Lansoprazole Kern Pharma 30 mg gastro-resistant hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Lansoprazole Kern Pharma 30 mg gastro-resistant hard capsules EFG

Read all of this leaflet carefully before you start taking this medicine.

• 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 consider any of the side effects you experience to be serious, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet

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

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

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

Your doctor may prescribe Lansoprazol Kern Pharma for the following indications:

• 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 Kern Pharma for an indication or at a dosage different from that stated in this leaflet. Follow your doctor's instructions regarding how to take the medicine.

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

Do not take Lansoprazol Kern Pharma:

• If you are allergic (hypersensitive) to lansoprazol or to any of the components of Lansoprazol Kern Pharma.
• If you are taking another medicine whose active ingredient is atazanavir (used in the treatment of HIV).

Warnings and precautions

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

Your doctor may have performed or may perform an additional test called endoscopy to diagnose your condition and/or rule out cancer.

If you experience diarrhea during treatment with Lansoprazol Kern Pharma, contact your doctor immediately, as Lansoprazol Kern Pharma has been associated with a slight increase in infectious diarrhea.

When taking lansoprazole, inflammation of the kidney may occur. Signs and symptoms may include decreased urine volume or presence of blood in the urine and/or hypersensitivity reactions such as fever, skin rash, and joint stiffness. You must report these signs to your doctor.

If your doctor has prescribed Lansoprazol Kern Pharma in addition to other medicines such as anti-inflammatory drugs for pain or rheumatism, also read the package leaflets of these medicines carefully.

If you have been taking Lansoprazol Kern Pharma for a long time (more than 1 year), your doctor will likely perform regular check-ups. During visits to your doctor, you should report any new or unusual symptoms or circumstances.

If you have ever had a skin reaction after treatment with a medicine similar to Lansoprazol Kern Pharma 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 Lansoprazol Kern Pharma. Remember to mention any other symptoms you may notice, such as joint pain.

Before taking this medicine, inform your doctor if you are scheduled to have a specific blood test (chromogranin A).

Use of other medicines

Inform your doctor or pharmacist if you are using or have recently used any other medicines, including those obtained without a prescription.

In particular, inform your doctor if you are taking medicines containing any of the following active substances, as Lansoprazol Kern Pharma may affect their action:

• ketoconazole, itraconazole, rifampicin (used to treat infections)
• digoxin (used to treat heart problems)
• 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 Kern Pharma with food and drinks

To achieve the best results from your medicine, Lansoprazol Kern Pharma should be taken at least 30 minutes before meals.

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant, or are breastfeeding, consult your doctor before taking this medicine.

Driving and operating machinery

Patients taking Lansoprazole Kern Pharma 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 capabilities may be impaired.

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

Descriptions of these effects can be found in the following sections.

Please read the information in this leaflet carefully.

If you have any doubts, consult your doctor, nurse, or pharmacist.

Important information about one of the components of Lansoprazol Kern Pharma

Lansoprazol Kern Pharma contains sucrose. If your doctor has informed you of an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Lansoprazol Kern Pharma

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

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

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

To properly remove the capsule from its packaging, it is recommended to:

1. Cut the blister along the indicated cutting line.
2. Separate the two aluminum layers at the marked spot and remove the capsule.

The dose of Lansoprazol Kern Pharma depends on your condition. The usual doses of Lansoprazol Kern Pharma for adults are listed below. However, your doctor may prescribe a different dose and treatment duration.

Treatment of heartburn and acid regurgitation: one 15 mg or 30 mg capsule daily for 4 weeks. If symptoms persist, inform your doctor. If symptoms do not improve after 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 given daily for 7 days.

The recommended antibiotic combinations are as follows:

• 30 mg Lansoprazol Kern Pharma with 250–500 mg clarithromycin and 1,000 mg amoxicillin.
• 30 mg Lansoprazol Kern Pharma 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. For the best results from your medication, take it at the correct time and do not miss any doses.

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

Prevention of duodenal or gastric ulcer in patients requiring continuous NSAID therapy: 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 Lansoprazol Kern Pharma treatment, your doctor will decide the appropriate dose for you.

Lansoprazol Kern Pharma must not be administered to children.

Always follow your doctor's instructions exactly. Consult your doctor if you have any doubts.

