Lansoprazole Flas Stada 30 mg orodispersible tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Lansoprazole Flas Stada 30 mg orodispersible tablets EFG

Read the entire leaflet carefully before you start taking this medicine, as 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 and must not be given to other people, even if they have the same symptoms as you, since it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet Contents

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

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

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

Lansoprazole is used for treatment in adults.

Your doctor may prescribe lansoprazole for the following indications:

• treatment of duodenal and gastric ulcers
• treatment of inflammation of the oesophagus (reflux esophagitis)
• prevention of reflux esophagitis
• treatment of heartburn and acid regurgitation
• treatment of infections caused by the bacterium Helicobacter pylori, in combination with antibiotics
• treatment or prevention of duodenal or gastric ulcers in patients requiring ongoing treatment with non-steroidal anti-inflammatory drugs (NSAIDs) (NSAID treatment is used for pain or inflammation)
• treatment of Zollinger-Ellison syndrome

Your doctor may have prescribed lansoprazole for an indication or at a dose different from that stated in this leaflet. Always follow your doctor's instructions regarding how to take the medicine.

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

Do not take Lansoprazol Flas Stada

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

Warnings and precautions

Tell your doctor if you have severe liver disease. Your doctor may need to adjust your dose.

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

If you experience severe or persistent diarrhoea during treatment with lansoprazole, contact your doctor immediately, as lansoprazole has been associated with a slight increase in infectious diarrhoea.

If your doctor has prescribed lansoprazole along with other medicines for the treatment of Helicobacter pylori infection (antibiotics) or together with anti-inflammatory drugs for pain or rheumatism, please also read the package leaflets of these medicines carefully.

If you take lansoprazole for more than three months, your blood magnesium levels may decrease. Low magnesium levels can cause fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, and increased heart rate. If you experience any of these symptoms, inform your doctor immediately. Low magnesium levels may also lead to reduced levels of potassium or calcium in the blood. Your doctor may decide to carry out regular blood tests to monitor your magnesium levels.

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

This medicine may affect how your 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 could indicate low vitamin B12 levels:

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

If you have been taking lansoprazole for a long time (more than 1 year), your doctor will likely monitor you regularly. During visits to your doctor, you should report any new or unusual symptoms or 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 used to reduce stomach acid.

Serious skin reactions have been reported with lansoprazole treatment, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS). Stop taking lansoprazole and contact your doctor immediately if you experience any symptoms related to serious skin reactions described in section 4.

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

Kidney inflammation may occur while taking lansoprazole. Signs and symptoms may include decreased urine volume or 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 Lansoprazol Flas Stada with other medicines

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

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

• HIV protease inhibitors such as atazanavir and nelfinavir (used in the treatment of 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 Lansoprazol 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 breastfeeding

If you are pregnant, breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before taking this medicine.

Driving and using machines

Patients taking lansoprazole may occasionally experience side effects such as dizziness, vertigo, tiredness, and visual disturbances. If you experience any of these side effects, you should exercise caution, as your reaction ability may be reduced.

You are solely responsible for deciding whether you are fit to drive or perform activities requiring a high level of concentration. Due to its effects or adverse reactions, the use of medicines may be one of the factors that reduce your ability to carry out these tasks safely.

Descriptions of these effects can be found in the following sections.

Please read the information in this leaflet carefully.

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

Lansoprazol Flas Stada contains aspartame

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

Aspartame contains a source of phenylalanine, which may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot properly eliminate it.

3. How to take Lansoprazol Flas Stada

Follow exactly the instructions for use of this medicine given by your doctor. If in doubt, consult your doctor or pharmacist again.

Place the tablet on the tongue and allow it to dissolve slowly. The tablet dissolves rapidly in the mouth, releasing microgranules which must be swallowed without chewing. Alternatively, the tablet may be swallowed whole with a glass of water.

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

Follow the instructions below for administration via syringe:

It is important to ensure that the syringe selected is appropriate.

