet contents:

1. What Pro-Ulco is and what it is used for

2. Before you take Pro-Ulco

3. How to take Pro-Ulco

4. Possible side effects

5. How to store Pro-Ulco

6. Contents of the pack and other information

1. What Pro-Ulco is and what it is used for

The active substance in Pro-Ulco is lansoprazole, a proton pump inhibitor. Proton pump inhibitors reduce the amount of acid produced by the stomach.

Your doctor may have prescribed Pro-Ulco for the following indications:

• Treatment of gastric and duodenal ulcers
• Treatment of inflammation of the oesophagus (reflux oesophagitis)
• Prevention of reflux oesophagitis
• Treatment of heartburn and acid regurgitation
• Treatment of infections caused by the bacterium Helicobacter pylori, in combination with antibiotics
• Treatment or prevention of duodenal or gastric ulcers in patients requiring ongoing treatment with non-steroidal anti-inflammatory drugs (NSAIDs) (NSAID therapy is used for pain or inflammation)
• Treatment of Zollinger-Ellison syndrome (a condition in which excessive amounts of acid are produced in the stomach)

Your doctor may have prescribed Pro-Ulco for a different indication or at a different dose than that stated in this leaflet. Follow your doctor's instructions regarding how to take the medicine.

2. Before taking Pro-Ulco

Do not take Pro-Ulco:

• If you are allergic (hypersensitive) to lansoprazole or to any of the other components of Pro-Ulco (listed in section 6)
• If you are taking another medicine containing the active substance atazanavir (used in the treatment of HIV).

Warnings and precautions

Talk to your doctor before starting to take Pro-Ulco:

If you have ever had a skin reaction after treatment with a medicine similar to Pro-Ulco used to reduce stomach acid.

If you develop a skin rash, especially in areas of skin exposed to sunlight, consult your doctor as soon as possible, as treatment with Pro-Ulco may need to be stopped. Remember to mention any other symptoms you may notice, such as joint pain.

When taking lansoprazole, inflammation of the kidney may occur. Signs and symptoms may include decreased urine volume or presence of blood in the urine and/or hypersensitivity reactions such as fever, skin rash, and joint stiffness. You must report these signs to your doctor.

If you are scheduled to have a specific blood test (Chromogranin A).

Inform your doctor if you have severe liver disease. Your doctor may need to adjust your dose.

Your doctor may perform or may have already performed an additional test called endoscopy to diagnose your condition and/or rule out cancer.

If you experience diarrhea during treatment with Pro-Ulco, contact your doctor immediately, as Pro-Ulco has been associated with a slight increase in infectious diarrhea.

If your doctor has prescribed Pro-Ulco along with other medicines for the treatment of Helicobacter pylori infection (antibiotics) or together with anti-inflammatory medicines for pain or rheumatism, also read the package leaflets of these medicines carefully.

If you have been taking Pro-Ulco for a long time (more than 1 year), your doctor will likely monitor you regularly. During visits to your doctor, you must report any new or unusual symptoms or circumstances.

Use with other medicines

Inform your doctor or pharmacist if you are using or have recently used any other medicines, including those obtained without a prescription.

In particular, inform your doctor if you are taking medicines containing any of the following active substances, as Pro-Ulco may affect their way of action:

• HIV protease inhibitors, such as nelfinavir and atazanavir (used to treat HIV infection)
• ketoconazole, itraconazole, rifampicin (used to treat infections)
• digoxin (used to treat heart problems)
• theophylline (used to treat asthma)
• tacrolimus (used to prevent transplant rejection)
• clopidogrel (used to prevent blood clots)
• warfarin (used to prevent blood clots)
• fluvoxamine (used to treat depression and other psychiatric disorders)
• antacids (used to treat heartburn or acid regurgitation)
• sucralfate (used to heal duodenal ulcers)
• St. John's wort (Hypericum perforatum) (used to treat mild depression)
• methotrexate (used to treat cancer and autoimmune diseases, among others)

Taking Pro-Ulco with food and drinks

To achieve the best results from your medicine, you should take Pro-Ulco at least 30 minutes before meals.

Pregnancy and breastfeeding

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

Driving and using machines

Patients taking Pro-Ulco may occasionally experience side effects such as dizziness, vertigo, fatigue, and visual disturbances. If you experience any of these side effects, you should exercise caution, as your reaction capability may be reduced.

