Anagasta 40 mg powder for injection solution

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Anagastra 40 mg powder for concentrate for solution for infusion

pantoprazole

Read the entire 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 questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could be harmful to them.
• If you experience any side effects, talk to your doctor, pharmacist or nurse, even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet:

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

1. What Anagastra is and what it is used for

Anagastra contains the active substance pantoprazole.

Anagastra is a selective proton pump inhibitor, a medicine that reduces the amount of acid produced in your stomach. It is used for the treatment of acid-related diseases of the stomach and intestine. This medicine is injected into a vein and will only be administered to you if your doctor considers that an injection of pantoprazole is, at this time, more suitable for you than pantoprazole tablets. Tablets will replace the injections as soon as your doctor considers it appropriate.

Anagastra is used for the treatment in adults of:

• Reflux esophagitis. This is an 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 Anagastra

Do not use Anagastra

• 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 (for example, omeprazole, lansoprazole, rabeprazole, esomeprazole)

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting to use Anagastra:

• If you have severe liver problems. Inform your doctor if you have ever had liver problems in the past. Your doctor will monitor your liver enzymes more frequently. If liver enzymes increase, treatment should be discontinued.
• Consult your doctor if you are taking protease inhibitors for HIV, 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 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 osteoporosis (for example, if you are taking corticosteroids).
• If you are taking Anagastra for more than 3 months, your blood magnesium levels may decrease. Low magnesium levels can cause fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, and 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 your magnesium levels.
• If you have ever had a skin reaction after treatment with a medicine similar to Anagastra 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 Anagastra. 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 taking 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
• If you notice blood in your stools, which may appear black or tarry (melena)
• Difficulty swallowing, or pain when swallowing
• Pale appearance and feeling weak (anemia)
  • Chest pain
  • Stomach pain
  • Severe or persistent diarrhea, as Anagastra has been associated with a small increased risk of infectious diarrhea.
  • Serious skin reactions have been reported with Anagastra treatment, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and erythema multiforme. Stop taking Anagastra and contact your doctor immediately if you experience any symptoms related to serious skin reactions described in section 4.

Your doctor will decide whether additional tests are needed to rule out malignancy, as pantoprazole may relieve symptoms of cancer and could delay diagnosis. If your symptoms persist despite treatment, further investigations will be carried out.

Children and adolescents

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

Use of Anagastra with other medicines

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.

Anagastra 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), as Anagastra 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 treatment with Anagastra, 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).

Talk to your doctor before taking Anagastra if you are scheduled for a specific urine test (for THC, tetrahydrocannabinol).

Pregnancy, breastfeeding, and fertility

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.

This medicine should only be used if your doctor considers that the benefit to you outweighs the potential risk to the fetus or infant.

Driving and use of machines

Anagastra has no effect or a negligible effect on the ability to drive or operate machinery.

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

Anagastra contains sodium

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

3. How to use Anagastra

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 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 you are prescribed more than two vials (80 mg) per day, the injections will be given in equal divided doses. Your doctor may temporarily prescribe a dose of more than four vials (160 mg) per day. If rapid control of stomach acid levels is needed, an initial dose of 160 mg (four vials) should be sufficient to considerably reduce stomach acid production.

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 Anagastra 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.

There are no known symptoms of overdose.

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 may cause adverse effects, although not everyone will experience them.

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effect not listed in this leaflet, inform your doctor or pharmacist.

• Severe allergic reactions (rare frequency: 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 (angioedema/Quincke's edema), 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 general condition, erosion (including slight bleeding) of eyes, nose, mouth/lips or genitals, or skin sensitivity/rash, particularly in areas of skin exposed to light/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.

• Circular or target-shaped slightly reddish spots on the trunk, often with blisters in the center, skin peeling, ulcers in mouth, throat, nose, genitals and eyes. These severe rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).

• Generalized rash, elevated body temperature, and lymphadenopathy (DRESS or drug hypersensitivity syndrome).

• Other serious conditions (frequency not known): yellowing of the skin and whites of the eyes (severe liver cell damage, jaundice), or fever, rash, enlarged kidneys sometimes with pain when urinating and lower back pain (severe kidney inflammation), which could possibly lead to kidney failure.

Other adverse effects are:

• Common (may affect up to 1 in 10 patients):

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

• Uncommon (may affect up to 1 in 100 patients):

headache; dizziness; diarrhea; feeling of dizziness, vomiting; bloating 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 spinal fractures.

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

altered or complete loss of taste; vision disorders 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; breast enlargement in men.

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

disorientation.

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

hallucination, 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 diarrhea.

Adverse effects identified through blood tests:

• Uncommon (may affect up to 1 in 100 patients):

Increased liver enzymes.

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

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

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

Reduction in platelet count, which could lead to bleeding or increased bruising; reduction in white blood cell count, which could lead to more frequent infections; abnormal reduction in the balance between 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 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 may 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 Anagastra

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

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Do not store above 25°C.

Keep the vial in the outer carton to protect it from light.

Use the reconstituted solution within 12 hours.

Use the reconstituted and diluted solution within 12 hours.

From a microbiological standpoint, the product should be used immediately. If not used immediately, the in-use storage duration 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 Anagastra 40 mg i.v. if you notice any change in its appearance (e.g., if cloudiness or precipitation is observed).

Medicines must not be disposed of via wastewater drains or household waste. Unused containers and medicines should be taken to a pharmacy’s SIGRE collection point. If in doubt, ask your pharmacist how to dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Anagastra

• The active substance is pantoprazole. Each vial contains 40 mg of pantoprazole (as sodium pantoprazole).

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

Appearance of the product and contents of the container of Anagastra

Anagastra is a white or almost white powder for injectable solution. It is supplied in a 10 ml clear glass vial (type I) with an aluminum cap and grey rubber stopper containing 40 mg of powder for injectable solution.

Anagastra is available in the following pack sizes:

Pack with 1 vial
Pack with 5 (5 packs of 1) vials
Hospital pack with 1 vial
Hospital pack with 5 (5 packs of 1) vials
Hospital pack with 10 (10 packs of 1) vials
Hospital pack with 20 (20 packs of 1) vials

Only some pack sizes may be commercially available.

Marketing Authorization Holder

Takeda GmbH
Byk Gulden Strasse, 2 (Konstanz) - 78467
Germany

Manufacturer

Takeda GmbH
Production site Singen
Robert Bosch Strasse, 8
78224 Singen
Germany

For further information on this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Local representative:

Takeda Farmacéutica España, S.A.
Calle Albacete, 5, 9th floor
Edificio Los Cubos
28027 Madrid
Spain
Tel: +34 91 790 42 22

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

Date of the most recent review of this leaflet: 03/2026

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:

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 may be administered directly or diluted in 100 ml of sodium chloride solution 9 mg/ml (0.9%) or glucose solution 50 mg/ml (5%) for infusion. For dilution, glass or plastic containers should be used.

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

After reconstitution, the solution may be used within 12 hours; however, from a microbiological standpoint, the product should be used immediately. If this is not possible, storage within the time and conditions of use is the responsibility of the user and should normally not exceed 12 hours at 25°C.

The medicine should be administered intravenously over 2–15 minutes.

Any unused portion remaining in the vial or any vial in which a change in visual appearance is observed (e.g., turbidity or precipitation) must be discarded.