Anagasta 40 mg gastro-resistant tablets

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Anagastra 40 mg gastro-resistant tablets

pantoprazole

Read the entire 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.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only and must not be given to other people,

even if they have the same symptoms as you, because it could harm them.

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

if they are effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What Anagastra is and what it is used for
2. What you need to know before taking Anagastra
3. How to take Anagastra
4. Possible side effects
5. How to store Anagastra
6. 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 proton pump inhibitor, a medicine that reduces the amount of acid produced in your stomach. It is used for the treatment of acid-related diseases of the stomach and intestine.

Anagastra is used in adults and adolescents from 12 years of age to treat:

• Gastroesophageal reflux disease (GORD). This is inflammation of your oesophagus (the tube connecting your throat to your stomach), accompanied by regurgitation of acid from the stomach.

Anagastra is used in adults to treat:

• Infection with a bacterium called Helicobacter pylori in patients with gastric and/or duodenal ulcer, in combination with two antibiotics (eradication therapy). The aim is to eliminate the bacterium and thereby reduce the likelihood of ulcer recurrence.

• Gastric and duodenal ulcers.

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

2. What you need to know before taking Anagastra

Do not take Anagastra

• If you are allergic to pantoprazole or to any of the other ingredients of this medicine

(listed in section 6).

• If you are allergic to medicines containing other proton pump inhibitors (for example, omeprazole, lansoprazole, rabeprazole, esomeprazole).

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before taking 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 if you are on long-term treatment with Anagastra. If liver enzymes increase, treatment should be discontinued.

• If you have reduced body stores of vitamin B12 or risk factors for this and are receiving pantoprazole treatment for a prolonged period. Like all medicines that reduce acid levels, pantoprazole may reduce the absorption of vitamin B12. Consult your doctor if you experience any of the following symptoms, which could indicate vitamin B12 deficiency:

• Extreme tiredness or lack of energy

• Tingling

• Sore or red tongue, mouth ulcers

• Muscle weakness

• Vision disturbances

• Memory problems, confusion, depression

• Consult your doctor if you are taking protease inhibitors for HIV, such as atazanavir (for treatment of HIV infection), at the same time as pantoprazole.

• Taking a proton pump inhibitor such as pantoprazole, especially for more than one 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 osteoporosis (for example, if you are taking corticosteroids).

• If you are taking Anagastra for more than three months, your blood magnesium levels may decrease. Low magnesium levels can cause fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, and increased heart rate. If you experience any of these symptoms, contact your doctor immediately. Low magnesium levels may also lead to decreased levels of potassium and calcium in the blood. 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 for reducing stomach acidity.
• If you develop a skin rash, especially in areas of skin exposed to sunlight, 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).

Contact your doctor immediately, before or after taking this medicine, if you notice any of the following symptoms, which may be signs of more serious conditions:

• Unintentional weight loss

• Vomiting, particularly if recurrent

• Blood in vomit: this may appear as dark, coffee-ground-like material in your vomit

• Blood in your stools, which may appear black or tarry (melena)

• Difficulty swallowing, or pain when swallowing

• Pale appearance and feeling weak (anemia)

• Chest pain

• Stomach pain

• Severe or persistent diarrhea, as Anagastra has been associated with a small increased risk of infectious diarrhea

• Serious skin reactions have been reported in association with Anagastra treatment, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and erythema multiforme. Stop taking Anagastra and contact your doctor immediately if you experience any symptoms related to serious skin reactions described in section 4.

Your doctor will decide whether additional tests are needed to rule out malignant disease, as pantoprazole may relieve symptoms of cancer and could delay diagnosis.

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

If you take Anagastra for a prolonged period (more than one year), your doctor will likely monitor you regularly. You should inform your doctor of any new or unexpected symptoms or events at each visit.

Children and adolescents

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

Taking Anagastra with other medicines

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

Anagastra may affect the effectiveness of other medicines. Inform your doctor if you are taking:

• Medicines such as ketoconazole, itraconazole, and posaconazole (used to treat fungal infections) or erlotinib (used for certain types of cancer), as Anagastra may reduce the effectiveness of these and other medicines.
• Warfarin and phenprocoumon, which affect blood clotting. You may require 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 Anagastra, as pantoprazole may increase methotrexate blood levels.
• Fluvoxamine (used to treat depression and other psychiatric conditions). 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 are scheduled to undergo a specific urine test (for THC, tetrahydrocannabinol).

Pregnancy, breastfeeding, and fertility

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

This medicine should only be used if your doctor considers that the benefit to you outweighs the potential risk to the fetus or infant.

Driving and using machines

Anagastra has no effect or a negligible effect 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 medicine contains less than 23 mg of sodium (1 mmol) per tablet; essentially, it is "sodium-free."

