Package Leaflet: Information for the User

Lansoprazol Flas Salvat 15 mgOral Dispersible Tablets

Lansoprazol

Read 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet (see section 4).

1. What isLansoprazol Flas Salvatand what it is used for

2. What you need to know before you start takingLansoprazol Flas Salvat

3. How to takeLansoprazol Flas Salvat

4. Possible side effects

5. Storage ofLansoprazol Flas Salvat

6. Contents of the pack and additional informationl

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

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

You should consult a doctor if you worsen or do not improve after 14 days.

Do not take Lansoprazol Flas Salvat:

• If you are allergic to lansoprazol or any of the other components of this medication (listed in section 6).

Warnings and precautions

Taking lansoprazol may cause inflammation in the kidneys. 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. Inform your doctor of these signs.

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 a malignant disease.

If you experience diarrhea during treatment with Lansoprazol Flas Salvat, contact your doctor immediately, as Lansoprazol Flas Salvat has been associated with a slight increase in infectious diarrhea.

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

The fact of taking a proton pump inhibitor such as Lansoprazol Flas Salvat, especially for a period of more than one year, 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 Salvat for a long time (more than 1 year), your doctor will likely perform regular check-ups. During your doctor's visits, inform them of any new or abnormal symptoms and circumstances.

Consult your doctor before starting to take Lansoprazol Flas:

• If you have reduced vitamin B12 reserves or risk factors for it and receive long-term treatment with lansoprazol. Like all medications that reduce acid production, lansoprazol may reduce vitamin B12 absorption.
• If you are scheduled to have a specific blood test (Cromogranina A).
• If you have ever had a skin reaction after treatment with a similar medication to Lansoprazol Flas for reducing stomach acid.
• 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 Lansoprazol Flas. Remember to mention any other symptoms you may notice, such as joint pain.

Taking Lansoprazol Flas Salvat with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Especially, inform your doctor if you are using medications containing any of the following active ingredients, as Lansoprazol Flas Salvat may affect their action:

• HIV protease inhibitors such as atazanavir and nelfinavir (used in HIV treatment)
• Methotrexate (used to treat autoimmune diseases and cancer)
• Ketoconazole, itraconazole, rifampicin (used to treat infections)
• Digoxin (used to treat heart problems)
• Warfarin (used to treat blood clots)
• 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 Salvat with food and drinks

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

Pregnancy, breastfeeding, and fertility

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

Driving and operating machinery

Patients taking Lansoprazol Flas Salvat may occasionally experience side effects such as dizziness, vertigo, fatigue, and visual disturbances. If you experience any of these side effects, you should exercise caution as your reaction time may be reduced.

You are the only one responsible for deciding whether you are fit to drive vehicles or perform activities that require a high level of concentration. Due to its effects or adverse reactions, one of the factors that may reduce your ability to carry out these operations safely is the use of medications.

In the following sections, you will find descriptions of these side effects.

Read this prospectus carefully.

If you have any doubts, ask your doctor, nurse, or pharmacist.

Lansoprazol Flas Salvat contains saccharose.

If your doctor has indicated that you have an intolerance to certain sugars, consult with them before taking this medication.

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

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.

You can also swallow the tablet whole with 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 oral administration using a syringe:

It is essential to 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.
• 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.
• Repeat the previous step if necessary.

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

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

The dose of Lansoprazol Flas Salvat depends on your general condition. The normal doses of Lansoprazol Flas Salvat 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 Salvat with 250-500 mg of clarithromycin and 1,000 mg of amoxicillin
• 30 mg of Lansoprazol Flas Salvat 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 Lansoprazol Flas Salvat treatment.

Use in children:

Lansoprazol Flas Salvat should not be administered to children.

If you take more Lansoprazol Flas Salvat than you should:

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

If you forget to take Lansoprazol Flas Salvat:

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 Salvat:

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 medication, ask your doctor or pharmacist.

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

The following side effects are frequent (may affect up to 1 in 10 people):

• 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

The following side effects are uncommon (may affect up to 1 in 100 people):

• depression
• joint or muscle pain
• fluid retention or swelling
• changes in blood cell count
• increased risk of hip, wrist, and spinal fracture

The following side effects are rare (may affect up to 1 in 1,000 people):

• 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)
• renal 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 mucosa)
• angioedema; contact your doctor immediately if you experience symptoms of angioedema, such as facial, tongue, or pharyngeal inflammation, difficulty swallowing, urticaria, and difficulty breathing.

The following side effects are very rare (may affect up to 1 in 10,000 people):

• 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 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 throat, pharynx, or mouth pain or urinary problems, consult your doctor immediately. A blood test will be performed to check for possible leukopenia (agranulocytosis).

Unknown frequency (cannot be estimated from available data):

• If you have been taking Lansoprazol Flas Salvat for more than three months, it is possible that magnesium levels in the blood may decrease. Low magnesium levels may cause fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, and increased heart rate. If you notice any of these symptoms, inform your doctor immediately. Low magnesium levels may also lead to a decrease in potassium or calcium levels in the blood. Your doctor may request regular blood tests to monitor magnesium levels.
• skin rash, possibly with joint pain
• visual hallucinations

If you notice side effects not mentioned in this leaflet or if you experience one of the side effects described severely, inform your doctor or pharmacist.

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 leaflet.

You can also report them directly through the Spanish System for 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.

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

Do not use this medication after the expiration date that appears on the packaging and carton. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Lansoprazol Flas Salvat

• The active ingredient is lansoprazol.

• The other components are sugar spheres (saccharose and cornstarch); magnesium carbonate; hypromellose; polisorbate 80; macrogol 6000; triethyl citrate; talc; copolymer of methacrylic acid and ethyl acrylate; copolymer of methyl acrylate, methacrylic acid and ethyl acrylate; microcrystalline cellulose; hydroxypropylcellulose; sodium saccharin; mannitol (E-421); tropical flavor; maleic acid; magnesium stearate.

Appearance of the product and contents of the packaging

Lansoprazol Flas Salvat 15 mg are white-grayish tablets containing microgranules.

Lansoprazol Flas Salvat 15 mg is presented in packaging of 14, 28 or 56 tablets.

Not all formats are marketed

Holder of the marketing authorization and manufacturer

Holder

Laboratorios SALVAT, S.A.

Gall 30-36

08950 Esplugues de Llobregat

Barcelona - Spain

Responsible for manufacturing

Laboratorios SALVAT, S.A.

Gall 30-36

08950 Esplugues de Llobregat

Barcelona - Spain

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132JH, Hoofddorp

The Netherlands

(Only for the United Kingdom and Sweden)

This medicine is authorized in the member states of the European Economic Area with the following names:

Lansoprazole Salvat 15 mg orodispersible tabletsFrance

Lansoprazolo Salvat 15 mg orodispersible tabletsItaly

Monolitum 15 mg orodispersible tabletsPortugal

Lansoprazole 15 mg orodispersible tabletsUnited Kingdom

Lansoprazol SUN 15 mg munsönderfallande tabletSweden

Last review date of this leaflet:December 2022

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)

http://www.aemps.gob.es/