Prospect: Patient Information

Pantoprazol SUN 20 mg gastro-resistant tablets EFG

Pantoprazol

Read this prospect carefully before starting to take this medicine, as it contains important information for you

- Keep this prospect, as you may need to read it again.

- If you have any doubts, consult your doctor, pharmacist, or nurse.

- This medicine has been prescribed only for you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.

- If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this prospect. See section 4.

1. What is Pantoprazol and how is it used

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

3. How to take Pantoprazol

4. Possible adverse effects

5. Storage of Pantoprazol

6. Contents of the package and additional information

Pantoprazolcontains the active substance pantoprazol.Pantoprazol is a selective proton pump inhibitor, a medication 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 is used for:

Pantoprazol is used in adults and adolescents aged 12 years and above to treat:

-Symptoms (for example, stomach burning, acid regurgitation, difficulty swallowing) associated with gastroesophageal reflux disease caused by acid reflux from the stomach.

-Long-term treatment of esophagitis caused by acid reflux (inflammation of the esophagus accompanied by acid regurgitation from the stomach) and prevention of relapses.

Pantoprazol is used in adults to treat:- Prevention of gastroduodenal ulcers induced by nonsteroidal anti-inflammatory drugs (NSAIDs, for example, ibuprofen), in patients at risk who require continued treatment with NSAIDs.

Do not take Pantoprazol

- if you are allergic to pantoprazole or any of the other ingredients of this medication (listed in section 6).

- if you are allergic to medications that contain other proton pump inhibitors.

Warnings and precautions

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

- If you have severe liver problems. Inform your doctor if you have ever had liver problems. Your doctor will monitor your liver enzyme levels more frequently, especially when you are on long-term treatment with Pantoprazol. If your liver enzyme levels increase, treatment should be discontinued.

- If you need to take nonsteroidal anti-inflammatory drugs (NSAIDs) continuously and take pantoprazol, as there is a higher risk of developing complications in the stomach and intestines. Any increased risk will be evaluated based on your personal risk factors, such as age (65 years or older), a history of stomach or duodenal ulcers, or gastrointestinal bleeding.

- If you have reduced vitamin B12 reserves or risk factors for it and receive treatment with pantoprazol for a long period of time. Like all medications that reduce acid production, pantoprazol may reduce vitamin B12 absorption.

- If you are taking HIV protease inhibitors such as atazanavir (for HIV treatment) at the same time as pantoprazol.

- If you are taking proton pump inhibitors such as pantoprazol, especially for more than a year, as this may slightly increase the risk of fractures of the hip, wrist, and spine. 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 are taking Pantoprazol 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, seizures, dizziness, increased heart rate. If you experience any of these symptoms, see your doctor immediately. Low magnesium levels can also cause a decrease in blood potassium and calcium levels. Your doctor may decide to perform regular blood tests to monitor your magnesium levels.
• If you have ever had a skin reaction after treatment with a similar medication to Pantoprazol for reducing stomach acid. If you experience a skin rash, especially in sun-exposed areas, consult your doctor as soon as possible, as it may be necessary to discontinue treatment with Pantoprazol. 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 medication, if you notice any of the following symptoms, which may be signs of more serious underlying conditions:

- Unintentional weight loss

- Vomiting, particularly if it is repeated

- Blood in your vomit: it may appear as a dark brown powder in your vomit.

- If you notice blood in your stool, which may appear black or melena

- Difficulty swallowing, or pain when swallowing

- Pale appearance and feeling of weakness (anemia)

- Chest pain

- Stomach pain

- Severe or persistent diarrhea, as this medication has been associated with a small increase in infectious diarrhea.

Your doctor will decide if you need additional testing to rule out cancer, as pantoprazol may alleviate cancer symptoms and potentially delay diagnosis. If your symptoms persist despite treatment, further investigations will be performed.

If you take pantoprazol for a prolonged period (more than a year), your doctor may regularly monitor you. You should inform your doctor of any new or unexpected symptoms and/or events each time you attend your appointment.

Children and adolescents

The use of Pantoprazol is not recommended in children, as it has not been tested in children under 12 years old.

Other medications and Pantoprazol

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication, including over-the-counter medications.

Pantoprazol may affect the efficacy of other medications, so inform your doctor if you are taking:

• Medications such as ketoconazole, itraconazole, and posaconazole (used to treat fungal infections), or erlotinib (used to treat certain types of cancer), as pantoprazol may make these and other medications less effective.
• Warfarin and phenprocoumon, which affect blood clotting. You may need additional monitoring.
• Medications used to treat HIV infection, such as atazanavir.
• Methotrexate (a chemotherapy medication used at high doses to treat cancer and psoriasis). If you are taking a high dose of methotrexate, your doctor may temporarily discontinue treatment with Pantoprazol.
• 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)

Pregnancy, breastfeeding, and fertility

There is insufficient data on the use of pantoprazol in pregnant women. Pantoprazol has been excreted in human breast milk.

If you are pregnant, breastfeeding, or think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

You should only use this medication if your doctor considers the benefits for you to be greater than the potential risk to the fetus or baby.

