Package Insert: Information for the User

Lansoprazole VIR 30 mg Hard Gastroresistant Capsules EFG

Read this package insert carefully before starting to take the medication.

• Keep this package insert as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed for you personally and should not be given to others even if they have the same symptoms, as it may harm them.

If you consider that any of the adverse effects you are experiencing are severe or if you notice any adverse effect not mentioned in this package insert, inform your doctor or pharmacist.

Lansoprazol VIR belongs to a group of medications called proton pump inhibitors that decrease the secretion of stomach acid.

Lansoprazol VIR is indicated for:

- the treatment of duodenal ulcers, gastric ulcers, and gastroesophageal reflux esophagitis.

- the treatment of Zollinger-Ellison syndrome, a disease characterized by a significant increase in stomach acid secretion.

- the treatment to eliminate a bacteria calledHelicobacter pyloriin patients with benign duodenal and gastric ulcers in combination with antibiotics.

- the acute treatment of gastric ulcers induced by certain medications called nonsteroidal anti-inflammatory drugs, as well as the prevention of the recurrence of ulcers in patients taking nonsteroidal anti-inflammatory drugs.

Do not take Lansoprazol VIR

• If you are allergic to lansoprazol or any of the components of the medication.
• If you are breastfeeding.

• If you have a severe kidney disease.

Be especially careful with Lansoprazol VIR

• If you have a severe liver disease.

• If you have any kidney disease.
• If you have ever had a skin reaction after treatment with a similar medication to Lansoprazol VIR for reducing stomach acid.
• If you suffer from a skin rash, especially in exposed skin areas to the sun, consult your doctor as soon as possible, as it may be necessary to interrupt treatment with Lansoprazol VIR. Remember to mention any other symptoms you may notice, such as joint pain.
• When taking lansoprazol, it may cause inflammation in the kidneys. 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 must inform your doctor of these signs.

Before taking this medication, inform your doctor if:

• You are scheduled to have a specific blood test (Cromogranina A).

Use of other medications

Inform your doctor or pharmacist if you are using, or have recently used, another medication, including those acquired without a prescription.

Certain medications may interact with Lansoprazol VIR; in these cases, it may be advisable to change the dose or interrupt treatment with one of the medications. It is especially important to inform your doctor if you are taking one of the following medications:

• Anti-acids containing aluminum and magnesium hydroxide and sucralfate, as it is recommended to wait an hour before taking Lansoprazol VIR.
• Any type of anticoagulant, such as warfarin.
• Antiepileptic medications, such as phenytoin.
• Medications that act on the central nervous system, such as diazepam.
• Theophylline.

Use in children

Lansoprazol VIR has not been studied in children and therefore its use is not recommended.

Pregnancy

Consult your doctor or pharmacist before using any medication.

Your doctor will assess the benefit/risk of administering Lansoprazol VIR if you are pregnant.

Lactation

Consult your doctor or pharmacist before using any medication.

Lansoprazol VIR is contraindicated during breastfeeding.

Driving and operating machinery

Lansoprazol VIR does not affect driving or operating machinery. Rarely, cases of drowsiness or dizziness have been reported. If you notice any of these symptoms, refrain from driving vehicles, operating machinery, or performing any activity that requires concentration.

Important information about one of the components of Lansoprazol VIR:

This medication contains saccharose. If your doctor has indicated that you have an intolerance to certain sugars, consult with him before taking this medication.

This medication does not contain gluten.

Follow these instructions unless your doctor has given you different instructions.

In these cases, it is advisable to ask your doctor for written instructions and make sure you understand them well.

Remember to take your medication.

Your doctor will indicate the duration of your treatment with Lansoprazol VIR. Do not stop treatment without talking to your doctor first.

The capsules should be taken with a little water.

To achieve the optimal effect, it should be taken in the morning about 30 minutes before breakfast, when Lansoprazol is administered once a day. When administered twice a day, it should be taken in the morning about 30 minutes before breakfast and about 1.5 hours after the last meal and about 30 minutes before dinner.

Peptic Ulcer

The recommended dose is 1 capsule of 30 mg per day for 4 weeks.

Gastric Ulcer

The recommended dose is 1 capsule of 30 mg per day for 4 weeks. If the ulcer has not healed, treatment may be continued for another 4 weeks with the same dose, at the doctor's discretion.

In the treatment of gastric ulcers induced by nonsteroidal anti-inflammatory drugs in patients who require treatment with these medications, the recommended dose is 1 capsule of 30 mg per day for 8 weeks.

To prevent the recurrence of gastric ulcers in patients who have already had them but need to continue treatment with anti-inflammatory drugs, the recommended dose is 1 capsule of 30 mg per day for as long as your doctor considers necessary.

