LANSOPRAZOL DAVUR 15 mg HARD GASTRORESISTENT CAPSULES

Introduction

Package Leaflet: Information for the User

Lansoprazole Davur 15 mg Hard Gastro-Resistant Capsules 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 and other information:

1. What is Lansoprazole Davur and what is it used for
2. What you need to know before you take Lansoprazole Davur
3. How to take Lansoprazole Davur
4. Possible side effects
5. Storage of Lansoprazole Davur
6. Contents of the pack and other information

1. What is Lansoprazole Davur and what is it used for

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

Your doctor may prescribe you Lansoprazole Davur for the following indications:

• Treatment of duodenal and gastric ulcers.
• Treatment of inflammation of the esophagus (reflux esophagitis).
• Prevention of reflux esophagitis.
• 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 is possible that your doctor has prescribed Lansoprazole Davur for another indication or at a different dose than indicated in this leaflet. Follow your doctor's instructions regarding the administration of the medicine.

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

2. What you need to know before you take Lansoprazole Davur

Do not take Lansoprazole Davur

• If you are allergic to lansoprazole or any of the other ingredients of this medicine (listed in section 6).
• If you are taking another medicine whose active substance is atazanavir (used in the treatment of HIV).

Warnings and precautions

Tell your doctor if you have a severe liver disease. It is possible that 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 you experience diarrhea during treatment with Lansoprazole Davur, contact your doctor immediately, as Lansoprazole Davur has been associated with a slight increase in infectious diarrhea.

If your doctor has prescribed Lansoprazole Davur 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.

Taking a proton pump inhibitor like lansoprazole, especially for a period of more than one year, may slightly increase the risk of fractures of the hip, wrist, or spine. Inform your doctor if you have osteoporosis or if you are taking corticosteroids (which may increase the risk of osteoporosis).

If you have been taking Lansoprazole Davur for a long time (more than 1 year), your doctor will probably perform regular check-ups. During your visits to the doctor, you should inform him of any new or abnormal symptoms or circumstances.

Consult your doctor before starting to take lansoprazole:

• If you have reduced body stores of vitamin B12 or risk factors for this and you receive long-term treatment with lansoprazole. Like all medicines that reduce the amount of acid, lansoprazole may reduce the absorption of vitamin B12.
• If a specific blood test (Chromogranin A) is scheduled.

• If you have ever had a skin reaction after treatment with a medicine similar to lansoprazole to reduce stomach acidity.
• If you suffer from 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 Davur. Remember to mention any other symptoms you may notice, such as joint pain.
• There have been reports of serious skin reactions in relation to treatment with lansoprazole [Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug hypersensitivity syndrome with eosinophilia and systemic symptoms (DRESS)]. Stop using lansoprazole and call your doctor immediately if you refer to any of the symptoms related to serious skin reactions described in section 4.
• When taking lansoprazole, kidney inflammation may occur. 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 should inform your doctor of these signs.

Taking Lansoprazol Davur with other medicines

Tell your doctor or pharmacist if you are using or have recently used other medicines, including those obtained without a prescription.

In particular, tell your doctor if you are using medicines that contain any of the following active substances, as Lansoprazole 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 with food and drinks

To get the best results from your medicine, you should take Lansoprazole Davur at least 30 minutes before meals with 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 taking this medicine.

Driving and using machines

Patient taking Lansoprazole Davur may occasionally experience side effects, such as dizziness, drowsiness, fatigue, and visual disturbances. If you experience any of these side effects, you should act with caution as your reaction ability may be reduced.

You are the only one responsible for deciding whether you are in a fit state 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 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 Davur contains sucrose and sodium

This medicine contains sucrose. If your doctor has told you that you have an intolerance to some sugars, consult with him before taking this medicine.

This medicine contains less than 1 mmol of sodium (23 mg) per capsule; this is essentially "sodium-free".

3. How to take Lansoprazole Davur

Follow exactly the administration instructions of this medicine 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 other alternative ways to take the medicine. Do not crush or chew the capsules or the contents of an emptied capsule, as this will make them not work properly.

If you take lansoprazole once a day, try to take it always at the same time. You may get better results if you take this medicine 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 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 or 30 mg capsule per day for 4 weeks. If symptoms do not improve after 4 weeks, consult your doctor.

Treatment of duodenal ulcer:one 30 mg capsule per day for 2 weeks.

