Prospect: information for the patient

Lansoprazol Flas Viatris 15 mg buccal dispersible tablets EFG

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

-Keep this prospect, as you may need to read it again.

-If you have any doubts, consult your doctor or pharmacist.

-This medication has been prescribed only to you, and you should not give it to other people, 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 prospect.See section 4.

The active ingredient of Lansoprazol Flas Viatrisis lansoprazol, which is a proton pump inhibitor.

Proton pump inhibitors reduce the amount of acid produced by the stomach.

Your doctor may prescribe lansoprazol for the following:

-Treatment of duodenal (intestine) and gastric ulcers.

-Treatment of esophagitis (esophageal inflammation) caused by acid reflux.

-Prevention of esophagitis caused by acid reflux.

-Treatment of stomach burning and acid regurgitation.

-Treatment of infections caused by the bacteriaHelicobacter pylori, when administered with an antibiotic.

-Treatment or prevention of duodenal (intestine) or gastric ulcers in patients who require continuous treatment with nonsteroidal anti-inflammatory drugs (NSAIDs) orNSAIDs (the treatment with NSAIDs is used to reduce pain or inflammation).

-Treatment of Zollinger-Ellison syndrome.

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

Do not take Lansoprazol Flas Viatris:

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

Warnings and precautions

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

• If you have liver problems. Your doctor may adjust the dose.
• If you have ever had a skin reaction after treatment with a similar medication to Lansoprazol Flas Viatris for reducing stomach acid.
• If you are scheduled to have a specific blood test (Cromogranina A).
• If you have low levels of vitamin B12 or are at risk for it and receive treatment with these medications for a long period of time. Like all medications that reduce acid production, lansoprazol may reduce vitamin B12 absorption.

This medication may affect how the body absorbs vitamin B12, particularly if you need to take it for a long time. Please contact your doctor if you notice any of the following symptoms, as they may indicate low vitamin B12 levels:

• Extreme fatigue or lack of energy.
• Pinpricks and numbness.
• Red or sore tongue, mouth ulcers.
• Muscle weakness.
• Altered vision.
• Memory problems, confusion, depression.

If you experience a skin rash, especially in sun-exposed areas, consult your doctor as soon as possible, as it may be necessary to discontinue treatment with lansoprazol. Remember to mention any other symptoms you notice, such as joint pain.

If your doctor has prescribed Lansoprazol Flas Viatris in addition to other medications for treating the infection caused by the Helicobacter pylori bacteria (antibiotics) or along with anti-inflammatory medications for pain or arthritis, read the prospectuses for these medications carefully.

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

When taking lansoprazol, inflammation in the kidneys 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. Inform your doctor of these signs.

If you take lansoprazol for more than three months, your blood magnesium levels may become very low. If you experience fatigue, disorientation, dizziness, or muscle spasms, convulsions (seizures), or an increased heart rate, contact your doctor immediately, as you may have low blood magnesium levels (see section 4 "Possible side effects"). Low blood magnesium levels can lead to decreased calcium and potassium levels in the blood. Therefore, your doctor may monitor your blood magnesium levels.

The use of a proton pump inhibitor like lansoprazol, especially for a period exceeding one year, may slightly increase the risk of hip, wrist, or spine fractures. Inform your doctor if you have osteoporosis or are taking corticosteroids (which may increase the risk of osteoporosis).

If you take lansoprazol for a prolonged period (more than 1 year), your doctor will likely perform regular check-ups. You should inform your doctor of any new circumstances or unusual symptoms.

During treatment

If you experience diarrhea during treatment with lansoprazol, contact your doctor immediately, as lansoprazol is associated with a small increase in infectious diarrhea.

Other medications and Lansoprazol Flas Viatris

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication, including those purchased without a prescription.

Especially, inform your doctor if you are taking medications containing the following:

-Protease inhibitors for HIV such as atazanavir and nelfinavir (used in HIV treatment).

-Methotrexate (used to treat autoimmune diseases and cancer).

-Ketoconazole (used to treat Cushing's syndrome - when the body produces an excess of cortisol).

-Itraconazole (used to treat fungal infections).

-Rifampicin (used to treat tuberculosis).

-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, such as aluminum hydroxide or magnesium carbonate).

-Sucralfate (used to heal ulcers).

-St. John's Wort or hypericum (Hypericum perforatum) (used to treat mild depression).

