ANAGASTRA 20 mg GASTRO-RESISTANT TABLETS

2. What you need to know before you take Anagastra

Do not take Anagastra

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

(including those listed in section 6)

• If you are allergic to medicines 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. Tell 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 your liver enzymes increase, treatment should be discontinued.

especially when you are on long-term treatment with Anagastra. If your liver enzymes increase, treatment should be discontinued.

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

as there is a higher risk of developing complications in the stomach and intestine.

Any increased risk will be assessed according to your personal risk factors such as age (65 years or older), history of stomach or duodenal ulcers, or stomach or intestinal bleeding.

such as age (65 years or older), history of stomach or duodenal ulcers, or stomach or intestinal bleeding.

• If you have low body stores of vitamin B12 or risk factors for this and receive long-term treatment with pantoprazole. Like all acid-reducing medicines, pantoprazole may reduce the absorption of vitamin B12. Consult your doctor if you notice any of the following symptoms, as they may indicate a vitamin B12 deficiency:

• Extreme tiredness or lack of energy
• Numbness
• Pain in the tongue or red tongue, mouth ulcers
• Muscle weakness
• Visual disturbances
• Memory problems, confusion, depression

• Tell your doctor if you are taking HIV protease inhibitors such as atazanavir (for HIV infection 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 hip, wrist, or spine fractures.

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 three months, it is possible that your blood magnesium levels may decrease. Low magnesium levels can cause fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, and increased heart rate. If you experience any of these symptoms, go to your doctor immediately. Low magnesium levels can also cause a decrease in blood potassium and calcium levels. 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 to reduce stomach acid.
• If you get a skin rash, especially in areas of skin exposed to sunlight, 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 have a specific blood test (Chromogranin A).

Tell your doctor immediatelybefore or after taking this medicine if you notice any of the following symptoms, which may be signs of more serious diseases:

which may be signs of more serious diseases:

• Unintentional weight loss
• Vomiting, especially if it is repeated
• Blood in the vomit: it may appear as a dark coffee grounds-like substance in your vomit
• If you notice blood in your stools, which may appear black or tarry
• Difficulty swallowing, or pain when swallowing
• Pale appearance and feeling of weakness (anemia)
• Chest pain
• Stomach pain
• Severe or persistent diarrhea, as this medicine has been associated with a small increase in infectious diarrhea.
• There have been reports of serious skin reactions in relation to treatment with Anagastra, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug hypersensitivity with eosinophilia and systemic symptoms (DRESS), and erythema multiforme. Stop taking Anagastra and call your doctor immediately if you experience any of the symptoms related to serious skin reactions described in section 4.

Your doctor will decide if you need any additional tests to rule out a malignant disease because pantoprazole may alleviate the symptoms of cancer and could delay its diagnosis.

because pantoprazole may alleviate the symptoms of cancer and could delay its diagnosis.

If, despite treatment, your symptoms persist, additional tests will be performed.

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

Children and adolescents

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

as it has not been tested in children under 12 years of age.

Taking Anagastra with other medicines

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

Anagastra may affect the efficacy of other medicines. Tell your doctor if you are taking:

• Medicines 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 medicines not work properly.

or erlotinib (used to treat certain types of cancer), as Anagastra may make these and other medicines not work properly.

• Warfarin and phenprocoumon, which affect blood coagulation. You may need additional monitoring.

You may need 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 stop treatment with Anagastra because pantoprazole may increase methotrexate levels in the blood.

because 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 need to have a specific urine test (for THC, tetrahydrocannabinol).

Pregnancy, breastfeeding, and fertility

There is not enough data on the use of pantoprazole in pregnant women. It has been reported that pantoprazole is excreted in breast milk in humans.

in humans.

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

or plan 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 is greater than the potential risk to the fetus or baby.

Driving and using machines

Anagastra has no influence or negligible influence on the ability to drive or use machines.

or use machines.

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

Anagastra contains sodium

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

3. How to take Anagastra

Follow the instructions for administration of this medicine exactly as indicated by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

as indicated by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

Method of administration:

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

without chewing or breaking them and swallow them whole with water.

The recommended dose is:

Adults and adolescents aged 12 years and older:

To treat symptoms associated with gastroesophageal reflux disease (heartburn, acid reflux, pain when swallowing)

The usual dose is one tablet per day.

This dose usually provides relief within 2-4 weeks, and if not, at most, within the following 4 weeks. Your doctor will tell you how long you should continue taking the medicine. After that, any recurring symptoms can be controlled by taking one tablet per day as needed.

as needed.

