Prospecto: Information for the User

Anagastra 40 mg powder for injectable solution

pantoprazol

Read this prospectus carefully before starting to take the medicine, because it contains important information for you

• Keep this prospectus, as you may need to read it again.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed only for you and should not be given to others even if they have the same symptoms as you, as it may harm them.
• If you experience adverse effects, consult your doctor, pharmacist, or nurse, even if they do not appear in this prospectus. See section 4.

1.What is Anagastra and for what it is used

2. What you need to know before starting to use Anagastra

3.How to use Anagastra

4.Possible adverse effects

5Storage of Anagastra

6. Contents of the package and additional information

Anagastra contains the active substance pantoprazol

Anagastrais a selective proton pump inhibitor, a medication that reduces the amount of acid produced in your stomach. It is usedfor the treatment of diseases related to stomach acid and intestine. 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. Pantoprazol tablets will replace injections as soon as your doctor considers it appropriate.

Anagastra is used for the treatment in adults of:

-Gastroesophageal 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.

No use Anagastra

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

Warnings and Precautions

Consult 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 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 hips, wrists, 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 Anagastra for more than three months, it is possible that magnesium levels in the blood 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 Anagastra for reducing stomach acid.
• If you suffer from a skin rash, especially in areas of the skin exposed to the sun, consult your doctor as soon as possible, as it may be necessary to interrupt treatment with Anagastra. 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 underlying diseases:

- Unintentional weight loss

- Vomiting, particularly if repeated

- Blood in the vomit: it may appear as a dark brown powder in your vomit

- If you notice blood in your stools, which may appear black or melena

- Difficulty swallowing, or pain when swallowing

- Pale appearance and feeling weak (anemia)

• Chest pain
• Abdominal pain
• Severe or persistent diarrhea, as Anagastra has been associated with a small increase in infectious diarrhea.
• Severe skin reactions have been reported in relation to Anagastra treatment, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and erythema multiforme. Stop taking Anagastra and call your doctor immediately if you experience any symptoms related to severe skin reactions described in section 4

Your doctor will decide if you need additional testing to rule out malignant disease, as pantoprazole may alleviate cancer symptoms and potentially delay diagnosis. If your symptoms persist despite treatment, further investigations will be performed.

Children and Adolescents

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

Use of Anagastra with other medications

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.

Anagastra 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 Anagastra may make these and other medications less effective.
• Warfarin and fenprocumon, which affect blood clotting. You may need additional monitoring.
• 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 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).

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

Pregnancy, Breastfeeding, and Fertility

There is insufficient data on the use of pantoprazole in pregnant women. Pantoprazole has been reported to be excreted in human breast milk.

If you are pregnant, breastfeeding, believe you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

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

Driving and Operating Machines

Anagastra has no influence or this is insignificant on the ability to drive or operate machines.

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

Anagastra contains sodium

This medication contains less than 1 mmol of sodium (23 mg) 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 gastroesophageal reflux esophagitis.

One vial (40 mg of pantoprazole) 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 pantoprazole) 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 controlrapidlystomach 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 haveseriousliver 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 Anagastra 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.

No known symptoms of overdose exist.

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

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

If you consider that any of the side effects you experience 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)may cause swelling of the tongue and/or throat, difficulty swallowing, hives (urticaria), difficulty breathing, swelling of the face due to an allergic reaction (Quincke's edema/angioedema), intense dizziness with very rapid heartbeats and excessive sweating.

• Severe skin disorders (frequency unknown; cannot be estimated from available data)):You may notice one or more of the following-blistering of the skin and a rapid deterioration of general conditions, erosion (including light bleeding) of eyes, nose, mouth/lips or genitalsor skin sensitivity/eruption, particularly in areas of skin exposed to light/sun. You may also have joint pain or symptoms similar to 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, Multiforme erythema),Lupuserythematosus subacute, Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), Photosensitivity). Circular or target-shaped red patches on the trunk, often with blisters in the center, peeling, ulcers in the mouth, throat, nose, genitals, and eyes. These severe exanthems may be preceded by fever and symptoms similar to the flu (Stevens-Johnson syndrome, toxic epidermal necrolysis). Generalized exanthem, elevated body temperature, and lymphadenopathy (DRESS or drug hypersensitivity).

• Other serious conditions (frequency unknown):Yellowing 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:

• Common(may affect 1 in 10 patients)

Phlebitis 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; swelling and flatulence (gas); constipation; dry mouth; abdominal pain and discomfort; hives on the skin, exanthem, rash; 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 available data)

Illusion, confusion (especially in patients with a history of these symptoms),sensation of tingling, pinching, 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 fat in the blood; 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 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 a possible side effect not listed in this leaflet. You can also report them directly through theSpanish 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.

Keepthis medicationout 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.

Do not store at a temperature above 25°C

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

Do not use Anagastra 40 mg i.v. if you observe a change in appearance (e.g., if you observe turbidity or precipitates)

Medicines should not be disposed of through drains or in the trash.Deposit the packaging and unused medications at the SIGRE collection point at the pharmacy.In case of doubtask your pharmacist how to dispose of the packaging and unused medications. By doing so, you will help protect the environment.

Composition ofAnagastra

The active ingredient is pantoprazol.Each vial contains 40 mg of pantoprazol (in the form of pantoprazol sodium).

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

Appearance of the product and contents of the packaging ofAnagastra

Anagastra is a white or off-white powder for injectable solution. It is presented ina 10 ml transparent glass vial (type I) with an aluminum capsule and a grey rubber stopper that contains 40 mg of powder for injectable solution.

Anagastra is available in the following packaging sizes:

Package with 1 vial

Package with 5 (5 packages of 1) vials

Clinical package with 1 vial

Clinical package with 5 (5 packages of 1) vials

Clinical package with 10 (10 packages of 1) vials

Clinical package with 20 (20 packages of 1) vials

Only some packaging sizes may be commercially available.

Marketing Authorization Holder

Takeda GmbHGmbH

Byk Gulden Strasse, 2 (Konstanz)-78467

Germany

Responsible for manufacturing

Takeda GmbH

Production site Singen

Robert Bosch Strasse, 8

78224 Singen

Germany

You can request more information about this medicine by contacting 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 medicine is authorized in the member states of the European Economic Area with the following names:

Last review date of this leaflet:04/2023

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

This information is intended solely for doctors or 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.

Anagastra 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 (e.g. if turbidity or precipitates are observed)