Lansoprazole Vir Pharma 30 mg gastro-resistant capsules EFG
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
PACKAGE LEAFLET: INFORMATION FOR THE USER
Lansoprazol Vir Pharma 30 mg
Gastro-resistant 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 only and must not be given to other people, even if they have the same symptoms, as 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, inform your doctor or pharmacist.
Leaflet contents:
- What Lansoprazol Vir Pharma is and what it is used for
- Before taking Lansoprazol Vir Pharma
- How to take Lansoprazol Vir Pharma
- Possible side effects
- Storage of Lansoprazol Vir Pharma
- Further information
1. What Lansoprazol Vir Pharma is and what it is used for
The active substance is lansoprazol, a proton pump inhibitor. Proton pump inhibitors reduce the amount of acid produced by the stomach.
Your doctor may prescribe Lansoprazol Vir Pharma for the following indications:
- Treatment of duodenal and gastric ulcers
- Treatment of inflammation of the oesophagus (reflux esophagitis)
- Prevention of reflux esophagitis
- Treatment of heartburn and acid regurgitation
- Treatment of infections caused by the bacterium Helicobacter pylori, in combination with antibiotics
- Treatment or prevention of duodenal or gastric ulcers in patients requiring long-term treatment with non-steroidal anti-inflammatory drugs (NSAIDs) (NSAID therapy is used for pain or inflammation)
- Treatment of Zollinger-Ellison syndrome
Your doctor may have prescribed Lansoprazol Vir Pharma for an indication or at a dose different from that stated in this leaflet. Follow your doctor's instructions regarding how to take the medicine.
2. Before taking Lansoprazol Vir Pharma
Do not take Lansoprazol Vir Pharma:
- If you are allergic (hypersensitive) to lansoprazole or to any of the other components of Lansoprazol Vir Pharma.
- If you are taking another medicine containing atazanavir (used in the treatment of HIV).
Take special care with Lansoprazol Vir Pharma
Inform your doctor if you have severe liver disease. Your doctor may need to adjust your dose.
Your doctor may have performed or may perform an additional test called endoscopy to diagnose your condition and/or rule out cancer.
If you experience diarrhea during treatment with Lansoprazol Vir Pharma, contact your doctor immediately, as Lansoprazol Vir Pharma has been associated with a slight increase in infectious diarrhea.
If your doctor has prescribed Lansoprazol Vir Pharma together with other medicines for the treatment of Helicobacter pylori infection (antibiotics) or together with anti-inflammatory drugs for pain or rheumatism, please also read carefully the package leaflets of these medicines.
If you have been taking Lansoprazol Vir Pharma for a long time (more than 1 year), your doctor will likely perform regular check-ups. During visits to your doctor, you must report any new or unusual symptoms or circumstances.
If you have ever had a skin reaction after treatment with a medicine similar to Lansoprazol Vir Pharma used to reduce stomach acidity.
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 discontinue treatment with Lansoprazol Vir Pharma. Remember to mention any other symptoms you may notice, such as joint pain.
When taking lansoprazole, inflammation of the kidney may occur. Signs and symptoms may include decreased urine volume or presence of blood in the urine and/or hypersensitivity reactions such as fever, skin rash, and joint stiffness. You should report these signs to your doctor.
Use of other medicines
Inform your doctor or pharmacist if you are using, or have recently used, any other medicines, including those obtained without a prescription.
In particular, inform your doctor if you are taking medicines containing any of the following active substances, as Lansoprazol Vir Pharma may affect their way of action:
- ketoconazole, itraconazole, rifampicin (used to treat infections)
- digoxin (used to treat heart problems)
- theophylline (used to treat asthma)
- tacrolimus (used to prevent transplant rejection)
- fluvoxamine (used to treat depression and other psychiatric disorders)
- antacids (used to treat heartburn or acid regurgitation)
- sucralfate (used to heal ulcers)
- St. John’s wort (Hypericum perforatum) (used to treat mild depression)
Taking Lansoprazol Vir Pharma with food and drinks
For optimal results, Lansoprazol Vir Pharma should be taken at least 30 minutes before meals.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, or are breastfeeding, consult your doctor before taking this medicine.
