PATIENT INFORMATION LEAFLET

Lansoprazol Mabo 15 mg Hard Gastric-Resistant Capsules EFG

Read this leaflet carefully before you start taking the 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.

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

Your doctor may prescribe Lansopraazol Mabo for the following indications:

• Treatment of duodenal and gastric ulcers
• Treatment of esophagitis caused by acid reflux
• Prevention of esophagitis caused by acid reflux
• 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) (NSAIDs are used for pain or inflammation)
• Treatment of Zollinger-Ellison syndrome

Your doctor may have prescribed Lansopraazol Mabo 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 Lansoprazol Mabo

• if you are allergic (hypersensitive) to lansoprazol or to any of the other components of Lansoprazol Mabo
• if you are taking another medicine whose active ingredient is atazanavir (used in the treatment of HIV)

Be careful with Lansoprazol Mabo

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

Your doctor may perform or have performed a supplementary test called endoscopy to diagnose your disease and/or rule out cancer.

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

If your doctor has prescribed Lansoprazol Mabo 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 prospectuses of these medicines carefully.

If you have been taking Lansoprazol Mabo for a long time (over 1 year), your doctor will probably perform regular checks. During your doctor's visits, you must inform them of any new or abnormal symptoms.

Consult your doctor before starting to take Lansoprazol MABO:

• If you have ever had a skin reaction after treatment with a similar medicine to Lansoprazol MABO to reduce 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 Lansoprazol MABO. Remember to mention any other symptoms you may notice, such as joint pain.

Before taking this medicine, inform your doctor if:

• You are scheduled to undergo a specific blood test (Cromogranin A)

When taking lansoprazol, it may cause inflammation in the kidneys. Symptoms and signs 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. Inform your doctor of these symptoms.

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 Lansoprazol Mabo may affect their mode of action:

• ketoconazole, itraconazole, rifampicin (used to treat infections)
• digoxin (used to treat heart problems)
• theophylline (used to treat asthma)
• tacrolimus (used to prevent transplant rejection)
• fluvoxamine (used to treat depression and other psychiatric disorders)
• antacids (used to treat stomach burning or acid regurgitation)
• sucralfate (used to heal ulcers)
• St. John's Wort (Hypericum perforatum) (used to treat mild depression)

Taking Lansoprazol Mabo with food and drinks

To get the best results from your medicine, take Lansoprazol Mabo 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 Lansoprazol Mabo 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 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 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 prospectus carefully.

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

Important information about some of the components of Lansoprazol Mabo

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

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 medication. Do not crush or chew the capsule or the contents of an empty capsule, as this will make it not work properly.

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

If you take Lansoprazol Mabo twice a day, you should take the first dose in the morning and the second dose at night.

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

Treatment of heartburn 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.

Long-term 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. Treatment is usually daily for 7 days.

The recommended antibiotic combinations are as follows:

• 30 mg of Lansoprazol Mabo with 250-500 mg of clarithromycin and 1,000 mg of amoxicillin.
• 30 mg of Lansoprazol Mabo with 250 mg of clarithromycin and 400-500 mg of metronidazole.

If you receive antibiotic 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 and do not miss any doses.

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, your doctor will decide the best dose for you based on your response to treatment with Lansoprazol Mabo.

Lansoprazol Mabo should not be administered to children.

Follow your doctor's administration instructions exactly. Consult your doctor if you have any doubts.

If you take more Lansoprazol Mabo than you should:

If you take more Lansoprazol Mabo than indicated, consult your doctor immediately or contact the Toxicology Information Service, phone: 91 562 04 20

If you forget to take Lansoprazol Mabo:

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 Lansoprazol Mabo:

Do not stop 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 questions about the use of this product, ask your doctor or pharmacist

Like all medicines, Lansoprazol Mabo can 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 count

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), tremor
• anemia (pallor)
• kidney problems
• pancreatitis
• inflammation of the liver (may be manifested by yellowish skin or eyes)
• chest swelling in males, 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. Symptoms of hypersensitivity reactions may include fever, rash, swelling, 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, Lansoprazol Mabo may cause a reduction in the number of white blood cells, which may lead to 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 leukopenia (agranulocytosis).

The following side effects are of unknown frequency:

• skin rash, possibly with joint pain.
• visual hallucinations.

If you are taking Lansoprazol MABO for more than three months, it is possible that blood magnesium levels may decrease. Low magnesium levels can cause fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, increased heart rate. If you experience any of these symptoms, see your doctor immediately. Low magnesium levels can 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.

If you are taking proton pump inhibitors such as Lansoprazol MABO, especially for a period of more than one year, you may have a slightly increased 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)

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, 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 Vigilance 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.

Store below 30°C.

Keep out of the reach and sight of children.

Do not use Lansoprazol Mabo after the expiration date that appears on the packaging, after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medicines at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of unused medicines.This will help protect the environment.

Composition of Lansoprazol Mabo 15 mg

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

- The other components are:

- sugar spheres (saccharose and cornstarch), sodium laurilsulfate, povidone, carboxymethylstarch sodium (Type A), dodecahydrate trisodium phosphate, hypromellose, copolymer of methacrylic acid and ethyl acrylate (1:1), triethylcitrate, titanium dioxide (E-171), and talc.

The printing ink of the capsules contains shellac, anhydrous ethanol, isopropyl alcohol, propylene glycol, n-butanol, ammonium hydroxide, potassium hydroxide, and iron oxide black (E172).

The gelatin capsule is composed of: gelatin and titanium dioxide (E-171). Appearance of the product and contents of the package

Lansoprazol Mabo 15 mg capsules are opaque white cap and body capsules, filled with beige micropellets. The capsules have been marked with black ink with the letter “L” on the cap and the number “15” on the body.

Packages in HDPE bottles with 28 gastro-resistant capsules.

Packages in aluminum/aluminum blisters of 28 and 56 gastro-resistant capsules.

Only some package sizes may be commercially available.

Marketing Authorization Holder

MABO-FARMA S.A.

Calle Rejas 2, 1st floor

28821 Coslada Madrid

Spain

Responsible for Manufacturing

Teva Pharma S.L.U.

Malpica Industrial Estate, c/ C 4.

50016 Zaragoza.

Date of the last review of this leaflet

January 2023

For detailed and updated information on this medication, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/