Pregnancy and breastfeeding

It is not recommended to take lansoprazol during pregnancy, as there is no data available.

The presence of lansoprazol in breast milk is unknown. Consult your doctor to determine whether it is more beneficial to continue taking this medication or to continue breastfeeding your baby.

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

Driving and operating machinery

Patients taking lansoprazol may experience side effects such as dizziness, vertigo (a sensation of rotational movement when sitting or standing), drowsiness, and vision problems. If you experience any of these side effects, you should exercise caution, as your reaction time may be reduced.

You are solely responsible for deciding whether you are capable of driving vehicles or performing other activities that require a high level of concentration. One of the factors that may reduce your ability to perform these activities 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, consult your doctor or pharmacist.

Lansoprazol Flas Viatris contains saccharose, aspartame, and sodium

This medication contains 5.97 mg of aspartame per tablet.

Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria, a rare genetic disorder in which phenylalanine accumulates in the body due to the inability to eliminate it correctly.

This medication contains saccharose.

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

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

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

The dose of lansoprazole depends on your general condition. The recommended doses of lansoprazole for adults are indicated below. In some cases, your doctor may prescribe a different dose and indicate 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 ulcers (intestine):one buccal dispersible tablet of 30 mg per day for 2 weeks.

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

Treatment of esophagitis (esophageal inflammation) caused by 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 infection caused byHelicobacter pylori:the recommended 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 in the evening. Treatment is usually daily for 7 days.

The recommended antibiotic combinations are as follows:

- 30 mg of lansoprazole with 250-500 mg of clarithromycin and 1,000 mg of amoxicillin.

- 30 mg of lansoprazole 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 lansoprazole at the right time and do not miss any doses.

Treatment of duodenal ulcers (intestine) or gastric ulcers in patients who need continuous treatment with nonsteroidal anti-inflammatory drugs (NSAIDs):one buccal dispersible tablet of 30 mg per day for 4 weeks.

Prevention of duodenal ulcers (intestine) or gastric ulcers in patients who need 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 recommended dose is two buccal dispersible tablets of 30 mg per day; subsequently, your doctor will decide on the best dose for you based on your response to lansoprazole treatment.

Use in patients with liver problems

If you have moderate or severe liver problems, your doctor may prescribe half the recommended dose.

Use in elderly patients

Your doctor may prescribe a lower dose if you are an elderly patient. The maximum recommended dose for elderly patients is 30 mg per day.

Use in children

Lansoprazole should not be administered to children.

How to take it

To get the best results with the medication, take lansoprazole at least 30 minutes before eating.

If you take lansoprazole once a day, try to take it at the same time every day. You may get the best results if you take lansoprazole on an empty stomach in the morning.

If you take lansoprazole twice a day, take the first dose in the morning and the second in the afternoon.

The lansoprazole tablets are easily broken, so you should handle them carefully. Do not handle the tablets with wet hands, as they may break.

1. To open the blister pack, hold the strip by the edges and separate one compartment from the rest of the strip by gently tearing the perforations around the blister.
2. Carefully remove the back of the blister. To open the non-perforated blister pack, be careful not to remove the back of the adjacent tablets.
3. Gently pull out the tablet.
4. Place the tablet in your mouth. The tablet will dissolve directly in your mouth and you will be able to swallow it more easily.

You can also swallow the tablet whole with a glass of water.

Your doctor may give you instructions on how to administer the tablet using a syringe if you have severe difficulty swallowing.

If you use a syringe:

-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 barrel.

-Replace the plunger in the syringe.

-For the 15 mg tablet: pull the plunger to draw 4 ml of water from the tap into the syringe.

-For the 30 mg tablet: pull the plunger to draw 10 ml of water from the tap into the syringe.

-Place the syringe with the mouth down and pull the plunger to draw 1 ml of air into the syringe.

-Shake the syringe gently for 10-20 seconds until the tablet has dissolved.

-Empty the contents of the syringe directly into the mouth.

-Fill the syringe with 2-5 ml of water from the tap to remove any remaining contents and empty it into the mouth.

-Repeat this last step if necessary.

If you use a nasogastric tube:

It is essential to carefully evaluate the suitability of the selected tube. The recommended diameter of the nasogastric tube to be used is 3.3 mm (size 10 on the French scale) or larger.

