Package Insert: Information for the Patient

Lansoprazol Stada 15 mg Hard Gastrorresistant 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 doubts, 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 you need to know before starting to take Lansoprazol Stada

1. How to take Lansoprazol Stada

1. Possible adverse effects

1. Storage of Lansoprazol Stada

1. Contents of the package and additional information

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

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

• 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 lansoprazol for another indication or at 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 get worse or do not improve after 14 days.

Do not take Lansoprazol Stada:

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

• If you are taking another medication whose active ingredient is atazanavir (used in the treatment of HIV).

Warnings and precautions

Consult your doctor or pharmacist before starting to take lansoprazole.

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 cancer.

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 for these medications carefully.

If you have been taking lansoprazole for a long time (over 1 year), your doctor will likely perform regular check-ups. During your doctor visits, you should inform them of any new or abnormal symptoms.

Consult your doctor before starting to take lansoprazol:

• If you have ever had a skin reaction after treatment with a similar medication to lansoprazole for reducing stomach acid.

• If you are scheduled to have a specific blood test (Cromogranin A).

• If you have low levels of vitamin B12 or risk factors for it and receive treatment with these medications for a long period of time. Like all medications that reduce the amount of acid, lansoprazole may reduce vitamin B12 absorption.

• 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.

• Severe skin reactions have been reported in relation to lansoprazole treatment [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 experience any of the symptoms related to severe skin reactions described in section 4.

• When taking lansoprazole, it may cause kidney inflammation. 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. You should inform your doctor of these signs.

Taking Lansoprazol Stada with other medications

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

Especially, inform your doctoror pharmacistif 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 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)

Taking Lansoprazol Stada with food and drinks

To get the best results from your medication, you should take lansoprazole at least 30 minutes before mealswith 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 doctoror pharmacistbefore 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 their effects or adverse reactions, one of the factors that may reduce your ability to perform these operations safely is the use of medications.

In the following sections, you will find the descriptions of these side effects. Read the information in this leaflet carefully.

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

Lansoprazol Stada 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 tablet; it is essentially "sodium-free".

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

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 medication. Do not crush or chew the capsules or the contents of an empty capsule, as this will make them ineffective.

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

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

The dose of lansoprazol depends on your general condition. The recommended doses 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 acid reflux:one capsule of 30 mg per day for 4 weeks

Long-term prevention of acid reflux esophagitis: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 usual 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 lansoprazol with 250 - 500 mg of clarithromycin and 1,000 mg of amoxicillin
• 30 mg of lansoprazol 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 starting dose is two capsules of 30 mg per day; your doctor will then decide on the best dose for you based on your response to lansoprazol treatment.

Use in children

Lansoprazol should not be administered to children.

If you take more Lansoprazol Stada than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested. It is recommended to bring the package insert and the medication packaging to the healthcare professional.

If you forget to take Lansoprazol Stada

If you forget to take a dose, take it as soon as you remember, unless the time for the next dose is almost due. 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 Lansoprazol Stada

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, lansoprazol can cause side effects, although not everyone will experience them.

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

• round or target-shaped, slightly reddish patches on the trunk, often with blisters in the center, peeling, mouth, 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 exanthema, elevated body temperature, and lymphadenopathy (DRESS syndrome or drug hypersensitivity syndrome).

Frequent side effects (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 stomach polyps

• 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 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 under the skin, bruises, 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 people):

• severe hypersensitivity reactions, including anaphylactic shock. Symptoms of hypersensitivity reactions may include fever, rash, swelling, and, in some cases, decreased 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, lansoprazol 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 leukopenia (agranulocytosis).

Unknown frequency (cannot be estimated from available data):

• If you are taking lansoprazol 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, convulsions, dizziness, increased heart rate. If you experience any of these symptoms, see your doctor immediately. Low magnesium levels may also cause a decrease in potassium and calcium levels in the blood. Your doctor may decide to perform periodic 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, convulsions, coma.

• If you are taking proton pump inhibitors such as lansoprazol, especially for a period of more than one year, you may slightly increase the risk of hip, wrist, and spinal column fractures. Inform your doctor if you have osteoporosis or if you are taking corticosteroids (may increase the risk of osteoporosis).
• skin rash, possibly with joint pain.
• visual hallucinations.

Reporting side effects

If you experienceany 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 Medicinal Products for Human Use: https://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, bottle label, and 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.

Medications 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. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Lansoprazol Stada Composition

• The active ingredient is lansoprazol
• The other components are:

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

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

Product appearance and packaging contents

These gastro-resistant capsules are available in blister packaging, with 28, 56, or 500 (clinical packaging) capsules.

They are also available in a bottle, with 28 capsules.

Only some packaging sizes may be commercially available.

Marketing authorization holder and manufacturer

Marketing authorization holder

STADA, S.L.

Frederic Mompou, 5

08960- Sant Just Desvern

Barcelona - Spain

[email protected]

Manufacturer

Laboratorios Liconsa, S.A.

Avda. Miralcampo, Nº 7,

Polígono Industrial Miralcampo,

19200 Azuqueca de Henares, Guadalajara

Spain

Last review date of this leaflet:June 2024

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