PROSPECTO : INFORMATION FOR THE USER

Anagastra 40 mg gastro-resistant tablets

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 other people,

although they may have the same symptoms as you, as it may harm them.

- If you experience any adverse effects, consult your doctor, pharmacist or nurse, even

if they are not listed 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 take Anagastra

3. How to take Anagastra

4. Possible adverse effects

5. Storage of Anagastra

6. Contents of the package and additional information

Anagastra contains the active substance pantoprazol

Anagastra is a selective proton pump inhibitor, a medication that reduces the amount of acid produced in your stomach. It is used for the treatment of diseases related to stomach acid and intestine.

Anagastra is used in adults and adolescents aged 12 and above to treat:

-Erosive esophagitis. This is an inflammation of your esophagus (the tube that connects your throat to your stomach) accompanied by regurgitation of acid from your stomach.

Anagastra is used in adults to treat:

- Infection caused by a bacteria called Helicobacter pylori in patients with stomach and/or duodenal ulcers in combination with two antibiotics (eradication treatment). The goal is to get rid of the bacteria and thus reduce the likelihood of ulcers reappearing

- Stomach and duodenal ulcers

-Zollinger-Ellison syndrome and other conditions in which too much acid is produced in the stomach

Do not take 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 (such as omeprazole, lansoprazole, rabeprazol, esomeprazole)

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take 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, especially when you are on long-term treatment with Anagastra. If liver enzyme levels increase, treatment should be interrupted.

- If you have decreased vitamin B12 reserves or risk factors for it and receive long-term treatment with pantoprazole. As all medications that reduce acid levels, pantoprazole may reduce vitamin B12 absorption. Consult your doctor if you notice any of the following symptoms, as they may indicate vitamin B12 deficiency:

- 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 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 developing osteoporosis (for example, if you are taking corticosteroids).

- If you are taking Anagastra for more than three months, it is possible that blood magnesium levels 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 decreased levels of potassium and calcium in the blood. Your doctor may decide to perform regular 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 sun-exposed areas, 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 diseases:

- Unintentional weight loss

- Vomiting, particularly if repeated

- Blood in vomit: may appear as a dark coffee powder in your vomit

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

- Difficulty swallowing or pain when swallowing

- Pale appearance and feeling of weakness (anemia)

- Chest pain

- Abdominal pain

- Severe or persistent diarrhea, as Anagastra has been associated with a small increase in infectious diarrhea.

- Cases of severe skin reactions have been reported in relation to Anagastra treatment, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug-induced hypersensitivity syndrome (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 delay diagnosis.

If your symptoms persist despite treatment, further investigations will be performed.

If you take Anagastra for a prolonged period (more than a year), your doctor may regularly monitor you. You should inform your doctor of any new or unexpected symptoms each time you attend your consultation.

Children and adolescents

Anagastra use is not recommended in children as it has not been tested in children under 12 years.

Concomitant use of Anagastra with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may 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) or erlotinib (used to treat certain types of cancer) as Anagastra may make these and other medications not work correctly.

- Warfarin and phenprocoumon, 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, tetrahidrocanabinol).

Pregnancy, breastfeeding, and fertility

No sufficient data is available on the use of pantoprazole in pregnant women. It has been reported that pantoprazole is excreted in breast milk.

If you are pregnant or breastfeeding, or if you think 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 machinery

Anagastra has no influence or insignificant influence on the ability to drive or operate machinery.

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

Anagastra contains sodium

This medication contains less than 23 mg of sodium (1 mmol) per tablet; it is essentially "sodium-free".

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Your doctor or pharmacist will provide you with the correct instructions for taking this medication.

Administration form:

Swallow the tablets whole with water, without chewing or breaking them, 1 hour before meals.

The recommended dose is:

Adults and adolescents 12 years and older:

For the treatment of esophagitis caused by reflux:

The usual dose is 1 tablet per day. Your doctor may recommend increasing the dose to 2 tablets per day. The treatment duration for esophagitis caused by reflux is usually between 4 and 8 weeks. Your doctor will tell you how long to take this medication.

Adults:

For the treatment of an infection caused by a bacteria called Helicobacter pylori in patients with stomach and/or duodenal ulcers in combination with two antibiotics (eradication treatment)

Treatment

Take 1 tablet twice a day, along with 2 antibiotic tablets, either amoxicillin, clarithromycin, and metronidazole (or tinidazole), each taken twice a day with your pantoprazole tablet. Take the first pantoprazole tablet 1 hour before breakfast and the second 1 hour before dinner. Follow your doctor's instructions and make sure to read the antibiotic packaging.

The treatment duration is usually 1 to 2 weeks.

For the treatment of stomach and duodenal ulcers:

The usual dose is 1 tablet per day. Your doctor may recommend doubling the dose. Your doctor will tell you how long to take this medication. The treatment duration for stomach ulcers is usually between 4 and 8 weeks, and for duodenal ulcers, it is usually between 2 and 4 weeks.

For long-term treatment of Zollinger-Ellison syndrome and other conditions that cause an increase in stomach acid production:

The initial recommended dose is 2 tablets per day. Take the 2 tablets 1 hour before a meal. Your doctor may adjust your dose based on the amount of stomach acid you produce. If you are prescribed more than 2 tablets per day, you should take them twice a day. If you are prescribed more than 4 tablets per day, you will be told exactly when to stop treatment.

