Pantoprazole bluefish

Pantoprazole Bluefish, 40 mg, enteric-coated tablets
Pantoprazolum
Please read the entire leaflet carefully before taking the medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm others, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents:

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 production of acid in the stomach. It is used in the treatment of stomach and intestinal disorders related to hydrochloric acid secretion.

Pantoprazole Bluefish is used in adults and adolescents aged 12 years and older for the treatment of:

• Gastroesophageal reflux disease (GERD). This is inflammation of the oesophagus (the tube connecting the throat to the stomach), accompanied by the backflow of hydrochloric acid from the stomach.

Pantoprazole Bluefish is used in adults for:

• Helicobacter pylori infection in patients with gastric and/or duodenal ulcer, in combination with two antibiotics (eradication therapy), to eliminate the bacteria and prevent ulcer recurrence.
• Gastric and/or duodenal ulcer disease.
• Zollinger-Ellison syndrome and other conditions associated with excessive hydrochloric acid secretion in the stomach.

2. Important information before using Pantoprazole Bluefish

When not to use Pantoprazole Bluefish

• if the patient is allergic to pantoprazole or any of the other ingredients of this medicine (listed in section 6);
• if the patient is allergic to medicines containing other proton pump inhibitors.

Warnings and precautions
Before starting to take Pantoprazole Bluefish, discuss this with your doctor,
pharmacist, or nurse.

• If the patient has severe liver function disorders. Inform the doctor if there has ever been any liver dysfunction. The doctor may recommend more frequent
  monitoring of liver enzyme activity, especially if long-term treatment with Pantoprazole Bluefish is required. If increased liver enzyme activity occurs, treatment should be discontinued.

• If the patient has vitamin B deficiency or risk factors indicating potential reduction in vitamin B levels, and is receiving long-term pantoprazole therapy. As with all medicines that reduce (inhibit) gastric acid secretion, pantoprazole may lead to reduced absorption of vitamin B__.

• If the patient is taking HIV protease inhibitors such as atazanavir (used in the treatment of HIV infection) concomitantly with pantoprazole, the patient should seek detailed advice from the doctor.

• Use of a proton pump inhibitor such as pantoprazole, especially for periods longer than 1 year, may slightly increase the risk of fractures of the hip, wrist, or spine. Inform the doctor if the patient has osteoporosis or is taking corticosteroids (which may increase the risk of osteoporosis).

• If the patient takes Pantoprazole Bluefish for longer than three months, magnesium levels in the blood may decrease, which could subsequently cause fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, and rapid heartbeat. If any of these symptoms occur, inform the doctor immediately. Low magnesium levels may also lead to reduced potassium and calcium levels in the blood. The doctor may decide that periodic blood magnesium monitoring is necessary.

• If the patient has ever had a skin reaction due to taking a medicine similar to Pantoprazole Bluefish that reduces gastric acid secretion.

• If the patient develops a skin rash, especially in areas exposed to sunlight, inform the doctor as soon as possible, as discontinuation of Pantoprazole Bluefish may be necessary. Also report any other adverse reactions, such as joint pain.

• If the patient is scheduled for a specific blood test (chromogranin A levels).

Inform the doctor immediately if any of the following symptoms occur before or during treatment, as they may indicate another, more serious condition:

• Unintentional weight loss;
• Vomiting, particularly if recurrent;
• Vomiting blood, which may look like dark coffee grounds;
• Blood in stool, black or tarry stools;
• Difficulty swallowing or pain during swallowing;
• Pallor and weakness (anaemia);
• Chest pain;
• Abdominal pain;
• Severe and/or persistent diarrhoea, as use of this medicine is associated with a small increased risk of infectious diarrhoea.

The doctor may decide to perform tests to rule out an underlying tumour, as treatment with pantoprazole may alleviate symptoms of tumour disease and delay diagnosis. If symptoms persist despite treatment, further investigations should be considered.
If Pantoprazole Bluefish is taken for a prolonged period (over 1 year), the patient will likely remain under continuous medical supervision. In such cases, any new or unexpected symptoms and the circumstances of their occurrence should be reported at every doctor's visit.

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

Pantoprazole Bluefish and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take, including those available without prescription.

