Lansoprazol sandoz 15 mg capsulas gastrorresistentes efg

Prospecto:information for the patient

Lansoprazol Sandoz 15 mg hard-gastroresistent EFG capsules

Lansoprazol Sandoz 30 mg hard-gastroresistent EFG capsules

Read this prospect carefully before starting to take the medicine, because 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 medicine has been prescribed only to you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

Content of theprospect

1. What Lansoprazol Sandoz is and for what it is used

1. What you need to know before starting to take Lansoprazol Sandoz
2. How to take Lansoprazol Sandoz
3. Possible adverse effects
4. Storage of Lansoprazol Sandoz
5. Contents of the package and additional information

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

Your doctor may prescribe lansoprazol for the following indications in adults:

• Treatment of duodenal and gastric ulcers
• Treatment of inflammation of the esophagus (gastroesophageal reflux esophagitis)
• Prevention of gastroesophageal reflux esophagitis
• Treatment of stomach burning and acid regurgitation
• Treatment of infections caused by the bacteriaHelicobacter 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 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 Sandoz

• If you are allergicto lansoprazol or to any of theothercomponentsofthis medication (including in the section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Lansoprazol Sandoz.

Inform your doctor if you have a severe liver disease. The doctor may need to adjust the dose.

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

In case of experiencing 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 together with anti-inflammatory medications to treat pain or rheumatism, read also carefully the leaflets of these medications.

If you are taking proton pump inhibitors such as lansoprazol, especially during a period of more than one year, it may slightly increase the risk of hip, wrist, and spinal fractures. Inform your doctor if you have osteoporosis (reduced bone density) or if you are taking corticosteroids (they may increase the risk of osteoporosis).

If you have been taking lansoprazol for a long time (more than 1 year), your doctor will probably perform regular checks.At your doctor's visits, you must inform him of any new or abnormal symptoms and circumstances.

Consult your doctor before starting to take lansoprazol:

• If you have reduced vitamin B12 reserves or risk factors for it and receive long-term treatment with lansoprazol. Like all medications that reduce the amount of acid, lansoprazol may reduce vitamin B12 absorption,
• If you are scheduled to undergo a specific blood test (Cromogranin A),
• If you have ever had a skin reaction after treatment with a similar medication to lansoprazol for reducing stomach acidity.
• 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.

When taking lansoprazol, it may cause inflammation in the kidneys. The 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. You must inform your doctor of these signs.

Other medications and Lansoprazol Sandoz

Inform your doctor or pharmacist if you are using, have used, or may need to use any other medication, including those purchased without a prescription.

Especially, inform your doctor if you are using medications containing any of the following active ingredients, as lansoprazol may affect their mode of 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 Sandoz with food and drinks

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using 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 their 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 effects.

Read this prospectus carefully.

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

Lansoprazol Sandoz contains sucrose and sodium.

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

This medication contains less than 1 mmol of sodium (23 mg) per capsule; it 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 again.

Swallow the capsule whole with a glass of water. If you have difficulty swallowing the capsule, your doctor will inform you of alternative ways to take the medication. Do not crush or chew the capsules or the contents of an empty capsule, as this will make them ineffective.

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

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

The dose of lansoprazoledepends on your general condition. The normal doses of lansoprazolefor 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 capsule 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 capsule of 30 mg per day for 2 weeks.

Treatment of gastric ulcer:one capsule of 30 mg per day for 4 weeks.

Treatment of esophagitis due to reflux:one capsule of 30 mg per day for 4 weeks.

Long-term prevention of esophagitis due to reflux:one capsule of 15 mg per day; your doctor may adjust the dose to one capsule of 30 mg per day.

Treatment of Helicobacter pylori infection:The normal dose is one capsule of 30 mg with two different antibiotics in the morning and one capsule of 30 mg with two different antibiotics at night. Treatment is usually daily for 7 days.

