Package Insert: Information for the Patient

Lansoprazol Aristo 15 mg Hard Gastroresistant Capsules EFG

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 should not be given to others, even 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 is Lansoprazol Aristo and what is it used for

2.What you need to know before starting to take Lansoprazol Aristo

3.How to take Lansoprazol Aristo

4.Possible adverse effects

5.Storage of Lansoprazol Aristo

6.Contents of the package and additional information

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

Your doctor may prescribe lansoprazole for the following indications in adults:

• Treatment of duodenal and gastric ulcers.
• Treatment of inflammation of the esophagus (gastroesophageal reflux esophagitis).
• Prevention of gastroesophageal 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 prescribed lansoprazole for another indication or a different dose than indicated in this leaflet. Follow exactly the administration instructions for this medication as indicated by your doctor

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

Do not take Lansoprazol Aristo

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

Warnings and precautions

Inform your doctor if you have a serious 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 a malignant disease.

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

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

The fact of taking a proton pump inhibitor such as lansoprazole, 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 (reduced bone density) or if your doctor has told you that you are at risk of developing osteoporosis (for example, if you are taking steroids).

If you have been taking Lansoprazol Aristo for a long time (more than 1 year), your doctor will probably perform regular checks. At your doctor's visits, you must inform them of any new or abnormal symptoms and circumstances.

Consult your doctor before starting to take this medication:

• If you have reduced vitamin B12 reserves or risk factors for it and receive long-term treatment with lansoprazole. Like all medications that reduce the amount of acid, lansoprazole may reduce vitamin B12 absorption.
• If you are scheduled to undergo a specific blood test (chromogranin A).
• If you have ever had a skin reaction after treatment with a similar medication to lansoprazole to reduce stomach acidity.
• 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 treatment with lansoprazole.

Remember to mention any other symptoms you may notice, such as joint pain

• Cases of severe skin reactions have been reported in relation to treatment with Lansoprazol Aristo (Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS)). Stop using lansoprazole and call your doctor immediately if you report any of the symptoms related to severe skin reactions described in section 4.
• When taking lansoprazole, inflammation in the kidneys may occur. The signs and symptoms may include decreased urine volume or blood in the urine and/or hypersensitivity reactions such as fever, hives, and joint stiffness. You should inform your doctor of such signs.

Use of Lansoprazol Aristo with other medications

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 or pharmacist if you are using medications that contain any of the following active ingredients, as lansoprazole may affect their mode of action:

-Protease inhibitors for HIV such as atazanavir or 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 heartburn or acid regurgitation),

-sucralfate (used to heal ulcers),

-St. John's Wort (Hypericum perforatum) (used to treat mild depression).

Use of Lansoprazol Aristo with food and drinks

To get the best results from your medication, you should take lansoprazole at least 30 minutes before meals with a glass of water.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Driving and operating machinery

Patients taking lansoprazole 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 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 perform 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.

Lansoprazol Aristo contains saccharose

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

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

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

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

The dose of lansoprazole depends on your general condition. The normal doses of lansoprazole 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 capsule of 15 mg or 30 mg per day for 4 weeks. 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 normal 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 lansoprazole with 250–500 mg of clarithromycin and 1,000 mg of amoxicillin.

-30 mg of lansoprazole 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 forget any dose.

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 initial normal dose is two capsules of 30 mg per day; subsequently, your doctor will decide the best dose for you based on your response to lansoprazole treatment.

Use in children

Lansoprazole should not be administered to children.

If you take more lansoprazole than you should

If you take more lansoprazole than indicated, consult your doctor immediately or contact the Toxicology Information Service, phone 91 562 04 20 immediately.

If you forget to take lansoprazole

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 make up for the missed dose.

If you interrupt treatment with lansoprazole

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 medications,even this medication can produce side effects, although not everyone will experience them.

If you start to notice any of the following side effects, stop taking lansoprazol Aristo and contact your doctor immediately:

• round or target-shaped, slightly reddish patches on the trunk, often with blisters in the center, peeling, mouth ulcers, throat, nose, genital, and eye ulcers. These severe skin eruptions may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis)
• generalized rash, elevated body temperature, and lymphadenopathy (DRESS syndrome or drug hypersensitivity syndrome)

Frequent side effects (may affect up to 1 in 10 patients):

• 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 stomach polyps.

Less frequent side effects (may affect up to 1 in 100 patients):

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

Rare side effects (may affect up to 1 in 1,000 patients):

• 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, hematomas, redness, and excessive sweating,
• light sensitivity,
• hair loss,
• tingling sensation (paresthesia), tremors,
• anemia (pale skin),
• kidney problems,
• pancreatitis,
• inflammation of the liver (may manifest as yellow skin or eyes),
• chest swelling 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 swelling, difficulty swallowing, urticaria, and difficulty breathing.

Very rare side effects (may affect up to 1 in 10,000 patients):

• 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),
• inflammation of the intestine (colitis)
• 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, Lansoprazol Aristo may cause a reduction in white blood cell count, 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 local infection symptoms such as throat, pharynx, or mouth pain or urinary problems, consult your doctor immediately. A blood test will be performed to check for possible leukopenia (agranulocytosis).

Unknown frequency (cannot be estimated from available data):

• if you have been taking lansoprazol Aristo for more than three months, it is possible that magnesium levels 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 may request regular blood tests to monitor magnesium levels.
• low sodium levels in the blood. Common symptoms include nausea and vomiting, headache, drowsiness, and fatigue, confusion, muscle weakness or spasms, irritability, seizures, coma.
• skin rash, possibly with joint pain
• visual hallucinations

!

Reporting 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 leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicinal Products for Human Use:www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

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, the bottle label, and the box. The expiration date is the last day of the month indicated.

Blister pack:Do not store at a temperature above 30°C. Store in the original packaging to protect it from moisture.

Bottle:Do not store at a temperature above 30°C. Keep the bottle perfectly closed to protect it from moisture.

Medicines should not be disposed of through drains or in the trash. Dispose of the containers and medicines you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. By doing so, you will help protect the environment.

Composition of LansoprazolAristo

- The active ingredient is lansoprazol.

- The other components are:

Content of the capsules:sugar spheres (sucrose and cornstarch), sodium lauryl sulfate, meglumine, mannitol (E421), hypromellose, macrogol, talc, polysorbate 80, titanium dioxide (E171), dispersion at 30% of methacrylic acid copolymer and ethyl acrylate (1:1).

Capsule coating:gelatin, titanium dioxide (E171), quinoline yellow (E104).

Appearance of the product and content of the packaging

These gastro-resistant capsules are available in blister packs containing: 28 capsules, clinical packaging of 500 capsules. They are also available in bottles containing: 28 capsules.

Only some packaging sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Aristo Pharma Iberia, S.L.

C/Solana, 26

28850 Torrejón de Ardoz, Madrid

Spain

Responsible manufacturer

Laboratorios liconsa, S.A.

Avda. Miralcampo, Nº 7, Industrial Estate Miralcampo,

19200 Azuqueca de Henares (Guadalajara).

Spain

Last review date of this leaflet:February 2024.

The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/