Pantoprazole Kern Pharma 40 mg gastro-resistant tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Pantoprazole Kern Pharma 40 mg gastro-resistant tablets EFG

Read the entire 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

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

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

Pantoprazole is a selective "proton pump inhibitor", a medicine that reduces the amount of acid produced in your stomach. It is used for the treatment of diseases related to stomach and intestinal acid.

Pantoprazol Kern Pharma is used for:

Adults and adolescents aged 12 years and older:

• Reflux esophagitis. This is inflammation of your esophagus (the tube connecting your throat to your stomach), accompanied by regurgitation of acid from the stomach.

Adults:

• Infection with a bacterium called Helicobacter pylori in patients with stomach and/or duodenal ulcer, in combination with two antibiotics (eradication therapy). The aim is to eliminate the bacterium and thereby reduce the likelihood of ulcers recurring.
• Stomach and duodenal ulcers, and
• Zollinger-Ellison syndrome and other conditions in which excessive stomach acid is produced.

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

Do not take Pantoprazol Kern Pharma

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

Warnings and precautions

Talk to 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 if you are on long-term treatment with pantoprazole. If liver enzymes increase, treatment should be discontinued.

• If you have reduced body stores of vitamin B12 or risk factors for this and are receiving pantoprazole treatment for a long period of time. Like all medicines that reduce acid levels, pantoprazole may reduce the absorption of vitamin B12. Consult your doctor if you experience any of the following symptoms, as they may indicate vitamin B12 deficiency:

• Extreme tiredness or lack of energy

• Tingling

• Sore 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 treatment of HIV infection) at the same time as pantoprazole.

• Taking a proton pump inhibitor such as pantoprazole, especially for more than one 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 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 used to reduce stomach acidity.

• If you are scheduled to have a specific blood test (chromogranin A).

• If you develop a skin rash, especially in areas of skin exposed to sunlight, 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 experience a decrease in blood magnesium levels. 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. In addition, low magnesium levels may lead to decreased levels of potassium and calcium in the blood. Your doctor may decide to perform periodic blood tests to monitor magnesium levels.

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

• Unintentional weight loss
• Vomiting, particularly if repeated
• Difficulty swallowing or pain when swallowing
• Blood in vomit: may appear as dark coffee-ground-like material in your vomit
• Pale appearance and feeling weak (anaemia)
  • Chest pain
  • Stomach pain
  • Blood in your stools, which may appear black or dark
• Severe or persistent diarrhoea, as pantoprazole has been associated with a small increased risk of infectious diarrhoea.
• Serious skin reactions have been reported in association with 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 serious skin reactions described in section 4.

Your doctor will decide whether additional tests are needed to rule out malignancy, as pantoprazole may relieve symptoms of cancer and could delay diagnosis. If your symptoms persist despite treatment, further investigations will be carried out.

If you take pantoprazole for a prolonged period (more than one year), your doctor will likely monitor you regularly. You should inform your doctor of any new or unexpected symptoms and/or events at each consultation.

Children and adolescents

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

Use of Pantoprazol Kern Pharma with other medicines

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

Pantoprazol Kern Pharma may affect the effectiveness of other medicines; therefore, inform your doctor if you are taking:

• Medicines such as ketoconazole, itraconazole, and posaconazole (used to treat fungal infections) or erlotinib (used for certain types of cancer), as Pantoprazol Kern Pharma may cause these and other medicines to be less effective.
• Warfarin and fenprocoumon, which affect blood clotting. You may require 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 discontinue 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).

Talk to your doctor before taking Pantoprazol Kern Pharma if you need to undergo a specific urine test (for THC, tetrahydrocannabinol).

Pregnancy, breastfeeding, and fertility

There are insufficient 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 plan to become pregnant, consult your doctor or pharmacist before using this medicine.

This medicine should only be used if your doctor considers that the benefit to you outweighs the potential risk to the fetus or baby.

Driving and using machines

Pantoprazol Kern Pharma has no effect or its effect is negligible on the ability to drive or use machines.

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

Pantoprazol Kern Pharma contains lactose and sodium

This medicine contains lactose. If your doctor has informed you of an intolerance to certain sugars, consult with him 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 instructions for administration of this medicine as given by your doctor. If in doubt, 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 aged 12 years and older:

For the treatment of reflux esophagitis

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

Adults:

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

One tablet twice daily, plus two antibiotic tablets—either amoxicillin, clarithromycin, and metronidazole (or tinidazole)—each to be taken twice daily along 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 package leaflets of the antibiotics.

