LANSOPRAZOL CINFA 15 mg GASTRO-RESISTANT CAPSULES

Introduction

Package Leaflet: Information for the User

Lansoprazole Cinfa 15 mg Gastro-Resistant Capsules EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

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

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

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

• Treatment of duodenal and stomach ulcers.
• Treatment of inflammation of the esophagus (reflux esophagitis).
• Prevention of inflammation of the esophagus (reflux esophagitis).
• Treatment of heartburn and acid regurgitation (acid reflux).
• Treatment of infections caused by the bacteria Helicobacter pylori, in combination with antibiotics.
• Treatment or prevention of duodenal or stomach ulcers in patients who require continuous treatment with non-steroidal anti-inflammatory drugs (NSAIDs) (NSAID treatment is used for pain or inflammation).
• Treatment of Zollinger-Ellison syndrome.

It may be that your doctor has prescribed lansoprazole for another indication or at a different dose than indicated in this leaflet. Follow your doctor's instructions for taking this medicine exactly.

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

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

Do not take lansoprazole cinfa

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

Warnings and precautions

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

• If you have severe liver disease. Your doctor may need to adjust the dose.
• Your doctor may have performed or may perform a complementary test called endoscopy to diagnose your disease and/or rule out a 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 in addition to other medicines intended for the treatment of Helicobacter pylori infection (such as antibiotics) or together with anti-inflammatory medicines to treat pain or rheumatism, also read the package leaflets of these medicines carefully.
  • Taking a proton pump inhibitor like lansoprazole, especially for a period of 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 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 probably have regular check-ups. During visits to your doctor, you should report any new or abnormal symptoms or circumstances.
  • If you have reduced body stores of vitamin B12 or risk factors for this and receive long-term treatment with lansoprazole. Like all acid-reducing medicines, lansoprazole may reduce the absorption of vitamin B12.
  • If you have ever had a skin reaction after treatment with a medicine similar to lansoprazole to reduce stomach acid.
  • If you get a skin rash, especially in areas of the skin exposed to the sun, consult your doctor as soon as possible, as it may be necessary to interrupt treatment with lansoprazole. Also, mention any other symptoms you may notice, such as joint pain.
  • If you are scheduled to have a specific blood test (Chromogranin A).

When taking lansoprazole, kidney inflammation may occur. The signs and symptoms can include decreased urine volume or the presence of 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 cinfa

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

In particular, tell your doctor or pharmacist if you are using medicines that contain any of the following active substances, as lansoprazole may affect their action:

• HIV protease inhibitors such as atazanavir and nelfinavir (used to treat 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 reflux)
• Sucralfate (used to heal ulcers)
• St. John's Wort (Hypericum perforatum) (used to treat mild depression)

Taking lansoprazole cinfa with food and drinks

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 breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking 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 act with caution as your reaction ability may be reduced.

You are the only one responsible for deciding whether you are in a fit state 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 can reduce your ability to perform these operations safely is the use of medicines.

In the following sections, you will find descriptions of these effects. Read the information in 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 told you that you have an intolerance to some sugars, consult with them 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 your doctor's or pharmacist's instructions for taking this medicine exactly. If you are in 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. Sometimes, your doctor may prescribe a different dose and indicate a different duration of treatment.

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

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

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

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

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

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. The treatment is usually daily and for 7 days.

The recommended antibiotic combinations are:

• 30 mg of lansoprazole with 250-500 mg of clarithromycin and 1000 mg of amoxicillin.
• 30 mg of lansoprazole with 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 medicine, take it at the right time and do not forget any dose.

Treatment of duodenal or stomach ulcers in patients who require continuous treatment with NSAIDs (medicines for inflammation or pain):one 30 mg lansoprazole capsule per day for 4 weeks.

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

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

Method of administration:

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

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

If you take lansoprazole twice a day, you should take the first dose in the morning and the second dose 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 Toxicology Information Service, phone: 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 forgotten doses.

If you forget to take a dose, take it as soon as possible unless the time of the next dose is near. In this case, skip the forgotten dose and take the next capsules as usual.

If you stop taking lansoprazole cinfa

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

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Common side effects (may affect up to 1 in 10 people):

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

Uncommon side effects (may affect up to 1 in 100 people):

• Depression.
• Pain in the joints or muscles.
• Fluid retention or swelling (edema).
• Changes in blood cell count.

Rare side effects (may affect up to 1 in 1,000 people):

• Fever.
• Restlessness, drowsiness, confusion, hallucinations, insomnia, visual disturbances, vertigo.
• Altered taste, loss of appetite, inflammation of the tongue (glossitis).
• Skin reactions such as burning sensation or itching, bruising, redness, and excessive sweating.
• Sensitivity to light.
• Hair loss.
• Numbness (paresthesia), tremors.
• Anemia (pallor).
• Kidney problems.
• Pancreatitis.
• Liver inflammation (may be manifested by yellowing of the skin or eyes).
• Chest swelling in males, impotence.
• Candidiasis (fungal infection, can affect the 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, and difficulty breathing.

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

• Severe hypersensitivity reactions, including anaphylactic shock (exaggerated allergic reaction that can cause death). The symptoms of a hypersensitivity reaction may include fever, rash, swelling, and, occasionally, a drop in blood pressure.
• Mouth inflammation (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, blisters, severe inflammation, and skin loss.
• Reduction in the number of white blood cells, which can 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. You will have a blood test to check for possible reduction of white blood cells (agranulocytosis).

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

• Rash, possibly with joint pain.
• If you are taking lansoprazole for more than three months, it is possible that your blood magnesium levels may decrease. Low magnesium levels can cause fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, and increased heart rate. If you have any of these symptoms, see your doctor immediately. Low magnesium levels can also cause a decrease in blood potassium or calcium levels. Your doctor may decide to perform periodic blood tests to monitor magnesium levels.
• Visual hallucinations.

Reporting of side effects

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

5. Storing lansoprazole cinfa

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

Do not store above 30 ºC.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Place the cartons and any remaining medicines in the SIGRE collection point at the pharmacy. If you have any doubts, ask your pharmacist how to dispose of cartons and medicines you no longer need. This will help protect the environment.

6. Container Content and Additional Information

Composition of Lansoprazol Cinfa

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

• Capsule content: 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: quinoline yellow (E-104), titanium dioxide (E-171), purified water, and gelatin.

Product Appearance and Container Content

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 aluminum/aluminum blisters. Each container contains 28, 56, or 500 (clinical container) capsules.

Only some package 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 Last Revision of this Prospectus:December 2022

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

QR code at: https://cima.aemps.es/cima/dochtml/p/66146/P_66146.html