LANSOPRAZOL SANDOZ 30 mg GASTRO-RESISTANT CAPSULES

Introduction

Leaflet: information for the patient

Lansoprazole Sandoz 15 mg hard gastro-resistant capsules EFG

Lansoprazole Sandoz 30 mg hard gastro-resistant capsules EFG

Read the entire leaflet carefully before starting to take the medicine, as it contains important information for you.

• Keep this leaflet, as 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 symptoms are the same as yours.
• If you experience 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 leaflet

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

1. What you need to know before taking Lansoprazole Sandoz
2. How to take Lansoprazole Sandoz
3. Possible side effects
4. Storage of Lansoprazole Sandoz
5. Contents of the pack and further information

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

The active substance 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 esophagus (reflux esophagitis)
• Prevention of reflux esophagitis
• Treatment of heartburn and acid reflux
• 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.

You may have been prescribed lansoprazole for another indication or at a different dose than indicated in this leaflet. Follow your doctor's instructions regarding the administration of the medicine.

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

2. What you need to know before taking Lansoprazole Sandoz

Do not take Lansoprazole Sandoz

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Lansoprazole Sandoz.

Inform 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 a complementary test called endoscopy to diagnose your disease and/or rule out a malignant disease.

In case you experience diarrhea during treatment with lansoprazole, contact your doctor immediately, as lansoprazole has been associated with a slight increase in infectious diarrhea.

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

If you are taking proton pump inhibitors like lansoprazole, especially for a period of more than one year, you may have a slightly increased risk of hip, wrist, and spine fractures. Inform 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 corticosteroids).

If you have been taking lansoprazole for a long time (more than 1 year), your doctor will probably have regular check-ups. During your doctor's visits, you should inform him of any new or unusual symptoms and circumstances.

Consult your doctor before starting to take lansoprazole:

• if you have reduced body stores of vitamin B12 or risk factors for this and receive long-term treatment with lansoprazole. Like all medicines that reduce acid, 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.
• There have been reports of serious skin reactions in relation to treatment with lansoprazole (Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug rash with eosinophilia and systemic symptoms (DRESS)). Stop using lansoprazole and call your doctor immediately if you experience any of the symptoms related to serious skin reactions described in section 4.
• If you experience 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.

When taking lansoprazole, kidney inflammation may occur. The signs and symptoms may include decreased urine output or the presence of blood in the urine and/or hypersensitivity reactions such as fever, skin rash, and joint stiffness. You should inform your doctor of these signs.

Other medicines and Lansoprazole Sandoz

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

In particular, inform your doctor or pharmacist if you are using medicines that contain any of the following active substances, as lansoprazole may affect their mode 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 reflux),
• sucralfate (used to heal ulcers),
• St. John's Wort (Hypericum perforatum) (used to treat mild depression).

Taking Lansoprazole Sandoz 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 and breastfeeding

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 reaction ability may be reduced.

You are the only one responsible for deciding whether you are in a fit state to drive vehicles or perform activities that require a high level of concentration. 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 the information in this leaflet carefully.

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

Lansoprazole Sandoz contains sucrose and sodium.

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

This medicine contains less than 1 mmol of sodium (23 mg) per capsule; this is, essentially, “sodium-free”.

3. How to take Lansoprazole Sandoz

Follow the instructions for administration of this medicine exactly as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

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

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

Treatment of duodenal ulcers:two 15 mg or one 30 mg capsules per day for 2 weeks.

Treatment of gastric ulcers:two 15 mg or one 30 mg capsules per day for 4 weeks.

Treatment of esophageal inflammation (reflux esophagitis):two 15 mg or one 30 mg capsules per day for 4 weeks.

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

Treatment of Helicobacter pyloriinfection:the normal dose is two 15 mg or one 30 mg capsules together with two different antibiotics in the morning and two 15 mg or one 30 mg capsules together with two different antibiotics in the evening. The treatment will normally be 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 due to an ulcer, it is unlikely that the ulcer will recur if the infection is successfully treated. To get the best results from your medicine, take it at the right time and do not forget any dose.

