LANSOPRAZOL VIATRIS 15 mg GASTRO-RESISTANT CAPSULES

Introduction

Package Leaflet: Information for the Patient

Lansoprazole Viatris 15 mg 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

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

1. What is Lansoprazole Viatris and what is it 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 prescribe you Lansoprazole Viatris for the following indications:

• Treatment of duodenal and gastric ulcers.
• Treatment of inflammation of the oesophagus (reflux oesophagitis).
• Prevention of reflux oesophagitis.
• 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 NSAIDs (NSAID treatment is used for pain or inflammation).
• Treatment of Zollinger-Ellison syndrome.

It may be that your doctor has prescribed lansoprazole 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 Viatris

Do not take Lansoprazole Viatris

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take lansoprazole:

• If you have ever had a skin reaction after treatment with a medicine similar to lansoprazole to reduce stomach acid.
• If you are scheduled to have a specific blood test (Chromogranin A).
• If you have low vitamin B12 body stores or risk factors for this and you receive long-term treatment with lansoprazole. Like all acid-reducing medicines, lansoprazole may reduce the absorption of vitamin B12.
• 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. Remember to mention any other symptoms you may notice, such as joint pain.

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 a complementary test called endoscopy to diagnose your disease and/or rule out cancer.

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

If your doctor has prescribed lansoprazole in addition to other medicines intended for the treatment of Helicobacter pyloriinfection (antibiotics) or together with anti-inflammatory medicines to treat pain or rheumatism, please read the package leaflets of these medicines carefully.

If you are being treated with lansoprazole for more than three months, it is possible that your magnesium level in the blood may decrease. Low magnesium levels can cause fatigue, involuntary muscle contractions, disorientation, convulsions, 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 calcium and potassium levels in the blood. Your doctor will decide whether it is convenient to regularly perform blood tests to monitor your magnesium levels.

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 report these signs to your doctor.

If you take proton pump inhibitors, such as lansoprazole, especially if you take them for more than a year, you may be at increased risk of fractures of the wrist, hip, or spine. Inform your doctor if you have osteoporosis (reduced bone density) or if you have been told that 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 probably perform regular check-ups. When you see your doctor, you should report any new or unusual symptoms and circumstances.

Other medicines and Lansoprazole Viatris

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

In particular, tell your doctor or pharmacist if you are taking medicines that contain 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 to treat 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 drinks

To get the best results from your medicine, you should take lansoprazole at least 30 minutes before meals with a glass of water.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

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

Breastfeeding

During breastfeeding, consult your doctor before taking this medicine. He will decide whether you should take this medicine or not.

Driving and using machines

Patient taking lansoprazole may 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 act with caution, as your reaction ability 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 its effects or adverse reactions, one of the factors that can reduce your ability to perform these operations safely is the use of medicines (see section 4).

In the following sections, you will find descriptions of these effects. Read the information in this leaflet carefully. If you have any further questions, ask your doctor or pharmacist.

Lansoprazole Viatris contains sucrose

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

3. How to take Lansoprazole Viatris

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

The dose of lansoprazole depends on your general condition. The recommended doses of lansoprazole for adults are indicated below. Sometimes, 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 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 ulcers:

• One 30 mg capsule per day for 2 weeks.

Treatment of gastric ulcers:

• One 30 mg capsule per day for 4 weeks.

Treatment of inflammation of the oesophagus (reflux oesophagitis):

• One 30 mg capsule per day for 4 weeks.

Long-term prevention of reflux oesophagitis:

• One 15 mg capsule per day, your doctor may adjust your dose to one 30 mg capsule per day.

Treatment of Helicobacter pyloriinfection:

• The recommended dose is one 30 mg capsule together with two different antibiotics in the morning and one 30 mg capsule together 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 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 because you have 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 usual initial 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.

Method of administration

Take the capsule whole 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 medicine. You should not crush or chew the capsules or the contents of a capsule, as this will make the medicine not work properly.

If you take this medicine 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, you should take the first dose in the morning and the second dose at night.

Use in children

Lansoprazole should not be administered to children.

If you take more Lansoprazole Viatris than you should

If you take more lansoprazole than you have been told, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone 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 of the next dose is near. In this case, skip the missed dose and take the next capsules as usual. Donot take a double dose to make up for the missed dose.

If you stop taking Lansoprazole Viatris

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.

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, 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 bleeding.

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

• Fever.
• Restlessness, drowsiness, confusion, hallucinations, insomnia, visual disturbances, vertigo.
• Taste disturbance, loss of appetite, inflammation of the tongue (glossitis).
• Skin reactions such as a burning sensation or itching under the skin, bruising, and redness.
• Excessive sweating.
• Sensitivity to light.
• Hair loss.
• Feeling of tingling on the skin (paresthesia).
• Pins and needles, tremors.
• Anemia (when the blood does not contain enough healthy red blood cells or hemoglobin).
• Kidney problems.
• Pancreatitis.
• Liver inflammation (may be manifested by yellowing of the skin or eyes).
• Swelling of the breasts in men.
• 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(may affect up to 1 in 10,000 people):

• Severe hypersensitivity reactions, including anaphylactic shock. The symptoms of a hypersensitivity reaction 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 serious 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 a possible reduction in white blood cells (agranulocytosis).

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

• If you have been taking lansoprazole for more than three months, it is possible that your magnesium levels in the blood may decrease. Low magnesium levels can cause fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, and increased heart rate. If you notice any of these symptoms, inform your doctor immediately. Low magnesium levels can also cause a decrease in 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, convulsions, rash, possibly with joint pain.
• Visual hallucinations.

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 Viatris

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

Do not use lansoprazole after the expiry date that appears on the labeling, on the blister, and on the bottle after EXP. The expiry date is the last day of the month indicated.

Blister: Do not store above 25°C. Store in the original package to protect from light.

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

Medicines should not be disposed of via wastewater or household waste. Deposit the containers and medicines you no longer need in the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Container contents and additional information

Composition of Lansoprazol Viatris

Each gastro-resistant 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.

Appearance of the product and container contents

Hard gelatin capsule of size 2 containing white or almost white granules, with opaque white cap and body, with axial printing 'MYLAN' over 'LN 15' on the cap and body in black ink.

It is available in blisters of 7, 14, 15, 28, 28 x 1, 30, 56, 60, 84, 98, 100, and 500 capsules, in multiple packs of 84 and 98, each containing 2 packs of 42 and 49 capsules, respectively, and bottles of 7, 14, 28, 30, 56, 60, 84, 98, 100, and 500 capsules. Not all 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

Generics (UK) Ltd

Station Close

Potters Bar, Hertfordshire

EN6 1TL

United Kingdom

or

Logiters Logistica Portugal S.A.

Estrada dos Arneiros, 4

Azambuja, 2050-544 Portugal

For further information on 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 Member States of the European Economic Areaand in the United Kingdom (Northern Ireland)under the following names:

Spain Lansoprazol Viatris 15 mg gastro-resistant 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:February 2023

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