• Remove the plunger from the syringe (at least a 10 ml syringe for the 30 mg tablet)
• Place the tablet into the barrel
• Replace the plunger into the syringe
• For the 30 mg tablet: pull the plunger to draw 10 ml of tap water into the syringe
• Invert the syringe and pull the plunger to draw 1 ml of air into the syringe
• Gently shake the syringe for 10–20 seconds until the tablet has dispersed
• The contents can be emptied directly into the mouth
• Refill the syringe with 2–5 ml of water to remove any residue and empty into the mouth

If you take lansoprazole once daily, try to take it at the same time each day. You may achieve better results if you take lansoprazole in the morning.

If you take lansoprazole twice daily, take the first dose in the morning and the second in the evening.

The dose of lansoprazole depends on your general condition. The usual doses of lansoprazole for adults are listed below. Occasionally, your doctor may prescribe a different dose and may recommend a different treatment duration.

Treatment of heartburn and acid regurgitation: One orodispersible tablet of 15 mg (appropriate dosage forms are available for this dose) or 30 mg daily for 4 weeks. If symptoms do not improve within 4 weeks, consult your doctor.

Treatment of duodenal ulcer: One orodispersible tablet of 30 mg daily for 2 weeks.

Treatment of gastric ulcer: One orodispersible tablet of 30 mg daily for 4 weeks.

Treatment of inflammation of the oesophagus (reflux esophagitis): One orodispersible tablet of 30 mg daily for 4 weeks.

Long-term prevention of reflux esophagitis: One orodispersible tablet of 15 mg daily (appropriate dosage forms are available for this dose); your doctor may adjust your dose to one orodispersible tablet of 30 mg daily.

Treatment of Helicobacter pylori infection: The usual dose is one orodispersible tablet of 30 mg together with two different antibiotics in the morning and one orodispersible tablet of 30 mg together with two different antibiotics in the evening. Treatment is usually given daily for 7 days.

The recommended antibiotic combinations are as follows:

• 30 mg lansoprazole with 250–500 mg clarithromycin and 1,000 mg amoxicillin.
• 30 mg lansoprazole with 250 mg clarithromycin and 400–500 mg metronidazole.

If you are receiving anti-infective treatment for an ulcer, the ulcer is unlikely to recur if the infection is successfully treated. To achieve the best results from your medicine, take it at the correct time and do not miss any doses.

Treatment of duodenal or gastric ulcer in patients requiring continuous NSAID therapy: One orodispersible tablet of 30 mg daily for 4 weeks.

Prevention of duodenal or gastric ulcer in patients requiring continuous NSAID therapy: One orodispersible tablet of 15 mg daily (appropriate dosage forms are available for this dose); your doctor may adjust your dose to one orodispersible tablet of 30 mg daily.

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

Use in children and adolescents

Lansoprazole must not be given to children.

If you take more Lansoprazol Flas Stada than you should

If you take more lansoprazole than you have been prescribed, contact your doctor immediately or call the Toxicology Information Service, telephone number 915 620 420.

If you forget to take Lansoprazol Flas Stada

If you forget to take a dose, take it as soon as possible unless the time for the next dose is approaching. In this case, skip the missed dose and take the next tablets as usual. Do not take a double dose to make up for missed doses.

If you stop taking Lansoprazol Flas Stada

Do not stop treatment prematurely even if symptoms improve. Your condition may not be completely healed and may recur if you do not complete the full course of treatment.

If you have any further 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 everyone will experience them.