The recommended antibiotic combinations are as follows:

• 30 mg of lansoprazolewith 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 it at the right time anddo not miss any doses.

Treatment of duodenal or gastric ulcer in patients requiring continuous treatment with NSAIDs:one capsule of 30 mg per day for 4 weeks.

Prevention of duodenal or gastric ulcer in patients requiring continuous treatment with NSAIDs:one capsule of 15 mg per day; your doctor may adjust the dose to one capsule of 30 mg per day.

Zollinger-Ellison syndrome:The initial normal dose is two capsules of 30 mg per day; your doctor will then decide on the best dose for you based on your response to lansoprazole treatment.

Use in children

Lansoprazole should not be administered to children

If you take more Lansoprazol Sandoz 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 Sandoz

If you forget to take a dose, take it as soon as you remember, unless the time for the next dose is almost due. In this case, skip the missed dose and take the capsules as usual. Do not take a double dose to make up for the missed dose.

If you interrupt treatment with Lansoprazol Sandoz

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 medications, this medication may cause side effects, although not everyone will experience them.

Frequent side effects (may affect up to 1 in 10 patients):

• 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.

Less frequent side effects (may affect up to 1 in 100 patients)

• depression,
• joint or muscle pain,
• fluid retention or swelling,
• changes in blood cell count.

Rare side effects (may affect up to 1 in 1,000 patients)

• 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 (pale skin),
• kidney 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 side effects (may affect up to 1 in 10,000 patients)

• 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 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).

Side effects of unknown frequency (cannot be estimated from available data)

• If you are 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 have any of these symptoms, see your doctor immediately. Low magnesium levels may also cause a decrease in potassium and calcium levels in the blood. Your doctor may decide to perform periodic blood tests to monitor magnesium levels,
• skin rash possibly with joint pain,
• visual hallucinations.

If you consider that any of the side effects you are experiencing are severe or if you notice any side effect not mentioned in this prospectus, 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 prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

Keepthis medicationout of the sight and reach of children.

Do not store at a temperature above 30°C.

Do not use this medication after the expiration date that appears on the packaging and blister, after CAD/EXP. The expiration date is the last day of the month indicated.

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 pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Lansoprazol Sandoz

• The active ingredient is lansoprazol.

Each gastro-resistant hard capsule contains 15 mg of lansoprazol

Each gastro-resistant hard capsule contains 30 mg of lansoprazol

• The other components are: sugar spheres (made up of cornstarch and sucrose), sodium lauryl sulfate, N-methylglucamine, mannitol (E-421), hypromellose, macrogol 6000, talc, poloxamer 80, titanium dioxide (E171) and a copolymer of methacrylic acid and ethyl acrylate.
• The capsule components are:

Lansoprazol Sandoz 15 mg: quinoline yellow (E104), titanium dioxide (E171), water and gelatin.

Lansoprazol Sandoz 30 mg: titanium dioxide (E171), water and gelatin.

Appearance of the product and contents of the packaging

Lansoprazol Sandoz 15 mg is presented in the form of gastro-resistant hard capsules of yellow opaque color that contain gastro-resistant lansoprazol granules in Alu/Alu blister packs, conditioned in a cardboard box. Each box contains 28 or 500 capsules.

Lansoprazol Sandoz 30 mg is presented in the form of gastro-resistant hard capsules of white opaque color that contain gastro-resistant lansoprazol granules in Alu/Alu blister packs, conditioned in a cardboard box. Each box contains 14, 28, 56 or 500 capsules.

Only some sizes of packaging may be commercially marketed.

Marketing Authorization Holder and Responsible for Manufacturing:

Marketing Authorization Holder

Sandoz Farmacéutica, S.A.
Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Responsible for Manufacturing:

Liconsa, S.A.

Avda. Miralcampo nº 7,

Polígono Industrial Miralcampo

19200 Azuqueca de Henares (Guadalajara)

Spain

Last review date of this leaflet: December 2022

Thedetailed 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