Leaflet: information for the user

Pantoprazol Sandoz 20 mg gastro-resistant tablets EFG

Read this leaflet carefully before you start taking the medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for you only and should not be given 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.

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

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

3. How to take Pantoprazol Sandoz

4. Possible side effects

5. Storage 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 the 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 older:

• Treatment of symptoms associated with gastroesophageal reflux disease (stomach burning, acid regurgitation, difficulty swallowing) caused by acid reflux from the stomach.
• Long-term treatment and prevention of relapses of reflux esophagitis (inflammation of the esophagus accompanied by acid regurgitation from the stomach).

Pantoprazol is used in adults for:

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

Do not take Pantoprazol Sandoz

- 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 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 discontinued,
• if you need to take nonsteroidal anti-inflammatory drugs (NSAIDs) continuously and take pantoprazole, as there is a higher risk of developing complications in the stomach and intestines. Any increased risk will be assessed in accordance with 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 acid-reducing medicines, pantoprazole may reduce vitamin B12 absorption,
• consult your doctor if you are taking HIV protease inhibitors such as atazanavir (for the treatment of HIV) 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 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 have any of these symptoms, see your doctor immediately. Low magnesium levels can also produce a decrease in blood potassium and calcium levels. Your doctor may decide to perform regular 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 medicine 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 discontinue treatment with pantoprazole. Remember to mention any other symptoms you may notice, such as joint pain.

Inform 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:

- 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 medicine 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 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 appointment.

Children and adolescents

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

Other medicines and Pantoprazol Sandoz

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

This is because 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 correctly,
• warfarin and phenprocoumon, which affect blood clotting. You may need additional monitoring,
• medicines 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 treatment with pantoprazole, 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 breastfeeding

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

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

You should only use this medicine if your doctor considers that the benefit for you is 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 side effects such as dizziness or blurred vision.

Pantoprazol Sandoz contains an azo dye and sodium

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

This medicine contains less than 1 mmol of sodium (23 mg) per gastro-resistant tablet; this 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.

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 to 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 esophagitis relapses due to reflux

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

Adults

• For the prevention of duodenal and stomach ulcers in patients who need continuous treatment with NSAIDs

The usual dose is one tablet a day.

Liver Insufficiency

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

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 Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount used.

If you forgot to take Pantoprazol Sandoz

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

If you interrupt the treatment with Pantoprazol Sandoz

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 (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 sun-exposed areas. You may also experience 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 severe 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 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; gynecomastia 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 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 the 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. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications.This will help protect the environment.

Pantoprazol Sandoz Composition

• The active ingredient is pantoprazol. Each gastro-resistant tablet contains 20 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 20 mg are yellow, oval-shaped (coated with a special layer), gastro-resistant tablets, approximately 8.9 x 4.6 mm in size.

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,

RO-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 20 mg magensaftresistente tabletten

Bélgica:Pantoprazol 20 mg maagsapresistente tabletten

Dinamarca:Pantoprazol“Sandoz” , enterotabletter 20 mg, pakningsstørrelser ≤ 28 stk

Grecia:OZEPRAN 20 mg γαστροανθεκτικ? δισκ?α

Italia:PANTOPRAZOLO SANDOZ

Países Bajos:PANTOPRAZOL SANDOZ 20 MG, MAAGSAPRESISTENTE TABLETTEN

Polonia:IPP 20, 20 mg, tabletki dojelitowe

Portugal:Pantoprazol Sandoz 20 mg comprimidos gastrorresistente

Suecia:Pantoprazol Sandoz 20 mg enterotabletter

Eslovenia:Acipan 20 mg gastrorezistentne tablete

Eslovaquia:Pantoprazol Sandoz 20 mg, gastrorezistentné tablety

Reino Unido:Pantoprazole 20 mg gastro resistant tablets

Last review date of this leaflet:January 2022

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/