Pantoprazole Bluefish

PATIENT INFORMATION LEAFLET: INFORMATION FOR THE USER

Pantoprazole Bluefish, 40 mg, gastro-resistant tablets

Pantoprazole

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

• 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 get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

• 1. What Pantoprazole Bluefish is and what it is used for
• 2. Before you take 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 the amount of acid produced in the stomach. It is used to treat diseases of the stomach and intestines caused by acid production.

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

• Reflux oesophagitis. This is an inflammation of the oesophagus (the tube that carries food from the mouth to the stomach) caused by acid from the stomach.

Pantoprazole Bluefish is used in adults for:

• Infection with a bacterium called Helicobacter pyloriin patients with peptic ulcers and (or) duodenal ulcers, in combination with two antibiotics (eradication therapy) to get rid of the bacterium and prevent recurrence of ulcers.
• Peptic ulcers and (or) duodenal ulcers.
• Zollinger-Ellison syndrome and other conditions where the stomach produces too much acid.

2. Before you take 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, tell your doctor, pharmacist, or nurse:

• If you have severe liver problems. You should tell your doctor if you have ever had liver problems. Your doctor may need to monitor your liver function more closely when you are taking Pantoprazole Bluefish, especially if you are taking it for a long time.

Control of acid production in the stomach may lead to an increase in the levels of a hormone called gastrin in the blood. This hormone can stimulate the growth of the stomach lining, leading to changes in the stomach lining that can sometimes result in cancer. However, it is not known whether long-term use of pantoprazole will result in an increased risk of cancer.

• If you have a vitamin B12 deficiency, as pantoprazole may reduce the absorption of vitamin B12.
• If you are taking a medicine called atazanavir (used to treat HIV infection), as pantoprazole may reduce its effectiveness.
• If you are taking a medicine called clopidogrel (used to prevent blood clots), as pantoprazole may reduce its effectiveness.
• If you have ever had a skin reaction with a medicine that reduces stomach acid, as you may be more likely to get a skin reaction with pantoprazole.
• If you get a rash on your skin, especially in areas exposed to the sun, tell your doctor as soon as possible, as you may need to stop taking Pantoprazole Bluefish. Also, tell your doctor if you get any other side effects.
• If you have to undergo a specific blood test (chromogranin A).

Tell your doctor immediately if you notice any of the following symptoms, which could be a sign of a more serious condition:

• Unintentional weight loss;
• Vomiting, especially when it is repeated;
• Blood in your vomit or black tarry stools;
• Difficulty swallowing or pain when swallowing;
• Pale skin and weakness (anaemia);
• Chest pain;
• Severe abdominal pain;
• Severe and/or persistent diarrhoea, as pantoprazole has been associated with a small increase in infectious diarrhoea.

Your doctor may decide to perform some tests to rule out malignant disease, as treatment with pantoprazole may alleviate the symptoms of the disease and delay diagnosis. If your symptoms persist despite treatment, further investigations will be necessary.

Children and adolescents

Pantoprazole Bluefish is not recommended for children under 12 years of age.

Pantoprazole Bluefish with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, 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 may reduce their effectiveness.
• Warfarin and phenprocoumon, which are used to thin the blood and prevent clots. Your doctor may need to monitor your blood more closely.
• Medicines used to treat HIV infection, such as atazanavir.
• Methotrexate (used to treat rheumatoid arthritis, psoriasis, and cancer), as pantoprazole may increase the levels of methotrexate in the blood.
• Fluvoxamine (used to treat depression and other mental health conditions), as your doctor may need to reduce the dose.
• Rifampicin (used to treat tuberculosis).
• St John's Wort (used to treat mild depression).

Pregnancy, breastfeeding, and fertility

There is limited information on the use of pantoprazole in pregnant women. Pantoprazole has been shown to pass into breast milk.

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

Pantoprazole Bluefish should only be used during pregnancy if the benefits to the mother outweigh the potential risks to the baby.

Driving and using machines

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

Do not drive or use machines if you experience side effects such as dizziness or blurred vision.

Pantoprazole Bluefish contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per 40 mg tablet, which is essentially sodium-free.

3. How to take Pantoprazole Bluefish

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Method of administration

Take the tablets 1 hour before a meal, without chewing or crushing them, with a glass of water.

Recommended dose:

Adults and adolescents aged 12 years and above

• For the treatment of reflux oesophagitis, the usual dose is one tablet per day. Your doctor may increase the dose to two tablets per day. The duration of treatment for reflux oesophagitis is usually 4 to 8 weeks. Your doctor will decide how long you need to take the medicine.

