Package Insert: Information for the User

Pantoprazol Kern Pharma 40 mg Gastrorresistant Tablets EFG

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, 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 any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Pantoprazol is aselective inhibitor of the “proton pump”, a medication that reduces the amount of acid produced in your stomach. It is used for the treatment of diseases related to stomach acid and intestine.

Pantoprazol Kern Pharma is used for:

Adults and adolescents aged 12 years and above:

-Gastroesophageal reflux esophagitis. It is an inflammation of your esophagus (the tube that connects your throat to your stomach) accompanied by regurgitation of acid from your stomach.

Adults:

-Infection of a bacteria calledHelicobacter pyloriin patients with stomach and/or duodenal ulcers in combination with two antibiotics (eradication treatment). The goal is to get rid of the bacteria and thus reduce the likelihood of ulcers reappearing.

-Stomach and duodenal ulcers, and

-Zollinger-Ellison syndrome and other conditions in which too much acid is produced in the stomach.

Do not take Pantoprazol Kern Pharma

• If you areallergicto pantoprazol or any of the other components of Pantoprazol Kern Pharma (listed in section 6).
• If you are allergic to medications that contain other proton pump inhibitors (e.g. omeprazole, lansoprazole, rabeprazole, esomeprazole).

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take Pantoprazol Kern Pharma.

• If you have severe liver problems. Inform your doctor if you have ever had liver problems in the past. Your doctor will monitor your liver enzymes more frequently, especially when you are on long-term treatment with pantoprazol. If liver enzyme levels increase, treatment should be discontinued.
• If you have reduced vitamin B12reserves or risk factors for it and receive pantoprazol treatment for a long period. As all medications that reduce acid levels, pantoprazol may reduce vitamin B12absorption. Consult your doctor if you notice any of the following symptoms, as they may indicate vitamin B12deficiency:

• Extreme fatigue or lack of energy
• Tickling
• Tongue pain or red tongue, mouth ulcers
• Muscle weakness
• Vision problems
• Memory problems, confusion, depression

• Consult your doctor if you are takingHIV protease inhibitorssuch as atazanavir (for HIV treatment) at the same time as pantoprazol.
• Taking a proton pump inhibitor like pantoprazol, especially for more than a year, may increase the risk of fractures of the hips, wrists, or spine. Inform your doctor if you have osteoporosis (reduced bone density) or if you have been told you are at risk of developing osteoporosis(e.g. if you are taking corticosteroids).
• If you have ever had a skin reaction after treatment with a similar medication to Pantoprazol Kern Pharma for reducing stomach acid.
• If you are scheduled to have a specific blood test (Cromogranin A).
• If you suffer from a skin rash, especially in sun-exposed areas, consult your doctor as soon as possible, as treatment with Pantoprazol Kern Pharma may need to be discontinued. Remember to mention any other symptoms you notice, such as joint pain.
• If you take pantoprazol for more than three months, you may experience a decrease in magnesium levels in your blood. Symptoms of low magnesium levels may include fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, or increased heart rate. If you experience any of these symptoms, inform your doctor immediately. Additionally, low magnesium levels may cause a decrease in potassium and calcium levels in your blood. Your doctor may decide to perform regular blood tests to monitor magnesium levels.

Inform your doctor immediatelybefore or after taking this medication, if you notice any of the following symptoms,which may be signs of more serious diseases:

-Unintentional weight loss

-Vomiting, particularly if repeated

-Difficulty swallowing or pain when swallowing

-Blood in vomit: may appear as a dark brown powder in your vomit

-Pale appearance and feeling of weakness (anemia)

• Chest pain
• Stomach pain
• Blood in your stool, which may appear black or dark

• Severe or persistent diarrhea, as pantoprazol has been associated with a small increase in infectious diarrhea.
• Severe skin reactions have been reported in relation to treatment with Pantoprazol Kern Pharma, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and erythema multiforme. Stop taking Pantoprazol Kern Pharma and contact your doctor immediately if you experience any of the symptoms related to severe skin reactions described in section 4.

Your doctor will decide if you need additional testing to rule out cancer, as pantoprazol may alleviate cancer symptoms and potentially delay diagnosis. If your symptoms persist despite treatment, further investigations will be performed.

If you take pantoprazol for a prolonged period (more than a year), your doctor may regularly monitor you. You should inform your doctor of any new or unexpected symptoms and/or events each time you attend your consultation.

Children and adolescents

The use of Pantoprazol Kern Pharma is not recommended in children, as it has not been tested in children under 12 years old.

Use of Pantoprazol Kern Pharma with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication, including over-the-counter medications.

