Package Insert: Information for the User

Pantoprazol Stada 20 mg Gastrorresistant Tablets EFG

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed for you only and should not be given to others who may 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 package insert. See section 4.

Pantoprazol Stadais a medication that decreases the secretion of acid in the stomach (selective inhibitor of the proton pump).

Pantoprazol 20 mg is used for

• treatment of mild gastroesophageal reflux disease (esophageal disorder due to acid rising from the stomach) and associated symptoms (e.g., heartburn, acid regurgitation, difficulty swallowing)
• long-term treatment and prevention of relapses in reflux esophagitis (esophageal inflammation).

• prevention of nonsteroidal anti-inflammatory drug (NSAID)-induced gastric and duodenal ulcers in patients at risk who require continued treatment with this type of medication.

Do not takePantoprazol Stada

• If you are allergic to pantoprazole, peanuts, or soy, or to any of the other components 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 Stada. Especially:

• 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 when you are on long-term treatment with pantoprazole. If liver enzyme levels increase, treatment should be discontinued.
• If you need to take nonsteroidal anti-inflammatory drugs (NSAIDs) continuously and take pantoprazole, as there is a higher risk of developing stomach and intestinal complications. Any increased risk will be evaluated based on individual risk factors such as age (65 years or older), history of stomach or duodenal ulcers, or gastrointestinal bleeding.
• If you have decreased vitamin B12 reserves or risk factors for it and receive long-term treatment with pantoprazole. Like all medications that reduce acid production, pantoprazole may reduce vitamin B12 absorption.
• Consult your doctor if you are taking HIV protease inhibitors such as atazanavir (for HIV treatment) at the same time as pantoprazole.
• Taking a proton pump inhibitor like pantoprazole, especially for more than a 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 developing osteoporosis (for example, if you are taking corticosteroids).
• 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, 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 potassium and calcium levels in the blood. 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 pantoprazole for reducing stomach acid.
• If you suffer from a skin rash, especially in sun-exposed areas, 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.
• You are scheduled to have a specific blood test (Cromogranin A).

Inform your doctor immediately if you notice any of the following symptoms, which may be signs of more serious underlying conditions:

• Unintentional weight loss
• Vomiting, particularly if repeated
• Blood in vomit: may appear as a dark brown powder in your vomit.
• 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 pantoprazole may alleviate cancer symptoms and potentially delay diagnosis. If your symptoms persist despite treatment, further investigations will be performed.

If you take pantoprazole 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 consultation.

Children and adolescents

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

Other medications and Pantoprazol Stada

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Pantoprazole may affect the efficacy of other medications. 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 pantoprazole 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 (used to treat rheumatoid arthritis, psoriasis, and cancer) – if you are taking methotrexate, your doctor may temporarily suspend your treatment with pantoprazole, 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)
• Holy thistle (Hypericum perforatum) (used to treat mild depression)

Pregnancy and breastfeeding

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

There is insufficient data on the use of pantoprazole in pregnant women. Pantoprazole has been detected in human breast milk.

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

Pantoprazole has no influence or has a negligible effect 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 Stada contains maltitol

This medication contains maltitol (E-965). If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

Pantoprazol Stada contains lecithin from soy

If you are allergic to peanuts or soy, do not use this medication.

Pantoprazol Stada contains sodium

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

Follow exactly the administration instructions of this medication 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 a little 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 one tablet a 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 one tablet a day.One tablet a day.

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

The usual dose is one tablet a day. If the disease reappears, your doctor may double the dose, in which case you can take pantoprazole 40 mg once a day. After recovery, you can reduce the dose again to one tablet of 20 mg a day.

Adults

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

The usual dose is one tablet a day.

Patients with liver problems

If you have severe liver problems, do not take more than one tablet of 20 mg a day.

Use in children and adolescents

This medication is not recommended for use in children under 12 years old.

If you take more Pantoprazol Stada than you should

Inform your doctor or pharmacist, or call the toxicology information service, phone 91 562 04 20 indicating the medication and the amount taken. It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

No symptoms of overdose are known.

If you forgot to take Pantoprazol Stada

Do not take a double dose to compensate for the missed doses.

Take your next dose as usual.

If you interrupt treatment with Pantoprazol Stada

Do 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 can 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 hospital's emergency service nearest to you:

• Severe allergic reactions(rare frequency:may affect up to 1 in 1,000 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:its frequency cannot be estimated with the available data): you may notice one or more of the following - blisters on the skin and a rapid deterioration of overall conditions, erosion (including light bleeding) of the eyes, nose/mouth/lips, or genitalsor skin sensitivity/eruption, particularly in areas of exposed skin to light/sun. You 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, Acute cutaneous lupus erythematosus, Pharmacological reaction with eosinophilia and systemic symptoms (DRESS), Photosensitivity).