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

• Very rarely, lansoprazole may cause severe hypersensitivity (allergic) reactions. Symptoms of a hypersensitivity reaction may include fever, rash, facial swelling, swollen lymph nodes, swelling of the tongue or pharynx, difficulty swallowing, urticaria, difficulty breathing, and sometimes a rapid drop in blood pressure.
• Very rarely, serious skin reactions have been reported with lansoprazole, which may be life-threatening. Symptoms include reddish spots on the trunk, which may appear as target-shaped or circular macules, often with central blisters, skin peeling, and ulcers in the mouth, throat, nose, genitals, and eyes. These serious skin rashes may be preceded by fever and flu-like symptoms [(Stevens-Johnson Syndrome (SJS), Toxic Epidermal Necrolysis (TEN)].
• Generalized 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, your blood magnesium levels may decrease. Low magnesium levels may cause fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, and increased heart rate. If you experience any of these symptoms, inform your doctor immediately. Low magnesium levels may also lead to reduced levels of potassium or calcium in the blood. Your doctor may decide to perform regular blood tests to monitor your magnesium levels.
• Very rarely, lansoprazole may cause a reduction in the number of white blood cells (agranulocytosis), which may reduce your resistance to infection, or may coexist with abnormal reductions in red blood cells, white blood cells, and platelets (pancytopenia). If you experience an infection with symptoms such as fever and a severe deterioration in your general condition, or fever with symptoms of localized infection such as sore throat/pharynx/mouth or urinary problems, or if you experience fatigue, pale skin, unexplained bruising, or prolonged bleeding, you must consult your doctor immediately. A blood test will be performed to check for possible reductions in blood cells.
• Rarely, lansoprazole may cause inflammation of the pancreas (pancreatitis), with symptoms including sudden, severe pain in the upper middle part of the abdomen that may radiate to the back, possibly causing nausea and vomiting.
• If you develop severe or persistent diarrhea during treatment with lansoprazole, contact your doctor immediately, as lansoprazole has been associated with a small increased risk of infectious diarrhea.

Other possible adverse effects

Common (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 polyps in the stomach

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

• depression
• joint or muscle pain
• fluid retention or swelling
• changes in blood cell counts
• 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, dizziness
• altered taste, loss of appetite, inflammation of the tongue (glossitis)
• skin reactions such as burning or itching sensation, bruising, redness, and excessive sweating
• photosensitivity
• hair loss
• tingling sensation (paresthesia), tremor
• anemia (pallor)
• kidney inflammation (tubulointerstitial nephritis); possible symptoms include changes in urine volume, blood in urine
• liver inflammation (may present as yellowing of the 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):

• inflammation of the mouth (stomatitis)
• inflammation of the intestine (colitis)
• increased laboratory values such as cholesterol and triglycerides
• decreased sodium concentration in blood; symptoms include nausea and vomiting, headache, drowsiness and fatigue, confusion, muscle weakness or spasms, irritability, seizures, 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):

• lupus-like or lupus-type skin rashes
• 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 not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Lansoprazole Flas Stada

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

Do not use this medicine after the expiry date stated on the blister and carton, after EXP. The expiry date refers to the last day of the month indicated.

Do not store above 25 °C. Store in the original packaging to protect from moisture.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at a pharmacy’s SIGRE collection point. If in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Lansoprazol Flas Stada

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

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

Coating: hypromellose 3 cps (E-464), low-substituted hydroxypropylcellulose, talc (E-553b), titanium dioxide (E-171), mannitol (E-241), dispersion of methacrylic acid copolymer and ethyl acrylate (1:1), polyacrylate dispersion, glycerol monostearate, 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 flavour (flavourings, corn maltodextrin, propylene glycol (E-1520)), magnesium stearate (vegetable origin) (E-470b).

Nature of the product and contents of the pack

Lansoprazol Flas Stada 30 mg orodispersible tablets are uncoated tablets, white to yellowish-white in colour, speckled with orange to dark brown pellets, marked with "30" on one side and smooth on the other. Each orodispersible tablet has a strawberry flavour.

Lansoprazol Flas Stada 30 mg orodispersible tablets are available in blister packs contained in cardboard cartons with 7, 14, 28, 30 and 56 tablets.

Only certain pack 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 medicinal product 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 most recent review of this leaflet: November 2024

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/.