-Remove the plunger from the syringe (use at least a 25 ml syringe for the 15 mg tablet and a 50 ml syringe for the 30 mg tablet).

-Place the tablet in the barrel.

-Replace the plunger in the syringe.

-For the 15 mg tablet: pull the plunger to draw 10 ml of water from the tap into the syringe.

-For the 30 mg tablet: pull the plunger to draw 25 ml of water from the tap into the syringe.

-Place the syringe with the mouth down and pull the plunger to draw 5 ml of air into the syringe.

-Shake the syringe gently for 10-20 seconds until the tablet has dissolved.

-Attach the syringe to the nasogastric tube and empty the contents of the syringe into it.

-For the 15 mg tablet:fill the syringe with 10 ml of water from the tap and empty its contents into the tube.

-For the 30 mg tablet:fill the syringe with 25 ml of water from the tap and empty its contents into the tube.

If you take more Lansoprazol Flas Viatris than you should

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

If you forget to take Lansoprazol Flas Viatris

If you forget to take a dose, take it as soon as you remember, unless the next dose is almost due.If this happens, do not take the missed dose and continue taking lansoprazole normally.

Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Lansoprazol Flas Viatris

Do not stop 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 can cause side effects, although not everyone will experience them.

Stop taking this medicine and immediately inform your doctor or go to the nearest hospital if you think you may be experiencing any of the following side effects:

• Increased number of infections causing fever, intense chills, sore throat, or respiratory infections. These symptoms may be indicative of a reduction in white blood cell count (leucopenia – rare, may affect up to 1 in 100 people).
• Fatigue, cold hands and feet, pale skin with the spontaneous appearance of petechiae, prolonged bleeding. These symptoms may be indicative of a severe reduction in all types of blood cells (pancytopenia – very rare, may affect up to 1 in 10,000 people).
• Severe and intense pain in the upper part of the stomach.The pain may spread to the back and may worsen after eating.These symptoms may be indicative of pancreatitis (rare, may affect up to 1 in 1,000 people).
• Yellowing of the skin or the white part of the eyes, loss of appetite, nausea, pale or cloudy stools, or cloudy urine. These symptoms may be indicative of severe liver problems (rare, may affect up to 1 in 1,000 people).
• Swelling of the face, lips, tongue, or throat causing difficulty swallowing or breathing, fever, hives, inflammation, and sometimes a rapid decrease in blood pressure. These symptoms may be indicative of a severe allergic reaction, including anaphylactic shock (rare, may affect up to 1 in 1,000 people).
• Production of little or no urine, cloudy or bloody urine, painful urination, or lower back pain. These symptoms may be indicative of severe kidney problems. These symptoms may be indicative of severe kidney problems (rare, may affect up to 1 in 1,000 people).
• Redness of the skin, blistering, severe inflammation, peeling, and skin loss. These symptoms may be indicative of severe skin reactions such as drug reaction with eosinophilia and systemic symptoms (DRESS) (frequency unknown, cannot be estimated from available data), Stevens-Johnson syndrome, or toxic epidermal necrolysis (very rare, may affect up to 1 in 10,000 people).
• Severe or persistent diarrhea. If you experience this side effect, inform your doctor, as this medicine has been associated with a slight increase in infectious diarrhea (very rare, may affect up to 1 in 10,000 people).
• Skin rash, possibly with joint pain (frequency unknown, cannot be estimated from available data).

Other possible side effects:

Common (may affect up to 1 in 10 people):

• Headache, dizziness.
• Diarrhea, constipation, stomach pain, nausea, vomiting, flatulence, dry mouth or throat.
• Skin rash, itching.
• Increased concentrations of liver enzymes in the blood, as observed through blood tests.
• Fatigue.
• Benign polyps in the stomach.

Rare (may affect up to 1 in 1,000 people):

• Depression.
• Muscle or joint pain.
• Fracture of the hip, wrist, or spine.
• Fluid retention or swelling.
• Changes in blood cell count.

Very rare (may affect up to 1 in 10,000 people):

• Fever.
• Pain or difficulty swallowing with white spots on the back of the throat. These symptoms may be indicative of a fungal infection in the esophagus.
• Restlessness, drowsiness.
• Confusion, seeing, feeling, or hearing things that do not exist (hallucinations), sleep problems (insomnia).
• Visual disturbances.
• Sensation of rotational movement of the body while standing (vertigo).
• Alteration of taste, loss of appetite, inflammation of the tongue (glossitis).
• Skin reactions such as burning or itching under the skin, bruises, redness, and excessive sweating.
• Sensitivity to light.
• Hair loss.
• Sensation of tingling (paresthesia), tremors.
• Anemia (pale skin).
• Swelling of the breasts in men, impotence.

