PANTECTA 20 mg GASTRO-RESISTANT TABLETS

Introduction

Leaflet: Information for the user

Pantecta 20 mg gastro-resistant tablets

pantoprazole

Read the entire leaflet carefully before starting to take the medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. See section 4.

Contents of the leaflet:

1. What is Pantecta and what is it used for
2. What you need to know before taking Pantecta
3. How to take Pantecta
4. Possible side effects
5. Storage of Pantecta
6. Package contents and additional information

1. What is Pantecta and what is it used for

Pantecta contains the active substance pantoprazole. Pantecta 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 intestinal acid.

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

• Symptoms (such as heartburn, acid reflux, pain when swallowing) associated with gastroesophageal reflux disease caused by acid reflux from the stomach.

• Long-term treatment of reflux esophagitis (inflammation of the esophagus accompanied by acid reflux from the stomach) and prevention of relapses.

Pantecta is used in adults to treat

Prevention of gastroduodenal ulcers induced by non-steroidal anti-inflammatory drugs (NSAIDs, such as ibuprofen) in patients at risk who require continuous treatment with these types of drugs.

2. What you need to know before taking Pantecta

Do not take Pantecta

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

Warnings and precautions

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

• If you have serious 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 your liver enzymes increase, treatment should be discontinued.
• If you need to take non-steroidal 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 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. If you have low vitamin B12 body stores or risk factors for it and receive long-term treatment with pantoprazole. Like all medicines that reduce acid, 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
• Consult 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 Pantecta for more than three months, your magnesium levels in the blood may decrease. Low magnesium levels can cause fatigue, muscle contractions, disorientation, convulsions, dizziness, increased heart rate. If you experience any of these symptoms, go to the doctor immediately. Low magnesium levels can also produce a decrease in 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 Pantecta to reduce stomach acid.
• If you suffer from 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 Pantecta. 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, 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 dark
• Difficulty swallowing, or pain when swallowing
• Pale appearance and feeling of weakness (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 serious skin reactions in relation to treatment with Pantecta, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug hypersensitivity with eosinophilia and systemic symptoms (DRESS), and erythema multiforme. Stop taking Pantecta 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, as pantoprazole may alleviate the symptoms of cancer and delay its diagnosis. If, despite treatment, your symptoms persist, complementary tests 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 or events each time you visit your doctor.

Children and adolescents

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

Taking Pantecta with other medicines

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

Pantecta may affect the efficacy 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 to treat certain types of cancer), as Pantecta may make these and other medicines not work properly.
• Warfarin and fenprocoumon, which affect blood coagulation. You may need additional checks.
• 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 Pantecta, 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 the dose.
• Rifampicin (used to treat infections).
• St. John's Wort (Hypericum perforatum) (used to treat mild depression).

Talk to your doctor before taking Pantecta 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 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

Pantecta has no significant influence on the ability to drive or use machines.

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

Pantecta contains sodium

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

3. How to take Pantecta

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

Method of administration:

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

The recommended dose is:

Adults and adolescents from 12 years of age:

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, within a maximum of 4 weeks. Your doctor will indicate how long you should continue taking the medicine. Any recurring symptoms can be controlled as needed by taking one tablet per day.

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 Pantecta 40 mg once a day. After healing, you can reduce the dose back to one 20 mg tablet per day.

Adults:

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

The usual dose is one tablet per day.

Patient with liver problems

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

Use in children and adolescents:

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

If you take more Pantecta 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 taken. No symptoms of overdose are known.

If you forget to take Pantecta

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

If you stop taking Pantecta

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

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone 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:

• Severe allergic reactions (rare; may affect up to 1 in 1,000 people):swelling of the tongue and/or throat, difficulty swallowing, hives, difficulty breathing, swelling of the face of allergic origin (Quincke's edema/angioedema), severe dizziness with rapid heartbeat and profuse sweating.
• Severe skin disorders (frequency not known:the frequency 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 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 hypersensitivity with eosinophilia and systemic symptoms (DRESS), photosensitivity). Circular or target-like red patches on the trunk, often with blisters in the center, peeling, mouth ulcers, throat, nose, genitals, and eyes. These severe skin 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, increased kidney size with occasional pain when urinating, and lower back pain (severe kidney inflammation), which may lead to kidney failure.

Other side effects are:

• Frequent (may affect up to 1 in 10 patients): Benign stomach polyps.
• Uncommon(may affect up to 1 in 100 patients)

Headache; dizziness; diarrhea; feeling of dizziness, vomiting; swelling 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; hives; 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 the available data)

Hallucinations, confusion (especially in patients with a history of these symptoms), numbness, tingling, burning sensation, or 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 fat levels in the blood; sudden drop in white blood cell count, associated with high fever.

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

Reduced platelet count, which may cause bleeding or more bruising than usual; reduced white blood cell count, which may lead to more frequent infections; abnormal reduction in the balance between red and white blood cell count, 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 side effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. You can also report them 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 Pantecta

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiration date stated 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 disposed of through wastewater or household waste. Place the packaging and any unused medicine in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Container Contents and Additional Information

Pantecta Composition

The active ingredient is pantoprazole. Each gastro-resistant tablet contains 20 mg of pantoprazole (in the form of 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, triethyl citrate.

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

Product Appearance and Container Contents of Pantecta

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

Pantecta 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 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 Lehnitzstrasse 70 - 98 (Oranienburg) - 16515 – 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 under the following names:

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/