LANSOPRAZOL PHARMA COMBIX 15 mg HARD GASTRORESISTENT CAPSULES

Introduction

Prospect: Information for the user

Lansoprazol Pharma Combix15 mg hard gastro-resistant capsules

Read the entire prospectus carefully before starting to take this medication, as it contains important information for you.

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

Contents of the prospectus

1. What is Lansoprazol Pharma Combix and what is it used for
2. What you need to know before taking Lansoprazol Pharma Combix
3. How to take Lansoprazol Pharma Combix
4. Possible adverse effects
5. Storage of Lansoprazol Pharma Combix
6. Package contents and additional information

1. What is Lansoprazol Pharma Combix and what is it used for

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

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

• Treatment of duodenal and gastric ulcers
• Treatment of esophageal inflammation (reflux esophagitis)
• Prevention of reflux esophagitis
• Treatment of heartburn 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 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 is possible that your doctor has prescribed you Lansoprazol Pharma Combix for another indication or at a different dose than indicated in this prospectus. Follow your doctor's instructions for administration of this medication exactly.

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

2. What you need to know before taking Lansoprazol Pharma Combix

Do not take Lansoprazol Pharma Combix:

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

Warnings and precautions

Tell your doctor if you have a severe liver disease. The 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.

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 you Lansoprazol in addition to other medications for the treatment of Helicobacter pyloriinfection (antibiotics) or together with anti-inflammatory medications to treat pain or rheumatism, also read the prospectuses of these medications carefully.

Taking a proton pump inhibitor like Lansoprazol, especially for a period longer 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 Lansoprazol for a long time (more than 1 year), your doctor will probably perform regular check-ups. During your doctor's visits, you should inform them of any new or unusual symptoms and circumstances.

Consult your doctor before starting to take lansoprazol:

• If you have reduced body stores of vitamin B12 or risk factors for it and receive long-term treatment with lansoprazol. Like all medications that reduce acid, lansoprazol may 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 medication similar to lansoprazol to reduce stomach acid.
• If you experience 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 lansoprazol. Remember to mention any other symptoms you may notice, such as joint pain.
• There have been reports of serious skin reactions in relation to treatment with Lansoprazol [Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug hypersensitivity syndrome with eosinophilia and systemic symptoms (DRESS)]. Stop using Lansoprazol and call your doctor immediately if you experience any of the symptoms related to serious skin reactions described in section 4.
• When taking lansoprazol, kidney inflammation can occur. The 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 inform your doctor of such signs.

Taking Lansoprazol Pharma Combix with other medications

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

In particular, inform your doctor or pharmacist if you are taking medications that contain any of the following active ingredients, as Lansoprazol may affect their mode of 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 Pharma Combix with food and drinks

To get the best results from your medication, you should take Lansoprazol Pharma Combix at least 30 minutes before meals with a glass of water.

Pregnancy, breastfeeding, and fertility

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

Driving and using machines

Patients taking Lansoprazol Pharma Combix 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 fit 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 medications.

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

Read the information in this prospectus carefully.

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

Lansoprazol Pharma Combix contains sucrose

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

3. How to take Lansoprazol Pharma Combix

Follow your doctor's instructions for administration of this medication exactly. If in 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 prevent them from working 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 usual doses of Lansoprazol Pharma Combix for adults are indicated below. Sometimes, 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 per day for 4 weeks. If symptoms do not improve after 4 weeks, consult your doctor.

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

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

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

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

Treatment of Helicobacter pyloriinfection:The usual dose is one 30 mg capsule with two different antibiotics in the morning and one 30 mg capsule with two different antibiotics at night. The treatment is usually taken daily for 7 days.

The recommended antibiotic combinations are:

• 30 mg of Lansoprazol Pharma Combix with 250-500 mg of clarithromycin and 1000 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 for 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 and do not forget any dose.

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

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

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

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 prescribed, consult your doctor or contact the Toxicology Information Service, Telephone 915 620 420, indicating the medication and the amount taken.

If you forget to take Lansoprazol Pharma Combix

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 missed dose and take the next capsules as usual. Do not take a double dose to make up for the missed dose.

If you interrupt treatment with Lansoprazol Pharma Combix

Do not interrupt treatment prematurely 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 medication, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medications, this medication can cause adverse effects, although not everyone will experience them.

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

• round or target-shaped patches of slightly reddish color on the torso, often with blisters in the center, peeling, ulcers in the mouth, throat, nose, genitals, and eyes. These serious skin rashes can be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• generalized exanthema, elevated body temperature, and lymphadenopathy (DRESS or drug hypersensitivity syndrome).

• Common adverse 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 polyps in the stomach

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

Rare adverse 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 or itching sensation, bruising, redness, and excessive sweating
• photosensitivity
• hair loss
• tingling sensation (paresthesia), tremors
• anemia (pallor)
• kidney problems
• pancreatitis
• liver inflammation (may manifest as yellowing of the skin or eyes)
• breast swelling in males, impotence
• candidiasis (fungal infection, can affect skin or mucous membranes)
• angioedema; contact your doctor immediately if you experience symptoms of angioedema, such as facial, tongue, or pharyngeal swelling, difficulty swallowing, urticaria, and difficulty breathing.

• Very rare adverse effects (may affect up to 1 in 10,000 people):
• severe hypersensitivity reactions, including anaphylactic shock. The symptoms of a hypersensitivity reaction 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 serious skin reactions with redness, blisters, severe inflammation, and skin loss
• in very rare cases, Lansoprazol Pharma Combix may cause a reduction in the number of white blood cells, which can lead to a decrease in 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 a possible reduction in white blood cells (agranulocytosis).

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

• If you have been taking Lansoprazol for more than three months, it is possible that your blood magnesium levels may decrease. Low magnesium levels can cause fatigue, muscle contractions, disorientation, convulsions, dizziness, and increased heart rate. If you notice any of these symptoms, inform your doctor immediately. Low magnesium levels can also lead to a decrease in potassium or calcium levels in the blood. Your doctor will likely 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 adverse effects:

If you experience any type of adverse effect, consult your doctor, pharmacist, or report them directly through the Spanish Pharmacovigilance System for Human Use Medications: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Lansoprazol Pharma Combix

Store below 30°C.

Keep this medication out of sight and reach of children.

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

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Container Content and Additional Information

Composition of Lansoprazol Pharma Combix

The active ingredient is lansoprazol. Each hard gastro-resistant capsule contains 15 mg of lansoprazol.

The other components are: sugar spheres (sucrose and corn starch), sodium lauryl sulfate, povidone, potato starch glycolate (Type A), disodium phosphate dodecahydrate, hypromellose, methacrylic acid-ethyl acrylate copolymer (1:1), triethyl citrate, titanium dioxide (E171), and talc.

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

The printing ink of the capsules contains shellac, anhydrous ethyl alcohol, isopropyl alcohol, propylene glycol, n-butyl alcohol, ammonium hydroxide, potassium hydroxide, and black iron oxide (E172).

Appearance of the Product and Container Content

Lansoprazol Pharma Combix 15 mg capsules are capsules with a white opaque cap and body, filled with beige micropellets. The capsules have been marked with black ink, with the letter “L” on the cap and the number “15” on the body.

Containers in HDPE bottles with 28 hard gastro-resistant capsules.

Containers in Aluminum/Aluminum blisters of 28 hard gastro-resistant capsules.

Only some package sizes may be marketed.

Marketing Authorization Holder and 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

Date of the Last Revision of this Prospectus: October 2024

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