Lansoprazole Teva-Ratiopharm 15 mg gastro-resistant hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Lansoprazole Teva-ratiopharm 15 mg gastro-resistant hard capsules EFG

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must 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 effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What Lansoprazole Teva-ratiopharm is and what it is used for
2. What you need to know before taking Lansoprazole Teva-ratiopharm
3. How to take Lansoprazole Teva-ratiopharm
4. Possible side effects
   1. How to store Lansoprazole Teva-ratiopharm
   2. Contents of the pack and other information

1. What Lansoprazol Teva-ratiopharm is and what it is used for

The active substance in Lansoprazol Teva-ratiopharm is lansoprazole, a proton pump inhibitor. Proton pump inhibitors reduce the amount of acid produced by the stomach.

Your doctor may prescribe lansoprazole for the following indications:

• Treatment of duodenal and gastric ulcers
• Treatment of inflammation of the oesophagus (reflux esophagitis)
• Prevention of reflux esophagitis
• Treatment of heartburn and acid regurgitation
• Treatment of infections caused by the bacterium Helicobacter pylori, in combination with antibiotics
• Treatment or prevention of duodenal or gastric ulcers in patients requiring ongoing treatment with non-steroidal anti-inflammatory drugs (NSAIDs) (NSAID therapy is used for pain or inflammation)
• Treatment of Zollinger-Ellison syndrome

Your doctor may have prescribed lansoprazole for an indication or at a dose different from that stated in this leaflet. Follow your doctor's instructions regarding how to take the medicine.

Consult a doctor if your condition worsens or if you do not improve after 14 days.

2. What you need to know before taking Lansoprazole Teva-ratiopharm

Do not take Lansoprazole Teva-ratiopharm

• 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 containing the active substance atazanavir (used in the treatment of HIV).

Warnings and precautions

Tell your doctor if you have severe liver disease. Your doctor may need to adjust your dose.

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

If you experience diarrhoea during treatment with lansoprazole, contact your doctor immediately, as lansoprazole has been associated with a slight increase in infectious diarrhoea.

If your doctor has prescribed lansoprazole in combination with other medicines used to treat Helicobacter pylori infection (antibiotics) or together with anti-inflammatory drugs for pain or rheumatism, read the package leaflets of these medicines carefully as well.

Taking a proton pump inhibitor such as lansoprazole, especially for more than one year, may slightly increase the risk of hip, wrist, or vertebral fractures. 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 for a long time (more than 1 year), your doctor will likely monitor you regularly. During visits to your doctor, you should report any new or unusual symptoms or circumstances.

Consult your doctor or pharmacist before starting lansoprazole:

• If you have reduced body stores of vitamin B12 or risk factors for this, and you are receiving long-term treatment with lansoprazole. Like all medicines that reduce acid levels, lansoprazole may reduce the absorption of vitamin B12.
• If you are scheduled to have a specific blood test (chromogranin A).
• If you have ever had a skin reaction after treatment with a medicine similar to lansoprazole used to reduce stomach acidity.
• If you develop a skin rash, especially in areas of skin exposed to sunlight, consult your doctor as soon as possible, as it may be necessary to discontinue treatment with Lansoprazole Teva-ratiopharm. Remember to mention any other symptoms you may notice, such as joint pain.
• Serious skin reactions have been reported with lansoprazole treatment [Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS)]. Stop using lansoprazole and contact your doctor immediately if you experience any of the symptoms related to serious skin reactions described in section 4.
• Kidney inflammation may occur during treatment with lansoprazole. Signs and symptoms may include decreased urine volume or blood in the urine and/or hypersensitivity reactions such as fever, rash, and joint stiffness. Inform your doctor if you experience any of these signs.

Taking Lansoprazole Teva-ratiopharm with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

In particular, inform your doctor if you are taking medicines containing any of the following active substances, as lansoprazole may affect their 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 Lansoprazole Teva-ratiopharm with food and drinks

For optimal effectiveness, take lansoprazole at least 30 minutes before meals with a glass of water.

Pregnancy, breastfeeding, and fertility

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

Driving and using machines

Patients taking lansoprazole may occasionally experience side effects such as dizziness, vertigo, fatigue, and visual disturbances. If you experience any of these side effects, exercise caution, as your reaction capabilities may be reduced.

You are solely responsible for deciding whether you are fit to drive or perform activities requiring high concentration. One of the factors that may reduce your ability to perform these tasks safely is the use of medicines.

The descriptions of these effects can be found in the following sections.

Read this leaflet carefully.

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

Lansoprazole Teva-ratiopharm contains sucrose and sodium

This medicine contains sucrose. If your doctor has diagnosed you with an intolerance to certain sugars, consult with him before taking this medicine.

This medicine contains less than 1 mmol of sodium (23 mg) per capsule; i.e., it is essentially “sodium-free”.

3. How to take Lansoprazol Teva-ratiopharm

Follow exactly the instructions for use of this medicine given by your doctor or pharmacist. If you are unsure, 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 medicine. Do not crush or chew the capsules or the contents of an emptied capsule, as this will prevent the medicine from working properly.

If you take lansoprazole once a day, try to take it at the same time each day. You may achieve better results if you take this medicine first thing in the morning.

If you take lansoprazole twice a day, you should take the first dose in the morning and the second in the evening.

The dose of lansoprazole depends on your general condition. The recommended doses for adults are given below. Occasionally, 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 daily for 4 weeks. If symptoms persist, inform your doctor.