The duration of treatment is normally one to two weeks.

For the treatment of gastric and duodenal ulcers

The usual dose is one tablet per day. Your doctor may double the dose.

Your doctor will advise you on how long to take this medicine. The treatment duration for gastric ulcers is usually between 4 and 8 weeks. The treatment duration for duodenal ulcers is normally between 2 and 4 weeks.

For long-term treatment of Zollinger-Ellison syndrome and other conditions in which there is increased gastric acid secretion

The recommended initial dose is two tablets per day.

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

If you are prescribed more than four tablets per day, you will be given specific instructions on when to end treatment.

Patients with kidney problems:

If you have kidney problems, you should not take pantoprazole for the eradication 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 eradication 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, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number 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 missed doses. Take your next dose as usual.

If you stop taking Pantoprazol Kern Pharma

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

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

4. Possible adverse effects

Like all medicines, Pantoprazole Kern Pharma may cause adverse effects, although not everyone experiences them.

If you experience any of the following adverse effects, stop taking these tablets immediately and inform your doctor straight away, or contact the emergency department of your 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, skin rash (urticaria), difficulty breathing, allergic swelling of the face (Quincke's edema/angioedema), severe dizziness with very rapid heartbeat and excessive sweating.
• Severe skin disorders (frequency not known: frequency cannot be estimated from available data): you may notice one or more of the following: blisters on the skin and a rapid worsening of general condition, erosion (including slight bleeding) of eyes, nose, mouth/lips or genitals, or skin sensitivity/rash, particularly in areas of skin exposed to light/sun. You may also experience joint pain or flu-like symptoms, 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's syndrome, Erythema multiforme, Subacute cutaneous lupus erythematosus, Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), Photosensitivity). Circular or target-shaped slightly reddish spots on the trunk, often with blisters in the center, skin peeling, ulcers in mouth, throat, nose, genitals and eyes. These serious rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis). Generalized rash, high body temperature, and swollen lymph nodes (DRESS or drug hypersensitivity).
• Other serious conditions (frequency not known: frequency cannot be estimated from available data): yellowing of the skin and whites of the eyes (severe liver cell damage, jaundice), or fever, rash, kidney enlargement with occasional pain when urinating and lower back pain (severe kidney inflammation), which may possibly lead to kidney failure.

Other adverse 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; diarrhoea; feeling of dizziness, vomiting; bloating and flatulence (gas); constipation; dry mouth; pain and discomfort in the abdomen; skin rash, exanthema, eruption; tingling; feeling of weakness, fatigue or general malaise; sleep disturbances; fractures of the hip, wrist and spine.

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

Altered or complete loss of taste sensation; vision disorders such as blurred vision; urticaria; joint pain; muscle pain; weight changes; increased body temperature; swelling in the extremities (peripheral oedema); 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 available data)

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

Adverse 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 levels of fat in the blood; sudden drop in circulating granular white blood cells, associated with high fever.

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

Reduction in the number of platelets, which could cause bleeding or more bruising than usual; reduction in the number of white blood cells, which could lead to more frequent infections; abnormal decrease in the balance between the number of red blood cells, white blood cells and platelets.

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

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

Reporting of adverse effects

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

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Pantoprazole Kern Pharma

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

Do not use this medicine after the expiry date stated on the packaging after “EXP”. The expiry date refers to the last day of the month indicated.

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

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

Medicines must not be disposed of via wastewater or household waste. Unused medicines and waste materials should be returned to the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Pantoprazole Kern Pharma

The active substance is pantoprazole. Each gastro-resistant tablet contains 40 mg of pantoprazole (as sodium sesquihydrate).

The other components are:

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

Coating: Methacrylic acid-ethyl acrylate copolymer (1:1) dispersion 30%, triethyl citrate (E1505), talc (E553b), colour mixture (Opadry II 85F32029 yellow containing partially hydrolysed polyvinyl alcohol, titanium dioxide (E171), macrogol/PEG 3350, talc and yellow iron oxide (E172)).

Appearance of the product and contents of the pack

Yellowish-yellow, oval-shaped gastro-resistant tablets.

Packs:

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

Packs containing 14 and 28 gastro-resistant tablets.

Marketing Authorisation 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 most recent review of this leaflet: September 2024

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