Lansoprazole Sandoz 30 mg gastro-resistant capsules EFG

Patient Information Leaflet

Introduction

Package leaflet: Information for the patient

Lansoprazole Sandoz 15 mg gastro-resistant hard capsules EFG

Lansoprazole Sandoz 30 mg gastro-resistant hard capsules EFG

Read the entire leaflet carefully before you start taking this medicine, as 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. Do not give it to other people, even if they have the same symptoms as you, because it could 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.

Leaflet contents

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

2. What you need to know before taking Lansoprazole Sandoz

3. How to take Lansoprazole Sandoz

4. Possible side effects

5. How to store Lansoprazole Sandoz

6. Contents of the pack and other 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 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 bacterium Helicobacter pylori, in combination with antibiotics
• Treatment or prevention of duodenal or gastric ulcers in patients requiring ongoing 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 an indication or at a dosage different from that stated in this leaflet. Follow your doctor's instructions regarding how to take the medicine.

You should consult a doctor if your condition worsens or does 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 to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor or pharmacist before taking Lansoprazole Sandoz.

Tell your doctor if you have severe liver disease. Your doctor may need to adjust your dose.

Your doctor may have carried out or may carry out an additional test called endoscopy to diagnose your condition and/or rule out 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 lansoprazole together with other medicines used to treat Helicobacter pylori infection (antibiotics) or together with anti-inflammatory medicines to treat pain or rheumatism, also read the package leaflets of these medicines carefully.

If you are taking proton pump inhibitors such as lansoprazole, especially for more than one year, there may be a slightly increased risk of fracture of the hip, wrist, or spine. 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 likely monitor you regularly. During visits to your doctor, you should report any new or unusual symptoms or circumstances.

Talk to your doctor before starting lansoprazole:

• if you have reduced body stores of vitamin B12 or risk factors for this and are receiving long-term treatment with lansoprazole. Like all medicines that reduce acid levels, lansoprazole could 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 used to reduce stomach acidity.
• Cases of serious skin reactions have been reported 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.
• 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 lansoprazole. Remember to mention any other symptoms you may notice, such as joint pain.

When taking lansoprazole, inflammation of the kidneys may occur. 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 Lansoprazole Sandoz

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

In particular, inform your doctor or pharmacist if you are taking medicines containing any of the following active substances, as lansoprazole may affect their 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 Lansoprazole Sandoz with food and drink

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 plan to become pregnant, consult your doctor or pharmacist 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 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 may be one of the factors that reduces your ability to carry out these tasks safely.

The following sections contain descriptions of these effects.

Read the information in this leaflet carefully.

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

Lansoprazole Sandoz contains sucrose and sodium.

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

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

3. How to take Lansoprazole Sandoz

Follow exactly the instructions for using this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

The dose of lansoprazole depends on your general condition. The usual doses of lansoprazole for adults are indicated 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: two 15 mg capsules or one 30 mg capsule daily for 2 weeks.

Treatment of gastric ulcer: two 15 mg capsules or one 30 mg capsule daily for 4 weeks.

Treatment of inflammation of the oesophagus (reflux oesophagitis): two 15 mg capsules or 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 two 15 mg capsules or one 30 mg capsule daily.

Treatment of Helicobacter pylori infection: the usual dose is two 15 mg capsules or one 30 mg capsule together with two different antibiotics in the morning, and two 15 mg capsules or one 30 mg capsule together with two different antibiotics at night. The treatment is normally given daily for 7 days.

The recommended antibiotic combinations are as follows:

• 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 treatment with NSAIDs: two 15 mg capsules or one 30 mg capsule daily for 4 weeks.

Prevention of duodenal or gastric ulcer in patients requiring continuous treatment with NSAIDs: one 15 mg capsule daily; your doctor may adjust the dose to two 15 mg capsules or one 30 mg capsule daily.

Zollinger-Ellison syndrome: the usual initial dose is four 15 mg capsules or 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.

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 prevent them 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 early morning. Lansoprazole should be taken at least 30 minutes before meals.

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

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 at: 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 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 Sandoz

Do not stop treatment prematurely, even if symptoms have improved. Your condition may not be completely cured and symptoms may 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 spots on the trunk, often with blisters in the center, skin peeling, mouth ulcers, throat, nose, genitals, and eyes. These severe skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• generalized rash, high body temperature, and lymphadenopathy (DRESS syndrome or drug hypersensitivity syndrome).

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

• 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
• benign polyps in the stomach

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 under the skin, bruising, redness, and excessive sweating
• photosensitivity
• 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 skin or mucosa)
• angioedema; contact your doctor immediately if you experience symptoms of angioedema, such as swelling of the face, tongue or pharynx, difficulty swallowing, urticaria, and breathing difficulties.

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

• severe hypersensitivity reactions, including anaphylactic shock. Symptoms of hypersensitivity reactions may include fever, rash, swelling, and sometimes a drop in 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 reduce 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).

Adverse effects with unknown frequency (cannot be estimated from available data)

• If you are 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, see your doctor 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.
• 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

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effect 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 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 Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide 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 stated on the packaging and blister, after EXP. 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 empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you are in doubt, please ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Lansoprazole Sandoz

• The active substance is lansoprazole.

Each gastro-resistant hard capsule contains 15 mg of lansoprazole.
Each gastro-resistant hard capsule contains 30 mg of lansoprazole.

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

Lansoprazole Sandoz 15 mg: quinoline yellow (E104), titanium dioxide (E171), water and gelatin.
Lansoprazole Sandoz 30 mg: titanium dioxide (E171), water and gelatin.

Nature of the product and contents of the pack

Lansoprazole Sandoz 15 mg is presented as yellow opaque gastro-resistant hard capsules containing gastro-resistant lansoprazole granules, in Alu/Alu blisters packed in a cardboard container. Each pack contains 28 or 500 capsules.

Lansoprazole Sandoz 30 mg is presented as white opaque gastro-resistant hard capsules containing gastro-resistant lansoprazole granules, in Alu/Alu blisters packed in a cardboard container. Each pack contains 14, 28, 56 or 500 capsules.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer:

Marketing Authorization Holder

Sandoz Farmacéutica, S.A.
Parque Norte Business Center
Roble Building
C/ Serrano Galvache, 56
28033 Madrid
Spain

Manufacturer:

Liconsa, S.A.
Avda. Miralcampo nº 7,
Miralcampo Industrial Estate
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 of Medicines and Health Products (AEMPS) http://www.aemps.gob.es