LANSOPRAZOL FLAS QUALIGEN 15 mg ORALLY DISINTEGRATING TABLETS

Introduction

Package Leaflet: Information for the User

Lansoprazole Flas Qualigen 15 mg Oral Dispersible Tablets

Read all of this leaflet carefully before you start taking this medicine, because it contains important information for you.

• 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 only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

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

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

The active substance 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 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 may be that your doctor has prescribed Lansoprazole Flas Qualigen 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. Before taking Lansoprazole Flas Qualigen

Do not take Lansoprazole Flas Qualigen:

• If you are allergic to lansoprazole or any of the other ingredients of this medicine (listed in section 6).
• If you are taking another medicine whose active substance 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 medicine similar to lansoprazole to reduce stomach acid.
• A specific blood test (Chromogranin A) is scheduled
• 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 lansoprazol. Remember to mention any other symptoms you may notice, such as joint pain.

Tell your doctor if you have a serious liver disease. The doctor may need to adjust the dose.

Your doctor may have performed or scheduled 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 Lansoprazole Flas Qualigen 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 are taking proton pump inhibitors like Lansoprazol 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 Lansoprazol Flas Qualigen for a long time (more than 1 year), your doctor will probably have regular check-ups. During visits to your doctor, you should report 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 report these signs to your doctor.

Other medicines and Lansoprazole Flas 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 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 medicine, you should take Lansoprazole Flas Qualigen at least 30 minutes before meals.

Pregnancy and breastfeeding

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

Lansoprazole 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 this happens, do not drive or use machines.

This medicine contains

If your doctor has told you that you have an intolerance to some sugars, consult with them before taking this medicine. It may cause cavities.

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

3. How to take Lansoprazole Flas Qualigen

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

To remove the tablet properly, it is recommended:

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

Place the tablet on the 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 through a syringe, in case you have serious difficulties swallowing.

Follow the instructions below in case of administration through 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 15 mg tablet and a 10 ml syringe for the 30 mg tablet).
• Place the tablet in the reservoir.
• Put the plunger back 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 let 1 ml of air in.

• Gently shake the syringe for 10-20 seconds until the tablet is dispersed.
• The contents can be emptied directly into the mouth.
• Refill the syringe with 2-5 ml of water to remove any remaining contents from the syringe and empty 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 usual doses of Lansoprazole Flas Qualigen 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 oral dispersible 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 oral dispersible tablet per day for 2 weeks.

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

Treatment of esophagus inflammation (reflux esophagitis):one 30 mg oral dispersible tablet per day for 4 weeks.

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

Treatment of Helicobacter pyloriinfection:The usual dose is one 30 mg oral dispersible tablet together with two different antibiotics in the morning and one 30 mg oral dispersible tablet 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 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 successfully treated. To get the best results from your medicine, take it at the right time and do not miss any doses.

Treatment of duodenal or gastric ulcers in patients who require continuous treatment with NSAIDs:one 30 mg oral dispersible tablet per day for 4 weeks.

Prevention of duodenal or gastric ulcers in patients who require continuous treatment with NSAIDs:one 15 mg oral dispersible tablet per day; your doctor may adjust the dose to one 30 mg oral dispersible tablet per day.

Zollinger-Ellison syndrome:The initial usual dose is two 30 mg oral dispersible tablets per day; subsequently, based on your response to treatment with Lansoprazole Flas Qualigen, the doctor will decide on 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 you should, consult your doctor immediately or call the Toxicology Information Service. Phone 915 620 420.

If you forget to take Lansoprazole Flas Qualigen

If you forget to take 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 oral dispersible 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 medicines, this medicine can cause side effects, although not everybody 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
• 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 swelling of the face, tongue, or pharynx, 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 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.
• 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, 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 of side effects:

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects 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. Storage of Lansoprazole Flas Qualigen

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

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

Medicines should not be disposed of via wastewater or household waste. Return the containers and medicines you no longer need to the pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

Composition of Lansoprazole Flas Qualigen

The active substance is lansoprazole.

The other ingredients 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, methyl methacrylate, and methacrylic acid, 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 contents of the pack

White-gray oral dispersible tablets containing microgranules.

Each pack contains 28 or 56 oral dispersible tablets.

Not all pack 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 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/