PANTOPRAZOL AUROVITAS 40 mg POWDER FOR INJECTABLE SOLUTION

Introduction

Package Leaflet: Information for the User

Pantoprazole Aurovitas 40 mg powder for solution for injection EFG

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.,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 Pantoprazole Aurovitas and what is it used for
2. What you need to know before you use Pantoprazole Aurovitas
3. How to use Pantoprazole Aurovitas
4. Possible side effects
5. Storage of Pantoprazole Aurovitas
6. Contents of the pack and other information

1. What is Pantoprazole Aurovitas and what is it used for

Pantoprazole Aurovitas contains the active substance pantoprazole sodium sesquihydrate.

Pantoprazole is a selective inhibitor of the "proton pump", a medicine that reduces the amount of acid produced in your stomach. It is used to treat 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 pantoprazole, at this time, is more convenient for you than pantoprazole tablets. The tablets will replace the injections as soon as your doctor considers it suitable.

Pantoprazole is used for the treatmentin adults of:

• 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 diseases in which too much acid is produced in the stomach.

2. What you need to know before you use Pantoprazole Aurovitas

Do not use Pantoprazole Aurovitas

• 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

Talk to your doctor, pharmacist, or nurse before you start using Pantoprazole Aurovitas.

• 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 HIV infection treatment) at the same time as pantoprazole.
• Taking a proton pump inhibitor like pantoprazole, especially for a period of more than one year, may slightly increase the risk of hip, wrist, and 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 using pantoprazole 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, or 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 to reduce stomach acid.
• If you get a skin rash, especially in areas of the skin exposed to the sun, talk to your doctor as soon as possible, as it may be necessary to stop treatment with pantoprazole. 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 using 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 dark coffee grounds in your vomit
• if you notice blood in your stools, which may be black or tar-like
• 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 because pantoprazole can alleviate the symptoms of cancer and could delay its diagnosis. If, despite treatment, your symptoms persist, additional tests will be performed.

Children and adolescents

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

Other medicines and Pantoprazole Aurovitas

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

Pantoprazole 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) or erlotinib (used to treat certain types of cancer), as pantoprazole may make these and other medicines not work properly.
• Warfarin and phenprocoumon, which affect blood coagulation. You may need additional tests.
• 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 your treatment with pantoprazole 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 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 has no influence 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 Aurovitas contains sodium

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

3. How to use Pantoprazole Aurovitas

Your nurse or doctor will give you 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 pantoprazole) per day.

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

Two vials (80 mg of pantoprazole) per day.

Afterwards, your doctor may adjust your 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 given in two equal doses. Your doctor may prescribe you temporarily 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 the amount of 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 use more Pantoprazole Aurovitas 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.

No symptoms of overdose are known.

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or nurse immediately, or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount administered.

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 experience any of the following side effects, tell 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 (Quincke's edema/angioedema), severe dizziness with very rapid heartbeat and excessive sweating.

• Severe skin disorders (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 your general condition, erosion (including slight bleeding) of eyes, nose, mouth/lips, or genitals, or sensitivity/skin rash, particularly in areas of the skin exposed to light or 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: frequency 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 sometimes with pain when urinating and pain in the lower back (severe kidney inflammation), which may lead to kidney failure.

Other side effects are:

• Frequent (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; nausea, vomiting; swelling and bloating (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 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); feeling of tingling, pinching, numbness, burning, or tingling, 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 blood fat levels; sudden decrease in circulating granulocytes, associated with high fever.

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

Decrease in platelet count, which may cause bleeding or more bruising than usual; decrease in white blood cell count, which may lead to more frequent infections; coexistence of an abnormal decrease in red blood cell, white blood cell, and platelet counts.

• 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 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 Aurovitas

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 and vial after EXP. The expiry date is the last day of the month stated.

Store below 30°C.

Store in the original package to protect from light.

After preparation, the reconstituted solution must be used within 12 hours if it has been further diluted or within 24 hours if it has not been diluted.

From a microbiological point of view, the product should be used immediately. If not used immediately, the storage times and conditions before use are the responsibility of the user.

Do not use the medicine if you notice that the appearance has changed (e.g., if turbidity or precipitation is observed).

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Container Contents and Additional Information

Composition of Pantoprazol Aurovitas

• The active ingredient is pantoprazole. Each vial contains 40 mg of pantoprazole (as sodium sesquihydrate).
• The other components are: disodium edetate and sodium hydroxide.

Appearance of the Product and Container Contents

White or almost white powder in a 10 ml transparent type I glass vial with a bromobutyl rubber stopper and an aluminum cap with a polypropylene disc.

Container sizes: 1 vial, 5 (5x1) vials, 10 (10x1) vials, and 20 (20x1) vials with powder for injectable solution.

Only some container sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Eugia Pharma (Malta) Limited

Vault 14, Level 2, Valletta Waterfront

Floriana, FRN 1914

Malta

Manufacturer:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

This medication is authorized in the member states of the European Economic Area under the following names:

Date of the last revision of this prospectus: March 2024

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

This information is intended only for healthcare professionals:

Reconstituted solution:

The solution for immediate use is prepared by injecting 10 ml of sodium chloride 0.9% injectable solution into the vial containing the powder. This solution can be administered directly. The reconstituted injectable solution is physically and chemically stable for 24 hours at 25°C.

Diluted solution:

The vial containing the powder is reconstituted with 10 ml of sodium chloride 0.9% injectable solution and then diluted with 100 ml of sodium chloride 0.9% injectable solution orglucose 5% solution (i.e., to a concentration of approximately 0.4 mg/ml).

The reconstituted and diluted solution of the medication is physically compatible and chemically stable for 12 hours at 25°C with sodium chloride 0.9% injectable solution and glucose 5% injectable solution. Plastic containers should be used for dilution.

Pantoprazol Aurovitas should not be prepared or mixed with solvents other than those specified.

After preparation, the reconstituted solution must be used within 12 hours if it has been diluted subsequently or within 24 hours if it has not been diluted.

From a microbiological point of view, the product must be used immediately. If it is not used immediately, the storage times and conditions are the responsibility of the user.

The medication should be administered intravenously over 2-15 minutes.

The contents of the vial are for single use by intravenous route. Any remaining product in the vial or those whose visual appearance has changed (e.g., if turbidity or precipitation is observed) should be discarded.

The appearance of the product after reconstitution is a clear or yellowish colorless solution.