Driving and using machines
Patients taking Lansoprazol Vir Pharma may occasionally experience side effects such as dizziness, vertigo, fatigue, and visual disturbances. If you experience any of these side effects, you should exercise caution, as your reaction capabilities may be reduced.
You are solely responsible for deciding whether you are fit to drive or perform activities requiring a high level of concentration. Due to its effects or adverse reactions, the use of medicines is one of the factors that may reduce your ability to carry out these tasks safely.
Descriptions of these effects can be found in the following sections.
Please read the information in this leaflet carefully.
If you have any doubts, ask your doctor, nurse, or pharmacist.
Important information about some of the components of Lansoprazol Vir Pharma
Lansoprazol Vir Pharma contains sucrose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.
Lansoprazol Vir Pharma 15 mg gastro-resistant capsules contain 0.118 mg of potassium per capsule, which should be taken into account in patients with renal impairment or in patients on potassium-restricted diets.
This medicine does not contain gluten.
3. How to take Lansoprazol Vir Pharma
Follow exactly the administration instructions for Lansoprazol Vir Pharma provided by your doctor. Consult your doctor or pharmacist if you have any doubts.
Take the capsule whole with a glass of water. If you have difficulty swallowing the capsule, your doctor will inform you of alternative ways to take the medication. Do not crush or chew the capsules or the contents of an emptied capsule, as this will prevent them from working properly.
If you take Lansoprazol Vir Pharma once a day, try to take it at the same time every day. You may achieve better results if you take Lansoprazol Vir Pharma in the morning.
If you take Lansoprazol Vir Pharma twice a day, you should take the first dose in the morning and the second in the evening.
The dose of Lansoprazol Vir Pharma depends on your overall condition. The usual doses of Lansoprazol Vir Pharma for adults are listed below. Occasionally, your doctor may prescribe a different dose and indicate a different treatment duration.
Treatment of heartburn and acid regurgitation: one 15 mg or 30 mg capsule daily for 4 weeks. If symptoms persist, inform your doctor. If symptoms do not improve within 4 weeks, consult your doctor.
Treatment of duodenal ulcer: one 30 mg capsule daily for 2 weeks.
Treatment of gastric ulcer: one 30 mg capsule daily for 4 weeks.
Treatment of inflammation of the esophagus (reflux esophagitis): one 30 mg capsule daily for 4 weeks.
Long-term prevention of reflux esophagitis: one 15 mg capsule daily; your doctor may adjust the dose to one 30 mg capsule daily.
Treatment of Helicobacter pylori infection: The usual dose is one 30 mg capsule taken in the morning together with two different antibiotics, and one 30 mg capsule taken in the evening together with two different antibiotics. The usual treatment duration is once daily for 7 days.
The recommended antibiotic combinations are as follows:
- 30 mg Lansoprazol Vir Pharma with 250–500 mg clarithromycin and 1,000 mg amoxicillin
- 30 mg Lansoprazol Vir Pharma with 250 mg clarithromycin and 400–500 mg metronidazole
If you are receiving anti-infective treatment for an ulcer, it is unlikely that the ulcer will recur if the infection is successfully treated. To achieve the best results from your medication, take it at the correct time and do not miss any doses.
Treatment of duodenal or gastric ulcer in patients requiring continuous NSAID therapy: one 30 mg capsule daily for 4 weeks.
Prevention of duodenal or gastric ulcer in patients requiring continuous NSAID therapy: one 15 mg capsule daily; your doctor may adjust the dose to one 30 mg capsule daily.
Zollinger-Ellison syndrome: The usual initial dose is two 30 mg capsules daily; subsequently, depending on your response to treatment with Lansoprazol Vir Pharma, your doctor will decide the best dose for you.
Lansoprazol Vir Pharma must not be administered to children.
Follow exactly the instructions given by your doctor. Consult your doctor if you have any doubts.
If you take more Lansoprazol Vir Pharma than you should
If you take more Lansoprazol Vir Pharma than prescribed, contact your doctor immediately or call the Toxicology Information Service at telephone number 915 620 420.
If you forget to take Lansoprazol Vir Pharma
If you forget to take a dose, take it as soon as possible unless it is almost time for your next dose. In that case, skip the missed dose and take the next capsules at the usual time. Do not take a double dose to make up for a missed dose.
If you stop taking Lansoprazol Vir Pharma
Do not stop treatment prematurely, even if symptoms have improved. Your condition may not be completely healed and could return if you do not complete the full course of treatment.