Adults

• For the treatment of infection with a bacterium called Helicobacter pyloriin patients with peptic ulcers and (or) duodenal ulcers, in combination with two antibiotics (eradication therapy), the dose is one tablet twice a day plus two tablets of antibiotics: amoxicillin, clarithromycin, or metronidazole (or tinidazole) taken twice a day with a tablet of pantoprazole. The first tablet of pantoprazole should be taken 1 hour before breakfast and the second tablet of pantoprazole 1 hour before dinner. Follow the instructions given by your doctor and read the patient information leaflet in the packs of the antibiotics. The treatment usually lasts for 1 to 2 weeks.
• For the treatment of peptic ulcers and (or) duodenal ulcers, the usual dose is one tablet per day. After consulting your doctor, the dose can be doubled. Your doctor will decide how long you need to take the medicine. The duration of treatment for peptic ulcers is usually 4 to 8 weeks. The duration of treatment for duodenal ulcers is usually 2 to 4 weeks.
• For long-term treatment of Zollinger-Ellison syndrome and other conditions where the stomach produces too much acid, the recommended initial dose is usually two tablets per day. Both tablets should be taken 1 hour before a meal. Later, the dose may be adjusted by your doctor, depending on the amount of acid produced in the stomach. If your doctor prescribes more than two tablets per day, you should take them twice a day. If your doctor prescribes a daily dose of more than four tablets, he will tell you when to stop taking the medicine.

Patients with kidney problems

Do not take Pantoprazole Bluefish for the eradication of Helicobacter pyloriif you have kidney problems.

Patients with liver problems

In severe liver disease, do not take more than one 20 mg tablet of pantoprazole per day (20 mg tablets are available for this purpose). In moderate or severe liver disease, do not take Pantoprazole Bluefish for the eradication of Helicobacter pylori.

Use in children and adolescents

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

Taking a higher dose of Pantoprazole Bluefish than recommended

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

Forgetting a dose of Pantoprazole Bluefish

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

Stopping treatment with Pantoprazole Bluefish

Do not stop taking the tablets without first talking to your doctor or pharmacist. If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Pantoprazole Bluefish can cause side effects, although not everybody gets them.

If you get any of the following side effects, stop taking the tablets and tell your doctor immediately or contact the casualty department of your nearest hospital:

• Severe allergic reactions (rare: may affect up to 1 in 1,000 people):swelling of the tongue and (or) throat, difficulty swallowing, hives (nettle rash), difficulty breathing, allergic swelling of the face (Quincke's oedema/angioedema), severe dizziness with rapid heartbeat and profuse sweating.
• Severe skin reactions (frequency not known):blistering of the skin and rapid deterioration of the patient's condition, erosion (with slight bleeding) of the eyes, nose, mouth/throat, or genitals (Stevens-Johnson syndrome, Lyell syndrome, polymorphic erythema) and sensitivity to light.
• Other severe reactions (frequency not known: cannot be estimated from the available data):yellowing of the skin and eyes (severe liver damage, jaundice) or fever, rash, and joint pain, and enlargement of the kidneys, sometimes with pain when urinating and pain in the lower back (severe kidney inflammation), which can lead to kidney failure.

Other side effects are:

Common(may affect up to 1 in 10 people)
Mild polyps in the stomach.
Uncommon(may affect up to 1 in 100 people)
Headache, dizziness, diarrhoea, nausea, vomiting, feeling of bloating in the abdomen and wind (flatulence), constipation, dry mouth, abdominal pain and discomfort, skin rash, redness, itching, fatigue, weakness, or general feeling of being unwell, sleep disorders, fractures of the hip, wrist, or spine.
Rare(may affect up to 1 in 1,000 people)
Disturbances or complete loss of the sense of taste, disturbances of vision, such as blurred vision; hives, joint pain, muscle pain, changes in body weight, increased body temperature, high fever, swelling of the extremities (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 had confusion before); low levels of sodium in the blood, low levels of magnesium in the blood (see section 2), feeling of tingling, prickling, itching, or burning, skin rash that may be associated with joint pain.

Side effects identified from blood tests:

Uncommon(may affect up to 1 in 100 people)
Elevated liver enzymes.
Rare(may affect up to 1 in 1,000 people)
Elevated bilirubin, elevated fats in the blood, sudden reduction in the number of blood platelets, which may cause an increased risk of bleeding or bruising, reduction in the number of white blood cells, which may lead to increased risk of infection.
Very rare(may affect up to 1 in 10,000 people)
Reduction in the number of blood platelets, which may cause an increased risk of bleeding or bruising, reduction in the number of white blood cells, which may lead to increased risk of infection, concurrent reduction in the number of red and white blood cells, as well as blood platelets.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet.

5. How to store Pantoprazole Bluefish

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

Do not store above 30°C.

Do not use this medicine after the expiry date which is stated on the carton after “EXP”. The expiry date refers to the last day of that 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 gastro-resistant 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 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 yellow, oval, biconvex, and coated tablets.

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 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 Saragossa, 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