Pantoprazole Sandoz 40 mg gastro-resistant tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Pantoprazole Sandoz 40 mg gastro-resistant tablets EFG

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

• Keep this leaflet; 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 and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What Pantoprazole Sandoz is and what it is used for
2. What you need to know before taking Pantoprazole Sandoz
3. How to take Pantoprazole Sandoz
4. Possible side effects

5 Storage of Pantoprazole Sandoz

1. Contents of the pack and other information

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

Pantoprazol Sandoz contains the active substance pantoprazole. Pantoprazole is a selective proton pump inhibitor, a medicine that reduces the amount of acid produced in your stomach. It is used to treat diseases related to stomach and intestinal acid.

Pantoprazole is used to treat adults and adolescents from the age of 12 to treat:

• Reflux esophagitis. This is inflammation of your esophagus (the tube connecting your throat to your stomach), accompanied by regurgitation of acid from the stomach.

Pantoprazole is used in adults to treat:

• Infection with a bacterium called Helicobacter pylori in patients with stomach and/or duodenal ulcer, in combination with two antibiotics (eradication therapy). The aim is to eliminate the bacteria and thereby reduce the likelihood of ulcer recurrence,
• Stomach and duodenal ulcers, Zollinger-Ellison syndrome, and other conditions in which excessive acid is produced in the stomach.

2. What you need to know before taking Pantoprazol Sandoz

Do not take Pantoprazol Sandoz

• if you are allergic to pantoprazole or to any of the other ingredients of this medicine (listed in section 6),
• if you are allergic to medicines containing 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 in the past. Your doctor will monitor your liver enzymes more frequently, especially if you are on long-term treatment with pantoprazole. If liver enzymes increase, treatment should be discontinued,
• if you have reduced body stores of vitamin B12 or risk factors for this and are receiving pantoprazole treatment for a long period of time. Like all medicines that reduce acid levels, pantoprazole may reduce the absorption of vitamin B12. Consult your doctor if you notice any of the following symptoms, as they may indicate vitamin B12 deficiency:
• Extreme tiredness or lack of energy
• Tingling
• Tongue pain or red tongue, mouth ulcers
• Muscle weakness
• Vision 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 such as pantoprazole, especially for more than one year, may increase the risk of fractures of the hip, wrist, or spine. Inform your doctor if you have osteoporosis (reduced bone density) or have been told you are at risk of osteoporosis (for example, if you are taking steroids),
• if you are taking pantoprazole for more than three months, your blood magnesium levels may decrease. Low magnesium levels can cause fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, and increased heart rate. If you experience any of these symptoms, contact your doctor immediately. Low magnesium levels may also lead to decreased levels of potassium and calcium 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 (chromogranin A),
• if you have ever had a skin reaction after treatment with a medicine similar to pantoprazole for reducing stomach acidity.

If you develop a skin rash, especially in areas of skin exposed to sunlight, 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 conditions:

• unintentional weight loss,
• vomiting, particularly if repeated,
• blood in vomit: this may appear as dark coffee-ground-like material in your vomit,
• if you notice blood in your stools, which may appear black or dark in colour,
• difficulty swallowing or pain when swallowing,
• pale appearance and feeling weak (anaemia),
• chest pain,
• stomach pain,
• severe or persistent diarrhoea, as this medicine has been associated with a small increased risk of infectious diarrhoea,
• serious skin reactions have been reported with pantoprazole treatment, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and erythema multiforme. Stop taking pantoprazole and contact your doctor immediately if you experience any symptoms related to serious skin reactions described in section 4.

Your doctor will decide whether you need additional tests to rule out malignancy, as pantoprazole may relieve symptoms of cancer and could delay diagnosis. If your symptoms persist despite treatment, further investigations will be carried out.

If you take pantoprazole for a prolonged period (more than one year), your doctor will likely monitor you regularly. You should inform your doctor of any new or unexpected symptoms or events at each visit.

Children and adolescents

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

Other medicines and Pantoprazol Sandoz

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

This is because pantoprazole may affect the effectiveness of other medicines. Therefore, inform your doctor if you are taking:

• medicines such as: ketoconazole, itraconazole, and posaconazole (used to treat fungal infections) or erlotinib (used for certain types of cancer), as pantoprazole may cause these and other medicines to be less effective,
• warfarin and phenprocoumon, which affect blood clotting. You may require 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 discontinue 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 undergo a specific urine test (for THC, tetrahydrocannabinol).

Pregnancy, breast-feeding, and fertility

There are insufficient data on the use of pantoprazole in pregnant women. It has been reported that pantoprazole is excreted in human breast milk.

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

This medicine should only be used if your doctor considers that the benefit to you outweighs the potential risk to the fetus or infant.

