Prospect: Information for the user

Lansoprazol Davur 15 mg hard-gastroresistent EFG capsules

Read this prospect carefully before starting to take the medicine, as 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 for you and should not be given to other people, even if they have the same symptoms, as it may harm them.

-If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

1.What is Lansoprazol Davur 15 mg and what is it used for

2.What you need to know before starting to take Lansoprazol Davur 15 mg

3.How to take Lansoprazol Davur 15 mg

4.Possible adverse effects

5.Storage of Lansoprazol Davur 15 mg

6.Contents of the package and additional information

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

Your doctor may prescribe Lansoprazol Davur 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 withantibiotics.

-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 Davur 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 Davur 15 mg:

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

- If you are taking another medication whose active ingredient is atazanavir (used in the treatment of HIV).

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 inflammation in the kidneys. 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 symptoms.

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 diarrhea during treatment with Lansoprazol Davur, contact your doctor immediately, as Lansoprazol Davur has been associated with a slight increase in infectious diarrhea.

If your doctor has prescribed Lansoprazol Davur 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 exceeding 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 Davur for a long time (over 1 year), your doctor will likely perform regular checks. During your doctor's visits, inform them 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 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 Davur. Remember to mention any other symptoms you may notice, such as joint pain.
• If you are scheduled to undergo a specific blood test (Cromogranina A).

Taking Lansoprazol Davur 15 mg with other medications

Inform your doctor or pharmacist if you are using or have recently used other medications, including those purchased without a prescription.

Especially, inform your doctor if you are using medications containing any of the following active ingredients, as Lansoprazol Davur may affect their mode of 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 Davur 15 mg with food and drinks

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

Pregnancy, breastfeeding, and fertility

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

Driving and operating machinery

Patients taking Lansoprazol Davur 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 descriptions of these side effects.

Read this prospectus carefully.

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

Lansoprazol Davur 15 mg contains saccharose and sodium

This medication contains saccharose. If your doctor has indicated that you have an intolerance to certain sugars, consult with them 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 for this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Take 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 not work properly.

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

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

The dose of Lansoprazol Davur depends on your general condition. The normal doses of Lansoprazol Davur 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 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. The treatment, usually, will be daily for 7 days.

The recommended antibiotic combinations are as follows:

- 30 mg of Lansoprazol Davur with 250–500 mg of clarithromycin and 1,000 mg of amoxicillin

- 30 mg of Lansoprazol Davur 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 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; subsequently, your doctor will decide the best dose for you based on your response to treatment with Lansoprazol Davur.

Use in children

Lansoprazol Davur should not be administered to children.

If you take more Lansoprazol Davur 15 mg than you should

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

If you forget to take Lansoprazol Davur 15 mg

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 Davur 15 mg

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.

The following side effects are frequent (can 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, benign polyps in the stomach
• skin rash, itching
• changes in liver function test values
• fatigue

The following side effects are infrequent (can affect up to 1 in 100 people):

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

The following side effects are rare (can 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 sensation under the skin, bruises, redness and excessive sweating
• light sensitivity
• hair loss
• tingling sensation (paresthesia), tremors
• anemia (pale skin)
• kidney problems
• pancreatitis
• inflammation of the liver (may manifest as 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.

The following side effects are very rare (can 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)
• 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, Lansoprazol Davur may cause a reduction in the number of white blood cells, which can 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 lansoprazol for more than three months, it is possible that magnesium levels in the blood may decrease. Low magnesium levels can cause fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, and increased heart rate. If you have any of these symptoms, see your doctor immediately. Low magnesium levels can also produce 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 are taking proton pump inhibitors such as Lansoprazol Davur, especially for a period of more than one year, it may slightly increase the risk of hip, wrist, and spinal column fractures. Inform your doctor if you have osteoporosis or if you are taking corticosteroids (they may increase the risk of osteoporosis).

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 leaflet. 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.

Store below 30°C.

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

Do not use this medication after the expiration date that appears on the packaging, after the expiration date abbreviation. The expiration date is the last day of the month indicated.

Medications should not be thrown down the drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. In this way, you will help protect the environment.

Composition of Lansoprazol Davur 15 mg capsules

• The active ingredient is lansoprazol. Each capsule contains 15 mg of lansoprazol.
• The other components are: sugar spheres (sucrose and cornstarch), sodium lauryl sulfate, povidone, carboxymethyl starch sodium (Type A), dodecahydrate trisodium phosphate, hypromellose, copolymer of methacrylic acid and ethyl acrylate (1:1), triethyl citrate, titanium dioxide, talc.

The capsule components are: gelatin, titanium dioxide (E171).

The printing ink of the capsules contains shellac, anhydrous ethanol, isopropyl alcohol, propylene glycol, n-butanol, ammonium hydroxide, potassium hydroxide, iron oxide black (E172).

Appearance of the product and contents of the packaging

Lansoprazol Davur 15 mg capsules arehard-gastroresistant capsules with a white opaque cap and body, filled with beige micropellets. The capsules have been marked with black ink with the letter “L” on the cap and the number “15” on the body.

Packaging in HDPE bottles with 28 hard-gastroresistant capsules.

Packaging in aluminum/aluminum blisters of 28 hard-gastroresistant capsules.

Only some packaging sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Teva Pharma, S.L.U.

C/Anabel Segura 11, Edificio Albatros B, 1st floor,

Alcobendas, 28108 Madrid (Spain)

Responsible manufacturer

Teva Pharma S.L.U.

Polígono Malpica c/C 4.

50016 Zaragoza.

Spain

Last review date of this leaflet: December 2022

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