LANSOPRAZOL PENSA 15 mg HARD GASTRORESISTENT CAPSULES

Introduction

Package Leaflet: Information for the User

Lansoprazole Pensa 15 mg Hard Gastro-Resistant Capsules EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

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• 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 pack and other information

1. What is Lansoprazole Pensa and what is it used for
2. What you need to know before you take Lansoprazole Pensa
3. How to take Lansoprazole Pensa
4. Possible side effects
5. Storing Lansoprazole Pensa

1. Contents of the pack and further information

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

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

Your doctor may prescribe you Lansoprazole 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 who require continuous treatment with non-steroidal anti-inflammatory drugs (NSAIDs) (NSAID treatment is used for pain or inflammation)
• Treatment of Zollinger-Ellison syndrome

It may be that your doctor has prescribed Lansoprazole Pensa for another indication or at a different dose than indicated in this leaflet. Follow your doctor's instructions regarding the taking of the medicine.

You should consult a doctor if you get worse or if you do not improve after 14 days.

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

Do not take Lansoprazole 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 a severe liver disease. Your doctor may need to adjust the dose.
• Your doctor may have performed or may perform a complementary test called endoscopy to diagnose your disease and/or rule out a 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 you Lansoprazole Pensa in addition to other medicines intended for the treatment of Helicobacter pyloriinfection (such as antibiotics) or together with anti-inflammatory drugs to treat pain or rheumatism, also read carefully the package leaflets of these medicines.

• If you suffer from osteoporosis or if you are taking corticosteroids (which may increase the risk of osteoporosis). Taking a proton pump inhibitor like Lansoprazole 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 if you 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 probably have you checked regularly. During your visits to your doctor, you should inform him of any new or abnormal symptoms or circumstances.
  • If you have reduced body stores of vitamin B12 or risk factors for this and receive long-term treatment with lansoprazole. Like all medicines that reduce acid, 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 to reduce stomach acidity.
  • If you get 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 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, 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 inform your doctor of these signs.

Using Lansoprazole Pensa with other medicines

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

In particular, tell your doctor if you are using medicines that contain any of the following active substances, as Lansoprazole Pensa 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 Pensa with food, drinks, and alcohol

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

Pregnancy, breast-feeding, and fertility

If you are pregnant or breast-feeding, 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 Pensa may occasionally experience side effects such as dizziness, vertigo, fatigue, and visual disturbances. If you experience any of these adverse effects, you should act with caution as your reaction ability may be reduced.

You are the only one 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 carry out these operations safely is the use of these medicines.

In the following sections, you will find descriptions of these effects.

Read carefully the information in this leaflet.

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

Important information about some of the ingredients of lansoprazole pensa

Lansoprazole Pensa contains sucrose and corn starch. If your doctor has told you that you have an intolerance to some sugars, consult with him before taking this medicine.

This medicine does not contain gluten.

3. How to take Lansoprazole Pensa

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

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 make them not work properly. If you have difficulty swallowing the capsule, your doctor will inform you of other alternative ways to take the medicine.

If you take Lansoprazole Pensa once a day, try to take it always at the same time. You may get 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 at night.

The dose of Lansoprazole Pensa depends on your general condition. The usual doses of Lansoprazole Pensa for adults are indicated below. Sometimes, your doctor may prescribe a different dose and indicate 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 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 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 at night. The usual treatment is once a day for 7 days.

The recommended antibiotic combinations are as follows:

• 30 mg of Lansoprazole Pensa with 250-500 mg of clarithromycin and 1000 mg of amoxicillin.
• 30 mg of Lansoprazole 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 come back if the infection is treated satisfactorily. 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 ulcer in patients who require continuous treatment with NSAIDs: one 30 mg capsule per day for 4 weeks.

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

Use in children

Lansoprazole Pensa should not be administered to children.

If you take more Lansoprazole Pensa than you should

If you have taken more Lansoprazole Pensa than you should, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount ingested. It is recommended to take the package and the package leaflet of the medicine 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 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 the missed doses.

If you stop taking Lansoprazole Pensa

Do not stop treatment early 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 all the treatment.

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

4. Possible side effects

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

Common (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

Uncommon (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
• taste disturbance, loss of appetite, tongue inflammation (glossitis)
• skin reactions such as a 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 be manifested by yellowing of the skin or eyes)
• breast swelling in males, impotence
• candidiasis (fungal infection, can affect the skin or mucous membranes)
• angioedema; contact your doctor immediately if you experience symptoms of angioedema, such as facial swelling, tongue or pharynx swelling, difficulty swallowing, hives, and difficulty breathing.

Very rare (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
• severe skin reactions with redness, blisters, severe inflammation, and skin loss
• in very rare cases, this medicine may cause a reduction in the number of white blood cells, which can cause 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. You will have a blood test to check for possible reduction of white blood cells (agranulocytosis).

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

If you are taking Lansoprazole Pensa for more than three months, it is possible that your blood magnesium levels may decrease. Low magnesium levels can cause fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, increased heart rate. If you have any of these symptoms, go to the doctor immediately. Low magnesium levels can also cause 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 like Lansoprazole Pensa, especially for a period of more than one year, you may have a slightly increased risk of hip, wrist, or vertebral fractures. 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 that any of the side effects you are suffering from is serious or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

Reporting of side effects

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

5. Storing Lansoprazole Pensa

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

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

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

Medicines should not be disposed of via wastewater or household waste. Place the packages and medicines you no longer need in the SIGRE collection point of the pharmacy. Ask your pharmacist how to dispose of packages and medicines you no longer need. This way, you will help protect the environment.

6. Container Content and Additional Information

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 methacrylic acid and ethyl acrylate copolymer (1:1) at 30%, triethyl citrate, sugar spheres (sucrose and corn starch).

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

Appearance of the Product and Container Content

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

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

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 Last Revision of this Prospectus: November 2022

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