Product Information for the User

Lansoprazol VIR 15mg Hard Gastric-Resistant Capsules EFG

Read this entire product information carefully before starting to take the medication.

• Keep this product information as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed to you personally and should not be given to other people even if they have the same symptoms, as it may harm them.

If you consider that any of the adverse effects you are experiencing is severe or if you notice any adverse effect not mentioned in this product information, 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:

- maintenance treatment of gastroesophageal reflux esophagitis.

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 extra cautious 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 hydroxide and magnesium or sucralfate, as it is recommended to wait an hour before taking Lansoprazol VIR.
• Any type of anticoagulant, such as warfarin.
• Antiepileptic medications, such as phenitoína.
• 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 evaluate 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.

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 tell you how long you should take Lansoprazol VIR. Do not stop treatment without talking to your doctor first.

Capsules should be taken with a little water.

To achieve the best effect, take it in the morning about 30 minutes before breakfast.

Gastroesophageal Reflux Esophagitis

The recommended dose for maintenance treatment is 1 capsule of 15 mg per day.

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

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

If you think the action of Lansoprazol VIR is too strong or too weak, tell your doctor or pharmacist.

If you took more Lansoprazol VIR than you should

If you have taken a higher number of capsules than your doctor 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 make up for the missed dose.

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 the levels of magnesium in the blood may decrease. Low levels of magnesium can cause fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, increased heart rate. If you experience any of these symptoms, seek medical attention immediately. Low levels of magnesium can also cause 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 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 (they may 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 that does not appear 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 15 mg

The active ingredient is lansoprazol. Each capsule contains 15 mg of lansoprazol.

The other components (excipients) are: Sugar spheres (saccharose and cornstarch), carboxymethylstarch sodium of potato, sodium laurylsulfate, povidone, trisodium dodecahydrate phosphate, hypromellose, copolymer of methacrylic acid and ethyl acrylate, triethylcitrate, 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 (E-172).

Appearance of the product and contents of the package

Lansoprazol Vir 15 mg gastro-resistant capsules are presented in the form of hard, gastro-resistant white-beige capsules. Containers in HDPE bottles or in aluminum/aluminum blisters. Each container contains 28 capsules

Holder of the marketing authorization and responsible for the manufacturing:

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)

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