Lansoprazole Aurovitas Spain 15 mg gastro-resistant hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Lansoprazol Aurovitas Spain 15 mg gastro-resistant hard capsules EFG

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• 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 you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Lansoprazol Aurovitas Spain is and what it is used for
2. What you need to know before taking Lansoprazol Aurovitas Spain
3. How to take Lansoprazol Aurovitas Spain
4. Possible adverse effects
5. How to store Lansoprazol Aurovitas Spain
6. Contents of the pack and other information

1. What Lansoprazole Aurovitas Spain is and what it is used for

The active substance in Lansoprazole Aurovitas Spain is lansoprazole, a proton pump inhibitor. Proton pump inhibitors reduce the amount of acid produced by the stomach.

Your doctor may have prescribed lansoprazole for the following indications in adults:

• Treatment of duodenal and gastric ulcers.
• Treatment of inflammation of the esophagus (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 continuous 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 lansoprazole for another indication or at a dose different from that stated in this leaflet. Always follow exactly the instructions for use of this medicine as given by your doctor.

You should consult a doctor if you worsen or do not improve after 14 days.

2. What you need to know before starting to take Lansoprazol Aurovitas Spain

Do not take Lansoprazol Aurovitas Spain if:

• You are allergic to lansoprazole or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Tell 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 to rule out malignant disease.

If you develop diarrhoea during treatment with lansoprazole, contact your doctor immediately, as lansoprazole has been associated with a slight increase in infectious diarrhoea.

If your doctor has prescribed lansoprazole together with other medicines used to treat Helicobacter pylori infection (antibiotics) or together with anti-inflammatory medicines to treat pain or rheumatism, please also read the package leaflets of these medicines carefully.

Taking a proton pump inhibitor such as lansoprazole, especially for more than one year, may slightly increase the risk of hip, wrist, or vertebral fractures. Inform your doctor if you have osteoporosis (reduced bone density) or if your doctor has told you that you are at risk of developing osteoporosis (for example, if you are taking steroids).

If you have been taking lansoprazole for a long time (more than 1 year), your doctor will likely monitor you regularly. During visits to your doctor, you should report any new or unusual symptoms or circumstances.

Consult your doctor or pharmacist before starting to take lansoprazole:

• If you have reduced body stores of vitamin B12 or risk factors for this, and you are to receive long-term treatment with lansoprazole. Like all medicines that reduce acid levels, lansoprazole may reduce the absorption of vitamin B12.
• If you are scheduled to have a specific blood test (chromogranin A).
• If you have ever had a skin reaction after treatment with a medicine similar to lansoprazole for reducing stomach acidity.
• If you develop a skin rash, especially on areas of skin exposed to sunlight, consult your doctor as soon as possible, as it may be necessary to stop treatment with lansoprazole. Remember to mention any other symptoms you may notice, such as joint pain.
• Serious skin reactions have been reported in association with lansoprazole treatment [Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS)]. Stop using lansoprazole and contact your doctor immediately if you experience any of the symptoms related to serious skin reactions described in section 4.
• Kidney inflammation may occur during treatment with lansoprazole. Signs and symptoms may include decreased urine volume or blood in the urine and/or hypersensitivity reactions such as fever, rash, and joint stiffness. You should report these signs to your doctor.

Other medicines and Lansoprazol Aurovitas Spain

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

In particular, inform your doctor or pharmacist if you are taking medicines containing any of the following active substances, as lansoprazole may affect their way of action:

• HIV protease inhibitors such as atazanavir and nelfinavir (used in the treatment of HIV)
• methotrexate (used to treat autoimmune diseases and cancer)
• ketoconazole, itraconazole, rifampicin (used to treat infections)
• digoxin (used to treat heart problems)
• warfarin (used to treat blood clots)
• 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 Aurovitas Spain with food and drink

For optimal results, take Lansoprazol Aurovitas Spain at least 30 minutes before meals with a glass of water.

Pregnancy, breast-feeding, and fertility

If you are pregnant, breast-feeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine.

Driving and using machines

Patients taking lansoprazole 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 ability 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 may be one of the factors that reduces your ability to carry out these tasks safely.

The following sections contain descriptions of these effects.

Please read the information in this leaflet carefully.

If you have any questions, ask your doctor, nurse, or pharmacist.

Lansoprazol Aurovitas Spain contains sucrose

If your doctor has informed you of an intolerance to certain sugars, consult him before taking this medicine.

3. How to take Lansoprazole Aurovitas Spain

Follow exactly the instructions given by your doctor for taking this medicine. If you are unsure, consult your doctor or pharmacist again.

Swallow 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 medicine. You must not crush or chew the capsules or the contents of an emptied capsule, as this would prevent the medicine from working properly.

If you take lansoprazole once daily, try to take it at the same time each day. You may achieve better results if you take lansoprazole in the morning.

If you take lansoprazole twice daily, you should take the first dose in the morning and the second in the evening.

The dose of lansoprazole depends on your general condition. The recommended doses for adults are given 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 do not improve after 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 oesophagus (reflux oesophagitis): one 30 mg capsule daily for 4 weeks.

