Pantoprazole Bluefish

PATIENT INFORMATION LEAFLET: USER INFORMATION

Pantoprazole Bluefish, 20 mg, gastro-resistant tablets

Pantoprazole

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

• 1. What is Pantoprazole Bluefish and what is it used for
• 2. Important information 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 is Pantoprazole Bluefish and what is it used for

Pantoprazole Bluefish contains the active substance pantoprazole. Pantoprazole Bluefish is a selective proton pump inhibitor, a medicine that reduces the amount of acid produced in the stomach. It is used to treat stomach and gut conditions related to acid production.

Pantoprazole Bluefish is used in adults and adolescents aged 12 years and above for:

• Treating symptoms (such as heartburn, acid reflux, pain when swallowing) associated with gastro-oesophageal reflux disease, caused by acid reflux from the stomach.
• Long-term treatment of reflux oesophagitis (inflammation of the oesophagus, accompanied by acid reflux) and prevention of its recurrence.

Pantoprazole Bluefish is used in adults for:

• Preventing duodenal and (or) gastric ulcers caused by non-steroidal anti-inflammatory drugs (NSAIDs, e.g. ibuprofen) in patients at risk who need to continuously take NSAIDs.

2. Important information before taking Pantoprazole Bluefish

When not to take Pantoprazole Bluefish

• If you are allergic to pantoprazole or 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

Before taking Pantoprazole Bluefish, discuss it with your doctor, pharmacist, or nurse.

• If you have severe liver problems. Inform your doctor if you have ever had liver problems. Your doctor may decide to monitor your liver enzymes more frequently, especially when taking long-term treatment with Pantoprazole Bluefish. If your liver enzymes increase, treatment with Pantoprazole Bluefish should be stopped.

Treatment with Pantoprazole Bluefish should be stopped if liver enzymes increase.

• If you need to take NSAIDs continuously and also take Pantoprazole Bluefish, due to the increased risk of stomach or gut complications. The increased risk will be assessed according to your individual risk factors, such as age (65 years or older), stomach or duodenal ulcers in your medical history, or stomach or gut bleeding.
• If you have a vitamin B12 deficiency or risk factors for a vitamin B12 deficiency, and you are taking long-term pantoprazole treatment. Like all medicines that reduce stomach acid, pantoprazole may lead to reduced vitamin B12 absorption.
• If you are taking HIV protease inhibitors, such as atazanavir (used to treat HIV infection), you should consult your doctor for specific advice.
• Taking a proton pump inhibitor like pantoprazole, especially for a period of more than 1 year, may slightly increase the risk of hip, wrist, or spine fractures. You should tell your doctor if you have osteoporosis or if you are taking corticosteroids (which can increase the risk of osteoporosis).
• If you take Pantoprazole Bluefish for a period longer than three months, you may experience a decrease in blood magnesium levels, which can cause fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, and rapid heartbeat. If you experience any of these symptoms, inform your doctor. Low blood magnesium levels can also cause low blood potassium and calcium levels. Your doctor may decide to periodically check your blood magnesium levels.
• If you have ever had a skin reaction after taking a medicine that reduces stomach acid, like Pantoprazole Bluefish.
• If you experience a skin rash, especially in areas exposed to sunlight, you should inform your doctor as soon as possible, as it may be necessary to stop taking Pantoprazole Bluefish. You should also inform your doctor about any other side effects, such as joint pain.
• If you are scheduled for a specific blood test (chromogranin A levels).

You should immediately inform your doctor if you experience any of the following symptoms, which may be signs of a more serious condition:

• Unintentional weight loss;
• Vomiting, especially if it is recurring;
• Bloody vomiting, which may look like coffee grounds;
• Blood in the stool, black or tarry stools;
• Difficulty swallowing or pain when swallowing;
• Pale skin and weakness (anaemia);
• Chest pain;
• Abdominal pain;
• Severe and/or persistent diarrhoea, as taking this medicine is associated with a small increased risk of infectious diarrhoea.

Your doctor may decide to perform tests to rule out an underlying malignant condition, as pantoprazole treatment may alleviate the symptoms of the malignant condition and delay its diagnosis. If symptoms persist despite treatment, further tests should be considered.

If you are taking Pantoprazole Bluefish for a long period (more than 1 year), you will likely be under regular supervision by your doctor. In this case, you should report any new and unexpected symptoms and their circumstances during each visit to your doctor.

Children and adolescents

Pantoprazole Bluefish is not recommended for use in children, as its efficacy has not been demonstrated in children under 12 years of age.

Pantoprazole Bluefish and other medicines

Tell your doctor or pharmacist about all the medicines you are taking, have recently taken, or might take, including those obtained without a prescription.

• Medicines such as ketoconazole, itraconazole, and posaconazole (used to treat fungal infections) or erlotinib (used to treat certain types of cancer), as Pantoprazole Bluefish may interfere with their proper functioning.
• Warfarin and phenprocoumon, which affect blood clotting and prevent thrombosis. Further tests may be necessary.
• 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 stop Pantoprazole Bluefish, as pantoprazole may increase methotrexate levels in the blood.
• Fluvoxamine (used to treat depression and other mental disorders) - if you are taking fluvoxamine, your doctor may reduce the dose.
• Rifampicin (used to treat infections).
• St. John's Wort (Hypericum perforatum) (used to treat mild depression).

Pregnancy, breastfeeding, and fertility

There are no sufficient data on the use of pantoprazole in pregnant women. The active substance of the medicine has been detected in breast milk.

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

The medicine should only be used if your doctor considers that the benefit to the mother outweighs the potential risk to the unborn child or baby.

Driving and using machines

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

Do not drive or operate machinery if you experience side effects such as dizziness or blurred vision.

