Package Leaflet: Information for the User

Pantoprazol Sandoz 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 or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others even if their symptoms are the same as yours. It may harm them.
• If you experience any side effects, talk to your doctor, pharmacist or nurse. See section 4.

1.What is Pantoprazol Sandoz and what it is used for

2.What you need to know before you start taking Pantoprazol Sandoz

3.How to take Pantoprazol Sandoz

4.Possible side effects

5Storage of Pantoprazol Sandoz

6. Contents of the pack and additional information

Pantoprazol Sandoz contains 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 to treat adults and adolescents aged 12 years and above for treating:

• Gastroesophageal reflux esophagitis. It is an inflammation of your esophagus (the tube that connects your throat to your stomach) accompanied by regurgitation of acid from your stomach.

Pantoprazol is used in adults to treat:

• Infection caused by a bacteria calledHelicobacter pyloriin 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 reappearing,
• Stomach and duodenal ulcers, and,

Zollinger-Ellison syndrome and other conditions in which too much acid is produced in the stomach.

Do not take Pantoprazol Sandoz

- 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 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 liver enzyme levels increase, treatment should be interrupted,
• if you have decreased vitamin B12 reserves or risk factors for it and receive pantoprazole treatment for a long period of time. 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 hip, wrist, or spinal fractures. Inform your doctor if you have osteoporosis or are taking corticosteroids (which may increase the risk of osteoporosis),
• if you are taking pantoprazole for 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 decreased potassium and calcium levels in the blood. Your doctor may decide to perform periodic blood tests to monitor magnesium levels,
• if you are scheduled to have a specific blood test (Cromogranin A),
• if you have ever had a skin reaction after treatment with a similar medication to pantoprazole 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 interrupt pantoprazole treatment. Remember to mention any other symptoms you may notice, such as joint pain.

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 diseases:

- unintended weight loss,

- vomiting, particularly if repeated,

- blood in vomit: it may appear as a dark brown powder in your vomit,

- if you notice blood in your stools, which may appear black or dark,

- 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 Sandoz

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

This is because pantoprazole 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 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 pantoprazole treatment, as 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 lactation

There is insufficient data on the use of pantoprazole in pregnant women. Pantoprazole has been reported to be excreted in human breast milk.

If you are pregnant, breastfeeding, believe you may be pregnant, or intend 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

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

You should not drive or operate machinery if you experience adverse effects such as dizziness or blurred vision.

Pantoprazol Sandoz contains an azo dye and sodium

This medication may cause allergic reactions because it contains azo dye Ponceau 4R (E124).

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 whole tablets, without chewing or crushing, with a little water, 1 hour before a meal.before a meal.

The recommended dose is:

Adults and adolescents 12 years and older

• For the treatment of esophagitis by reflux

The usual dose is one tablet a day. Your doctor may indicate an increase to 2 tablets a 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 calledHelicobacter pyloriin patients with stomach and/or duodenal ulcer in combination with two antibiotics (eradication treatment)

One tablet twice a day plus the two antibiotic tablets, either amoxicillin, clarithromycin, and metronidazole (or tinidazole),eachmust be taken twice a daywith your pantoprazole tablet. Take thefirstpantoprazole tablet 1 hour before breakfast and thesecond1 hour before dinner. Follow your doctor's instructions and make sure to read the antibiotic prospectuses.The treatment duration is usually 1 to 2 weeks.

• For the treatment of stomach and duodenal ulcers

The usual dose is one tablet a 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 normally 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 initial recommended dose is two tablets a 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 two tablets a day, you should take the tablets divided into two times a day.

If you are prescribed more than four tablets a day, you will be told exactly when to stop treatment.

Renal Insufficiency

If you have kidney problems, you should not take pantoprazole for the elimination ofHelicobacter pylori.

Liver Insufficiency:

If you have severe liver problems, you should not take more than one 20 mg pantoprazole tablet a 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 elimination ofHelicobacter pylori.

Use in children and adolescents

These tablets are not recommended for use in children under 12 years old.

If you take more Pantoprazol Sandoz than you should

If you have taken more Pantoprazol Sandoz than you should, consult your doctor, pharmacist, or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Pantoprazol Sandoz

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

If you interrupt treatment with Pantoprazol Sandoz

Do not stop taking these tablets without consulting your doctor or pharmacist first.

