Pantoprazole Bluefish 40 mg gastro-resistant tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Pantoprazole Bluefish 40 mg gastro-resistant tablets EFG

Read the entire leaflet carefully before starting to take this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult 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, since 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.

Package leaflet:

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

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

Pantoprazol contains the active substance pantoprazol. Pantoprazol 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.

Pantoprazol is used in adults and adolescents from 12 years of age to treat:

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

Pantoprazol 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 ulcers recurring.
• 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 starting to take Pantoprazole Bluefish

Do not take Pantoprazole Bluefish

• 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 other medicines containing proton pump inhibitors.

Warnings and precautions

Consult your doctor or pharmacist or nurse before starting to take Pantoprazol Bluefish:

• 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 Pantoprazol Bluefish. 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 pantoprazol. Like all medicines that reduce acid levels, pantoprazol may reduce the absorption of vitamin B12.
• If you are taking HIV protease inhibitors such as atazanavir (for treatment of HIV infection) at the same time as pantoprazol.
• Taking a proton pump inhibitor such as pantoprazol, 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 if you have been told you are at risk of osteoporosis (for example, if you are taking corticosteroids).
• If you have been taking Pantoprazol Bluefish for more than three months, your blood magnesium levels may decrease. Low magnesium levels can cause fatigue, involuntary muscle contractions, confusion, seizures, dizziness, and 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 Pantoprazol Bluefish used to reduce 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 Pantoprazol Bluefish. Remember to mention any other symptoms you may notice, such as joint pain.
• If you are scheduled to undergo a specific blood test (chromogranin A).

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:

• unintentional weight loss
• vomiting, particularly if repeated
• blood in vomit: it may appear as dark coffee-ground material in your vomit
• if you notice blood in your stools, which may appear black or dark in color
• difficulty swallowing or pain when swallowing
• pale appearance and feeling weak (anemia)
• chest pain
• stomach pain
• severe or persistent diarrhea, as Pantoprazol Bluefish has been associated with a small increased risk of infectious diarrhea.

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

If you take Pantoprazol Bluefish 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 Pantoprazol Bluefish is not recommended in children, as it has not been studied in children under 12 years of age.

Other medicines and Pantoprazol Bluefish

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

Pantoprazol Bluefish 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 Pantoprazol Bluefish may cause these and other medicines to not work properly.
• 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 Pantoprazol Bluefish, as pantoprazole may increase methotrexate blood levels.
• 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 lactation

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, breastfeeding, 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 is greater than the potential risk to the fetus or infant.

Driving and use of machines

Pantoprazole Bluefish has no influence or this influence is negligible on the ability to drive or use machines.

Do not drive or operate machinery if you experience adverse effects such as dizziness or visual disturbances.

Pantoprazole Bluefish contains Sodium

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

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

Administration method:

Take the tablets 1 hour before meals, without chewing or breaking them, swallowing them whole with water.

The recommended dose is:

Adults and adolescents from 12 years of age:

For the 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):

One tablet twice daily, plus 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 treatment duration is normally 1 to 2 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 to 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 associated with increased gastric acid secretion:

The recommended initial dose is two tablets daily. Take both tablets 1 hour before a meal. Subsequently, your doctor may adjust your dose depending on the amount of gastric acid secreted. If you are prescribed more than two tablets daily, you should take the tablets divided into two doses per day. If you are prescribed 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 Bluefish 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 Pantoprazol Bluefish 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 Bluefish than you should

If you or someone you know accidentally takes more than the recommended dose (overdose), you should contact a doctor immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, stating the medication and the amount ingested.

Inform your doctor or pharmacist. There are no known symptoms of overdose.

If you forget to take Pantoprazol Bluefish

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

If you stop treatment with Pantoprazole Bluefish

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

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 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.

• 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: cannot be estimated from available data): you may notice one or more of the following – skin blisters and rapid deterioration in general health, erosion (including slight bleeding) in eyes, nose, mouth/lips or genitals, or skin sensitivity/rash, particularly in areas of skin 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. (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: 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 with occasional pain when urinating and lower back pain (severe kidney inflammation), which could 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; pain and discomfort in the abdomen; skin rash, exanthema, eruption; itching; feeling of weakness, tiredness 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, vision disorders such as blurred vision; urticaria; joint pain; muscle pain; weight changes; increased body temperature; high fever; swelling in the limbs (peripheral oedema); allergic reactions; depression; breast enlargement in men, agranulocytosis (severe reduction in the number of white blood cells in the blood, making infections more likely), disturbances in taste.

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

Disorientation.

Not known (frequency cannot be estimated from available data):

Hallucinations, confusion (especially in patients with a history of these symptoms), tingling sensation, pricking, numbness, burning or pins and needles, 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 lipid levels, sudden drop in circulating granular white blood cells, associated with high fever.

Very rare (may affect up to 1 in 10,000 people): reduced platelet count, which could lead to bleeding or increased bruising; reduced white blood cell count, which could lead to more frequent infections; abnormal reduction in the balance between 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 blood (see section 2).

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor or pharmacist, 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: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Pantoprazole Bluefish

Keep out of sight and reach of children.

Store below 30 °C.

Do not use this medicine after the expiry date stated on the container after "EXP.:". The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the container and additional information

Composition of Pantoprazole Bluefish

• The active substance is pantoprazole. Each gastro-resistant tablet contains 40 mg of pantoprazole (as sodium pantoprazole sesquihydrate).
• The other components are: anhydrous disodium phosphate, mannitol, microcrystalline cellulose, sodium croscarmellose, magnesium stearate, hypromellose, triethyl citrate, sodium carboxymethylstarch (Type A) (from potato), methacrylic acid-ethyl acrylate copolymer (1:1), and yellow iron oxide (E172).

Appearance of the Product and Contents of the Package

Pantoprazole Bluefish 40 mg gastro-resistant tablets are yellow, oval, biconvex, and smooth. The tablet dimensions are as follows:

• Width: 6.35 mm ± 0.32 mm (6.03 mm - 6.67 mm)
• Length: 12.00 mm ± 0.60 mm (11.40 mm - 12.60 mm)

Pack sizes:

Blister packs containing: 7, 14, 28, 56, and 100 gastro-resistant tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturing Responsible Party

Marketing Authorization Holder

Bluefish Pharmaceuticals AB

P.O. Box 49013;

100 28 Stockholm;

Sweden

Responsible for Manufacturing

Bluefish Pharmaceuticals AB

Gävlegatan 22,

113 30 Stockholm,

Sweden

Teva Pharma, S.L.U.,

C/ C, nº 4, Poligono Industrial Malpica

50016 Zaragoza,

Spain

Further information on this medicinal product is available from the local representative of the Marketing Authorization Holder:

Bluefish Pharma S.L.U.,

P.O. Box 36007, 2832094 Madrid,

Branch 36

This medicine is authorized in the European Economic Area member states under the following names:

Date of the most recent review of this leaflet: December 2022

Detailed 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/