PANTOZOL CONTROL 20 mg GASTRO-RESISTANT TABLETS

Introduction

Package Leaflet: Information for the Patient PANTOZOL Control 20 mg Gastro-Resistant Tabletspantoprazol

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

Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor or pharmacist exactly.

• Keep this package leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. See section 4.
• You should consult a doctor if your symptoms worsen or do not improve after 2 weeks.
• You must not use PANTOZOL Control tablets for more than 4 weeks without consulting a doctor.

Contents of the Package Leaflet:

1. What PANTOZOL Control is and what it is used for.
2. What you need to know before taking PANTOZOL Control.
3. How to take PANTOZOL Control
4. Possible side effects
5. Storage of PANTOZOL Control
6. Package Contents and Additional Information

1. What PANTOZOL Control is and what it is used for

PANTOZOL Control contains the active ingredient pantoprazol, which blocks the "pump" that produces acid in the stomach. Therefore, this medication reduces the amount of acid in your stomach.

PANTOZOL Control is used for the short-term treatment of symptoms of reflux (e.g., heartburn and acid regurgitation) in adults.

Reflux is the backflow of acid from the stomach into the throat (esophagus), which can cause inflammation and pain. This can cause symptoms such as a painful burning sensation in the chest, which can reach the throat (heartburn) and leave a sour taste in the mouth (acid regurgitation).

You may notice relief from acid reflux symptoms and heartburn after a single day of treatment with PANTOZOL Control, but this does not mean that the medication provides immediate relief. You may need to take the tablets for 2-3 consecutive days for symptom relief to occur.

You should consult a doctor if your symptoms worsen or do not improve after 2 weeks.

2. What you need to know before taking PANTOZOL Control

Do not take PANTOZOL Control:

• if you are allergic to pantoprazol or any of the other components of this medication (listed in section 6)
• if you are taking HIV protease inhibitors such as atazanavir, nelfinavir (for the treatment of HIV infection). See "Using PANTOZOL Control with other medications".

Warnings and Precautions

Consult your doctor or pharmacist before starting to take PANTOZOL Control:

• if you have received treatment for heartburn or dyspepsia continuously for 4 or more weeks.
• if you are over 55 years old and take daily treatment for dyspepsia without a medical prescription.
• if you are over 55 years old and experience new or recently changed reflux symptoms.
• if you have previously had a gastric ulcer or stomach surgery.
• if you have liver problems or jaundice (yellowing of the skin or eyes).
• if you regularly visit your doctor for severe discomfort or illness.
• if you are scheduled to undergo an endoscopy or a breath test with urea.
• if you have ever had a skin reaction after treatment with a medication similar to PANTOZOL Control to reduce stomach acidity.
• if you are scheduled to undergo a specific blood test (Chromogranin A)
• if you are taking HIV protease inhibitors, such as atazanavir, nelfinavir (for HIV infection treatment) at the same time as pantoprazol, consult your doctor in this case.

You must not take this product for more than 4 weeks without consulting your doctor. If reflux symptoms (acid stomach or acid regurgitation) persist for more than 2 weeks, consult your doctor, who will assess the need to take this medication long-term.

If you take PANTOZOL Control for longer periods, additional risks may occur, such as:

• reduced absorption of Vitamin B12, and Vitamin B12 deficiency if the patient already has low Vitamin B12 reserves
• fracture of the hip, wrist, or spine, especially if the patient suffers from osteoporosis or is taking corticosteroids (which can increase the risk of osteoporosis).
• decrease in blood magnesium levels (possible symptoms: fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, increased heart rate). Additionally, low magnesium levels can cause a decrease in blood potassium and calcium levels. You should consult your doctor if you have been taking this medication for more than 4 weeks. Your doctor will decide whether to perform periodic blood tests to monitor magnesium levels.

Inform your doctor immediatelybefore or after taking this medication if you notice any of the following symptoms, which could be signs of a more serious illness:

• Involuntary weight loss (not related to any diet or exercise).
• Vomiting, especially if it is repeated.
• Blood in the vomit, which may appear as dark coffee grounds in the vomit.
• Notice blood in your stool, which may appear black or like tar.
• Difficulty swallowing or pain when swallowing.
• You are pale or feel weak (anemia).
• Chest pain.
• Stomach pain.
• Severe and/or persistent diarrhea, as this medication has been associated with a slight increase in the occurrence of infectious diarrhea.
• If you experience 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 interrupt treatment with PANTOZOL Control.

