PANTOPRAZOL BLUEFISH 40 mg GASTRO-RESISTANT TABLETS

Introduction

Package Leaflet: Information for the User

Pantoprazole Bluefish40mggastro-resistant tabletsEFG

Read all of this leaflet carefully before you start taking this medicine because 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 or 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 signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

1. What is Pantoprazole Bluefish and what is it used for
2. What you need to know before you take Pantoprazole Bluefish
3. How to take Pantoprazole Bluefish
4. Possible side effects
5. Storage of 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 is a selective inhibitor of the "proton pump", a medicine that reduces the amount of acid produced in your stomach. It is used for the treatment of diseases related to stomach and intestine acid.

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

• Reflux oesophagitis. This is an inflammation of your oesophagus (the tube that connects your throat to your stomach) accompanied by regurgitation of acid from the stomach.

Pantoprazole is used in adults for the treatment of:

• Infection of a bacterium called Helicobacter pyloriin patients with stomach and/or duodenal ulcer in combination with two antibiotics (eradication therapy). The goal is to get rid of the bacterium and thus reduce the likelihood of ulcers recurring.
• Stomach and duodenal ulcers
• Zollinger-Ellison syndrome and other conditions in which too much acid is produced in the stomach.

2. What you need to know before you take Pantoprazole Bluefish

Do not 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 other medicines that contain proton pump inhibitors.

Warnings and precautions

Consult your doctor or pharmacist or nurse before starting to take Pantoprazole 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 when you are on long-term treatment with Pantoprazole Bluefish. In case of increased liver enzymes, treatment should be discontinued.
• If you have reduced body stores of vitamin B12 or risk factors for this and you receive long-term treatment with pantoprazole. Like all medicines that reduce acid, pantoprazole may reduce the absorption of vitamin B12.
• If you are taking HIV protease inhibitors such as atazanavir (for the treatment of HIV infection) at the same time as pantoprazole.
• Taking a proton pump inhibitor like pantoprazole, especially for more than one year, may increase the risk of hip, wrist, or spine fractures. Inform your doctor if you have osteoporosis (reduced bone density) or if you have been told that you are at risk of osteoporosis (for example, if you are taking corticosteroids).
• If you are taking Pantoprazole Bluefish for more than three months, it is possible that your blood magnesium levels may decrease. Low magnesium levels can cause fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, increased heart rate. If you have any of these symptoms, see your doctor immediately. Low magnesium levels can also cause a decrease in blood potassium and calcium levels. Your doctor may decide to perform periodic blood tests to monitor your magnesium levels.
• If you have ever had a skin reaction after treatment with a medicine similar to Pantoprazole Bluefish to reduce stomach acid.
• If you get a skin rash, especially in areas of skin exposed to sunlight, consult your doctor as soon as possible, as it may be necessary to stop treatment with Pantoprazole Bluefish. Remember to mention any other symptoms that you may notice, such as joint pain
• If you are scheduled to have a specific blood test (Chromogranin A).

Tell your doctor immediately, before or after taking this medicine, if you notice any of the following symptoms, which may be signs of more serious diseases:

• unintentional weight loss
• vomiting, particularly if it is repeated
• blood in the vomit: it may appear as a dark brown powder in your vomit
• if you notice blood in your stools, which may appear black or dark
• difficulty swallowing or pain when swallowing
• pale appearance and feeling of weakness (anaemia)
• chest pain
• stomach pain
• severe or persistent diarrhoea, as Pantoprazole Bluefish has been associated with a small increase in infectious diarrhoea.

Your doctor will decide if you need any additional tests to rule out a malignant disease because pantoprazole may alleviate the symptoms of cancer and could delay its diagnosis. If, despite treatment, your symptoms persist, complementary tests will be performed.

If you take Pantoprazole Bluefish for a prolonged period (more than one year), your doctor may perform regular follow-up. You should inform your doctor of any symptoms and/or new or unexpected events each time you visit your doctor.

Children and adolescents

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

Other medicines and Pantoprazole Bluefish

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Pantoprazole Bluefish may affect the efficacy 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 to treat certain types of cancer) as Pantoprazole Bluefish may make these and other medicines not work properly.
• Warfarin and phenprocoumon, which affect blood clotting. You may need additional checks.
• 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 treatment with Pantoprazole Bluefish because pantoprazole may increase methotrexate levels in the blood.
• Fluvoxamine (used to treat depression and other psychiatric diseases) 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 breast-feeding

There is not enough data on the use of pantoprazole in pregnant women. It has been reported that in humans, pantoprazole is excreted in breast milk.

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

You should only use this medicine if your doctor considers that the benefit for you is greater than the potential risk to the fetus or baby.

Driving and using machines

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

Do not drive or use machines if you experience side effects such as dizziness and visual disturbances.

Pantoprazole Bluefish contains Sodium

This medicine contains less than 1 mmol of sodium (23 mg) per gastro-resistant tablet; this is, essentially "sodium-free".

3. How to take Pantoprazole Bluefish

Follow the instructions for administration of this medicine exactly as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Method of administration

Take the tablets 1 hour before meals without chewing or breaking them and swallow them whole with water.

The recommended dose is:

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 indicate an increase to 2 tablets per day. The treatment time for reflux oesophagitis is usually between 4 and 8 weeks. Your doctor will indicate how long you should take this medicine.

