Lansoprazole Mabo 15 mg gastro-resistant hard capsules EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Lansoprazole Mabo 15 mg Gastro-resistant hard capsules EFG

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.

Contents of the leaflet

1. What Lansoprazole Mabo is and what it is used for
2. Before taking Lansoprazole Mabo
3. How to take Lansoprazole Mabo
4. Possible side effects
5. How to store Lansoprazole Mabo
6. Further information

1. What Lansopraazol Mabo is and what it is used for

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

Your doctor may have prescribed Lansoprazol Mabo for the following indications:

• Treatment of duodenal and gastric ulcers
• Treatment of inflammation of the esophagus (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 Lansoprazol Mabo for an indication or at a dosage different from that stated in this leaflet. Follow your doctor's instructions regarding how to take the medicine.

2. Before taking Lansoprazol Mabo

Do not take Lansoprazol Mabo

• if you are allergic (hypersensitive) to lansoprazole or to any of the other ingredients of Lansoprazol Mabo
• if you are taking another medicine containing atazanavir (used in the treatment of HIV).

Exercise special caution with Lansoprazol Mabo

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 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 together with other medications intended for the treatment of Helicobacter pylori infection (antibiotics) or together with anti-inflammatory drugs for pain or rheumatism, please also read the package leaflets of these medications carefully.

If you have been taking Lansoprazol Mabo for a long time (more than 1 year), your doctor will likely schedule regular check-ups. During your visits, you must inform your doctor of any new or unusual symptoms or circumstances.

Consult your doctor before starting to take Lansoprazol MABO:

• If you have ever had a skin reaction after treatment with a medicine similar to Lansoprazol MABO 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 discontinue 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 have a specific blood test (Chromogranin A)

Use of lansoprazol may cause inflammation of the kidneys. 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.

Use of 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 Lansoprazol Mabo may affect their 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 heartburn 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

For optimal results, Lansoprazol Mabo should be taken 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 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 capacity 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 perform these tasks safely is your use of medicines.

Descriptions of these effects can be found in the following sections.

Please read the information in this leaflet carefully.

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

Important information about some of the components of Lansoprazol Mabo

Lansoprazol Mabo contains sucrose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Lansoprazol Mabo

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 capsule or the contents of an emptied capsule, as this will prevent the medicine from working properly.

If you take Lansoprazol Mabo once daily, try to take it at the same time each day. You may achieve better results if you take Lansoprazol Mabo in the morning.

If you take Lansoprazol Mabo twice daily, take the first dose in the morning and the second in the evening.

The dose of Lansoprazol Mabo depends on your condition. The usual doses of Lansoprazol Mabo 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 oesophagus (reflux oesophagitis): one 30 mg capsule daily for 4 weeks.

Long-term 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 taken in the morning together with two different antibiotics, and one 30 mg capsule taken in the evening together with two different antibiotics. Treatment is usually given daily for 7 days.

The recommended antibiotic combinations are as follows:

• 30 mg Lansoprazol Mabo with 250–500 mg clarithromycin and 1,000 mg amoxicillin.
• 30 mg Lansoprazol Mabo 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 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 Lansoprazol Mabo treatment, your doctor will decide the best dose for you.

Lansoprazol Mabo must not be given to children.

Always follow your doctor's instructions exactly. If you have any doubts, consult your doctor.

If you take more Lansoprazol Mabo than you should

If you take more Lansoprazol Mabo than prescribed, contact your doctor immediately or call the Toxicology Information Service, telephone: 91 562 04 20.

If you forget to take Lansoprazol Mabo

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 at the usual time. Do not take a double dose to make up for the missed dose.

If you stop taking Lansoprazol Mabo

Do not stop treatment prematurely, even if symptoms improve. Your condition may not be completely healed 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 medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, Lansoprazole Mabo may cause adverse effects, although not everyone experiences them.

The following adverse 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 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 100 patients):

• depression
• joint or muscle pain
• fluid retention or swelling
• changes in blood cell counts

The following adverse effects are rare (occur in less than 1 in 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 men, 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 throat, difficulty swallowing, hives, and breathing difficulties.

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

• severe hypersensitivity reactions, including anaphylactic shock. Symptoms of hypersensitivity may include fever, rash, swelling and, occasionally, low blood pressure
• inflammation of the mouth (stomatitis)
• colitis (inflammation of the intestine)
• changes in laboratory values, such as levels of sodium, cholesterol and triglycerides
• very severe skin reactions with redness, blisters, severe swelling and skin loss
• in very rare cases, Lansoprazole Mabo may cause a reduction in the number of white blood cells, which could decrease resistance to infections. If you develop an infection with symptoms such as fever and severe deterioration in your general condition, or fever accompanied by 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).

The following adverse effects have unknown frequency:

• Skin rash, possibly with joint pain.
• Visual hallucinations.

If you are taking Lansoprazole Mabo 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, seek medical attention 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.

If you are taking proton pump inhibitors such as Lansoprazole Mabo, especially for a period longer than one year, there may be a slight increase in the risk of fractures of the hip, wrist and spine. Inform your doctor if you have osteoporosis or are taking corticosteroids (which may increase the risk of osteoporosis).

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, 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 Lansoprazol Mabo

Store below 30°C.

Keep out of the reach and sight of children.

Do not use Lansoprazol Mabo after the expiry date stated on the packaging, after EXP. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE Point in your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines you no longer need. This will help protect the environment.

6. Additional Information

Composition of Lansoprazol Mabo 15 mg

The active substance is lansoprazole. Each capsule contains 15 mg of lansoprazole.

• The other components are: ,

• sugar spheres (sucrose and corn starch), sodium lauryl sulfate, povidone, sodium carboxymethyl potato starch (Type A), trisodium phosphate dodecahydrate, hypromellose, methacrylic acid and ethyl acrylate copolymer (1:1), triethyl citrate, titanium dioxide (E-171) and talc.

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

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

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

Packaging in HDPE bottles containing 28 gastro-resistant capsules.

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

Only certain pack sizes may be marketed.

Marketing Authorization Holder

MABO-FARMA S.A.

Calle Vía de los Poblados, 3,

Edificio 6, 28033 Madrid,

Spain.

Manufacturer

Teva Pharma S.L.U.

Polígono Malpica c/ C 4.

50016 Zaragoza.

Date of the most recent revision of this leaflet

January 2023

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/