Lansoprazole Viatris 15 mg gastro-resistant capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Lansoprazol Viatris 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 you, since it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Lansoprazol Viatris is and what it is used for

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

Your doctor may have prescribed Lansoprazol Viatris for the following indications in adults:

• 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 continuous treatment with NSAIDs (NSAID therapy is used for pain or inflammation).
• Treatment of Zollinger-Ellison syndrome.

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

You should consult a doctor if your condition worsens or does not improve after 14 days.

2. What you need to know before taking Lansoprazole Viatris

Do not take Lansoprazole Viatris

• If you are allergic to lansoprazole or to any of the other ingredients of this medicine (listed in section 6).

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 cancer.

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 together with other medicines for the treatment of Helicobacter pylori infection (antibiotics) or together with anti-inflammatory medicines for pain or rheumatism, please also read the package leaflets of these medicines carefully.

If you take proton pump inhibitors such as lansoprazole, especially if taken for more than one year, your risk of fractures of the wrist, hip or spine may increase. Inform your doctor if you have osteoporosis (reduced bone density) or if you have been told you are at risk of osteoporosis (for example, if you are taking steroids).

If you have been taking lansoprazole for a long time (more than 1 year), your doctor will likely monitor you regularly. When you see your doctor, you should report any new or unusual symptoms or circumstances.

Talk to your doctor or pharmacist before starting lansoprazole:

• If you have low 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 stop treatment with lansoprazole. Remember to mention any other symptoms you may notice, such as joint pain.
• Serious skin reactions have been reported [Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS)] associated with lansoprazole treatment. Stop using lansoprazole and seek immediate medical attention if you notice any of the symptoms related to these serious skin reactions described in section 4.
• Kidney inflammation may occur while taking 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. You should report these signs to your doctor.

Other medicines and Lansoprazole Viatris

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription.

In particular, inform your doctor or pharmacist if you are taking medicines containing any of the following active substances, as their use with lansoprazole may affect how these medicines work:

• 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).

Lansoprazole Viatris with food and drink

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

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, consult your doctor or pharmacist before taking this medicine.

Driving and using machines

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

You are solely responsible for deciding whether you are fit to drive or perform other activities requiring a high level of concentration. Due to its effects or adverse reactions, the use of medicines may be one of the factors that reduces your ability to carry out these tasks safely.

Descriptions of these effects can be found in the following sections. Please read this leaflet carefully. If you have any doubts, ask your doctor or pharmacist.

Lansoprazole Viatris contains sucrose

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

3. How to take Lansoprazole Viatris

Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. If you are unsure, consult your doctor or pharmacist again.

The dose of lansoprazole depends on your general condition. The recommended doses of lansoprazole for adults are given below. Occasionally, your doctor may prescribe a different dose and indicate the duration of your treatment.

Treatment of heartburn and acid regurgitation:

• one 15 mg or 30 mg capsule daily for 4 weeks.

If symptoms persist, inform your doctor.

If symptoms do not improve after 4 weeks, please consult 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 oesophagus (reflux oesophagitis):

• one 30 mg capsule daily for 4 weeks.

Long-term prevention of reflux oesophagitis:

• one 15 mg capsule daily; your doctor may adjust your 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 course is 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 caused by infection, it is unlikely that the ulcer will recur if the infection is successfully treated. To get 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 treatment with NSAIDs: one 30 mg capsule daily for 4 weeks.

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

Zollinger-Ellison syndrome: the usual initial dose is two 30 mg capsules daily. Afterwards, depending on your response to lansoprazole treatment, your doctor will decide the best dose for you.

Method of administration

Take the capsule whole with a glass of water before a meal. If you have difficulty swallowing the capsule, your doctor will inform you of alternative ways to take your medicine. Do not crush or chew the capsules or their contents, as this will prevent the medicine from working properly.

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

If you take lansoprazole twice daily, you should take the first dose in the morning and the second at night.

Use in children

Lansoprazole must not be given to children.

If you take more Lansoprazole Viatris than you should

If you take more lansoprazole than prescribed, contact your doctor or pharmacist immediately or call the Toxicology Information Service at 915 620 420.

If you forget to take Lansoprazole Viatris

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

If you stop taking Lansoprazole Viatris

Do not stop treatment prematurely, even if 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.

Stop using lansoprazole and seek immediate medical attention if you notice any of the following symptoms:

• Red, flat, target-shaped or circular rashes on the trunk, often with central blisters, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes. These serious rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).

• Generalized skin rash, high body temperature, and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

Common (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, and urticaria.
• Changes in liver function test results.
• Fatigue.
• Benign polyps in the stomach.

Uncommon (may affect up to 1 in 100 people):

• Depression.
• Joint or muscle pain.
• Fractures of the wrist, hip, or spine.
• Fluid retention or swelling.
• Decrease in blood cell count. You may notice unusual bruising or bleeding of the skin.

