PATIENT INFORMATION LEAFLET

Lansoprazol Qualigen 30 mg Hard Gastrorresistant Capsules EFG

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

2.What you need to know beforestartingtotake Lansoprazol Qualigen 30 mg

3. How to take Lansoprazol Qualigen

4. Possible side effects

5. Storage of Lansoprazol Qualigen

6.Contents of the pack and additional information

The active ingredient of Lansoprazol Qualigen is lansoprazol, a proton pump inhibitor. Proton pump inhibitors reduce the amount of acid produced by the stomach.

Your doctor may prescribe lansoprazol for the following indications:

• Treatment of duodenal and gastric ulcers
• Treatment of esophagus inflammation (acid reflux esophagitis)
• Prevention of acid reflux esophagitis
• Treatment of stomach burning 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 requiring

continuous treatment with nonsteroidal anti-inflammatory drugs (NSAIDs) (NSAID treatment is used for pain or inflammation)

• Treatment of Zollinger-Ellison syndrome

Your doctor may have prescribed lansoprazol for another indication or a different dose than indicated in this leaflet. Follow your doctor's instructions for taking the medication.

Do not take Lansoprazol Qualigen

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

- if you are taking another medicine whose active ingredient is atazanavir (used in the treatment of HIV)

Warnings and precautionsConsult your doctor or pharmacist before starting to take Lansoprazol Qualigen:

- If you have a serious liver disease. Your doctor may need to adjust the dose.

• Your doctor may perform or have performed a supplementary test called endoscopy to diagnose your condition and/or rule out cancer.

• If 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 for the treatment of Helicobacter pylori infection (antibiotics) or together with anti-inflammatory drugs to treat pain or rheumatism, read also carefully the leaflets of these medicines.

• If you have been taking lansoprazole for a long time (over 1 year), your doctor will probably make regular checks. At your doctor's visits, you must inform him of any new or abnormal symptoms and circumstances.

• If you are taking proton pump inhibitors such as Lansoprazol Qualigen, especially for a period of over one year, it may slightly increase the risk of hip, wrist, and spinal fractures. Inform your doctor if you have osteoporosis or if you are taking corticosteroids (they may increase the risk of osteoporosis).

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

• You are expected to undergo a specific blood test (Cromogranin A)

• If you suffer from a skin rash, especially in sun-exposed areas, 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, it may cause kidney inflammation. 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 must inform your doctor of these signs.

Other medicines and Lansoprazol Qualigen

Inform your doctor or pharmacist if you are using or have recently used other

medicines, including those purchased without a prescription.

Especially, inform your doctor if you are using medicines that contain any of the following active ingredients, 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 Lansoprazol 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 operating machinery

Lansoprazol Qualigen is unlikely to affect your ability to drive or use tools or machines. Adverse 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 saccharose and sodium

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

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

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

Swallow 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 medication. Do not crush or chew the capsules or the contents of an empty capsule, as this will make them not work properly.

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

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

The dose of lansoprazol depends on your general condition. The normal doses of lansoprazol for adults are indicated below. Occasionally, your doctor may prescribe a different dose and a different duration of treatment.

Treatment of heartburn and acid regurgitation:one capsule of 15 mg or 30 mg 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 capsule of 30 mg per day for 2 weeks.

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

Treatment of esophagitis due to reflux:one capsule of 30 mg per day for 4 weeks.

Long-term prevention of esophagitis due to reflux:one capsule of 15 mg per day; your doctor may adjust the dose to one capsule of 30 mg per day.

Treatment of Helicobacter pylori infection:The normal dose is one capsule of 30 mg with two different antibiotics in the morning and one capsule of 30 mg with two different antibiotics at night. The treatment, usually, will be daily for 7 days.

The recommended antibiotic combinations are as follows:

- 30 mg of Lansoprazol Qualigen with 250–500 mg of clarithromycin and 1,000 mg of amoxicillin

- 30 mg of Lansoprazol 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 recur if the infection is treated satisfactorily. To get the best results from your medication, take it at the right time anddo not forget any dose.

