LANSOPRAZOL KERN PHARMA 15 mg HARD GASTRO-RESISTANT CAPSULES

Introduction

Package Leaflet: Information for the User

Lansoprazole Kern Pharma 15 mg hard gastro-resistant 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 further questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

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

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

Your doctor may prescribe you Lansoprazole 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 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 may be that your doctor has prescribed Lansoprazole Kern Pharma for another indication or at a different dose than indicated in this leaflet. Follow your doctor's instructions regarding the taking of the medicine.

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

Do not take Lansoprazole Kern Pharma:

• If you are allergic (hypersensitive) to lansoprazole or any of the other ingredients of Lansoprazole Kern Pharma.
• If you are taking another medicine whose active substance is atazanavir (used to treat HIV).

Warnings and precautions

Tell your doctor if you have a severe liver disease. It may be necessary for the doctor 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 cancer.

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

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

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

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

If you have ever had a skin reaction after treatment with a medicine similar to Lansoprazole Kern Pharma to reduce stomach acid.

If you get 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 Lansoprazole 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

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

In particular, tell your doctor if you are using medicines that contain any of the following active substances, as Lansoprazole Kern Pharma may affect their mode of 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 Lansoprazole Kern Pharma with food and drinks

To get the best results from your medicine, you should take Lansoprazole Kern Pharma capsules 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 using machines

Patients taking Lansoprazole Kern Pharma may occasionally experience side effects, such as dizziness, drowsiness, 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 in a fit state 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 these medicines.

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

Read the information in this leaflet carefully.

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

Important information about some of the ingredients of Lansoprazole Kern Pharma

Lansoprazole Kern Pharma contains sucrose. If your doctor has told you that you have an intolerance to some sugars, consult with them before taking this medicine.

3. How to take Lansoprazole Kern Pharma

Take the capsule whole with a glass of water. If you have difficulty swallowing the capsule, your doctor will inform you of other alternative ways to take the medicine. Do not crush or chew the capsules or the contents of an emptied capsule, as this will make them not work properly.

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

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

To extract the capsule properly, it is recommended:

1. Cut the blister by the marked cutting line.
2. Separate the two aluminum layers at the indicated place and extract the capsule.

The dose of Lansoprazole Kern Pharma depends on your general condition. The normal doses of Lansoprazole Kern Pharma for adults are indicated below. Sometimes, 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 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 30 mg capsule per day for 2 weeks.

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

Treatment of esophagus 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 normal dose is one 30 mg capsule together with two different antibiotics in the morning and one 30 mg capsule together with two different antibiotics in the evening. The treatment will normally be daily for 7 days.

The recommended combinations of antibiotics are as follows:

• 30 mg of Lansoprazole Kern Pharma with 250-500 mg of clarithromycin and 1000 mg of amoxicillin
• 30 mg of Lansoprazole Kern Pharma 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 come back if the infection is treated satisfactorily. To get the best results from your medicine, take it at the right time and do not forget any dose.

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

Prevention of duodenal or gastric ulcer 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 normal initial dose is two 30 mg capsules per day; subsequently, based on your response to treatment with Lansoprazole Kern Pharma, the doctor will decide the best dose for you.

Lansoprazole Kern Pharma should not be administered to children.

Follow your doctor's instructions for administration exactly. Consult your doctor if you have doubts.

If you take more Lansoprazole Kern Pharma than you should

If you take more Lansoprazole Kern Pharma than you have been prescribed, consult your doctor or pharmacist, go to the nearest hospital, or contact the Toxicology Information Service, tel. 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Lansoprazole Kern Pharma

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

If you stop taking Lansoprazole Kern Pharma

Do not stop treatment prematurely because the symptoms have improved. It is possible that your condition has not been completely cured and may come back if you do not finish the entire treatment.

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

4. Possible side effects

Like all medicines, Lansoprazole Kern Pharma can cause side effects, although not everybody gets them.

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

• headache, dizziness
• diarrhea, constipation, stomach pain, nausea, 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 uncommon (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 like Lansoprazole Kern Pharma, especially for a period of more than one year, you may have a slightly increased risk of hip, wrist, and spine fractures. Inform your doctor if you have osteoporosis or if you are taking corticosteroids (which can 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, dizziness
• taste disturbance, loss of appetite, tongue inflammation (glossitis)
• skin reactions such as a burning sensation or itching under the skin, bruising, redness, and excessive sweating.
• sensitivity to light
• hair loss
• tingling sensation (paresthesia), tremor
• anemia (pallor)
• kidney problems
• pancreatitis
• liver inflammation (which may be manifested by yellowing of the skin or eyes)
• breast swelling in males, impotence
• candidiasis (fungal infection, can affect the skin or mucous membranes)
• angioedema; contact your doctor immediately if you experience symptoms of angioedema, such as swelling of the face, tongue, or pharynx, difficulty swallowing, hives, 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. The symptoms of a hypersensitivity reaction may include fever, rash, swelling, and, in some cases, a drop in blood pressure
• mouth inflammation (stomatitis)
• colitis (inflammation of the intestine)
• changes in analytical values, such as sodium, cholesterol, and triglyceride levels
• severe skin reactions with redness, blisters, severe inflammation, and skin loss
• in very rare cases, Lansoprazole Kern Pharma may cause a reduction in the number of white blood cells, which can 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. You will have a blood test to check for a possible reduction in white blood cells (agranulocytosis).

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

• Visual hallucinations

• If you are taking lansoprazole for more than three months, it is possible that your blood magnesium levels may decrease. Low magnesium levels can cause fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, increased heart rate. If you have any of these symptoms, go to the doctor immediately. Low magnesium levels can 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 side effects, talk to your doctor or pharmacist, even if it is possible side effects that are not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Lansoprazole Kern Pharma

Keep out of the reach and sight of children.

Do not use Lansoprazole Kern Pharma after the expiration date stated on the packaging. The expiration date is the last day of the month indicated.

Do not store above 25°C.

Bottle: Keep the container tightly closed.

Blister: Store in the original package.

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

6. Contents of the pack and other information

Composition of Lansoprazole Kern Pharma

• The active substance is lansoprazole. Each capsule contains 15 mg of lansoprazole.
• The other ingredients (excipients) are: hypromellose (E-464), talc, titanium dioxide (E-171), dispersion of methacrylic acid and ethyl acrylate copolymer (1:1) at 30%, triethyl citrate, sugar spheres (sucrose and cornstarch).

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

Appearance of the product and contents of the pack

Lansoprazole Kern Pharma is presented in the form of hard gastro-resistant capsules, white opaque, containing spherical granules with a 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 last revision of this leaflet: December 2022

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