Rare (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, and redness.
• Excessive sweating.
• Light sensitivity.
• Hair loss.
• Tingling sensation on the skin (paresthesia).
• Prickling and tremors.
• Anemia (when the blood does not contain enough healthy red blood cells or hemoglobin).
• Kidney problems.
• Pancreatitis.
• Liver inflammation (may present as yellowing of the skin or eyes).
• Breast enlargement in males.
• Impotence.
• Candidiasis (fungal infection, may affect the skin or mucosa).
• 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 (may affect up to 1 in 10,000 people):

• Severe hypersensitivity reactions, including anaphylactic shock. Symptoms of hypersensitivity may include fever, rash, swelling, and sometimes a drop in blood pressure.
• Intestinal inflammation (colitis).
• Inflammation of the mouth (stomatitis).
• Changes in laboratory values such as sodium levels (low), cholesterol and triglycerides (high).
• Very severe skin reactions with redness, blisters, severe swelling, and skin loss.
• In very rare cases, lansoprazole may cause a reduction in the number of white blood cells and decrease your resistance to infections. If you develop an infection with symptoms such as fever and a serious 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 a possible reduction in white blood cells (agranulocytosis).

Frequency not known (frequency cannot be estimated from available data):

• If you have been taking lansoprazole for more than three months, your blood magnesium levels may decrease. Low magnesium levels may cause fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, and increased heart rate. If you experience any of these symptoms, inform your doctor immediately. Low magnesium levels may also lead to decreased potassium or calcium levels in the blood. Your doctor may decide to perform regular blood tests to monitor your magnesium levels.
• Low sodium levels in the blood. Common symptoms include nausea and vomiting, headache, drowsiness and fatigue, confusion, weakness or muscle spasms, irritability, seizures, rash, possibly with joint pain.
• Visual hallucinations.

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via 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 Viatris

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

Do not use this medicine after the expiry date stated on the labelling, blister pack, and bottle after EXP. The expiry date refers to the last day of the month indicated.

Blister pack: Do not store above 25°C. Keep in the original packaging to protect from light.

Bottle: Do not store above 25°C. Keep in the original packaging to protect from light. Use within 30 days after opening. After opening, keep the container tightly closed.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point in your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This helps protect the environment.

6. Package contents and other information

Composition of Lansoprazol Viatris

• The active substance is lansoprazole. Each gastro-resistant hard capsule contains 15 mg of lansoprazole.
• The other components are sugar spheres, magnesium carbonate, sucrose (see section 2 “Lansoprazol Viatris contains sucrose”), corn starch, hydroxypropylcellulose, methacrylic acid and ethyl acrylate copolymer, talc, macrogol, titanium dioxide (E 171), polysorbate 80, gelatin, and anhydrous colloidal silica. The printing ink contains shellac, strong ammonia solution, black iron oxide (E 172), and potassium hydroxide.

Nature of the product and contents of the container

White or almost white gastro-resistant hard gelatin capsule of size 2, containing white or almost white granules, with an opaque white cap and body, printed axially with 'MYLAN' over 'LN 15' on the cap and body in black ink.

Available in blisters of 7, 14, 15, 28, 28 x 1, 30, 56, 60, 84, 98, 100 and 500 hard capsules; multiple packs of 84 and 98, each containing 2 packs of 42 and 49 hard capsules respectively; and bottles of 7, 14, 28, 30, 56, 60, 84, 98, 100 and 500 hard capsules. Only certain pack sizes may be marketed.

Marketing Authorization Holder

Viatris Limited
Damastown Industrial Park
Mulhuddart, Dublin 15
Dublin
Ireland

Manufacturer:

McDermott Laboratories Limited trading as Gerard Laboratories
35/36 Baldoyle Industrial Estate
Grange Road, Dublin 13
Ireland

or

Mylan Hungary Kft.
H-2900, Komárom
Mylan utca.1
Hungary

or

Viatris Sante
360 Avenue Henri Schneider
69330 Meyzieu
France

or

Logiters Logistica Portugal S.A.
Estrada dos Arneiros, 4
2050-306 Azambuja
Portugal

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Viatris Pharmaceuticals, S.L.U.
C/ General Aranaz, 86
28027 - Madrid
Spain

This medicinal product is authorized in the European Economic Area countries and in the United Kingdom (Northern Ireland) under the following names:

Spain: Lansoprazol Viatris 15 mg gastro-resistant hard capsules EFG
France: Lansoprazole Viatris Sante 15 mg gastro-resistant capsule
Portugal: Lansoprazol Mylan
United Kingdom (Northern Ireland): Lansoprazole 15 mg gastro-resistant capsules

This leaflet was last revised in: December 2025

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