PANTOPRAZOL KERN PHARMA 40 mg GASTRO-RESISTANT TABLETS

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

Do not take Pantoprazol Kern Pharma

• If you are allergic to pantoprazole or any of the other ingredients of Pantoprazol Kern Pharma (listed in section 6).
• If you are allergic to medicines 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. Tell 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 there is an increase in liver enzymes, treatment should be discontinued.
• If you have reduced body stores of vitamin B12 or risk factors for this and you receive treatment with pantoprazole for a long period of time. Like all medicines that reduce acid, pantoprazole may reduce the absorption of vitamin B12. Consult your doctor if you notice any of the following symptoms, as they may indicate a vitamin B12 deficiency:

• Extreme tiredness or lack of energy
• Numbness
• Tongue pain or redness, mouth ulcers
• Muscle weakness
• Vision problems
• Memory problems, confusion, depression

• Tell your doctor if you are taking HIV protease inhibitors such as atazanavir (for HIV infection treatment) at the same time as pantoprazole.
• Taking a proton pump inhibitor like pantoprazole, especially for more than a year, may increase the risk of hip, wrist or spine fractures. Tell your doctor if you have osteoporosis (reduced bone density) or if you have been told you are at risk of osteoporosis (e.g. if you are taking corticosteroids).
• If you have ever had a skin reaction after treatment with a medicine similar to Pantoprazol Kern Pharma to reduce stomach acid.
• If you are scheduled to have a specific blood test (Chromogranin A).
• If you get a skin rash, especially in areas of skin exposed to the sun, tell your doctor as soon as possible, as you may need to stop taking Pantoprazol Kern Pharma. Also, mention any other symptoms that you notice, such as joint pain.
• If you take pantoprazole for more than three months, you may suffer from a decrease in blood magnesium levels. Symptoms of low magnesium levels can include fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness or increased heart rate. If you have any of these symptoms, tell your doctor immediately. Additionally, low magnesium levels can cause a decrease in blood potassium and calcium levels. Your doctor may decide to perform periodic blood tests to monitor magnesium levels.

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

• Unintentional weight loss
• Vomiting, particularly if it is repeated
• Difficulty swallowing or pain when swallowing
• Blood in the vomit: it may appear as a dark coffee grounds-like substance in your vomit
• Pale appearance and feeling of weakness (anemia)
  • Chest pain
  • Stomach pain
  • Blood in your stools, which may appear black or dark

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

Your doctor will decide if you need any additional tests to rule out a malignant disease because pantoprazole may alleviate the symptoms of cancer and could delay its diagnosis. If, despite treatment, your symptoms persist, additional tests will be performed.

If you take pantoprazole for a prolonged period (more than a year), your doctor may monitor you regularly. You should tell your doctor about any new or unexpected symptoms or events each time you visit your doctor.

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 of age.

Using Pantoprazol Kern Pharma with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.

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

• Medicines 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 medicines not work properly.
• Warfarin and phenprocoumon, which affect blood coagulation. You may need additional monitoring.
• Medicines 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 stop treatment with Pantoprazol Kern Pharma, as pantoprazole may increase methotrexate levels in the 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).

Talk to 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 not enough data on the use of pantoprazole in pregnant women. It has been reported that in humans, pantoprazole is excreted in breast milk.

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

You should only use this medicine if your doctor considers that the benefit for you is greater than the potential risk to the fetus or baby.

Driving and using machines

Pantoprazol Kern Pharma has no or negligible influence on the ability to drive or use machines.

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

Pantoprazol Kern Pharma contains lactose and sodium

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

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

3. How to take Pantoprazol Kern Pharma

Follow exactly the administration instructions of this medicine given by your doctor. If you are unsure, consult your doctor or pharmacist again.

Method of administration:

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

The recommended dose is:

Adults and adolescents from 12 years:

For the treatment of reflux esophagitis

The usual dose is one tablet per day. Your doctor may prescribe an increase to 2 tablets per day. The treatment duration for reflux esophagitis is usually between 4 and 8 weeks. Your doctor will tell you how long to take this medicine.

Adults:

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

One tablet twice a day plus the two antibiotic tablets, either amoxicillin, clarithromycin and metronidazole (or tinidazole), each taken twice a day with your pantoprazole tablet. Take the first pantoprazole tablet 1 hour before breakfast and the second 1 hour before dinner. Follow your doctor's instructions and make sure to read the leaflets of the antibiotics.

