Package Insert: Information for the Patient

Lansoprazol Viatris 30 mg Enteric-Coated Capsules EFG

Read this entire package insert carefully before starting to take this medication because it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert.See section 4.

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

2.What you need to know before starting to take Lansoprazol Viatris

3.How to take Lansoprazol Viatris

4.Possible adverse effects

5.Storage of Lansoprazol Viatris

6.Contents of the package and additional information

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

Your doctor may prescribe Lansoprazol Viatris 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 bacteriaHelicobacter pylori, in combination with antibiotics.
• Treatment or prevention of duodenal or gastric ulcers in patients requiring continuous treatment with NSAIDs (NSAID treatment is 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.

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

Do not take Lansoprazol ViatrisViatris

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take lansoprazol:

• If you have ever had a skin reaction after treatment with a similar medication to lansoprazol for reducing stomach acid.
• If you are scheduled to have a specific blood test (Cromogranina A).
• If you have reduced vitamin B12reserves or risk factors for it and receive long-term treatment with lansoprazol. As all medications that reduce the amount of acid, lansoprazol may reduce vitamin B12absorption.
• If you have a skin rash, especially in sun-exposed areas, consult your doctor as soon as possible, as it may be necessary to interrupt lansoprazol treatment. Remember to mention any other symptoms you may notice, such as joint pain.

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

Your doctor may perform or have performed a supplementary test called endoscopy to diagnose your condition and/or rule out cancer.

In case of diarrhea during lansoprazol treatment, 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 together with anti-inflammatory medications for pain or arthritis, please read the leaflets for these medications carefully.

If you are taking lansoprazol 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, seizures, dizziness, and increased heart rate. If you experience any of these symptoms, inform your doctor immediately. Low magnesium levels can also cause a decrease in blood calcium and potassium levels. Your doctor will decide if regular blood tests are necessary to monitor your magnesium levels.

Lansoprazol may cause kidney inflammation. 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. Inform your doctor of these signs.

If you take proton pump inhibitors, such as lansoprazol, especially if you take them for more than a year, you may be at increased risk of osteoporosis-related fractures of the wrist, hip, or spine. Inform your doctor if you have osteoporosis or if they have told you that you are at risk of developing osteoporosis (for example, if you are taking steroids).

If you have been taking lansoprazol for a long time (more than 1 year), your doctor will likely perform regular checks. When you see your doctor, inform them of any new or abnormal symptoms and circumstances.

Other medications and Lansoprazol Viatris

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take other medications, including those purchased without a prescription.

Especially, inform your doctor or pharmacist if you are taking medications that contain any of the following active ingredients, as their use with lansoprazol may affect how these medications work:

• Protease inhibitors for HIV 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 stomach burning or acid regurgitation).
• Sucralfate (used to heal ulcers).
• St. John's Wort (Hypericum perforatum) (used to treat mild depression).

Lansoprazol Viatris with food and drinks

To get the best results from your medication, take lansoprazol at least 30 minutes before meals with a glass of water.

Pregnancy and breastfeeding

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

Pregnancy

If you are pregnant, it is not recommended that you take lansoprazol.

Breastfeeding

During breastfeeding, consult your doctor before taking this medication. They will decide if you should take this medication or not.

Driving and operating machinery

Patients taking lansoprazol may occasionally experience side effects such as dizziness, vertigo (feeling that everything is spinning or swaying), fatigue, and visual disturbances. If you experience any of these side effects, you should exercise caution, as your reaction time may be reduced. If you are affected, do not drive or operate machinery.

You are the only one responsible for deciding whether you are fit to drive vehicles or perform other activities that require a high level of concentration. Due to the effects or adverse reactions of your medications (see section 4), one of the factors that may reduce your ability to perform 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 or pharmacist.

Lansoprazol Viatris contains saccharose

If your doctor has told you that you have an intolerance to certain sugars, consult with them or your pharmacist before taking this medication.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult again with your doctor or pharmacist.

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

Treatment of stomach burning 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, please 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 your 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 in the evening.

The usual treatment will be daily for 7 days.

The recommended antibiotic combinations are as follows:

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

If you receive anti-infective treatment because you have a 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 usual initial dose is two capsules of 30 mg per day, and then, depending on your response to lansoprazole treatment, your doctor will decide the best dose for you.

Method of administration

Take the entire capsule with a glass of water before eating. If you have difficulty swallowing the capsule, your doctor will inform you of other alternative ways to take your medication. Do not crush or chew the capsules or the contents of a capsule, as this will make the medication not work properly.

