LANSOPRAZOL FLAS QUALIGEN 30 mg ORALLY DISINTEGRATING TABLETS

Introduction

Package Leaflet: Information for the User

Lansoprazole Flas Qualigen 30 mg Orally Disintegrating Tablets

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

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, 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 side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Lansoprazole Flas Qualigen and what is it used for
2. What you need to know before taking Lansoprazole Flas Qualigen
3. How to take Lansoprazole Flas Qualigen
4. Possible side effects
5. Storage of Lansoprazole Flas Qualigen
6. Package Contents and Additional Information

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

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

Your doctor may prescribe you Lansoprazole Flas Qualigen for the following indications:

• Treatment of duodenal and gastric ulcers
• Treatment of esophageal inflammation (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 you Lansoprazole Flas Qualigen for another indication or at a different dose than indicated in this package leaflet. Follow your doctor's instructions regarding the administration of the medication.

2. What you need to know before taking Lansoprazole Flas Qualigen

Do not take Lansoprazole 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 Lansoprazole Flas Qualigen:

• If you have ever had a skin reaction after treatment with a medication similar to lansoprazole to reduce stomach acidity.
• If you are scheduled to undergo a specific blood test (Chromogranin A)
• If you suffer from 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.

Inform your doctor if you have a severe liver disease. It is possible that the 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 Flas Qualigen, contact your doctor immediately, as Lansoprazole Flas Qualigen has been associated with a slight increase in infectious diarrhea.

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

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 been taking Lansoprazole Flas Qualigen for a long time (more than 1 year), your doctor will probably have you undergo regular check-ups. During your doctor's visits, you should inform them of any new or abnormal symptoms and circumstances.

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.

Other Medications and Lansoprazole Flas Qualigen

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

In particular, inform your doctor if you are using medications that contain any of the following active ingredients, as Lansoprazole Flas Qualigen 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 Flas Qualigen with Food and Drinks

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

Pregnancy and Breastfeeding

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

Driving and Using Machines

It is unlikely that Lansoprazole Flas Qualigen will 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 Medication Contains Sucrose 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; this is essentially "sodium-free".

3. How to Take Lansoprazole Flas Qualigen

Follow your doctor's or pharmacist's instructions for administering this medication exactly. In case of doubt, consult your doctor again.

To remove the tablet properly, it is recommended:

• Cut the blister pack along the indicated cutting line.
• Separate the two aluminum layers at the indicated place and remove the tablet.

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

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

Follow these instructions in case of administration via a syringe:

It is important that you check that the selected syringe is the appropriate one.

• Remove the plunger from the syringe (at least a 5 ml syringe for the 15mg tablet and a 10 ml syringe for the 30 mg tablet).
• Place the tablet in the reservoir.
• Put the plunger back into 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.

• Gently shake the syringe for 10-20 seconds until the tablet is dispersed.
• The contents can be poured directly into the mouth.
• Refill the syringe with 2-5 ml of water to remove any remaining contents from the syringe and pour it into the mouth.

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

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

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

Treatment of Heartburn and Acid Regurgitation:one 15 mg or 30 mg orally disintegrating tablet 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 orally disintegrating tablet per day for 2 weeks.

Treatment of Gastric Ulcer:one 30 mg orally disintegrating tablet per day for 4 weeks.

Treatment of Esophageal Inflammation (Reflux Esophagitis):one 30 mg orally disintegrating tablet per day for 4 weeks.

Long-term Prevention of Reflux Esophagitis:one 15 mg orally disintegrating tablet per day; your doctor may adjust the dose to one 30 mg orally disintegrating tablet per day.

Treatment of Helicobacter pyloriInfection:The normal dose is one 30 mg orally disintegrating tablet along with two different antibiotics in the morning and one 30 mg orally disintegrating tablet along with two different antibiotics at night. The normal treatment is once a day for 7 days.

The recommended antibiotic combinations are as follows:

• 30 mg of Lansoprazole Flas Qualigen with 250-500 mg of clarithromycin and 1000 mg of amoxicillin
• 30 mg of Lansoprazole 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 and do not miss any doses.

Treatment of Duodenal or Gastric Ulcer in Patients who Require Continuous Treatment with NSAIDs:one 30 mg orally disintegrating tablet per day for 4 weeks.

Prevention of Duodenal or Gastric Ulcer in Patients who Require Continuous Treatment with NSAIDs:one 15 mg orally disintegrating tablet per day; your doctor may adjust the dose to one 30 mg orally disintegrating tablet per day.

Zollinger-Ellison Syndrome:The initial normal dose is two 30 mg orally disintegrating tablets per day; subsequently, based on your response to treatment with Lansoprazole Flas Qualigen, the doctor will decide the best dose for you.

Use in Children

Lansoprazole Flas Qualigen should not be administered to children.

If You Take More Lansoprazole Flas Qualigen Than You Should

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

If You Miss a Dose of Lansoprazole Flas Qualigen

If you miss a dose, take it as soon as possible unless the time for the next dose is near. In this case, skip the missed dose and take the next orally disintegrating tablets as usual. Do not take a double dose to make up for the missed dose.

If You Stop Taking Lansoprazole Flas Qualigen

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 medications, this medication can have side effects, although not everyone gets them.

Common side effects (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 stomach polyps

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

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

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

• fever
• restlessness, drowsiness, confusion, hallucinations, insomnia, visual disturbances, dizziness
• altered taste, 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, hives, and difficulty breathing.

Very rare side effects (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, occasionally, 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 Flas Qualigen 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 undergo a blood test to check for a 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 your blood magnesium levels may decrease. Low magnesium levels can cause fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, increased heart rate. If you experience 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.

Reporting Side Effects:

If you experience any side effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use:

https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Lansoprazole Flas Qualigen

Keep this medication out of sight and reach of children.

Do not use Lansoprazole Flas Qualigen after the expiration date shown on the blister pack and carton. The expiration date is the last day of the month indicated.

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

6. Package Contents and Additional Information

Composition of Lansoprazole Flas Qualigen

The active ingredient is lansoprazole.

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 - ethyl acrylate copolymer, methacrylate copolymer, microcrystalline cellulose (E-460i), hydroxypropylcellulose (E-463), sodium saccharin (E-954ii), mannitol (E-421), tropical flavor, malic acid (E-296), magnesium stearate (E-572).

Appearance of the Product and Package Contents

White-gray orally disintegrating tablets containing microgranules.

Each package contains 28 or 56 orally disintegrating tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

08970 Sant Joan Despí

Barcelona – Spain

Manufacturer

Laboratorios SALVAT, S.A.

Gall 30 - 36

08950 Esplugues de Llobregat

(Barcelona)

Spain

Date of Last Revision of this Package Leaflet:

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/