Prospecto: Information for the User

Pantecta 20 mg gastro-resistant tablets

pantoprazol

Read this prospect carefully before starting to take the medicine, because it contains important information for you.

• Keep this prospect, 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 others 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 do not appear in this prospect. See section 4.

1.What is Pantecta and what is it used for

2.What you need to know before starting to take Pantecta

3.How to take Pantecta

4.Possible adverse effects

5.Storage of Pantecta

6.Contents of the package and additional information

Pantecta contains the active substance pantoprazol. Pantecta 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.

Pantecta is used in adults and adolescents aged 12 years 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.

Pantecta 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 Pantecta

• If you are allergic to pantoprazole or any of the other ingredients of this medication (listed in section 6).
• If you are allergic to medications that contain other proton pump inhibitors.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take Pantecta:

• 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 Pantecta. If liver enzyme levels increase, treatment should be discontinued.
• If you need to take nonsteroidal anti-inflammatory drugs (NSAIDs) continuously and take Pantecta, as there is a higher risk of developing stomach and intestinal complications. 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 gastrointestinal bleeding. If you have decreased vitamin B12 reserves or risk factors for it and receive long-term treatment with pantoprazole. Like all acid-reducing medications, pantoprazole may reduce vitamin B12 absorption. Consult your doctor if you notice any of the following symptoms, as they may indicate vitamin B12 deficiency:
• • Extreme fatigue or lack of energy
  • Tickling
  • Pain or redness in the tongue or mouth ulcers
  • Muscle weakness
  • Vision problems
  • Mental confusion, depression
• Consult your doctor if you are taking HIV protease inhibitors such as atazanavir (for HIV treatment) at the same time as pantoprazole.
• Long-term use of 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 (e.g., if you are taking corticosteroids).
• If you are taking Pantecta 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, increased heart rate. If you experience any of these symptoms, see your doctor immediately. Low magnesium levels can also cause a decrease in potassium and calcium levels 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 Pantecta for reducing stomach acid.
• If you experience a skin rash, especially in sun-exposed areas, consult your doctor as soon as possible, as it may be necessary to discontinue Pantecta treatment. Remember to mention any other symptoms you may notice, such as joint pain.
• If you are scheduled to have a specific blood test (Cromogranin A).

Inform your doctor immediately 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 your stool, which may appear black or dark

- Difficulty swallowing or pain when swallowing

- Pale appearance and feeling weak (anemia)

• Chest pain
• Stomach pain
• Severe or persistent diarrhea, as Pantecta has been associated with a small increase in infectious diarrhea.
• There have been reports of severe skin reactions associated with Pantecta treatment, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and erythema multiforme. Stop taking Pantecta and contact 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 cancer, as pantoprazole may alleviate cancer symptoms and potentially delay diagnosis. If your symptoms persist despite treatment, further investigations will be performed.

If you take Pantecta 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 and/or events each time you attend your appointment.

Children and adolescents

The use of Pantecta is not recommended in children, as it has not been tested in children under 12 years old.

Taking Pantecta with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication, including over-the-counter medications.

Pantecta 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 Pantecta may make these and other medications less effective.
• Warfarin and fenprocumon, which affect blood clotting. You may need additional monitoring.
• Medications used to treat HIV, such as atazanavir.
• Methotrexate (used to treat rheumatoid arthritis, psoriasis, and cancer). If you are taking methotrexate, your doctor may temporarily discontinue Pantecta 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 your dose.
• Rifampicin (used to treat infections).
• St. John's Wort (Hypericum perforatum) (used to treat mild depression).

Consult your doctor before taking Pantecta if you need to have a specific urine test (for THC, tetrahidrocanabinol).

Pregnancy, breastfeeding, and fertility

There is insufficient data on the use of pantoprazole in pregnant women. Pantoprazole has been reported to be excreted in human breast milk.

If you are pregnant, breastfeeding, or 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

Pantecta has no influence or has a negligible 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.

Pantecta 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.

Administration form:

Take the tablets 1 hour before meals without chewing or breaking them. 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. Subsequently, any recurring symptom can be controlled as needed by taking1 tablet per day.

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

The usual dose is 1 tablet per day. If the disease recurs, your doctor may double the dose, in which case you can take Pantecta 40 mgonceper day. After recovery, you can reduce the dose again to1 tabletof 20 mg per day.

Adults:

For the prevention of duodenal and stomach ulcers in patients requiring continued 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 than1 tablet of 20 mg per day.

Use in children and adolescents:

This medication is not recommended for use in children under 12 years.

If you take more Pantecta than you should

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

If you forgot to take Pantecta

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

If you interrupt treatment with Pantecta

Do not stop taking these tabletswithout 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 medicinecan cause side effects, although 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 emergency service at 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, hives (urticaria), difficulty breathing, allergic swelling of the face (Quincke's edema/angioedema), intense dizziness with very rapid heartbeats and excessive sweating.
• Severe skin changes (frequency unknown: its frequency cannot be estimated with the available data):you may notice one or more of the following-blistering on the skin and a rapid deterioration of overall conditions, erosion (including mild bleeding) of eyes, nose, mouth/lips or genitalsor skin sensitivity/eruption, particularly in areas of exposed skin 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, Multiform erythema, Acute cutaneous lupus erythematosus, Pharmacological reaction with eosinophilia and systemic symptoms (DRESS), Photosensitivity).Round or target-shaped patches 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 symptoms similar to the flu (Stevens-Johnson syndrome, toxic epidermal necrolysis). Generalized exanthem, elevated body temperature, and lymphadenopathy (DRESS or drug hypersensitivity).

• Other serious conditions (frequency unknown):yellow discoloration of the skin and the white of the eyes (severe liver cell damage, jaundice), or fever, hives, increased kidney size with occasional pain while urinating and lower back pain (severe kidney inflammation), possibly causing renal failure.

Other side effects are:

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

• Rare(mayaffect 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(mayaffect 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 eruption, possibly with joint pain,inflammatory bowel disease causing persistent watery diarrhea.

Side effects identified through blood tests:

• Rare(mayaffect up to 1 in 100 patients)

Increased liver enzymes.

• Rare(mayaffect 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(mayaffect up to 1 in 10,000 patients)

Reduction in the number of platelets that could cause bleeding or more frequent bruising; 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 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 theSpanish 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.

Keepthis medicationout of the sight and reach of children.

Do not usethis medicationafter 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.Deposit the packaging and medications you no longer need at the SIGRE collection pointat the pharmacy.In case of doubtplease ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Pantecta

The active ingredient is pantoprazol.Each gastro-resistant tablet contains 20 mg of pantoprazol (in the form of sodium sesquihydrate).

Theother componentsare:

Core:carbonate of sodium (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 Pantecta packaging

Gastro-resistant tablet (tablet) of yellow color, oval, biconvex, and with the imprint “P20” on one of the faces.

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

Pantecta 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, 112 gastro-resistant tablets.

Clinical packaging 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 packaging 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 packaging sizes.

Marketing Authorization Holder

Takeda GmbH

Byk Gulden Strasse, 2 (Konstanz)-78467

Germany

Responsible for manufacturing

TAKEDA GMBH
Lehnitzstrasse 70 - 98 (Oranienburg) - 16515 – Germany

For more information about this medication, 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 medication is authorized in the member states of the European Economic Area with the following names:

Last review date of this leaflet: 04/2023

For detailed information about this medication, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/