Treatment of duodenal or gastric ulcer in patients requiring continuous treatment with NSAIDs:one capsule of 30 mg per day for 4 weeks.

Prevention of duodenal or gastric ulcer in patients requiring continuous treatment with NSAIDs:one capsule of 15 mg per day; your doctor may adjust the dose to one capsule of 30 mg per day.

Zollinger-Ellison syndrome:The initial normal dose is two capsules of 30 mg per day;

subsequently, depending on your response to lansoprazol treatment, your doctor will decide on the best dose for you.

Use in children

Lansoprazol should not be administered to children.

If you take more Lansoprazol Qualigen than you should

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

If you forget to take Lansoprazol Qualigen

If you forget to take a dose, take it as soon as you remember, unless the time for the next dose is near.

In this case, skip the missed dose and take the capsules as usual. Do not take a double dose to compensate for the missed dose.

If you interrupt treatment with Lansoprazol Qualigen

Do not interrupt treatment before time because symptoms have improved. It is possible that your condition has not been fully cured and may recur if you do not complete all treatment.

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Frequent (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

Less frequent (occur in less than 1 in 100 patients):

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
• alteration of taste, loss of appetite, inflammation of the tongue (glossitis)
• skin reactions such as burning or itching sensation under the skin, bruises, redness and excessive sweating
• sensitivity to light
• hair loss
• tingling sensation (paresthesia), tremor
• anemia (pale skin)
• kidney problems
• pancreatitis
• inflammation of the liver (may manifest as yellowish skin or eyes)
• swelling of the chest in men, impotence
• candidiasis (fungal infection, may affect the skin or mucous membranes)
• angioedema; contact your doctor immediately if you experience symptoms of angioedema, such as facial swelling, tongue or throat swelling, difficulty swallowing, urticaria, and difficulty breathing.

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

• severe hypersensitivity reactions, including anaphylactic shock. Symptoms of hypersensitivity reactions may include fever, rash, swelling, and, in some cases, a drop in blood pressure
• inflammation of the mouth (stomatitis)
• colitis (inflammation of the intestine)
• changes in analytical values, such as sodium, cholesterol, and triglyceride levels
• very severe skin reactions with redness, vesicles, severe inflammation, and skin loss
• in very rare cases, lansoprazole may cause a reduction in the number of white blood cells, which may lead to a decrease in 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 possible reduction in white blood cells (agranulocytosis).

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

• skin rash, possibly with joint pain.
• visual hallucinations
• If you are taking lansoprazole for more than three months, it is possible that blood magnesium levels may decrease. Low magnesium levels can cause fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, increased heart rate. If you experience any of these symptoms, see your doctor immediately. Low magnesium levels can also cause a decrease in potassium and calcium levels in the blood. Your doctor may decide to perform periodic blood tests to monitor magnesium levels.

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 that does not appear in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

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

Store below 30°C.

Do not use lansoprazol after the expiration date that appears 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 through drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. In this way, you will help protect the environment.

Composition of Lansoprazol Qualigen 30 mg

The active ingredient is lansoprazol.

The other components are: sugar spheres (sucrose and cornstarch), sodium carboxymethylstarch from potato, sodium laurylsulfate, povidone (E-1201), tri-sodium phosphate, hypromellose (E-464), copolymer of methacrylic acid and ethyl acrylate, triethyl citrate, titanium dioxide (E-171), talc (E-553b).

The capsule components are: gelatin, titanium dioxide (E-171).

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

Appearance of the product and contents of the packaging

Lansoprazol Qualigen 30 mg is presented in the form of hard, gastro-resistant white-beige capsules. Each package contains 14 or 28 capsules.

Only some package sizes may be commercially available.

Holder of the marketing authorization and responsible manufacturer

The holder of the marketing authorization is:

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

08970 Sant Joan Despí

Barcelona – Spain

The responsible manufacturer is:

Teva Pharma, S.L.U.

Polígono Malpica c/C 4.

50016 (Zaragoza)

Spain

Last review date of this prospectus:November 2022

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