PANTOPRAZOL SANDOZ 40 mg GASTRO-RESISTANT TABLETS

2. What you need to know before you take Pantoprazole Sandoz

Do not take Pantoprazole 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 serious liver problems. Tell your doctor if you have ever had liver problems in the past. Your doctor will perform more frequent monitoring of liver enzymes, especially when you are on long-term treatment with pantoprazole. In case of an increase in liver enzymes, treatment should be discontinued,
• if you have decreased body reserves of vitamin B12 or risk factors for it and receive long-term treatment with pantoprazole. Like all acid-reducing medicines, pantoprazole may reduce the absorption of vitamin B12. Consult your doctor if you notice any of the following symptoms, as they may indicate a vitamin B12 deficiency:
• Extreme fatigue or lack of energy
• Numbness
• Pain in the tongue or red tongue, ulcers in the mouth
• Muscle weakness
• Visual disturbances
• Memory problems, confusion, depression
• consult your doctor if you are taking HIV protease inhibitors such as atazanavir (for the treatment of HIV infection) 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 spine fractures. Inform your doctor if you have osteoporosis (reduced bone density) or if you have been told that you are at risk of osteoporosis (for example, if you are taking steroids,
• 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, convulsions, 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 periodic blood tests to monitor magnesium levels,
• if you are scheduled to have a specific blood test (Chromogranin A),
• if you have ever had a skin reaction after treatment with a medicine similar to pantoprazole to reduce stomach acid.

If you suffer a skin rash, especially in areas of the skin exposed to the sun, 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.

Tell 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:

• unintentional weight loss,
• vomiting, particularly if it is repeated,
• blood in the vomit: it may appear as a dark coffee grounds-like substance 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,
• cases of severe skin reactions have been reported in relation to treatment with pantoprazole, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug sensitivity with eosinophilia and systemic symptoms (DRESS), and erythema multiforme. Stop taking pantoprazole and call your doctor immediately if you experience any of the symptoms related to severe skin reactions described in section 4.

Your doctor will decide if you need any additional tests to rule out a malignant disease because pantoprazole can alleviate the symptoms of cancer and may delay its diagnosis. If, despite treatment, your symptoms persist, complementary tests will be performed.

If you take pantoprazole for a prolonged period (more than a year), your doctor may perform regular follow-up. You should inform your doctor of any symptoms and/or new or unexpected events each time you visit your doctor.

Children and adolescents

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

Other medicines and Pantoprazole Sandoz

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

This is because pantoprazole can 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 properly,
• warfarin and phenprocoumon, which affect blood coagulation. You may need additional checks,
• 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).

Talk to your doctor before taking pantoprazole if you need to have a specific urine test (for THC, tetrahydrocannabinol).

Pregnancy, breastfeeding, and fertility

There is not enough data on the use of pantoprazole in pregnant women. It has been reported that in humans, pantoprazole is excreted in breast milk.

If you are pregnant or breastfeeding, think you may be pregnant, or plan 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 to you is greater than the potential risk to the fetus or baby.

Driving and using machines

Pantoprazole has no significant influence on the ability to drive or use machines.

You should not drive or use machines if you experience side effects such as dizziness or blurred vision.

Pantoprazole Sandoz contains an azo colorant and sodium

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

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

3. How to take Pantoprazole Sandoz

Follow the instructions for administration of this medicine exactly as indicated by your doctor or pharmacist. If you are in doubt, consult your doctor or pharmacist again.

Method of administration

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

The recommended dose is:

Adults and adolescents from 12 years

• For the treatment of reflux esophagitis

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

Adults

• For the treatment of an infection with a bacterium calledHelicobacter pyloriin patients with stomach and/or duodenal ulcers in combination with two antibiotics (eradication treatment)

One tablet twice a day plus the two antibiotic tablets, either amoxicillin, clarithromycin, and metronidazole (or tinidazole), each to be taken twice a day with your pantoprazole tablet. Take the first pantoprazole tablet 1 hour before breakfast and the second 1 hour before dinner. Follow your doctor's instructions and make sure to read the leaflets of the antibiotics. The duration of treatment is usually one to two weeks.

