Pantoprazole Sun 40 mg gastro-resistant tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Pantoprazole SUN 40 mg gastro-resistant tablets EFG

Pantoprazole

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

Leaflet contents:

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

1. What Pantoprazole is and what it is used for

Pantoprazole contains the active substance pantoprazole. Pantoprazole is a selective proton pump inhibitor, a medicine that reduces the amount of acid produced in your stomach. It is used to treat acid-related diseases of the stomach and intestine.

Pantoprazole is used for:

Pantoprazole is used in adults and adolescents aged 12 years and older to treat:

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

Pantoprazole is used in adults to treat:

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

2. What you need to know before taking Pantoprazole

Do not take Pantoprazole

• if you are allergic to pantoprazole or to any of the other ingredients of this medicine (listed in section 6).
• if you are allergic to medicines containing other proton pump inhibitors.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking Pantoprazole

• If you have severe liver problems. Inform your doctor if you have ever had liver problems. 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 need to take non-steroidal anti-inflammatory drugs (NSAIDs) continuously while taking pantoprazole, as there is an increased risk of developing stomach and intestinal complications. Any increase in risk will be assessed according to personal risk factors, such as age (65 years or older), history of stomach or duodenal ulcer, or gastrointestinal bleeding.

• If you have low 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, pantoprazole may reduce the absorption of vitamin B12.

• If you are taking HIV protease inhibitors such as atazanavir (for treatment of HIV infection) at the same time as pantoprazole.

• If you are taking proton pump inhibitors such as pantoprazole, especially for more than one year, there may be a slight increase in the risk of hip, wrist, or spine fractures. Inform your doctor if you have osteoporosis (reduced bone density) or if you are taking corticosteroids (which may increase the risk of osteoporosis).

  • If you have been taking Pantoprazole for more than three months, your blood magnesium levels may decrease. Low magnesium levels can cause fatigue, involuntary muscle contractions, confusion, seizures, dizziness, and increased heart rate. If you experience any of these symptoms, contact your doctor immediately. Low magnesium levels may also lead to decreased levels of potassium and calcium in the blood. Your doctor may decide to perform periodic blood tests to monitor magnesium levels.
  • If you have ever had a skin reaction after treatment with a medicine similar to Pantoprazole used to reduce stomach acidity. 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 Pantoprazole treatment. Remember to mention any other symptoms you may notice, such as joint pain.

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

Inform 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
• blood in vomit: this may appear as dark, coffee-ground-like material in your vomit
• blood in your stools, which may appear black or tarry (melena)
• difficulty swallowing, or pain when swallowing
• pale appearance and feeling weak (anaemia)
• chest pain
• stomach pain
• severe or persistent diarrhoea, as this medicine has been associated with a small increased risk of infectious diarrhoea.

Your doctor will decide whether additional tests are needed to rule out malignant disease, as pantoprazole may relieve cancer symptoms 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 or events at each visit.

Children and adolescents

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

Other medicines and Pantoprazole

Tell 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.

Pantoprazole 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 pantoprazole may cause these and other medicines to not work properly.
• Warfarin and phenprocoumon, which affect blood clotting. You may need additional monitoring.
• Medicines used to treat HIV infection, such as atazanavir.
• Methotrexate (a chemotherapeutic agent used at high doses to treat cancer and psoriasis). If you are taking a high dose of methotrexate, your doctor may temporarily discontinue your Pantoprazole treatment.
• 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).

Pregnancy, breast-feeding 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 breast-feeding, think you may be pregnant, or are planning 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

Pantoprazole has no effect or an insignificant effect on the ability to drive or use machines. However, you should not drive or operate machinery if you experience adverse effects such as dizziness or blurred vision.

Pantoprazole SUN contains sodium:

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

3. How to take Pantoprazole

Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

Method of administration:

Take the tablets 1 hour before meals without chewing or breaking them and swallow them whole with water. 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 the dose to 2 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 together with your pantoprazole tablet. Take the first pantoprazole tablet 1 hour before breakfast and the second pantoprazole tablet 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 tell you how long you should 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 you produce. If you are prescribed more than two tablets per day, you should take the tablets divided into two daily doses.

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 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 purpose).
• 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 pantoprazole than you should

Inform your doctor or pharmacist, or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested. Symptoms of overdose are not known.

If you forget to take pantoprazole

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

If you stop taking pantoprazole

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

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.

