Patient Information

Lansoprazol Pharma Combix30 mg Hard Gastropersistent Capsules EFG

Read this entire 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. 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.

The active ingredient of Lansoprazol Pharma Combix is lansoprazole, a proton pump inhibitor. Proton pump inhibitors reduce the amount of acid produced by the stomach.

Your doctor may prescribe Lansoprazol Pharma Combix for the following indications in adults:

• Treatment of duodenal and gastric ulcers
• Treatment of inflammation of the esophagus (gastroesophageal reflux esophagitis)
• Prevention of gastroesophageal reflux esophagitis
• 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 Pharma Combix 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 Pharma Combix:

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

Warnings and precautions

Inform your doctor if you have a severe liver disease. Your 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 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 medications for the treatment of Helicobacter pylori infection (antibiotics) or together with anti-inflammatory drugs to treat pain or rheumatism, read the leaflets of these medications carefully.

The fact of taking a proton pump inhibitor like Lansoprazol, 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 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.

Consult your doctor before starting to take lansoprazole:

• If you have reduced vitamin B12 reserves or risk factors for it and receive long-term treatment with lansoprazole. Like all medications that reduce the amount of acid, lansoprazole 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 lansoprazole 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 lansoprazole. Remember to mention any other symptoms you may notice, such as joint pain.
• Severe skin reactions have been reported in relation to treatment with Lansoprazol [Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS)]. Stop using Lansoprazol and call your doctor immediately if you experience any of the symptoms related to severe skin reactions described in section 4.
• Taking lansoprazole may cause inflammation in the kidneys. Signs and symptoms may include decreased urine volume or blood in the urine and/or hypersensitivity reactions such as fever, hives, and joint stiffness. Inform your doctor of such signs.

Administration of Lansoprazol Pharma Combix with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication, including those purchased without a prescription.

Especially, inform your doctor or pharmacist if you are taking medications containing any of the following active ingredients, as Lansoprazol Pharma Combix 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)

Administration of Lansoprazol Pharma Combix with food and beverages

To get the best results from your medication, take Lansoprazol 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 plan to become pregnant, consult your doctor or pharmacist before taking this medication.

Driving and operating machinery

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 Pharma Combix contains saccharose

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

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

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

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

The dose of Lansoprazol Pharma Combix depends on your general condition. The normal doses of Lansoprazol Pharma Combix 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 caused by acid reflux:one capsule of 30 mg per day for 4 weeks.

Long-term prevention of acid reflux esophagitis: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 normal 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 treatment, usually, will be daily for 7 days.

The recommended antibiotic combinations are as follows:

• 30 mg of Lansoprazol Pharma Combix with 250–500 mg of clarithromycin and 1,000 mg of amoxicillin
• 30 mg of Lansoprazol Pharma Combix 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 medication, take it at the right time anddo not forget 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 initial normal dose is two capsules of 30 mg per day; subsequently, your doctor will decide the best dose for you based on your response to treatment with Lansoprazol Pharma Combix.

Use in children

Lansoprazol Pharma Combix should not be administered to children.

If you take more Lansoprazol Pharma Combix than you should

If you take more Lansoprazol Pharma Combix than indicated, consult your doctor immediately or contact the Toxicology Information Service, Teléfono 915 620 420, indicating the medication and the amount ingested.

If you forget to take Lansoprazol Pharma Combix

If you forget to take a dose, take it as soon as possible 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 compensate for the missed dose.

If you interrupt treatment with Lansoprazol Pharma Combix

Do not interrupt 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.

If you start to notice any of the following side effects, stop taking Lansoprazol Pharma Combix and contact your doctor immediately:

• round or target-shaped red spots on the trunk, often with blisters in the center, peeling, mouth ulcers, throat, nose, genital, and eye ulcers. These severe skin eruptions 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 side effects (may affect up to 1 in 10 people):

• 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

• Rare side effects (may affect up to 1 in 100 people):
• depression
• joint or muscle pain
• fluid retention or swelling
• changes in blood cell count

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

• 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 people):
• 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)
• inflammation of the intestine (colitis)
• changes in analytical values, such as sodium, cholesterol, and triglyceride levels
• very severe skin reactions with redness, vesicles, severe inflammation, and skin loss
• In rare cases, Lansoprazol Pharma Combix may cause a reduction in the number of white blood cells, which may 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 local infection symptoms such as throat, pharynx, or mouth pain or urinary problems, consult your doctor immediately. A blood test will be performed to check for possible leukopenia (agranulocytosis).

Unknown frequency (cannot be estimated from available data):

• If you have been taking Lansoprazol for more than three months, it is possible that magnesium levels in the blood may decrease. Low magnesium levels may cause fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, and increased heart rate. If you notice any of these symptoms, inform your doctor immediately. Low magnesium levels may also lead to a decrease in potassium or calcium levels in the blood. Your doctor may request regular 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, convulsions, coma.
• skin rash, possibly with joint pain.
• 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.

Store below 30°C.

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

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.

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

Composition of Lansoprazol Pharma Combix

The active ingredient is lansoprazol. Each gastro-resistant hard capsule contains 30 mg of lansoprazol.

The other components are: sugar spheres (saccharose and cornstarch), sodium laurilsulfate, povidone, carboxymethylstarch from potato (Type A), dodecahydrate trisodium phosphate, hypromellose, copolymer of methacrylic acid and ethyl acrylate (1:1), triethylcitrate, titanium dioxide (E171), and talc.

The capsule components are: gelatin, titanium dioxide (E171).

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 (E172).

Appearance of the product and contents of the packaging

Lansoprazol Pharma Combix 30 mg capsules are opaque white cap and body capsules, filled with beige micropellets. The capsules have been marked with black ink, with the letter “L” on the cap and the number “30” on the body.

Packaging in HDPE bottles with 14 and 28 gastro-resistant hard capsules.

Packaging in aluminum/aluminum blisters of 14 and 28 hard gastro-resistant capsules.

Only some packaging sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

The marketing authorization holder is:

Laboratorios Combix, S.L.U.

C/ Badajoz 2, Edificio 2

28223 Pozuelo de Alarcón, Madrid

Spain

The manufacturer is:

Teva Pharma, S.L.U.

Polígono Malpica, c/C 4

50016 Zaragoza

Spain

Last review date of this leaflet: October 2024.

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