ANAGASTRA 40 mg GASTRO-RESISTANT TABLETS

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Anagastra 40 mg gastro-resistant tablets

pantoprazole

Read all of this 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.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

• Tell your doctor, pharmacist, or nurse if you get any side effects.

What is in this leaflet:

1. What Anagastra is and what it is used for
2. What you need to know before you take Anagastra
3. How to take Anagastra
4. Possible side effects

5 Storage of Anagastra

1. 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 inhibitor of the "proton pump", a medicine that reduces the amount of acid produced in your stomach. It is used to treat diseases related to stomach and intestine acid.

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

• Reflux esophagitis. This is an inflammation of your esophagus (the tube that connects your throat to your stomach) accompanied by acid reflux from the stomach.

Anagastra is used in adults to treat:

• Infection with a bacterium 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 ulcer recurrence

Stomach and duodenal ulcers

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

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).

If you are allergic to medicines that contain other proton pump inhibitors (e.g., omeprazole, lansoprazole, rabeprazole, esomeprazole)

Warnings and precautions

Tell your doctor, pharmacist, or nurse before taking 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.

If you have reduced 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 fatigue 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.

Tell your doctor if you have osteoporosis (reduced bone density) or if you have been told you are at risk of osteoporosis (e.g., if you are taking corticosteroids).

• If you take Anagastra for more than three months, your blood magnesium levels may decrease. Low magnesium levels can cause fatigue, muscle contractions, disorientation, convulsions, dizziness, increased heart rate. If you experience any of these symptoms, see your doctor immediately. Low magnesium levels can also lead to decreased 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 medicine similar to Anagastra to reduce stomach acid.

If you get 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 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).

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:

• Unintentional weight loss
• Vomiting, particularly if it is repeated
• Blood in your vomit: it may appear as a dark brown coffee grounds-like substance in your vomit
• If you notice blood in your stool, 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 Anagastra 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 rash 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.

If your symptoms persist despite treatment, further 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 new or unexpected symptoms or 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.

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.

Warfarin and phenprocoumon, which affect blood coagulation. 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 discontinue treatment with Anagastra because pantoprazole may increase methotrexate levels in the blood.

Tell your doctor if you are taking 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 human breast milk.

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking 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.

Do 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

Take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

Method of administration:

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 aged 12 years and older:

For the treatment of reflux esophagitis:

The usual dose is one tablet per day. Your doctor may increase the dose to 2 tablets per day. The treatment duration for reflux esophagitis is usually between 4 and 8 weeks. Your doctor will tell you how long to take this medicine.

Adults:

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

One tablet twice a day plus the two antibiotic tablets, either amoxicillin, clarithromycin, and metronidazole (or tinidazole), each taken twice a day with your pantoprazole tablet. Take the first pantoprazole tablet one hour before breakfast and the second one hour before dinner. Follow your doctor's instructions and read the leaflets of the antibiotics

The treatment duration is usually 1 to 2 weeks.

For the treatment of stomach and duodenal ulcers:

The usual dose is one tablet per day. The dose may be doubled by your doctor.

Your doctor will tell you how long to take this medicine. The treatment duration for stomach ulcers is usually between 4 and 8 weeks. The treatment duration for duodenal ulcers is usually between 2 and 4 weeks.

For long-term treatment of Zollinger-Ellison syndrome and other conditions in which there is an increase in stomach acid secretion:

The initial recommended dose is two tablets per day. Take the two tablets one hour before a meal. Your doctor may adjust the dose later, depending on the amount of acid secretion you produce. If you are prescribed more than two tablets per day, you should take the tablets divided into two doses per day. If you are prescribed more than four tablets per day, you will be told exactly when to stop treatment.

Patients with kidney problems:

• If you have kidney problems, you should not take Anagastra for the elimination of Helicobacter pylori.

Patients with liver problems

• If you have severe liver problems, you should not take more than one 20 mg pantoprazole tablet per day (20 mg pantoprazole tablets are available for this purpose).

If you have moderate or severe liver problems, you should not take Anagastra for the elimination of Helicobacter pylori.

Use in children and adolescents

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

If you take more Anagastra than you should

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

If you forget to take Anagastra

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

If you stop taking Anagastra

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

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

4. Possible Adverse Effects

Like all medicines, Anagastra can have adverse effects, although not all people suffer from them.

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

• Severe allergic reactions (rare frequency; 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 of allergic origin (Quincke's edema/angioedema), intense dizziness with very rapid heartbeats and profuse sweating.
• Severe skin disorders (frequency unknown; frequency cannot be estimated from 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 experience 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-shaped spots of slightly reddish color 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 flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis). Generalized exanthem, elevated body temperature, and lymphadenopathy (DRESS or drug hypersensitivity).
• Other severe conditions (frequency unknown; frequency cannot be estimated from available data): yellowing of the skin and whites of the eyes (severe liver cell damage, jaundice), or fever, rash, increased kidney size sometimes with pain when urinating and pain in the lower back (severe kidney inflammation), which may lead to kidney failure.

Other adverse 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; feeling of dizziness, vomiting; swelling and flatulence (gas); constipation; dry mouth; pain and discomfort in the abdomen; rash on the skin, exanthem, eruption; tingling; 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; vision disturbances such as blurred vision; hives; joint pain; muscle pain; weight changes; increased body temperature; high fever; swelling in the limbs (peripheral edema); allergic reactions; depression; increased breast size in men.

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

Disorientation

• Frequency unknown (cannot be estimated from available data)

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

Adverse 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 blood fat levels; 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 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)

Decrease in sodium, magnesium, calcium, or potassium levels in the 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 that is not listed in this prospectus.

You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es

By reporting adverse effects, you can contribute to providing 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 expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

This medicine does not require special storage conditions.

Medicines should not be thrown down the drain or into the trash. Deposit the packaging and medicines you no longer need at the SIGRE point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Anagastra

The active ingredient is pantoprazole. Each gastro-resistant tablet contains 40 mg of pantoprazole (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 Package Contents of Anagastra

Gastro-resistant tablet (tablet) of yellow color, oval, biconvex, and with the printing "P40" on one of the faces.

Packaging: bottles (high-density polyethylene packaging 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 package sizes:

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

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

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

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

Not all package 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 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

Phone: +34 91 790 42 22

This medicine is authorized in the Member States of the European Economic Area under the following names:

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

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