Package Insert: Information for the User

Anagastra 20 mg gastro-resistant tablets

pantoprazol

Read this package insert carefully before starting to take the medicine, because

it contains important information for you

- Keep this package insert, 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

even if they 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 package insert. See section 4.

1. What Anagastra is 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 to treat diseases related to

stomach and intestinal acid.

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

· Symptoms (for example, stomach burning, acid regurgitation, difficulty swallowing) associated with

gastroesophageal reflux disease caused by acid reflux from the stomach.

· Long-term treatment of esophagitis caused by acid reflux (inflammation of the esophagus accompanied by

acid regurgitation from the stomach) and prevention of relapses.

Anagastra is used in adults to treat:

· Prevention of gastroduodenal ulcers induced by nonsteroidal anti-inflammatory drugs (NSAIDs, for example, ibuprofen)

in patients at risk who require continued treatment with this type of medication.

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, rabeprazole, 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 discontinued.

-If you need to take nonsteroidal anti-inflammatory drugs (NSAIDs) continuously and take Anagastra, as there is a higher risk of developing complications in the stomach and intestines.

Any increased risk will be evaluated based on individual risk factors such as age (65 years or older), history of stomach or duodenal ulcers or hemorrhage.

-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 observe 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 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 (e.g., 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 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 sun-exposed areas, consult your doctor as soon as possible, as it may be necessary to discontinue Anagastra treatment. 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 brown powder in your vomit

Blood in stool: 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 this medication 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 report 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, despite treatment, your symptoms persist, 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 and/or events each time you attend your consultation.

Children and adolescents

The use of Anagastra 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 for fungal infections) or erlotinib (used for 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 for HIV treatment, such as atazanavir.

- Methotrexate (used to treat rheumatoid arthritis, psoriasis, and cancer), if you are taking methotrexate, your doctor may temporarily discontinue Anagastra treatment 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 the 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 need 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 noted that in humans, 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.

This medication should only be used if your doctor considers the benefit 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 adverse 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:

Take the tablets 1 hour before meals without chewing or breaking them and swallow them whole with water.

The recommended dose is:

Adults and adolescents 12 years and older:

For treating symptoms associated with gastroesophageal reflux disease (stomach burning, acid regurgitation, difficulty swallowing)

The usual dose is 1 tablet per day.

This dose usually provides relief within 2-4 weeks, and if not, within a maximum of 4 weeks. Your doctor will tell you how long you should continue taking the medication. Any recurring symptoms can be controlled as needed by taking 1 tablet per day.

For long-term treatment and prevention of esophagitis relapses due to gastroesophageal reflux

The usual dose is 1 tablet per day. If the disease returns, your doctor may double the dose, in which case you can take Anagastra 40 mg once a day. After recovery, you can reduce the dose again to 1 tablet of 20 mg per day.

Adults:

For the prevention of duodenal and stomach ulcers in patients requiring long-term treatment with NSAIDs

The usual dose is 1 tablet per day.

Patients with liver problems:

- If you have severe liver problems, do not take more than 1 tablet of 20 mg per day.

Use in children and adolescents:

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

If you take more Anagastra than you should:

Inform your doctor or pharmacist or call the Toxicology Information Service telephone 91 562 04 20, indicating the medication and the amount ingested. No symptoms of overdose are known.

If you forget to take Anagastra:

Do not take a double dose to compensate for the missed doses. 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, pharmacist, or nurse.

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

However, 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:

-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, allergic swelling of the face (Quincke's edema/angioedema), intense dizziness with very rapid heartbeats and excessive sweating.

-Severe skin alterations (frequency unknown; cannot be estimated from 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 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, 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):Yellowing of the skin and the white of the eyes (severe liver cell damage, jaundice), or fever, hives, increased kidney size with occasional pain when urinating 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; feeling 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 the sense 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 up to 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 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 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 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.

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

the 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 20 mg of

pantoprazole (in the form of sodium sesquihydrate).

The other components are:

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

Coating: hypromellose, povidone K25, titanium dioxide (E171), iron oxide yellow

(E172), propylene glycol (E1520), ethyl acrylate-methacrylic acid copolymer (1:1), polysorbate 80,

sodium lauryl sulfate, triethyl citrate.

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

Appearance of the product and contents of the Anagastra package

Gastro-resistant tablet (tablet) of yellow color, oval, biconvex, and with the

impression “P20” on one of the faces.

Packages: 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 package sizes:

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

Clinical packages with 50, 56, 84, 90, 112, 140, 140 (10x14 or 5x28), 150 (10x15), 280 (20x14 or 10x28), 500, 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 packages with 50, 56, 84, 90, 112, 140, 50(50x1), 140(10x14 or 5x28), 150(10x15), 280(20x14 or 10x28), 500, 700(5x140) gastro-resistant tablets.

They may not be commercially available in all package sizes.

Marketing Authorization Holder

Takeda GmbH

Byk Gulden Strasse, 2 (Konstanz)-78467

Germany

Responsible for manufacturing

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

Space 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