Package Insert: Information for the User

Lansoprazole 15 mg Hard Gastroresistant Capsules EFG

Read the Entire 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 Adverse Effects, Consult Your Doctor or Pharmacist, Even If They Do Not Appear in This Package Insert. See Section 4.

6.Contents of the Package and Additional Information

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

Your doctor may prescribe Lansoprazol Pensa 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 byHelicobacter 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 Pensa 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 take Lansoprazol Pensa

• 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 Lansoprazol Pensa:

• If you have osteoporosis or are taking corticosteroids (which may increase the risk of osteoporosis). Taking a proton pump inhibitor like Lansoprazol Pensa, especially for a period of more than one year, may slightly increase the risk of hip, wrist, or vertebral fractures. Inform your doctor if you have osteoporosis or are taking corticosteroids (which may increase the risk of osteoporosis).
• • If you have been taking Lansoprazol Pensa for a long time (more than 1 year), your doctor will probably perform regular checks. During your doctor's visits, you must inform them of any new or abnormal symptoms and circumstances.
  • 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 have ever had a skin reaction after treatment with a similar medication to Lansoprazol Pensa to reduce 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 treatment with Lansoprazol Pensa. Remember to mention any other symptoms you may notice, such as joint pain.
  • If you are scheduled to undergo a specific blood test (Cromogranin A).

Taking lansoprazole 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 must inform your doctor of these signs.

Use of Lansoprazol Pensa with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Especially, inform your doctor if you are using medications that contain any of the following active ingredients, as Lansoprazol Pensa 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 heartburn or acid reflux)
• sucralfate (used to heal ulcers)
• St. John's Wort (Hypericum perforatum) (used to treat mild depression)

Taking Lansoprazol Pensa with food, drinks, and alcohol

To get the best results from your medication, you should take Lansoprazol Pensa capsules at least 30 minutes before meals.

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 Lansoprazol Pensa may occasionally experience side effects such as dizziness, vertigo, fatigue, and visual disturbances. If you experience any of these adverse 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 carry out these operations safely is the use of these 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.

Important information about some of the components of Lansoprazol Pensa

Lansoprazol Pensa contains sucrose and cornstarch. If your doctor has indicated that you have an intolerance to certain sugars, consult with them before taking this medication.

This medication does not contain gluten.

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

This medication is administered orally.

Take the entire capsule with a glass of water. Do not crush or chew the capsules or the contents of an empty capsule, as this will make them act inadequately. If you have difficulty swallowing the capsule, your doctor will inform you of alternative ways to take the medication.

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

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

The dose of Lansoprazol Pensa depends on your general condition. The normal doses of Lansoprazol Pensa 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 15 mg or 30 mg capsule 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 30 mg capsule per day for 2 weeks.

Treatment of gastric ulcer: one 30 mg capsule per day for 4 weeks.

Treatment of esophagitis due to acid reflux: one 30 mg capsule per day for 4 weeks.

Long-term prevention of acid reflux esophagitis: one 15 mg capsule per day; your doctor may adjust the dose to one 30 mg capsule per day.

Treatment of Helicobacter pylori infection

The normal dose is one 30 mg capsule with two different antibiotics in the morning and one 30 mg capsule with two different antibiotics at night. The normal treatment duration is once a day for 7 days.

The recommended antibiotic combinations are as follows:

• 30 mg of Lansoprazol Pensa with 250-500 mg of clarithromycin and 1,000 mg of amoxicillin.
• 30 mg of Lansoprazol Pensa 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 30 mg capsule per day for 4 weeks.

Prevention of duodenal or gastric ulcer in patients requiring 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 initial normal dose is two 30 mg capsules per day; subsequently, your doctor will decide on the best dose for you based on your response to Lansoprazol Pensa treatment.

Use in children

Lansoprazol Pensa should not be administered to children.

If you take more Lansoprazol Pensa than you should

If you have taken more Lansoprazol Pensa than you should, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount taken. It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

If you forget to take Lansoprazol Pensa

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 Lansoprazol Pensa

Do not interrupt 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 doubts about the use of this product, ask your doctor or pharmacist.

Like all medicines, Lansoprazol Pensa can cause side effects, although not everyone will experience them.

Frequent (may affect up to 1 in 100 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

Less frequent (may affect up to 1 in 100 people):

• depression
• joint or muscle pain
• fluid retention or swelling
• changes in blood cell count

Rare (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)
• reactions such as burning or itching sensation under the skin, bruises, redness and excessive sweating.
• sensitivity to light
• hair loss
• tingling sensation (paresthesia), tremors
• anemia (pale skin)
• kidney problems
• pancreatitis
• inflammation of the liver (may manifest as yellow 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 swelling, difficulty swallowing, urticaria and difficulty breathing.

Very rare (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
• severe skin reactions with redness, vesicles, severe inflammation, and skin loss
• in very rare cases, this medication 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 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 unknown (cannot be estimated from available data):

If you are taking Lansoprazol Pensa for more than three months, it is possible that blood magnesium levels may decrease. Low magnesium levels can 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 produce a decrease in blood potassium and calcium levels. Your doctor may decide to perform periodic blood tests to monitor magnesium levels.

If you are taking proton pump inhibitors such as Lansoprazol Pensa, especially for a period of more than one year, it 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 (they may increase the risk of osteoporosis).

skin rash, possibly with joint pain.

Visual hallucinations.

If you consider that any of the side effects you are experiencing is severe or if you notice any side effect not mentioned in this prospectus, inform your doctor or pharmacist.

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 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 packaging after "Cad." The expiration date is the last day of the month indicated.

Do not store at a temperature above25°C.Store in the original packaging.

Medications should not be disposed of through drains or in the trash. Deposit the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Lansoprazol Pensa

• The active ingredient is lansoprazol. Each capsule contains 15 mg of lansoprazol.
• The other components (excipients) are: hypromellose (E-464), talc, titanium dioxide (E-171), dispersion of the copolymer of acrylic acid and ethyl acrylate (1:1) at 30%, triethyl citrate, sugar spheres (sucrose and cornstarch).

The capsule components are: titanium dioxide (E-171), gelatin, purified water, and ink (shellac lacquer and iron oxide black (E-172)).

Appearance of the product and content of the packaging

Lansoprazol Pensa are hard, gastro-resistant capsules of white opaque color that contain pellets with gastro-resistant coating.

Lansoprazol Pensa 15 mg is presented in blister packs of 28 or 56 capsules, and in a bottle of 28 capsules.

Marketing Authorization Holder

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Responsible for manufacturing

Towa Pharmaceutical Europe, S.L.

C/ de Sant Martí 75-97

08107 Martorelles (Barcelona)

Spain

Last review date of this leaflet: November 2022

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