PANTOPRAZOLE BLUEFISH

Pantoprazole Bluefish, 20 mg, gastro-resistant tablets
Pantoprazolum
Please read the entire leaflet carefully before using this medicine, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• 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. This medicine may harm others, even if their symptoms are the same.
• If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Leaflet contents:

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

Pantoprazole Bluefish contains the active substance pantoprazole. Pantoprazole Bluefish is a selective "proton pump inhibitor," a medicine that reduces acid secretion in the stomach. It is used to treat stomach and intestinal disorders related to hydrochloric acid secretion.

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

• Treating symptoms (e.g. heartburn, acid regurgitation, pain on swallowing) associated with gastro-oesophageal reflux disease (GORD), caused by the backflow of hydrochloric acid from the stomach.
• Long-term treatment of reflux oesophagitis (inflammation of the oesophagus accompanied by regurgitation of gastric acid) and prevention of its recurrence.

Pantoprazole Bluefish is used in adults for:

• Prevention of peptic ulcers of the duodenum and/or stomach caused by non-steroidal anti-inflammatory drugs (NSAIDs, e.g. ibuprofen) in patients at risk who require continuous NSAID therapy.

2. Important information before using Pantoprazole Bluefish

When not to use Pantoprazole Bluefish

• if the patient is allergic to pantoprazole or to 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 impairment. Inform the doctor if there has ever been any liver disorder. The doctor may recommend more frequent monitoring of liver enzyme activity, especially if long-term treatment with Pantoprazole Bluefish is required.
  If liver enzyme activity increases, treatment should be discontinued.

• If the patient is taking non-steroidal anti-inflammatory drugs (NSAIDs) continuously and is also taking Pantoprazole Bluefish, due to an increased risk of gastrointestinal complications. The increased risk will be assessed according to patient-specific risk factors such as age (65 years or older), history of gastric or duodenal ulcers, or gastrointestinal bleeding.

• If the patient has vitamin B_{12} deficiency or has risk factors indicating possible reduced vitamin B_{12} levels and is being treated long-term with pantoprazole. As with all medicines that reduce (inhibit) gastric acid secretion, pantoprazole may lead to reduced absorption of vitamin B_{12}.

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

• The 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, blood magnesium levels may decrease, which could subsequently cause fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, and rapid heartbeat. If the patient experiences any of these symptoms, inform the doctor immediately. Low blood 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 effects, such as joint pain.

• If a specific blood test (chromogranin A level) is planned for the patient.

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

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

The doctor may decide to perform tests to rule out an underlying malignant disease, as treatment with pantoprazole may relieve symptoms of cancer and delay diagnosis. If symptoms persist despite treatment, further investigations should be considered.
If Pantoprazole Bluefish is taken for a prolonged period (more than 1 year), the patient will likely be under continuous medical supervision. In such cases, report any new or unexpected symptoms and the circumstances of their occurrence during each doctor visit.

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 any other medicines the patient is currently taking, has recently taken, or plans to take, including over-the-counter medicines. Since Pantoprazole Bluefish may affect the effectiveness of other medicines, inform the doctor if the patient is taking:

• Medicines such as ketoconazole, itraconazole, 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 medicines.
• Warfarin and phenprocoumon, which affect blood clotting and prevent thrombosis. Additional tests may be required.
• Medicines used to treat 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 to treat 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 to treat 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 breast milk.
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
The medicine may be used only if the doctor considers that the benefit outweighs the potential risk to the unborn child or infant.

Driving and operating machinery
Pantoprazole Bluefish has no effect or has a negligible effect on the ability to drive 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 20 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 a doctor or pharmacist. If in doubt,
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 above

• For treatment of symptoms (e.g. heartburn, acid regurgitation, pain when swallowing) associated with gastroesophageal reflux disease The usual dose is one tablet per day. This dose usually provides relief within 2–4 weeks of treatment—no later than within the following 4 weeks. Your doctor will decide how long you should take the medicine. Recurring symptoms may be managed by taking one tablet per day as needed.
• For long-term treatment and prevention of relapse of reflux oesophagitis The usual dose is one tablet per day. If symptoms return, your doctor may recommend doubling the dose. In this case, one tablet of Pantoprazole Bluefish 40 mg per day may be used. After symptoms subside, the dose may be reduced again to one tablet (20 mg) per day.

Adults:

• For prevention of duodenal and/or gastric ulcers in patients who must continuously take NSAIDs The usual dose is one tablet per day.

Patients with impaired liver function
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 more 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 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 doubts concerning 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 everyone 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 the 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 (skin rash resembling nettle rash), breathing difficulties, angioedema (Quincke's oedema/angio-oedema), severe dizziness with rapid heartbeat and excessive sweating.
• Severe skin reactions (frequency unknown: frequency cannot be estimated from available data): 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): 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 and 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, limb swelling (peripheral oedema), allergic reactions, depression, gynaecomastia (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 levels in blood, decreased magnesium levels in blood (see section 2), sensations of itching, pricking, tingling, burning or numbness, painful rash, 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 cause 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 reactions occur, including any adverse reactions 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 authorisation holder.
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store Pantoprazole Bluefish

Keep the medicine out of the sight and reach of children.
Store below 30°C.
Do not use this medicine after the expiry date stated on the cardboard box 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 no longer required. These measures 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 20 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 available as oval, concave, smooth, yellow 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 in cardboard boxes containing 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 European Economic Area member states under the following names: