Lansoprazole Pharma Combix 15 mg gastro-resistant hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Lansoprazol Pharma Combix 15 mg gastro-resistant hard 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you. It could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if the adverse effects are not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Lansoprazol Pharma Combix is and what it is used for
2. What you need to know before taking Lansoprazol Pharma Combix
3. How to take Lansoprazol Pharma Combix
4. Possible side effects
5. How to store Lansoprazol Pharma Combix
6. Contents of the pack and other information

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

The active substance in 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 (reflux esophagitis)
• Prevention of reflux esophagitis
• Treatment of heartburn and acid regurgitation
• Treatment of infections caused by the bacterium Helicobacter pylori, in combination with antibiotics
• Treatment or prevention of duodenal or gastric ulcers in patients requiring long-term treatment with non-steroidal anti-inflammatory drugs (NSAIDs) (NSAID therapy is used for pain or inflammation)
• Treatment of Zollinger-Ellison syndrome

Your doctor may have prescribed Lansoprazol Pharma Combix for an indication or at a dosage different from that stated in this leaflet. Always follow exactly the administration instructions given by your doctor.

You should consult a doctor if your condition worsens or if you do not improve after 14 days.

2. What you need to know before starting to take Lansoprazol Pharma Combix

Do not take Lansoprazol Pharma Combix:

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

Warnings and precautions

Tell your doctor if you have severe liver disease. Your doctor may need to adjust your dose.

Your doctor may have performed or may perform an additional test called endoscopy to diagnose your condition and/or rule out 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 along with other medicines for treating Helicobacter pylori infection (antibiotics) or together with anti-inflammatory drugs for pain or rheumatism, please also read the package leaflets of these medicines carefully.

Taking a proton pump inhibitor such as lansoprazole, especially for 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 (e.g., if you are taking steroids).

If you have been taking lansoprazole for a long time (more than 1 year), your doctor will likely monitor you regularly. During visits to your doctor, you should report any new or unusual symptoms or circumstances.

Consult your doctor before starting to take lansoprazole:

• If you have reduced body stores of vitamin B12 or risk factors for this and are receiving long-term treatment with lansoprazole. Like all medicines that reduce acid levels, lansoprazole could reduce the absorption of vitamin B12.
• If you are scheduled to undergo a specific blood test (chromogranin A).
• If you have ever had a skin reaction after treatment with a medicine similar to lansoprazole used to reduce stomach acidity.
• If you develop a skin rash, especially in areas of skin exposed to sunlight, consult your doctor as soon as possible, as it may be necessary to discontinue treatment with lansoprazole. Remember to mention any other symptoms you may notice, such as joint pain.
• Serious skin reactions have been reported with lansoprazole treatment [Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS)]. Stop using lansoprazole and contact your doctor immediately if you experience any of the symptoms related to serious skin reactions described in section 4.
• Kidney inflammation may occur while taking lansoprazole. 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 must report such signs to your treating physician.

Taking Lansoprazol Pharma Combix with other medicines

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

In particular, inform your doctor or pharmacist if you are taking medicines containing any of the following active substances, as lansoprazole may affect their 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 medicine, 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 are planning to become pregnant, consult your doctor or pharmacist before taking this medicine.

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 exercise caution, as your reaction ability may be reduced.

You are solely responsible for deciding whether you are fit to drive or perform activities requiring a high level of concentration. Due to its effects or adverse reactions, the use of medicines is one of the factors that may reduce your ability to carry out these tasks safely.

The following sections contain descriptions of these effects.

Please read this leaflet 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 him before taking this medicine.

3. How to take Lansoprazol Pharma Combix

Follow exactly the instructions given by your doctor for taking this medicine. If in doubt, consult your doctor or pharmacist again.

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

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

If you take Lansoprazol Pharma Combix twice daily, you should take the first dose in the morning and the second in the evening.

The dose of Lansoprazol Pharma Combix depends on your general condition. The usual doses of Lansoprazol Pharma Combix for adults are given below. Occasionally, 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 capsule daily for 4 weeks. If symptoms do not improve within 4 weeks, consult your doctor.

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

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

Treatment of inflammation of the esophagus (reflux esophagitis): one 30 mg capsule daily for 4 weeks.

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

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

The recommended antibiotic combinations are as follows:

• 30 mg Lansoprazol Pharma Combix with 250–500 mg clarithromycin and 1,000 mg amoxicillin
• 30 mg Lansoprazol Pharma Combix with 250 mg clarithromycin and 400–500 mg metronidazole

If you are receiving anti-infective treatment for an ulcer, the ulcer is unlikely to recur if the infection is successfully treated. To achieve the best results from your medicine, take it at the correct time and do not miss any doses.