Esophagitis due to gastroesophageal reflux

The recommended dose for acute treatment is 1 capsule of 30 mg per day for 4 weeks. Depending on the evolution, treatment may be continued for another 4 weeks with the same dose, at the doctor's discretion.

Eradiation ofHelicobacter pylori

For this indication, your doctor will recommend a treatment that will also include combined antibiotics with Lansoprazol VIR.

The recommended guidelines are:

- 1 capsule of 30 mg of Lansoprazol VIR with1 gramof amoxicillin and 500 mg of clarithromycin twice a day for 7 days, or

- 1 capsule of 30 mg of Lansoprazol VIR with 250 mg or 500 mg of clarithromycin and 400 mg of metronidazole twice a day for 7 days.

Zollinger-Ellison Syndrome

The recommended initial dose is 2 capsules of 30 mg per day. This dose may be increased or decreased, as needed, based on clinical or secretion examinations performed periodically for long-term control of this condition. From 120 mg, it is recommended to divide the daily dose into two administrations.

Due to the limited experience with this medication, it is not recommended to use Lansoprazol VIR beyond the recommended treatment periods.

If you are over 65 years old, your doctor will not need to make any adjustments to the dose.

If you estimate that the action of Lansoprazol VIR is too strong or too weak, inform your doctor or pharmacist.

If you took more Lansoprazol VIR than you should

If you have taken a number of capsules greater than what your doctor has indicated, consult your doctor or pharmacist immediately, or call the toxicology information service, phone 91 562 04 20 indicating the medication and the amount used. It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

If you forgot to take Lansoprazol VIR

If you forget to take a dose, take it as soon as you can.

Do not take a double dose to compensate for the missed dose.

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Like all medications, Lansoprazol VIR may cause adverse effects.

The adverse effects that may occur while taking this medication are: diarrhea, constipation, nausea, vomiting, abdominal pain, flatulence, gastritis, cough, headache, drowsiness, fatigue, and dizziness. In some patients, occasional redness of the skin and itching have appeared. Generally, these symptoms are mild and disappear over time.

Frequent: Benign polyps in the stomach.

In rare cases, alterations in blood tests have been observed, such as: increased cholesterol, triglycerides, liver enzymes, increased potassium and uric acid, decreased white blood cells and platelets, as well as increased eosinophils (blood cells), and increased proteins in urine.

Unknown frequency

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, seek medical attention 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 your magnesium levels.

If you are taking proton pump inhibitors such as Lansoprazol VIR, especially for a period of more than one year, you may slightly increase the risk of hip, wrist, and spinal 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.

Visual hallucinations.

Reporting Adverse Effects

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

Store below 30°C

Keep Lansoprazol VIR out of sight and reach of children.

Keep the container tightly closed after each use.

Expiration Date

Do not use Lansoprazol VIR after the expiration date that appears on the label after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash.Deposit the containers and medicines you no longer need at the SIGRE collection pointof the pharmacy. If in doubt, please ask your pharmacist how to dispose of the containers and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Lansoprazol VIR 30 mg

The active ingredient is lansoprazol. Each capsule contains 30 mg of lansoprazol.

The other components (excipients) are: Sugar spheres (saccharose and cornstarch), sodium carboxymethylstarch from potato, sodium lauryl sulfate, povidone, dodecahydrate trisodium phosphate, hypromellose, copolymer of methacrylic acid and ethyl acrylate, triethyl citrate, titanium dioxide, talc.

The capsule components are: Gelatin, titanium dioxide (E-171).

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

Appearance of the product and contents of the package

Lansoprazol VIR 30 mg gastro-resistant capsules are presented in the form of hard, gastro-resistant white-beige capsules.

Packages in HDPE bottles or in aluminum/aluminum blisters.

Each package contains 14 and 28 capsules.

Holder of the marketing authorization and responsible for the manufacture:

Holder:

Industria Química y Farmacéutica VIR, S.A.

C/ Laguna 66-68-70 Polígono Industrial URTINSA II.

28923 Alcorcón (Madrid)

Manufacturing responsible:

Industria Química y Farmacéutica VIR, S.A.

C/ Laguna 66-68-70 Polígono Industrial URTINSA II.

28923 Alcorcón (Madrid)

TEVA PHARMA, S.L.U.

Polígono Malpica c/C 4.

50016 Zaragoza.

Last review date of this leaflet: December 2022.

“Logo"

Industria Química y Farmacéutica VIR, S.A.

C/ Laguna 66-68-70 Polígono Industrial URTINSA II.

28923 Alcorcón (Madrid)

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