Pantoprazole Sandoz 20 mg gastro-resistant tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Pantoprazole Sandoz 20 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 side effects, consult your doctor, pharmacist, or nurse, even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet:

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. How to store Pantoprazole Sandoz
6. 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 for the treatment of acid-related diseases of the stomach and intestine.

Pantoprazole is used to treat adults and adolescents aged 12 years and older:

• Symptoms associated with gastroesophageal reflux disease (heartburn, acid regurgitation, pain when swallowing) caused by reflux of acid from the stomach.
• Long-term treatment and prevention of relapses of reflux esophagitis (inflammation of the esophagus accompanied by acid regurgitation from the stomach).

Pantoprazole is used in adults for:

• Prevention of gastroduodenal ulcers induced by non-steroidal anti-inflammatory drugs (NSAIDs, e.g., ibuprofen) in patients at risk who require ongoing NSAID treatment.

2. What you need to know before starting to take 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

Talk to your doctor, pharmacist, or nurse before taking 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 need to take NSAIDs (non-steroidal anti-inflammatory drugs) continuously while taking pantoprazole, as there is an increased risk of developing stomach and intestinal complications. Any increase in risk will be assessed based on individual risk factors such as age (65 years or older), history of stomach or duodenal ulcer, or gastrointestinal bleeding,
• 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 experience any of the following symptoms, which could 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 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, confusion, seizures, dizziness, or 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 your 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: it may appear as dark coffee-ground-like specks in your vomit,
• blood in your stools, which may appear black or dark,
• difficulty swallowing or pain when swallowing,
• pale appearance and feeling weak (anemia),
• chest pain,
• stomach pain,
• severe or persistent diarrhea, as this medicine has been associated with a small increased risk of infectious diarrhea,
• 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 additional tests are needed to rule out malignancy, as pantoprazole may relieve cancer symptoms 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 reduce the effectiveness of these and other medicines,
• 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 pantoprazole treatment, as pantoprazole may increase methotrexate levels in the blood,
• fluvoxamine (used to treat depression and other psychiatric conditions). 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, breastfeeding, 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 breastfeeding, think you may be pregnant, or plan 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 baby.

Driving and using machines

Pantoprazole has no effect or a negligible effect 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 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”.

3. How to take Pantoprazol Sandoz

Follow exactly the instructions for use of this medicine as 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 symptoms associated with gastroesophageal reflux disease (heartburn, acid regurgitation, painful swallowing)

The usual dose is one tablet daily.

This dose generally provides relief within 2 to 4 weeks, and if not, at most within the following 4 weeks. Your doctor will advise you on how long you should continue taking the medicine. Afterwards, any recurring symptoms can be managed as needed by taking one tablet daily.

• For long-term treatment and prevention of relapse of reflux esophagitis

The usual dose is one tablet daily. If the disease recurs, your doctor may double your dose, in which case you may take pantoprazole 40 mg once daily. After healing, the dose may be reduced again to one 20 mg tablet daily.

Adults

• For prevention of duodenal and gastric ulcers in patients requiring ongoing treatment with NSAIDs

The usual dose is one tablet daily.

Hepatic impairment

If you have severe liver problems, you must not take more than one 20 mg tablet daily.

Use in children and adolescents

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, pharmacist, or call the Toxicology Information Service immediately at telephone number: 91 562 04 20, stating the medicine and amount taken.

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 can cause adverse effects, although not everyone will experience them.

If you experience any of the following adverse effects, stop taking these tablets immediately and contact your doctor or the emergency department of your nearest hospital 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 oedema/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. You may also experience joint pain or flu-like symptoms, fever, swollen glands (e.g., in the armpit), and blood tests may show changes in certain white blood cells or liver enzymes.
  • circular or target-shaped slightly reddish spots on the trunk, often with blisters in the centre, skin peeling, ulcers in mouth, throat, nose, genitals and eyes. 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 syndrome).

• 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 may possibly lead to kidney failure.

Other possible adverse effects include:

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

Benign gastric polyps.

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

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

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

disturbance or complete loss of taste sensation, visual disturbances such as: blurred vision; urticaria; joint pain; muscle pain; weight changes; increased body temperature; fever, swelling in the limbs (peripheral oedema); allergic reactions; depression; enlargement of the breasts in men.

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

Disorientation.

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

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

sensation of tingling, pricking, numbness, burning or stinging, skin rash, possibly with joint pain, inflammation of the large intestine causing persistent watery diarrhoea.

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 may cause bleeding or more bruising than usual; reduction in white and red blood cell counts which may lead to more frequent infections, together with decreased counts of white and red blood cells and platelets in the blood.

• 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 type of 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 which is stated on the blister pack and on the container after 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 or household waste. Dispose of unused medicines and their containers at the SIGRE point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Pantoprazol Sandoz

• The active substance is pantoprazole. Each gastro-resistant tablet contains 20 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, 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 of the product and contents of the pack

Pantoprazol Sandoz 20 mg are yellow, oval-shaped gastro-resistant tablets (coated with a special layer), approx. 8.9 x 4.6 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 of 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 Polska 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

Date of the most recent review of this leaflet: February 2025

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