Lansoprazole CINFA 30 mg gastro-resistant capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Lansoprazole cinfa 30 mg gastro-resistant capsules EFG

Read all of this 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 and must not be given to other people, even if they have the same symptoms as you. It may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What is lansoprazole cinfa and what is it used for

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

Your doctor may prescribe this medicine for the following indications in adults:

• Treatment of duodenal and gastric ulcers.
• Treatment of inflammation of the oesophagus (reflux oesophagitis).
• Prevention of inflammation of the oesophagus (reflux oesophagitis).
• Treatment of heartburn and acid regurgitation (passage of acidic contents rising up from the stomach).
• 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 treatment is used for pain or inflammation).
• Treatment of Zollinger-Ellison syndrome.

Your doctor may have prescribed lansoprazole for an indication or at a dose different from that stated in this leaflet. Follow exactly the administration instructions for this medicine as indicated by your doctor.

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

2. What you need to know before taking lansoprazole cinfa

Do not take Lansoprazole cinfa

• 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 starting to take Lansoprazole cinfa:

• 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 malignant disease.

• If 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 lansoprazole along with other medicines for the treatment of Helicobacter pylori infection (such as antibiotics) or together with anti-inflammatory medicines for pain or rheumatism, read the package leaflets of these medicines carefully as well.

  • Taking a proton pump inhibitor such as lansoprazole, especially for more than one year, may slightly increase the risk of fractures 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 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.

  • If you have low body stores of vitamin B12 or risk factors for this, and you are receiving long-term treatment with lansoprazole. Like all medicines that reduce acid, lansoprazole could reduce the absorption of vitamin B12.
  • If you have ever had a skin reaction after treatment with a medicine similar to lansoprazole 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 stop treatment with lansoprazole. Remember to mention any other symptoms you may notice, such as joint pain.
  • If you are scheduled to have a specific blood test (chromogranin A).
  • 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.

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

Other medicines and Lansoprazole cinfa

Inform 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 cinfa 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, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and using machines

It is unlikely that lansoprazole will affect your ability to drive or use tools or machines. However, adverse effects such as dizziness and visual disturbances may occur (see section 4). If these occur, you should not drive or use machines.

You are solely responsible for deciding whether you are fit to drive vehicles 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 descriptions of these effects can be found in the following sections. Please read this leaflet carefully.

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

Lansoprazole cinfa contains sucrose.

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

Lansoprazole cinfa contains sodium.

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

3. How to take lansoprazole cinfa

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

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

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

Treatment of duodenal ulcer: one 30 mg capsule of lansoprazole daily for 2 weeks.

Treatment of gastric ulcer: one 30 mg capsule of lansoprazole daily for 4 weeks.

Treatment of inflammation of the esophagus (reflux esophagitis): one 30 mg capsule of lansoprazole daily for 4 weeks.

Long-term prevention of reflux esophagitis: one 15 mg capsule of lansoprazole daily; your doctor may adjust the dose to one 30 mg capsule of lansoprazole daily.

Treatment of Helicobacter pylori infection: The usual dose is one 30 mg lansoprazole capsule together with two different antibiotics in the morning, and one 30 mg lansoprazole capsule together with two different antibiotics in the evening. Treatment is normally 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, recurrence of the ulcer is unlikely if the infection is successfully treated. To achieve 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 (medicines for inflammation or pain): one 30 mg capsule of lansoprazole daily for 4 weeks.

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

Zollinger-Ellison syndrome: The usual initial dose is two 30 mg capsules of lansoprazole daily; thereafter, depending on your response to lansoprazole treatment, your doctor will decide the best dose for you.

Method of administration:

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 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 morning.

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

Use in children

Lansoprazole must not be given to children.

If you take more Lansoprazole cinfa than you should

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

If you forget to take Lansoprazole cinfa

Do not take a double dose to make up for missed doses.

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 following capsules as usual.

If you stop treatment with Lansoprazole cinfa

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 will experience 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, and 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).
• Generalized rash, high body temperature, and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

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

• Headache, dizziness.
• Diarrhea, constipation, stomach pain, nausea and vomiting, flatulence (gas), dryness or soreness in the mouth or throat.
• Skin rash (swelling and redness of the skin), itching.
• Changes in liver function test results.
• Tiredness.
• Benign polyps in the stomach.

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

• Depression.
• Joint or muscle pain.
• Fluid retention or swelling (edema).
• Changes in blood cell counts.

Rare adverse effects (may affect up to 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, 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 patients):

• Severe hypersensitivity reactions, including anaphylactic shock (an exaggerated allergic reaction that may be life-threatening). Symptoms of hypersensitivity may include fever, rash, swelling, and sometimes low blood pressure.
• Inflammation of the mouth (stomatitis).
• Colitis (inflammation of part of the intestine).
• Changes in laboratory test values, such as levels of sodium (hyponatremia), cholesterol, and triglycerides.
• Very severe skin reactions with redness, blisters, severe swelling, and skin loss.
• Decreased white blood cell count, which may reduce your resistance to infections. If you develop an infection with symptoms such as fever and a marked deterioration in your general condition, or fever with signs of localized infection such as sore throat/pharynx/mouth or urinary problems, contact your doctor immediately. A blood test will be performed to check for possible reduction in white blood cells (agranulocytosis).

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

• Skin rash, possibly accompanied by joint pain.
• If you are taking lansoprazole for more than three months, blood magnesium levels 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 advice immediately. Low magnesium levels may also lead to reduced levels of potassium or 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.
• Visual hallucinations.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can 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 cinfa

Keep this medicine out of sight and reach of children.

Do not store above 30 °C.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Lansoprazol cinfa

• The active substance is lansoprazole. Each gastro-resistant capsule contains 30 mg of lansoprazole.

• The other components are:

• Capsule contents: sugar spheres (containing sucrose, corn starch, purified water), sodium lauryl sulfate, N-methylglucamine, mannitol (E-421), hypromellose (E-464), macrogol 6000, talc (E-553b), polysorbate 80 (E-433), titanium dioxide (E-171), and Eudragit® L30-D55 (30% dispersion of methacrylic acid and ethyl acrylate copolymer (1:1)).

• Capsule composition: titanium dioxide (E-171), purified water, and gelatin.

Appearance of the product and contents of the pack

Lansoprazol cinfa is presented as white opaque, hard gastro-resistant capsules with cap and body.

It is available in aluminum/aluminum blisters. Each pack contains 14, 28, 56, or 500 capsules (hospital pack).

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono industrial Areta

31620 Huarte (Navarra) - Spain

Date of the latest revision of this leaflet: June 2025

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/).

You can access detailed and up-to-date information on this medicinal product by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and outer packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/66145/P_66145.html

QR code to: https://cima.aemps.es/cima/dochtml/p/66145/P_66145.html