Lansoprazole Mabo 30 mg gastro-resistant hard capsules EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Lansoprazol Mabo 30 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 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

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

1. What Lansoprazol 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 prescribe Lansoprazol Mabo for the following indications:

• Treatment of duodenal and gastric 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 bacterium Helicobacter pylori, in combination with antibiotics
• Treatment or prevention of duodenal or gastric ulcers in patients requiring long-term 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 dose 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 components of Lansoprazol Mabo
• if you are taking another medicine whose active substance is 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 the dose.

Your doctor may have performed or may perform an additional test called endoscopy to diagnose your condition and/or to 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 medicines for the treatment of Helicobacter pylori infection (antibiotics) or in combination with anti-inflammatory drugs for pain or rheumatism, please also read the package leaflets of these medicines carefully.

If you have been taking Lansoprazol Mabo for a long time (more than 1 year), your doctor will likely perform 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 should report these signs to your doctor.

Use of other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might take 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 effectiveness, 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 capabilities may be reduced.

You are solely responsible for deciding whether you are fit to drive or to perform activities requiring a high level of concentration. Due to its effects or adverse reactions, the use of medicines may be one of the factors that reduce your ability to safely carry out these tasks.

The following sections contain descriptions of these effects.

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. You must 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 individual 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 treatment: one 30 mg capsule daily for 4 weeks.

Prevention of duodenal or gastric ulcer in patients requiring ongoing NSAID treatment: 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 treatment with Lansoprazol Mabo, your doctor will decide the appropriate dose for you.

Lansoprazol Mabo must not be administered to children.

Always follow your doctor's 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 prescribed, contact your doctor immediately or call the Toxicology Information Service at: 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 a missed dose.

If you stop taking Lansoprazol Mabo

Do not stop treatment prematurely, even if symptoms improve. Your condition may not be fully healed and could 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 produce adverse effects, although not everyone experiences them.

The following adverse effects are common (occur in more than 1 in 100 patients):

• headache, dizziness
• diarrhoea, 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 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
• taste disturbances, 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 (paraesthesia), tremor
• anaemia (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 10,000 patients):

• severe hypersensitivity reactions, including anaphylactic shock. Symptoms of hypersensitivity reactions may include fever, rash, swelling, and sometimes a drop in blood pressure
• inflammation of the mouth (stomatitis)
• colitis (inflammation of the intestine)
• changes in laboratory test 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 can reduce 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).

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, it is possible that your blood magnesium levels may decrease. Low magnesium levels may 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 your 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 (as these may increase the risk of osteoporosis).

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may 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 Lansoprazole Mabo

Store below 30°C.

Keep out of the reach and sight of children.

Do not use Lansoprazole Mabo after the expiry date stated on the packaging, following 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 containers at the SIGRE collection point at 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 30 mg

• The active substance is lansoprazole. Each capsule contains 30 mg of lansoprazole.
• The other components are: sugar spheres (sucrose and corn starch), sodium lauryl sulfate, povidone, sodium starch glycolate from potato (Type A), trisodium phosphate dodecahydrate, hypromellose, methacrylic acid and ethyl acrylate copolymer (1:1), triethyl citrate, titanium dioxide (E-171), talc.
• The gelatin capsule is composed of: gelatin and titanium dioxide (E-171).
• The printing ink for the capsules contains shellac, anhydrous ethyl alcohol, isopropyl alcohol, propylene glycol, n-butyl alcohol, ammonium hydroxide, potassium hydroxide, black iron oxide (E172).

Appearance of the product and contents of the pack

Lansoprazole 30 mg capsules are capsules with an opaque white cap and body, filled with beige micropellets. The capsules are printed with black ink, with the letter "L" on the cap and the number "30" on the body.

Pack sizes in HDPE bottles containing 14 and 28 gastro-resistant capsules.

Aluminum/Aluminum blister packs containing 14, 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/