PATIENT INFORMATION LEAFLET

Lansoprazol Vir Pharma15 mg

Enteric-coated Capsules EFG

Read this leaflet carefully before you start taking the medicine.

• 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. Do not pass it on to others even if their symptoms are the same. It may harm them.
• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.

1.What Lansoprazol Vir Pharma is and what it is used for

2.Before taking Lansoprazol Vir Pharma

3.How to take Lansoprazol Vir Pharma

4.Possible side effects

5.Storage of Lansoprazol Vir Pharma

6.Further information

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

Your doctor may prescribe Lansoprazol Vir Pharma for the following indications:

• Treatment of duodenal and gastric ulcers
• Treatment of esophagitis caused by acid reflux
• Prevention of esophagitis caused by acid reflux
• 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 Vir Pharma 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 Vir Pharma:

• If you are allergic (hypersensitive) to lansoprazole or to any of the other components of Lansoprazol Vir Pharma.
• If you are taking another medication whose active ingredient is atazanavir (used in the treatment of HIV).

Be especially careful with Lansoprazol Vir Pharma

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

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

In case of experiencing diarrhea during treatment with Lansoprazol Vir Pharma, contact your doctor immediately, as Lansoprazol Vir Pharma has been associated with a slight increase in infectious diarrhea.

If your doctor has prescribed Lansoprazol Vir Pharma in addition to other medications intended for the treatment of Helicobacter pylori infection (antibiotics) or together with anti-inflammatory medications to treat pain or arthritis, read the prospectuses of these medications carefully.

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

If you have ever had a skin reaction after treatment with a similar medication to Lansoprazol Vir Pharma 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 Vir Pharma. Remember to mention any other symptoms you may notice, such as joint pain.

When taking lansoprazole, it may cause kidney inflammation. Symptoms and signs 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.

Use of other medications

Inform your doctor or pharmacist if you are using or have recently used other medications, including those purchased without a prescription.

Especially, inform your doctor if you are using medications containing any of the following active ingredients, as Lansoprazol Vir Pharma may affect their action:

• ketoconazole, itraconazole, rifampicin (used to treat infections)
• digoxin (used to treat heart problems)
• 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)

Taking Lansoprazol Vir Pharma with food and drinks

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

Pregnancy and breastfeeding

If you are pregnant, or think you may be pregnant, or are breastfeeding, consult your doctor before taking this medication.

Driving and operating machines

Patients taking Lansoprazol Vir Pharma 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 in a condition to drive vehicles or perform activities that require a high level of concentration. Due to its effects or adverse reactions, one of the factors that may reduce your ability to carry out 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, nurse, or pharmacist.

Important information about some of the components of Lansoprazol Vir Pharma

Lansoprazol Vir Pharma contains sucrose. If your doctor has indicated that you have an intolerance to certain sugars, consult with them before taking this medication.

Lansoprazol Vir Pharma 15 mg gastro-resistant capsules contain 0.118 mg of potassium per capsule, which should be taken into account in patients with renal insufficiency or patients on low-potassium diets.

This medication does not contain gluten.

Follow exactly the administration instructions for Lansoprazol Vir Pharma as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

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 Vir Pharma once a day, try to take it at the same time every day. You may get better results if you take Lansoprazol Vir Pharma in the morning.

If you take Lansoprazol Vir Pharma twice a day, take the first dose in the morning and the second dose at night.

The dose of Lansoprazol Vir Pharma depends on your general condition. The normal doses of Lansoprazol Vir Pharma 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 normal 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 normal treatment duration is once a day for 7 days.

The recommended antibiotic combinations are as follows:

• 30 mg of Lansoprazol Vir Pharma with 250–500 mg of clarithromycin and 1,000 mg of amoxicillin
• 30 mg of Lansoprazol Vir Pharma 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 initial normal dose is two capsules of 30 mg per day; your doctor will then decide the best dose for you based on your response to Lansoprazol Vir Pharma treatment.

Lansoprazol Vir Pharma should not be administered to children.

Follow exactly the administration instructions provided by your doctor. Consult your doctor if you have any doubts.

If you take more Lansoprazol Vir Pharma than you should

If you take more Lansoprazol Vir Pharma than prescribed, consult your doctor immediately or contact the Toxicology Information Service, Teléfono 915 620 420.

If you forget to take Lansoprazol Vir Pharma

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 Vir Pharma

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 full treatment.

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

Like all medicines, Lansoprazol Vir Pharma can cause side effects, although not everyone will experience them.

The following side effects are frequent (occur in more than 1 in 100 patients):

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

The following side effects are infrequent (occur in less than 1 in 100 patients):

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

The following side effects are rare (occur in less than 1 in 1,000 patients):

• 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 be manifested by yellowish skin or eyes)
• swelling of the chest 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, difficulty swallowing, urticaria, and difficulty breathing.

The following side effects are very rare (occur in less than 1 in 10,000 patients):

• 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 rare cases, Lansoprazol Vir Pharma may cause a reduction in the number of white blood cells, which may lead to 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 of white blood cells (agranulocytosis).

Unknown frequency:

If you are takingLansoprazol Vir Pharmafor more than three months, it is possible that the levels of magnesium in the blood may decrease. Low levels of magnesium may cause fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, and increased heart rate. If you experience any of these symptoms, see your doctor immediately. Low levels of magnesium may also produce a decrease in potassium and calcium levels in the blood. Your doctor may decide to perform periodic blood tests to monitor magnesium levels.

If you are taking proton pump inhibitors such asLansoprazol Vir Pharma, 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).

Skin rash, possibly with joint pain.

If you consider that any of the side effects you experience are severe or if you notice any side effect not mentioned in this prospectus, inform your doctor or pharmacist.

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this prospectus. 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 out of the reach and sight of children.

Do not use Lansoprazol Vir Pharma after the expiration date that appears on the packaging, after the expiration date abbreviation. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medicines at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medicines.This will help protect the environment.

Lansoprazol Vir Pharma Composition

The active ingredient is lansoprazol.

The other components are: sugar spheres (saccharose and cornstarch without gluten), sodium carboxymethylstarch from potato without gluten, sodium laurylsulfate, povidone, trisodium dodecyl phosphate, hypromellose, copolymer of methacrylic acid and ethyl acrylate, triethyl citrate, titanium dioxide (E-171) and talc. The gelatin capsule is composed of: gelatin and titanium dioxide (E-171).

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

Product Appearance and Packaging Content

Lansoprazol Vir Pharma 15 mg gastro-resistant capsules are presented in the form of hard gastro-resistant capsules, containing gastro-resistant spherical microgranules of lansoprazol, in a package of 28 capsules.

Marketing Authorization Holder and Responsible Manufacturer

The marketing authorization holder is:

Industria Química y Farmacéutica VIR, S.A.

C/ Laguna 66-70, Polígono Industrial URTINSA II

28923 Alcorcón (Madrid)

Spain

The manufacturer is:

Teva Pharma, S.L.U.

Polígono Malpica c/C, 4

50016 Zaragoza.

Spain

or

Industria Química y Farmacéutica VIR, S.A.

C/ Laguna 66-70, Poligono Industrial URTINSA II

28923 Alcorcón (Madrid)

Spain

This leaflet was approved inDecember 2022

The detailed and updated information of this medication is available on the webpage of the Spanish Agency of Medicaments and Health Products (AEMPS)http://www.aemps.gob.es/