Pantoprazol Kern Pharma may affect the efficacy of other medications, so inform your doctor if you are taking:

• Medications such asketoconazole, itraconazole, and posaconazole (used to treat fungal infections) or erlotinib (used to treat certain types of cancer), as Pantoprazol Kern Pharma may make these and other medications less effective.
• Warfarinandfenprocumon, which affect blood clotting. You may need additional monitoring.
• Medications used to treat HIV, such as atazanavir.
• Methotrexate (used to treat rheumatoid arthritis, psoriasis, and cancer). If you are taking methotrexate, your doctor may temporarily discontinue treatment with Pantoprazol Kern Pharma, as pantoprazol may increase methotrexate levels in your blood.
• Fluvoxamine (used to treat depression and other psychiatric disorders). If you are taking fluvoxamine, your doctor may reduce your dose.
• Rifampicin (used to treat infections).
• St. John's Wort (Hypericum perforatum) (used to treat mild depression).

Consult your doctor before taking Pantoprazol Kern Pharma if you need to have a specific urine test (for THC, tetrahidrocanabinol).

Pregnancy, breastfeeding, and fertility

There is insufficient data on the use of pantoprazol in pregnant women.Pantoprazol has been reported to be excreted in breast milk.

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

You should only use this medication if your doctor considers the benefits for you to be greater than the potential risk to the fetus or baby.

Driving and operating machinery

Pantoprazol Kern Pharma has no influence or insignificant influence on your ability to drive or operate machinery.

You should not drive or operate machinery if you experience side effects such as dizziness or blurred vision.

Pantoprazol Kern Pharma contains lactose and sodium

This medication contains lactose. If your doctor has told you that you have a lactose intolerance, consult with them before taking this medication.

This medication contains less than 23 mg of sodium (1 mmol) per tablet; it is essentially "sodium-free".

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Administration form:

Take the whole tablets, without chewing or breaking them, with a little water, 1 hour before a meal.

The recommended dose is:

Adults and adolescents 12 years and older:

For the treatment of esophagitis caused by reflux

The usual dose is 1 tablet per day.Your doctor may indicate an increase to 2 tablets per day. The treatment time for esophagitis caused by reflux usually lasts between 4 and 8 weeks. Your doctor will tell you for how long to take this medication.

Adults:

For the treatment of an infection caused by a bacteria called Helicobacter pylori in patients with stomach and/or duodenal ulcers in combination with two antibiotics (eradication treatment)

1 tablet twice a day plus the 2 antibiotic tablets, either amoxicillin, clarithromycin, and metronidazole (or tinidazole),eachmust be taken twice a daywith your pantoprazole tablet. Take thefirstpantoprazole tablet 1 hour before breakfast and thesecond1 hour before dinner. Follow your doctor's instructions and make sure to read the antibiotic prospectuses.

The treatment duration is usually 1 to 2 weeks.

For the treatment of stomach and duodenal ulcers

The usual dose is 1 tablet per day. The dose may be doubled by your doctor.

Your doctor will tell you for how long to take this medication. The treatment duration for stomach ulcers is usually between 4 and 8 weeks. The treatment duration for duodenal ulcers is usually between 2 and 4 weeks.

For long-term treatment of Zollinger-Ellison syndrome and other conditions in which there is an increase in stomach acid production

The recommended initial dose is 2 tablets per day.

Take the 2 tablets 1 hour before a meal. Your doctor may then adjust your dose, depending on the amount of stomach acid you produce. If you are prescribed more than 2 tablets per day, you should take the tablets twice a day.

If you are prescribed more than 4 tablets per day, you will be told exactly when to stop treatment.

Patients with kidney problems:

If you have kidney problems,you should not take pantoprazole for the elimination ofHelicobacter pylori.

Patients with liver problems:

If you have severe liver problems, you should not take more than1 tablet of 20 mg of pantoprazole per day(for this case, tablets of 20 mg of pantoprazole are available).

If you have moderate or severe liver problems, you should not take pantoprazole for the elimination ofHelicobacter pylori.

Use in children and adolescents

These tablets are not recommended for use in children under 12 years old.

If you take more Pantoprazol Kern Pharma than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, or call the Toxicological Information Service, phone91 562 04 20indicating the medication and the amount ingested. There are no known symptoms of overdose.

If you forgot to take Pantoprazol Kern Pharma

Do not take a double dose to compensate for the missed doses.Take your next dose as usual.

If you interrupt treatment with Pantoprazol Kern Pharma

Do not stop taking these tablets without consulting your doctor or pharmacist first.

