LANSOPRAZOL FLAS STADA 30mg ORALLY DISINTEGRATING TABLETS

Introduction

Package Leaflet: Information for the User

Lansoprazole Flas Stada 30 mg Orodispersible Tablets EFG

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 signs of illness are the same as yours.
• If you get 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 Stada and what is it used for
2. What you need to know before you take Lansoprazole Flas Stada
3. How to take Lansoprazole Flas Stada
4. Possible side effects
5. Storage of Lansoprazole Flas Stada
6. Contents of the pack and other information

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

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

Lansoprazole is used for the treatment in adults.

Your doctor may prescribe you lansoprazole for the following indications:

• treatment of duodenal and gastric ulcers
• treatment of inflammation of the oesophagus (reflux oesophagitis)
• prevention of reflux oesophagitis
• 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 for another indication or at a different dose than indicated in this leaflet. Follow your doctor's instructions for taking the medicine.

2. What you need to know before you take Lansoprazole Flas Stada

Do not take Lansoprazole Flas Stada

• if you are allergic to lansoprazole or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Tell your doctor if you have a severe liver disease. 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 a malignant disease.

In case of experiencing severe or persistent diarrhea during treatment with lansoprazole, contact your doctor immediately, as lansoprazole has been associated with a slight increase in infectious diarrhea.

If your doctor has prescribed lansoprazole 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 carefully the package leaflets of these medicines.

If you take lansoprazole for more than three months, it is possible that the magnesium levels in your blood may decrease. Low magnesium levels can cause fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, increased heart rate. If you experience any of these symptoms, inform your doctor immediately. Low magnesium levels can also lead to a reduction in potassium or calcium levels in the blood. Your doctor may decide to perform regular blood tests to monitor your magnesium levels.

Taking a proton pump inhibitor like lansoprazole, especially for a period longer than one year, may slightly increase the risk of fractures of the hip, wrist, or spine. Inform your doctor if you have osteoporosis (reduced bone density) or if your doctor has told you that you are at risk of osteoporosis (for example, if you are taking steroids).

This medicine may affect the way 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 levels of vitamin B12:

• Extreme tiredness or lack of energy
• Numbness
• Red or sore tongue, mouth ulcers
• Muscle weakness
• Altered vision
• Memory problems, confusion, depression

If you have been taking lansoprazole for a long time (more than 1 year), your doctor will probably perform regular check-ups. During visits to your doctor, you should report any new or unusual symptoms and circumstances.

Consult your doctor before starting to take lansoprazole

• If you are scheduled to have a specific blood test (Chromogranin A).
• If you have ever had a skin reaction after treatment with a medicine similar to lansoprazole to reduce stomach acid.

There have been reports of serious skin reactions in relation to treatment with lansoprazole, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug rash with eosinophilia and systemic symptoms (DRESS). Stop using lansoprazole and call your doctor immediately if you experience any of the symptoms related to serious skin reactions described in section 4.

If you experience 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.

When taking lansoprazole, kidney inflammation may occur. The signs and symptoms can include decreased urine output 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.

Taking Lansoprazole Flas Stada with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

In particular, tell your doctor or pharmacist if you are taking medicines that contain any of the following active substances, as lansoprazole may affect their action:

• HIV protease inhibitors such as atazanavir and nelfinavir (used to treat HIV)
• 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 heartburn or acid regurgitation)
• sucralfate (used to heal ulcers)
• St. John's Wort (Hypericum perforatum) (used to treat mild depression)

Taking Lansoprazole Flas Stada with food and drinks

To get the best results from your medicine, you should take lansoprazole at least 30 minutes before meals.

Pregnancy and breast-feeding

If you are pregnant, or 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

Patients taking lansoprazole may occasionally experience side effects such as dizziness, vertigo, fatigue, and visual disturbances. If you experience any of these side effects, you should act with caution as your ability to react may be reduced.

You are the only person responsible for deciding whether you are in a fit state to drive or perform activities that require a high level of concentration. Due to its effects or adverse reactions, one of the factors that can reduce your ability to perform these operations safely is the use of medicines.