If you have any other doubts 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 (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: the frequency cannot be estimated from 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 genitals, or a rash, particularly in exposed areas to the 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, subacute lupus erythematosus, drug reactions with eosinophilia and systemic symptoms (DRESS), photosensitivity).
• Other serious conditions (unknown frequency: cannot be estimated from 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 back pain in the lower part of the back (severe kidney inflammation), which may lead to kidney failure.

Other possible 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; 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 fracture, wrist fracture, and spinal column fracture

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

Alteration or complete loss of taste, visual disturbances such as: blurred vision; urticaria; joint pain; muscle pain; weight changes; increased body temperature; fever, swelling in the extremities (peripheral edema); allergic reactions; depression; increased breast size 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),

decrease in sodium, magnesium, calcium, or potassium levels in the blood (see section 2), 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:

• 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 fats in the blood, acute drop in the number of white blood cells in the blood, 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 and red blood cells that could lead to more frequent infections, along with a decrease in the number of white and red blood cells in the blood, as well as the number of platelets.

Reporting of side effects:

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, 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 blister pack and on the packaging after CAD/EXP. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Do not use this medication after 6 months of the first opening of the HDPE bottle.

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. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need.This will help protect the environment.

Pantoprazol Sandoz Composition

• The active ingredient is pantoprazol. Each gastro-resistant tablet contains 40 mg of pantoprazol (as sesquihydrate of sodium).
• The other components (excipients) are:

Core:calcium stearate, microcrystalline cellulose, crospovidone (Type A), hydroxypropylcellulose (type EXF), anhydrous sodium carbonate, anhydrous colloidal silica.

Covering:hypromellose, yellow iron oxide (E172), macrogol 400, copolymer of methacrylic acid and ethyl acrylate (1:1), polysorbate 80, ponceau 4R (E124), quinoline yellow (E104), sodium lauryl sulfate, titanium dioxide (E171), triethyl citrate.

Product Appearance and Packaging Content

Pantoprazol Sandoz 40 mg are yellow, oval-shaped (coated with a special layer) gastro-resistant tablets of approximately 11.7 x 6.0 mm.

They are available in:

Blister packs of 7, 10, 14, 15, 20, 28, 30, 50, 56, 56x1, 60, 84, 90, 98, 100, 100x1, 140, 168 tablets

Bottles of 14, 28, 56, 98, 100, 105, 250, 500 tablets

Only some packaging sizes may be marketed.

Marketing Authorization Holder and Responsible Manufacturer

Marketing Authorization Holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Responsible Manufacturer

Lek Pharmaceuticals d.d.

Verovskova 57,

SLO-1526 Ljubljana

Slovenia

or

Lek Poslka Akcyjna

ul. Domaniewska 50 C,

02-672 Warszawa

Poland

or

Salutas Pharma GmbH

Otto-von-Guericke-Allee 1

39179 Barleben

Germany

or

Lek Pharmaceuticals d.d

Trimlini 2D 9220

Lendava

Slovenia

or

Sandoz S.R.L.

Str. Livezeni nr. 7A,

540472 Targu-Mures

Romania

or

Lek S.A.

Ul. Podlipie 16

95-010 Strykow

Poland

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

Austria:Pantoprazol Sandoz 40 mg magensaftresistente tabletten

Bélgica:Pantoprazol 40 mg maagsapresistente tabletten

Dinamarca:Pantoprazol “Sandoz”, enterotabletter 40 mg

Grecia:OZEPRAN 40 mg γαστροανθεκτικ? δισκ?α

Italia:PANTOPRAZOLO SANDOZ 40 mg compresse gastroresistenti

Países Bajos:PANTOPRAZOL SANDOZ 40 MG, MAAGSAPRESISTENTE TABLETTEN

Polonia:IPP 40, 40 mg, tabletki dojelitowe

Portugal:Pantoprazol Sandoz 40 mg Comprimido gastrorresistente

Suecia:Pantoprazol Sandoz 40 mg enterotabletter

Eslovenia:Acipan 40 mg gastrorezistentne tablete

Eslovaquia:Pantoprazol Sandoz 40 mg, gastrorezistentné tablety

Reino Unido:Pantoprazole 40 mg gastro-resistant tablets

Last review date of this leaflet:January 2022

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