Package Insert: Information for the User

Lansoprazole Flas Qualigen 30 mg Buccal Tablets

Read this package insert carefully before starting to take the medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

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

Your doctor may prescribe Lansoprazol Flas Qualigen for the following indications:

• Treatment of duodenal and gastric ulcers
• Treatment of esophagitis caused by acid reflux
• Prevention of esophagitis caused by acid reflux
• 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) (NSAIDs are used for pain or inflammation)
• Treatment of Zollinger-Ellison syndrome

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

Do not take Lansoprazol Flas Qualigen:

• If you are allergic to lansoprazole or any of the other components of this medication (listed in section 6).
• If you are taking another medication whose active ingredient is atazanavir (used in the treatment of HIV).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Lansoprazol Flas Qualigen:

• If you have ever had a skin reaction after treatment with a similar medication to lansoprazole for reducing stomach acid.
• If you are scheduled to have a specific blood test (Cromogranina 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.

Inform your doctor if you have a severe liver disease. Your doctor may need to adjust the dose.

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

In case of experiencing diarrhea during treatment with Lansoprazol Flas Qualigen, contact your doctor immediately, as Lansoprazol Flas Qualigen has been associated with a slight increase in infectious diarrhea.

If your doctor has prescribed Lansoprazol Flas Qualigen in addition to other medications for the treatment of Helicobacter pylori infection (antibiotics) or together with anti-inflammatory medications to treat pain or rheumatism, read the leaflets of these medications carefully.

If you are taking proton pump inhibitors such as Lansoprazol Qualigen, especially for a period of more than 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 (which may increase the risk of osteoporosis).

If you have been taking Lansoprazol Flas Qualigen for a long time (over 1 year), your doctor will likely perform regular check-ups. During your doctor visits, you should inform them of any new or abnormal symptoms and circumstances.

When taking lansoprazole, kidney inflammation may occur. 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.

Other medications and Lansoprazol Flas Qualigen

Inform your doctor or pharmacist if you are using or have recently used other medications, including those purchased without a prescription.

Especially, inform your doctor if you are using medications containing any of the following active ingredients, as Lansoprazol Flas Qualigen may affect their 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 stomach burning or acid regurgitation)
• sucralfate (used to heal ulcers)
• St. John's Wort (Hypericum perforatum) (used to treat mild depression)

Taking Lansoprazol Flas Qualigen with food and drinks

To get the best results from your medication, take Lansoprazol Flas Qualigen at least 30 minutes before meals.

Pregnancy and breastfeeding

If you are pregnant, or think you may be pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medication.

Driving and operating machinery

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

This medication contains saccharose and sodium

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.It may cause tooth decay.

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

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor again.

To extract the tablet properly, it is recommended:

• Cut the blister along the marked line.
• Separate the two aluminum layers at the indicated place and extract the tablet.

Place the tablet on the tongue and let it dissolve slowly. The tablet dissolves quickly in the mouth, releasing some microgranules that must be swallowed without chewing with the help of a glass of water.

Your doctor may give you instructions to administer the tablet using a syringe, in case you have serious difficulties swallowing.

Follow the instructions below in case of administration using a syringe:

It is essential to check that the selected syringe is the appropriate one.

• Extract the plunger from the syringe (at least a 5 ml syringe for the 15 mg tablet and a 10 ml syringe for the 30 mg tablet).
• Place the tablet in the reservoir.
• Replace the plunger in the syringe.
• For the 15 mg tablet: fill the syringe with 4 ml of water.
• For the 30 mg tablet: fill the syringe with 10 ml of water.

Invert the syringe and pull the plunger to allow 1 ml of air to enter.

• Agitate the syringe gently for 10-20 seconds until the tablet has dispersed.
• The contents can be emptied directly into the mouth.
• Replace the syringe with 2-5 ml of water to eliminate any remaining residue and empty it into the mouth.

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

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

The dose of Lansoprazol Flas Qualigen depends on your general condition. The normal doses of Lansoprazol Flas Qualigen for adults are indicated below. In some cases, your doctor may prescribe a different dose and a different duration of treatment.

