Package Leaflet: Information for the User

Lansoprazol Flas Stada 15 mg Buccal Tablets EFG

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

-Keep this leaflet, as 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 is Lansoprazol Flas Stada and what it is used for

2.What you need to know before you start taking Lansoprazol Flas Stada

3.How to take Lansoprazol Flas Stada

4.Possible side effects

5.Storage of Lansoprazol Flas Stada

6.Contents of the pack and additional information

The active ingredient of Lansoprazol Flas Stada 15 mg is lansoprazol, a proton pump inhibitor. Proton pump inhibitors reduce the amount of acid produced by the stomach.

Lansoprazol is used for the treatment in adults.

Your doctor may prescribe lansoprazol for the following indications:

-Treatment of duodenal and gastric ulcers.

-Treatment of esophagitis caused by reflux.

-Prevention of esophagitis caused by reflux.

-Treatment of stomach burning and acid regurgitation.

-Treatment of infections caused by the Helicobacter pylori bacteria, in combination with antibiotics.

-Treatment or prevention of duodenal or gastric ulcers in patients requiring continuous treatment with nonsteroidal anti-inflammatory drugs (NSAIDs) (NSAID treatment is used for pain or inflammation).

-Treatment of Zollinger-Ellison syndrome.

Your doctor may have prescribed lansoprazol for another indication or a different dose than indicated in this leaflet. Follow your doctor's instructions regarding the use of the medication.

Do not take lansoprazol:

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

-if you are taking a medication that contains the active ingredient atazanavir (used to treat HIV)

Warnings and precautions

Consult your doctor before starting to take lansoprazol

• if you have a serious liver disease. Your doctor may need to adjust the dose
• if you have ever had a skin reaction after treatment with a similar medication to lansoprazol 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. Remember to mention any other symptoms you may notice, such as joint pain
• You are scheduled to have a specific blood test (Cromogranina A)
• 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

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

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

If your doctor has prescribed lansoprazol 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 like lansoprazol, especially for a period of over one year, may slightly increase the risk of fractures of the hip, wrist, or vertebrae. Inform your doctor if you have osteoporosis or are taking corticosteroids (which may increase the risk of osteoporosis).

If you have been taking lansoprazol for a long time (over 1 year), your doctor will likely perform regular checks. In your doctor's visits, you must inform them of any new or exceptional symptoms and circumstances.

When taking lansoprazol, kidney inflammation may occur. Symptoms and signs 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.

Taking Lansoprazol Flas Stada 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 or pharmacist if you are taking medications that contain any of the following active ingredients, as lansoprazol may affect their mode of action:

- ketoconazol, itraconazol, rifampicina (used to treat infections)

- digoxina (used to treat heart problems)

- teofilina (used to treat asthma)

- tacrolimus (used to prevent transplant rejection)

- fluvoxamina (used to treat depression and other psychiatric disorders)

- anti-acids (used to treat stomach burning or acid regurgitation)

- sucralfato (used to heal ulcers)

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

Taking Lansoprazol Flas Stada with food and drinks

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

Pregnancy and breastfeeding

If you are pregnant, or in the lactation period believe you may be pregnant or intend to become pregnant, consult your doctor or pharmacist before taking this medication.

Driving and operating machines

Patients taking lansoprazol 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 in a condition 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 the descriptions of these side effects.

Read this prospectus carefully.

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

Lansoprazol Flas Stada contains aspartamo

This medication contains 5.25 mg of aspartamo in each buccal dispersible tablet.

Aspartamo contains a source of phenylalanine that may be harmful in the case of phenylketonuria (PKU), a rare genetic disease in which phenylalanine accumulates because the body is unable to eliminate it correctly.

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

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

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

The dose of lansoprazol depends on your general condition. The normal doses of lansoprazol 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 or two buccal dispersible tablets of 15 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:two buccal dispersible tablets of 15 mg per day for 2 weeks.

Treatment of stomach ulcer:two buccal dispersible tablets of 15 mg per day for 4 weeks.

Treatment of esophagitis due to reflux:two buccal dispersible tablets of 15 mg per day for 4 weeks.

Long-term prevention of esophagitis due to reflux:one buccal dispersible tablet of 15 mg per day. Your doctor may adjust your dose to two buccal dispersible tablets of 15 mg per day.