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

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

Use in children

Lansoprazole should not be administered to children.

If you take more Lansoprazol Viatris than you should

If you take more lansoprazole than indicated, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 915 620 420.

If you forget to take Lansoprazol Viatris

If you forget to take a dose, take the next dose as soon as possible, unless the next dose is almost due. In this case, skip the missed dose and take the capsules as usual.Do nottake a double dose to make up for the missed dose.

If you interrupt treatment with Lansoprazol Viatris

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 all treatment.

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

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, skin itching and urticaria.
• Changes in liver function test values.
• 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 the number of blood cells. You may notice unusual bruising or that your skin bleeds.

Rare(may 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 under the skin, hematomas, and redness.
• Excessive sweating.
• Sensitivity to light.
• Hair loss.
• Sensation of tingling on the skin (paresthesia).
• Pins and tremors.
• Anemia (when the blood does not contain enough healthy red blood cells or hemoglobin).
• Renal problems.
• Pancreatitis.
• Inflammation of the liver (may manifest as yellow skin or eyes).
• Swelling of the breasts 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 swelling of the face, tongue, or pharynx, difficulty swallowing, urticaria, and difficulty breathing.

Very rare(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 sometimes a drop in blood pressure.
• Intestinal inflammation (colitis).
• Mouth inflammation (stomatitis).
• Changes in analytical values such as sodium levels (low levels), cholesterol, and triglycerides (high levels).
• Very severe skin reactions with redness, blisters, severe inflammation, and skin loss.
• In very rare cases, lansoprazole may cause a reduction in the number of white blood cells and may decrease 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 of white blood cells (agranulocytosis).

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

• If you have been taking lansoprazole 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, increased heart rate. If you notice any of these symptoms, inform your doctor immediately. Low magnesium levels may also lead to a decrease in blood potassium or calcium levels. 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, convulsions, 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.

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

Do not use lansoprazol after the expiration date that appears on the labeling, on the blister pack, and on the bottle after CAD. The expiration date is the last day of the month indicated.

Blister pack: Do not store at a temperature above 25°C. Store in the original packaging to protect from light.

Bottle: Do not store at a temperature above 25°C. Store in the original packaging to protect from light. Use within 30 days after opening. Once opened, store the container perfectly closed.

Medicines should not be disposed of through drains or in the trash. Deposit the containers and medicines you no longer need at your pharmacy's SIGRE collection point. Ask your pharmacist how to dispose of the containers and medicines you no longer need. In this way, you will help protect the environment.

Composition of Lansoprazol Viatris

Each gastro-resistant capsule contains 30 mg of lansoprazol.

The other components are sugar spheres, magnesium carbonate, sucrose (see section 2 “Lansoprazol Viatris contains sucrose”), cornstarch, hydroxypropylcellulose, methacrylic acid copolymer and ethyl acrylate copolymer, talc, macrogol, titanium dioxide (E 171), polisorbate 80, gelatin, anhydrous colloidal silica, brilliant blue FCF (E 133) and erythrosine (E 127). The printing ink contains shellac, strong ammonia solution, iron oxide black (E 172) and potassium hydroxide.

Appearance of the product and contents of the pack

Hard gelatin capsule size 0 that contains white or almost white granules, with a pink opaque coating and body, with axial printing ‘MYLAN’ over ‘LN 30’ on the coating and body in black ink.

It is available in blisters of 7, 14, 28, 28 x 1, 30, 56, 60, 84, 98, 100 and 500 capsules, in multiple packs of 84 and 98 that each contain 2 packs of 42 and 49 capsules, respectively and bottles of 7, 14, 28, 30, 56, 60, 84, 98, 100 and 500 capsules. Some pack sizes may only be marketed.

Marketing Authorization Holder

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Responsible for manufacturing:

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

Generics (UK) Ltd

Station Close

Potters Bar, Hertfordshire

EN6 1TL

UK

or

Logiters Logistica Portugal S.A.

Estrada dos Arneiros, 4

Azambuja, 2050-544

Portugal

Further information on this medicinal product can be obtained by contacting 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 member states of the European Economic Area and in the United Kingdom (Northern Ireland) with the following names:

SpainLansoprazol Viatris 30 mg gastro-resistant capsules EFG

FranceLansoprazole Viatris Sante 30 mg gastro-resistant tablet

PortugalLansoprazol Mylan

UK (Northern Ireland)Lansoprazole 30 mg gastro-resistant capsules

This leaflet was last revised in:February 2023

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