Package Insert: Information for the Patient

Monolitum Flas 30 mg Buccodispersable Tablets

Lansoprazole

Read this entire package insert carefully before starting to take this medication,because it contains important information for you.

• Keep this package insert as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribedonly for you,and you should notgive it to otherseven if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

1. What Monolitum Flas is and for what it is used

2. What you need to know before starting to take Monolitum Flas

3. How to take Monolitum Flas

4. Possible adverse effects

5. Storage of Monolitum Flas

6. Contents of the package and additional information

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

Your doctor may prescribe Monolitum Flas 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 Monolitum Flas for another indication or at a different dose than indicated in this leaflet. Follow your doctor's instructions for taking the medication.

You should consult a doctor if you worsen or do not improve after 14 days.

Do not takeMonolitum

• If you are allergic to lansoprazole or any of the other ingredients of this medication (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Monolitum:

• If you have decreased vitamin B12 reserves or risk factors for it and receive long-term treatment with lansoprazole. Like all medications that reduce the amount of acid, Monolitum may reduce vitamin B12 absorption.
• If you are scheduled to have a specific blood test (Cromogranina A).
• If you have ever had a skin reaction after treatment with a similar medication to Monolitum for reducing 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 Monolitum treatment. Remember to mention any other symptoms you may notice, such as joint pain.

When taking lansoprazole, it may cause kidney inflammation. Signs and symptoms may include decreased urine volume or blood in the urine and/or hypersensitivity reactions such as fever, skin rash, and joint stiffness. You must inform your doctor of these signs.

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 diagnostic test called endoscopy to diagnose your condition and/or rule out malignant disease.

In case of diarrhea during treatment withMonolitum, contact your doctor immediately, as Monolitum has been associated with a slight increase in infectious diarrhea.

If your doctor has prescribedMonolitumin addition to other medications for the treatment of Helicobacter pylori infection (antibiotics) or with anti-inflammatory medications to treat pain or arthritis, read the prospectuses of these medications carefully.

The fact of taking a proton pump inhibitor like Monolitum, especially for a period of more than one year, may slightly increase the risk of fractures of the hip, wrist, or vertebrae. Inform your doctor if you have osteoporosis or are taking corticosteroids (which may increase the risk of osteoporosis).

If you have been takingMonolitumfor a long time (over 1 year), your doctor will likely perform regular checks. During your doctor visits, you must inform them of any new or abnormal symptoms and circumstances.

Other medications and Monolitum

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication, including those purchased without a prescription.

Especially, inform your doctor if you are using medications containing any of the following active ingredients, as Monolitum may affect their mode of action:

• Protease inhibitors for HIV such as atazanavir and nelfinavir (used in HIV treatment)
• Methotrexate (used to treat autoimmune diseases and cancer)
• Ketoconazole, itraconazole, rifampicin (used to treat infections)
• Digoxin (used to treat heart problems)
• Warfarin (used to treat blood clots)
• 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)

Monolitum with food and drinks

To get the best results from your medication, you must takeMonolitumat least 30 minutes before meals.

Pregnancy and breastfeeding

If you are pregnant, or in a breastfeeding period, believe you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medication.

Driving and operating machines

Patients takingMonolitummay occasionally experience side effects such as dizziness, vertigo, fatigue, and visual disturbances. If you experience any of these side effects, you must act with caution as your reaction time may be reduced.

You are the only one responsible for deciding whether you are in a condition 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 medications.

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

Read this prospectus carefully.

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

Monolitum contains saccharose and sodium

This medication contains saccharose. If your doctor has indicated that you have an intolerance to certain sugars, consult with them before taking this medication.

This medication contains less than 23 mg of sodium (1 mmol) per capsule; it is essentially "sodium-free".

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Place the tablet on the tongue and let it dissolve slowly. The tablet dissolves quickly in the mouth, releasing some microgranules that must be swallowed without chewing. You can also swallow the tablet whole with a glass of water.

Your doctor may give you instructions to administer the tablet using a syringe, in case you have serious difficulties swallowing.

Follow the instructions below in case of administration using a syringe:

It is essential to check that the selected syringe is the right one.

• Extract the plunger from the syringe (at least a 5 ml syringe for the 15 mg tablet and a 10 ml syringe for the 30 mg tablet).
• Place the tablet in the reservoir.
• Replace the plunger in the syringe.
• For the 15 mg tablet: fill the syringe with 4 ml of water.
• For the 30 mg tablet: fill the syringe with 10 ml of water.
• Invert the syringe and pull the plunger to allow 1 ml of air to enter.
• Agitate the syringe gently for 10-20 seconds until the tablet has dispersed.
• The contents can be emptied directly into the mouth.
• Replace the syringe with 2-5 ml of water to eliminate any remaining contents and empty it into the mouth.

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

If you take Monolitum Flas twice a day, take the first dose in the morning and the second at night.