Treatment of Helicobacter pylori infection:The normal dose is two buccal dispersible tablets of 15 mg with two different antibiotics in the morning and two buccal dispersible tablets of 15 mg with two different antibiotics at night. Treatment is usually daily for 7 days.

The recommended antibiotic combinations are as follows:

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

- 30 mg of lansoprazol 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 forget any dose.

Treatment of duodenal or stomach ulcer in patients requiring continuous treatment with NSAIDs:two buccal dispersible tablets of 15 mg per day for 4 weeks.

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

Zollinger-Ellison syndrome:The initial normal dose is four buccal dispersible tablets of 15 mg per day; subsequently, your doctor will decide the best dose for you based on your response to lansoprazol treatment.

Use in children and adolescents

Lansoprazol should not be administered to children.

If you take more Lansoprazol Flas Stada than you should

If you take more lansoprazol than indicated, consult your doctor immediately, or contact the Toxicology Information Service, Teléfono 915 620 420.

If you forget to take Lansoprazol Flas Stada

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 Stada

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.

If diarrhea occurs during treatment with lansoprazole, contact your doctor immediately, as lansoprazole has been associated with a small increase in infectious diarrhea.

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 stomach polyps

Occasional(may affect up to 1 in 100 people):

-depression

-joint or muscle pain

-fluid retention or swelling

-changes in blood cell counts

-increased risk of wrist, hip, or spinal fracture

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, hematomas, redness, and excessive sweating

-sensitivity to light

-hair loss

-tingling sensation (paresthesia), tremors

-anemia (pallor)

-renal problems

-pancreatitis

-inflammation of the liver (may manifest as yellow skin or eyes)

-swelling of the chest in men, 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(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, 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, lansoprazole may cause a reduction in the number of white blood cells, which may 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. A blood test will be performed to check for possible reduction in white blood cells (agranulocytosis).

Frequency not known (the frequency cannot be estimated from the available data)

• if you have been taking lansoprazole 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.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es.By reporting adverse 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 blister and box, after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 25°C. Store in the original packaging to protect it from humidity.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection point of the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

Composition of Lansoprazol Flas Stada

- The active ingredient is lansoprazol. A buccal dispersible tablet contains 15 mg of lansoprazol.

-The other components are:

Tablet core:microcrystalline cellulose, light magnesium carbonate, low-substituted hydroxypropylcellulose, low-substituted hydroxypropylcellulose (E-463).

Coating:hypromellose 3 cps (E-464), low-substituted hydroxypropylcellulose, talc (E-553b), titanium dioxide (E-171), mannitol (E-241), dispersion of copolymer of acrylic acid and ethyl acrylate (1:1), dispersion of polyacrylate, monoestearate of glycerol, polyethylene glycol 6000, triethyl citrate, polysorbate 80, citric acid (E-330), yellow iron oxide (E-172) red iron oxide (E-172), talc (E-553b), F-Melt type C (mannitol, xylitol, microcrystalline cellulose, crospovidone, dibasic calcium phosphate), crospovidone, microcrystalline cellulose, aspartame (E-951), strawberry flavor (aromatizers, cornstarch maltodextrin, propylene glycol (E-1520)), magnesium stearate (vegetable origin) (E-470b).

Appearance of the product and contents of the package

Lansoprazol Flas Stada 15 mg buccal dispersible tablets are non-coated tablets of white to light yellow color, speckled with pellets of orange to dark brown color, with the mark “15” on one face and smooth on the other. Each buccal dispersible tablet has a strawberry flavor.

Lansoprazol Flas Stada 15 mg buccal dispersible tablets are available in blisters packaged in cardboard boxes containing 7, 14, 28, 30, and 56 tablets.

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern

(Barcelona)

Spain

[email protected]

Responsible manufacturer

STADA Arzneimittel AG

Stadastrasse 2 – 18

61118 Bad Vilbel

Germany

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

Italy:LANSOPRAZOLO EG STADA

Spain:Lansoprazol Flas Stada 15 mg buccal dispersible tablets EFG

United Kingdom: Lansoprazole 15 mg orodispersible tablets

Last review date of this leaflet:January 2023

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