LANSOPRAZOL QUALIGEN 15 mg GASTRO-RESISTANT CAPSULES

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Lansoprazole Qualigen 15 mg hard gastro-resistant capsules EFG

Read all of this leaflet carefully before you start taking this medicine.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you, do not pass it on to others, it may harm them, even if their symptoms are the same as yours.

If you experience any serious side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Contents of the pack and other information:

1. What is Lansoprazole Qualigen and what is it used for
2. What you need to know before you take Lansoprazole Qualigen
3. How to take Lansoprazole Qualigen
4. Possible side effects
5. Storing Lansoprazole Qualigen
6. Contents of the pack and further information

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

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

Your doctor may prescribe lansoprazole for the following indications:

• 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 the bacteria 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 for another indication or at a different dose than indicated in this leaflet. Follow your doctor's instructions regarding the administration of the medicine.

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

Do not take Lansoprazole Qualigen

• if you are allergic (hypersensitive) to lansoprazole or any of the other ingredients of this medicine (listed in section 6).
• if you are taking another medicine containing the active substance atazanavir (used to treat HIV).

Warnings and precautions

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

• 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 cancer.

• In case you experience diarrhea during treatment with lansoprazole, contact your doctor immediately, as lansoprazole has been associated with a slight increase in infectious diarrhea.

• If your doctor has prescribed lansoprazole in addition to other medicines intended for the treatment of Helicobacter pyloriinfection (antibiotics) or together with anti-inflammatory drugs to treat pain or rheumatism, also read the package leaflets of these medicines carefully.

• If you have been taking lansoprazole for a long time (more than 1 year), your doctor will probably have you checked regularly. During your visits to the doctor, you should inform him of any new or abnormal symptoms and circumstances.

• If you are taking proton pump inhibitors like Lansoprazole Qualigen, especially for a period of more than one year, you may have a slightly increased risk of hip, wrist, and spine fractures. Inform your doctor if you have osteoporosis or if you are taking corticosteroids (which can increase the risk of osteoporosis).

• If you have ever had a skin reaction after treatment with a medicine similar to lansoprazole to reduce stomach acidity.

• A specific blood test (Chromogranin A) is planned

• If you experience 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. Remember to mention any other symptoms you may notice, such as joint pain.

• When taking lansoprazole, kidney inflammation may occur. The signs and symptoms can include decreased urine output or the presence of blood in the urine and/or hypersensitivity reactions such as fever, rash, and joint stiffness. You should inform your doctor of these signs.

Other medicines and Lansoprazole Qualigen

Tell your doctor or pharmacist if you are using or have recently used other medicines, including those obtained without a prescription.

In particular, tell your doctor if you are using medicines that contain any of the following active substances, as lansoprazole may affect their mode of action:

• ketoconazole, itraconazole, rifampicin (used to treat infections)
• digoxin (used to treat heart problems)
• 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 Qualigen with food and drinks

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

Pregnancy and breastfeeding

Consult your doctor or pharmacist before taking this medicine.

Driving and using machines

Lansoprazole Qualigen is unlikely to affect your ability to drive or use tools or machines. Side effects such as dizziness and visual disturbances (see section 4) may occur. If they do, you should not drive or use machines.

This medicine contains sucrose and sodium

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

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; this is essentially "sodium-free".

3. How to take Lansoprazole Qualigen

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

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. You should 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 once a day, try to take it always at the same time. You may get better results if you take lansoprazole in the morning.

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

The dose of lansoprazole depends on your general condition. The normal doses of lansoprazole 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 normal 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 treatment is usually daily for 7 days.

The recommended antibiotic combinations are as follows:

• 30 mg of Lansoprazole Qualigen with 250-500 mg of clarithromycin and 1000 mg of amoxicillin
• 30 mg of Lansoprazole Qualigen 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 ulcers in patients who require continuous treatment with NSAIDs:one 30 mg capsule per day for 4 weeks.

Prevention of duodenal or gastric ulcers 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 normal dose is two 30 mg capsules per day; subsequently, based on your response to treatment with lansoprazole, the doctor will decide the best dose for you.

Use in children

Lansoprazole should not be administered to children.

If you take more Lansoprazole Qualigen than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Lansoprazole Qualigen

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 dose.

If you stop taking Lansoprazole Qualigen

Do not stop treatment prematurely 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 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, this medicine can cause side effects, although not everybody gets them.

Common (occur in more than 1 in 100 patients):

• 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 polyps in the stomach

Uncommon (occur in less than 1 in 100 patients):

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

Rare (occur in less than 1 in 1,000 patients):

• fever
• restlessness, drowsiness, confusion, hallucinations, insomnia, visual disturbances, vertigo
• taste disturbance, loss of appetite, tongue inflammation (glossitis)
• skin reactions such as 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, urticaria, and difficulty breathing.

Very rare (occur in less than 1 in 10,000 patients):

• 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
• very severe skin reactions with redness, blisters, severe inflammation, and skin loss
• in very rare cases, lansoprazole 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. A blood test will be performed 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.
• Visual hallucinations
• If you are taking lansoprazole 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.

Reporting of side effects:

If you experience any side effects, talk to your doctor or pharmacist, even if they are 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 help provide more information on the safety of this medicine.

5. Storing Lansoprazole Qualigen

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

Store below 30°C.

Do not use lansoprazole after the expiration date stated on the packaging, after the expiration date abbreviation. The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE collection point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and further information

Composition of Lansoprazole Qualigen 15 mg

The active substance is lansoprazole.

The other ingredients are: sugar spheres (sucrose and corn starch), sodium starch glycolate, sodium lauryl sulfate, povidone (E-1201), disodium phosphate, hypromellose (E-464), methacrylic acid and ethyl acrylate copolymer, triethyl citrate, titanium dioxide (E-171), talc (E-553b).

The ingredients of the capsule are: gelatin, titanium dioxide (E-171).

The ingredients of the ink are: shellac (E-904), anhydrous ethyl alcohol, isopropyl alcohol, propylene glycol (E-1520), n-butyl alcohol, ammonium hydroxide, potassium hydroxide, and black iron oxide (E-172).

Appearance of the product and contents of the pack

Lansoprazole Qualigen 15 mg is presented in the form of hard gastro-resistant capsules, white-beige in color. Each pack contains 28 capsules.

Marketing authorization holder and manufacturer

The marketing authorization holder is:

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

08970 Sant Joan Despí

Barcelona – Spain

The manufacturer is:

Teva Pharma, S.L.U.

Polígono Malpica c/C 4.

50016 (Zaragoza)

Spain

Date of the last revision of this leaflet:November 2022

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