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

Treatment of esophageal inflammation (reflux esophagitis):one 30 mg capsule per day for 4 weeks.

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

Treatment of Helicobacter pyloriinfection:The normal dose is one 30 mg capsule together with two different antibiotics in the morning and one 30 mg capsule together with two different antibiotics at night. The treatment will normally be daily for 7 days.

The recommended combinations of antibiotics are as follows:

• 30 mg of lansoprazole with 250-500 mg of clarithromycin and 1000 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 come back if the infection is treated satisfactorily. 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 capsule per day for 4 weeks.

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

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

Use in children

This medicine should not be administered to children.

If you take more Lansoprazole Davur than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, go to the nearest hospital, or call the Toxicology Information Service, phone 915 620 420, indicating the medicine and the amount ingested.

If you forget to take Lansoprazole Davur

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

If you stop taking Lansoprazole Davur

Do not stop treatment before time because the symptoms have improved. It is possible that your condition has not been completely cured and may come back if you do not finish all the treatment.

If you have any other questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you start to notice any of the following side effects, stop taking lansoprazole and contact your doctor immediately:

• round or target-like red spots on the trunk, often with blisters in the center, peeling, ulcers in the mouth, throat, nose, genitals, and eyes. These serious skin rashes can be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• generalized exanthema, elevated body temperature, and lymphadenopathy (DRESS or drug hypersensitivity syndrome).

Common 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 stomach polyps.

Uncommon 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, vertigo
• altered taste, loss of appetite, inflammation of the tongue (glossitis)
• skin reactions such as burning sensation or itching under the skin, bruising, redness, and excessive sweating
• sensitivity to light
• hair loss
• tingling sensation (paresthesia), tremor
• anemia (pallor)
• kidney problems
• pancreatitis
• liver inflammation (may manifest as yellowing of the skin or eyes)
• breast swelling in males, impotence
• candidiasis (fungal infection, can affect the skin or mucous membranes)
• angioedema; contact your doctor immediately if you experience symptoms of angioedema, such as swelling of the face, tongue, or pharynx, 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. The symptoms of hypersensitivity reaction 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 serious skin reactions with redness, vesicles, severe inflammation, and skin loss
• in very rare cases, Lansoprazole 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. You will have a blood test to check for possible reduction of white blood cells (agranulocytosis).

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

• if you are taking lansoprazole for more than three months, it is possible that your blood magnesium levels 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, go to the 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
• low sodium levels in the blood. Common symptoms include nausea and vomiting, headache, drowsiness, and fatigue, confusion, muscle weakness or spasms, irritability, convulsions, coma
• skin rash, possibly with joint pain.
• visual hallucinations.

If you are taking proton pump inhibitors like Lansoprazole Davur, especially for a period of more than one year, you may slightly increase the risk of fractures of the hip, wrist, or spine. Inform your doctor if you have osteoporosis or if you are taking corticosteroids (which may increase the risk of osteoporosis).

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Lansoprazole Davur

Store below 30°C.

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

Do not use this medicine after the expiry date which is stated on the carton, after EXP. The expiry date is the last day of the month stated.

Medicines should not be disposed of via wastewater or household waste. Place the empty cartons and unused medicine in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of cartons and unused medicines. This will help protect the environment.

6. Container Content and Additional Information

Composition of Lansoprazol Davur 15 mg capsules

• The active ingredient is lansoprazole. Each capsule contains 15 mg of lansoprazole.
• The other components are: sugar spheres (sucrose and corn starch), sodium lauryl sulfate, povidone, sodium carboxymethyl potato starch (type A), dodecahydrate disodium phosphate, hypromellose, copolymer of methacrylic acid and ethyl acrylate (1:1), triethyl citrate, titanium dioxide (E171), and talc.

The components of the capsule are: gelatin and titanium dioxide (E171).

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

Appearance of the Product and Container Content

Lansoprazol Davur 15 mg capsules are 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.

Containers in HDPE bottles with 28 hard gastro-resistant capsules.

Containers in Aluminum/Aluminum blisters of 28 hard gastro-resistant capsules

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Teva Pharma, S.L.U.

C/Anabel Segura 11, Edificio Albatros B, 1ª planta,

Alcobendas, 28108 Madrid (Spain)

Manufacturer

Teva Pharma S.L.U.

Polígono Malpica c/C 4.

50016 Zaragoza.

Spain

Date of the Last Revision of this Prospectus:June 2025

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