LANSOPRAZOL MABO 15 mg HARD GASTRO-RESISTANT CAPSULES

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Lansoprazole Mabo 15 mg Gastro-resistant Hard Capsules

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. It may harm them, even if their symptoms are the same as yours.
• If you experience any of the side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Contents of the pack

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

1. What is Lansoprazole Mabo and what is it 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 you Lansoprazole 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 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

It is possible that your doctor has prescribed you Lansoprazole Mabo for another indication or at a different dose than indicated in this leaflet. Follow your doctor's instructions regarding the taking of the medicine.

2. Before taking Lansoprazole Mabo

Do not take Lansoprazole Mabo

• if you are allergic (hypersensitive) to lansoprazole or any of the other ingredients of Lansoprazole Mabo
• if you are taking another medicine whose active substance is atazanavir (used to treat HIV).

Be careful with Lansoprazole Mabo

Tell your doctor if you have a severe liver disease. It is possible that 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.

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

If your doctor has prescribed you Lansoprazole Mabo 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 carefully the package leaflets of these medicines.

If you have been taking Lansoprazole Mabo for a long time (more than 1 year), your doctor will probably have regular check-ups. During your visits to the doctor, you should inform him of any new or unusual symptoms or circumstances.

Consult your doctor before starting to take Lansoprazole MABO:

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

Before taking this medicine, inform your doctor if:

• A specific blood test (Chromogranin A) is scheduled

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 inform your doctor of these signs.

Use of other medicines

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

In particular, inform your doctor if you are using medicines that contain any of the following active substances, as Lansoprazole 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 heartburn or acid regurgitation)
• sucralfate (used to heal ulcers)
• St. John's Wort (Hypericum perforatum) (used to treat mild depression)

Taking Lansoprazole Mabo with food and drinks

To get the best results from your medicine, you should take Lansoprazole 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 using machines

Patients taking Lansoprazole Mabo 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 in a fit state 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 perform these operations safely is the use of medicines.

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

Read the information in this leaflet carefully.

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

Important information about some of the ingredients of Lansoprazole Mabo

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

3. How to take Lansoprazole Mabo

Take the capsule whole with a glass of water. If you have difficulty swallowing the capsule, your doctor will inform you of other alternative ways to take the medicine. 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 Lansoprazole Mabo once a day, try to take it always at the same time. You may get better results if you take Lansoprazole Mabo in the morning.

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

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

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 ulcer:one 30 mg capsule per day for 2 weeks.

Treatment of gastric ulcer:one 30 mg capsule per day for 4 weeks.

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

Long-term 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 at night. The treatment will normally be daily for 7 days.

The recommended combinations of antibiotics are as follows:

• 30 mg of Lansoprazole Mabo with 250-500 mg of clarithromycin and 1000 mg of amoxicillin.
• 30 mg of Lansoprazole Mabo 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, depending on your response to treatment with Lansoprazole Mabo, the doctor will decide the best dose for you.

Lansoprazole Mabo should not be administered to children.

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

If you take more Lansoprazole Mabo than you should

If you take more Lansoprazole Mabo than you have been told, consult your doctor immediately or contact the Toxicology Information Service, telephone: 91 562 04 20.

If you forget to take Lansoprazole Mabo

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 the missed dose.

If you stop taking Lansoprazole Mabo

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, Lansoprazole Mabo 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 stomach polyps.
• 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

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
• inflammation of the liver (may be manifested by yellowing of the skin or eyes)
• breast swelling in males, 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, 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, blisters, severe inflammation, and skin loss
• in very rare cases, Lansoprazole Mabo may cause a reduction in the number of white blood cells, which can cause 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).

The following side effects are of 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 can cause fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, increased heart rate. If you have any of these symptoms, go to the doctor immediately. Low magnesium levels can also cause a decrease in blood potassium and calcium levels. Your doctor may decide to perform periodic blood tests to monitor magnesium levels.

If you are taking proton pump inhibitors like Lansoprazole MABO, especially for a period of more than one year, you may have a slightly increased risk of hip, wrist, and spine fractures. Inform your doctor if you have osteoporosis or if you are taking corticosteroids (which can increase the risk of osteoporosis).

Reporting of side effects

If you experience any side effect, consult your doctor or pharmacist, even if it is possible that it is not listed in this leaflet. You can also report them directly through the Spanish Medicines Monitoring System for Human Use: https://www.notificaram.es. By reporting side 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, after EXP. 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. In case of doubt, ask your pharmacist how to dispose of medicines you no longer need. This way, you will help protect the environment.

6. Further information

Composition of Lansoprazole Mabo 15 mg

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

• The other ingredients are:

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

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

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

Lansoprazole Mabo 15 mg capsules are capsules with a white opaque cap and body, 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.

Packaging in HDPE bottles with 28 gastro-resistant capsules.

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

It is possible that only some pack sizes are marketed.

Marketing authorization holder

MABO-FARMA S.A.

Vía de los Poblados, 3,

Building 6, 28033 Madrid,

Spain.

Manufacturer

Teva Pharma S.L.U.

Polígono Malpica c/ C 4.

50016 Zaragoza.

Date of last revision of this leaflet

January 2023

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