You are solely responsible for deciding whether you are fit to drive or to perform activities requiring a high level of concentration. Due to its effects or adverse reactions, one of the factors that may reduce your ability to safely carry out these tasks is the use of medicines.

The descriptions of these effects can be found in the following sections.

Read the information in this leaflet carefully.

If you have any doubts, ask your doctor, nurse, or pharmacist.

Important information about some of the components of Pro-Ulco

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

This medicine does not contain gluten.

3. How to take Pro-Ulco

Follow exactly the instructions for administering Pro-Ulco given by your doctor. Consult your

doctor or pharmacist if you have any doubts.

Dosage

The dose of Pro-Ulco depends on your general condition. The usual doses of Pro-Ulco for adults are

listed below. Occasionally, your doctor may prescribe a different dose and indicate a different

treatment duration.

Use in adults

Treatment of heartburn and acid regurgitation: one 15 mg or 30 mg capsule daily for 4 weeks. If symptoms persist, inform your doctor. If symptoms do not improve after 4 weeks, consult your doctor.

Treatment of duodenal ulcer: one 30 mg capsule daily for 2 weeks.

Treatment of gastric ulcer: one 30 mg capsule daily for 4 weeks.

Treatment of inflammation of the oesophagus (reflux oesophagitis): one 30 mg capsule daily for 4 weeks.

Prevention of reflux oesophagitis: one 15 mg capsule daily; your doctor may adjust the dose to one 30 mg capsule daily.

Treatment of Helicobacter pylori infection: The usual dose is one 30 mg capsule together with two different antibiotics in the morning and one 30 mg capsule together with two different antibiotics in the evening. Treatment is normally daily for 7 days.

The recommended antibiotic combinations are as follows:

• 30 mg Pro-Ulco with 250–500 mg clarithromycin and 1,000 mg amoxicillin
• 30 mg Pro-Ulco with 250 mg clarithromycin and 400–500 mg metronidazole

If you are receiving anti-infective treatment for an ulcer, the ulcer is unlikely to recur if the infection is successfully treated. To achieve the best results from your medicine, take it at the correct time and do not miss any doses.

Treatment of duodenal or gastric ulcer in patients requiring continuous NSAID therapy: one 30 mg capsule daily for 4 weeks.

Prevention of duodenal or gastric ulcer in patients requiring continuous NSAID therapy: one 15 mg capsule daily; your doctor may adjust the dose to one 30 mg capsule daily.

Zollinger-Ellison syndrome: The usual initial dose is two 30 mg capsules daily; subsequently, depending on your response to Pro-Ulco treatment, your doctor will decide the best dose for you.

Use in children

Pro-Ulco must not be given to children.

Method of administration

Swallow the capsule whole with a glass of water. If you have difficulty swallowing the capsule, your doctor will inform you of alternative ways to take the medicine. Do not crush or chew the capsules or the contents of an emptied capsule, as this will prevent them from working properly.

Take Pro-Ulco at least 30 minutes before meals (see section “Taking Pro-Ulco with food and drink”).

If you take Pro-Ulco once daily, try to take it at the same time each day. You may achieve better results if you take Pro-Ulco first thing in the morning.

If you take Pro-Ulco twice daily, take the first dose in the morning and the second in the evening.

If you take more Pro-Ulco than you should

If you take more Pro-Ulco than prescribed, consult your doctor immediately or call the Toxicology Information Service immediately at telephone number 915 620 420.

If you forget to take Pro-Ulco

If you forget to take a dose, take it as soon as possible unless it is almost time for your next dose. In that case, skip the missed dose and take the next capsules as usual. Do not take a double dose to make up for a missed dose.

If you stop treatment with Pro-Ulco

Do not stop treatment prematurely, even if symptoms have improved. Your condition may not have been completely cured, and symptoms may return if you do not complete the full course of treatment.

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

4. Possible adverse effects

Like all medicines, Pro-Ulco may produce adverse effects, although not everyone experiences them.