Very rare (may affect up to 1 in 10,000 people):

• Inflammation of the mouth (stomatitis).
• Decrease in sodium concentration in the blood, symptoms include nausea and vomiting, headache, drowsiness, and fatigue, confusion, muscle weakness or spasms, irritability, convulsions, coma. Your doctor may decide to perform periodic blood tests to monitor your sodium levels.
• Increased concentration of cholesterol or lipids in the blood (observed through blood tests).

Frequency unknown (cannot be estimated from available data):

• Visual hallucinations.
• If you have been taking lansoprazole for more than three months, it is possible that your magnesium levels in the blood may decrease.A low magnesium level may cause fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, or increased heart rate. If you experience any of these symptoms, inform your doctor immediately. A low magnesium level may also cause a decrease in potassium or calcium levels in the blood. Your doctor may decide to perform periodic blood tests to monitor your 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 leaflet. You can also report them directly through the Spanish System for the Vigilance 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.

Store in the original packaging to protect it from moisture.

Bottles: Once opened, use within 100 days. Keep the bottle perfectly closedto protect its contents from moisture.

Do not use this medication after the expiration date that appears on the blister pack, on the box, and on the bottle after CAD or EXP.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 containers and medications you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medications you no longer need. By doing so, you will help protect the environment.

Lansoprazol Flas Viatris Composition

The active ingredient is lansoprazol.

The other components are: sugar spheres, light magnesium carbonate (E-504), crospovidona (E-1202), hydroxypropylcellulose (E-463), copolymer of methacrylic acid and ethyl acrylate (1:1), triethyl citrate (E-1505), sodium hydroxide (E-524), talc (E-553b), polisorbate (E-433), macrogol, red iron oxide (E-172), yellow iron oxide (E-172), mannitol (E-421), microcrystalline cellulose (E-460), carboxymethylstarch sodium type A (from potato starch), aspartame (E-951), sodium lauryl sulfate, sodium bicarbonate (E-500), citric acid monohydrate (E-330), strawberry flavor [flavoring, cornstarch and propylene glycol (E-152)]and magnesium stearate. (See section 2 “Lansoprazol Flas Viatris contains sucrose, aspartame and sodium”).

Appearance of the product and contents of the package

The medicine is presented in the form of orally disintegrating tablets (solid oral formulation)that dissolve to release gastric-resistant microgranules.

Lansoprazol Flas Viatris 15 mg are round, white to yellowish tablets, with specks of color between orange and dark brown, flat, with beveled edge, marked with “LP1” on one face and “M” on the other.

The orally disintegrating tablets of Lansoprazol Flas Viatris 15 mg are available in:

• Blister packs of 7, 14, 28, 30, 56, 90 and 98 tablets.
• Single-dose blister packs of 28 tablets.
• Plastic bottles with hydrophilic cotton and screw cap containing30, 100 and 500 tablets.

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Manufacturer

Generics [UK] Ltd

Station Close, Potters Bar, Hertfordshire, EN6 1TL

United Kingdom

or

McDermott Laboratories Limited trading as Gerard Laboratories

35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13

Ireland

or

Mylan Hungary Kft.

H-2900, Komárom Mylan utca 1

Hungary

or

Mylan UK Healthcare Limited

Building 20, Station Close, Potters Bar, EN6 1TL

United Kingdom

Further information about this medicine can be obtained by contacting the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

This medicine is authorized in the member states of the European Economic Areaand the United Kingdom (Northern Ireland)with thefollowing names:

SpainLansoprazol Flas Viatris 15 mg orally disintegrating tablets EFG

FranceLansoprazole Viatris 15 mg orodispersible tablet

ItalyLansoprazolo Mylan Generics Italia

MaltaLansoprazole 15 mg orodispersible tablets

PortugalLansoprazole Mylan

United KingdomLansoprazole 15 mg Orodispersible tablets

SwedenLansoprazol Viatris 15 mg muns?underfallande tablet

Last review date of this leaflet:July 2023

Further detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)https://www.aemps.gob.es/