Package Insert: Information for the Patient

Lansoprazole Aurovitas Spain 15 mg Hard Gastroresistant Capsules EFG

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

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others who 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 package insert. See section 4.

1.What is Lansoprazole Aurovitas Spain and how is it used

2.What you need to know before starting to take Lansoprazole Aurovitas Spain

3.How to take Lansoprazole Aurovitas Spain

4.Possible adverse effects

5.Storage of Lansoprazole Aurovitas Spain

6.Contents of the package and additional informationadditional

The active ingredient of Lansoprazol Aurovitas Spain 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 (acid reflux esophagitis).

-Prevention of acid 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 a different dose than indicated in this leaflet. Followexactlythe administration instructions for this medication as indicated byyour doctor.

You should consult a doctor if you worsen or do not improve after 14 days.

Do not take LansoprazolAurovitas Spainn:

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

Warnings and precautions

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

When taking lansoprazol, it may cause kidney inflammation. 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.

Your doctor may perform or have performed a diagnostic test called endoscopy to diagnose your condition 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 the prospectuses of these medications carefully.

The fact of taking a proton pump inhibitor such as lansoprazol, especially for a period of more than one year, may slightly increase the risk of hip, wrist, or vertebral 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).

If you have been taking lansoprazol for a long time (more than 1 year), your doctor will probably perform regular check-ups. During your doctor's visits, inform them of any new or abnormal symptoms.

Consult your doctoror pharmacistbefore starting to take lansoprazol:

-If you have reduced vitamin B12 reserves or risk factors for it and receive long-term treatment with lansoprazol. As all medications that reduce the amount of acid, lansoprazol may reduce vitamin B12 absorption.

-If you are scheduled to undergo a specific blood test (Cromogranina A).

-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.

Other medications and LansoprazolAurovitas Spain

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 using medications that contain any of the following active ingredients, as lansoprazol may affect their action:

-Protease inhibitors for HIV 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 LansoprazolAurovitas Spainwith food and drinks

To get the best results from your medication, take Lansoprazol Aurovitas Spain at least 30 minutes before mealswith a glass of water.

Pregnancy, breastfeeding, and fertility

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

Driving and operating machinery

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 perform 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, nurse, or pharmacist.

Lansoprazol Aurovitas Spaincontains saccharose

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

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

Swallow the capsule whole with a glass of water. If you have difficulty swallowing the capsule, your doctor will inform you of other 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 not work properly.

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 at night.

The dose of lansoprazol depends on your general condition. The recommended doses 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 capsule of 15 mg or 30 mg per day for 4 weeks. 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 acid reflux:one capsule of 30 mg per day for 4 weeks.

Long-term prevention of acid reflux esophagitis: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 usual 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. The usual treatment is once a day 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 antibiotic 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 usual initial dose is two capsules of 30 mg per day; subsequently, your doctor will decide on the best dose for you based on your response to lansoprazol treatment.

Use in children

Lansoprazol should not be administered to children.

If you take more Lansoprazol Aurovitas Spain than you should

If you take more lansoprazol than indicated, or in case of accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service immediately at 91 562 04 20.

If you forget to take Lansoprazol Aurovitas Spain

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 capsules as usual. Do not take a double dose to make up for the missed dose.

If you interrupt treatment with Lansoprazol Aurovitas Spain

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

Frequent side effects (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 polyps in the stomach

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

-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 people):

-fever

-restlessness, drowsiness, confusion, hallucinations, insomnia, visual disturbances, dizziness

-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

-tingling sensation (paresthesia), tremors

-anemia (pale skin)

-kidney problems

-pancreatitis

-inflammation of the liver (may be manifested by yellowish 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 people):

-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)

-inflammation of the intestine (colitis)

-changes in laboratory 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).

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, increased heart rate. If you experience 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.
• low sodium levels in the blood. Common symptoms include nausea and vomiting, headache, drowsiness and fatigue, confusion, muscle weakness or spasms, irritability, seizures, coma.
• skin rash, possibly with joint pain.
• visual hallucinations.

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 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.

Do not use this medication after the expiration date that appears on the blister pack, the bottle label, and the box after CAD. The expiration date is the last day of the month indicated.

Blister pack:Do not store at a temperature above 30°C. Store in the original packaging to protect it from moisture.

Bottle:Do not store at a temperature above 30°C. Keep the bottle perfectly closed to protect it from moisture.

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

Composition of Lansoprazol Aurovitas Spain

- The active ingredient is lansoprazol

- The other components are:

Content of the capsules:sugar spheres (sucrose and cornstarch), sodium lauryl sulfate, meglumine, mannitol (E421), hypromellose, macrogol, talc, polisorbate 80, titanium dioxide (E171), dispersion at 30% of methacrylic acid and ethyl acrylate copolymer (1:1)

15 mg:

Capsule coating:gelatin, titanium dioxide (E171), quinoline yellow (E104)

Appearance of the product and content of the packaging

15 mg:

These gastro-resistant capsules are available in blister packs containing: 28 capsules, clinical packaging of 500 capsules. They are also available in bottles containing: 28 capsules.

Only some packaging sizes may be marketed.

Marketing authorization holder and responsible manufacturer

The marketing authorization holder is:

Aurovitas Spain, S.A.U.

Avda. de Burgos 16-D

28036 Madrid

Spain

The manufacturer is:

Laboratorios Liconsa, S.A.

Avda. Miralcampo, Nº 7, Industrial Estate Miralcampo,

19200 Azuqueca de Henares (Guadalajara)

Spain

Last review date of this leaflet:December 2022

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