3. How to take Anagastra

Follow exactly the administration instructions for this medicine as given by your
doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Method of administration:

Take the tablets one 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 instruct you to increase this to two
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 infection with a bacterium called Helicobacter pylori in patients
with gastric and/or duodenal ulcer, in combination with two antibiotics (eradication therapy):

One tablet twice daily, plus two antibiotic tablets—either amoxicillin, clarithromycin, and metronidazole (or tinidazole)—each to be taken twice daily together 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 make sure to read the package leaflets of the antibiotics.

The treatment duration is normally one to two weeks.

For the treatment of gastric and duodenal ulcers:

The usual dose is one tablet per day. Your doctor may double the dose. Your doctor will inform you of how long to take this medicine. The treatment duration for gastric ulcers is usually between 4 and 8 weeks. The treatment duration for duodenal ulcers is normally between 2 and 4 weeks.

For long-term treatment of Zollinger-Ellison syndrome and other conditions in which
increased gastric acid secretion occurs:

The recommended initial dose is two tablets per day. Take both tablets one hour before a meal. Subsequently, your doctor may adjust your dose depending on the amount of gastric acid secreted. If you are prescribed more than two tablets per day, you should take the tablets divided into two daily doses. 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 eradication 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 case).

• If you have moderate or severe liver problems, you should not take Anagastra for the eradication 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:

Inform your doctor or pharmacist or call the Toxicology Information Service at 91 562 04 20, indicating the medicine 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 missed doses. Take your next dose as usual.

If you stop taking Anagastra:

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

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

4. Possible adverse effects

Like all medicines, Anagastra may have adverse effects, although not everyone experiences them.

If you experience any of the following adverse effects, stop taking these tablets immediately and contact your doctor right away, or go to the nearest hospital emergency department.

• Severe allergic reactions (rare frequency; may affect up to 1 in 1,000 people): swelling of the tongue and/or throat, difficulty swallowing, rash (urticaria), breathing difficulties, allergic swelling of the face (Quincke's edema/angioedema), severe dizziness with very rapid heartbeat and excessive sweating.
• Severe skin disorders (frequency not known; cannot be estimated from available data): you may notice one or more of the following – skin blisters and rapid deterioration in general condition, erosion (including slight bleeding) of eyes, nose, mouth/lips or genitals, or skin sensitivity/rash, particularly in areas of skin exposed to light/sun. You may also experience joint pain or flu-like symptoms, 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 slightly reddish spots on the trunk, often with blisters in the center, skin peeling, ulcers in mouth, throat, nose, genitals and eyes. These severe rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis). Widespread rash, elevated body temperature, and swollen lymph nodes (DRESS or drug hypersensitivity).
• Other serious conditions (frequency not known; cannot be estimated from available data): yellowing of the skin and whites of the eyes (severe liver cell damage, jaundice), or fever, rash, kidney enlargement sometimes with pain on urination and lower back pain (severe kidney inflammation), which may possibly lead to kidney failure.

Other adverse effects are:

• Frequent (may affect up to 1 in 10 patients): Benign gastric polyps.
• 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; tingling; feeling of weakness, fatigue or general malaise; sleep disturbances; hip, wrist and spinal fractures.

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

Altered or complete loss of taste sensation; vision disturbances such as blurred vision; urticaria; joint pain; muscle pain; weight changes; increased body temperature; high fever; swelling in the limbs (peripheral edema); 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 available data)

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

Adverse 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 lipid levels; sudden drop in circulating granular white blood cells, associated with high fever.

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

Reduction in platelet count which could lead to bleeding or increased bruising; reduction in white blood cell count which could lead to more frequent infections; abnormal imbalance in the levels of red blood cells, white blood cells, and platelets.

• Frequency not known (cannot be estimated from available data)

Decreased levels of sodium, magnesium, calcium or potassium 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 they are possible adverse effects not listed in this leaflet.

You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Anagastra

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging after
CAD. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at a SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of Anagastra

The active substance is pantoprazole. Each gastro-resistant tablet contains 40 mg of
pantoprazole (as sodium sesquihydrate).

The 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.

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

Appearance of the product and pack contents of Anagastra

Yellow, oval, biconvex gastro-resistant tablet (tablet) with the imprint “P40” on one side.

Packaging: bottles (high-density polyethylene container with low-density polyethylene screw cap) and blisters (Alu/Alu blisters) without cardboard outer carton or with cardboard carton (pocket pack).

Anagastra is available in the following pack sizes:

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

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

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

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

Not all pack 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

For further information about this medicinal product, please contact 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 medicinal product is authorized in the Member States of the European Economic Area under the following names:

Date of the most recent review of this leaflet: 04/2023

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