PANTOPRAZOL SUN 40 mg GASTRO-RESISTANT TABLETS

Introduction

Package Leaflet: Information for the Patient

Pantoprazole SUN 40 mg Gastro-Resistant Tablets

Pantoprazole

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information:

1. What is Pantoprazole and what is it used for
2. What you need to know before you take Pantoprazole
3. How to take Pantoprazole
4. Possible side effects

5 Storage of Pantoprazole

1. Contents of the pack and further information

1. What is Pantoprazole and what is it used for

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

Pantoprazole is used for:

Pantoprazole is used in adults and adolescents from 12 years of age to treat:

• Reflux esophagitis. This is an inflammation of your esophagus (the tube that connects your throat to your stomach) accompanied by acid regurgitation 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 treatment). The goal is to get rid of the bacteria and thus reduce the likelihood of ulcers recurring.
• Stomach and duodenal ulcers.
• Zollinger-Ellison syndrome and other conditions in which too much acid is produced in the stomach.

2. What you need to know before you take Pantoprazole

Do not take Pantoprazole

• 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.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take Pantoprazole

• If you have severe liver problems. Tell your doctor if you have ever had liver problems. Your doctor will monitor you more frequently for liver enzymes, especially when you are on long-term treatment with Pantoprazole. If liver enzymes increase, treatment should be discontinued.
• If you need to take medicines called NSAIDs continuously and take pantoprazole, as there is a higher risk of developing stomach and intestine complications. 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 low body reserves of vitamin B12 or risk factors for it and receive long-term treatment with pantoprazole. Like all medicines that reduce acid, pantoprazole could reduce the absorption of vitamin B12.
• If you are taking HIV protease inhibitors such as atazanavir (for HIV infection treatment) at the same time as pantoprazole.
• If you are taking proton pump inhibitors like pantoprazole, especially for a period of more than one year, you may have a slightly increased risk of hip, wrist, and spine fractures. Tell your doctor if you have osteoporosis (reduced bone density) or if you are taking corticosteroids (which can increase the risk of osteoporosis).
• If you are taking Pantoprazole for more than three months, it is possible that your blood magnesium levels may decrease. Low magnesium levels can cause fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, increased heart rate. If you have any of these symptoms, see your doctor immediately. Low magnesium levels can also produce a decrease in blood potassium and calcium levels. 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 to reduce stomach acid. If you suffer from 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 Pantoprazole. 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).

Tell your doctor immediately, before 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
• blood in the vomit: it may appear as a dark coffee grounds-like substance in your vomit.
• difficulty swallowing, or pain when swallowing
• pale appearance and feeling of weakness (anemia)
• chest pain
• stomach pain
• severe or persistent diarrhea, as this medicine has been associated with a small increase in infectious diarrhea.

Your doctor will decide if you need any additional tests to rule out a malignant disease, as 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 one year), your doctor may monitor you regularly. You should inform your doctor of any symptoms and/or new or unexpected events each time you visit your doctor

Children and adolescents

The use of Pantoprazole is not recommended in children as it has not been tested 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 take any other medicines, including those obtained without a prescription.

Pantoprazole 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 pantoprazole may make these and other medicines not work properly.
• Warfarin and fenprocoumon, which affect blood coagulation. You may need additional checks.
• Medicines used to treat HIV infection, such as atazanavir.
• Methotrexate (a chemotherapeutic medicine used at high doses to treat cancer and psoriasis). If you are taking a high dose of methotrexate, your doctor may temporarily discontinue your treatment with Pantoprazole.
• Fluvoxamine (used to treat depression and other psychiatric diseases) 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, 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 plan to become pregnant, consult your doctor or pharmacist before using 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

Pantoprazole has no significant 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.

Pantoprazole SUN contains sodium:

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

3. How to take Pantoprazole

Follow the instructions for administration of this medicine exactly as indicated by your doctor. If you are 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 from 12 years of age:

For the treatment of reflux esophagitis:

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

Adults:

For the treatment of an infection with a bacterium called Helicobacter pylori in patients with stomach and/or duodenal ulcers 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 to be taken twice a day 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 leaflets of the antibiotics.