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

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

Zollinger-Ellison syndrome: The usual initial dose is two 30 mg capsules daily; subsequently, depending on your response to treatment with Lansoprazol Pharma Combix, your doctor will decide the appropriate dose for you.

Use in children

Lansoprazol Pharma Combix must not be given to children.

If you take more Lansoprazol Pharma Combix than you should

If you take more Lansoprazol Pharma Combix than prescribed, contact your doctor immediately or call the Toxicology Information Service at telephone number 915 620 420, indicating the medicine 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 it is almost time for your next dose. In that case, skip the missed dose and take the next capsules at the usual time. Do not take a double dose to make up for a missed dose.

If you stop taking Lansoprazol Pharma Combix

Do not stop treatment prematurely, even if symptoms have improved. Your condition may not be completely healed and may recur if you do not complete the full course of treatment.

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

4. Possible adverse effects

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

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

• circular or target-shaped slightly reddish spots on the trunk, often with blisters in the center, peeling, mouth, throat, nose, genital, and eye ulcers. These serious skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).

• generalized rash, high body temperature, and lymphadenopathy (DRESS syndrome 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 soreness in mouth or throat

• skin rash, itching

• changes in liver function test results

• fatigue

• benign gastric polyps

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

• depression

• joint or muscle pain

• fluid retention or swelling

• changes in blood cell counts

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

• fever

• restlessness, drowsiness, confusion, hallucinations, insomnia, visual disturbances, dizziness

• taste disturbances, 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), tremor

• anemia (pallor)

• kidney problems

• pancreatitis

• liver inflammation (may present as yellowing of the skin or eyes)

• breast swelling in males, impotence

• candidiasis (fungal infection, may affect skin or mucosa)

• angioedema; contact your doctor immediately if you experience symptoms of angioedema, such as swelling of the face, tongue, or pharynx, difficulty swallowing, hives, or breathing difficulties.

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

• severe hypersensitivity reactions, including anaphylactic shock. Symptoms of hypersensitivity may include fever, rash, swelling, and occasionally low blood pressure

• inflammation of the mouth (stomatitis)

• inflammation of the intestine (colitis)

• changes in laboratory values, such as levels of sodium, cholesterol, and triglycerides

• very severe skin reactions with redness, blisters, severe swelling, and skin loss

• in very rare cases, Lansoprazole Pharma Combix may cause a reduction in the number of white blood cells, which can reduce your resistance to infections. If you develop an infection with symptoms such as fever and severe deterioration in your general condition, or fever with signs of localized 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).

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

• If you have been taking Lansoprazole for more than three months, your blood magnesium levels may decrease. Low magnesium levels may cause fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, and increased heart rate. If you experience any of these symptoms, inform your doctor immediately. Low magnesium levels may also lead to decreased levels of potassium or calcium in the blood. Your doctor will likely request regular blood tests to monitor your magnesium levels.
• Low blood sodium levels. Common symptoms include nausea and vomiting, headache, drowsiness and fatigue, confusion, muscle weakness or spasms, irritability, seizures, coma.
• Skin rash, possibly with joint pain.
• Visual hallucinations.

Reporting of adverse effects:

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

5. Storage of Lansoprazole Pharma Combix

Store below 30°C.

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

Do not use this medicine after the expiry date stated on the packaging, after EXP. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of Lansoprazol Pharma Combix

The active substance is lansoprazole. Each gastro-resistant hard capsule contains 15 mg of lansoprazole.

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

Components of the capsule: gelatin, titanium dioxide (E171).

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

Nature of the product and contents of the pack

Lansoprazol Pharma Combix 15 mg capsules are opaque white hard gastro-resistant capsules with a white cap and body, filled with beige micropellets. The capsules are printed in black ink, with the letter “L” on the cap and the number “15” on the body.

Packs of 28 gastro-resistant hard capsules in HDPE bottles.

Aluminum/Aluminum blister packs containing 28 gastro-resistant hard capsules.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Laboratorios Combix, S.L.U.

C/ Badajoz 2, Edificio 2

28223 Pozuelo de Alarcón, Madrid

Spain

Manufacturer:

Teva Pharma, S.L.U.

Polígono Malpica, c/ C 4

50016 Zaragoza

Spain

Date of the most recent revision of this summary: October 2024

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.