Driving and operating machinery

Pantoprazol has no influence or has a negligible influence on your ability to drive or operate machinery. Do not drive or operate machinery if you experience side effects such as dizziness or blurred vision.

Pantoprazol SUN contains sodium:

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

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist.In case of doubt, consult your doctor or pharmacist again.

Administration form: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 12 years and older:

For treating symptoms associated with gastroesophageal reflux disease (stomach burning, acid regurgitation, difficulty swallowing)

The usual dose is 1 tablet per day.

This dose usually provides relief within 2-4 weeks, and if not, within a maximum of 4 weeks. Your doctor will tell you how long you should continue taking the medication. Subsequently, any recurring symptom can be controlled, as needed, by taking 1 tablet per day.

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

The usual dose is 1 tablet per day. If the disease returns, your doctor may double the dose, in which case you can use Pantoprazol 40 mg, once a day. After recovery, you can reduce the dose again to 1 tablet of 20 mg per day.

Adults:

For the prevention of duodenal and stomach ulcers in patients requiring continued treatment with NSAIDs:

The usual dose is 1 tablet per day.

Patients with liver problems:

• If you have severe liver problems, do not take more than 1 tablet of 20 mg per day.

Use in children and adolescents:

• It is not recommended to use these tablets in children under 12 years old.

If you take more Pantoprazol than you shouldInform your doctor or pharmacist or call the Toxicological Information Service, phone 915 620 420, indicating the medication and the amount ingested. No symptoms of overdose are known.

If you forgot to take Pantoprazol

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

If you interrupt treatment with PantoprazolDo not stop taking these tablets without consulting your doctor or pharmacist first.

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

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

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

• Severe allergic reactions (rare, may affect up to 1 in 1000 people): swelling of the tongue and/or throat, difficulty swallowing, hives (urticaria), difficulty breathing, allergic swelling of the face (Quincke's edema/angioedema), intense dizziness with very rapid heartbeats and excessive sweating.
• Severe skin alterations (unknown frequency, cannot be estimated from available data): blisters on the skin and rapid deterioration of general condition, erosion (including mild bleeding) of eyes, nose, mouth/lips or genitals or skin sensitivity/eruption, particularly in exposed skin areas to light/sun, may also have joint pain or symptoms similar to the flu, fever, swollen lymph nodes (e.g., in the armpit) and blood tests may show changes in certain white blood cells or liver enzymes. (Stevens-Johnson syndrome, Lyell syndrome, Multiform erythema, Subacute cutaneous lupus erythematosus, Pharmacological reaction with eosinophilia and systemic symptoms (DRESS), Photosensitivity).

- Other severe conditions (unknown frequency, cannot be estimated from available data):yellow discoloration of the skin and white of the eyes (severe liver cell damage, jaundice) or fever, hives, enlarged kidneys with occasional pain while urinating and lower back pain (severe kidney inflammation) possibly leading to renal failure.

Other side effects are:

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

Benign polyps in the stomach

- Infrequent(may affect up to 1 in 100 people):

• Dizziness, vertigo, diarrhea, sensation of dizziness, vomiting, bloating and flatulence (gas), constipation, dry mouth, abdominal pain and discomfort; hives on the skin, exanthema, rash, tingling; feeling of weakness, fatigue or general discomfort, sleep disturbances, fracture ofhip, wrist or spine

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

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

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

disorientation

- Unknown frequency

Alucination, 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), sensation of tingling, pinching, numbness, burning or numbness; skin rash, possibly with joint pain, Inflammatory bowel disease causing persistent watery diarrhea

Side effects identified through blood tests:

• Infrequent(may affect up to 1 in 100 people)

increased liver enzymes

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

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

• Unknown frequency(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 type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

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

Medicines should not be disposed of through drains or in the trash. Dispose of the containers and medicines you no longer need at the SIGRE collection point of your usual pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Pantoprazol SUN 20 mg gastro-resistant tablets

The active ingredient ispantoprazol. Each gastro-resistant tablet contains 20 mg of

pantoprazol (as pantoprazol 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:copolymer of methacrylic acid and ethyl acrylate (1:1), triethyl citrate, sodium lauryl sulfate, titanium dioxide (E-171), talc.

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

Gastro-resistant tablets in oval biconvex shape, coated with enteric film of white color.

This medicine is presented in blister packs of 7, 14, 15, 28, 30, 50, 56, 60, 90, 98, 100, and 500 tablets (clinical pack) or HDPE bottles 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 package sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Sun Pharmaceutical Industries Europe B.V.,

Polarisavenue 87,

2132JH Hoofddorp, Netherlands

Responsible for manufacturing

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

Phone: +3493 342 78 90

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

FrancePantoprazole SUN 20 mg, gastro-resistant tablet

GermanyPANTOPRAZOL BASICS 20 mg gastro-resistant tablets

ItalyPANTOPRAZOLO SUN

PolandRanloc

SpainPantoprazol SUN 20 mg gastro-resistant tablets EFG

Date of the last review of this leaflet:May 2022

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