PRO ULCO 15 mg GASTRO-RESISTANT CAPSULES

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Pro-Ulco 15 mg gastro-resistant capsules

Lansoprazole

Read all of this leaflet carefully before you start taking this medicine.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others, as it may harm them, even if their symptoms are the same as yours.
• If you experience any of the side effects, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Contents of the pack:

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

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

1. Contents of the pack and further information

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

The active substance 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 you Pro-Ulco for the following indications:

• Treatment of stomach 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 bacteria Helicobacter pylori, in combination with antibiotics
• Treatment or prevention of duodenal or gastric ulcers in patients who require continuous treatment with non-steroidal anti-inflammatory drugs (NSAIDs) (NSAID treatment is used for pain or inflammation)
• Treatment of Zollinger-Ellison syndrome (a condition in which the stomach produces too much acid)

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

2. Before taking Pro-Ulco

Do not take Pro-Ulco:

• If you are allergic (hypersensitive) to lansoprazole or any of the other ingredients of Pro-Ulco (listed in section 6)
• If you are taking another medicine whose active substance is atazanavir (used to treat 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 medicine similar to Pro-Ulco to reduce stomach acid.

If you get a rash, especially in areas of the skin exposed to the sun, 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.

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

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

Tell your doctor if you have severe liver disease. The doctor may need to adjust the dose.

Your doctor may have performed or may perform a complementary test called endoscopy to diagnose your disease 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 in addition to other medicines intended for the treatment of Helicobacter pyloriinfection (antibiotics) or together with anti-inflammatory drugs to treat 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 probably have you checked regularly. During your visits to the doctor, you should report any new or abnormal symptoms and circumstances.

Use of other medicines

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

In particular, tell your doctor if you are using medicines that contain any of the following active substances, as Pro-Ulco may affect their mode 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 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, 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 act with caution as your reaction ability may be reduced.

You are the only one responsible for deciding whether you are fit 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 can reduce your ability to perform these operations safely is the use of medicines.

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

Read this leaflet carefully.

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

Important information about some of the ingredients of Pro-Ulco

This medicine contains sucrose. 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.

3. How to take Pro-Ulco

Follow your doctor's instructions for taking Pro-Ulco exactly. Consult your doctor or pharmacist if you have any doubts.

Dosage

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

Use in adults

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

Treatment of stomach ulcers:one 30 mg capsule per day for 4 weeks.

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

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

Treatment of Helicobacter pyloriinfection:The normal 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. The treatment will normally be daily for 7 days.

The recommended antibiotic combinations are as follows:

• 30 mg of Pro-Ulco with 250-500 mg of clarithromycin and 1000 mg of amoxicillin
• 30 mg of Pro-Ulco with 250 mg of clarithromycin and 400-500 mg of metronidazole

If you are receiving 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 medicine, take it at the right time and do not forget any dose.

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

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

Zollinger-Ellison syndrome:The initial normal dose is two 30 mg capsules per day; subsequently, based on your response to treatment with Pro-Ulco, the doctor will decide the best dose for you.

Use in children

Pro-Ulco should not be administered to children.

Method of administration

Take 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 empty 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 drinks”).

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

If you take Pro-Ulco twice a day, you should take the first dose in the morning and the second dose 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, Telephone 915 620 420.

If you forget to take Pro-Ulco

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

If you stop taking Pro-Ulco

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

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

4. Possible side effects

Like all medicines, Pro-Ulco can cause side effects, although not everybody gets them.

The following side effects are common (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 polyps in the stomach
• skin rash, itching
• changes in liver function test values
• fatigue

The following side effects are uncommon (occur in less than 1 in 100 patients):

• depression
• joint or muscle pain
• fluid retention or swelling
• changes in blood cell count
• if you are taking proton pump inhibitors like Pro-Ulco, especially for a period of more than one year, you may have an increased risk of hip, wrist, and spine fractures. Tell your doctor if you have osteoporosis or if you are taking corticosteroids (which can 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
• taste disturbance, loss of appetite, inflammation of the tongue (glossitis)
• skin reactions such as burning sensation or itching under the skin, bruising, redness, and excessive sweating
• sensitivity to light
• hair loss
• tingling sensation (paresthesia), tremor
• anemia (pallor)
• kidney problems
• pancreatitis
• liver inflammation (which can manifest as yellowing of the skin or eyes)
• breast swelling in men, impotence
• candidiasis (fungal infection, can affect the skin or mucous membranes)
• angioedema; contact your doctor immediately if you experience symptoms of angioedema, such as swelling of the face, tongue, or pharynx, difficulty swallowing, hives, 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 a hypersensitivity reaction may include fever, rash, swelling, difficulty breathing, and in some cases a drop in blood pressure.
• mouth inflammation (stomatitis)
• colitis (inflammation of the intestine)
• changes in analytical values, such as sodium, cholesterol, and triglyceride levels
• very serious skin reactions with redness, blisters, severe inflammation, and skin loss
• in very rare cases, Pro-Ulco may cause a reduction in the number of white blood cells, which can lead to a decrease in 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. You will have a blood test to check for possible reduction of white blood cells (agranulocytosis).
• low levels of red blood cells, white blood cells, and platelets (pancytopenia)

The following side effects have a frequency that cannot be estimated from the available data:

• skin rash, possibly with joint pain.

• if you are taking Pro-Ulco for more than three months, it is possible that your blood magnesium levels may decrease. Low magnesium levels can cause fatigue, muscle contractions, disorientation, convulsions, dizziness, and increased heart rate. If you experience any of these symptoms, go to the doctor immediately. Low magnesium levels can also lead to a decrease in blood potassium and calcium levels. Your doctor may decide to perform periodic blood tests to monitor magnesium levels.
• visual hallucinations.

Reporting of side effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are possible side effects not listed in this leaflet. You can also report them directly through the Spanish Medicines Monitoring System: https://www.notificaram.es. By reporting side 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, after the expiry date abbreviation. The expiry date is the last day of the month indicated.

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

6. Contents of the pack and further information

Composition of Pro-Ulco 15 mg

• The active substance is lansoprazole. Each capsule contains 15 mg of lansoprazole.
• The other ingredients 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), 30% dispersion of methacrylic acid and ethyl acrylate copolymer (1:1).

The ingredients of the capsule are: 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 hard gastro-resistant capsules containing lansoprazole microgranules.

The capsules have a white opaque body and a red opaque head. The microgranules are white or grayish-white.

Each pack contains 28 capsules.

Marketing authorisation 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

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

Viatris Pharmaceuticals, S.L.

C/ General Aranaz, 86

28027 Madrid

Spain

This leaflet was last revised in November 2022

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