• Other serious conditions(unknown frequency:its frequency cannot be estimated with the available data): yellowing of the skin and the white of the eyes (severe liver cell damage, jaundice), or fever, hives, increased kidney size with occasional pain while urinating, and lower back pain (severe kidney inflammation), possibly leading to kidney 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)

Headache; dizziness; diarrhea; feeling 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; hip, wrist, and spinal column fractures.

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

Alteration or complete absence of taste; visual disturbances such as blurred vision; hives; 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(cannot be estimated from the available data)

Illusion, confusion (especially in patients with a history of these symptoms), feeling of tingling, pinching, numbness, burning, or numbness,skin rash, possibly with joint pain, inflammation of the large intestine 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 1,000 people)

Increased bilirubin; increased levels of fat in the blood; sudden drop in granular white blood cells in circulation, 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 that could lead to more frequent infections; abnormal reduction in the balance between the number of red and white blood cells, as well as platelets.

• Unknown frequency(cannot be estimated from the available data)

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

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a side effect that does not appear in this leaflet. You can also report them directly through the national notification system included in 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 blister pack and on the box after CAD. The expiration date is the last day of the month indicated.

For tablets packaged in plastic bottles: Use Pantoprazol Stada within three months following the first opening of the bottle.

Do not store at a temperature above 25 °C.

Medications should not be disposed of through drains or in the trash. Deposit the containers and medications you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition ofPantoprazol Stada

The active ingredient is pantoprazol. Each gastro-resistant tablet contains 20 mg of pantoprazol (present in the form of 22,575 mg of pantoprazol sodium sesquihydrate)

The other components are:

Core

Maltitol (E 965), crospovidone type B, sodium carmellose, sodium carbonate (E 500) calcium stearate.

Covering

Poly (vinyl alcohol), talc (E 553b), titanium dioxide (E 171), macrogol 3350, soy lecithin, yellow iron oxide (E 172), sodium carbonate (E 500), copolymer of acrylic acid-methacrylic acid (1:1), triethyl citrate (E 1505).

Appearance of the product and contents of the package

Gastro-resistant oval-shaped tablets of yellow color.

Available in:

Pantoprazol Stada 20 mg savailable in blisters of 2 (starting package), 7, 10, 14, 15, 20, 28, 30, 30x1, 50, 56, 60, 90, 98, 100, 120, 126, 140, 140 (10x14) (5x28), 154, 196, 280 (20x14) (10x28), 500, 700 (5x140)tablets, and in bottles of2 (starting package), 7, 10, 14, 15, 20, 28, 30, 30x1, 50, 56, 60, 90, 98, 100, 120, 126, 140, 140 (10x14) (5x28), 154, 196, 280 (20x14) (10x28), 500, 700 (5x140)tablets.

Not all package sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing:

Holderof the marketing authorization

STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

info@stada .es

Responsible for manufacturing

STADA Arzneimittel AG

Stadastr. 2-18,

D-61118 Bad Vilbel,

Germany

or

Centrafarm Services B.V.

Van de Reijstraat 31-E

4814 NE Breda

Netherlands

or

Lamp S. Prospero S.P.A

Via della Pace, 25/A

41030 San Prospero (MO)

Italy

or

Sofarimex

Industria Quimicae Farmaceutica, SA

Av. das Industrias

Alto de Colaride, Agualva

2735-213 Cacem

Portugal

or

STADA Arzneimittel GmbH

Muthgasse 36/2

1190 Wien

Austria

or

Eurogenerics N.V.

Heizel Esplanade B 22

1020 Brussels

Belgium

or

Sanico NV

Veedijk 59

B-2300 Turnhout

Belgium

or

STADA M&D SRL

Str. Trascaului nr. 10,

Municipiul Turda,

Judet Cluj 401135,

Romania

This medicine is authorized in the member states of the European Economic Area with the following names:

DE (RMS):Pantoprazol STADA 20 mg magensaftresistente Tabletten

AT:Pantoprazol Stada 20 mg - magensaftresistente Tabletten

BE:Pantoprazole EG 20 mg maagsapresistente tabletten

DK:Pantoprazol STADA

ES:Pantoprazol Stada 20 mg comprimidos gastrorresistentes EFG

FR:Pantoprazole EG 20 mg, comprimé gastro-résistant

IE:Pantium 20 mg gastro-resistant tablet

IT:Pantoprazolo EG 20 mg compressa gastroresistenti

LU:Pantoprazole EG 20 mg comprimé gastro-résistants

NL:Pantoprazole CF 20 mg

PL:Gastrostad 20 mg

PT:Pantoprazol Ciclum 20 mg comprimido gastroresistente

Last review date of this leaflet:April 2023

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