Package Leaflet: Information for the User

Pantoprazol Stada 40 mg gastro-resistant tablets EFG

Read this leaflet carefully before you start taking this medicine because 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 others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

Pantoprazol Stadais a medication that reduces stomach acid secretion (proton pump inhibitor).

Pantoprazol 40 mg is used

• in combination with antibiotics for the treatment of duodenal ulcer and gastric ulcer. This treatment consists of the eradication of Helicobacter pylori, the microorganism causing the disease (pathogen) responsible for causing stomach and intestinal ulcers.
• for the treatment of duodenal ulcer
• for the treatment of gastric ulcer
• for the treatment of moderate to severe gastroesophageal reflux esophagitis (inflammation of the esophagus)
• for long-term treatment in diseases with a significant increase in stomach acid secretion (such as Zollinger-Ellison syndrome).

Do not takepantoprazole

• 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 containing other proton pump inhibitors.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take pantoprazole. Especially:

• 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 liver enzyme levels increase, treatment should be interrupted.
• 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 takingprotease inhibitors for HIV such asatazanavir (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 takingpantoprazolefor more than three months, it is possible that 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 magnesium levels.
• If you have ever had a skin reaction after treatment with a similar medication topantoprazoleto reduce 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 interrupt treatment withpantoprazole. 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,before or after taking this medication, if you notice any of the following symptoms, which may be signs of more serious diseases:

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

If you takepantoprazolefor 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 ofpantoprazoleis 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) aspantoprazolemay make these and other medications not work correctly.
• 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 interrupt treatment withpantoprazoleas pantoprazole may increase methotrexate levels in the blood.
• 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 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 are insufficient data for the use of Pantoprazole in pregnant women.

Pantoprazole has been reported to be excreted 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 machines

Pantoprazole has no influence or insignificant influence on the ability to drive or operate machines.

You should not drive or operate machines 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 soy lecithin

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 pantoprazole-resistant 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 FormTake 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

• Treatment of esophagitis by reflux

The usual dose is 1 tablet per day. Your doctor may indicate an increase to 2 tablets per day. The treatment time for esophagitis by reflux usually lasts between 4 and 8 weeks. Your doctor will tell you for how long to take this medication.

Adults

• For the treatment of an infection with a bacteria called Helicobacter pylori in patients with stomach and/or duodenal ulcers in combination with two antibiotics (eradication treatment)

The following combinations are recommended:

or

or

Take the first tablet of pantoprazole 1 hour before breakfast and the second tablet of pantoprazole 1 hour before dinner. Follow your doctor's instructions and make sure to read the prospectus of these antibiotics. The treatment duration is usually 1 to 2 weeks.

• For the treatment of stomach and duodenal ulcers

The usual dose is 1 tablet per day. The dose may be doubled by your doctor.

Your doctor will tell you for how long to take this medication. The treatment duration for stomach ulcers is usually between 4 and 8 weeks. The treatment duration 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 production

The recommended starting dose is usually 2 tablets per day. Take the two tablets 1 hour before a meal. Your doctor may then adjust your dose, depending on the amount of stomach acid you produce. If you are prescribed more than 2 tablets per day, you should take the tablets divided into two doses per day.

If your doctor prescribes more than 4 tablets per day, you will be told exactly when to stop treatment.

Patients with kidney problems

If you have kidney problems, you should not takepantoprazolefor the elimination ofHelicobacter pylori

Patients with liver problems

If you have severe liver problems, you should not take more than 1 tablet of 20 mg of pantoprazole per day (for this case, tablets of 20 mg of pantoprazole are available).

If you have moderate or severe liver problems, you should not takepantoprazolefor the elimination ofHelicobacter pylori.

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

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

No known symptoms of overdose.

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 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 hospital's emergency service nearest to you:

• Severe allergic reactions(very rare: 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(frequency unknown: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 eyes, nose, mouth/lips or genitals or 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(frequency unknown: 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 size of the kidneys sometimes with painful urination and lower back pain (severe kidney inflammation), possibly causing 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; 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; hip, wrist, and spinal column fractures.

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

Alteration or complete loss 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 1 in 10,000 people)

Disorientation

• Frequency unknown(cannot be estimated from the available data)

Illusion, confusion (especially in patients with a history of these symptoms), sensation 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:

• 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 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.

• Frequency unknown(cannot be estimated from the 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, pharmacist, or nurse, even if it is side effects that do 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. Dispose of the containers and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, 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 of Pantoprazol Stada:

The active ingredient is pantoprazol. Each gastro-resistant tablet contains 40 mg of pantoprazol (present in the form of 45,150 mg of pantoprazol sodium sesquihydrate)

The other components are:

Core

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

Coating

Poly (vinyl alcohol), talc (E553b), titanium dioxide (E 171), macrogol 3350, soy lecithin, yellow iron oxide (E 172), sodium carbonate (E 500), acid copolymer (1:1) of methacrylic acid and ethyl acrylate, triethyl citrate (E1505).

Appearance of the product and contents of the package

Oval-shaped gastro-resistant tablets of yellow color.

It is available in:

Pantoprazol Stada 40 mg is available 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 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.

Not all package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Responsible manufacturer

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

Eurogenerics N.V.

Heizel Esplanade B 22, 1020 Brussels

Belgium

or

Sanico NV

Veedijk 59

B-2300 Turnhout

Belgium

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

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 40 mg magensaftresistente Tabletten

AT:Pantoprazol Stada 40 mg - magensaftresistente Tabletten

BE:Pantoprazole EG 40 mg maagsapresistente tabletten

DK:Pantoprazol STADA

ES:Pantoprazol Stada 40 mg comprimidos gastrorresistentes EFG

IT:Pantoprazolo EG 40 mg compressa gastroresistenti

LU:Pantoprazole EG 40 mg comprimé gastro-résistants

NL:Pantoprazole CF 40 mg

PL:Gastrostad 40 mg

PT:Pantoprazol Ciclum 40 mg comprimido gastroresistente

Last review date of this leaflet:April 2023

For detailed and updated information on this medicine, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/