LANSOPRAZOL VIR PHARMA 15 mg GASTRO-RESISTANT CAPSULES

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Lansoprazole Vir Pharma15 mg

Gastro-resistant capsules EFG

Read the package leaflet carefully before starting to take the medicine.

• Keep this package leaflet, as 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. Do not pass it on to others, as it may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet.

Contents of the package leaflet:

1. What is Lansoprazole Vir Pharma and what is it used for
2. Before taking Lansoprazole Vir Pharma
3. How to take Lansoprazole Vir Pharma
4. Possible side effects
5. Storage of Lansoprazole Vir Pharma
6. Further information

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

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

Your doctor may prescribe you Lansoprazole Vir Pharma for the following indications:

• Treatment of duodenal and gastric ulcers
• Treatment of inflammation of the esophagus (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 who require continuous treatment with non-steroidal anti-inflammatory drugs (NSAIDs) (NSAID treatment is used for pain or inflammation)
• Treatment of Zollinger-Ellison syndrome

It is possible that your doctor has prescribed you Lansoprazole Vir Pharma for another indication or at a different dose than indicated in this package leaflet. Follow your doctor's instructions regarding the administration of the medicine.

2. Before taking Lansoprazole Vir Pharma

Do not take Lansoprazole Vir Pharma:

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

Be careful with Lansoprazole Vir Pharma

Tell your doctor if you have a severe liver disease. It is possible that the doctor may need to adjust the 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 Vir Pharma, contact your doctor immediately, as Lansoprazole Vir Pharma has been associated with a slight increase in infectious diarrhea.

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

If you have been taking Lansoprazole Vir Pharma for a long time (more than 1 year), your doctor will probably perform regular check-ups on you. During your visits to the doctor, you should inform him of any new or abnormal symptoms and circumstances.

If you have ever had a skin reaction after treatment with a medicine similar to Lansoprazole Vir Pharma to reduce stomach acidity.

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 Vir Pharma. Remember to mention any other symptoms you may notice, such as joint pain.

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 inform your doctor of these signs.

Use of other medicines

Tell your doctor or pharmacist if you are using or have recently used other medicines, including those obtained without a prescription.

In particular, inform your doctor if you are using medicines that contain any of the following active substances, as Lansoprazole Vir Pharma may affect their mode of 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 heartburn or acid regurgitation)
• sucralfate (used to heal ulcers)
• St. John's Wort (Hypericum perforatum) (used to treat mild depression)

Taking Lansoprazole Vir Pharma with food and drinks

To get the best results from your medicine, you should take Lansoprazole Vir Pharma at least 30 minutes before meals.

Pregnancy and breastfeeding

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

Driving and using machines

Patients taking Lansoprazole 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 act with caution as your reaction ability 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 can reduce your ability to perform these operations safely is the use of medicines.

In the following sections, you will find descriptions of these effects.

Read the information in this package leaflet carefully.

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

Important information about some of the components of Lansoprazole Vir Pharma

Lansoprazole Vir Pharma contains sucrose. If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medicine.

Lansoprazole 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 in patients with low-potassium diets.

This medicine does not contain gluten.

3. How to take Lansoprazole Vir Pharma

Follow your doctor's instructions for the administration of Lansoprazole Vir Pharma exactly. Consult your doctor or pharmacist if you have any doubts.

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 make them not work properly.

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

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

The dose of Lansoprazole Vir Pharma depends on your general condition. The normal doses of Lansoprazole Vir Pharma for adults are indicated 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 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 30 mg capsule per day for 2 weeks.

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

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

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

Treatment of Helicobacter pyloriinfection:The normal dose is one 30 mg capsule together with two different antibiotics in the morning and one 30 mg capsule together with two different antibiotics at night. The normal treatment is once a day for 7 days.

The recommended antibiotic combinations are as follows:

• 30 mg of Lansoprazole Vir Pharma with 250-500 mg of clarithromycin and 1000 mg of amoxicillin
• 30 mg of Lansoprazole Vir Pharma with 250 mg of clarithromycin and 400-500 mg of metronidazole

If you receive anti-infective treatment due to an ulcer, it is unlikely that the ulcer will recur 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 initial normal dose is two 30 mg capsules per day; subsequently, based on your response to treatment with Lansoprazole Vir Pharma, the doctor will decide the best dose for you.

