Package Leaflet: Information for the User

Lansoprazol Kern Pharma 15 mg Hard Capsules (Gastro-resistant EFG)

Read the entirepackage leaflet carefully before you start taking the medicine.

• Keep this package 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 pass it on to others even if their symptoms are the same. It may harm them.

• If you think you have suffered a side effect, you can report it directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects, you can help provide more information on the safety of this medicine.

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

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

3. How to take Lansoprazol Kern Pharma

4. Possible side effects

5. Storage of Lansoprazol Kern Pharma

6. Contents of the pack and additional information

The active ingredient is lansoprazole, 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 esophagus inflammation (acid reflux esophagitis).
• Prevention of acid reflux esophagitis.
• Treatment of stomach burning and acid regurgitation.
• Treatment of infections caused by the bacteriaHelicobacter pylori, in combination with antibiotics.
• Treatment or prevention of duodenal or gastric ulcers in patients requiring continuous treatment with nonsteroidal anti-inflammatory drugs (NSAIDs) (NSAID treatment is used for pain or inflammation).
• Treatment of Zollinger-Ellison syndrome.

Your doctor may have prescribed Lansoprazol Kern Pharma for another indication or at a different dose than indicated in this leaflet. Follow your doctor's instructions for taking the medication.

Do not take Lansoprazol Kern Pharma:

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

Warnings and precautions

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

Your doctor may perform or have performed a supplementary test called endoscopy to diagnose your disease and/or rule out cancer.

In case of experiencing 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, kidney inflammation may occur. Symptoms and signs may include decreased urine volume or the presence of blood in the urine and/or hypersensitivity reactions such as fever, skin rash, and joint stiffness. Inform your doctor of these signs.

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

If you have been taking Lansoprazol Kern Pharma for a long time (over 1 year), your doctor will likely perform regular checks. During your doctor's visits, inform them of any new or abnormal symptoms and circumstances.

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

Before taking this medication, inform your doctor if you are scheduled to undergo a specific blood test (Cromogranin A).

Use of other medications

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

Especially, inform your doctor if you are using medications containing any of the following active ingredients, 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 stomach burning 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 get the best results from your medication, take Lansoprazol Kern Pharma capsules at least 30 minutes before meals.

Pregnancy and breastfeeding

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

Driving and operating machines

Patients taking Lansoprazol 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 time 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 the effects or adverse reactions of these medications, one of the factors that may reduce your ability to perform these operations safely is the use made of these medications.

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

Read this prospectus carefully.

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

Important information about one of the components of Lansoprazol Kern Pharma

Lansoprazol Kern Pharma contains saccharose. If your doctor has indicated that you have an intolerance to certain sugars, consult with them before taking this medication.

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

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

To extract the capsule properly, it is recommended:

1. Cut the indentation along the marked cutting line.

2. Separate the two aluminum layers at the indicated location and extract the capsule.

The dose of Lansoprazol Kern Pharma depends on your general condition. The normal doses of Lansoprazol Kern Pharma for adults are indicated below. In some cases, your doctor may prescribe a different dose and indicate 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 persist, inform your doctor. 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 due to reflux: one capsule of 30 mg per day for 4 weeks.

Long-term prevention of esophagitis due to reflux: 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 ofLansoprazol Kern Pharmawith 250–500 mg of clarithromycin and 1,000 mg of amoxicillin
• 30 mg ofLansoprazol Kern Pharmawith 250 mg of clarithromycin and 400–500 mg of metronidazole

If you receive antibiotic 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 Kern Pharma.

Lansoprazol Kern Pharma should not be administered to children.

Follow exactly the administration instructions given by your doctor. 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 indicated, consult your doctor or pharmacist, go to the nearest hospital, or contact the Toxicology Information Service, tel. 91 562 04 20 indicating the medication and the amount ingested.

If you forget to take Lansoprazol Kern Pharma

If you forget to take a dose, take it as soon as you remember, 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 Kern Pharma

Do not stop 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 product, ask your doctor or pharmacist.

Like all medicines, Lansoprazol Kern Pharma may cause side effects, although not everyone will experience them.

The following side effects are frequent (occur in more than 1 in 100 patients):

• 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

The following side effects are infrequent (occur in less than 1 in 100 patients):

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

If you are taking proton pump inhibitors such as Lansoprazol Kern Pharma 15mg, especially for a period of more than one year, it may slightly increase the risk of hip, wrist, and spinal fractures. Inform your doctor if you have osteoporosis or if you are taking corticosteroids (they may increase the risk of osteoporosis).

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

• 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 sensation under the skin, hematomas, redness, and excessive sweating
• light sensitivity
• hair loss
• tingling sensation (paresthesia), tremor
• anemia (pale skin)
• renal problems
• pancreatitis
• inflammation of the liver (may manifest as yellowish 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 inflammation, difficulty swallowing, urticaria, and difficulty breathing.

The following side 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, in some cases, a drop in blood pressure
• inflammation of the mouth (stomatitis)
• colitis (inflammation of the intestine)
• changes in analytical values, such as sodium, cholesterol, and triglyceride levels
• severe skin reactions with redness, vesicles, severe inflammation, and skin loss
• In very rare cases, Lansoprazol Kern Pharma may cause a reduction in the number of white blood cells, which may 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. A blood test will be performed to check for possible reduction in white blood cells (agranulocytosis).

Unknown frequency(cannot be estimated from available data)

• Visual hallucinations

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

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 Vigilance of Medicinal Products for Human Use:www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep out of reach and sight of children.

Do not use Lansoprazol Kern Pharma after the expiration date that appears on the packaging. The expiration date is the last day of the month indicated.

Do not store at a temperature above 25°C.

Bottle: Keep the container perfectly closed.

Blister: Store in the original packaging.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medicines at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medicines. By doing so, you will help protect the environment.

Composition of Lansoprazol Kern Pharma

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

-The other components (excipients) are: hypromellose (E-464), talc, titanium dioxide (E-171), dispersion of methacrylic acid copolymer and ethyl acrylate (1:1) at 30%, triethyl citrate, sugar spheres (sucrose and cornstarch).

The capsule components are: titanium dioxide (E-171), gelatin, purified water, and ink (shellac lacquer and iron oxide black (E-172)).

Appearance of the product and content of the packaging

Lansoprazol Kern Pharma is presented in the form of hard, gastro-resistant capsules of white opaque color that contain spherical granules with gastro-resistant coating.

Each package contains 28 capsules.

Holder of the marketing authorization

Kern Pharma, S.L.

Venus, 72 - Pol. Ind.Colón II

08228 Terrassa - Barcelona

Spain

Responsible for manufacturing

TOWA PHARMACEUTICAL EUROPE, S.L.

C/ de Sant Martí, 75-97

08107 Martorelles – Barcelona

Spain

Last review date of this leafletin: December 2022

The detailed and updated information of this medication is available on the webpage of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/