Prospect: Information for the user

Pantecta 40 mg gastro-resistant tablets

pantoprazol

Read this prospect carefully before starting to take this medicine, as 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 are not listed in this prospect. See section 4.

1.What is Pantecta and for what it is used

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

3.How to take Pantecta

4.Possible adverse effects

5Storage 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 and above to treat:

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

Pantecta is used in adults to treat:

-Infection caused by a bacteria calledHelicobacter pyloriin 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 ulcers reappearing

-Stomach and duodenal ulcers,

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

Do not take Pantecta

• 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 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 have decreased vitamin B12 reserves or risk factors for it and receive long-term treatment with pantoprazole. Like all medications that reduce acid production, 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.
• 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 Pantecta 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 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 suffer from 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 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 underlying diseases:

- Unintentional weight loss

- Vomiting, particularly if repeated

- Blood in vomit: may appear as a dark brown powder in your vomit

- If you notice blood in your stool, which may appear black or dark

- Difficulty swallowing or pain when swallowing

- Pale appearance and feeling of weakness (anemia)

• Chest pain
• Abdominal pain
• Severe or persistent diarrhea, as Pantecta has been associated with a small increase in infectious diarrhea.
• Severe skin reactions have been reported in relation to Pantecta treatment, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug-induced hypersensitivity syndrome (DRESS), and erythema multiforme. Stop taking Pantecta and contact your doctor immediately if you experience any of the 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 regularly monitor you. 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 infection, 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 undergo 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, believe 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 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.

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 and swallow them whole with water.

Recommended dose:

Adults and adolescents 12 years and older:

For the treatment of esophagitis by reflux:

The usual dose is 1 tablet per day. Your doctor may indicate an increase to 2 tablets per day. The treatment time for esophagitis by reflux usually ranges from 4 to 8 weeks. Your doctor will tell you for how long to take this medication.

Adults:

For the treatment of an infection with a bacteria calledHelicobacter pyloriin patients with stomach and/or duodenal ulcer in combination with two antibiotics (eradication treatment)

1 tablet twice a day plus the 2 antibiotic tablets, either amoxicillin, clarithromycin and metronidazole (or tinidazole),eachmust be taken twice a daywith your pantoprazole tablet. Take thefirstpantoprazole tablet 1 hour before breakfast and thesecond1 hour before dinner. Follow your doctor's instructions and make sure to read the antibiotic prospectuses.

The treatment duration is usually 1 to 2 weeks.

For the treatment of stomach and duodenal ulcers:

The usual dose is 1 tablet per day. The dose may be doubled by your doctor.

Your doctor will tell you for how long to take this medication. 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 production:

The initial recommended dose is 2 tablets per day. Take the 2 tablets 1 hour before a meal. Your doctor may then adjust your dose, depending on the amount of stomach acid you produce. If you are prescribed more than 2 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 Pantecta for the elimination ofHelicobacter pylori.

Patients with liver problems

If you have severe liver problems, you should not take more than1 tablet of 20 mg of pantoprazole per day(for this case, tablets of 20 mg of pantoprazole are available).

If you have moderate or severe liver problems, you should not take Pantecta for the elimination ofHelicobacter pylori.

Use in children and adolescents

These tablets are not recommended for use in children under 12 years old.

If you take more Pantecta than you should

Tell your doctor or pharmacist. There are no known symptoms of overdose.

If you forgot to take Pantecta

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

If you interrupt treatment with Pantecta

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

If you have any other doubts about the use of this medication, ask your doctor or pharmacist or nurse.

Like all medicines, this medicine may 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 nearest hospital's emergency service.

• 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, swelling of the face due to an allergic reaction (Quincke's edema/angioedema), intense dizziness with very rapid heartbeats and excessive sweating.
• Severe skin alterations (frequency unknown; cannot be estimated with available data)):You may notice one or more of the following-blistering on the skin and a rapid deterioration of overall conditions, erosion (including light 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 red spots 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; cannot be estimated with available data)):yellow discoloration of the skin and the white of the eyes (severe liver cell damage, jaundice), or fever, hives, increased size of the kidneys sometimes with painful urination 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.

- 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 fracture, wrist fracture, and spinal column fracture.

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

Loss or complete absence of taste; visual disturbances such as blurred vision; urticaria; joint pain; muscle pain; weight changes; elevated 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)

Aluminum deposition, confusion (especially in patients with a history of these symptoms), sensation of tingling, pinching, numbness, burning, or numbness,skin rash, possibly with joint pain, inflammatory bowel disease 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; 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 theSpanish System for the 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 doubtask 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 40 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 packaging of Pantecta

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

Packaging: bottles (polyethylene high-density container with a polyethylene low-density closure 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 gastro-resistant tablets.

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

Blister packaging with7, 10, 14, 15, 24, 28, 30, 48, 49, 56, 60, 84, 90, 98, 98(2x49), 100, 112, 168gastro-resistant tablets.

Clinical packaging with 50, 90, 100, 140, 50(50x1), 140(10x14), 150(10x15), 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. Production site Oranienburg

Lehnitzstrasse, 70-98

(Oranienburg)-16515

Germany

or

Delpharm Novara S.r.l.

Via Crosa, 86

28065 Cerano (NO)

Italy

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

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

More detailed information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/