If you take more Lansoprazol Kern Pharma than you should

If you take more Lansoprazol Kern Pharma than prescribed, consult your doctor or pharmacist, go to the nearest hospital, or contact the Toxicology Information Service at tel. 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Lansoprazol Kern Pharma

If you forget 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 Kern Pharma

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

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

4. Possible adverse effects

Like all medicines, Lansoprazole Kern Pharma may cause adverse effects, although not everyone experiences them.

The following adverse effects are common (occur in more than 1 in 100 patients):

• headache, dizziness
• diarrhoea, constipation, stomach pain, nausea, and vomiting, flatulence, dryness or pain in mouth or throat
• skin rash, itching
• changes in liver function test values
• fatigue
• benign polyps in the stomach

The following adverse effects are uncommon (occur in less than 1 in 100 patients):

• depression
• joint or muscle pain
• fluid retention or swelling
• changes in blood cell counts

If you are taking proton pump inhibitors such as Lansoprazole Kern Pharma 30 mg, especially for a period longer than one year, the risk of hip, wrist, and spine fractures may be slightly increased. Inform your doctor if you have osteoporosis or are taking corticosteroids (which may increase the risk of osteoporosis).

The following adverse effects are rare (occur in less than 1 in 1,000 patients):

• fever
• restlessness, drowsiness, confusion, hallucinations, insomnia, visual disturbances, dizziness
• altered taste, loss of appetite, inflammation of the tongue (glossitis)
• skin reactions such as burning or itching sensation under the skin, bruising, redness, and excessive sweating
• sensitivity to light
• hair loss
• tingling sensation (paraesthesia), tremor
• anaemia (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 mucous membranes)
• angioedema; contact your doctor immediately if you experience symptoms of angioedema such as swelling of the face, tongue or throat, difficulty swallowing, urticaria, or breathing difficulties.

The following adverse effects are very rare (occur in less than 1 in 10,000 patients):

• severe hypersensitivity reactions, including anaphylactic shock. Symptoms of hypersensitivity reactions may include fever, rash, swelling, and occasionally low blood pressure
• inflammation of the mouth (stomatitis)
• colitis (inflammation of the intestine)
• changes in laboratory values, such as levels of sodium, cholesterol, and triglycerides
• severe skin reactions with redness, blisters, severe swelling, and skin loss
• in very rare cases, Lansoprazole Kern Pharma may cause a reduction in the number of white blood cells, which may decrease your resistance to infections. If you develop an infection with symptoms such as fever and a severe deterioration in your general condition, or fever with signs 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).

Frequency not known (cannot be estimated from available data)

• Visual hallucinations

• If you are taking lansoprazole for more than three months, magnesium levels in the blood 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, see your doctor immediately. Low magnesium levels may also lead to decreased levels of potassium and calcium in the blood. Your doctor may decide to perform periodic blood tests to monitor your magnesium levels.

• Skin rash, possibly with joint pain.

Reporting of adverse effects

If you experience any type of adverse effect, consult 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: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Lansoprazol Kern Pharma

Keep out of the reach and sight of children.

Do not use Lansoprazol Kern Pharma after the expiry date stated on the container. The expiry date refers to the last day of the month indicated.

Do not store above 25°C.

Bottle: Keep the container tightly closed.

Blister: Store in the original packaging.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at a SIGRE point in your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

• The active substance is lansoprazole. Each capsule contains 30 mg of lansoprazole.
• The other components (excipients) are: hypromellose (E-464), talc, titanium dioxide (E-171), methacrylic acid-ethyl acrylate copolymer (1:1) dispersion 30%, triethyl citrate, sugar spheres (sucrose and corn starch).

Components of the capsule shell: titanium dioxide (E-171), gelatin, purified water, and ink (shellac and black iron oxide (E-172)).

Appearance of the product and contents of the pack

Lansoprazol Kern Pharma is presented as white, opaque, hard gastro-resistant capsules containing spherical granules with gastro-resistant coating.

Each pack contains 28 capsules.

Marketing Authorization Holder

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Manufacturer

TOWA PHARMACEUTICAL EUROPE, S.L.

C/ de Sant Martí, 75-97

08107 Martorelles – Barcelona

Spain

Date of the most recent revision of this leaflet: December 2022

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