LANSOPRAZOL ARISTO 15 mg HARD GASTRO-RESISTANT CAPSULES

Introduction

Patient Information Leaflet

Lansoprazole Aristo 15 mg gastro-resistant hard capsules

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• 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 signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

1. What is Lansoprazole Aristo and what is it used for
2. What you need to know before you take Lansoprazole Aristo
3. How to take Lansoprazole Aristo
4. Possible side effects
5. Storage of Lansoprazole Aristo
6. Contents of the pack and other information

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

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

Your doctor may prescribe you lansoprazole for the following indications in adults:

• Treatment of duodenal and gastric ulcers.
• Treatment of inflammation of the oesophagus (reflux oesophagitis).
• Prevention of reflux oesophagitis.
• Treatment of heartburn and acid regurgitation.
• Treatment of infections caused by the bacteria Helicobacter pylori, in combination with antibiotics.
• Treatment or prevention of duodenal or gastric ulcers in patients who require continuous treatment with non-steroidal anti-inflammatory drugs (NSAIDs) (NSAID treatment is used for pain or inflammation).
• Treatment of Zollinger-Ellison syndrome.

It is possible that your doctor has prescribed you lansoprazole for another indication or at a different dose than that indicated in this leaflet. Follow your doctor's instructions exactly.

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

2. What you need to know before you take Lansoprazole Aristo

Do not take Lansoprazole Aristo

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

Warnings and precautions

Tell your doctor if you have a severe liver disease. The doctor may need to adjust the dose.

Your doctor may have performed or may perform an additional test called endoscopy to diagnose your disease and/or rule out a malignant disease.

If you experience 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 you lansoprazole in addition to other medicines for the treatment of Helicobacter pyloriinfection (antibiotics) or together with anti-inflammatory drugs to treat pain or rheumatism, also read the package leaflets of these medicines carefully.

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

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

Consult your doctor before starting to take this medicine:

• If you have reduced vitamin B12 body stores or risk factors for this and you receive long-term treatment with lansoprazole. Like all acid-reducing medicines, lansoprazole may reduce the absorption of vitamin B12.
• If a specific blood test (chromogranin A) is scheduled.
• If you have ever had a skin reaction after treatment with a medicine similar to lansoprazole to reduce stomach acid.
• If you get 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 interrupt treatment with lansoprazole.

Remember to mention any other symptoms you may notice, such as joint pain

• There have been reports of serious skin reactions in relation to treatment with Lansoprazole Aristo (Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug rash 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.
• When taking lansoprazole, kidney inflammation can occur. The signs and symptoms may include decreased urine output or blood in the urine and/or hypersensitivity reactions such as fever, rash, and joint stiffness. You should report such signs to your doctor.

Taking Lansoprazole Aristo with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.

In particular, tell your doctor or pharmacist if you are using medicines that contain any of the following active substances, as lansoprazole may affect their action:

• HIV protease inhibitors such as atazanavir or nelfinavir (used to treat 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 Lansoprazole Aristo with food and drinks

To get the best results from your medicine, you should take lansoprazole at least 30 minutes before meals with a glass of water.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Patients taking lansoprazole may occasionally experience side effects such as dizziness, drowsiness, fatigue, and visual disturbances. If you experience any of these side effects, you should act with caution as your ability to react may be reduced.

You are the only person responsible for deciding whether you are fit to drive or perform tasks that require a high level of attention. Due to its effects or adverse reactions, one of the factors that can reduce your ability to perform these operations safely is the use of medicines.

In the following sections, you will find descriptions of these effects.

Read this leaflet carefully.

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

Lansoprazole Aristo contains sucrose

If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

3. How to take Lansoprazole Aristo

Follow your doctor's instructions exactly. If you are in doubt, 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. Do not crush or chew the capsules or the contents of an empty capsule, as this will prevent them from working properly.

If you take lansoprazole once a day, try to take it at the same time every day. You may get better results if you take lansoprazole in the morning.

If you take lansoprazole twice a day, you should take the first dose in the morning and the second dose at night.

The dose of lansoprazole depends on your general condition. The usual doses of lansoprazole for adults are indicated below. Sometimes, your doctor may prescribe a different dose and indicate a different duration of treatment.

Treatment of heartburn and acid regurgitation:one 15 mg or 30 mg capsule per day for 4 weeks. If symptoms do not improve after 4 weeks, consult your doctor.

Treatment of duodenal ulcers:one 30 mg capsule per day for 2 weeks.

Treatment of gastric ulcers:one 30 mg capsule per day for 4 weeks.

Treatment of oesophageal inflammation (reflux oesophagitis):one 30 mg capsule per day for 4 weeks.

Long-term prevention of reflux oesophagitis:one 15 mg capsule per day; your doctor may adjust the dose to one 30 mg capsule per day.

Treatment of Helicobacter pyloriinfection:The usual dose is one 30 mg capsule together with two different antibiotics in the morning and one 30 mg capsule together with two different antibiotics in the evening. The treatment is usually taken daily for 7 days.