Treatment of duodenal or gastric ulcers in patients who require continuous treatment with NSAIDs:two 15 mg or one 30 mg capsules 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 two 15 mg or one 30 mg capsules per day.

Zollinger-Ellison syndrome:the initial normal dose is four 15 mg or two 30 mg capsules per day; subsequently, depending on your response to treatment with lansoprazole, the doctor will decide on the best dose for you.

Use in children

Lansoprazole should not be administered to children.

How to take this medicine

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 medicine. Do not crush or chew the capsules or the contents of an emptied capsule, as this will make them not work properly.

If you take lansoprazole once a day, try to take it always at the same time. You may get better results if you take lansoprazole in the morning. Lansoprazole should be taken at least 30 minutes before meals.

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

If you take more Lansoprazole Sandoz than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Lansoprazole Sandoz

If you forget to take a dose, take it as soon as possible unless the time of the next dose is near. In this case, skip the missed dose and take the next capsules as usual. Do not take a double dose to make up for the missed dose.

If you stop taking Lansoprazole Sandoz

Do not stop treatment prematurely because the symptoms have improved. It is possible that your condition has not been completely cured and may recur if you do not complete 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 and contact your doctor immediately:

• round or target-like red spots on the trunk, often with blisters in the center, peeling, ulcers in the mouth, throat, nose, genitals, and eyes. These serious 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 or drug hypersensitivity syndrome).

Common side 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 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 a burning sensation or itching under the skin, bruising, redness, and excessive sweating,
• sensitivity to light,
• hair loss,
• tingling sensation (paresthesia), tremors,
• anemia (pallor),
• kidney problems,
• pancreatitis,
• inflammation of the liver (may manifest as yellowing of the skin or eyes),
• breast swelling in males, 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 may cause a reduction in the number of white blood cells, which can lead to a decrease in 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, consult your doctor immediately. A blood test will be performed to check for a possible reduction in white blood cells (agranulocytosis).

Side effects of unknown frequency(cannot be estimated from the available data)

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

If you consider that any of the side effects you are experiencing is serious or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

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 them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Lansoprazole Sandoz

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

Do not store above 30°C.

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

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

6. Container Content and Additional Information

Composition of Lansoprazol Sandoz

• The active ingredient is lansoprazol.

Each hard gastro-resistant capsule contains 15 mg of lansoprazol.

Each hard gastro-resistant capsule contains 30 mg of lansoprazol

• The other components are: sugar spheres (constituted by corn starch and sucrose), sodium lauryl sulfate, N-methylglucamine, mannitol (E-421), hypromellose, macrogol 6000, talc, polysorbate 80, titanium dioxide (E171) and methacrylic acid - ethyl acrylate copolymer.
• The components of the capsule are:

Lansoprazol Sandoz 15 mg: quinoline yellow (E104), titanium dioxide (E171), water and gelatin.

Lansoprazol Sandoz 30 mg: titanium dioxide (E171), water and gelatin.

Appearance of the Product and Container Content

Lansoprazol Sandoz 15 mg is presented in the form of hard gastro-resistant capsules of opaque yellow color that contain gastro-resistant lansoprazol granules in Alu/Alu blisters packaged in a cardboard box. Each box contains 28 or 500 capsules.

Lansoprazol Sandoz 30 mg is presented in the form of hard gastro-resistant capsules of opaque white color that contain gastro-resistant lansoprazol granules in Alu/Alu blisters packaged in a cardboard box. Each box contains 14, 28, 56 or 500 capsules.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer:

Marketing Authorization Holder

Sandoz Farmacéutica, S.A. Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer:

Liconsa, S.A.

Avda. Miralcampo nº 7,

Polígono Industrial Miralcampo

19200 Azuqueca de Henares (Guadalajara)

Spain

Date of the Last Revision of this Prospectus:May 2025.

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