For long-term treatment and prevention of relapses of reflux esophagitis

The usual dose is one tablet per day. If the disease recurs, your doctor may double the dose, in which case you can take Anagastra 40 mg once a day. After healing, you can reduce the dose back to one 20 mg tablet per day.

back to one 20 mg tablet per day.

Adults:

To prevent duodenal and stomach ulcers in patients who require continued treatment with NSAIDs

The usual dose is one tablet per day.

Patient with liver problems

• If you have severe liver problems, you should not take more than one 20 mg tablet per day.

per day.

Use in children and adolescents:

The use of these tablets is not recommended in children under 12 years of age.

under 12 years of age.

If you take more Anagastra than you should

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

indicating the medicine and the amount taken. No symptoms of overdose are known.

If you forget to take Anagastra

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

as usual.

If you stop taking Anagastra

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

first.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

although not everybody gets them.

If you experience any of the following side effects, stop taking these tablets and inform your doctor immediately, or contact the emergency department of the nearest hospital:

or contact the emergency department of the nearest hospital:

• Severe allergic reactions (rare; may affect up to 1 in 1,000 people): swelling of the tongue and/or throat, difficulty swallowing, rash (urticaria), difficulty breathing, swelling of the face of allergic origin (Quincke's edema/angioedema), intense dizziness with very rapid heartbeats and profuse sweating.
• Severe skin disorders (frequency not known; cannot be estimated from the available data): you may notice one or more of the following - blisters on the skin and rapid deterioration of general conditions, erosion (including slight bleeding) of eyes, nose, mouth/lips, or genitals, or sensitivity/skin rash, particularly in areas of skin exposed to light/sun. You may also have joint pain or symptoms similar to those of 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, erythema multiforme, subacute cutaneous lupus erythematosus, drug reaction with eosinophilia and systemic symptoms (DRESS), photosensitivity). Circular or target-like reddish patches on the trunk, often with blisters in the center, peeling, ulcers in the mouth, throat, nose, genitals, and eyes. These severe rashes can be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis). Generalized rash, high body temperature, and lymphadenopathy (DRESS or drug hypersensitivity).

• Other serious conditions (frequency not known): yellowing of the skin and whites of the eyes (severe liver cell damage, jaundice), or fever, rash, increase in kidney size with occasional pain when urinating, and lower back pain (severe kidney inflammation), which can lead to kidney failure.

which can lead to kidney failure.

Other side effects are:

• Frequent (may affect up to 1 in 10 patients): benign polyps in the stomach.
• 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; numbness; feeling of weakness, fatigue, or general malaise; sleep disturbances; hip, wrist, and spine fractures.

• Rare (may affect up to 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; peripheral edema (swelling in the extremities); 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 the available data)

Hallucinations, confusion (especially in patients with a history of these symptoms), numbness, tingling, burning sensation, or feeling of numbness, skin rash, possibly with joint pain, inflammation of the large intestine that causes persistent watery diarrhea.

Side 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 fat levels; sudden drop in white blood cells, associated with high fever.

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

Decreased platelet count, which can cause bleeding or more bruising than usual; decreased white blood cell count, which can lead to more frequent infections; abnormal decrease in the balance between red and white blood cells, as well as platelets.

• Frequency not known (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 side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet.

This includes any possible side effects not listed in this leaflet.

You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side 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.

out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date is the last day of the month stated.

after EXP. The expiry date is the last day of the month stated.

This medicine does not require any special storage conditions.

does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Return the containers and any unused medicine to the pharmacy. If you are unsure, ask your pharmacist how to dispose of the containers and any unused medicine. This will help protect the environment.

6. Container Content and Additional Information

Anagastra Composition

The active ingredient is pantoprazol. Each gastro-resistant tablet contains 20 mg of

pantoprazol (in the form of sodium sesquihydrate).

Other components are:

Core: sodium carbonate (anhydrous), 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), polysorbate 80,

sodium lauryl sulfate, triethyl citrate.

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

Appearance of the Product and Container Content of Anagastra

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

printing “P20” on one of the faces.

Containers: bottles (high-density polyethylene container with a screw cap made of low-density polyethylene) and blisters (Alu/Alu blisters) without cardboard reinforcement, or with cardboard reinforcement (pocket pack).

Anagastra is available in the following container 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 containers with 50, 56, 84, 90, 112, 140, 140 (10x14 or 5x28), 150 (10x15), 280 (20x14 or 10x28), 500, 700 (5x140), gastro-resistant tablets.

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

Clinical containers 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.

Not all container sizes may be marketed.

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 medication 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

Phone: +34 91 790 42 22

This medication is authorized in the member states of the European Economic Area with the following names:

Names of the Medication in each Member State:

Date of the last revision of this prospectus: 04/2023

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