PANTOPRAZOL SUN 20 mg GASTRO-RESISTANT TABLETS

Introduction

Package Leaflet: Information for the Patient

Pantoprazole SUN 20 mg Gastro-Resistant Tablets EFG

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:

• Symptoms (e.g., heartburn, acid reflux, difficulty swallowing) associated with

gastroesophageal reflux disease caused by acid reflux from the stomach.

• Treatment of reflux esophagitis (inflammation of the esophagus accompanied by

acid reflux from the stomach) and prevention of relapses.

Pantoprazole is used in adults to treat: - prevention of gastroduodenal ulcers induced by non-steroidal anti-inflammatory drugs (NSAIDs, e.g., ibuprofen), in patients at risk who require continuous treatment with NSAIDs.

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 containing other proton pump inhibitors.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take 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 when you are on long-term treatment with Pantoprazole. If your liver enzymes increase, 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 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 intestine bleeding.
• If you have low vitamin B12 body stores or risk factors for this and receive treatment with pantoprazole for a long period. Like all acid-reducing medicines, pantoprazole may 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 more than a year, you may have a slightly increased risk of hip, wrist, and spine fractures. Inform your doctor if you have osteoporosis (reduced bone density) or if you are taking corticosteroids (which can increase the risk of osteoporosis).
• If you take Pantoprazole for more than three months, your magnesium levels in the blood may decrease. Low magnesium levels can cause fatigue, muscle contractions, disorientation, convulsions, dizziness, increased heart rate. If you experience any of these symptoms, go to your doctor immediately. Low magnesium levels can also lead to a decrease in potassium and calcium levels in the blood. Your doctor may decide to perform periodic blood tests to monitor your magnesium levels.
• If you have ever had a skin reaction after treatment with a medicine similar to Pantoprazole to reduce stomach acid. If you get a skin rash, especially in areas of the 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.
• if you notice blood in your stools, which may appear black or tarry
• 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, 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 inform your doctor of any new or unexpected symptoms or 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 monitoring.
• Medicines used to treat HIV infection, such as atazanavir.
• Methotrexate (a chemotherapy medicine used at high doses to treat cancer and psoriasis). If you are taking a high dose of methotrexate, your doctor may temporarily stop 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 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 to you is greater than the potential risk to the fetus or baby.

Driving and using machines

Pantoprazole 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.

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

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist.

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 treating symptoms associated with gastroesophageal reflux disease (heartburn, acid reflux, difficulty swallowing)

The usual dose is one tablet per day.

This dose usually provides relief within 2-4 weeks, and if not, within the next 4 weeks. Your doctor will tell you how long you should take the medicine. After that, any recurring symptoms can be controlled by taking one tablet per day as needed.

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 use Pantoprazole 40 mg once a day. After healing, you can reduce the dose back to one 20 mg tablet per day.

Adults:

For the prevention of duodenal and stomach ulcers in patients who require continuous treatment with NSAIDs:

The usual dose is one tablet per day.

Patient 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 Pantoprazole than you shouldInform your doctor or pharmacist or call the Toxicology Information Service, telephone 915 620 420, 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 PantoprazoleDo 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 1,000 people): swelling of the tongue and/or throat, difficulty swallowing, rash (urticaria), difficulty breathing, swelling of the face of allergic origin (Quinke's edema/angioedema), intense dizziness with very rapid heartbeats and profuse sweating.
• Severe skin reactions (frequency not known, 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/reaction, particularly in areas of skin exposed to light/sun, may also have 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 syndrome, erythema multiforme, subacute cutaneous lupus erythematosus, drug reaction with eosinophilia and systemic symptoms (DRESS), photosensitivity).

• Other serious conditions (frequency not known, 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 lead to kidney failure.

Other side effects are:

• Common (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, 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, fractures of the hip, wrist, or spine

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

Distortion or complete loss of taste, vision changes 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 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 people)

Increased liver enzymes

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

Increased bilirubin; increased blood fat levels; acute decrease in circulating granulocytes, associated with high fever

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

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 concurrent reduction in the number of red and white blood cells, as well as platelets.

• Frequency not known(cannot be estimated from available data) decreased 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, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to 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 20 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 refers to 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 any unused medicine to your pharmacist. They will dispose of it in an environmentally friendly way. This will help to protect the environment.

6. Container Content and Additional Information

Composition of Pantoprazol SUN 20 mg Gastro-Resistant Tablets

The active ingredient is pantoprazole. Each gastro-resistant tablet contains 20 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.

Appearance of Pantoprazol SUN 20 mg Gastro-Resistant Tablets and Container Content

Oval-shaped, biconvex tablets, coated with a white enteric film.

This medication is available in blister packs of 7, 14, 15, 28, 30, 50, 56, 60, 90, 98, 100, and 500 tablets (clinical packaging) or HDPE bottle packs containing 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

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 EEA member states under the following names:

France Pantoprazole SUN 20 mg, gastro-resistant tablet

Germany PANTOPRAZOL BASICS 20 mg, stomach acid-resistant tablets

Italy PANTOPRAZOLO SUN

Poland Ranloc

Spain Pantoprazol SUN 20 mg gastro-resistant tablets EFG

Date of the Last Revision of this Leaflet:May 2022

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