The recommended combinations of antibiotics are as follows:

• 30 mg of lansoprazole with 250-500 mg of clarithromycin and 1000 mg of amoxicillin.
• 30 mg of lansoprazole with 250 mg of clarithromycin and 400-500 mg of metronidazole.

If you receive anti-infective treatment for an ulcer, it is unlikely that the ulcer will come back if the infection is treated successfully. To get the best results from your medicine, take it at the right time and do not miss any dose.

Treatment of duodenal or gastric ulcers in patients who require continuous treatment with NSAIDs:one 30 mg capsule per day for 4 weeks.

Prevention of duodenal or gastric ulcers in patients who require continuous treatment with NSAIDs:one 15 mg capsule per day; your doctor may adjust the dose to one 30 mg capsule per day.

Zollinger-Ellison syndrome:The usual initial dose is two 30 mg capsules per day; subsequently, based on your response to treatment with lansoprazole, the doctor will decide the best dose for you.

Use in children

Lansoprazole should not be given to children.

If you take more lansoprazole than you should

If you take more lansoprazole than you have been prescribed, contact your doctor immediately or contact the Toxicology Information Service, telephone 91 562 04 20.

If you forget to take lansoprazole

If you forget to take a dose, take it as soon as you remember, unless it is nearly time for your next dose. In this case, skip the missed dose and take the next capsules as usual. Do not take a double dose to make up for forgotten doses.

If you stop taking lansoprazole

Do not stop treatment early because your symptoms have improved. It is possible that your condition has not been completely cured and may come back if you do not finish the entire treatment.

If you have any other questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

• round or target-like red spots on the trunk, often with blisters in the centre, peeling, ulcers in the mouth, throat, nose, genitals, and eyes. These serious skin rashes can be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis)
• generalized rash, high body temperature, and swollen lymph nodes (DRESS or drug hypersensitivity syndrome)

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

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

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

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

Rare side 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 sensation or itching, bruising, redness, and excessive sweating,
• sensitivity to light,
• hair loss,
• tingling sensation (paresthesia), tremors,
• anaemia (pallor),
• kidney problems,
• pancreatitis,
• inflammation of the liver (which can cause yellowing of the skin or eyes),
• breast swelling in men, impotence,
• candidiasis (fungal infection, can 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 pharynx, difficulty swallowing, hives, and difficulty breathing.

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

• severe hypersensitivity reactions, including anaphylactic shock. The symptoms of a hypersensitivity reaction may include fever, rash, swelling, and, in some cases, a drop in blood pressure,
• inflammation of the mouth (stomatitis),
• inflammation of the intestine (colitis)
• changes in analytical values, such as sodium, cholesterol, and triglyceride levels,
• very serious skin reactions with redness, blisters, severe inflammation, and skin loss,
• in very rare cases, Lansoprazole Aristo may cause a reduction in the number of white blood cells, which can lead to a decrease in your resistance to infections. If you experience an infection with symptoms such as fever and severe deterioration of your general condition, or fever with symptoms of local infection such as sore throat/pharynx/mouth or urinary problems, contact 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 the available data):

• if you have been taking Lansoprazole Aristo for more than three months, it is possible that your blood magnesium levels may decrease. Low magnesium levels can cause fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, and increased heart rate. If you notice any of these symptoms, inform your doctor immediately. Low magnesium levels can also lead to a decrease in potassium or calcium levels in the blood. Your doctor will probably ask for regular blood tests to monitor your magnesium levels.
• low sodium levels in the blood. Common symptoms include nausea and vomiting, headache, drowsiness, and fatigue, confusion, muscle weakness or spasms, irritability, convulsions, coma.
• skin rash, possibly with joint pain
• visual hallucinations

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Monitoring System for Human Use: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Lansoprazole Aristo

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

Do not use this medicine after the expiry date which is stated on the blister, label, and carton. The expiry date is the last day of the month stated.

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

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

Medicines should not be disposed of via wastewater or household waste. Return the containers and any unused medicines to the pharmacy. If you are in doubt, ask your pharmacist how to dispose of the containers and any unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Lansoprazol Aristo

• The active ingredient is lansoprazol.
• The other components are:

Content of the capsules:sugar spheres (sucrose and corn 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).

Coating of the capsules:gelatin, titanium dioxide (E171), quinoline yellow (E104).

Appearance of the product and packaging content

These gastro-resistant capsules are available in blister packs containing: 28 capsules, clinical pack of 500 capsules. They are also available in bottles containing: 28 capsules.

Only some pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Aristo Pharma Iberia, S.L.

C/Solana, 26

28850 Torrejón de Ardoz, Madrid

Spain

Manufacturer

Laboratorios Liconsa, S.A.

Avda. Miralcampo, Nº 7, Polígono Industrial Miralcampo,

19200 Azuqueca de Henares (Guadalajara).

Spain

Date of the last revision of this prospectus:February 2024.

Detailed 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/