Package Insert: Information for the User

Pantoprazol Tarbis 40 mg Powder for Injectable Solution EFG

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package insert. See section 4.

1. What is Pantoprazol Tarbis and how is it used

2. What you need to know before starting to use Pantoprazol Tarbis

3. How to use Pantoprazol Tarbis

4. Possible adverse effects

5. Storage of Pantoprazol Tarbis

6. Contents of the package and additional information

Pantoprazol Tarbis contains the active substance pantoprazol. Pantoprazol Tarbis is a selective proton pump inhibitor, a medication that reduces the amount of acid produced in your stomach. It is used for the treatment of diseases related to stomach and intestinal acid.

This medication is injected into a vein and will only be administered if your doctor considers that the injection of pantoprazol at this time is more convenient for you than pantoprazol tablets. The tablets will replace the injections as soon as your doctor considers it appropriate.

Pantoprazol is used for the treatment in adults of:

• Gastroesophageal reflux esophagitis. It is an inflammation of your esophagus (the tube that connects your throat to your stomach) accompanied by regurgitation of acid from the stomach.
• Stomach and duodenal ulcers
• Zollinger-Ellison syndrome and other conditions in which too much acid is produced in the stomach.

No use Pantoprazol Tarbis

-If you are allergic to pantoprazole or any of the other components of this medication(listed in section 6)

-If you are allergic to medications that contain other proton pump inhibitors

Warnings and Precautions

Consult your doctor, pharmacist, or nurse before starting to use this medication

• 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. If liver enzyme levels increase, treatment should be interrupted.
• Consult your doctor if you are taking HIV protease inhibitors such as atazanavir (for HIV 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 fractures of the hip, wrist, or spine.
• Inform your doctor if you have osteoporosis (reduced bone density) or if you have been told you are at risk of developing osteoporosis (for example, if you are taking corticosteroids).
• If you are taking this medication for more than three months, it is possible that blood magnesium levels may decrease. Low magnesium levels can cause fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, increased heart rate. If you experience any of these symptoms, see your doctor immediately. Low magnesium levels can also cause a decrease in potassium and calcium levels in the blood. 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 similar medication to pantoprazole to reduce stomach acid.
• If you suffer from a skin rash, especially in areas of skin exposed to the sun, consult your doctor as soon as possible, as it may be necessary to interrupt treatment with this medication. Remember to mention any other symptoms you may notice, such as joint pain.
• If you are scheduled to undergo a specific blood test (Cromogranin A).

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

• Unintentional weight loss
• Vomiting, particularly if repeated
• Blood in the vomit: it may appear as a dark brown powder in your vomit.
• Noticing blood in your stools, which may appear black or melena
• Difficulty swallowing, or pain when swallowing
• Pale appearance and feeling of weakness (anemia)
• Chest pain
• Stomach pain
• Severe or persistent diarrhea, as pantoprazole 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, as pantoprazole may alleviate cancer symptoms and delay diagnosis. If your symptoms persist despite treatment, additional explorations will be performed.

Children and adolescents

The use of this medication is not recommended in children, as it has not been tested in children under 18 years old.

Other medications and Pantoprazol Tarbis

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication, including over-the-counter medications.

Pantoprazole may affect the efficacy of other medications, inform your doctor if you are taking:

• Medications such as ketoconazole, itraconazole, and posaconazole (used to treat fungal infections) as pantoprazole may make these and other medications not work correctly.
• Warfarin and phenprocoumon, which affect blood clotting.You may need additional controls.
• Medications 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 interrupt treatment with this medication, 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, breastfeeding, and fertility

There is insufficient data on the use of pantoprazole in pregnant women. It has been noted that in humans, pantoprazole is excreted in breast milk.

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

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

Driving and operating machinery

Pantoprazole has no influence or insignificant influence on the ability to drive or operate machinery.

You should not drive or operate machinery if you experience side effects such as dizziness or blurred vision.

Important information about some of the components of Pantoprazol Tarbis

This medication contains less than 23 mg of sodium (1 mmol) per vial; it is essentially "sodium-free".

Your nurse or doctor will administer the daily dose as an injection into a vein over a period of 2-15 minutes.

The recommended dose is:

Adults

For the treatment of gastric ulcers, duodenal ulcers, and reflux esophagitis.

One vial (40 mg of pantoprazol) per day.

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

Two vials (80 mg of pantoprazol) per day.

Your doctor may then adjust your dose, depending on the amount of stomach acid you produce. If you are prescribed more than two vials (80 mg) per day, the injections will be administered in equal doses. Your doctor may temporarily prescribe a dose of more than four vials (160 mg) per day. If you need to quickly control your stomach acid levels, an initial dose of 160 mg (four vials) should be sufficient to significantly reduce stomach acid levels.

Patients with liver problems

If you have severe liver problems, the daily injection should be only 20 mg (half a vial).

Use in children and adolescents

This medication is not recommended for use in children and adolescents under 18 years old.

If you use more Pantoprazol Tarbis than you should

This medication is controlled with caution by your nurse or doctor, so it is very unlikely that you will receive more than you should. There are no known symptoms of overdose.

If you have any other questions about the use of this medication, ask your doctor, pharmacist, or nurse.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

If you consider that any of the side effects you are experiencing are severe or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

• Severe allergic reactions (rare, may affect up to 1 in 1,000 people):swelling of the tongue and/or throat, difficulty swallowing, hives (urticaria), difficulty breathing, allergic swelling of the face (Quincke's edema/angioedema), intense dizziness with very rapid heartbeats and excessive sweating.