Patients with kidney problems:

- If you have kidney problems, do not take Anagastra for Helicobacter pylori elimination.

Patients with liver problems

- If you have severe liver problems, do not take more than 1 tablet of 20 mg pantoprazole per day (for this case, 20 mg pantoprazole tablets are available).

- If you have moderate or severe liver problems, do not take Anagastra for Helicobacter pylori elimination.

Use in children and adolescents

This medication is not recommended for children under 12 years old.

If you take more Anagastra than you should

Tell your doctor or pharmacist or call the Toxicology Information Service at 91 562 04 20, indicating the medication and the amount ingested. There are no known symptoms of overdose.

If you forget to take Anagastra

Do not take a double dose to make up for the missed dose. Take your next dose as usual.

If you interrupt treatment with Anagastra

Do not stop taking these tablets without consulting your doctor or pharmacist first.

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

Like all medicines, Anagastra can have side effects, although not everyone will experience them.

Not everyone will experience them.

If you experience any of the following side effects, stop taking these tablets and inform your doctor immediately, or contact the hospital's emergency service nearest to you.

Stop taking these tablets and inform your doctor immediately, or contact the hospital's emergency service nearest to you.

Stop taking these tablets and inform your doctor immediately, or contact the hospital's emergency service nearest to you.

-Severe allergic reactions(rare; may affect up to 1 in 1,000 people): 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 alterations(frequency unknown; its frequency cannot be estimated with the available data): you may notice one or more of the following - blisters on the skin and a rapid deterioration of general conditions, erosion (including light bleeding) of eyes, nose, mouth/lips or genitals or 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 lymph nodes (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, Acute cutaneous lupus erythematosus, Pharmacological 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 severe conditions(frequency unknown; its frequency cannot be estimated with the available data): yellowing of the skin and the white of the eyes (severe liver cell damage, jaundice), or fever, hives, enlarged kidneys sometimes with painful urination and lower back pain (severe kidney inflammation), possibly leading to renal failure.

Other side effects are:

- Frequent(may affect up to 1 in 10 patients): benign polyps in the stomach.

-Infrequent(may affect up to 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; sensation of weakness, fatigue or general malaise; sleep disturbances; hip, wrist, and spinal column fractures.

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

Alteration or complete absence of taste; visual disturbances such as blurred vision; urticaria; joint pain; muscle pain; weight changes; elevated 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 the available data)

Illusion, confusion (especially in patients with a history of these symptoms), sensation of tingling, pinching, numbness, burning sensation or numbness, skin rash, possibly with joint pain, intestinal inflammation causing persistent watery diarrhea.

Side effects identified through blood tests:

-Infrequent(may affect up to 1 in 100 patients)

Increased liver enzymes.

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

Increased bilirubin; increased levels of fat in the blood; sudden drop in granular white blood cells in circulation, associated with high fever.

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

Reduction in the number of platelets that could cause bleeding or more frequent 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 unknown(cannot be estimated from the available data)

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

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist or nurse, even if it is a possible side effect that does not appear in this leaflet.

You can also report them directly through the Spanish System for the Vigilance of Medicinal Products for Human Use:www.notificaRAM.es

By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out 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.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and

medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask

your pharmacist how to dispose of the packaging and medications you no longer need.This

will help protect the environment.

Composition of Anagastra

The active ingredient is pantoprazole. Each gastro-resistant tablet contains 40 mg of

pantoprazole (in the form of sodium sesquihydrate).

The other components are:

Core: anhydrous sodium carbonate, mannitol, crospovidone, povidone K90, calcium stearate.

Coating: hypromellose, povidone K25, titanium dioxide (E171), yellow iron oxide (E172), propylene glycol (E1520)

, ethyl acrylate-methacrylic acid copolymer (1:1), poloxamer 80, sodium lauryl sulfate, triethyl citrate.

Printing ink: shellac, red, yellow, and black iron oxide (E172), concentrated ammonia solution.

Appearance of the product and contents of the Anagastra packaging

Gastro-resistant tablet (tablet) of yellow color, oval, biconvex shape, with the imprint “P40” on one face.

Packaging: bottles (polyethylene high-density container with a polyethylene low-density closure with a screw thread) and blisters (Alu/Alu blisters) without cardboard reinforcement or with cardboard reinforcement (pocket pack).

Anagastra is available in the following packaging sizes:

Bottles with 7, 10, 14, 15, 24, 28, 30, 48, 49, 56, 60, 84, 90, 98, 98 (2x49), 100 gastro-resistant tablets.

Clinical packs with 50, 90, 100, 140, 140 (10x14), 150 (10x15), 700 (5x140) gastro-resistant tablets.

Blisters with 7, 10, 14, 15, 24, 28, 30, 48, 49, 56, 60, 84, 90, 98, 98 (2x49), 100, 112, 168 gastro-resistant tablets.

Clinical packs with 50, 90, 100, 140, 50 (50x1), 140 (10x14), 150 (10x15), 500, 700 (5x140) gastro-resistant tablets.

Not all packaging sizes may be commercially available.

Marketing Authorization Holder

Takeda GmbH

Byk Gulden Strasse, 2 (Konstanz)-78467

Germany

Manufacturer

Takeda GmbH.

Production site Oranienburg

Lehnitzstrasse, 70-98

16515 Oranienburg

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