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

Read this leaflet carefully.

If you have any further questions, ask your doctor or pharmacist.

Lansoprazole Flas Stada contains aspartame

This medicine contains 10.50 mg of aspartame in each orodispersible tablet.

Aspartame is a source of phenylalanine, which may be harmful in cases of phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body is unable to eliminate it properly.

3. How to take Lansoprazole Flas Stada

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

Place the tablet on the tongue and suck it slowly. The tablet dissolves rapidly in the mouth, releasing microgranules that should 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 through a syringe, in case you have serious difficulties swallowing.

Follow the following instructions in case of administration through a syringe:

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

• remove the plunger from the syringe (at least a 10 ml syringe for the 30 mg tablet)
• place the tablet in the reservoir
• replace the plunger in the syringe
• for the 30 mg tablet: pull the plunger to introduce 10 ml of tap water into the syringe
• invert the syringe and pull the plunger to introduce 1 ml of air
• shake the syringe gently 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 once a day, try to take it always at the same time. You can get better results if you take lansoprazole in the morning.

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

The dose of lansoprazole depends on your general condition. The normal doses of lansoprazole 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 orodispersible tablet (there are suitable doses available for this dosification) or 30 mg once a day for 4 weeks. If symptoms do not improve after 4 weeks, consult your doctor.

Treatment of duodenal ulcer:one 30 mg orodispersible tablet once a day for 2 weeks.

Treatment of gastric ulcer:one 30 mg orodispersible tablet once a day for 4 weeks.

Treatment of inflammation of the oesophagus (reflux oesophagitis):one 30 mg orodispersible tablet once a day for 4 weeks.

Long-term prevention of reflux oesophagitis:one 15 mg orodispersible tablet once a day (there are suitable doses available for this dosification); your doctor may adjust the dose to one 30 mg orodispersible tablet once a day.

Treatment of Helicobacter pyloriinfection:The normal dose is one 30 mg orodispersible tablet together with two different antibiotics in the morning and one 30 mg orodispersible tablet together with two different antibiotics in the evening. The treatment will normally be once a day for 7 days.

The recommended combinations of antibiotics are the following:

• 30 mg of lansoprazole 30 mg with 250-500 mg of clarithromycin and 1000 mg of amoxicillin.
• 30 mg of lansoprazole 30 mg 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 forget any dose.

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

Prevention of duodenal or gastric ulcers in patients who require continuous treatment with NSAIDs:one 15 mg orodispersible tablet once a day (there are suitable doses available for this dosification); your doctor may adjust the dose to one 30 mg orodispersible tablet once a day.

Zollinger-Ellison syndrome:The initial normal dose is two 30 mg orodispersible tablets once a day; subsequently, depending on your response to treatment with lansoprazole, the doctor will decide the best dose for you.

Use in children and adolescents

Lansoprazole should not be administered to children.

If you take more Lansoprazole Flas Stada than you should

If you take more lansoprazole than you have been told, contact your doctor immediately, or contact the Toxicology Information Service, Telephone 915 620 420.

If you forget to take Lansoprazole 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 next orodispersible tablets as usual. Do not take a double dose to make up for forgotten doses.

If you stop taking Lansoprazole Flas Stada

Do not stop treatment early 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 medicine, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