Driving and using machines

Pantoprazole has no effect or its effect is negligible on the ability to drive or use machines.

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 medicine may cause allergic-type 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; hence, it is essentially “sodium-free”.

3. How to take Pantoprazole Sandoz

Follow exactly the instructions for use of this medicine given by your doctor or pharmacist. If 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 aged 12 years and older

• For the treatment of reflux esophagitis

The usual dose is one tablet daily. Your doctor may instruct you to increase this to 2 tablets daily. The treatment period for reflux esophagitis is usually between 4 and 8 weeks. Your doctor will advise you on how long to take this medicine.

Adults

• For the treatment of infection with a bacterium called Helicobacter pylori in patients with gastric and/or duodenal ulcer, in combination with two antibiotics (eradication therapy)

One tablet twice daily, together with two antibiotic tablets—either amoxicillin, clarithromycin, and metronidazole (or tinidazole)—each to be taken twice daily along 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 package leaflets of the antibiotics. The duration of treatment is normally one to two weeks.

• For the treatment of gastric and duodenal ulcers

The usual dose is one tablet daily. Your doctor may double the dose.

Your doctor will advise you on how long you should take this medicine. The usual duration of treatment for gastric ulcers is between 4 and 8 weeks. The usual duration of treatment for duodenal ulcers is normally between 2 and 4 weeks.

• For long-term treatment of Zollinger-Ellison syndrome and other conditions associated with increased gastric acid secretion

The recommended initial dose is two tablets daily.

Take both tablets 1 hour before a meal. Afterwards, your doctor may adjust your dose depending on the amount of gastric acid secreted. If more than two tablets daily are prescribed, you should take the tablets in two divided doses per day.

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

Renal impairment

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

Hepatic impairment:

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

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 Pantoprazol Sandoz than you should

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

If you forget to take Pantoprazol Sandoz

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

If you stop taking Pantoprazol Sandoz

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

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

If you experience any of the following adverse effects, stop taking these tablets immediately and contact your doctor or go to the nearest hospital emergency department without delay.

• Severe allergic reactions (rare frequency: may affect up to 1 in 1,000 people): swelling of the tongue and/or throat, difficulty swallowing, rash (urticaria), difficulty breathing, allergic swelling of the face (Quincke's edema/angioedema), severe dizziness with very rapid heartbeat and excessive sweating.

• Severe skin disorders (frequency not known: frequency cannot be estimated from available data): you may notice one or more of the following:

  • blisters on the skin and rapid deterioration in general condition, erosion (including slight bleeding) of eyes, nose, mouth/lips or genitals, or skin sensitivity/rash particularly in areas exposed to light/sun.
  • circular or target-shaped slightly reddish spots on the trunk, often with blisters in the center, peeling, mouth, throat, nose, genital or eye ulcers. These severe rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
  • widespread rash, elevated body temperature and swollen lymph nodes (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, enlarged kidneys with occasional pain when urinating and lower back pain (severe kidney inflammation), which could possibly lead to kidney failure.

Other possible adverse effects are:

• Common (may affect up to 1 in 10 people):

Benign gastric polyps.

• Uncommon (may affect up to 1 in 100 people):

headache; dizziness; diarrhea; feeling of lightheadedness, vomiting; bloating and flatulence; constipation; dry mouth; abdominal pain and discomfort; skin rash, exanthema, eruption; tingling; feeling of weakness, tiredness or general malaise; sleep disturbances, hip, wrist or spinal fractures.

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

disturbance or complete loss of taste sensation, vision disorders such as: blurred vision; urticaria; joint pain; muscle pain; weight changes; increased 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 available data):

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

), sensations of tingling, pricking, numbness, burning or stinging, skin rash, possibly accompanied by joint pain, inflammation of the large intestine causing persistent watery diarrhea.

Adverse 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 associated with high fever.

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

reduction in platelet count which could lead to bleeding or unusual bruising; reduction in white and red blood cell counts which could lead to more frequent infections, together with decreased white and red blood cell counts and platelet count.

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

Reporting of adverse effects:

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

5. Storage of Pantoprazole Sandoz

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

Do not use this medicine after the expiry date stated on the blister pack and on the outer packaging following CAD/EXP. The expiry date refers to the last day of the month indicated.

No special storage conditions are required.

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

Medicines must not be disposed of via wastewater drains or household waste. Unused medicines and their containers should be returned to the SIGRE point at your pharmacy. If you are in doubt, please consult your pharmacist on how to dispose of medicines and containers you no longer require. This will help protect the environment.

6. Contents of the pack and other information

Composition of Pantoprazole Sandoz

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

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

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

Appearance of the product and contents of the pack

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

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 containing 14, 28, 56, 98, 100, 105, 250, 500 tablets

Only certain 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

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 the most recent review of this leaflet: February 2025

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/