PATIENT INFORMATION LEAFLET

Pro-Ulco 15 mg gastro-resistant capsules

Lansoprazole

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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others even if their symptoms are the same. It may harm them.
• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.

1. Before taking Pro-Ulco
2. How to take Pro-Ulco
3. Possible side effects
4. Storage of Pro-Ulco

6. Contents of the pack and additional information

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

Your doctor may prescribe Pro-Ulco for the following indications:

• Treatment of stomach and duodenal ulcers
• Treatment of esophagus inflammation (acid reflux esophagitis)
• Prevention of acid reflux esophagitis
• Treatment of stomach burning and acid regurgitation
• Treatment of infections caused by the bacteria Helicobacter pylori, in combination with antibiotics
• Treatment or prevention of duodenal or gastric ulcers in patients requiring continuous treatment with nonsteroidal anti-inflammatory drugs (NSAIDs) (NSAID treatment is used for pain or inflammation)
• Treatment of Zollinger-Ellison syndrome(a condition in which a high

amount of acid is produced in the stomach)

Your doctor may have prescribed Pro-Ulco for another indication or at a different dose than indicated in this leaflet. Follow your doctor's instructions for taking the medication.

Do not take Pro-Ulco:

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

Warnings and precautions

Consult your doctor before starting to take Pro-Ulco:

If you have ever had a skin reaction after treatment with a similar medicine to Pro-Ulco for reducing stomach acid

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

Lansoprazole may cause inflammation in the kidneys. Signs and symptoms may include decreased urine volume or the presence of 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 are scheduled to have a specific blood test (Cromogranin A)

Inform your doctor if you have a serious liver disease. Your doctor may need to adjust the dose

Your doctor may have performed or will perform a diagnostic test called endoscopy to diagnose your condition and/or rule out cancer

In case 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 in addition to other medicines for the treatment of Helicobacter pylori infection (antibiotics) or together with anti-inflammatory drugs to treat pain or rheumatism, read the leaflets for these medicines carefully

If you have been taking Pro-Ulco for a long time (over 1 year), your doctor will probably perform regular checks. During your visits to your doctor, you should inform them of any new or abnormal symptoms and circumstances

Use of other medicines

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

Especially, inform your doctor if you are using medicines containing any of the following active ingredients, as Pro-Ulco may affect their action:

• Inhibitors of HIV protease, 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 clot formation)
• Warfarin (used to prevent blood clot formation)
• Fluvoxamine (used to treat depression and other psychiatric disorders)
• Antacids (used to treat stomach burning 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 get the best results from your medicine, you should take Pro-Ulco at least 30 minutes before meals

Pregnancy and breastfeeding

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

Driving and operating machinery

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 time may be reduced

You are the only one responsible for deciding whether you are in a condition to drive vehicles or perform activities that require a high level of concentration. Due to its effects or adverse reactions, one of the factors that may reduce your ability to carry out these operations safely is the use of medicines

In the following sections, you will find the descriptions of these side effects

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

This medicine does not contain gluten

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

Consult your doctor or pharmacist if you have any doubts.

Dosage

The dosage of Pro-Ulco depends on your general condition. The normal doses of Pro-Ulco for adults are indicated below. In some cases, your doctor may prescribe a different dose and indicate a different duration of treatment.

Use in adults

Treatment of stomach burning and acid regurgitation:one capsule of 15 mg or 30 mg per day 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 capsule of 30 mg per day for 2 weeks.

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

Treatment of esophagitis due to reflux:one capsule of 30 mg per day for 4 weeks.

Prevention of esophagitis due to reflux:one capsule of 15 mg per day; your doctor may adjust the dose to one capsule of 30 mg per day.

Treatment of Helicobacter pylori infection:The normal dose is one capsule of 30 mg with two different antibiotics in the morning and one capsule of 30 mg with two different antibiotics at night. The treatment, usually, will be daily for 7 days.

The recommended antibiotic combinations are as follows:

-30 mg of Pro-Ulco with 250-500 mg of clarithromycin and 1,000 mg of amoxicillin

30 mg of Pro-Ulco with 250 mg of clarithromycin and 400-500 mg of metronidazole

If you receive anti-infective treatment due to an ulcer, it is unlikely that the ulcer will recur if the infection is treated satisfactorily. To get the best results from your medication, take it at the right time anddo not forget any dose.

Treatment of duodenal or gastric ulcer in patients requiring continuous treatment with NSAIDs:one capsule of 30 mg per day for 4 weeks.

Prevention of duodenal or gastric ulcer in patients requiring continuous treatment with NSAIDs:one capsule of 15 mg per day; your doctor may adjust the dose to one capsule of 30 mg per day.

