Leaflet: information for the user

Lansoprazole Cinfa 15 mg gastro-resistant capsules

Read this 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 give it to others even if they have the same symptoms as you, as it may harm them.

-If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

2.What you need to know before starting to take lansoprazole cinfa.

3.How to take lansoprazole cinfa.

4.Possible side effects.

5.Storage of lansoprazole cinfa.

6.Contents of the pack and additional information.

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

Your doctor may prescribe lansoprazol cinfa for the following indications in adults:

-Treatment of duodenal and stomach ulcers.

-Treatment of inflammation of the esophagus (acid reflux esophagitis).

-Prevention of inflammation of the esophagus (acid reflux esophagitis).

-Treatment of stomach burning and acid regurgitation (acid content rising from the stomach).

-Treatment of infections caused by the bacteriaHelicobacter pylori, in combination with antibiotics.

-Treatment or prevention of duodenal or stomach ulcers in patients requiring continuous treatment with nonsteroidal anti-inflammatory drugs (NSAIDs) (NSAID treatment is used for pain or inflammation).

-Treatment of Zollinger-Ellison syndrome.

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

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

Do not take lansoprazol cinfa

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take lansoprazol cinfa:

-If you have a severe liver disease. Your doctor may need to adjust the dose.

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

-If you experience 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 medicines for the treatment of Helicobacter pylori infection (such as antibiotics) or together with anti-inflammatory drugs to treat pain or rheumatism, read also carefully the leaflets of these medicines.

-If you have been taking lansoprazol for a long time (more than 1 year), your doctor will probably make regular checks. At your doctor's visits, you must inform him of any new or abnormal symptoms and circumstances.

• If you have reduced vitamin B12 reserves or risk factors for it and receive long-term treatment with lansoprazol. Like all medicines that reduce the amount of acid, lansoprazol may reduce the absorption of vitamin B12.
• If you have ever had a skin reaction after treatment with a similar medicine to lansoprazol for reducing stomach acid.
• 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.
• If you are scheduled to have a specific blood test (Cromogranina A).

When taking lansoprazol, an inflammation of the kidney 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.

Other medicines and lansoprazol cinfa

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

Especially, inform your doctor or pharmacist if you are using medicines that contain any of the following active ingredients, as lansoprazol may affect their mode of action:

• inhibitors of HIV protease 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 the passage of acidic stomach contents into the esophagus –acid regurgitation).
• sucralfate (used to heal ulcers)
• St. John's Wort (Hypericum perforatum) (used to treat mild depression).

Taking lansoprazol cinfa with food and drinks

To get the best results from your medicine, you must 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, consult your doctor or pharmacist before using this medicine.

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 must act with 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 medicines.

In the following sections, you will find the descriptions of these side effects. Read carefully the information in this leaflet.

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

Lansoprazol cinfa contains saccharose.

This medicine contains saccharose. If your doctor has told you that you have an intolerance to certain sugars, consult him before taking this medicine.

Lansoprazol cinfa contains sodium.

This medicine contains less than 1 mmol of sodium (23 mg) per capsule; this 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 again.

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

Treatment of heartburn and acid regurgitation:one capsule of 15 mg or 30 mg of lansoprazole 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 of lansoprazole per day for 2 weeks.

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

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

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

Treatment of Helicobacter pylori infection:The usual dose is one capsule of 30 mg of lansoprazole together with two different antibiotics in the morning and one capsule of 30 mg of lansoprazole together with two different antibiotics in the evening. The treatment, usually, is daily and for 7 days.

The recommended antibiotic combinations are as follows:

-30 mg oflansoprazolewith 250–500 mg of clarithromycin and 1,000 mg of amoxicillin.

-30 mg oflansoprazolewith 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 forget any dose.

Treatment of duodenal or stomach ulcer in patients requiring continuous treatment with NSAIDs (anti-inflammatory or pain medications):one capsule of 30 mg of lansoprazole per day for 4 weeks.

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

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

Administration form:

Take the capsule whole with a glass of water. If you have difficulty swallowing the capsule, your doctor will inform you of other 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 ineffective.

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

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

Use in children:

Lansoprazole should not be administered to children.

If you take more lansoprazole cinfa 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 lansoprazole cinfa:

Do not take a double dose to compensate for the missed doses.

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.

If you interrupt treatment with lansoprazole cinfa:

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 doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may 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 (gas), dryness or pain in the mouth or throat.
• Skin rash (swelling and redness of the skin), 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 (edema).
• Changes in blood cell counts.

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.
• Sensitivity to light.
• Hair loss.
• Prickling sensation (paresthesia), tremor.
• Anemia (pallor).
• Renal problems.
• Pancreatitis.
• Inflammation of the liver (may manifest as yellowish 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 (exaggerated allergic reaction that can be fatal). 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 a part of the intestine).
• Changes in analytical values, such as sodium levels (hyponatremia), cholesterol, and triglycerides
• Very severe skin reactions with redness, vesicles, severe inflammation, and skin loss.
• Reduction in the number of white blood cells, which may cause 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).

Unknown frequency (cannot be estimated from available data):

• Skin rash, possibly with joint pain.
• If you are taking lansoprazole for more than three months, it is possible that 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 can also cause a decrease in potassium or calcium levels in the blood. Your doctor may decide to perform periodic blood tests to monitor magnesium levels.
• Visual hallucinations.

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.

Do not store at a temperature above 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 lansoprazol cinfa

• The active ingredient is lansoprazol. Each gastro-resistant capsule contains 15 mg of lansoprazol.
• The other components are:

-Capule content: sugar spheres (containing sacarose, cornstarch, purified water), sodium laurilsulfate, N-methylglucamine, mannitol (E-421), hypromellose (E-464), macrogol 6000, talc (E-553b), polisorbate 80 (E-433), titanium dioxide (E-171) and Eudragit®L30-D55 (dispersion at 30 % of copolymer of methacrylic acid and ethyl acrylate (1:1)).

-Capule composition: quinoline yellow (E-104), titanium dioxide (E-171), purified water and gelatin.

Appearance of the product and contents of the packaging

Lansoprazol cinfa is presented in the form of hard, gastro-resistant capsules with a yellow opaque cap and body containing white or almost white spherical microgranules.

It is presented in Aluminio/Aluminio blisters. Each package contains 28, 56 or 500 (clinical package) capsules.

Only some package sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Cinfa Laboratories, S.A.

Carretera Olaz-Chipi, 10. Areta Industrial Estate

31620 Huarte (Navarra) - Spain

Last review date of this leaflet:December 2022

Detailed information about this medicine 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 medicine by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address:https://cima.aemps.es/cima/dochtml/p/66146/P_66146.html

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