LANSOPRAZOL PENSA 30 mg HARD GASTRORESISTENT CAPSULES

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 is possible 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 it worsens or does not improve after 14 days.

2. What you need to know before taking Lansoprazole Pensa

Do not take Lansoprazole Pensa

• if you are allergic to lansoprazole or 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 Lansoprazole Pensa in addition to other medications intended for the treatment of Helicobacter pyloriinfection (such as antibiotics) or together with anti-inflammatory medications to treat pain or rheumatism, also read the package leaflets of these medications carefully.

• If you suffer from osteoporosis or if you are taking corticosteroids (which can 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 suffer from osteoporosis or if you are taking corticosteroids (which can 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 regular check-ups with you. During visits to your doctor, you should inform them 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 can 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 at least 30 minutes before meals.

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 Pensa may occasionally experience side effects such as dizziness, drowsiness, fatigue, and visual disturbances. If you experience any of these side effects, you should act with caution as your ability to react may be reduced.

You are the only one responsible for deciding whether you are fit to drive 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 these medications.

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

Read the information in this leaflet carefully.

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

This medicine does not contain gluten.

3. How to take Lansoprazole Pensa

Follow the instructions for administration of Lansoprazole Pensa indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

This medicine is administered orally.

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 Pensa once a day, try to take it always at the same time. You can 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 dose 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.

Use in adults

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 inflammation of the esophagus (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 combinations of antibiotics are as follows:

• 30 mg of Lansoprazole Pensa 30 mg capsules with 250-500 mg of clarithromycin and 1000 mg of amoxicillin.
• 30 mg of Lansoprazole Pensa 30 mg capsules 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 medicine, take it at the right time and do not miss 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 initial usual dose is two 30 mg capsules per day. Subsequently, based on your response to treatment with Lansoprazole Pensa, the 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, telephone 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 missed doses.

If you stop taking Lansoprazole Pensa

Do not stop treatment prematurely because the symptoms have improved. It is possible that your condition has not been completely cured and may recur if you do not complete the entire 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, benign stomach polyps, nausea and vomiting, flatulence, dryness or pain in the 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 count

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

• fever
• restlessness, drowsiness, confusion, hallucinations, insomnia, visual disturbances, dizziness
• 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 a possible reduction in white blood cells (agranulocytosis).

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

• Skin rash, possibly with joint pain.
• 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, see your 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 can increase the risk of osteoporosis).
• 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 that are 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. Storing Lansoprazole Pensa

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

Do not use Lansoprazole Pensa after the expiry date 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. Deposit the packages and medicines that you no longer need in the SIGRE collection point of the pharmacy. Ask your pharmacist how to dispose of packages and medicines that 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 30 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))

Product Appearance and Container Content

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

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

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 Leaflet: November 2022

Detailed and updated 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/