LANSOPRAZOL VIR 30 mg HARD GASTRO-RESISTANT CAPSULES

Introduction

Package Leaflet: Information for the User

Lansoprazole VIR 30 mg Hard Gastro-Resistant Capsules EFG

Read all of this leaflet carefully before you start taking this medicine.

• 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 symptoms are the same as yours.

If you experience any of the side effects, or if you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Contents of the Package Leaflet

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

1. What is Lansoprazole VIR and what is it used for

Lansoprazole VIR belongs to a group of medicines called proton pump inhibitors that reduce stomach acid secretion.

Lansoprazole VIR is indicated for:

• treatment of duodenal ulcer, gastric ulcer, and gastroesophageal reflux esophagitis.
• treatment of Zollinger-Ellison syndrome, a disease characterized by a significant increase in stomach acid secretion.
• treatment to eliminate a bacterium called Helicobacter pylori in patients with benign duodenal and gastric ulcers in combination with antibiotics.
• acute treatment of gastric ulcers induced by non-steroidal anti-inflammatory drugs, as well as prevention of ulcer recurrence in patients taking non-steroidal anti-inflammatory drugs.

2. Before taking Lansoprazole VIR

Do not take Lansoprazole VIR

• If you are allergic to lansoprazole or any of the components of the medicine.
• If you are breastfeeding.

• If you have severe kidney disease.

Be cautious with Lansoprazole VIR

• If you have severe liver disease.

• If you have kidney disease.
• If you have ever had a skin reaction after treatment with a medicine similar to Lansoprazole VIR to reduce stomach acidity.
• If you experience 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 discontinue treatment with Lansoprazole VIR. Remember to mention any other symptoms you may notice, such as joint pain.
• When taking lansoprazole, kidney inflammation may occur. Signs and symptoms may include decreased urine volume or blood in the urine and/or hypersensitivity reactions such as fever, skin rash, and joint stiffness. You should inform your doctor of these signs.

Before taking this medicine, inform your doctor if:

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

Use of other medicines

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

Certain medicines may interact with Lansoprazole VIR; in these cases, it may be convenient to change the dose or discontinue treatment with one of the medicines. It is especially important that you inform your doctor if you are taking any of the following medicines:

• If you are taking antacids that contain aluminum hydroxide and magnesium or sucralfate, it is recommended to wait one hour before taking Lansoprazole VIR.
• If you are taking any type of anticoagulant such as warfarin.
• If you are taking antiepileptic medicines such as phenytoin.
• If you are taking medicines that act on the central nervous system such as diazepam.
• If you are taking theophylline.

Use in children

The use of Lansoprazole VIR has not been studied in children, and therefore, its use is not recommended.

Pregnancy

Consult your doctor or pharmacist before using any medicine.

Your doctor will assess the benefit/risk of administering Lansoprazole VIR in case you are pregnant.

Breastfeeding

Consult your doctor or pharmacist before using any medicine.

Lansoprazole VIR is contraindicated during breastfeeding.

Driving and using machines

Lansoprazole VIR does not affect driving ability or machine operation. Rarely, cases of drowsiness or dizziness have been reported. If you experience any of these symptoms, avoid driving vehicles, using machines, or performing any activity that requires concentration.

Important information about some of the components of Lansoprazole VIR:

This medicine contains sucrose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

This medicine does not contain gluten.

3. How to take Lansoprazole VIR

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

In these cases, it is convenient to ask the doctor for written instructions and make sure you have understood them well.

Remember to take your medicine.

Your doctor will indicate the duration of your treatment with Lansoprazole VIR. Do not discontinue 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, 30 minutes before breakfast, when lansoprazole is administered once a day. When administered twice a day, it should be taken in the morning, 30 minutes before breakfast, and at night, one and a half hours after the last food intake and 30 minutes before dinner.

Duodenal 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 4 more weeks with the same dose, at the doctor's discretion.

In the treatment of gastric ulcers induced by non-steroidal anti-inflammatory drugs in patients who need to continue treatment with these medications, the recommended dose is 1 capsule of 30 mg once a day for 8 weeks.

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

Gastroesophageal Reflux Esophagitis

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 4 more weeks with the same dose, at the doctor's discretion.

Eradiation ofHelicobacter pylori

For this indication, your doctor will recommend a treatment that includes antibiotics combined with Lansoprazole VIR.

The recommended guidelines are:

• 1 capsule of 30 mg of Lansoprazole VIR with 1 gram of amoxicillin and 500 mg of clarithromycin twice a day for 7 days, or
• 1 capsule of 30 mg of Lansoprazole VIR with 250 mg or 500 mg of clarithromycin and 400 mg of metronidazole twice a day for 7 days.

Zollinger-Ellison Syndrome

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

Since experience with this medicine is limited, it is not recommended to use Lansoprazole VIR for longer than the recommended periods.

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

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

If you took more Lansoprazole VIR than you should

If you have taken a number of capsules higher than the one indicated by the doctor, consult your doctor or pharmacist immediately, or call the toxicology information service, phone 91 562 04 20, indicating the medicine and the amount used. It is recommended to take the package and the package leaflet of the medicine to the healthcare professional.

If you forgot to take Lansoprazole 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 forgotten dose.

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4. Possible side effects

Like all medicines, Lansoprazole VIR can cause side effects.

The side effects that may occur while taking this medicine are: diarrhea, constipation, nausea, vomiting, abdominal pain, flatulence, gastritis, cough, headache, drowsiness, fatigue, and dizziness. In some patients, skin redness and itching have occasionally appeared. These symptoms are usually mild and disappear over time.

Frequent: Benign polyps in the stomach.

Rarely, changes 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 protein in urine.

Frequency unknown

If you are taking Lansoprazole for more than three months, it is possible that magnesium levels in the blood may decrease. Low magnesium levels can cause fatigue, 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 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 like Lansoprazole VIR, 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.

Visual hallucinations.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not mentioned in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: http://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

Store below 30°C

Keep Lansoprazole VIR out of the sight and reach of children.

Keep the container tightly closed after each use.

Expiration date

Do not use Lansoprazole VIR after the expiration date shown on the label after EXP. The expiration date is the last day of the month indicated.

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

6. Further information

Composition of Lansoprazole VIR 30 mg

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

The other components (excipients) are: sugar spheres (sucrose and cornstarch), sodium starch glycolate, sodium lauryl sulfate, povidone, disodium phosphate dodecahydrate, hypromellose, methacrylic acid - ethyl acrylate copolymer, triethyl citrate, titanium dioxide, talc.

The components of the capsule are: gelatin, 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, black iron oxide (E172)

Appearance of the product and package contents

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

Packaging in HDPE bottles or aluminum/aluminum blisters.

Each package contains 14 and 28 capsules.

Marketing Authorization Holder and Manufacturer:

Holder:

Industria Química y Farmacéutica VIR, S.A.

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

28923 Alcorcón (Madrid)

Manufacturers:

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.

Date of the last revision 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 about this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es