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

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

Treatment of inflammation of the esophagus (reflux esophagitis): one 30 mg capsule daily for 4 weeks.

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

Treatment of Helicobacter pylori infection: The recommended dose is one 30 mg capsule taken in the morning together with two different antibiotics, and one 30 mg capsule taken in the evening together with two different antibiotics. The usual treatment duration is once daily for 7 days.

The recommended antibiotic combinations are as follows:

• 30 mg lansoprazole with 250–500 mg clarithromycin and 1,000 mg amoxicillin.
• 30 mg lansoprazole with 250 mg clarithromycin and 400–500 mg metronidazole.

If you are receiving anti-infective treatment for an ulcer, the ulcer is unlikely to recur if the infection is successfully treated. To achieve the best results from your medicine, take it at the correct time and do not miss any doses.

Treatment of duodenal or gastric ulcer in patients requiring continuous NSAID therapy: one 30 mg capsule daily for 4 weeks.

Prevention of duodenal or gastric ulcer in patients requiring continuous NSAID therapy: one 15 mg capsule daily; your doctor may adjust the dose to one 30 mg capsule daily.

Zollinger-Ellison syndrome: The recommended initial dose is two 30 mg capsules daily; subsequently, depending on your response to lansoprazole treatment, your doctor will decide the most appropriate dose for you.

Use in children

This medicine should not be given to children.

If you take more Lansoprazol Teva-ratiopharm than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, go to the nearest hospital, or call the Toxicology Information Service at 91 562 04 20, stating the medicine and the amount ingested.

If you forget to take Lansoprazol Teva-ratiopharm

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

If you stop taking Lansoprazol Teva-ratiopharm

Do not stop treatment prematurely, even if your symptoms have improved. Your condition may not be completely healed and could return if you do not complete the full course of treatment.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

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

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

Common adverse effects (may affect up to 1 in 10 people)

• headache, dizziness
• diarrhea, constipation, stomach pain, nausea and vomiting, flatulence, dryness or pain in mouth or throat
• skin rash, itching
• changes in liver function test values
• fatigue
• benign gastric polyps.

Uncommon adverse effects (may affect up to 1 in 100 people)

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

Rare adverse effects (may affect up to 1 in 1,000 people)

• fever
• restlessness, drowsiness, confusion, hallucinations, insomnia, visual disturbances, dizziness
• taste disturbances, loss of appetite, inflammation of the tongue (glossitis)
• skin reactions such as burning or itching sensation under the skin, bruising, redness, and excessive sweating
• photosensitivity
• hair loss
• tingling sensation (paresthesia), tremor
• anemia (pallor)
• kidney problems
• pancreatitis
• liver inflammation (may present as yellowing of the skin or eyes)
• breast swelling in males, impotence
• candidiasis (fungal infection, may affect 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, or breathing difficulties.

Very rare adverse 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 occasionally low blood pressure
• inflammation of the mouth (stomatitis)
• colitis (inflammation of the intestine)
• changes in laboratory values, such as levels of sodium, cholesterol, and triglycerides
• very severe skin reactions with redness, blisters, severe swelling, and skin loss
• in very rare cases, Lansoprazol Davur may cause a reduction in the number of white blood cells, which can decrease your resistance to infections. If you develop an infection with symptoms such as fever and severe deterioration in your general condition, or fever with signs of localized 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).

Frequency unknown (cannot be estimated from available data)

• if you are taking lansoprazole for more than three months, magnesium levels in the blood may decrease. Low magnesium levels can cause fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, and increased heart rate. If you experience any of these symptoms, see your doctor immediately. Low magnesium levels may also lead to decreased levels of potassium and calcium in the blood. Your doctor may decide to perform periodic blood tests to monitor magnesium levels
• low levels of sodium 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.

If you are taking proton pump inhibitors such as Lansoprazol Davur, especially for a period longer than one year, there may be a slight increase in the risk of fractures of the hip, wrist, and spine. Inform your doctor if you have osteoporosis or if you are taking corticosteroids (which may increase the risk of osteoporosis).

Reporting of adverse effects

If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Lansoprazole Teva-ratiopharm

Store below 30°C.

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

Do not use this medicine after the expiry date stated on the packaging, after EXP. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Lansoprazol ratiopharm 15 mg gastro-resistant hard capsules

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

Components of the capsule shell: gelatin and titanium dioxide (E171).

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

Appearance of the product and contents of the pack

Lansoprazol ratiopharm 15 mg are capsules with an opaque white cap and body, filled with beige micropellets. The capsules are printed in black ink with the letter “L” on the cap and the number “15” on the body.

Packs in HDPE bottles containing 28, 56 and 500 gastro-resistant hard capsules.

Packs in aluminium/aluminium blisters containing 28, 56 and 500 gastro-resistant hard capsules.

Only certain 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, 1st floor,

Alcobendas, 28108 Madrid (Spain)

Manufacturer

Teva Pharma, S.L.U.

C/C, n 4 Polígono Industrial Malpica

Zaragoza 50016 (Spain)

Date of the most recent revision of this leaflet: June 2025

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (Agencia Española de Medicamentos y Productos Sanitarios - AEMPS) http://www.aemps.gob.es/

You can access detailed and up-to-date information about this medicinal product by scanning with your mobile phone (smartphone) the QR code included on the outer packaging. You may also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/66147/P_66147.html