Treatment of heartburn and acid regurgitation:one buccal dispersible tablet 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 buccal dispersible tablet of 30 mg per day for 2 weeks.

Treatment of gastric ulcer:one buccal dispersible tablet of 30 mg per day for 4 weeks.

Treatment of esophagitis due to acid reflux:one buccal dispersible tablet of 30 mg per day for 4 weeks.

Long-term prevention of acid reflux esophagitis:one buccal dispersible tablet of 15 mg per day; your doctor may adjust your dose to one buccal dispersible tablet of 30 mg per day.

Treatment of Helicobacter pylori infection:The normal dose is one buccal dispersible tablet of 30 mg with two different antibiotics in the morning and one buccal dispersible tablet of 30 mg with two different antibiotics at night. The normal treatment duration is once a day for 7 days.

The recommended antibiotic combinations are as follows:

• 30 mg of Lansoprazol Flas Qualigen with 250-500 mg of clarithromycin and 1,000 mg of amoxicillin
• 30 mg of Lansoprazol Flas 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 miss any doses.

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

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

Zollinger-Ellison syndrome:The initial normal dose is two buccal dispersible tablets of 30 mg per day; subsequently, your doctor will decide the best dose for you based on your response to treatment with Lansoprazol Flas Qualigen.

Use in children:

Lansoprazol Flas Qualigen should not be administered to children.

If you take more Lansoprazol Flas Qualigen than you should:

If you take more Lansoprazol Flas Qualigen than indicated, consult your doctor immediately or call the Toxicological Information Service immediately. Phone 915 620 420.

If you forget to take Lansoprazol Flas 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 buccal dispersible tablets as usual. Do not take a double dose to compensate for the missed dose.

If you interrupt treatment with Lansoprazol Flas 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 the entire treatment.

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

Like all medicines, this medicine can have side effects, although not everyone will experience them.

Frequent side effects (occurring 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 stomach polyps

Rare side effects (occurring in less than 1 in 100 patients):

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

Very rare side effects (occurring 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, hematomas, redness and excessive sweating
• light sensitivity
• hair loss
• tingling sensation (paresthesia), tremor
• anemia (pallor)
• kidney problems
• pancreatitis
• inflammation of the liver (may manifest as yellowish skin or eyes)
• chest 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 facial swelling, tongue or throat swelling, difficulty swallowing, urticaria, and difficulty breathing.

Very rare side effects (occurring 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, decreased 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, Lansoprazol Flas Qualigen may cause a reduction in the number of white blood cells, which may lead to 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 possible reduction in white blood cells (agranulocytosis).

Unknown frequency (Cannot be estimated from available data):

• skin rash, possibly with joint pain.
• visual hallucinations
• If you are taking lansoprazol for more than three months, it is possible that magnesium levels in the blood 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 produce 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 side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side 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 side effects, you can contribute to providing more information on the safety of this medicine.

Keepthis medicationout of the sight and reach of children.

Do not use Lansoprazol Flas Qualigen after the expiration date that appears on the blister and the box. The expiration date is the last day of the month indicated.

Medicines should not be thrown down the drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection pointof 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 Flas Qualigen

The active ingredient is lansoprazol.

The other components are sucrose, cornstarch, magnesium carbonate (E-504i), hypromellose (E-464), polysorbate 80 (E-433), polyethylene glycol 6000, triethyl citrate, talc, methacrylic acid copolymer and ethyl acrylate copolymer, methyl methacrylate and methacrylic acid copolymer, microcrystalline cellulose (E-460i), hydroxypropyl cellulose (E-463), sodium saccharin (E-954ii), mannitol (E-421), tropical flavor, maleic acid (E-296), magnesium stearate (E-572).

Appearance of the product and contents of the packaging

White-grayish buccal tablets containing microgranules.

Each package contains 28 or 56 buccal tablets.

Only some package sizes may be commercially available.

Holder of the marketing authorization

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

08970 Sant Joan Despí

Barcelona – Spain

Responsible for manufacturing

Laboratorios SALVAT, S.A.

Gall 30 - 36

08950 Esplugues de Llobregat

(Barcelona)

Spain

Date of the last review of this leaflet:

November 2022

The 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/