Pantoprazole Aurovitas 40 mg powder for injection solution EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Pantoprazole Aurovitas 40 mg powder for injectable solution POM

Read the entire leaflet carefully before you start using this medicine, as it contains important information for you.

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

Leaflet contents

1. What Pantoprazole Aurovitas is and what it is used for
2. What you need to know before using Pantoprazole Aurovitas
3. How to use Pantoprazole Aurovitas
4. Possible side effects
5. How to store Pantoprazole Aurovitas
6. Contents of the pack and other information

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

Pantoprazol Aurovitas contains the active substance pantoprazole sodium sesquihydrate.

Pantoprazole is a selective "proton pump inhibitor", a medicine that reduces the amount of acid produced in your stomach. It is used to treat acid-related diseases of the stomach and intestine.

This medicine is administered by intravenous injection and will only be given to you if your doctor considers that an injection of pantoprazole is currently more suitable for you than pantoprazole tablets. Tablets will replace injections as soon as your doctor considers it appropriate.

Pantoprazole is used to treat the following conditions in adults:

• Reflux esophagitis. This is inflammation of your esophagus (the tube connecting your throat to your stomach), accompanied by regurgitation of acid from the stomach.
• Gastric and duodenal ulcers.
• Zollinger-Ellison syndrome and other conditions in which excessive acid is produced in the stomach.

2. What you need to know before using Pantoprazol Aurovitas

Do not use Pantoprazol Aurovitas

• If you are allergic to pantoprazole or to any of the other ingredients of this medicine (listed in section 6).
• If you are allergic to medicines containing other proton pump inhibitors.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting to use Pantoprazol Aurovitas.

• If you have severe liver problems. Inform your doctor if you have ever had liver problems. Your doctor may monitor your liver enzymes more frequently. If liver enzymes increase, treatment should be discontinued.
• Consult your doctor if you are taking HIV protease inhibitors such as atazanavir (for treatment of HIV infection) at the same time as pantoprazole.
• Taking a proton pump inhibitor such as pantoprazole, especially for more than one year, may slightly increase the risk of fractures of the hip, wrist, and spine. 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 using pantoprazole for more than three months, your blood magnesium levels may decrease. Low magnesium levels can cause fatigue, involuntary muscle contractions, confusion, seizures, dizziness, or increased heart rate. If you experience any of these symptoms, contact your doctor immediately. Low magnesium levels may also lead to decreased levels of potassium and calcium 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 medicine similar to pantoprazole used to reduce stomach acidity.
• If you develop a skin rash, especially in areas of skin exposed to sunlight, consult your doctor as soon as possible, as it may be necessary to discontinue treatment with pantoprazole. 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).

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

• unintentional weight loss
• vomiting, particularly if repeated
• blood in vomit: this may appear as dark coffee-ground-like material in your vomit
• notice blood in your stools, which may be black or tar-like
• difficulty swallowing or pain when swallowing
• pale appearance and feeling weak (anemia)
• chest pain
• stomach pain
• severe or persistent diarrhoea, as pantoprazole has been associated with a small increased risk of infectious diarrhoea

Your doctor will decide whether you need additional tests to rule out a malignant disease, as pantoprazole may relieve cancer symptoms and could delay diagnosis. If your symptoms persist despite treatment, further investigations will be carried out.

Children and adolescents

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

Other medicines and Pantoprazol Aurovitas

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

Pantoprazole 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 for certain types of cancer), as pantoprazole may reduce the effectiveness of these and other medicines.
• Warfarin and phenprocoumon, which affect blood clotting. You may require additional monitoring.
• 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 your pantoprazole treatment, as pantoprazole may increase methotrexate levels in the blood.
• Fluvoxamine (used to treat depression and other psychiatric conditions) – 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 are insufficient data on the use of pantoprazole in pregnant women. It has been reported that pantoprazole is excreted in human breast milk.

If you are pregnant or breastfeeding, think you may be pregnant, or are planning 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 outweighs the potential risk to the fetus or infant.

Driving and using machines

The effect of pantoprazole on the ability to drive or operate machinery is negligible or none.

However, do not drive or operate machinery if you experience adverse effects such as dizziness or blurred vision.

Pantoprazol Aurovitas contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per vial and is therefore considered essentially “sodium-free”.