Zollinger-Ellison syndrome:The initial normal dose is two capsules of 30 mg per day;

subsequently, based on your response to treatment with Pro-Ulco, your doctor will decide the best dose for you.

Use in children

Pro-Ulco should not be administered to children.

Administration form

Take the capsule whole with a glass of water. If you have difficulty swallowing the capsule, your doctor will inform you of other alternative ways to take the medication. Do not crush or chew the capsules or the contents of an empty capsule, as this will make them ineffective.

Take Pro-Ulco at least 30 minutes before meals (see section “Taking Pro-Ulco with food and drinks

”).

If you take Pro-Ulco once a day, try to take it at the same time every day. You may get better results if you take Pro-Ulco in the morning.

If you take Pro-Ulco twice a day, take the first dose in the morning and the second at night.

If you take more Pro-Ulco than you should

If you take more Pro-Ulco than indicated, consult your doctor immediately or call the Toxicological Information Service, Telephone 915 620 420.

If you forget to take Pro-Ulco

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

If you interrupt treatment with Pro-Ulco

Do not interrupt treatment before time because symptoms have improved. It is possible that your condition has not been fully cured and may recur if you do not complete the entire treatment.

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

Like all medicines, Pro-Ulco may cause side effects, although not everyone will experience them.

The following side effects are frequent (occur in more than 1 in 100 patients):

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

The following side effects are infrequent (occur in less than 1 in 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 of more than one year, it may increase the risk of hip, wrist, and spinal fractures. Inform your doctor if you have osteoporosis or if you are taking corticosteroids (they may increase the risk of osteoporosis).

The following side effects are rare (occur in less than 1 in 1,000 patients):

• fever
• restlessness, drowsiness, confusion, hallucinations, insomnia, visual disturbances, vertigo
• alteration of taste, loss of appetite, inflammation of the tongue (glossitis)
• skin reactions such as burning or itching sensation under the skin, hematomas, redness, and excessive sweating
• light sensitivity
• hair loss
• tingling sensation (paresthesia), tremors
• anemia (pallor)
• renal problems
• pancreatitis
• inflammation of the liver (may manifest as yellowish skin or eyes)
• swelling of the chest in men, impotence
• candidiasis (fungal infection, may affect the skin or mucous membranes)
• angioedema; contact your doctor immediately if you experience symptoms of angioedema, such as facial swelling, tongue, or throat inflammation, difficulty swallowing, urticaria, and difficulty breathing.

The following side effects are very rare (occur in less than 1 in 10,000 patients):

• severe hypersensitivity reactions, including anaphylactic shock. The symptoms of hypersensitivity reactions may include fever, rash, swelling, difficulty breathing, and in some cases, a drop in blood pressure.
• inflammation of the mouth (stomatitis)
• colitis (inflammation of the intestine)
• changes in analytical values, such as sodium, cholesterol, and triglyceride levels
• very severe skin reactions with redness, vesicles, severe inflammation, and skin loss
• in very rare cases, Pro-Ulco may cause a reduction in the number of white blood cells, which may cause a decrease in your resistance to infections. If you experience an infection with symptoms such as fever and severe deterioration of your general condition, or fever with symptoms of local infection 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 side effects are of 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, it is possible that magnesium levels in the blood may decrease. Low magnesium levels may cause fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, and 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.

-visual hallucinations.

Reporting of side effects

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

Do not store at a temperature above30°C.

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

Do not use Pro-Ulco after the expiration date that appears on the packaging, after the expiration date abbreviation. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash.Deposit empty containers and unused medicines at the SIGRE collection pointof the pharmacy.Ask your pharmacist how to dispose of empty containers and unused medicines. In this way, you will help protect the environment.

Composition of Pro-Ulco 15 mg

- The active ingredient is lansoprazol. Each capsule contains 15 mg of lansoprazol.

- The other components are: sugar spheres (consisting of cornstarch, 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), dispersion at 30% of methacrylic acid and ethyl acrylate copolymer (1:1).

The capsule components are: titanium dioxide (E 171), erythrosine (E 127), iron oxide red (E 172), and gelatin.

Appearance of the product and content of the packaging

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

The capsules have a white opaque body and a red opaque head. The microgranules are white or light gray in color.

Each package contains 28 capsules.

Holder of the marketing authorization and responsible for manufacturing

Viatris Healthcare Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Responsible for manufacturing

Recipharm Parets, S.L.

Ramón y Cajal 2,

08150 Parets del Vallès, Barcelona

You can request more information about this medication by contacting the local representative of the marketing authorization holder :

Viatris Pharmaceuticals, S.L.

C/ General Aranaz, 86

28027 Madrid

Spain

This leaflet was reviewed in November 2022

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