• Severe skin alterations (frequency unknown; its frequency cannot be estimated with the available data):You may notice one or more of the following - blisters on the skin and a rapid deterioration of general conditions, erosion (including light bleeding) of eyes, nose, mouth/lips or genitals or skin sensitivity/eruption, particularly in areas of exposed skin to light/sun. You may also have joint pain or symptoms similar to the flu, fever, swollen lymph nodes (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, acute cutaneous lupus erythematosus, pharmacological reaction with eosinophilia and systemic symptoms (DRESS), photosensitivity).

• Other serious conditions (frequency unknown):yellow discoloration of the skin and the white of the eyes (severe liver cell damage, jaundice), or fever, hives, increased kidney size sometimes with painful urination or lower back pain (severe kidney inflammation), possibly leading to renal failure.

Other side effects are:

• Frequent(may affect 1 in 10 patients)

Vein wall inflammation and blood clots (thrombophlebitis) at the site of medication injection, benign polyps in the stomach.

• Uncommon(may affect 1 in 100 patients)

Headache; dizziness; diarrhea; sensation of dizziness, vomiting; bloating and flatulence (gas); constipation; dry mouth; abdominal pain and discomfort; hives on the skin, exanthema, eruption; tingling; feeling of weakness, fatigue or general malaise; sleep disturbances; hip, wrist, and spinal column fractures.

• Rare(may affect 1 in 1,000 patients)

Alteration or complete loss of taste; visual disturbances such as blurred vision; urticaria; joint pain; muscle pain; weight changes; increased body temperature; high fever; swelling in the extremities (peripheral edema); allergic reactions; depression; gynecomastia in men.

• Very rare(may affect 1 in 10,000 patients)

Disorientation

• Frequency unknown(cannot be estimated from the available data)

Illusion, confusion (especially in patients with a history of these symptoms), sensation of tingling, pinpricks, numbness, burning, or numbness, skin eruption, possibly with joint pain, inflammatory bowel disease causing persistent watery diarrhea.

Side effects identified through blood tests:

• Uncommon(may affect 1 in 100 patients)

Increased liver enzymes.

• Rare(may affect 1 in 1,000 patients)

Increased bilirubin; increased blood fat; sudden drop in granular white blood cells in circulation, associated with high fever.

• Very rare(may affect 1 in 10,000 patients)

Reduction in the number of platelets that could cause bleeding or more frequent bruising; 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 unknown(cannot be estimated from the available data)

Decreased sodium, magnesium, calcium, or potassium levels in the blood (see section 2).

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is possible side effects that do not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es.

By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

This medication does not require any special storage temperature.

Store the vial in the outer packaging to protect it from light.

Use the reconstituted solution within 12 hours

Use the reconstituted and diluted solution within 12 hours

From a microbiological point of view, the product should be used immediately. If not used immediately, the storage time in use and the previous conditions of its use are the responsibility of the user and should normally not exceed 12 hours at a temperature above 25°C.

Do not use Pantoprazol Tarbis 40 mg if you observe that the visual appearance has changed (for example: if you observe turbidity or precipitates)

Medications should not be disposed of through drains or trash. If in doubt, ask your pharmacist how to dispose of packaging and medications that you no longer need. In this way, you will help protect the environment.

Composition of Pantoprazol Tarbis

The active ingredient is pantoprazol. Each vial contains 40 mg of Pantoprazol.

After reconstitution, 1 ml of injectable solution contains 4 mg of pantoprazol.

The other components are: disodium edetate and sodium hydroxide (E 524) (to adjust the pH).

Appearance of the product and contents of the package

Pantoprazol Tarbis is a white or off-white powder for injectable solution. It is presented in a transparent glass vial (type I) of 10 ml with a grey rubber stopper and an aluminum seal containing 40 mg of powder for injectable solution.

Pantoprazol Tarbis is available in packages of 1, 5, 10, 20 and 50 glass vials with powder for injectable solution in a cardboard box.

Only some package sizes may be marketed.

Marketing Authorization Holder

Tarbis Farma S.L.

Gran Vía Carlos III, 94

08028 Barcelona

Spain

Responsible for manufacturing

Pharmadox Healthcare Ltd.

KW20A Kordin Industrial Park

Paola, PLA 3000

Malta

Amarox Pharma B.V.

Rouboslaan 32

2252 TR Voorschoten

Netherlands

This medicine is authorized in the member states of the European Economic Area with the following names:

Germany:Pantoprazol Amarox 40 mg Powder for the preparation of an injection solution

Netherlands:Pantoprazol Amarox 40 mg powder for solution for injection

Spain: Pantoprazol Tarbis 40 mg powder for injectable solution EFG

Date of the last review of this leaflet:January 2023

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es

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This information is intended solely for doctors or healthcare professionals:

The solution for immediate use is prepared by injecting 10 ml of sodium chloride solution 9 mg/ml (0.9%) into the vial containing the powder. This solution can be administered directly or diluted in 100 ml of sodium chloride solution 9 mg/ml (0.9%) or glucose 5% for injection or glucose solution 55 mg/ml (5%) for injection. For dilution, glass or plastic containers should be used.

Pantoprazol Tarbis should not be prepared or mixed with other solvents different from those specified.

After reconstitution, the solution can be used within 12 hours, although from a microbiological point of view, the product should be used immediately. If not, conservation within the time and conditions of use are the responsibility of the user and are normally not greater than 12 hours and 25°C.

The medicine will be administered intravenously over 2-15 minutes.

Any remaining product in the vial or any vial in which a change in its visual appearance is detected (for example: if turbidity or precipitates are observed) should be discarded.