Package Insert: Information for the User

Monolitum 30 mg Hard Gastroresistant Capsules EFG

Lansoprazole

Read this package insert carefully before starting to take this medication, as 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 prescribed only for you, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.

• Ifyou experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

6. Contents of the pack and additional information

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

Your doctor may prescribe Monolitum for the following indications:

-Treatment of duodenal and gastric ulcers

-Treatment of esophagitis caused by acid reflux

-Prevention of acid reflux esophagitis

-Treatment of stomach burning and acid regurgitation

-Treatment of infections caused by the bacteriaHelicobacter pylori, in combination with antibiotics

-Treatment or prevention of duodenal or gastric ulcers in patients requiring continuous treatment with nonsteroidal anti-inflammatory drugs (NSAIDs) (NSAID treatment is used for pain or inflammation)

-Treatment of Zollinger-Ellison syndrome

Your doctor may have prescribedMonolitumfor 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 components 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 inflammation in the kidneys. Signs and symptoms 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 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 with Monolitum, contact your doctor immediately, as Monolitum has been associated with a slight increase in infectious diarrhea.

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

The fact of taking a proton pump inhibitor like Monolitum, especially for a period exceeding 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 taking Monolitum for a long time (over 1 year), your doctor will likely perform regular checks. During your doctor's visits, you should 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, take Monolitum at 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 machinery

Patients taking Monolitum may experience occasional 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 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.

Read the descriptions of these effects in the following sections.

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.

Take the entire capsule 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 capsules or the contents of an empty capsule, as this will make them not work properly.

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

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

The dose of Monolitum depends on your general condition. The recommended doses of Monolitum for adults are indicated below. In some cases, your doctor may prescribe a different dose and indicate 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 recommended 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 Monolitum with 250–500 mg of clarithromycin and 1,000 mg of amoxicillin
• 30 mg of Monolitum 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 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 recommended initial dose is two capsules of 30 mg per day; subsequently, your doctor will decide on the best dose for you based on your response to treatment with Monolitum.

Use in children:

Monolitum should not be administered to children.

If you take moreMonolitum than you should

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

If you forget to take Monolitum

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 compensate for the missed dose.

If you interrupt treatment with Monolitum

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, hematomas, 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, tongue, or throat swelling, 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, lansoprazole may cause a reduction in the number of white blood cells, which may lead to 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. 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 probably ask you to have 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 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.

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

Do not store at a temperature above 30°C.

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.

Unused medications should not be disposed of through drains or in the trash. Deposit empty containers and unused medications at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of empty containers and unused medications. By doing so, you will help protect the environment.

Composition of Monolitum

• The active ingredient is lansoprazol.
• The other components (excipients) are: sugar spheres (sacarosa and cornstarch), magnesium carbonate, hypromellose, polisorbate 80, macrogol 6000, triethyl citrate, talc, titanium dioxide (E-171), copolymer of methacrylic acid and ethyl acrylate and sodium hydroxide. The gelatin capsule is composed of: titanium dioxide (E-171), erythrosine, iron oxide red, and gelatin.

Appearance of the product and content of the packaging

Monolitum 15 mg hard-gastrorresistant capsules are presented in the form of hard-gastrorresistant capsules, which contain spherical gastrorresistant granules of lansoprazol, in packs of 28 and 56 capsules.

Only some sizes of packs may be commercially available.

Holder of the marketing authorization

Laboratorios Salvat, S.A.

C/ Gall, 30-36 - 08950

08950 Esplugues de Llobregat

Barcelona - Spain

Responsible for manufacturing

Laboratorios Salvat, S.A.

C/Gall, 30-36 – 08950

Esplugues de Llobregat

Barcelona – Spain

or

PHARMALOOP, S.L.

C/Bolivia, 15 – Polig.Industrial Azque

28806 Alcalá de Henares,

Madrid – 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/