Package Insert: Information for the User

Lansoprazole cinfamed 30 mg Hard Gastropellet EFG

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others who may have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

The active ingredient 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 esophagitis caused by acid reflux
• Prevention of esophagitis caused by acid reflux
• Treatment of stomach burning 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 requiring continuous treatment with nonsteroidal anti-inflammatory drugs (NSAIDs) (NSAIDs are used for pain or inflammation)
• Treatment of Zollinger-Ellison syndrome

Your doctor may have prescribed lansoprazol for another indication or at a different dose than indicated in this leaflet. Follow exactly the administration instructions for this medication as indicated by your doctor.

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

Do not take Lansoprazol cinfamed

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

Warnings and precautions

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

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

In case of experiencing diarrhea during treatment with lansoprazol, contact your doctor immediately, as lansoprazol has been associated with a slight increase in infectious diarrhea.

If your doctor has prescribed lansoprazol in addition to other medications for the treatment of Helicobacter pylori infection (antibiotics) or together with anti-inflammatory medications to treat pain or rheumatism, read the prospectuses of these medications carefully.

The fact of taking a proton pump inhibitor such as lansoprazol, especially for a period exceeding 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 lansoprazol for a long time (more than 1 year), your doctor will probably perform regular checks. During your doctor's visits, you must inform them of any new or abnormal symptoms and circumstances.

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

Consult your doctor before starting to take lansoprazol:

• If you have reduced vitamin B12 reserves or risk factors for it and receive long-term treatment with lansoprazol. Like all medications that reduce the amount of acid, lansoprazol may reduce vitamin B12 absorption.
• If you are scheduled to undergo a specific blood test (Cromogranin A).
• If you have ever had a skin reaction after treatment with a similar medication to lansoprazol for reducing stomach acidity.
• If you suffer from a skin rash, especially in sun-exposed areas, consult your doctor as soon as possible, as it may be necessary to interrupt treatment with lansoprazol. Remember to mention any other symptoms you may notice, such as joint pain.

Other medications and Lansoprazol cinfamed

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Especially, inform your doctor or pharmacist if you are taking medications containing any of the following active ingredients, as lansoprazol may affect their mode of action:

• Protease inhibitors for HIV such as atazanavir and nelfinavir (used in HIV treatment)
• 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 stomach burning 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 drinks

To get the best results from your medication, take lansoprazol at least 30 minutes before meals with a glass of water.

Pregnancy and breastfeeding

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

Driving and operating machines

Patients taking lansoprazol 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 time may be reduced.

You are the only one responsible for deciding whether you are in a condition 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 may reduce your ability to carry out these operations safely is the use of medications.

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

Read this prospectus carefully.

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

Lansoprazol cinfamed contains saccharose

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

Lansoprazol cinfamed contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per capsule; it is essentially "sodium-free".

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist.

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

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

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

The dose of lansoprazol depends on your general condition. The recommended doses of lansoprazol for adults are indicated below. In some cases, your doctor may prescribe a different dose and a different duration of treatment.

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

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

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

Treatment of esophagitis due to reflux:one capsule of 30 mg per day for 4 weeks.

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

Treatment of Helicobacter pylori infection:The recommended dose is one capsule of 30 mg with two different antibiotics in the morning and one capsule of 30 mg with two different antibiotics at night. The recommended treatment is once a day for 7 days.

The recommended antibiotic combinations are as follows:

• 30 mg of Lansoprazolcinfamedwith 250–500 mg of clarithromycin and 1,000 mg of amoxicillin
• 30 mg of Lansoprazolcinfamedwith 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 treated satisfactorily. To get the best results from your medication, take it at the right time anddo not miss any dose.

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

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

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

Use in children:

Lansoprazol should not be administered to children.

If you take more Lansoprazol cinfamed than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Lansoprazol cinfamed

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

If you interrupt treatment with Lansoprazol cinfamed

Do not stop treatment before time because symptoms have improved. It is possible that your condition has not been fully cured and may recur if you do not complete the entire treatment.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Frequent side 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 polyps in the stomach

Less frequent side effects (may affect up to 1 in 100 patients):

• 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 patients):

• fever,
• restlessness, drowsiness, confusion, hallucinations, insomnia, visual disturbances, vertigo,
• alteration of taste, loss of appetite, inflammation of the tongue (glossitis),
• skin reactions such as burning or itching, hematomas, redness and excessive sweating,
• light sensitivity,
• hair loss,
• tingling sensation (paresthesia), tremors,
• anemia (pale skin),
• kidney problems,
• pancreatitis,
• inflammation of the liver (may manifest as yellow skin or eyes),
• chest swelling in men, impotence,
• candidiasis (fungal infection, may affect the skin or mucous membranes),
• angioedema; contact your doctor immediately if you experience symptoms of angioedema, such as facial swelling, tongue or throat swelling, difficulty swallowing, urticaria, and difficulty breathing.

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

• severe hypersensitivity reactions, including anaphylactic shock. Symptoms of hypersensitivity reactions may include fever, rash, swelling, and, in some cases, a drop in blood pressure,
• inflammation of the mouth (stomatitis),
• colitis (inflammation of the intestine),
• changes in analytical values, such as sodium, cholesterol, and triglyceride levels,
• very severe skin reactions with redness, vesicles, severe inflammation, and, in rare cases, skin loss. Lansoprazole 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, consult your doctor immediately. A blood test will be performed to check for possible reduction in white blood cells (agranulocytosis).

Side effects of 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, it is possible that 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 experience any of these symptoms, see your doctor immediately. Low magnesium levels can also cause a decrease in potassium and calcium levels in the blood. Your doctor may decide to perform periodic blood tests to monitor magnesium levels.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Store below 30°C.

Do not use this medication after the expiration date that appears on the packaging, after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Cinfamed Lansoprazol

• The active ingredient is lansoprazol. Each gastro-resistant capsule contains 30 mg of lansoprazol.
• The other components are: sugar spheres (containing sacarosa and cornstarch), sodium laurilsulfate, povidone, carboxymethylcellulose sodium (type A) (from potato), trisodium dodecyl phosphate dodecahydrate, hypromellose, copolymer of methacrylic acid and ethyl acrylate (1:1), triethyl citrate, titanium dioxide (E-171), and talc.

The gelatin capsule is composed of: gelatin and titanium dioxide (E-171).

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

Appearance of the product and contents of the package

Cinfa Lansoprazol 30 mg gastro-resistant capsules EFG are hard gelatin capsules with a white opaque cap and body, filled with white to beige micropellets. The capsules have been marked with black ink with the letter “L” on the cap and the number “30” on the body.

Packages in HDPE bottles with 14 or 28 gastro-resistant capsules.

Packages in aluminum/aluminum blisters of 14 or 28 gastro-resistant capsules.

Only some package sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Cinfa Laboratories, S.A.

Carretera Olaz-Chipi, 10. Industrial Estate Areta

31620 Huarte (Navarra) - Spain

Responsible for manufacturing

TEVA PHARMA, S.L.U.

Malpica Industrial Estate c/C, 4

50016 Zaragoza.

or

Cinfa Laboratories, S.A.

Carretera Olaz-Chipi, 10. Industrial Estate Areta

31620 Huarte (Navarra) - Spain

Last review date of this prospectus:December 2022

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

You can access detailed and updated information about this medication by scanning with your smartphone the QR code included in the prospectus and packaging. You can also access this information at the following internet address:https://cima.aemps.es/cima/dochtml/p/66350/P_66350.html

QR code to:https://cima.aemps.es/cima/dochtml/p/66350/P_66350.html