Lansoprazole Vir 15 mg gastro-resistant hard capsules EFG
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Lansoprazol VIR 15mg gastro-resistant hard capsules EFG
Read the entire 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 it may harm them.
If you consider any of the side effects you experience to be severe, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.
Leaflet contents
- What Lansoprazole is and what it is used for
- Before you take Lansoprazole VIR
- How to take Lansoprazole VIR
- Possible side effects
- How to store Lansoprazole VIR
- 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:
- maintenance treatment of gastroesophageal reflux disease-associated esophagitis.
2. Before taking Lansoprazol VIR
Do not take Lansoprazole VIR
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If you are allergic to lansoprazole or to any of the components of the medicine.
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If you are breastfeeding.
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If you have a severe kidney disease.
Special precautions with Lansoprazol VIR
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If you have severe liver disease.
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If you have any kidney disease.
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If you have ever had a skin reaction after treatment with a medicine similar to Lansoprazol VIR used to reduce stomach acid.
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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.
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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
Inform your doctor or pharmacist if you are taking, or have recently taken, 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 anticoagulants 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 using any medication.
Your doctor will assess the benefit/risk of administering Lansoprazol VIR if you are pregnant.
Breast-feeding
Consult your doctor or pharmacist before using any medication.
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 informed you of 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 understood them correctly.
Remember to take your medicine.
Your doctor will tell you how long your treatment with Lansoprazol VIR should last. Do not stop treatment without first talking to your doctor.
The capsules should be swallowed with some water.
To achieve the optimal effect, take the medicine in the morning, about 30 minutes before breakfast.
Gastroesophageal reflux esophagitis
The recommended dose for maintenance treatment is 1 capsule of 15 mg daily.
Because experience with this medicine is limited, the use of Lansoprazol VIR beyond the recommended time periods is not recommended.
If you are over 65 years old, your doctor will not need to adjust the dose.
If you think that the effect of Lansoprazol VIR is too strong or too weak, tell your doctor or pharmacist.
If you have taken more Lansoprazol VIR than you should have
If you have taken more capsules than your doctor prescribed, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at 91 562 04 20, stating the name of the medicine and the amount taken. It is recommended to bring the medicine's packaging and leaflet to the healthcare professional.
If you forget to take Lansoprazol VIR
If you forget to take a dose, take it as soon as possible.
Do not take a double dose to make up for the missed dose.
4. Possible adverse effects
Like all medicines, Lansoprazole 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 occasional patients, skin redness and itching have appeared. Generally, these symptoms are mild and disappear with time.
Frequent: Benign gastric polyps.
Rarely, changes in blood test results have been observed, such as: increased cholesterol, triglycerides, liver enzymes, increased potassium and uric acid levels, decreased white blood cells and platelets, 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 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 blood. Your doctor may decide to perform periodic blood tests to monitor your magnesium levels.
If you are taking proton pump inhibitors such as Lansoprazole 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 Lansoprazol VIR
Store below 30°C.
Keep Lansoprazol VIR out of the sight and reach of children.
Keep the container tightly closed after each use.
Expiry
Do not use Lansoprazol VIR after the expiry date stated on the label after EXP. The expiry date is the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE point located at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of unused medicines and their containers. This will help protect the environment.
6. Additional Information
Composition of Lansoprazol VIR 15 mg
The active substance is lansoprazole. Each capsule contains 15 mg of lansoprazole.
The other components (excipients) are: Sugar spheres (sucrose and maize starch), sodium carboxymethyl starch from potato, sodium lauryl sulfate, povidone, trisodium phosphate dodecahydrate, hypromellose, methacrylic acid-ethyl acrylate copolymer, triethyl citrate, titanium dioxide, talc.
Components of the capsule shell: gelatin, titanium dioxide (E-171).
The printing ink for the capsules contains: shellac, anhydrous ethanol, isopropyl alcohol, propylene glycol, n-butyl alcohol, ammonium hydroxide, potassium hydroxide, black iron oxide (E-172).
Appearance of the product and contents of the pack
Lansoprazol VIR 15 mg gastro-resistant capsules are presented as white-beige, hard gastro-resistant capsules. Packaged in HDPE bottles or aluminum/aluminum blisters. Each package contains 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 medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es