• For the treatment of stomach and duodenal ulcers

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

Your doctor will indicate how long you should take this medicine. The treatment time for stomach ulcers is usually between 4 and 8 weeks. The treatment time 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 secretion

The initial recommended dose is two tablets per day.

Take the two tablets 1 hour before a meal. Later, your doctor may adjust the dose, depending on the amount of acid secretion you produce. If you are prescribed more than two tablets per day, you should take the tablets divided into two doses per day.

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

Renal insufficiency

If you have kidney problems, you should not take pantoprazole for the eradication of Helicobacter pylori.

Hepatic insufficiency:

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

If you have moderate or severe liver problems, you should not take pantoprazole for the eradication of Helicobacter pylori.

Use in children and adolescents

The use of these tablets is not recommended in children under 12 years of age.

If you take more Pantoprazole Sandoz than you should

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

If you forget to take Pantoprazole Sandoz

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

If you stop taking Pantoprazole Sandoz

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

If you have any further questions on the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

• Severe allergic reactions (frequency rare:may affect up to 1 in 1,000 people): swelling of the tongue and/or throat, difficulty swallowing, hives (urticaria), difficulty breathing, swelling of the face of allergic origin (angioedema/Quincke's edema), intense dizziness with very rapid heartbeats and profuse sweating.
• Severe skin reactions (frequency not known:frequency cannot be estimated from the available data): you may notice one or more of the following:
• • blisters on the skin and rapid deterioration of general conditions, erosion (including slight bleeding) of eyes, nose, mouth/lips, or genitals, or sensitivity to skin/eruption, particularly in sun-exposed areas.
  • Round or target-like patches of slightly reddish color on the trunk, often with blisters in the center, peeling, ulcers in the mouth, throat, nose, genitals, and eyes. These severe rashes can be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
  • Generalized rash, elevated body temperature, and lymph node enlargement (DRESS or drug hypersensitivity).

• Other serious conditions (frequency not known): yellowing of the skin and whites of the eyes (severe liver cell damage, jaundice), or fever, rash, increase in kidney size with occasional pain when urinating, and pain in the lower 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.

• Uncommon(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; skin rash, exanthema, eruption; numbness; feeling of weakness, fatigue, or general malaise; sleep disturbances, hip, wrist, and spine fractures

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

alteration or complete loss of taste, vision disturbances such as: blurred vision; hives; joint pain; muscle pain; weight changes; elevated body temperature; fever, swelling in the limbs (peripheral edema); allergic reactions; depression; breast enlargement in men.

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

Disorientation.

• Frequency not known(cannot be estimated from the available data):

Hallucinations, confusion (especially in patients with a history of these symptoms),

), feeling of numbness, pins and needles, burning, or tingling, skin rash, possibly with joint pain, inflammation of the large intestine that causes 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 blood fat levels, sudden drop in white blood cell count in the blood, associated with high fever.

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

reduction in platelet count, which may cause bleeding or more bruising than usual; reduction in white and red blood cell count in the blood, which may lead to more frequent infections, along with a decrease in white and red blood cell count in the blood, as well as platelet count.

• Frequency not known(frequency cannot be estimated from the available data): reduction in sodium, magnesium, calcium, or potassium levels in the blood (see section 2)..

Reporting of side effects:

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible side effects that are not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Pantoprazol Sandoz

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

Do not use this medicine after the expiry date which is stated on the blister and on the carton after CAD/EXP. The expiry date is the last day of the month indicated.

No special storage conditions are required.

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

Medicines should not be disposed of via wastewater or household waste. Place the cartons and any remaining medicines in the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of the cartons and any remaining medicines. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Pantoprazol Sandoz

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

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

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

Appearance and Package Contents of the Product

Pantoprazol Sandoz 40 mg are yellow, oval, gastro-resistant tablets (with a special coating) approximately 11.7 x 6.0 mm in size.

They are available in:

Blisters 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

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

Lek Pharmaceuticals d.d.

Verovskova 57,

SLO-1526 Ljubljana

Slovenia

or

or

Lek S.A

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

Date of Last Revision of this Leaflet:February 2025

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/