PANTOPRAZOL BLUEFISH 20 mg GASTRO-RESISTANT TABLETS

Introduction

Package Leaflet: Information for the User

Pantoprazole Bluefish 20 mg Gastro-Resistant Tablets EFG

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 Package Leaflet

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 from 12 years of age to treat:

• Symptoms (such as heartburn, acid reflux, pain when swallowing) associated with gastroesophageal reflux disease caused by acid reflux from the stomach.

• Long-term treatment of reflux esophagitis (inflammation of the esophagus accompanied by acid reflux from the stomach) and prevention of relapses.

Pantoprazole is used in adults to treat:

Prevention of gastroduodenal ulcers caused by non-steroidal anti-inflammatory drugs (NSAIDs, such as ibuprofen) in patients at risk who require continued treatment with NSAIDs.

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 medicines that contain other 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 you more frequently for liver enzymes, especially when you are on long-term treatment with Pantoprazole Bluefish. If there is an increase in liver enzymes, treatment should be discontinued.
• If you need to take medicines called NSAIDs continuously and take Pantoprazole Bluefish, as there is a greater risk of developing complications in the stomach and intestine. Any increased risk will be assessed according to your personal risk factors such as age (65 years or older), history of stomach or duodenal ulcers or bleeding in the stomach or intestine.
• If you have decreased body stores of vitamin B12 or risk factors for it and receive long-term treatment with pantoprazole. Like all medicines that reduce acid, pantoprazole may reduce the absorption of vitamin B12.
• Consult your doctor if you are taking HIV protease inhibitors such as atazanavir (for HIV infection treatment) at the same time as pantoprazole.
• Taking a proton pump inhibitor like pantoprazole, especially for more than a 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 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, muscle contractions, disorientation, convulsions, dizziness, increased heart rate. If you experience any of these symptoms, see your doctor immediately. Low magnesium levels can also produce a decrease in blood potassium and calcium levels. Your doctor may decide to perform periodic blood tests to monitor 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 the skin exposed to the sun, consult your doctor as soon as possible, as it may be necessary to discontinue treatment with Pantoprazole Bluefish. Remember to mention any other symptoms 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 (anemia)
• chest pain
• stomach pain
• severe or persistent diarrhea, as Pantoprazole Bluefish has been associated with a small increase in infectious diarrhea.

Your doctor will decide if you need any additional tests to rule out a malignant disease because pantoprazole can alleviate the symptoms of cancer and may 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 a year), your doctor may monitor you regularly. You should inform your doctor of any new symptoms and/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 effectiveness 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, as pantoprazole may increase methotrexate levels in the blood.
• Fluvoxamine (used to treat depression and other psychiatric disorders). 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 Breastfeeding

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 breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

You should only use this medicine if your doctor considers that the benefit to 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. Swallow them whole with water.

The recommended dose is:

Adults and adolescents from 12 years of age:

For treating symptoms associated with gastroesophageal reflux disease (heartburn, acid reflux, pain when swallowing)

The usual dose is one tablet per day. This dose usually provides relief within 2-4 weeks, and if not, at most, within the following 4 weeks. Your doctor will tell you how long you should continue taking the medicine. After that, any recurring symptoms can be controlled by taking one tablet per day, as needed.

For long-term treatment and prevention of relapses of reflux esophagitis

The usual dose is one tablet per day. If the disease returns, your doctor may double the dose, in which case you can take Pantoprazole Bluefish 40 mg once a day. After healing, you can reduce the dose back to one 20 mg tablet per day.

Adults:

For the prevention of duodenal and stomach ulcers in patients who require continued treatment with NSAIDs

The usual dose is one tablet per day.

Patients with liver problems:

If you have severe liver problems, you should not take more than one 20 mg tablet per day.

Use in children and adolescents:

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

If you take more Pantoprazole Bluefish than you should

Inform your doctor or pharmacist or call the Toxicology Information Service telephone 91 562 04 20, indicating the medicine and the amount taken.

No symptoms of overdose are known.

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 consulting your doctor or pharmacist first.

If you have any further questions on the use of this medicine, 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 (rare:may affect up to 1 in 1,000 people): swelling of the tongue and/or throat, difficulty swallowing, rash (hives), difficulty breathing, swelling of the face of allergic origin (angioedema), 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 light/sun. 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 cell damage, jaundice), or fever, rash, increase in kidney size with occasional pain when urinating, and pain in the lower back (severe kidney inflammation), which may possibly cause 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; diarrhea; 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; hip, wrist, and spine fractures.

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

Alteration or complete loss of taste, vision disturbances such as blurred vision; hives; joint pain; muscle pain; weight changes; increased body temperature; high fever; swelling in the limbs (peripheral edema); 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), tingling, pinching, numbness, burning sensation, skin rash, possibly with joint pain.

Persistent watery diarrhea.

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 white blood cells, associated with high fever.

Very rare(may affect up to 1 in 10,000 people): reduction in platelet count, which could lead to bleeding or more bruising than usual; reduction in white blood cell count, which could lead to more frequent infections; abnormal reduction in the balance between 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 it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: 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 medicine to your pharmacist. 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

Composition of Pantoprazole Bluefish

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

Appearance of the product and packaging

Pantoprazole Bluefish 20 mg gastro-resistant tablets are yellow, oval, biconvex, smooth. The dimensions of the tablets 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 with: 14, 28, 56, and 100 gastro-resistant tablets.

Not all pack 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, Polígono 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,

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