Pantoprazole Stada 40 mg gastro-resistant tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Pantoprazole Stada 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 side effects, talk to 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 Stada is and what it is used for
2. What you need to know before taking Pantoprazole Stada
3. How to take Pantoprazole Stada
4. Possible side effects
5. How to store Pantoprazole Stada
6. Contents of the pack and other information

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

Pantoprazol Stada is a medicine that reduces stomach acid secretion (a selective proton pump inhibitor).

Pantoprazol 40 mg is used

• in combination with antibiotics for the treatment of duodenal ulcer and gastric ulcer. This treatment involves the eradication of Helicobacter pylori, the causative microorganism (pathogen) responsible for stomach and intestinal ulcers.
• for the treatment of duodenal ulcer
• for the treatment of gastric ulcer
• for the treatment of moderate to severe reflux esophagitis (inflammation of the esophagus)
• for long-term treatment of conditions characterized by a marked increase in gastric acid secretion (such as Zollinger-Ellison syndrome).

2. What you need to know before taking Pantoprazole Stada

DO NOT take pantoprazole

• If you are allergic to pantoprazole, peanuts or soy, 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 starting to take pantoprazole. Especially:

• 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 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 long-term treatment with pantoprazole. Like all medicines that reduce acid levels, pantoprazole may reduce the absorption of vitamin B12.
• 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 corticosteroids).
• If you are taking pantoprazole for more than three months, magnesium levels in your blood may decrease. Low magnesium levels can cause fatigue, involuntary muscle contractions, confusion, seizures, dizziness, increased heart rate. If you experience any of these symptoms, seek medical attention 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 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.
• You are scheduled to have a specific blood test (chromogranin A).

Contact 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: may appear as dark coffee-ground-like material in your vomit
• notice blood in your stools, which may appear black or tarry (melena)
• 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.

Your doctor will decide whether you need additional tests 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 and/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 Pantoprazole Stada

Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines.

Pantoprazole may affect the effectiveness of other medicines. 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 work less effectively.
• 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)

Pregnancy and breastfeeding

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.

There are insufficient data on the use of Pantoprazole in pregnant women.

It has been reported that pantoprazole is excreted in human breast milk.

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 a negligible effect 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.

Pantoprazole Stada contains maltitol

This medicine contains maltitol (E-965). If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medicine.

Pantoprazole Stada contains soy lecithin

If you are allergic to peanuts or soy, do not use this medicine.

Pantoprazole Stada contains sodium

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

3. How to take Pantoprazol Stada

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 1 hour before meals without chewing or breaking them, and swallow them whole with a little water.

The recommended dose is:

Adults and adolescents aged 12 years and older

• Treatment of reflux esophagitis

The usual dose is one tablet daily. Your doctor may instruct you to increase the dose to 2 tablets daily. The treatment duration 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)

The following combinations are recommended:

Morning	Night
1 tablet of pantoprazole 40 mg	1 tablet of pantoprazole 40 mg
1,000 mg of amoxicillin	1,000 mg of amoxicillin
500 mg of clarithromycin	500 mg of clarithromycin

o

Morning	Night
1 tablet of pantoprazole 40 mg	1 tablet of pantoprazole 40 mg
400 – 500 mg of metronidazole	400 – 500 mg of metronidazole
250 – 500 mg of clarithromycin	250 – 500 mg of clarithromycin

o

Morning	Night
1 tablet of pantoprazole 40 mg	1 tablet of pantoprazole 40 mg
1,000 mg of amoxicillin	1,000 mg of amoxicillin
400 – 500 mg of metronidazole	400 – 500 mg of metronidazole

Take the first pantoprazole tablet 1 hour before breakfast and the second pantoprazole tablet 1 hour before dinner. Follow your doctor's instructions and make sure to read the package leaflet for these 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 indicate how long you should take this medicine. The treatment duration for gastric 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 with increased gastric acid secretion

The recommended starting dose is normally two tablets daily. Take both tablets 1 hour before a meal. Afterwards, your doctor may adjust your dose depending on your level of gastric acid secretion. If you are prescribed more than two tablets daily, you should take the tablets divided into two doses per day.

If your doctor prescribes more than four tablets daily, you will be informed exactly when to stop treatment.

Patients with kidney problems

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

Patients with liver problems

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 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 Pantoprazol Stada than you should

Contact your doctor, pharmacist, or call the Toxicology Information Service immediately at 91 562 04 20, indicating the medication and the amount taken. It is recommended to bring the medication packaging and package leaflet to the healthcare professional.

There are no known symptoms of overdose.

If you forget to take Pantoprazol Stada

Do not take a double dose to make up for forgotten doses.