Pantoprazole Bluefish contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per 20 mg tablet, which is essentially sodium-free.

3. How to take Pantoprazole Bluefish

Take this medicine always as directed by your doctor or pharmacist. If you are not sure, ask your doctor or pharmacist.

Method of administration:

Take the medicine 1 hour before a meal, without chewing or breaking the tablet. Swallow the tablet whole with water.

Recommended dose:

Adults and adolescents aged 12 years and above

• For treating symptoms (such as heartburn, acid reflux, pain when swallowing) associated with gastro-oesophageal reflux disease, the usual dose is one tablet per day. This dose usually provides relief after
• 2 - 4 weeks of treatment - at the latest within the next 4 weeks. Your doctor will decide how long you should take the medicine. Recurring symptoms can be controlled by taking one tablet per day, when necessary.
• -For long-term treatment and prevention of recurrence of reflux oesophagitis, the usual dose is one tablet per day. If symptoms of the disease return, your doctor may recommend doubling the dose. In this case, one tablet per day of Pantoprazole Bluefish 40 mg can be taken. After symptoms have subsided, the dose can be reduced to one tablet (20 mg) per day.

Adults:

• -For preventing duodenal and (or) gastric ulcers in patients who need to continuously take NSAIDs, the usual dose is one tablet per day.

Patients with liver problems

In case of severe liver disease, do not take more than one 20 mg tablet per day.

Use in children and adolescents

These tablets are not recommended for use in children under 12 years of age.

Taking a higher dose of Pantoprazole Bluefish than recommended

Consult your doctor or pharmacist. Symptoms of overdose are not known.

Missing a dose of Pantoprazole Bluefish

Do not take a double dose to make up for a forgotten dose. Take the next planned dose at the usual time.

Stopping treatment with Pantoprazole Bluefish

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

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you experience any of the following side effects, stop taking the tablets and inform your doctor or contact the emergency department of your nearest hospital immediately.

• Severe allergic reactions (rare: may affect up to 1 in 1000 people):swelling of the tongue and/or throat, difficulty swallowing, hives (nettle rash), difficulty breathing, allergic swelling of the face (Quincke's oedema/anaphylactic shock), severe dizziness with rapid heartbeat and excessive sweating.
• Severe skin reactions (frequency not known: cannot be estimated from the available data):blistering of the skin and rapid worsening of the general condition, erosive lesions of the eyes, nose, mouth/ lips, or genitals (Stevens-Johnson syndrome, Lyell syndrome, polymorphic erythema) and increased sensitivity to light.
• Other severe reactions (frequency not known):yellowing of the skin and eyes (severe liver damage, jaundice) or fever, rash, and kidney problems, which may lead to kidney failure.

Other side effects include:

Common(may affect up to 1 in 10 people)

Mild stomach polyps.

Uncommon(may affect up to 1 in 100 people)

Headache, dizziness, diarrhoea, nausea, vomiting, feeling of fullness in the stomach and bloating with gas (flatulence), constipation, dry mouth, stomach pain and discomfort, skin rash, redness, skin eruptions, itching, weakness, fatigue, or general feeling of being unwell, sleep disturbances, fractures of the hip, wrist, or spine.

Rare(may affect up to 1 in 1000 people)

Disturbances or complete loss of taste, visual disturbances such as blurred vision; hives, joint pain, muscle pain, changes in body weight, increased body temperature, high fever, swelling of the limbs (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 the available data)

Hallucinations, confusion (especially in patients who have experienced these symptoms before); decreased sodium levels in the blood, decreased magnesium levels in the blood (see section 2), feeling of tingling, prickling, itching, burning, or numbness, skin rash that may be accompanied by joint pain, inflammation of the colon, which can cause persistent, watery diarrhoea.

Side effects detected by blood tests:

Uncommon(may affect up to 1 in 100 people)

Increased liver enzymes.

Rare(may affect up to 1 in 1000 people)

Increased bilirubin levels, increased fat levels in the blood, sudden decrease in the number of circulating granulocytes - white blood cells, associated with high fever.

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

Decreased platelet count, which may cause more frequent bleeding and bruising, decreased white blood cell count, which may lead to more frequent infections, concurrent, abnormal decrease in the number of red and white blood cells, as well as platelets.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: + 48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl

Side effects can also be reported to the marketing authorisation holder.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Pantoprazole Bluefish

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

Store in a temperature below 30°C.

Do not use this medicine after the expiry date stated on the carton after "Expiry date". The expiry date refers to the last day of the month stated.

Do not use this medicine if you notice visible signs of deterioration.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Pantoprazole Bluefish contains

• The active substance is pantoprazole. Each gastro-resistant tablet contains 20 mg of pantoprazole (as sodium pentahydrate).
• The other ingredients are: anhydrous disodium phosphate, mannitol, microcrystalline cellulose, sodium croscarmellose, magnesium stearate, hypromellose, triethyl citrate, sodium carboxymethylcellulose (type A), methacrylic acid-ethyl acrylate copolymer (1:1), yellow iron oxide (E172).

What Pantoprazole Bluefish looks like and contents of the pack

Pantoprazole Bluefish is available as oval, convex, smooth yellow tablets.

The dimensions of the tablet are:

• 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:

Blisters in cardboard boxes containing 14, 28, 56, and 100 gastro-resistant tablets.

Not all pack sizes may be marketed.

Marketing authorisation holder

Bluefish Pharmaceuticals AB, P.O. Box 49013, 100 28 Stockholm, Sweden

Manufacturer

Bluefish Pharmaceuticals AB, Gävlegatan 22, 113 30 Stockholm, Sweden

Teva Pharma, S.L.U., C / C, nr 4, Poligono Industrial Malpica, 50016 Zaragoza, Spain

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

Date of last revision of the leaflet:13.08.2020