Lansoprazole Pensa 30 mg gastro-resistant hard capsules EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Lansoprazole 30 mg gastro-resistant hard capsules EFG

Read the entire leaflet carefully before you start taking this medicine.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, since it could harm them.
• If you experience adverse effects, consult your doctor or pharmacist, even if these are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Lansoprazol Pensa is and what it is used for

2. What you need to know before taking Lansoprazol Pensa

3. How to take Lansoprazol Pensa

4. Possible adverse effects

5. How to store Lansoprazol Pensa

6. Contents of the pack and other information

1. What Lansoprazol Pensa is and what it is used for

The active substance in Lansoprazol Pensa is lansoprazole, 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 inflammation of the esophagus (reflux esophagitis)
• Prevention of reflux esophagitis
• Treatment of heartburn and acid regurgitation
• Treatment of infections caused by Helicobacter pylori, in combination with antibiotics
• Treatment or prevention of duodenal or gastric ulcers in patients requiring continuous treatment with non-steroidal anti-inflammatory drugs (NSAIDs) (NSAID therapy is used for pain or inflammation)
• Treatment of Zollinger-Ellison syndrome

Your doctor may have prescribed Lansoprazol Pensa for an indication or at a dosage different from that stated in this leaflet. Follow your doctor's instructions regarding how to take the medicine. You should consult a doctor if your condition worsens or does not improve after 14 days.

2. What you need to know before taking Lansoprazol Pensa

Do not take Lansoprazol Pensa

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Lansoprazole Pensa:

• If you have severe liver disease. Your doctor may need to adjust the dose.

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

• If you experience diarrhea during treatment with Lansoprazole Pensa. Contact your doctor immediately, as Lansoprazole Pensa has been associated with a slight increase in infectious diarrhea.

• If your doctor has prescribed Lansoprazole Pensa along with other medicines for the treatment of Helicobacter pylori infection (such as antibiotics) or together with anti-inflammatory drugs for pain or rheumatism, also read carefully the package leaflets of these medicines.

• If you have osteoporosis or are taking corticosteroids (which may increase the risk of osteoporosis). Taking a proton pump inhibitor such as Lansoprazole Pensa, especially for 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 Lansoprazole Pensa for a long time (more than 1 year), your doctor will likely monitor you regularly. During visits to your doctor, you should report any new or unusual symptoms or circumstances.
  • If you have reduced body stores of vitamin B12 or risk factors for this, and are receiving long-term treatment with lansoprazole. Like all medicines that reduce acid levels, lansoprazole may reduce the absorption of vitamin B12.
  • If you have ever had a skin reaction after treatment with a medicine similar to Lansoprazole Pensa used to reduce stomach acidity.
  • If you develop a skin rash, especially in areas of skin exposed to sunlight, consult your doctor as soon as possible, as it may be necessary to discontinue treatment with Lansoprazole Pensa. Remember to mention any other symptoms you may notice, such as joint pain.
  • If you are scheduled to have a specific blood test (chromogranin A).

When taking lansoprazole, inflammation of the kidney may occur. Signs and symptoms may include decreased urine volume or 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.

Use of Lansoprazole Pensa with other medicines

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

In particular, inform your doctor if you are taking medicines containing any of the following active substances, as Lansoprazole Pensa may affect their action:

• HIV protease inhibitors such as atazanavir and nelfinavir (used in the treatment of 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 Pensa with food, drinks, and alcohol

For optimal effectiveness of your medicine, Lansoprazole Pensa should be taken at least 30 minutes before meals.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you might be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and operating machinery

Patients taking Lansoprazole 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 capabilities may be impaired.

You are solely responsible for determining whether you are fit to drive vehicles or perform tasks requiring a high degree of concentration. Due to its effects or adverse reactions, the use of this medicine may be one of the factors that reduces your ability to safely carry out such activities.

Descriptions of these effects are provided in the following sections.

Please read the information in this leaflet carefully.

If you have any doubts, consult your doctor or pharmacist.

Important information about some of the components of lansoprazole pensa

Lansoprazole Pensa contains sucrose and maize starch. If your doctor has informed you of an intolerance to certain sugars, consult with him before taking this medicine.

This medicine does not contain gluten.

3. How to take Lansoprazole Pensa

Follow exactly the instructions for taking Lansoprazole Pensa as given by your doctor. If you have any doubts, consult your doctor or pharmacist.

This medicine is taken orally.

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 medicine. Do not crush or chew the capsules or the contents of an emptied capsule, as this will prevent the medicine from working properly.

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

If you take Lansoprazole Pensa twice a day, you should take the first dose in the morning and the second in the evening.

The dose of Lansoprazole Pensa depends on your overall condition. The usual doses of Lansoprazole Pensa for adults are listed below. Occasionally, your doctor may prescribe a different dose and indicate a different treatment duration.

Use in adults

Treatment of heartburn and acid regurgitation: one 15 mg or 30 mg capsule daily for 4 weeks. If symptoms persist, inform your doctor. If symptoms do not improve within 4 weeks, consult your doctor.

Treatment of duodenal ulcer: one 30 mg capsule daily for 2 weeks.

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

Treatment of inflammation of the oesophagus (reflux oesophagitis): one 30 mg capsule daily for 4 weeks.

Long-term prevention of reflux oesophagitis: one 15 mg capsule daily; your doctor may adjust the dose to one 30 mg capsule daily.

Treatment of Helicobacter pylori infection: the usual 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 usual treatment duration is once daily for 7 days.