3. How to use Pantoprazol Aurovitas

Your nurse or doctor will administer your daily dose as an intravenous injection 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 conditions associated with increased gastric acid secretion

Two vials (80 mg of pantoprazole) per day.

Subsequently, your doctor may adjust your dose depending on the amount of gastric acid you produce. If more than two vials (80 mg) per day are prescribed, the injections will be given in two equal doses. Your doctor may temporarily prescribe a dose exceeding four vials (160 mg) per day. If rapid control of stomach acid levels is required, an initial dose of 160 mg (four vials) should be sufficient to substantially reduce gastric acid production.

Patients with liver problems

If you have severe liver impairment, 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 Pantoprazol Aurovitas than you should

This medicine is carefully controlled by your nurse or doctor, so it is very unlikely that you will receive more than you should.

Symptoms of overdose are not known.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medication and the amount administered.

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

4. Possible adverse effects

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

If you experience any of the following adverse effects, tell your doctor immediately or contact the nearest hospital's emergency service:

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

• Severe skin disorders (frequency not known: frequency cannot be estimated from available data): you may notice one or more of the following – blisters on the skin and rapid deterioration in your general condition, erosion (including slight bleeding) of the eyes, nose, mouth/lips or genitals, or skin sensitivity/rash, particularly in areas of skin exposed to light or sun. You may also experience joint pain or flu-like symptoms, 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's 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 available data): yellowing of the skin and whites of the eyes (severe liver cell damage, jaundice) or fever, rash, kidney enlargement sometimes with pain on urination and lower back pain (severe kidney inflammation), which could possibly lead to kidney failure.

Other adverse 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 gastric polyps.

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

Headache; dizziness; diarrhoea; nausea, vomiting; bloating and flatulence; constipation; dry mouth; abdominal pain and discomfort; skin rash, exanthema, eruption; itching; feeling of weakness, tiredness or general malaise; sleep disturbances; fracture of the hip, wrist or spine.

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

Altered or loss of taste sensation; visual disturbances such as blurred vision; urticaria; joint pain; muscle pain; weight changes; increased body temperature; high fever; swelling in the extremities (peripheral oedema); 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 available data)

Hallucinations, confusion (especially in patients with a history of these symptoms); tingling sensation, pricking, numbness, burning or stinging sensation, skin rash, possibly with joint pain, inflammation of the large intestine causing persistent watery diarrhoea.

Adverse 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 lipid levels; sudden drop in circulating granular white blood cells, associated with high fever.

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

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

• Frequency not known (cannot be estimated from available data)

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

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse 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 stated on the carton and vial after EXP. The expiry date refers to the last day of the month indicated.

Store below 30°C.

Keep in the original packaging to protect from light.

After reconstitution, the solution should be used within 12 hours if further diluted, or within 24 hours if not diluted.

From a microbiological standpoint, the product should be used immediately. If not used immediately, the user is responsible for ensuring the duration and conditions of storage prior to use.

Do not use the medicine if you notice any change in its appearance (e.g., if cloudiness or precipitation is observed).

Medicines must not be disposed of via wastewater or household waste. If you are unsure how to dispose of unused medicines or packaging, consult your pharmacist. This will help protect the environment.

6. Contents of the pack and other information

Composition of Pantoprazole Aurovitas

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

Nature of the product and pack contents

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

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

Only some pack 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

Further information on this medicinal product is available from the local representative of the Marketing Authorization Holder:

Aurovitas Spain, S.A.U.
Avda. de Burgos, 16-D
28036 Madrid
Spain

This medicinal product is authorized in the European Economic Area member states under the following names:

Date of the most recent review of this summary: March 2024

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

This information is intended for healthcare professionals only:

Reconstituted solution:

The solution for immediate use is prepared by injecting 10 ml of sodium chloride 0.9% injection solution into the vial containing the powder. This solution may 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% injection solution and subsequently diluted with 100 ml of sodium chloride 0.9% injection solution or glucose 5% injection solution (i.e., to a concentration of approximately 0.4 mg/ml).

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

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

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

From a microbiological standpoint, the product should be used immediately. If not used immediately, the user is responsible for the storage times and conditions prior to use.

The medicinal product must be administered intravenously over 2–15 minutes.

The vial contents are for single intravenous use only. Any unused portion of the product remaining in the vial or any vial with a changed appearance (e.g., turbidity or precipitation observed) must be discarded.

The appearance of the product after reconstitution is a clear, colourless or slightly yellow solution.