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

• Severe allergic reactions (rare frequency – may affect up to 1 in 1,000 people): swelling of the tongue and/or throat, difficulty swallowing, 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 unknown – cannot be estimated from available data): skin blistering and rapid deterioration in general condition, erosion (including slight bleeding) of the eyes, nose, mouth/lips or genitals, or skin sensitivity/rash, particularly in areas of skin exposed to light/sun; may also include 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).

• Other serious conditions (frequency unknown – cannot be estimated from available data): yellowing of the skin and whites of the eyes (severe liver cell damage, jaundice) or fever, rash, enlarged kidneys with occasional pain when urinating and lower back pain (severe kidney inflammation), which may possibly lead to kidney failure.

Other adverse effects include:

• Common (may affect up to 1 in 10 people):

Benign gastric polyps

• Uncommon (may affect up to 1 in 100 people):

  • Headache, dizziness, diarrhoea, feeling of dizziness, vomiting, bloating and flatulence (gas), constipation, dry mouth, abdominal pain and discomfort; skin rash, exanthema, eruption, tingling; feeling of weakness, fatigue or general malaise, sleep disturbances, hip, wrist or vertebral fractures

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

Distortion or complete loss of taste sensation, visual disturbances such as blurred vision; urticaria, joint pain, muscle pain, weight changes, increased body temperature; high fever, swelling in the limbs (peripheral edema), allergic reactions, depression, breast enlargement in men.

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

disorientation

• Frequency not known

Hallucinations, confusion (especially in patients with a history of these symptoms),
decreased levels of sodium in the blood, decreased levels of magnesium in the blood (see section 2), sensation of tingling, pricking, numbness, burning or stinging; 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 people)

increase in liver enzymes

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

increase in bilirubin; increase in blood fat levels; acute decrease in the circulation of granular white blood cells, associated with high fever

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

reduction in the number of platelets, which could lead to bleeding or more bruising than usual; reduction in the number of white blood cells, which could lead to more frequent infections; abnormal concurrent reduction in 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 blood (see section 2).

Reporting of adverse effects

If you experience any adverse effect, talk to 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: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Pantoprazol SUN 40 mg gastro-resistant tablets

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

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

This medicine does not require any special storage conditions.

Bottle: Pantoprazol SUN should be used within 100 days after first opening.

Medicines must not be disposed of via wastewater or household waste. Unused medicines and their containers should be returned to the SIGRE Point at your usual pharmacy. If you have any doubts, please ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Pantoprazol SUN 20 mg gastro-resistant tablets

The active substance is pantoprazole. Each gastro-resistant tablet contains 20 mg of
pantoprazole (as pantoprazole sodium sesquihydrate).

The other components are:

Tablet core: anhydrous sodium carbonate, mannitol, crospovidone type A, hydroxypropyl cellulose, microcrystalline cellulose, calcium stearate.

Sub-coating: hypromellose, propylene glycol, povidone K30, titanium dioxide (E171), yellow iron oxide (E-172).

Enteric coating: methacrylic acid-ethyl acrylate copolymer (1:1), triethyl citrate, sodium lauryl sulfate, titanium dioxide (E171), talc.

Appearance of Pantoprazol SUN 20 mg gastro-resistant tablets and pack contents

Oval, biconvex, enteric-coated film tablets of whitish colour.

This medicine is available in blister packs containing 7, 14, 15, 28, 30, 50, 56, 60, 90, 98, 100 and 500 gastro-resistant tablets (clinical pack), or in HDPE bottles with screw cap and desiccant containing 60 or 100 gastro-resistant tablets. DO NOT EAT the desiccant. Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Sun Pharmaceutical Industries Europe B.V.,
Polarisavenue 87,
2132JH Hoofddorp, The Netherlands

Manufacturer

Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132 JH Hoofddorp
The Netherlands

or

TERAPIA S.A.
124 Fabricii Street.,
400632 Cluj Napoca
Romania

Local representative

Sun Pharma Laboratorios, S.L.
Rambla de Catalunya 53-55
08007 Barcelona, Spain
Tel: +34 93 342 78 90

This product is authorised in the EEA Member States under the following names:

France: Pantoprazole CRISTERS PHARMA 20 mg, comprimé gastro-résistant
Germany: PANTOPRAZOL BASICS 20 mg magensaftresistente Tabletten
Italy: PANTOPRAZOLO SUN
Poland: Ranloc
Spain: Pantoprazol SUN 20 mg comprimidos gastrorresistentes EFG

Date of the most recent revision of this leaflet: November 2025

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