PANTOPRAZOL KERN PHARMA 20 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 this medicine (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 treatment with 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. In case of an increase in liver enzymes, treatment should be discontinued.
  • If you need to take non-steroidal anti-inflammatory drugs (NSAIDs) continuously and take pantoprazole, as there is a higher risk of developing complications in the stomach and intestine. Any increased risk will be assessed according to your personal risk factors such as age (65 years or older), history of stomach or duodenal ulcers or stomach or intestinal bleeding.
  • If you have decreased body reserves of vitamin B12 or risk factors for it and receive long-term treatment with pantoprazole. 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 fatigue or lack of energy
• Tingling
• Pain in the tongue or red 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 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. Inform 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 experience a skin rash, especially in areas of skin exposed to the sun, consult your doctor as soon as possible, as it may be necessary to discontinue treatment with Pantoprazol Kern Pharma. Remember to mention any other symptoms you may notice, such as joint pain.
• • If you take pantoprazole for more than three months, you may suffer from a decrease in magnesium levels in your blood. Symptoms of low magnesium levels may include fatigue, involuntary muscle contractions, disorientation, convulsions, 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 periodic blood tests to monitor magnesium levels.

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

• unintentional weight loss
• vomiting, especially if it is repeated
• difficulty swallowing or pain when swallowing
• blood in your vomit: it may appear as a dark brown powder 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.
• cases of severe skin reactions have been reported in relation to treatment with Pantoprazol Kern Pharma, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug hypersensitivity 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 severe 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, complementary tests will be performed.

If you take pantoprazole for a prolonged period (more than a year), your doctor may monitor you regularly. You should inform your doctor of any new symptoms and/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 those obtained without a prescription.

Pantoprazol Kern Pharma may affect the efficacy of other medicines, so inform 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 cause them and other medicines to not work properly.
• Warfarin and phenprocoumon, which affect blood coagulation. You may need additional checks.
• 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 discontinue treatment with Pantoprazol Kern Pharma, as pantoprazole 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).

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 pantoprazole is excreted in human 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 and 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 the instructions for administration of this medicine exactly as indicated 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:

To treat symptoms associated with gastroesophageal reflux disease (heartburn, acid regurgitation, pain when swallowing)

The usual dose is one tablet per day.

This dose usually provides relief within 2-4 weeks, and if not, within the following 4 weeks. Your doctor will tell you how long you should continue taking the medicine. If symptoms recur, you can control them by taking one tablet per day .

For long-term treatment and prevention of relapses of reflux esophagitis

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 back to one 20 mg tablet per day.

Adults:

To prevent duodenal and stomach ulcers in patients who require continued treatment with NSAIDs

The usual dose is one tablet per day.

Patients with liver problems

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

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

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 side effects

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

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

• Severe allergic reactions (rare:may affect up to 1 in 1,000 people): swelling of the tongue and/or throat, difficulty swallowing, rash (urticaria), difficulty breathing, swelling of the face of allergic origin (Quincke's edema/angioedema), severe dizziness with very rapid heartbeat and profuse sweating.
• Severe skin disorders (frequency not known:frequency cannot be estimated from the available data): you may notice one or more of the following: blisters on the skin and 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 have 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 hypersensitivity with eosinophilia and systemic symptoms (DRESS), photosensitivity). Circular or target-shaped reddish spots on the trunk, often with blisters in the center, desquamation, mouth ulcers, throat ulcers, nose ulcers, genital ulcers and eye ulcers. These severe rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis). Generalized rash, elevated body temperature and lymphadenopathy (DRESS or drug hypersensitivity).
• Other serious conditions (frequency not known:frequency cannot be estimated from 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 lower back pain (severe kidney inflammation), which may possibly cause kidney failure.

Other side effects are:

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

Benign polyps in the stomach.

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

Headache; dizziness; diarrhea; feeling of dizziness, vomiting; swelling and flatulence (gas); constipation; dry mouth; abdominal pain and discomfort; skin rash, exanthema, rash; tingling; feeling of weakness, fatigue or general malaise; sleep disturbances; hip, wrist and spine fractures.

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

Alteration or complete loss of taste; vision changes such as blurred vision; urticaria; joint pain; muscle pain; weight changes; elevated body temperature; swelling in the limbs (peripheral edema); allergic reactions; depression; breast enlargement in men.

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

Disorientation.

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

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

Side effects identified through blood tests:

• Uncommon(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; sharp drop in white blood cell count in the circulation, associated with high fever.

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

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

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

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

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects 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 Pantoprazol Kern Pharma

Keep this medicine 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 indicated month.

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

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

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medicines at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Packaging contents and additional information

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 ingredients are:

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

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

Appearance of the product and packaging contents

Yellow-ochre colored, prolonged-release tablets.

Packaging:

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

Packaging containing 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 leaflet:September 2024

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