If you have any further questions about the use of this product, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, Lansoprazol Vir Pharma may cause adverse effects, although not everyone experiences them.
The following adverse effects are common (occur in more than 1 in 100 patients):
- headache, dizziness
- diarrhea, constipation, stomach pain, nausea and vomiting, flatulence, dryness or pain in mouth or throat
- skin rash, itching
- changes in liver function test values
- fatigue
The following adverse effects are uncommon (occur in less than 1 in 100 patients):
- depression
- joint or muscle pain
- fluid retention or swelling
- changes in blood cell counts
The following adverse effects are rare (occur in less than 1 in 1,000 patients):
- fever
- restlessness, drowsiness, confusion, hallucinations, insomnia, visual disturbances, dizziness
- taste disturbances, loss of appetite, inflammation of the tongue (glossitis)
- skin reactions such as burning or itching sensation under the skin, bruising, redness, and excessive sweating
- light sensitivity
- hair loss
- tingling sensation (paresthesia), tremor
- anemia (pallor)
- kidney problems
- pancreatitis
- liver inflammation (may present as yellowing of the skin or eyes)
- breast swelling in males, impotence
- candidiasis (fungal infection, may affect the skin or mucous membranes)
- angioedema; contact your doctor immediately if you experience symptoms of angioedema such as swelling of the face, tongue or throat, difficulty swallowing, hives, or breathing difficulties.
The following adverse effects are very rare (occur in less than 1 in 10,000 patients):
- severe hypersensitivity reactions, including anaphylactic shock. Symptoms of hypersensitivity may include fever, rash, swelling, and occasionally low blood pressure
- inflammation of the mouth (stomatitis)
- colitis (inflammation of the intestine)
- changes in laboratory values, such as levels of sodium, cholesterol, and triglycerides
- very severe skin reactions with redness, blisters, severe swelling, and skin loss
- in very rare cases, Lansoprazol Vir Pharma may cause a reduction in the number of white blood cells, which can decrease your resistance to infections. If you develop an infection with symptoms such as fever and severe deterioration in your general condition, or fever with signs of localized infection such as sore throat/pharynx/mouth or urinary problems, consult your doctor immediately. A blood test will be performed to check for possible reduction in white blood cells (agranulocytosis).
Frequency not known:
If you are taking Lansoprazol Vir Pharma for more than three months, 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, seek medical attention 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 magnesium levels.
If you are taking proton pump inhibitors such as Lansoprazol Vir Pharma, 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.
If you consider any of the adverse effects you experience to be serious, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Lansoprazol Vir Pharma
Store below 30°C.
Keep out of the reach and sight of children.
Do not use Lansoprazol Vir Pharma after the expiry date stated on the packaging, following the abbreviation for expiry date. The expiry date refers to 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 in your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.
6. Additional information
Composition of Lansoprazol Vir Pharma
The active substance is lansoprazole.
The other components are: sugar spheres (sucrose and gluten-free maize starch), sodium carboxymethylstarch from potato (gluten-free), sodium lauryl sulfate, povidone, trisodium phosphate dodecahydrate, hypromellose, copolymer of methacrylic acid and ethyl acrylate, triethyl citrate, titanium dioxide (E-171), and talc. The capsule shell is composed of: gelatin and 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, and black iron oxide (E172).
Appearance of the product and contents of the pack
Lansoprazol Vir Pharma 30 mg gastro-resistant capsules are presented as hard gastro-resistant capsules containing spherical gastro-resistant microgranules of lansoprazole, in packs of 14 and 28 capsules.
Marketing Authorization Holder and Manufacturer
The Marketing Authorization Holder is:
Industria Química y Farmacéutica VIR, S.A.
C/ Laguna 66-70, Polígono Industrial URTINSA II
28923 Alcorcón (Madrid)
Spain
The manufacturer is:
Teva Pharma, S.L.U.
Polígono Malpica c/C, 4
50016 Zaragoza
Spain
or
Industria Química y Farmacéutica VIR, S.A.
C/ Laguna 66-70, Polígono Industrial URTINSA II
28923 Alcorcón (Madrid)
Spain
This patient information leaflet was approved in December 2022
Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS): http://www.aemps.gob.es/