Lansoprazole Pensa 15 mg gastro-resistant hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Lansoprazole pensa 15 mg gastro-resistant hard capsules EFG

Read the entire leaflet carefully before starting to take this medicine, as it contains important information for you.

- 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 any adverse effects, consult your doctor or pharmacist, even if the effects are not listed in this leaflet. See section 4.

Package 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 side effects

5. How to store Lansoprazol Pensa

6. Contents of the pack and other information

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

The active substance in Lansoprazole Pensa is lansoprazole, a proton pump inhibitor. Proton pump inhibitors reduce the amount of acid produced by the stomach.

Your doctor may prescribe Lansoprazole Pensa for the following indications in adults:

• Treatment of duodenal and gastric ulcers
• Treatment of inflammation of the oesophagus (reflux oesophagitis)
• Prevention of reflux oesophagitis
• 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 ongoing 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 Lansoprazole 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 starting to take Lansoprazol Pensa

Do not take Lansoprazol Pensa

• if you are allergic to lansoprazole or to any of the other ingredients 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 have performed or may perform 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 intended for the treatment of Helicobacter pylori infection (such as antibiotics) or together with anti-inflammatory drugs to treat pain or rheumatism, read carefully the package leaflets of these medicines as well.

• 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 perform regular check-ups. 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 could 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 volume of urine 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 capsules 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 deciding whether you are fit to drive vehicles or perform activities that require a high level of concentration. Due to its side effects or adverse reactions, the use of this medication may be one of the factors that reduces your ability to carry out such tasks safely.

Descriptions of these effects can be found in the following sections.

Please read 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 using this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

This medicine is administered orally.

Take the capsule whole with a glass of water. 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 have difficulty swallowing the capsule, your doctor will inform you of alternative ways to take the medicine.

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

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

The dose of Lansoprazole Pensa depends on your general 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.

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 taken in the morning together with two different antibiotics, and one 30 mg capsule taken in the evening together with two different antibiotics. The usual treatment duration is 7 days.

The recommended antibiotic combinations are as follows:

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

If you are receiving anti-infective treatment for an ulcer, it is unlikely that the ulcer will 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 ongoing NSAID therapy: one 30 mg capsule daily for 4 weeks.

Prevention of duodenal or gastric ulcer in patients requiring ongoing 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 most appropriate 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 Toxicology Information Service at telephone number 91 562 04 20, stating the medicine and the amount ingested. It is recommended to bring the medicine 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 the time for your next dose is approaching. 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 symptoms have improved. Your condition may not be completely healed and may recur 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 cause adverse effects, although not everyone experiences them.

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

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

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
• altered taste, loss of appetite, inflammation of the tongue (glossitis)
• skin reactions such as burning or itching sensation under the skin, bruising, redness and excessive sweating
• sensitivity to light
• hair loss
• tingling sensation (paraesthesia), tremor
• anaemia (pallor)
• kidney problems
• pancreatitis
• inflammation of the liver (may present 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 throat, difficulty swallowing, urticaria, or 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, 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 local infection symptoms 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):

If you are taking Lansoprazole Pensa for more than three months, magnesium levels in the blood may decrease. Low magnesium levels can cause fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, and increased heart rate. If you experience any of these symptoms, seek medical attention 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 your 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).

Skin rash, possibly with joint pain.

Visual hallucinations.

If you consider any of the adverse effects you experience to be severe or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

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 Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Lansoprazole Pensa

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging after Exp. The expiry date is the last day of the month indicated.

Do not store above 25°C. Store in the original container.

Medicines must 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 dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Lansoprazol Pensa

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

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

Nature of the product and contents of the pack

Lansoprazol Pensa are hard, gastro-resistant capsules, opaque white in color, containing gastro-resistant coated pellets.

Lansoprazol Pensa 15 mg is available in blister packs containing 28 or 56 capsules, 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 review of this leaflet: November 2022

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