LANSOPRAZOL STADA 15 mg HARD GASTRO-RESISTANT CAPSULES

Introduction

Package Leaflet: Information for the Patient

Lansoprazole Stada 15 mg Hard Gastric-Resistant Capsules EFG

Read the package leaflet carefully before starting to take this medicine because it contains important information for you.

• Keep this package leaflet, as 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the package leaflet:

1. What is Lansoprazole Stada and what is it used for

1. What you need to know before you take Lansoprazole Stada

1. How to take Lansoprazole Stada

1. Possible side effects

1. Storage of Lansoprazole Stada

1. Packaging contents and further information

1. What is Lansoprazole Stada and what is it used for

The active substance of Lansoprazole Stada 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 (reflux esophagitis)

• Prevention of reflux esophagitis

• 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

Your doctor may have prescribed lansoprazole for another indication or at a different dose than stated in this leaflet. Follow your doctor's instructions for taking this medicine exactly.

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

2. What you need to know before you take Lansoprazole Stada

Do not take Lansoprazole Stada:

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

• If you are taking another medicine whose active substance is atazanavir (used to treat HIV).

Warnings and precautions

Consult your doctor or pharmacist before starting to take lansoprazole.

Tell your doctor if you have a severe liver disease. The doctor may need to adjust the dose.

Your doctor may have performed or may perform an additional test called endoscopy to diagnose your disease and/or rule out cancer.

In case you experience 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 medicines intended for the treatment of Helicobacter pyloriinfection (antibiotics) or together with anti-inflammatory drugs to treat pain or rheumatism, also read the package leaflets of these medicines carefully.

If you have been taking lansoprazole for a long time (more than 1 year), your doctor will probably have regular check-ups. During visits to your doctor, you should report any new or abnormal symptoms and circumstances.

Consult your doctor before starting to take lansoprazole:

• If you have ever had a skin reaction after treatment with a medicine similar to lansoprazole to reduce stomach acid.

• If a specific blood test (Chromogranin A) is scheduled.

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

• If you experience 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. Remember to mention any other symptoms you may notice, such as joint pain.

• There have been reports of serious skin reactions in relation to treatment with lansoprazole [Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug rash with eosinophilia and systemic symptoms (DRESS)]. Stop using lansoprazole and call your doctor immediately if you experience any of the symptoms related to serious skin reactions described in section 4.

• When taking lansoprazole, kidney inflammation may occur. The 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 report these signs to your doctor.

Taking Lansoprazole Stada with other medicines

Tell your doctor or pharmacist that you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.

In particular, inform your doctor or pharmacist if you are using medicines that contain any of the following active substances, as lansoprazole may affect their mode of action:

• HIV protease inhibitors such as atazanavir and nelfinavir (used to treat HIV)
• 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)

Taking Lansoprazole Stada with food and drinks

To get the best results from your medicine, 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 are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

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 act with caution as your reaction ability may be reduced.

You are the only person 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 can 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 package leaflet carefully.

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

Lansoprazole Stada contains sucrose

If your doctor has told you that you have an intolerance to some sugars, consult him before taking this medicine.

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; this is essentially "sodium-free".

3. How to take Lansoprazole Stada

Follow your doctor's instructions for taking this medicine exactly. If you are in 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 other alternative ways to take the medicine. Do not crush or chew the capsules or the contents of an emptied 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 dose at night.

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

Treatment of heartburn and acid regurgitation:one 15 mg or 30 mg capsule per day for 4 weeks. 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 esophagus inflammation (reflux esophagitis):one 30 mg capsule per day for 4 weeks

Long-term prevention of reflux esophagitis: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 in the evening. The treatment will normally be daily for 7 days.

The recommended combinations of antibiotics are as follows:

• 30 mg of lansoprazole with 250 - 500 mg of clarithromycin and 1000 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 come back if the infection is treated successfully. 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 recommended starting dose is two 30 mg capsules per day; subsequently, based on your response to treatment with lansoprazole, the doctor will decide the best dose for you.

Use in children

Lansoprazole should not be administered to children.

If you take more Lansoprazole Stada than you should

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

If you forget to take Lansoprazole Stada

If you forget to take a dose, take it as soon as possible unless the time of 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 missed doses.

If you stop taking Lansoprazole Stada

Do not stop treatment prematurely because the symptoms have improved. It is possible that your condition has not been completely cured and may come back if you do not finish the entire treatment.

If you have any other questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, lansoprazole can cause side effects, although not everybody gets them.

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

• round or target-like red spots on the trunk, often with blisters in the center, scaling, ulcers in the mouth, throat, nose, genitals, and eyes. These serious skin rashes can be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• generalized rash, high body temperature, and swollen lymph nodes (DRESS or drug hypersensitivity syndrome).

Common 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

Uncommon side effects (may affect up to 1 in 100 people):

• depression

• joint or muscle pain

• fluid retention or swelling

• changes in blood cell count

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

• fever

• restlessness, drowsiness, confusion, hallucinations, insomnia, visual disturbances, vertigo

• altered taste, loss of appetite, tongue inflammation (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

• liver inflammation (may manifest as yellowing of the skin or eyes)

• breast swelling in males, impotence

• candidiasis (fungal infection, may 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.

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

• 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

• mouth inflammation (stomatitis)

• colitis (inflammation of the intestine)
• changes in analytical values, such as sodium, cholesterol, and triglyceride levels

• very serious skin reactions with redness, blisters, severe inflammation, and skin loss
• In very rare cases, lansoprazole may cause a reduction in the number of white blood cells, which can 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 a possible reduction in white blood cells (agranulocytosis).

Frequency not known (cannot be estimated from the available data):

• If you are taking lansoprazole for more than three months, it is possible that your blood magnesium levels may decrease. Low magnesium levels can cause fatigue, muscle contractions, disorientation, convulsions, dizziness, increased heart rate. If you experience any of these symptoms, go to the doctor immediately. Low magnesium levels can also lead to a decrease in blood potassium and calcium levels. 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 like lansoprazole, 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).
• Skin rash, possibly with joint pain.
• Visual hallucinations.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Lansoprazol Stada

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

Do not use this medicine after the expiration date that appears on the blister pack, label, and carton. The expiration date is the last day of the indicated month.

Blister pack: Do not store above 30°C. Store in the original package to protect from moisture.

Bottle: Do not store above 30°C. Keep the bottle tightly closed to protect from moisture.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medicines at the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package contents and additional information

Composition of Lansoprazol Stada

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

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

Coating of the capsules:gelatin, titanium dioxide (E171), quinoline yellow (E104)

Appearance of the product and package contents

These gastro-resistant capsules are available in blister packs, containing 28, 56, or 500 (clinical package) capsules.

They are also available in bottles, containing 28 capsules.

Only certain package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Laboratorio 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

Date of the last revision of this prospectus:June 2024

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