Lansoprazole Vir 30 mg gastro-resistant hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Lansoprazole VIR 30 mg gastro-resistant hard capsules EFG

Read all of this leaflet carefully before you start taking this 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 personally and must not be given to others, even if they have the same symptoms as you, because it may harm them.

If you consider any of the side effects you experience to be serious, or if you notice any side effects not listed in this leaflet, please inform your doctor or pharmacist.

Contents of the leaflet

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

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

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

Lansoprazol VIR is indicated for:

• the treatment of duodenal ulcer, gastric ulcer, and gastroesophageal reflux-induced esophagitis.
• the treatment of Zollinger-Ellison syndrome, a condition characterized by a marked increase in the stomach's acid secretion.
• the treatment to eradicate a bacterium called Helicobacter pylori in patients with benign duodenal and gastric ulcers, in combination with antibiotics.
• the short-term treatment of gastric ulcers induced by medicines known as non-steroidal anti-inflammatory drugs (NSAIDs), as well as the prevention of ulcer recurrence in patients taking NSAIDs.

2. Before taking Lansoprazol VIR

Do not take Lansoprazole VIR

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

• If you are breastfeeding.

• If you have a severe kidney disease.

Special precautions with Lansoprazol VIR

• If you have severe liver disease.

• If you have any kidney disease.

• If you have ever had a skin reaction after treatment with a medicine similar to Lansoprazol VIR used to reduce stomach acid.

• If you develop a skin rash, especially in areas of skin exposed to sunlight, consult your doctor as soon as possible, as it may be necessary to stop treatment with Lansoprazol VIR. Remember to mention any other symptoms you may notice, such as joint pain.

• Kidney inflammation may occur while taking lansoprazole. Signs and symptoms may include reduced urine volume or presence of blood in the urine and/or hypersensitivity reactions such as fever, skin rash, and joint stiffness. You must report these signs to your doctor.

Before taking this medicine, tell your doctor if:

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

Use of other medicines

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

Certain medicines may interact with Lansoprazol VIR; in such cases it may be necessary to adjust 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 containing aluminium hydroxide and magnesium or sucralfate, it is recommended to wait one hour before taking Lansoprazol VIR.
• If you are taking anticoagulant medicines such as warfarin.
• If you are taking antiepileptic medicines such as phenytoin.
• If you are taking medicines acting on the central nervous system such as diazepam.
• If you are taking theophylline.

Use in children

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

Pregnancy

Consult your doctor or pharmacist before taking any medicine.

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

Breast-feeding

Consult your doctor or pharmacist before taking any medicine.

Lansoprazol VIR is contraindicated during breast-feeding.

Driving and using machines

Lansoprazol VIR does not affect the ability to drive or operate machinery. Rarely, cases of drowsiness or dizziness have been reported. If you experience any of these symptoms, refrain from driving vehicles, operating machinery, or performing any activity requiring concentration.

Important information about some of the components of Lansoprazol VIR:

This medicine contains sucrose. If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine.

This medicine does not contain gluten.

3. How to take Lansoprazol VIR

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

In such cases, it is advisable to request written instructions from your doctor and make sure you have fully understood them.

Remember to take your medicine.

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

The capsules should be swallowed with some water.

For optimal effect, take the medicine in the morning, about 30 minutes before breakfast, when lansoprazole is administered once daily. When administered twice daily, it should be taken in the morning about 30 minutes before breakfast and in the evening one and a half hours after the last intake of food and about 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 another 4 weeks at the same dose, at the physician's discretion.

For the treatment of gastric ulcer induced by nonsteroidal anti-inflammatory drugs in patients who need to continue treatment with these medications, the recommended dose is 1 capsule of 30 mg once daily for 8 weeks.

To prevent recurrence of gastric ulcer in patients who have previously suffered from it but require ongoing treatment with anti-inflammatory drugs, the recommended dose is 1 capsule of 30 mg once daily for as long as your doctor considers necessary.

Gastroesophageal reflux esophagitis

The recommended dose for acute treatment is 1 capsule of 30 mg daily for 4 weeks. Depending on the patient's progress, the treatment may be extended for another 4 weeks at the same dose, at the physician's discretion.

Eradication of Helicobacter pylori

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

The recommended regimens are:

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

Zollinger-Ellison Syndrome

The recommended initial dose is 2 capsules of 30 mg daily. This dose may be increased or decreased at the physician's discretion, based on clinical and secretory assessments performed periodically for long-term control of this condition. For daily doses exceeding 120 mg, it is recommended to divide the daily dose into two administrations.

Due to limited experience with this medication, the use of Lansoprazol VIR beyond the recommended treatment durations is not advised.

If you are over 65 years of age, no dose adjustment is necessary.

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

If you have taken more Lansoprazol VIR than you should have

If you have taken more capsules than prescribed by your doctor, consult your doctor or pharmacist immediately, or call the Toxicology Information Service at 91 562 04 20, indicating the medication and amount taken. It is recommended to bring the medicine package and leaflet to the healthcare professional.

If you forget to take Lansoprazol VIR

If you miss a dose, take it as soon as you remember.

Do not take a double dose to make up for the missed dose.

4. Possible adverse effects

Like all medicines, Lansoprazol VIR may cause adverse effects.

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

Frequent: Benign polyps in the stomach.

Rarely, changes in blood test results 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, involuntary muscle contractions, disorientation, seizures, dizziness, and increased heart rate. If you experience any of these symptoms, consult your doctor immediately. Low magnesium levels may also lead to decreased levels of potassium and calcium in the blood. 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 longer than one year, there may be a slight increase in the risk of fractures of the hip, wrist, and spine. Inform your doctor if you have osteoporosis or if you are taking corticosteroids (which may increase the risk of osteoporosis).

Skin rash, possibly with joint pain.

Visual hallucinations.

Reporting of 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 leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: http://www.notificaram.es. By reporting adverse effects, you can help provide 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.

Expiry

Do not use Lansoprazole VIR after the expiry date stated on the label after EXP. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of medicines and containers you no longer need. This will help protect the environment.

6. Additional Information

Composition of Lansoprazol VIR 30 mg

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

The other components (excipients) are: Sugar spheres (sucrose and maize starch), sodium carboxymethyl potato starch, sodium lauryl sulfate, povidone, trisodium phosphate dodecahydrate, hypromellose, methacrylic acid and ethyl acrylate copolymer, triethyl citrate, titanium dioxide, talc.

Capsule shell components: gelatin, 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, black iron oxide (E172).

Appearance of the product and contents of the package

Lansoprazol VIR 30 mg gastro-resistant capsules are presented as white-beige hard gastro-resistant capsules.

Packaging in HDPE bottles or aluminum/aluminum blisters.

Each package contains 14 or 28 capsules.

Marketing Authorization Holder and Manufacturer:

Marketing Authorization 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 most recent review 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 up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es