Lansoprazole Cinfamed 15 mg gastro-resistant capsules EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Lansoprazole cinfamed 15 mg gastro-resistant hard capsules EFG

Read this 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; do not pass it on to others, 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 these effects are not listed in this leaflet. See section 4.

Leaflet Contents

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

2. What you need to know before taking Lansoprazole cinfamed

3. How to take Lansoprazole cinfamed

4. Possible side effects

5. How to store Lansoprazole cinfamed

6. Contents of the pack and other information

1. What Lansoprazol cinfamed is and what it is used for

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

Your doctor may prescribe Lansoprazol cinfamed 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 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 an indication or at a dosage different from that stated in this leaflet. Follow exactly the administration instructions for this medicine as indicated by your doctor.

You should consult a doctor if your condition worsens or does not improve after 14 days.

2. What you need to know before starting to take Lansoprazol cinfamed

Do not take Lansoprazol cinfamed

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

Warnings and precautions

Inform 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 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 together with other medicines for the treatment of Helicobacter pylori infection (antibiotics) or together with anti-inflammatory medicines for 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 before starting to take lansoprazole:

• If you have low body stores of vitamin B12 or risk factors for this and are receiving long-term treatment with lansoprazole. Like all medicines that reduce acid, 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.
• 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.
• 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.
• Kidney inflammation may occur while taking 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 cinfamed

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 Lansoprazol cinfamed with food and drink

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

Pregnancy, breast-feeding and fertility

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

Driving and using machines

Lansoprazole is unlikely to 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 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 reduce your ability to carry out these activities safely.

Descriptions of these effects can be found in the following sections.

Please read the information in this leaflet carefully.

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

Lansoprazol cinfamed contains sucrose

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

Lansoprazol cinfamed 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 cinfamed

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

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 the medicine from working properly.

If you take lansoprazole once a day, try to take it at the same time each day. You may achieve better results if you take this medicine 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 condition. The recommended doses of lansoprazole for adults are listed 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 within 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 recommended dose is one 30 mg capsule together with two different antibiotics in the morning and one 30 mg capsule together with two different antibiotics at night. The recommended treatment duration is once daily for 7 days.

The recommended antibiotic combinations are as follows:

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

If you are receiving anti-infective treatment for an ulcer, it is unlikely that the ulcer will recur 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 NSAID treatment: one 30 mg capsule daily for 4 weeks.

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

Zollinger-Ellison syndrome: The recommended initial dose is two 30 mg capsules daily; subsequently, depending on your response to lansoprazole treatment, your doctor will decide the most appropriate dose for you.

Use in children

Lansoprazole must not be given to children.

If you take more Lansoprazole cinfamed than you should

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

If you forget to take Lansoprazole cinfamed

If you forget to take a dose, take it as soon as possible unless it is almost time for your next dose. In this 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 cinfamed

Do not stop treatment prematurely, even if symptoms improve. Your condition may not be completely healed and 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 lesions on the trunk, often with blisters in the center, peeling, mouth, throat, nose, genital, and eye ulcers. These serious skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis)
• generalized rash, elevated body temperature, and lymphadenopathy (DRESS syndrome or drug hypersensitivity syndrome).

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

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

• 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 patients):

• 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 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, hives, or breathing difficulties.

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

• severe hypersensitivity reactions, including anaphylactic shock. Symptoms of hypersensitivity may include fever, rash, swelling, and occasionally low blood pressure
• inflammation of the mouth (stomatitis)
• colitis (inflammation of the intestine)
• 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 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):

• skin rash, possibly with joint pain
• visual hallucinations
• 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, 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 levels of sodium in the blood. Common symptoms include nausea and vomiting, headache, drowsiness and fatigue, confusion, muscle weakness or spasms, irritability, seizures, coma.

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 can 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 cinfamed

Keep this medicine out of sight and reach of children.

Store below 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 must not be disposed of via wastewater drains or household waste. Dispose of unused medicines and their packaging at the SIGRE Point located at your pharmacy. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Lansoprazol cinfamed

• The active substance is lansoprazole. Each gastro-resistant hard capsule contains 15 mg of lansoprazole.
• The other components are: sugar spheres (containing sucrose and corn starch), sodium lauryl sulfate, povidone, sodium carboxymethylstarch (type A) (from potato), dodecahydrate trisodium phosphate, hypromellose, methacrylic acid-ethyl acrylate copolymer (1:1), triethyl citrate, titanium dioxide (E-171) and talc. The gelatin capsule consists of: gelatin and titanium dioxide (E-171).

The printing ink for the capsules contains shellac, anhydrous ethanol, isopropyl alcohol, propylene glycol, n-butyl alcohol, ammonium hydroxide, potassium hydroxide, and black iron oxide (E-172).

Appearance of the product and contents of the pack

Lansoprazol cinfamed 15 mg gastro-resistant hard capsules EFG are opaque white hard gelatin capsules with a cap and body. The capsules are printed in black ink with the letter “L” on the cap and the number “15” on the body.

Packs containing HDPE bottles with 28 gastro-resistant capsules.

Packs containing aluminium/aluminium blisters with 28 gastro-resistant capsules.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Manufacturer

TEVA PHARMA, S.L.U.

Polígono Malpica c/C, 4

50016 Zaragoza.

or

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

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

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

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the leaflet and packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/66349/P_66349.html

QR code to: https://cima.aemps.es/cima/dochtml/p/66349/P_66349.html