PANTOPRAZOL TARBIS 40 mg POWDER FOR INJECTABLE SOLUTION

Introduction

Package Leaflet: Information for the User

Pantoprazol Tarbis 40 mg Powder for Solution for Injection 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, 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, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Pack

1. What is Pantoprazol Tarbis and what is it used for
2. What you need to know before you take Pantoprazol Tarbis
3. How to take Pantoprazol Tarbis
4. Possible side effects
5. Storage of Pantoprazol Tarbis
6. Contents of the pack and other information

1. What is Pantoprazol Tarbis and what is it used for

Pantoprazol Tarbis contains the active substance pantoprazol. Pantoprazol Tarbis 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.

This medicine is injected into a vein and will only be given to you if your doctor considers that 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:

• Reflux esophagitis. It is an inflammation of your esophagus (the tube that connects your throat with 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.

2. What you need to know before you take Pantoprazol Tarbis

Do not take Pantoprazol Tarbis

• If you are allergic to pantoprazol 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

Talk to your doctor, pharmacist, or nurse before you start taking this medicine

• If you have severe liver problems. Tell your doctor if you have ever had liver problems. Your doctor will monitor your liver enzymes more frequently. In case of an increase in liver enzymes, treatment should be discontinued.
• Talk to your doctor if you are taking HIV protease inhibitors such as atazanavir (for the treatment of HIV infection) at the same time as pantoprazol.
• Taking a proton pump inhibitor like pantoprazol, especially for more than a year, may increase the risk of hip, wrist, or spine fractures.
• Tell 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 this medicine 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, rapid heartbeat. If you have any of these symptoms, go to the 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 magnesium levels.
• If you have ever had a skin reaction after treatment with a medicine similar to pantoprazol to reduce stomach acid.
• If you get a skin rash, especially in areas of skin exposed to the sun, talk to your doctor as soon as possible, as it may be necessary to discontinue treatment with this medicine. Also, 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 coffee grounds-like substance in your vomit.
• If you notice blood in your stools, which may appear black or tarry
• Difficulty swallowing, or pain when swallowing
• Pale appearance and feeling of weakness (anemia)
• Chest pain
• Stomach pain
• Severe or persistent diarrhea, as pantoprazol 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 pantoprazol can alleviate the symptoms of cancer and may delay its diagnosis. If, despite treatment, your symptoms persist, complementary tests will be performed.

Children and Adolescents

The use of this medicine is not recommended in children as it has not been tested in children under 18 years of age.

Other medicines and Pantoprazol Tarbis

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.

Pantoprazol may affect the efficacy of other medicines. Tell your doctor if you are taking:

• Medicines such as ketoconazole, itraconazole, and posaconazole (used to treat fungal infections), as pantoprazol may make these and other medicines not work properly.
• Warfarin and phenprocoumon, which affect blood coagulation. 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 discontinue treatment with this medicine because pantoprazol can increase methotrexate levels in the blood.
• Fluvoxamine (used to treat depression and other psychiatric diseases). If you are taking fluvoxamine, your doctor may reduce the dose.
• Rifampicin (used to treat infections)
• St. John's Wort (Hypericum perforatum) (used to treat mild depression)

Pregnancy, Breast-feeding, and Fertility

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

If you are pregnant or breast-feeding, 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 to you is greater than the potential risk to the fetus or baby.

Driving and Using Machines

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

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

Important Information about Some of the Ingredients of Pantoprazol Tarbis

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

3. How to Take Pantoprazol Tarbis

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 secretion.

Two vials (80 mg of pantoprazol) per day.

Subsequently, your doctor may adjust the dose, depending on the amount of acid secretion 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 prescribe a dose of more than four vials (160 mg) per day for a short period. 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.

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

The use of these injections is not recommended in children and adolescents under 18 years of age.

If you Take More Pantoprazol Tarbis than you Should

This medicine 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 further questions on the use of this product, ask your doctor, pharmacist, or nurse.

4. Possible Side Effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

• Severe allergic reactions (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 (Quincke's edema/angioedema), severe dizziness with rapid heartbeat and excessive sweating.

• Severe skin reactions (frequency not known;frequency 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 conditions, erosion (including slight bleeding) of 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):yellowing of the skin and the whites of the eyes (severe liver cell damage, jaundice), or fever, rash, increase in kidney size, sometimes with pain when urinating, or pain in the lower back (severe kidney inflammation), which may lead to kidney failure.

Other side effects are:

• Common (may affect up to 1 in 10 people)

Inflammation of the vein wall and blood clots (thrombophlebitis) at the injection site, benign stomach polyps.

• Uncommon (may affect up to 1 in 100 people)

Headache; dizziness; diarrhea; feeling of dizziness, vomiting; swelling and flatulence (gas); constipation; dry mouth; abdominal pain and discomfort; skin rash, exanthema, eruption; tingling; 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; urticaria; joint pain; muscle pain; weight changes; increased body temperature; high fever; swelling in the limbs (peripheral edema); 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 with a history of these symptoms), tingling, pinching, numbness, burning sensation, or numbness, skin rash, possibly with joint pain, inflammation of the large intestine that causes 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 fat in the blood; sudden drop in white blood cell count, 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, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through 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 Pantoprazol Tarbis

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

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.

This medicine does not require any special storage conditions.

Keep 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 and conditions prior to use are the responsibility of the user and normally should not exceed 12 hours at a temperature above 25°C.

Do not use Pantoprazol Tarbis 40 mg if you notice that the appearance has changed (e.g., if you notice turbidity or precipitation)

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. Container Contents and Additional Information

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) (for pH adjustment).

Appearance of the Product and Container Contents

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

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

Only some pack sizes may be marketed.

Marketing Authorization Holder

Tarbis Farma S.L.

Gran Vía Carlos III, 94

08028 Barcelona

Spain

Manufacturer

Pharmadox Healthcare Ltd.

KW20A Kordin Industrial Park

Paola, PLA 3000

Malta

Amarox Pharma B.V.

Rouboslaan 32

2252 TR Voorschoten

Netherlands

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Germany: Pantoprazol Amarox 40 mg Pulver zur Herstellung einer Injektionslösung

Netherlands: Pantoprazol Amarox 40 mg poeder voor oplossing voor injectie

Spain: Pantoprazol Tarbis 40 mg polvo para solución inyectable EFG

Date of the Last Revision of this Leaflet:January 2023

Detailed and updated 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

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This information is intended only for healthcare professionals:

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

Pantoprazol Tarbis should not be prepared or mixed with solvents other than 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, the storage within the time and conditions of use is the responsibility of the user and should not normally exceed 12 hours and 25°C.

The medicinal product 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 (e.g., if turbidity or precipitations are observed) should be discarded.