The recommended antibiotic combinations are as follows:

• 30 mg Lansoprazole Pensa capsules with 250–500 mg clarithromycin and 1,000 mg amoxicillin.
• 30 mg Lansoprazole Pensa capsules with 250 mg clarithromycin and 400–500 mg metronidazole.

If you are receiving anti-infective treatment for an ulcer, the ulcer is unlikely to recur if the infection is successfully treated. To achieve the best results from your medicine, take it at the correct time and do not miss any doses.

Treatment of duodenal or gastric ulcer in patients requiring continuous NSAID therapy: one 30 mg capsule daily for 4 weeks.

Prevention of duodenal or gastric ulcer in patients requiring continuous NSAID therapy: one 15 mg capsule daily; your doctor may adjust the dose to one 30 mg capsule daily.

Zollinger-Ellison syndrome: the usual initial dose is two 30 mg capsules daily. Subsequently, depending on your response to treatment with Lansoprazole Pensa, your doctor will decide the best dose for you.

Use in children

Lansoprazole Pensa must not be given to children.

If you take more Lansoprazole Pensa than you should

If you have taken more Lansoprazole Pensa than you should, contact your doctor or pharmacist immediately, or call the Spanish Poison Information Service at 91 562 04 20, indicating the medicine and the amount ingested. It is recommended to bring the medicine's packaging and leaflet to the healthcare professional.

If you forget to take Lansoprazole Pensa

If you forget to take a dose, take it as soon as possible unless it is almost time for your next dose. In that case, skip the missed dose and take the next capsules at the usual time. Do not take a double dose to make up for a missed dose.

If you stop taking Lansoprazole Pensa

Do not stop treatment prematurely, even if your symptoms have improved. Your condition may not be completely healed, and symptoms may return if you do not complete the full course of treatment.

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

4. Possible adverse effects

Like all medicines, Lansoprazole Pensa may produce adverse effects, although not everyone experiences them.

Frequent (may affect up to 1 in 100 people):

• headache, dizziness
• diarrhoea, constipation, stomach pain, benign gastric polyps, nausea and vomiting, flatulence, dryness or pain in mouth or throat
• skin rash, itching
• changes in liver function test values
• fatigue

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

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

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

• fever
• restlessness, drowsiness, confusion, hallucinations, insomnia, visual disturbances, dizziness
• taste disturbances, loss of appetite, inflammation of the tongue (glossitis)
• skin reactions such as burning or itching sensation under the skin, bruising, redness, and excessive sweating
• light sensitivity
• hair loss
• tingling sensation (paraesthesia), tremor
• anaemia (pallor)
• kidney problems
• pancreatitis
• liver inflammation (may present as yellowing of the skin or eyes)
• breast swelling in males, impotence
• candidiasis (fungal infection, may affect skin or mucosa)
• angioedema; contact your doctor immediately if you experience symptoms of angioedema such as swelling of the face, tongue or pharynx, difficulty swallowing, hives, or breathing difficulties.

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

• severe hypersensitivity reactions, including anaphylactic shock. Symptoms of hypersensitivity may include fever, rash, swelling and, occasionally, a drop in blood pressure
• inflammation of the mouth (stomatitis)
• colitis (inflammation of the intestine)
• changes in laboratory values, such as levels of sodium, cholesterol and triglycerides
• severe skin reactions with redness, blisters, severe swelling and skin loss
• in very rare cases, this medicine may cause a reduction in the number of white blood cells, which may decrease your resistance to infections. If you develop an infection with symptoms such as fever and severe deterioration in your general condition, or fever with signs 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 (cannot be estimated from available data):

• Skin rash, possibly with joint pain.
• If you are taking Lansoprazole Pensa for more than three months, blood magnesium levels may decrease. Low magnesium levels may cause fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, and increased heart rate. If you experience any of these symptoms, seek medical advice immediately. Low magnesium levels may also lead to decreased levels of potassium and calcium in the blood. Your doctor may decide to perform periodic blood tests to monitor magnesium levels.
• If you are taking proton pump inhibitors such as Lansoprazole Pensa, especially for a period longer than one year, there may be a slight increase in the risk of fractures of the hip, wrist and spine. Inform your doctor if you have osteoporosis or if you are taking corticosteroids (which may increase the risk of osteoporosis).
• Visual hallucinations.

Reporting of adverse effects

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

5. Storage of Lansoprazol Pensa

Keep this medicine out of sight and reach of children.

Do not use Lansoprazol Pensa after the expiry date which is stated on the container after Exp. The expiry date refers to the last day of the month indicated.

Do not store above 25°C. Keep in the original packaging.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. Ask your pharmacist how to properly dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the container and additional information

Composition of Lansoprazol Pensa

• The active substance is lansoprazole. Each capsule contains 30 mg of lansoprazole.
• The other components (excipients) are: hypromellose (E-464), talc, titanium dioxide (E-171), copolymer of methacrylic acid and ethyl acrylate (1:1) dispersion at 30%, triethyl citrate, sugar spheres (sucrose and corn starch).

Components of the capsule shell: titanium dioxide (E-171), gelatin, purified water, and ink (shellac lacquer and black iron oxide (E-172)).

Appearance of the product and contents of the container

Lansoprazol Pensa gastro-resistant hard capsules are opaque white in color and contain gastro-resistant coated pellets.

Lansoprazol Pensa 30 mg is available in packs of 28 or 56 capsules in blister packs, and in bottles containing 28 capsules.

Marketing Authorization Holder

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Manufacturer

Towa Pharmaceutical Europe, S.L.

C/ de Sant Martí 75-97

08107 Martorelles (Barcelona)

Spain

Date of the most recent revision of this leaflet: November 2022

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/