The dose of Monolitum Flas depends on your general condition. The usual doses of Monolitum Flas 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 buccal dispersible tablet 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 buccal dispersible tablet of 30 mg per day for 2 weeks.

Treatment of gastric ulcer:one buccal dispersible tablet of 30 mg per day for 4 weeks.

Treatment of esophagitis due to reflux:one buccal dispersible tablet of 30 mg per day for 4 weeks.

Long-term prevention of esophagitis due to reflux:one buccal dispersible tablet of 15 mg per day; your doctor may adjust your dose to one buccal dispersible tablet of 30 mg per day.

Treatment of Helicobacter pylori infection:The usual dose is one buccal dispersible tablet of 30 mg with two different antibiotics in the morning and one buccal dispersible tablet 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 Monolitum Flas with 250-500 mg of clarithromycin and 1,000 mg of amoxicillin

- 30 mg of Monolitum Flas with 250 mg of clarithromycin and 400-500 mg of metronidazole

If you receive 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 medication, take it at the right time anddo not miss any doses.

Treatment of duodenal or gastric ulcer in patients requiring continuous treatment with NSAIDs:one buccal dispersible tablet of 30 mg per day for 4 weeks.

Prevention of duodenal or gastric ulcer in patients requiring continuous treatment with NSAIDs:one buccal dispersible tablet of 15 mg per day; your doctor may adjust your dose to one buccal dispersible tablet of 30 mg per day.

Zollinger-Ellison syndrome:The usual initial dose is two buccal dispersible tablets of 30 mg per day; subsequently, your doctor will decide the best dose for you based on your response to treatment with Monolitum Flas.

Use in children and adolescents

Monolitum Flas should not be administered to children and adolescents.

If you take more Monolitum Flas than you should

If you take more Monolitum Flas than indicated, consult your doctor immediately or contact the Toxicology Information Service, phone 915 620 420 immediately.

If you forget to take Monolitum Flas

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 buccal dispersible tablets as usual. Do not take a double dose to compensate for the missed dose.

If you interrupt treatment with Monolitum Flas

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 medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Frequent side effects.

They may affect up to 1 in 10 people.

• headache, dizziness
• diarrhea, constipation, stomach pain, nausea and vomiting, flatulence, dryness or pain in the mouth or throat
• skin rash, itching
• changes in liver function test values
• fatigue
• benign polyps in the stomach

Less frequent side effects.

They may affect up to 1 in 100 people.

• depression
• joint or muscle pain
• fluid retention or swelling
• changes in blood cell count
• increased risk of hip, wrist, and spinal fractures

Rare side effects.

They may affect up to 1 in 1,000 people.

• 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, bruises, redness, and excessive sweating
• light sensitivity
• hair loss
• tingling sensation (paresthesia), tremors
• anemia (pallor)
• kidney problems
• pancreatitis
• inflammation of the liver (may manifest as yellowish skin or eyes)
• swelling of the chest in men, 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.

Very rare side effects.

They may affect up to 1 in 10,000 people.

• 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, Monolitum Flas 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 throat, pharynx, or mouth pain or urinary problems, consult your doctor immediately. A blood test will be performed to check for possible reduction in white blood cells (agranulocytosis).

Frequency not known:

• If you have been taking Monolitum Flas for more than three months, it is possible that the levels of magnesium in the blood may decrease. Low magnesium levels may cause fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, and increased heart rate. If you notice any of these symptoms, inform your doctor immediately. Low magnesium levels may also lead to a decrease in potassium or calcium levels in the blood. Your doctor will likely request regular blood tests to monitor magnesium levels.
• skin rash, possibly with joint pain
• visual hallucinations

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 prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance 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.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the blister pack and the box 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 the containers and medications you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the containers and medications you no longer need. In this way, you will help protect the environment.

Composition of Monolitum Flas

• The active ingredient is lansoprazol.
• The other components (excipients) are sucrose, cornstarch, magnesium carbonate, hypromellose; Polysorbate 80, polyethylene glycol 6000, triethyl citrate, talc copolymer of methacrylic acid and ethyl acrylate, copolymer of methyl acrylate, methacrylic acid, and ethyl acrylate, microcrystalline cellulose, hydroxypropyl cellulose, sodium saccharin, mannitol, tropical flavor (contains cornstarch maltodextrin (releases glucose), gum arabic (E-414), and propylene glycol (E-1520), maleic acid, and magnesium stearate).

Appearance of the product and content of the packaging

Monolitum Flas is presented in the form of buccal dispersible tablets of a grayish-white color containing microgranules.

Each package contains 28 or 56 buccal dispersible tablets.

Holder of the marketing authorization and responsible for manufacturing

Laboratorios Salvat, S.A.

C/Gall 30-36 - 08950

Esplugues de Llobregat

Barcelona - Spain

Last review date of this leaflet:November 2022

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)

http://www.aemps.gob.es/