Pro Ulco 30 mg gastro-resistant capsules
SpainTable of Contents
Patient Information Leaflet
Introduction
PACKAGE LEAFLET: INFORMATION FOR THE USER
Pro-Ulco 30 mg gastro-resistant capsules
Lansoprazole
Read this 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; do not give it to others, even if they have the same symptoms as you, as it may harm them.
- If you consider any of the side effects you experience to be severe, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.
Leaflet contents:
- What Pro-Ulco is and what it is used for
- Before you take Pro-Ulco
- How to take Pro-Ulco
- Possible side effects
- How to store Pro-Ulco
- 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 prescribe Pro-Ulco for the following indications:
- Treatment of duodenal and gastric ulcers
- Treatment of inflammation of the oesophagus (reflux esophagitis)
- Prevention of reflux esophagitis
- 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
Your doctor may have prescribed Pro-Ulco for a different indication or at a dose different from 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 whose active ingredient is 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 acidity.
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 stop treatment with Pro-Ulco. 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 intended for the treatment of Helicobacter pylori infection (antibiotics) or together with anti-inflammatory drugs to treat pain or rheumatism, please 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 inform them of 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 clot formation)
- 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 exercise caution, as your reaction capabilities may be reduced.
You are solely responsible for deciding whether you are fit to drive or 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 that you have an intolerance to certain sugars, consult with him before taking this medicine.
This medicine does not contain gluten.
3. How to take Pro-Ulco
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. You must not crush or chew the capsules or the contents of an emptied capsule, as this will prevent the medicine from working properly.
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 in the morning.
If you take Pro-Ulco twice daily, you should take the first dose in the morning and the second dose in the evening.
The dose of Pro-Ulco depends on your overall 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.
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 within 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 esophagus (reflux esophagitis): one 30 mg capsule daily for 4 weeks.
Long-term prevention of reflux esophagitis: 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. The usual treatment duration is once 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 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 ongoing NSAID therapy: one 30 mg capsule daily for 4 weeks.
Prevention of duodenal or gastric ulcer in patients requiring ongoing 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; thereafter, depending on your response to Pro-Ulco treatment, your doctor will determine the best dose for you.
Pro-Ulco must not be given to children.
Follow your doctor's instructions exactly. Consult your doctor if you have any doubts.
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 nearly time for your next dose. In that case, skip the missed dose and take the next capsules at the usual time. Do not take a double dose to make up for the missed dose.
If you stop taking Pro-Ulco
Do not stop treatment early, even if symptoms improve. Your condition may not be completely healed and 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 in every 100 patients):
- headache, dizziness
- diarrhea, 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 in every 100 patients):
- depression
- joint or muscle pain
- fluid retention or swelling
- changes in blood cell count
- 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 (these may increase the risk of osteoporosis).
The following adverse effects are rare (occur in less than 1 in 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 (paresthesia), tremor
- anemia (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 mucous membranes)
- angioedema; contact your doctor immediately if you experience symptoms of angioedema, such as swelling of the face, tongue or throat, difficulty swallowing, hives, or difficulty breathing.
The following adverse effects are very rare (occur in less than 1 in every 10,000 patients):
- severe hypersensitivity reactions, including anaphylactic shock. Symptoms of hypersensitivity may include fever, rash, swelling, difficulty breathing, 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 severe deterioration in your general condition, or fever with signs 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 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 can 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 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 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 must not be disposed of via wastewater or household waste. Dispose of empty containers and unused 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 30 mg
The active substance is lansoprazole.
The other components are: sugar spheres (composed of corn starch, sucrose and purified water), sodium lauryl sulfate, N-methylglucamine, mannitol, hypromellose, macrogol 6000, talc, polysorbate 80, titanium dioxide (E171), 30% dispersion of methacrylic acid copolymer and ethyl acrylate (1:1).
Components of the capsule: titanium dioxide (E 171), erythrosine (E 127), black and red iron oxides (E 172) and gelatin.
Appearance of the product and contents of the pack
Pro-Ulco 30 mg are gastro-resistant hard capsules containing lansoprazole microgranules.
The capsules have an opaque grey body and an opaque red cap. The microgranules are white or greyish-white.
Each pack contains 28 capsules.
Marketing Authorization Holder and Manufacturer Responsible
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
Spain
For further information about this medicine, 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 medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS): http://www.aemps.gob.es