Adults:

For the treatment of an infection with a bacterium called Helicobacter pylori in patients with stomach and/or duodenal ulcer in combination with two antibiotics (eradication therapy)

One tablet twice a day plus the two antibiotic tablets, either amoxicillin, clarithromycin and metronidazole (or tinidazole), each to be taken twice a day with your pantoprazole tablet. Take the first pantoprazole tablet one hour before breakfast and the second one hour before dinner. Follow your doctor's instructions and make sure to read the leaflets of the antibiotics.

The duration of treatment is usually one to two weeks.

For the treatment of stomach and duodenal ulcers:

The usual dose is one tablet per day. The dose may be doubled by your doctor.

Your doctor will indicate how long you should take this medicine. The treatment time for stomach ulcers is usually between 4 and 8 weeks. The treatment time for duodenal ulcers is usually between 2 and 4 weeks.

For long-term treatment of Zollinger-Ellison syndrome and other conditions in which there is an increase in stomach acid secretion:

The initial recommended dose is two tablets per day. Take the two tablets one hour before a meal. Subsequently, your doctor may adjust the dose, depending on the amount of acid secretion you produce. If you are prescribed more than two tablets per day, you should take the tablets divided into two doses per day. If you are prescribed more than four tablets per day, you will be told exactly when to stop treatment.

Patients with kidney problems

If you have kidney problems, you should not take Pantoprazole Bluefish for the eradication of Helicobacter pylori.

Patients with liver problems

If you have severe liver problems, you should not take more than one 20 mg pantoprazole tablet per day (for this case, 20 mg pantoprazole tablets are available).

If you have moderate or severe liver problems, you should not take Pantoprazole Bluefish for the eradication of Helicobacter pylori.

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

If you or someone you know has taken more than the prescribed dose (overdose), you should contact a doctor immediately or call the Toxicology Information Service, telephone: 91 562 04 20, indicating the medicine and the amount taken).

Tell your doctor or pharmacist. There are no known symptoms of overdose.

If you forget to take Pantoprazole Bluefish

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

If you stop taking Pantoprazole Bluefish

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

If you have any further questions on the use of this product, ask your doctor or 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 these tablets and inform your doctor immediately or contact the emergency department of the nearest hospital.

• Severe allergic reactions (frequency rare:may affect up to 1 in 1,000 people): swelling of the tongue and/or throat, difficulty swallowing, rash (urticaria), difficulty breathing, swelling of the face of allergic origin (angioedema/Quincke's oedema), severe dizziness with very rapid heartbeat and profuse sweating.
• Severe skin reactions (frequency not known: cannot be estimated from the available data): you may notice one or more of the following - blisters on the skin and rapid deterioration of general health, erosion (including slight bleeding) in eyes, nose, mouth/lips or genitals or sensitivity/skin rash, particularly in areas of skin exposed to sunlight. You may also have joint pain or symptoms similar to those of the flu, 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 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 the available data):yellowing of the skin and the whites of the eyes (severe liver damage, jaundice), or fever, rash, increased kidney size with occasional pain when urinating and pain in the lower back (severe kidney inflammation), which may possibly lead to kidney failure.

Other side 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; abdominal pain and discomfort; skin rash, exanthema, eruption; itching; feeling of weakness, fatigue or general malaise; sleep disturbances; fracture of the hip, wrist and spine.

Rare(may affect up to 1 in 1,000 people):

Alteration or complete loss of taste, vision disturbances 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; breast enlargement in men, agranulocytosis (severe decrease in the number of white blood cells in the blood, making infections more likely), taste disturbances.

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

Disorientation.

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

Hallucinations, confusion (especially in patients with a history of these symptoms), sensation of tingling, pinching, numbness, burning sensation or numbness, skin rash, possibly with joint pain.

Inflammation of the large intestine that causes persistent watery diarrhoea.

Side 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 blood fat levels, sharp drop in granular white blood cells in the circulation, associated with high fever.

Very rare(may affect up to 1 in 10,000 people): reduction in the number of platelets that could lead to bleeding or more bruising than usual; reduction in the number of white blood cells that could lead to more frequent infections, abnormal reduction in the balance between the number of red and white blood cells, as well as platelets.

Frequency not known(cannot be estimated from the available data): decrease in sodium, magnesium, calcium or potassium levels in the blood (see section 2).

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. You can also report side effects directly via the Spanish Medicines Monitoring System for Human Use: www.notificaRAM.es. By reporting side 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 which is stated on the packaging after "EXP:". The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Return any unused tablets to a pharmacy for disposal. If you have any further questions on the disposal of unused tablets, ask your pharmacist. This will help protect the environment.

6. Contents of the pack and other information

Composition of Pantoprazol Bluefish

• The active ingredient is pantoprazole. Each gastro-resistant tablet contains 40 mg of pantoprazole (as sodium sesquihydrate of pantoprazole)
• The other ingredients 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 Packaging Contents

The Pantoprazol Bluefish 40 mg gastro-resistant tablets are yellow, oval, biconvex, and smooth. The dimensions of the tablets are as follows:

• Width: 6.35 mm ± 0.32 mm (6.03 mm - 6.67 mm)
• Length: 12.00 mm ± 0.60 mm (11.40 mm - 12.60 mm)

Package sizes:

Blisters with: 7, 14, 28, 56, and 100 gastro-resistant tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization 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

Further information about this medicinal product can be obtained from the local representative of the marketing authorization holder:

Bluefish Pharma S.L.U.,

AP 36007, 2832094 Madrid,

Sucursal 36

This Medicinal Product is Authorized in the Member States of the European Economic Area under the Following Names:

Date of the Last Revision of this Leaflet:December 2022

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