The duration of treatment 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 indicate how long you should take this medicine. The treatment time for stomach ulcers is usually between 4 and 8 weeks. The treatment time 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 initial recommended dose is two tablets per day.

Take the two tablets 1 hour before a meal. Later, 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 you should finish the 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 (for this case, 20 mg pantoprazole tablets are available).
• 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, telephone 91 562 04 20, indicating the medicine and the amount taken. No symptoms of overdose are known.

If you forget to take Pantoprazole

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

If you stop taking Pantoprazole

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, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine 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 1000 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), intense dizziness with very rapid heartbeat and profuse sweating.
• Severe skin reactions (frequency unknown, cannot be estimated from available data): 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, may also have joint pain or symptoms similar to 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).
• 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, increased kidney size with occasional pain when urinating, and lower back pain (severe kidney inflammation) may possibly cause kidney failure.

Other side effects are:

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

Benign polyps in the stomach

• Uncommon (may affect up to 1 in 100 people):
  • Headache, dizziness, diarrhea, feeling of dizziness, vomiting, swelling, 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 spine fractures
• Rare(may affect up to 1 in 1000 people)

Distortion or complete loss of taste, vision 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 sodium levels in the blood, decreased magnesium levels in the blood (see section 2), tingling, pinching, numbness, burning sensation, or numbness; 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 people)

increased liver enzymes

• Rare(may affect up to 1 in 1000 people)

increased bilirubin; increased blood fat levels; acute decrease in circulating 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 that could cause bleeding or more bruising than usual; reduction in the number of white blood cells, which could lead to more frequent infections; abnormal reduction in the number of red and white blood cells, as well as platelets.

• Frequency not known(cannot be estimated from 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: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Pantoprazole 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 carton after EXP. The expiry date is the last day of the month shown.

This medicine does not require any special storage conditions.

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

Medicines should not be disposed of via wastewater or household waste. Return the containers and any unused medicines to your usual pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and unused medicines. This will help protect the environment.

6. Container Content and Additional Information

Composition of Pantoprazol SUN 40 mg Gastro-Resistant Tablets

The active ingredient is pantoprazole. Each gastro-resistant tablet contains 40 mg of

pantoprazole (as pantoprazole sodium sesquihydrate).

The other ingredients 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 (E-171), talc, yellow iron oxide (E-172).

Appearance of Pantoprazol SUN 40 mg Gastro-Resistant Tablets and Container Content

Yellow, enteric-coated, oval, biconvex, and smooth tablets on both sides.

This medicinal product is presented in blister packs of 7, 14, 15, 28, 30, 50, 56, 60, 90, 98, 100, and 500 tablets (clinical packaging) or HDPE bottle packs with 60 or 100 gastro-resistant tablets. The bottle contains a desiccant bag with silica gel. DO NOT EAT the contents of the bag. Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sun Pharmaceutical Industries Europe B.V.,

Polarisavenue 87,

2132JH Hoofddorp, Netherlands

Manufacturer

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132 JH Hoofddorp

Netherlands

or

TERAPIA S.A.

124 Fabricii Street.,

400632 Cluj Napoca

Romania

or

Alkaloida Chemical Company Zrt.H-4440, Tiszavasvári,Kabay János u. 29.

Hungary

Local Representative

Sun Pharma Laboratorios, S.L.

Rambla de Catalunya 53-55

08007 Barcelona. Spain

Tel:+34 93 342 78 90

This product is authorized in the EEA member states under the following names:

France Pantoprazole SUN 40 mg, gastro-resistant tablet

Germany PANTOPRAZOL BASICS 40 mg stomach acid-resistant tablets

Italy PANTOPRAZOLO SUN

Poland Ranloc

Spain Pantoprazol SUN 40 mg gastro-resistant tablets EFG

Date of the Last Revision of this Leaflet:October 2023

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