Long-term prevention of reflux oesophagitis: 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 treatment is normally given daily for 7 days.

The recommended antibiotic combinations are the following:

• 30 mg lansoprazole with 250–500 mg clarithromycin and 1,000 mg amoxicillin
• 30 mg lansoprazole with 250 mg clarithromycin and 400–500 mg metronidazole

If you are receiving anti-infective treatment for an ulcer, the ulcer is unlikely to recur if the infection is successfully treated. To obtain the best results from your medicine, 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 lansoprazole treatment, your doctor will decide the best dose for you.

Use in children

Lansoprazole must not be given to children.

If you take more Lansoprazole Aurovitas Spain than you should

If you take more lansoprazole than prescribed, or in case of accidental ingestion, contact your doctor or pharmacist immediately or call the Poison Information Service immediately at telephone number 91 562 04 20.

If you forget to take Lansoprazole Aurovitas Spain

If you forget to take a dose, take it as soon as possible unless the time for the next dose is approaching. 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 Lansoprazole Aurovitas Spain

Do not stop treatment prematurely just because 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 medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

If you start to notice any of the following adverse effects, stop taking lansoprazole and contact your doctor immediately:

• circular or target-shaped slightly reddish skin rashes on the trunk, often with blisters in the center, peeling, mouth ulcers, and sores in the throat, nose, genitals, and eyes. These severe skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• widespread rash, high body temperature, and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

Common adverse effects (may affect up to 1 in 10 people):

• headache, dizziness
• diarrhea, constipation, stomach pain, nausea and vomiting, flatulence, dryness or pain in the mouth or throat
• skin rash, itching
• changes in liver function test results
• fatigue
  • benign gastric polyps.

Uncommon adverse effects (may affect up to 1 in 100 people):

• depression
• joint or muscle pain
• fluid retention or swelling
• changes in blood cell counts.

Rare adverse effects (may affect up to 1 in 1,000 people):

• fever
• restlessness, drowsiness, confusion, hallucinations, insomnia, visual disturbances, dizziness
• altered taste, loss of appetite, inflammation of the tongue (glossitis)
• skin reactions such as burning or itching sensation, 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 men, impotence
• candidiasis (fungal infection, may affect skin or mucous membranes)
• angioedema; contact your doctor immediately if you experience symptoms of angioedema, such as swelling of the face, tongue, or pharynx, difficulty swallowing, hives, or breathing difficulties.

Very rare adverse effects (may affect up to 1 in 10,000 people):

• severe hypersensitivity reactions, including anaphylactic shock. Symptoms of hypersensitivity may include fever, rash, swelling, and occasionally low blood pressure
• inflammation of the mouth (stomatitis)
• inflammation of the intestine (colitis)
• 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, lansoprazole 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 a significant worsening of your general condition, or fever accompanied by local infection symptoms such as sore throat/pharynx/mouth or urinary problems, consult your doctor immediately. A blood test will be performed to check for a possible reduction in white blood cells (agranulocytosis).

Frequency not known (cannot be estimated from available data):

• if you have been taking lansoprazole 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 notice any of these symptoms, inform your doctor immediately. Low magnesium levels may also lead to decreased levels of potassium or calcium in the blood. Your doctor will likely request regular blood tests to monitor magnesium levels.
• low sodium levels in the blood. Common symptoms include nausea and vomiting, headache, drowsiness and fatigue, confusion, muscle weakness or spasms, irritability, seizures, coma
• skin rash, possibly with joint pain
• visual hallucinations.

Reporting of adverse effects:

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Lansoprazole Aurovitas Spain

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the blister, the label of the bottle, and the outer carton following EXP. The expiry date refers to the last day of the month indicated.

Blister: Do not store above 30°C. Keep in the original packaging to protect from moisture.

Bottle: Do not store above 30°C. Keep the bottle tightly closed to protect from moisture.

Medicines must not be disposed of via wastewater drains or household waste. Return any unused medicines and their containers to the SIGRE point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Lansoprazol Aurovitas Spain

• The active substance is lansoprazole.
• The other components are:

Capsule contents: sugar spheres (sucrose and maize starch), sodium lauryl sulfate, meglumine, mannitol (E421), hypromellose, macrogol, talc, polysorbate 80, titanium dioxide (E171), 30% dispersion of methacrylic acid and ethyl acrylate copolymer (1:1)

15 mg:

Capsule shell: gelatin, titanium dioxide (E171), quinoline yellow (E104)

Nature of the product and pack contents

15 mg:

This medicine is available in blister packs containing 28 capsules. It is also available in bottles containing 28 and 500 capsules (hospital pack).

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos 16-D

28036 Madrid

Spain

Manufacturer:

Laboratorios Liconsa, S.A.

Avda. Miralcampo, No. 7, Polígono Industrial Miralcampo,

19200 Azuqueca de Henares (Guadalajara)

Spain

Date of the most recent revision of this leaflet: May 2025

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