Lansoprazole Vir Pharma should not be administered to children.

Follow your doctor's instructions for administration exactly. Consult your doctor if you have any doubts.

If you take more Lansoprazole Vir Pharma than you should

If you take more Lansoprazole Vir Pharma than indicated, consult your doctor immediately or contact the Toxicology Information Service, Telephone 915 620 420.

If you forget to take Lansoprazole Vir Pharma

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

If you stop taking Lansoprazole Vir Pharma

Do not stop treatment prematurely because the symptoms have improved. It is possible that your condition has not been completely cured and may recur if you do not complete the entire treatment.

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

4. Possible side effects

Like all medicines, Lansoprazole Vir Pharma can cause side effects, although not everybody gets them.

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

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

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

• fever
• restlessness, drowsiness, confusion, hallucinations, insomnia, visual disturbances, vertigo
• altered taste, loss of appetite, inflammation of the tongue (glossitis)
• skin reactions such as burning sensation or itching under the skin, bruising, redness, and excessive sweating
• sensitivity to light
• hair loss
• tingling sensation (paresthesia), tremor
• anemia (pallor)
• kidney problems
• pancreatitis
• inflammation of the liver (may be manifested by yellowing of the skin or eyes)
• breast swelling in males, 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, hives, 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. The symptoms of hypersensitivity reaction may include fever, rash, swelling, and, occasionally, 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, blisters, severe inflammation, and skin loss
• in very rare cases, Lansoprazole Vir Pharma may cause a reduction in the number of white blood cells, which can cause a decrease in 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. You will have a blood test to check for a possible reduction in white blood cells (agranulocytosis).

Frequency unknown:

If you are taking Lansoprazole Vir Pharma 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, convulsions, dizziness, increased heart rate. If you experience any of these symptoms, go to the doctor immediately. Low magnesium levels can also cause a decrease in blood potassium and calcium levels. Your doctor may decide to perform periodic blood tests to monitor magnesium levels.

If you are taking proton pump inhibitors like Lansoprazole Vir Pharma, especially for a period of more than one year, you may have a slightly increased risk of hip, wrist, and spine fractures. Inform your doctor if you have osteoporosis or if you are taking corticosteroids (which can increase the risk of osteoporosis).

Skin rash, possibly with joint pain.

If you consider that any of the side effects you are experiencing is serious or if you notice any side effect not mentioned in this package leaflet, inform your doctor or pharmacist.

Reporting of side effects

If you experience any side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect not listed in this package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Lansoprazole Vir Pharma

Store below 30°C.

Keep out of the reach and sight of children.

Do not use Lansoprazole Vir Pharma after the expiration date stated 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 via wastewater or household waste. Place the packaging and medicines you no longer need in the SIGRE collection point at the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Further information

Composition of Lansoprazole Vir Pharma

The active substance is lansoprazole.

The other components are: sugar spheres (sucrose and gluten-free cornstarch), sodium carboxymethyl potato starch, sodium lauryl sulfate, povidone, disodium phosphate dodecahydrate, hypromellose, methacrylic acid and ethyl acrylate copolymer, triethyl citrate, titanium dioxide (E-171), and talc. The gelatin capsule is composed of: gelatin and titanium dioxide (E-171).

The ink used for printing on the capsules contains: shellac, anhydrous ethyl alcohol, isopropyl alcohol, propylene glycol, n-butyl alcohol, ammonium hydroxide, potassium hydroxide, iron oxide black (E172)

Appearance of the product and packaging contents

Lansoprazole Vir Pharma 15 mg gastro-resistant capsules are presented in the form of hard gastro-resistant capsules, which contain spherical gastro-resistant microgranules of lansoprazole, in a package of 28 capsules.

Marketing authorization holder and 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 package leaflet was approved inDecember 2022

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