Prospect: information for the user

Lansoprazol Teva-ratiopharm 15 mg hard-gastrorresistant EFG capsules

Read this prospect carefully before starting to take this 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 present the same symptoms of the disease, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they do not appear in this prospect. See section 4.

1.Lansoprazol Teva-ratiopharm 15 mg and its use

2.What you need to know before starting to take Lansoprazol Teva-ratiopharm 15 mg

3.How to take Lansoprazol Teva-ratiopharm 15 mg

4.Adverse effects

1. Storage of Lansoprazol Teva-ratiopharm 15 mg
2. Contents of the package and additional information

The active ingredient of Lansoprazol Teva-ratiopharm 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:

• 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 bacteria Helicobacter 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.

Do not take Lansoprazol Teva-ratiopharm

• 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, 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 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 hip, wrist, or vertebral fractures. Inform your doctor if you have osteoporosis or are taking corticosteroids (which may increase the risk of osteoporosis).

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

Consult your doctor or pharmacist 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 acid production, 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 Teva-ratiopharm. Remember to mention any other symptoms you may notice, such as joint pain.
• If you are scheduled to undergo a specific blood test (Cromogranin A).

Taking Lansoprazol Teva-ratiopharm 15 mg with other medications

Inform your doctor or pharmacist that you are taking, have taken recently, or may need to take any other medication.

Especially, inform your doctor if you are using medications that contain 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 heartburn or acid reflux)
• Sucralfate (used to heal ulcers)
• St. John's Wort (Hypericum perforatum) (used to treat mild depression)

Taking Lansoprazol Teva-ratiopharm 15 mg with food and drinks

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

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 fit to drive vehicles or perform activities that require a high level of concentration. Due to the effects or adverse reactions of the medication, one of the factors that may reduce your ability to carry out these operations safely is the use of the medication.

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 Teva-ratiopharm contains sucrose and sodium

This medication contains sucrose. If your doctor has indicated that you have a certain sugar intolerance, 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 of this medication as indicated by your doctor or pharmacist. 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 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 dose at night.

The dose of lansoprazol depends on your general condition. The recommended doses of lansoprazol 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 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 recommended 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 Teva-ratiopharm with 250–500 mg of clarithromycin and 1,000 mg of amoxicillin.
• 30 mg of Lansoprazol Teva-ratiopharm 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 successfully. 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 recommended initial 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 lansoprazol treatment.

Use in children:

Lansoprazol should not be administered to children.

If you take more Lansoprazol Teva-ratiopharm 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 Teva-ratiopharm:

If you forget to take a dose, take it as soon as you remember, unless 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 Teva-ratiopharm:

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 common (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 uncommon (can affect up to 1 in 100 people):

• depression
• joint or muscle pain
• fluid retention or swelling
• changes in blood cell count.
• if you are taking proton pump inhibitors such as Lansoprazol Teva-ratiopharm , especially for 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 or if you are taking corticosteroids (they may increase the risk of osteoporosis).

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, 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)
• chest swelling 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 Teva-ratiopharm 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 lansoprazol for more than three months, it is possible that blood magnesium levels may decrease. Low magnesium levels may cause fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, and increased heart rate. If you experience any of these symptoms, go to 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

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 CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash.Deposit the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. In case of doubtask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Lansoprazol ratiopharm 15 mg hard-gastroresistent capsules

• The active ingredient is lansoprazol. Each capsule contains 15 mg of lansoprazol.
• The other components are: sugar spheres (sacarosa and cornstarch), sodium laurilsulfate, povidone, potato starch (type A), dodecahydrate trisodium phosphate, hypromellose, copolymer of methacrylic acid and ethyl acrylate (1:1) trietilcitrato, titanium dioxide (E171), talc.

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

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

Appearance of the product and content of the container

Lansoprazol ratiopharm 15 mg are hard-gastroresistent 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.

HDPE bottles with 28, 56, and 500 hard-gastroresistent capsules.

Aluminum/Aluminum blisters with 28, 56, and 500 hard-gastroresistent capsules.

Only some sizes of containers may be commercially marketed.

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.

C/C, n 4 Industrial Park Malpica

Zaragoza 50016 (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/ ”

You can access detailed and updated information about this medicine by scanning the QR code included in the packaging with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/66147/P_66147.html