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

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

If you experience any of the following side effects, stop taking these tablets and inform your doctor immediately, or contact the nearest hospital's emergency service:

• Severe allergic reactions (rare frequency:may affect up to 1 in 1,000 people): swelling of the tongue and/or throat, difficulty swallowing, hives (urticaria), difficulty breathing, allergic swelling of the face (Quincke's edema/angioedema), intense dizziness with very rapid heartbeats and excessive sweating.
• Severe skin alterations (unknown frequency:its frequency cannot be estimated with the available data): you may notice one or more of the following: blisters on the skin and a rapid deterioration of overall conditions, erosion (including light bleeding) of eyes, nose, mouth/lips or genitals or skin sensitivity/eruption, particularly in areas of exposed skin to light/sun. You may also have joint pain or symptoms similar to the flu, fever, swollen lymph nodes (e.g., in the armpit) and blood tests may show changes in certain white blood cells or liver enzymes. (Stevens-Johnson syndrome, Lyell syndrome, Multiform erythema, Acute cutaneous lupus erythematosus, Pharmacological reaction with eosinophilia and systemic symptoms (DRESS), Photosensitivity). Circular or target-shaped red patches on the trunk, often with blisters in the center, peeling, ulcers in the mouth, throat, nose, genitals, and eyes. These severe exanthems may be preceded by fever and symptoms similar to the flu (Stevens-Johnson syndrome, toxic epidermal necrolysis). Generalized exanthem, elevated body temperature, and lymphadenopathy (DRESS or drug hypersensitivity).
• Other severe conditions (unknown frequency:its frequency cannot be estimated with the available data):yellowing of the skin and the white of the eyes (severe liver cell damage, jaundice), or fever, hives, increased kidney size with occasional pain while urinating and lower back pain (severe kidney inflammation), possibly leading to renal failure.

Other side effects are:

• Frequent(may affect up to 1 in 10 patients)

Benign stomach polyps.

• Infrequent(may affect up to 1 in 100 patients)

Headache; dizziness; diarrhea; sensation of dizziness, vomiting; bloating and flatulence (gas); constipation; dry mouth; abdominal pain and discomfort; hives on the skin, exanthem, rash; tingling; feeling of weakness, fatigue, or general discomfort; sleep disturbances; hip, wrist, and spinal column fractures.

• Rare(may affect up to 1 in 1,000 patients)

Alterationor complete absence of the sense of taste;vision disturbances such as blurred vision; urticaria; joint pain; muscle pain; weight changes; elevated body temperature; swelling in the extremities (peripheral edema); allergic reactions; depression; gynecomastia in men.

• Very rare(may affect up to 1 in 10,000 patients)

Disorientation.

• Unknown frequency(cannot be estimated from the available data)

Hallucination, confusion (especially in patients with a history of these symptoms),sensation of tingling, pinching, numbness, burning, or numbness, skin eruption, possibly with joint pain; inflammatory bowel disease causing persistent watery diarrhea.

Side effects identified through blood tests:

• Infrequent(may affect up to 1 in 100 patients)

Liver enzyme increase.

• Rare(may affect up to 1 in 1,000 patients)

Bilirubin increase; increase in blood lipid levels;brusque drop in granular white blood cells in circulation, associated with high fever.

• Very rare(may affect up to 1 in 10,000 patients)

Platelet reduction, which could cause bleeding or more frequent bruising; reduction of white blood cells, which could lead to more frequent infections; abnormal reduction of the balance between red and white blood cells, as well as platelets.

• Unknown frequency(cannot be estimated from the available data)

Decrease in blood sodium, magnesium, calcium, or potassium levels (see section 2).

Reporting 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 prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance 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 medication.

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

Do not use this medication after the expiration date that appears on the packaging after “CAD”. The expiration date is the last day of the month indicated.

Container:Store below 30°C. Store in the original packaging. Keep the container perfectly closed.

Blister:Store below 30°C. Store in the original packaging.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Pantoprazol Kern Pharma

The active ingredient is pantoprazol.Each gastro-resistant tablet contains 40 mg of pantoprazol (in the form of sodium sesquihydrate).

The other components are:

Core: Microcrystalline cellulose (E460i), lactose monohydrate, sodium croscarmellose, anhydrous colloidal silica, magnesium stearate (vegetal).See section 2Pantoprazol Kern Pharma contains lactose and sodium.

Coating: Acid methacrylic copolymer (1:1) dispersion 30%, triethyl citrate (E1505), talc (E553b), color mixture (opadry II 85F32029 yellow containing partially hydrolyzed polyvinyl alcohol, titanium dioxide (E171), macrogol/PEG 3350, talc, and yellow iron oxide (E172).

Appearance of the product and contents of the packaging

Yellow ochre-colored, oval-shaped gastro-resistant tablets.

Packaging:

HDPE bottles (HDPE container with a polyethylene or polypropylene closure with a polyethylene or polypropylene thread) and blisters (Alu/Alu blisters).

Packaging with 14 and 28 gastro-resistant tablets.

Marketing Authorization Holder

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 leaflet:September 2024

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