The treatment duration is usually one to two weeks.

For the treatment of stomach and duodenal ulcers

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

Your doctor will tell you how long to take this medicine. 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 secretion

The recommended initial dose is two tablets per day.

Take the two tablets 1 hour before a meal. Afterwards, your doctor may adjust the dose, depending on the amount of acid secretion you produce. If you are prescribed more than two tablets per day, you should take the tablets divided into two doses per day.

If you are prescribed more than four 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 of Helicobacter pylori.

Patients with liver problems:

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

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

Use in children and adolescents

The use of these tablets is not recommended in children under 12 years of age.

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 Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount ingested. There are no known symptoms of overdose.

If you forget to take Pantoprazol Kern Pharma

Do not take a double dose to make up for forgotten doses. Take your next dose as usual.

If you stop taking Pantoprazol Kern Pharma

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

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

4. Possible Adverse Effects

Like all medicines, Pantoprazol Kern Pharma can cause adverse effects, although not all people suffer from them.

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

• 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, swelling of the face of allergic origin (Quincke's edema/angioedema), intense dizziness with very rapid heartbeats and profuse sweating.
• Severe skin disorders (frequency unknown: their 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 general conditions, erosion (including slight bleeding) of eyes, nose, mouth/lips or genitals or sensitivity/skin rash, particularly in areas of skin exposed to light/sun. You may also experience joint pain or symptoms similar to those of the flu, fever, swollen glands (e.g., in the armpit) and blood tests may show changes in certain white blood cells or liver enzymes. (Stevens-Johnson syndrome, Lyell syndrome, erythema multiforme, subacute cutaneous lupus erythematosus, drug reaction with eosinophilia and systemic symptoms (DRESS), photosensitivity). Circular or target-shaped spots of slightly reddish color 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 flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis). Generalized exanthem, elevated body temperature, and lymphadenopathy (DRESS or drug hypersensitivity).
• Other severe conditions (frequency unknown: their frequency cannot be estimated with the available data): yellowing of the skin and whites of the eyes (severe liver cell damage, jaundice), or fever, rash, increased kidney size with occasional pain when urinating and pain in the lower back (severe kidney inflammation), which may possibly cause kidney failure.

Other adverse effects are:

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

Benign polyps in the stomach.

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

Headache; dizziness; diarrhea; feeling of dizziness, vomiting; bloating and flatulence (gas); constipation; dry mouth; pain and discomfort in the abdomen; skin rash, exanthem, eruption; tingling; feeling of weakness, fatigue, or general malaise; sleep disturbances; fracture of the hip, wrist, and spine.

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

Alteration or complete loss of taste; vision disturbances such as blurred vision; hives; joint pain; muscle pain; weight changes; increased body temperature; swelling in the extremities (peripheral edema); allergic reactions; depression; increased breast size in men.

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

Disorientation.

• Frequency unknown(cannot be estimated from the available data)

Hallucination, confusion (especially in patients with a history of these symptoms), tingling sensation, pinching, numbness, burning sensation, or numbness, skin rash, possibly with joint pain; inflammation of the large intestine that causes persistent watery diarrhea.

Adverse 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 blood fat levels; sudden drop in white blood cell count, associated with high fever.

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

Reduced platelet count, which could lead to bleeding or more bruising than usual; reduced white blood cell count, which could lead to more frequent infections; abnormal reduction in the balance between red and white blood cell count, as well as platelets.

• Frequency unknown(cannot be estimated from the available data)

Decreased levels of sodium, magnesium, calcium, or potassium in the blood (see section 2).

Reporting adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es.

By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Conservation of Pantoprazol Kern Pharma

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

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

Bottle: Store below 30°C. Keep in the original packaging. Keep the bottle perfectly closed.

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

Medicines should not be thrown away through the sewers or in the trash. Deposit the packaging and medicines you no longer need at the SIGRE Point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

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 (vegetable). See section 2 Pantoprazol Kern Pharma contains lactose and sodium.

Coating: Methacrylic acid-ethyl acrylate 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 Package Contents

Gastro-resistant tablets of yellow-ochre color and oval shape.

Packaging:

Bottles (high-density polyethylene packaging with a screw cap made of low-density polyethylene or polypropylene) 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

Manufacturer

Towa Pharmaceutical Europe, S.L.

C/ de Sant Martí, 75-97

08107 Martorelles – Barcelona

Spain

Date of the Last Revision of this Prospectus:September 2024

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