Take your next dose as usual.

If you stop treatment with Pantoprazol Stada

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 right away, or contact the emergency department of your nearest hospital:

• 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 of skin exposed to light/sunlight. 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. (Stevens-Johnson syndrome, Lyell's syndrome, Erythema multiforme, Subacute cutaneous lupus erythematosus, Drug reaction with eosinophilia and systemic symptoms (DRESS), Photosensitivity).

• Other serious conditions (frequency not known: frequency cannot be estimated from available data): yellowing of the skin and whites of the eyes (severe liver cell damage, jaundice), or fever, rash, enlarged kidneys sometimes with pain on urination and lower back pain (severe kidney inflammation), which may possibly lead to kidney failure.

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

• 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; high fever; swelling of the extremities (peripheral oedema); 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)

Hallucination, confusion (especially in patients with a history of these symptoms), sensation of tingling, pricking, numbness, burning or anaesthesia, 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 levels of fat in the blood; sudden drop in granular white blood cells in circulation, associated with high fever.

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

Reduction in the number of platelets, which could lead to bleeding or more bruising than usual; reduction in the number of white blood cells, which could lead to more frequent infections; abnormal decrease in the balance between the number of red blood cells, white blood cells, and platelets.

• Frequency not known (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 an adverse effect not listed in this leaflet. You can also report them directly via the national reporting system included in the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Pantoprazol Stada

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 carton after EXP. The expiry date refers to the last day of the month indicated.

For tablets packed in plastic bottles: Use Pantoprazol Stada within three months after first opening the bottle.

Do not store above 25 °C.

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE Point in your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Pantoprazol Stada:

The active substance is pantoprazole. Each gastro-resistant tablet contains 40 mg of pantoprazole (present as 45.150 mg of sodium pantoprazole sesquihydrate).

The other components are:

Core

Maltitol (E 965), crospovidone type B, sodium carmellose, sodium carbonate (E 500), calcium stearate.

Coating

Poly(vinyl alcohol), talc (E 553b), titanium dioxide (E 171), macrogol 3350, soybean lecithin, yellow iron oxide (E 172), sodium carbonate (E 500), methacrylic acid-ethyl acrylate copolymer (1:1), triethyl citrate (E 1505).

Appearance of the product and contents of the pack

Yellow, oval-shaped gastro-resistant tablets.

Available in:

Pantoprazol Stada 40 mg is available in blisters of 2 (starter pack), 7, 10, 14, 15, 20, 28, 30, 30x1, 50, 56, 60, 90, 98, 100, 120, 126, 140, 140 (10x14) (5x28), 154, 196, 280 (20x14) (10x28), 500, 700 (5x140) tablets, and in bottles of 2 (starter pack), 7, 10, 14, 15, 20, 28, 30, 30x1, 50, 56, 60, 90, 98, 100, 120, 126, 140, 140 (10x14) (5x28), 154, 196, 280 (20x14) (10x28), 500, 700 (5x140) tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer

STADA Arzneimittel AG

Stadastr. 2-18,

D-61118 Bad Vilbel,

Germany

or

Centrafarm Services B.V.

Van de Reijstraat 31-E

4814 NE Breda

Netherlands

or

Eurogenerics N.V.

Heizel Esplanade B 22, 1020 Brussels

Belgium

or

Sanico NV

Veedijk 59

B-2300 Turnhout

Belgium

or

Lamp S. Prospero S.P.A

Via della Pace, 25/A

41030 San Prospero (MO)

Italy

or

Sofarimex

Industria Quimica e Farmaceutica, SA

Av. das Industrias

Alto de Colaride, Agualva

2735-213 Cacem

Portugal

or

STADA Arzneimittel GmbH

Muthgasse 36/2

1190 Wien

Austria

or

STADA M&D SRL

Str. Trascaului nr. 10,

Municipiul Turda,

Judet Cluj 401135,

Romania

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

DE (RMS): Pantoprazol STADA 40 mg magensaftresistente Tabletten

AT: Pantoprazol Stada 40 mg - magensaftresistente Tabletten

BE: Pantoprazole EG 40 mg maagsapresistente tabletten

DK: Pantoprazol STADA

ES: Pantoprazol Stada 40 mg comprimidos gastrorresistentes EFG

IT: Pantoprazolo EG 40 mg compressa gastroresistenti

LU: Pantoprazole EG 40 mg comprimé gastro-résistants

NL: Pantoprazole CF 40 mg

PL: Gastrostad 40 mg

PT: Pantoprazol Ciclum 40 mg comprimido gastroresistente

Date of the most recent review of this leaflet: April 2023

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