Pantoprazole Bluefish 20 mg gastro-resistant tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Pantoprazole Bluefish 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, as 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 you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if these effects are not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

Pantoprazol Bluefish 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 to treat acid-related diseases of the stomach and intestine.

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

• Symptoms (e.g., heartburn, acid regurgitation, pain on swallowing) associated with gastroesophageal reflux disease caused by acid reflux from the stomach.

• Long-term treatment of reflux esophagitis (inflammation of the esophagus accompanied by acid regurgitation from the stomach) and prevention of relapses.

Pantoprazol is used in adults to treat:

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

2. What you need to know before taking Pantoprazol 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 medicines containing other 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 need to take non-steroidal anti-inflammatory drugs (NSAIDs) continuously while taking Pantoprazol Bluefish, as there is an increased risk of developing stomach and intestinal complications. Any increase in risk will be assessed according to personal 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 you 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 if you have been told you are at risk of osteoporosis (for example, if you are taking corticosteroids).
• If you are taking Pantoprazol Bluefish 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 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 have 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 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 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 malignant disease, 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 Pantoprazol Bluefish for a prolonged period (more than one year), your doctor will likely monitor you regularly. You should report any new or unexpected symptoms and/or events to your doctor at each visit.

Children and adolescents

Pantoprazole Bluefish is not recommended for use in children, as it has not been studied in children under 12 years of age.

Other medicines and Pantoprazol Bluefish

Tell 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 work improperly.
• Warfarin and fenprocoumon, 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 into human breast milk.

If you are pregnant, breastfeeding, think you might 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 use of machines

Pantoprazol 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 and visual disturbances.

Pantoprazol 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 Pantoprazol Bluefish

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 1 hour before meals without chewing or breaking them. Swallow them whole with water.

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 per day. This dose generally provides relief within 2–4 weeks, and if not, within a maximum of 4 weeks. Your doctor will advise you on how long you should continue taking the medicine. Afterwards, any recurring symptoms can be managed by taking one tablet per day as needed.

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

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

Adults:

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

The usual dose is one tablet per day.

Patients with liver problems

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

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

Inform your doctor or pharmacist or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested, indicating the medicine and the amount ingested.

Symptoms of overdose are not known.

If you forget to take Pantoprazol Bluefish

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

If you interrupt treatment with Pantoprazole Bluefish

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 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, facial swelling of allergic origin (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—blisters on the skin and a rapid deterioration in general health, erosion (including slight bleeding) in the 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 may possibly lead to kidney failure.

Other adverse effects are:

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

Benign polyps in the stomach

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; fracture of hip, wrist or 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; enlargement of breasts in men, agranulocytosis (severe reduction in the number of white blood cells in the blood, making infections more likely), disturbances of taste.

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

Disorientation.

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

Hallucination, confusion (especially in patients with a history of these symptoms), tingling sensation, pricking, numbness, burning or anaesthetic sensation, 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 fats 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 bruising more than usual; reduction in the number of white blood cells, which could lead to more frequent infections; abnormal decrease in the balance between red blood cells, white blood cells, and platelets.

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

decrease in blood levels of sodium, magnesium, calcium or potassium (see section 2).

Reporting of adverse effects

If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may 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 packaging 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 containers at the SIGRE Point at your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This way, you will help protect the environment.

6. Contents of the pack and other information

Composition of Pantoprazol Bluefish

• The active substance is pantoprazole. Each gastro-resistant tablet contains 20 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 carboxymethyl starch (Type A) (from potato), methacrylic acid-ethyl acrylate copolymer (1:1), and yellow iron oxide (E172).

Appearance of the product and contents of the pack

Pantoprazole Bluefish 20 mg gastro-resistant tablets are yellow, oval, biconvex, smooth tablets. The tablet dimensions are as follows:

• Width: 5.85 mm ± 0.29 mm (5.56 mm - 6.14 mm)
• Length: 8.35 mm ± 0.42 mm (7.93 mm - 8.77 mm)

Pack sizes:

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

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer Responsible

Marketing Authorization Holder

Bluefish Pharmaceuticals AB

P.O. Box 49013;

100 28 Stockholm;

Sweden

Manufacturer Responsible

Bluefish Pharmaceuticals AB

Gävlegatan 22,

113 30 Stockholm,

Sweden

Teva Pharma, S.L.U.,

C/ C, nº 4, Polígono Industrial Malpica

50016 Zaragoza,

Spain

For further information regarding this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Bluefish Pharma S.L.U.,

P.O. Box 36007, 28320 Madrid,

Office 36

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

Date of last review of this leaflet: December 2022

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