Remember to mention any other symptoms you may notice, such as joint pain.

Your doctor may decide that it is necessary to perform some tests.

If you are going to have a blood test, inform your doctor that you are taking this medication.

You may notice relief from acid reflux symptoms and heartburn after a single day of treatment with PANTOZOL Control, but this does not mean that the medication provides immediate relief. You must not take it as a preventive measure.

If you have experienced symptoms of dyspepsia or heartburn repeatedly over time, remember to visit your doctor periodically.

Children and Adolescents

PANTOZOL Control must not be used by children and adolescents under 18 years of age due to the lack of safety information in this age group.

Other Medications and PANTOZOL Control

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medication. Especially medications that contain any of the following active ingredients:

• HIV protease inhibitors such as atazanavir, nelfinavir (used to treat HIV infection). You must not use PANTOZOL Control if you are taking HIV protease inhibitors. See "Do not take PANTOZOL Control";
• ketoconazole (used to treat fungal infections)
• warfarin and phenprocoumon (used to make blood more liquid and prevent clot formation). You may need to have additional blood tests. methotrexate (used to treat rheumatoid arthritis, psoriasis, and cancer). If you are taking methotrexate, your doctor may temporarily suspend your treatment with PANTOZOL Control because pantoprazol can increase methotrexate levels in the blood.

Do not take PANTOZOL Control with other medications that limit the amount of acid produced in the stomach, such as another proton pump inhibitor (omeprazol, lansoprazol, or rabeprazol) or an H2 antagonist (e.g., ranitidine, famotidine).

However, if necessary, you can take PANTOZOL Control with antacids (e.g., magaldrate, algic acid, sodium bicarbonate, aluminum hydroxide, magnesium carbonate, or combinations).

Pregnancy and Breastfeeding

You must not take this medication if you are pregnant or breastfeeding.

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

Driving and Using Machines

If you experience side effects such as dizziness or vision changes, you must not drive or use machines.

3. How to Take PANTOZOL Control

Follow the administration instructions for this medication indicated by your doctor or pharmacist exactly. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is one tablet per day. Do not exceed the recommended dose of 20 mg of pantoprazol per day.

You should take this medication for at least 2-3 consecutive days. Stop taking PANTOZOL Control when you are completely free of symptoms. You may notice relief from acid reflux symptoms and heartburn after a single day of treatment with PANTOZOL Control, but this does not mean that the medication provides immediate relief.

If you do not notice relief from symptoms after taking this medication for 2 consecutive weeks, consult your doctor.

Do not take PANTOZOL Control tablets for more than 4 weeks without consulting your doctor.

Take the tablet before one of the main meals, at the same time every day. You should swallow the tablet whole with a little water. Do not chew or break the tablet.

If you take more PANTOZOL Control than you should

Inform your doctor or pharmacist if you have taken a higher dose than recommended. If possible, bring your medication and this package leaflet with you.

If you forget to take PANTOZOL Control

Do not take a double dose to make up for the forgotten dose. Take the normal dose the next day, at the usual time.

If you have any other questions about the use of this medication, consult your doctor or pharmacist.

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone experiences them.

Inform your doctor immediatelyor contact the emergency department of the nearest hospital if you notice any of the following side effects. Stop taking this medication immediately, but bring this package leaflet and/or the tablets with you.

• Severe allergic reactions(rare: may affect up to 1 in 1,000 people): hypersensitivity reactions, also called anaphylactic reactions, anaphylactic shock, and angioedema. Typical symptoms are: swelling in the face, lips, mouth, tongue, and/or throat, which can cause difficulty swallowing or breathing, hives (urticaria), intense dizziness with very rapid heartbeats, and excessive sweating.
• Severe skin reactions(frequency not known: cannot be estimated from available data):skin rash with swelling, blister formation, or skin peeling, skin loss, and bleeding around the eyes, nose, mouth, or genitals, and rapid deterioration of your general health, or skin rash after sun exposure.
• Other serious side effects(frequency not known): yellowing of the skin and eyes (due to severe liver damage), or kidney problems such as pain when urinating and pain in the lower back with fever.