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

• In very rare cases, lansoprazole may cause severe hypersensitivity (allergic) reactions. The symptoms of a hypersensitivity reaction may include fever, rash, swelling of the face, inflamed lymph nodes, swollen tongue or pharynx, difficulty swallowing, hives, difficulty breathing, and sometimes a rapid decrease in blood pressure.
• In very rare cases, severe skin reactions have been reported with lansoprazole that can be life-threatening. The symptoms include reddish spots on the torso, the spots are target-shaped or circular, often with central blisters, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin rashes can be preceded by fever and flu-like symptoms [(Stevens-Johnson Syndrome (SJS), Toxic Epidermal Necrolysis (TEN)].
• Widespread skin rash, high body temperature, and enlarged lymph nodes [Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS, frequency not known)].
• If you take lansoprazole for more than three months, it is possible that the magnesium levels in your blood may decrease. Low magnesium levels can cause fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, increased heart rate. If you have any of these symptoms, inform your doctor immediately. Low magnesium levels can also lead to a reduction in potassium or calcium levels in the blood. Your doctor may decide to perform regular blood tests to monitor your magnesium levels.
• In very rare cases, lansoprazole may cause a decrease in the number of white blood cells (agranulocytosis) and your resistance to infection may be decreased or coexisting abnormal reductions in the number of red and white blood cells, as well as platelets (pancytopenia). 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, or you experience fatigue, pale skin with unexplained bruising or bleeding for longer than usual, you should consult your doctor immediately. A blood test will be performed to check for possible reduction of blood cells.
• In rare cases, lansoprazole may cause pancreatitis and its symptoms include sudden severe pain in the middle of the upper abdomen that can radiate to the back, which can cause nausea and vomiting.
• If you experience severe or persistent diarrhea during treatment with lansoprazole, contact your doctor immediately, as lansoprazole has been associated with a small increase in infectious diarrhea.

Other possible adverse effects

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

• headache, dizziness
• 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(may affect up to 1 in 100 people):

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

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

• fever
• restlessness, drowsiness, confusion, hallucinations, insomnia, visual disturbances, vertigo
• altered taste, loss of appetite, tongue inflammation (glossitis)
• skin reactions such as burning sensation or itching, bruising, redness, and excessive sweating
• sensitivity to light
• hair loss
• tingling sensation (paresthesia), tremor
• anemia (pallor)
• kidney inflammation (interstitial nephritis), possible symptoms include changes in urine volume, blood in the urine
• liver inflammation (may manifest as yellowish skin or eyes)
• breast swelling in males, impotence
• candidiasis (fungal infection, may affect the esophageal mucosa)

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

• mouth inflammation (stomatitis)
• intestine inflammation (colitis)
• increase in analytical values, such as cholesterol and triglycerides
• decrease in sodium concentration in 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.

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

• forms of lupus or lupus-like rash related to the skin
• skin rash, possibly with joint pain (Subacute Cutaneous Lupus Erythematosus)
• 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 Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Lansoprazol Flas Stada

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiration date that appears on the blister pack 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 moisture.

Medicines should not be thrown down the drain or into the trash. Deposit the packaging and medicines you no longer need at the SIGRE Point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Lansoprazol Flas Stada

• The active ingredient is lansoprazole. One orodispersible tablet contains 30 mg of lansoprazole.
• The other components are:

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

Coating: hypromellose 3 cps (E464), low-substitution hydroxypropylcellulose, talc (E-553b), titanium dioxide (E-171), mannitol (E-241), copolymer dispersion of methacrylic acid and ethyl acrylate (1:1), polyacrylate dispersion, glycerol monostearate, polyethylene glycol 6000, 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 (flavorings, corn maltodextrin, propylene glycol (E-1520)), vegetable magnesium stearate (E-470b).

Appearance of the Product and Package Contents

Lansoprazol Flas Stada 30 mg orodispersible tablets are uncoated white to off-white tablets, speckled with orange to dark brown pellets, with the mark "30" on one face and smooth on the other. Each orodispersible tablet has a strawberry flavor.

Lansoprazol Flas Stada 30 mg orodispersible tablets are available in blister packs packaged in cardboard boxes containing 7, 14, 28, 30, and 56 tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern

(Barcelona)

[email protected]

Manufacturer

STADA Arzneimittel AG

Stadastrasse 2 – 18

61118 Bad Vilbel

Germany

or

STADA Arzneimittel GmbH

Muthgasse 36

1190 Vienna

Austria

This medicine is authorized in the Member States of the European Economic Area under the following names:

Italy: LANSOPRAZOLO EG STADA

Portugal: Lansoprazol Ciclum

Spain: Lansoprazol Flas Stada 30 mg orodispersible tablets EFG

Date of the last revision of this prospectus:November 2024

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.