The following adverse effects are frequent (occur in more than 1 out of every 100 patients):

• headache, dizziness
• diarrhoea, constipation, stomach pain, nausea and vomiting, flatulence, dryness or pain in mouth or throat
• benign polyps in the stomach
• skin rash, itching
• changes in liver function test values
• fatigue

The following adverse effects are uncommon (occur in less than 1 out of every 100 patients):

• depression
• joint or muscle pain
• fluid retention or swelling
• changes in blood cell counts
• if you are taking proton pump inhibitors such as Pro-Ulco, especially for a period longer than one year, your risk of hip, wrist, and spine fractures may increase. Inform your doctor if you have osteoporosis or are taking corticosteroids (which may increase the risk of osteoporosis).

The following adverse effects are rare (occur in less than 1 out of every 1,000 patients):

• fever
• restlessness, drowsiness, confusion, hallucinations, insomnia, visual disturbances, dizziness
• altered taste, loss of appetite, inflammation of the tongue (glossitis)
• skin reactions such as burning or itching sensation under the skin, bruising, redness, and excessive sweating
• light sensitivity
• hair loss
• tingling sensation (paraesthesia), tremor
• anaemia (pallor)
• kidney problems
• pancreatitis
• liver inflammation (may present as yellowing of the skin or eyes)
• breast swelling in males, impotence
• candidiasis (fungal infection, may affect skin or mucosa)
• angioedema; contact your doctor immediately if you experience symptoms of angioedema, such as swelling of the face, tongue or pharynx, difficulty swallowing, urticaria, or breathing difficulties.

The following adverse effects are very rare (occur in less than 1 out of every 10,000 patients):

• severe hypersensitivity reactions, including anaphylactic shock. Symptoms of hypersensitivity reactions may include fever, rash, swelling, breathing difficulties, and sometimes low blood pressure.
• inflammation of the mouth (stomatitis)
• colitis (inflammation of the intestine)
• changes in laboratory values, such as sodium, cholesterol, and triglyceride levels
• very severe skin reactions with redness, blisters, severe swelling, and skin loss
• in very rare cases, Pro-Ulco may cause a reduction in the number of white blood cells, which may decrease your resistance to infections. If you develop an infection with symptoms such as fever and a severe deterioration in your general condition, or fever with local infection symptoms such as sore throat/pharynx/mouth or urinary problems, consult your doctor immediately. A blood test will be performed to check for possible reduction in white blood cells (agranulocytosis).
• low levels of red blood cells, white blood cells, and platelets (pancytopenia)

The following adverse effects have unknown frequency (cannot be estimated from available data):

• skin rash, possibly with joint pain.

• if you are taking Pro-Ulco for more than three months, magnesium levels in the blood 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 magnesium levels.

• visual hallucinations.

Reporting of adverse effects

If you experience any type of 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 Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Pro-Ulco

Do not store above 30°C.

Keep the product out of the reach and sight of children.

Do not use Pro-Ulco after the expiry date stated on the packaging, following the abbreviation for the expiry date. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater drains or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. Ask your pharmacist how to properly dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Pro-Ulco 15 mg

• The active substance is lansoprazole. Each capsule contains 15 mg of lansoprazole.
• The other components are: sugar spheres (composed of corn starch, sucrose and purified water), sodium lauryl sulfate, N-methylglucamine, mannitol (E 421), hypromellose (E 464), macrogol 6000, talc (E 553b), polysorbate 80, titanium dioxide (E171), 30% dispersion of methacrylic acid and ethyl acrylate copolymer (1:1).

Components of the capsule shell: titanium dioxide (E 171), erythrosine (E 127), red iron oxide (E 172) and gelatin.

Appearance of the product and contents of the pack

Pro-Ulco 15 mg are gastro-resistant hard capsules containing lansoprazole microgranules.

The capsules have an opaque white body and an opaque red cap. The microgranules are white or greyish-white in colour.

Each pack contains 28 capsules.

Marketing Authorization Holder and Manufacturer

Viatris Healthcare Limited
Damastown Industrial Park
Mulhuddart, Dublin 15
Dublin
Ireland

Manufacturer

Recipharm Parets, S.L.
Ramón y Cajal 2,
08150 Parets del Vallès, Barcelona

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Viatris Pharmaceuticals, S.L.
C/ General Aranaz, 86
28027 Madrid
Spain

This patient information leaflet was last reviewed in November 2022

Detailed 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