Other side effects include:

• Common side effects(may affect up to 1 in 10 people): Benign polyps in the stomach.

• Uncommon side effects(may affect up to 1 in 100 people): Headache; dizziness; diarrhea; nausea, vomiting; swelling and flatulence (gas); constipation; dry mouth; stomach discomfort and pain; hives or skin rash; itching; feeling of weakness, fatigue, or general malaise; sleep disorders; increased liver enzymes in blood tests, and fracture of the hip, wrist, or spine.

• Rare side effects:

Distortion or complete loss of taste; vision disorders such as blurred vision; joint pain; muscle pain; weight changes; elevated body temperature; swelling of the limbs; depression; increased bilirubin and fat levels in the blood (detected in blood tests), increased breast size in men; high fever, and sharp drop in circulating granulocytes (observed in blood tests).

• Very rare side effects(may affect up to 1 in 10,000 people): Disorientation, decreased platelet count in the blood, which can lead to more frequent bleeding or bruising than normal; decreased white blood cell count, which can lead to more frequent infections; coexistence of an abnormal reduction in the number of red blood cells, white blood cells, and platelets (observed in blood tests).

• Frequency not known

Hallucinations, confusion (especially in patients with a history of these symptoms); decreased sodium levels in the blood; decreased magnesium levels in the blood, skin rash, possibly with joint pain, sensation of tingling, numbness, paresthesia (tingling), burning, or numbness, inflammation of the large intestine that causes persistent watery diarrhea.

Reporting Side Effects

If you experience any side effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this package leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of PANTOZOL Control

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

Do not use this medication after the expiration date stated on the carton and blister after 'EXP'. The expiration date is the last day of the month indicated.

Store in the original package to protect from moisture.

Medications should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package Contents and Additional Information

PANTOZOL Control Composition

• The active ingredient is pantoprazol. Each tablet contains 20 mg of pantoprazol (as sodium sesquihydrate).
• - The other components are:
• • Core: Sodium carbonate (anhydrous), mannitol, crospovidone, povidone K90, and calcium stearate
  • Coating: Hypromellose, povidone, titanium dioxide (E171), yellow iron oxide (E172), propylene glycol, ethyl acrylate-methacrylic acid copolymer, sodium lauryl sulfate, polysorbate 80, and triethyl citrate.
  • Printing ink: Shellac, red, black, and yellow iron oxide (E172), and concentrated ammonia solution.

Product Appearance and Package Contents

The gastro-resistant tablets are yellow, oval, biconvex, coated, and printed with “P20” on one side.

PANTOZOL Control is available in Alu/Alu blisters with or without cardboard reinforcement.

The packages contain 7 or 14 gastro-resistant tablets.

Not all package sizes may be marketed.

Marketing Authorization Holder

Takeda GmbH

Byk-Gulden-Straße 2, 78467 Konstanz

Germany

Manufacturer:

Takeda GmbH. Manufacturing site located in Oranienburg Lehnitzstraße 70-98, 16515 Oranienburg Germany

For more information about this medicinal product, please contact the local representative of the marketing authorization holder:

Date of the last revision of this leaflet: {MM/YYYY}

Detailed information on this medicinal product is available on the European Medicines Agency website http://www.ema.europa.eu/.

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The following lifestyle and dietary recommendations may also help alleviate symptoms of heartburn or acid reflux:

• Avoid heavy meals
• Eat more slowly

• Quit smoking
• Reduce alcohol and caffeine consumption
• Lose weight (if you are overweight)
• Avoid wearing tight clothing or belts
• Avoid eating during the three hours before bedtime
• Elevate the head of your bed (if you experience symptoms at night)
• Reduce intake of foods that may cause heartburn. This may include: chocolate, pepper, green mint, fried foods, and high-fat foods, acidic foods, spices, citrus fruits and juices, and tomatoes.