Since Pantoprazole Bluefish may affect the effectiveness of other medicines, inform the doctor if the patient is taking:

• Medicines such as ketoconazole, itraconazole, and posaconazole (used to treat fungal infections) or erlotinib (used in certain types of cancer), because Pantoprazole Bluefish may inhibit the proper action of these and other drugs.
• Warfarin and phenprocoumon, which affect blood clotting and prevent thrombosis. Additional tests may be required.
• Medicines used in the treatment of HIV infection, such as atazanavir.
• Methotrexate (used in the treatment of rheumatoid arthritis, psoriasis, and cancer conditions) – when methotrexate is used, the doctor may temporarily discontinue Pantoprazole Bluefish, as pantoprazole may increase methotrexate blood levels.
• Fluvoxamine (used in the treatment of depression and other psychiatric disorders) – if the patient is taking fluvoxamine, the doctor may recommend reducing the dose.
• Rifampicin (used to treat infections).
• St John’s wort (Hypericum perforatum) (used in the treatment of mild depression).

Pregnancy, breastfeeding, and fertility
There are insufficient data on the use of pantoprazole in pregnant women. It has been shown that the active substance passes into human breast milk.
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
The medicine may be used only if the doctor considers the benefit to outweigh the potential risk to the unborn child or infant.

Driving and operating machinery
Pantoprazole Bluefish has no effect or negligible effect on the ability to drive motor vehicles and operate machinery.
Do not drive or operate machinery if the patient experiences adverse effects such as dizziness or visual disturbances.

Pantoprazole Bluefish contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per 40 mg tablet, which means the medicine is considered "sodium-free".

3. How to use Pantoprazole Bluefish

This medicine should always be taken as directed by your doctor or pharmacist. If you have any doubts,
you should consult your doctor or pharmacist.
Method of administration
Take the medicine 1 hour before a meal, without chewing or dividing the tablet. Swallow the tablet whole
with water.
Recommended dose:
Adults and adolescents aged 12 years and older

• For the treatment of reflux esophagitis The usual dose is one tablet per day. Your doctor may recommend increasing the dose to two tablets per day. The treatment period for reflux esophagitis usually lasts 4 to 8 weeks. Your doctor will decide how long you should take the medicine.

Adults

• For the treatment of infection with a bacterium called Helicobacter pylori in patients with duodenal and/or gastric ulcers, in combination with two antibiotics (eradication therapy): One tablet twice daily plus two antibiotics: amoxicillin, clarithromycin, or metronidazole (or tinidazole), each taken twice daily together with the pantoprazole tablet. The first pantoprazole tablet should be taken 1 hour before breakfast and the second pantoprazole tablet 1 hour before dinner. Follow your doctor's instructions and read the patient leaflets included in the antibiotic packaging. Treatment usually lasts one to two weeks.
• For the treatment of gastric and/or duodenal ulcers The usual dose is one tablet per day. After consultation with your doctor, the dose may be doubled. Your doctor will decide how long you should take the medicine. The treatment period for gastric ulcers usually lasts 4 to 8 weeks. The treatment period for duodenal ulcers usually lasts 2 to 4 weeks.
• For long-term treatment of Zollinger-Ellison syndrome and other conditions associated with excessive hydrochloric acid secretion in the stomach The usual initial dose is two tablets per day. Both tablets should be taken 1 hour before meals. Later, the dosage may be adjusted appropriately by your doctor depending on the amount of hydrochloric acid secreted in the stomach. If more than two tablets per day are prescribed, they should be taken in two divided doses. If your doctor prescribes a daily dose exceeding four tablets, you will be given specific instructions on when to discontinue the medicine.

Patients with kidney function disorders
If you have kidney problems, do not take Pantoprazole Bluefish for Helicobacter pylori eradication.
Patients with liver function disorders
In severe liver disease, do not take more than one 20 mg pantoprazole tablet per day (tablets containing 20 mg pantoprazole are available for this purpose).
Pantoprazole Bluefish should not be used for Helicobacter pylori eradication in patients with moderate or severe liver disease.
Use in children and adolescents
These tablets are not recommended for use in children under 12 years of age.
Taking more than the recommended dose of Pantoprazole Bluefish
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 missed dose. Take the next scheduled dose at the usual time.
Stopping Pantoprazole Bluefish
Do not stop taking the tablets without first consulting your doctor or pharmacist.
If you have any further questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
If any of the following adverse reactions occur, stop taking the
tablets immediately and contact your doctor or go to the emergency department
of your nearest hospital without delay.

