Leaflet: information for the user

Pantoprazol Kern Pharma 20 mg gastro-resistant tablets EFG

Read this leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

2. What you need to know before you start taking Pantoprazol Kern Pharma

3. How to take Pantoprazol Kern Pharma

4. Possible side effects

5. Storage of Pantoprazol Kern Pharma

6. Contents of the pack and additional information

Pantoprazolis a selective proton pump inhibitor, 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 12 years and older:

• Treatment of symptoms associated with gastroesophageal reflux disease (stomach burning, acid regurgitation, difficulty swallowing) caused by acid reflux from the stomach.

• Long-term treatment and prevention of recurrences of esophagitis caused by acid reflux (inflammation of the esophagus accompanied by acid regurgitation from the stomach).

Adults:

• Prevention of gastroduodenal ulcers induced by nonsteroidal anti-inflammatory drugs (NSAIDs, for example, ibuprofen) in patients at risk who require continued treatment with this type of medication.

Do not take Pantoprazol Kern Pharma

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 pantoprazole. If liver enzyme levels increase, treatment should be interrupted.
  • If you need to take nonsteroidal anti-inflammatory drugs (NSAIDs) continuously and take pantoprazole, as there is a higher risk of developing complications in the stomach and intestines. Any increased risk will be evaluated based on individual risk factors such as age (65 years or older), history of stomach or duodenal ulcers, or gastrointestinal bleeding.
  • If you have decreased vitamin B12 reserves or risk factors for it and receive long-term treatment with pantoprazole. Like all medications that reduce acid production, pantoprazole may reduce vitamin B12 absorption. Consult your doctor if you notice any of the following symptoms, as they may indicate vitamin B12 deficiency:
• Extreme fatigue or lack of energy
• Tickling
• Pain or redness of the tongue, mouth ulcers
• Muscle weakness
• Vision problems
• Memory problems, confusion, depression
• • Consult your doctor if you are taking HIV protease inhibitors such as atazanavir (for HIV treatment) at the same time as pantoprazole.
  • Long-term use of a proton pump inhibitor like pantoprazole, especially for more than a year, may increase the risk of fractures of the hip, wrist, 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 (chromogranin A).
• If you experience 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 interrupted. Remember to mention any other symptoms you notice, such as joint pain.
• • If you take pantoprazole for more than three months, you may experience decreased magnesium levels in the 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 decreased potassium and calcium levels in the blood. Your doctor may decide to perform regular blood tests to monitor magnesium levels.

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

• 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
• Abdominal pain
• Blood in your stool, which may appear black or dark
• Severe or persistent diarrhea, as pantoprazole 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-induced hypersensitivity syndrome with eosinophilia and systemic symptoms (DRESS), and erythema multiforme. Stop taking Pantoprazol Kern Pharma and contact your doctor immediately if you experience any symptoms related to severe skin reactions described in section 4.

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

If you take pantoprazole 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 appointment.

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 as ketoconazole, 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.
• Warfarin and fenprocoumon, which affect blood clotting. You may need additional monitoring.
• Medications used to treat HIV infection, such as atazanavir.
• Methotrexate (used to treat rheumatoid arthritis, psoriasis, and cancer). If you are taking methotrexate, your doctor may temporarily interrupt treatment with Pantoprazol Kern Pharma, as pantoprazole may increase methotrexate levels in the blood.
• Fluvoxamine (used to treat depression and other psychiatric conditions). 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, tetrahydrocannabinol).

Pregnancy, breastfeeding, and fertility

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

If you are pregnant, breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication. This medication should only be used 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 negligible influence on the 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 of 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.

Recommended dose is:

Adults and adolescents 12 years and older:

For treating symptoms associated with gastroesophageal reflux disease (stomach burning, acid regurgitation, difficulty swallowing)

The usual dose is one tablet per day.

This dose usually provides relief within 2-4 weeks, and if not, within a maximum of 4 weeks. Your doctor will tell you how long you should continue taking the medication. Any repeated symptoms can be controlled as needed by taking one tablet per day.when symptoms recur..

For long-term treatment and prevention of esophagitis relapses

The usual dose is one tablet per day. If the disease recurs, your doctor may double the dose, in which case you can take pantoprazole 40 mg, once a day. After healing, you can reduce the dose again to one 20 mg tablet per day.

Adults:

For the prevention of duodenal and stomach ulcers in patients requiring long-term treatment with NSAIDs

The usual dose is one tablet per day.

Patients with liver problems

If you have severe liver problems, do not take more than one 20 mg tablet per day.

Use in children and adolescents

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

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, phone 91 562 04 20, indicating the medication and the amount ingested. No symptoms of overdose are known.

If you forgot to take Pantoprazol Kern Pharma

Do not take a double dose to compensate for the missed dose. 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: cannot be estimated with available data):You may notice one or more of the following: blisters on the skin and rapid deterioration of overall condition, erosion (including light bleeding) of eyes, nose, mouth/lips, or genitals, or skin sensitivity/eruption, particularly in exposed skin areas 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, mouth ulcers, throat, nose, genital, and eye ulcers. These severe exanthems may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis). Generalized exanthem, elevated body temperature, and lymphadenopathy (DRESS or drug hypersensitivity).
• Other severe conditions (unknown frequency: cannot be estimated with available data):Yellowing of the skin and the white of the eyes (severe liver cell damage, jaundice), or fever, hives, occasional kidney enlargement with pain while urinating, and back pain (severe kidney inflammation), which may lead to kidney 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; swelling 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)

Alteration or complete absence of taste; visual 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 available data)

Illusion, confusion (especially in patients with a history of these symptoms), sensation of tingling, pinching, numbness, burning, or numbness; skin rash, 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)

Increased liver enzymes.

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

Increased bilirubin; increased levels of fat in the blood; sudden drop in granular white blood cells in circulation, associated with high fever.

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

Reduced platelet count, which could cause bleeding or more frequent bruising; reduced white blood cell count, which could lead to more frequent infections; abnormal imbalance between red and white blood cell counts, as well as platelet counts.

• Unknown frequency (cannot be estimated from available data)

Decreased sodium, magnesium, calcium, or potassium levels in the blood (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 not listed in this prospectus. You can also report them directly through the Spanish System for 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 Pantoprazol Kern Pharma after the expiration date that appears on the packaging after “CAD”. The expiration date is the last day of the month indicated.

Container: No special storage conditions are required. Store in the original packaging. Keep the container perfectly closed.

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

Medicines should not be disposed of through drains or in the trash. Deposit the 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 Pantoprazol Kern Pharma

The active ingredient is pantoprazol. Each gastro-resistant tablet contains 20 mg of pantoprazol (in the form of sodium sesquihydrate).

The other components are:

Core: Microcrystalline cellulose (E-460i), lactose monohydrate, sodium croscarmellose, anhydrous colloidal silica, magnesium stearate (vegetal). See section 2Pantoprazol Kern Pharma contains lactose and sodium.

Coating: Color mixture (opadry II 85F32081 yellow), acid methacrylic copolymer (1:1) dispersion 30%, triethyl citrate (E1505), talc (E553b).

Appearance of the product and contents of the packaging

Yellow ochre-coated elongated tablets.

Packaging:

Bottles (high-density polyethylene container with a polyethylene low-density or polypropylene closure with a polyethylene or polypropylene screw cap) and blisters (Alu/Alu blister).

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/