• Severe allergic reactions (rare: may occur in up to 1 in 1,000 people): swelling of the tongue and (or) throat, difficulty swallowing, hives (rash resembling nettle rash), breathing difficulties, angioedema of the face (Quincke's oedema/angioedema), severe dizziness with rapid heartbeat and excessive sweating.
• Severe skin reactions (frequency unknown): formation of skin blisters and sudden deterioration in general condition, erosions (with slight bleeding) of the eyes, nose, mouth/oral cavity or genital organs (Stevens-Johnson syndrome, Lyell's syndrome, erythema multiforme), and photosensitivity.
• Other severe reactions (frequency unknown: frequency cannot be estimated from available data): yellowing of the skin and eyes (severe liver cell damage, jaundice) or fever, rash, and kidney problems manifested by their enlargement, sometimes with pain during urination and pain in the lower back (severe kidney inflammation), which may lead to kidney failure.

Other adverse reactions include:
Common (may occur in up to 1 in 10 people)
Benign gastric polyps.
Uncommon (may occur in up to 1 in 100 people)
Headache, dizziness, diarrhoea, nausea, vomiting, feeling of fullness in the abdomen, bloating with flatulence (passing wind), constipation, dry mouth, abdominal pain and discomfort, skin rash, erythema, skin eruptions, itching, fatigue, exhaustion or general malaise, sleep disturbances, fractures of the hip, wrist or spine.
Rare (may occur in up to 1 in 1,000 people)
Disturbances or complete loss of taste sensation, visual disturbances such as blurred vision; urticaria, joint pain, muscle pain, changes in body weight, elevated body temperature, high fever, swelling of limbs (peripheral oedema), allergic reactions, depression, breast enlargement in males.
Very rare (may occur in up to 1 in 10,000 people)
Disorientation.
Frequency unknown (cannot be estimated from available data)
Hallucinations, confusional state (particularly in patients who have previously experienced such symptoms); decreased sodium concentration in blood, decreased magnesium concentration in blood (see section 2), sensation of itching, pricking, tingling, burning or numbness, rash possibly accompanied by joint pain, inflammation of the large intestine causing persistent watery diarrhoea.

Adverse reactions identified through blood tests:
Uncommon (may occur in up to 1 in 100 people)
Increased liver enzyme activity.
Rare (may occur in up to 1 in 1,000 people)
Increased bilirubin levels, increased blood lipid levels, sudden decrease in circulating granulocytes - white blood cells, associated with high fever.
Very rare (may occur in up to 1 in 10,000 people)
Decreased platelet count, which may lead to more frequent bleeding and bruising, decreased white blood cell count, which may increase susceptibility to infections, concurrent abnormal decrease in red blood cells, white blood cells and platelets.

Reporting of adverse reactions
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store Pantoprazole Bluefish

Keep this medicine out of sight and reach of children.
Store below 30°C.
Do not use this medicine after the expiry date stated on the cardboard packaging after
"Expiry date". The expiry date refers to the last day of the stated month.
Do not use this medicine if you notice any visible signs of deterioration.
Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines you no longer use. This will help protect
the environment.

6. Contents of the pack and other information

What Pantoprazole Bluefish contains

• The active substance is pantoprazole. Each enteric-coated tablet contains 40 mg of pantoprazole (as sodium sesquihydrate).
• The other ingredients are: disodium phosphate anhydrous, mannitol, microcrystalline cellulose, sodium croscarmellose, magnesium stearate, hypromellose, triethyl citrate, sodium carboxymethyl starch (type A), methacrylic acid and ethyl acrylate copolymer (1:1), yellow iron oxide (E172).

What Pantoprazole Bluefish looks like and contents of the pack
Pantoprazole Bluefish is an oval, concave, smooth, yellow tablet.
The dimensions of the tablet are:

• width: 6.35 mm ± 0.32 mm (6.03 mm - 6.67 mm)
• length: 12 mm ± 0.6 mm (11.4 mm - 12.6 mm)

Pack sizes:
Blister packs in cardboard boxes containing 7, 14, 28, 56 and 100 enteric-coated 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, No 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: