PANTOPRAZOL PENSAVITAL 20 mg GASTRO-RESISTANT TABLETS

Introduction

Package Leaflet: Information for the User

Pantoprazole Pensavital 20 mg Gastro-Resistant Tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

Follow the instructions for administration of the medicine contained in this leaflet or as indicated by your doctor or pharmacist.

• Keep this leaflet, 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 not listed in this leaflet. See section 4.
• You should consult a doctor if your symptoms worsen or do not improve after 14 days.

Contents of the Package Leaflet:

1. What is Pantoprazole Pensavital and what is it used for
2. What you need to know before taking Pantoprazole Pensavital
3. How to take Pantoprazole Pensavital
4. Possible side effects
5. Storage of Pantoprazole Pensavital
6. Contents of the pack and further information

1. What is Pantoprazole Pensavital and what is it used for

Pantoprazole Pensavital contains the active substance pantoprazole, which blocks the "pump" that produces acid in the stomach. Therefore, this medicine reduces the amount of acid in the stomach.

Pantoprazole Pensavital is used for the short-term treatment of symptoms of reflux (such as 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 one day of treatment with Pantoprazole Pensavital, but this does not mean that the medicine 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 14 days.

2. What you need to know before taking Pantoprazole Pensavital

Do not take Pantoprazole Pensavital:

• If you are allergic (hypersensitive) to pantoprazole, lactose, or any of the other components of this medicine (listed in section 6).
• If you are taking any medicine that contains atazanavir (for the treatment of HIV infection).
• If you are under 18 years old.
• If you are pregnant or breastfeeding.

Warnings and precautions

Consult your doctor first:

• 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 have new or recently changed 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 going to have an endoscopy or a breath test with urea.
• If you have ever had a skin reaction after treatment with a medicine similar to Pantoprazole Pensavital 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 interrupt treatment with Pantoprazole Pensavital. Remember to mention any other symptoms you may notice, such as joint pain.

If you take Pantoprazole Pensavital for longer periods, there may be additional risks such as a decrease in magnesium levels in the blood (possible symptoms: fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, or increased heart rate). Additionally, low magnesium levels can cause a decrease in potassium and calcium levels in the blood. You should consult your doctor if you have been taking this medicine for more than 4 weeks. Your doctor will decide whether to perform periodic blood tests to monitor magnesium levels.

Tell your doctor immediatelybefore or after taking this medicine, 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.
• Difficulty swallowing or pain when swallowing.
• Blood in the vomit, which may appear as dark coffee grounds in the vomit.
• You are pale or feel weak (anemia).
• Chest pain.
• Stomach pain.
• You notice blood in your stools, which may appear black or like tar.
• Severe and/or persistent diarrhea, as Pantoprazole Pensavital has been associated with a slight increase in the occurrence of infectious diarrhea.

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 medicine.

You may notice relief from acid reflux symptoms and heartburn after one day of treatment with Pantoprazole Pensavital, but this does not mean that the medicine provides immediate relief. Do not take it as a preventive measure.

If you have had symptoms of dyspepsia or heartburn repeatedly for some time, remember to visit your doctor periodically.

Before taking this medicine, tell your doctor if:

• You are scheduled to have a specific blood test (Chromogranin A).

Using Pantoprazole Pensavital with other medicines

Pantoprazole Pensavital may prevent other medicines from working properly.

Tell your doctor if you are using any medicine that contains any of the following active substances:

• Ketoconazole (used to treat fungal infections)
• Warfarin or phenprocoumon (used to make blood more liquid and prevent clot formation). You may have additional blood tests.
• Atazanavir (used to treat HIV infection). Do not take Pantoprazole Pensavital if you are taking atazanavir.

Do not take Pantoprazole Pensavital with other medicines that limit the amount of acid produced in the stomach, such as another proton pump inhibitor (omeprazole, lansoprazole, or rabeprazole) or an H2 antagonist (e.g., ranitidine, famotidine).

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

Tell your doctor or pharmacist that you are taking, have recently taken, or may need to take any other medicine.

Taking Pantoprazole Pensavital with food and drinks

The tablets should be swallowed whole, with some liquid before a meal.

Pregnancy, breastfeeding, and fertility

Do not take Pantoprazole Pensavital 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.

Driving and using machines

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

Pantoprazole Pensavital contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

3. How to take Pantoprazole Pensavital

Follow the instructions for administration of the medicine contained in this leaflet or as indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

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

You should take this medicine for at least two or three consecutive days. Stop taking Pantoprazole Pensavital when you are completely free of symptoms. You may notice relief from acid reflux symptoms and heartburn after one day of treatment with Pantoprazole Pensavital, but this does not mean that the medicine provides immediate relief.

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

Do not take Pantoprazole Pensavital 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.

Use in children and adolescents

Pantoprazole Pensavital should not be used in children or adolescents under 18 years old.

If you take more Pantoprazole Pensavital than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount taken.

No symptoms of overdose are known.

If you forget to take Pantoprazole Pensavital

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

If you stop taking Pantoprazole Pensavital

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

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

• Severe allergic reactions (rare): 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 rapid heartbeat and excessive sweating.
• Severe skin reactions (frequency unknown): skin rash with swelling, blistering, or peeling of the skin, 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 unknown): 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.

• Feeling of tingling, prickling, paresthesia (tingling), burning, or numbness (frequency unknown).

The frequency of the possible side effects described below is classified as follows:

Very common (affects more than 1 in 10 people).

Common (affects between 1 and 10 people in 100).

Uncommon (affects between 1 and 10 people in 1,000).

Rare (affects between 1 and 10 people in 10,000).

Very rare (affects less than 1 in 10,000 people).

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

• Common side effects(may affect up to 1 in 10 people)

Benign polyps in the stomach.

• Uncommon side effects(affect between 1 and 10 people in 1,000)

Headache; dizziness; diarrhea; feeling of dizziness, nausea, vomiting; swelling and flatulence (gas); constipation; dry mouth; stomach pain and discomfort; hives or skin rash; itching; feeling of weakness, fatigue, or general malaise; sleep disorders; increased liver enzymes in blood tests.

• Rare side effects(affect between 1 and 10 people in 10,000)

Distortion or complete loss of taste; vision disorders such as blurred vision; hives; joint pain; muscle pain; weight changes; increased body temperature; swelling in the limbs (peripheral edema); allergic reactions; depression; increased bilirubin and fat levels in the blood (detected in blood tests); increased breast size in men; high fever and sudden drop in white blood cell count (observed in blood tests).

• Very rare side effects(affect less than 1 in 10,000 people)

Disorientation; decrease in platelet count in the blood, which can lead to more frequent bleeding or bruising; decrease in white blood cell count, which can lead to more frequent infections; coexistence of an abnormal decrease in red blood cell, white blood cell, and platelet count (observed in blood tests).

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

Hallucinations, confusion (especially in patients with a history of these symptoms), decreased sodium levels, decreased magnesium levels in the blood.

If you are taking Pantoprazole Pensavital for more than three months, it is possible that magnesium levels in the blood may decrease. Low magnesium levels can cause fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, and increased heart rate. If you have 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 periodic blood tests to monitor magnesium levels.

If you are taking proton pump inhibitors like Pantoprazole Pensavital, especially for a period of more than one year, you may have a slightly increased risk of hip, wrist, and spine fractures. Tell your doctor if you have osteoporosis or if you are taking corticosteroids (which can increase the risk of osteoporosis).

Skin rash, possibly with joint pain. Inflammation of the large intestine that causes persistent watery diarrhea.

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: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Pantoprazole Pensavital

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

Do not use this medicine after the expiration date that appears on the packaging after EXP. The expiration date is the last day of the month indicated.

Bottle: No special storage conditions are required. Keep the bottle tightly closed.

Blister: Store below 30°C. Store in the original packaging.

Medicines should not be disposed of via wastewater or household waste. Deposit 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. Contents of the pack and further information

Composition of Pantoprazole Pensavital

• The active substance is pantoprazole. Each gastro-resistant tablet contains 20mg of pantoprazole (as sodium sesquihydrate).
• The other components (excipients) are: microcrystalline cellulose (E-460), lactose monohydrate, sodium croscarmellose, anhydrous colloidal silica, magnesium stearate (vegetable). The coating contains methacrylic acid-ethyl acrylate copolymer (1:1) dispersion 30%, triethyl citrate (E1505), talc (E553b), and Opadry II 85F32081 Yellow (containing partially hydrolyzed polyvinyl alcohol, titanium dioxide (E171), macrogol/PEG 3350, talc, and yellow iron oxide (E172) and quinoline yellow aluminum lake (E-104)).

Appearance of the product and pack contents

Yellow-ochre, prolonged-release tablets.

Packaging:

• Bottles (HDPE packaging with screw cap and desiccant capsule (LDPE/HDPE)) of 14 tablets.
• Al/Al blister packs of 14 tablets.

Marketing authorization holder

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Manufacturer

Towa Pharmaceutical Europe, S.L.

C/ Sant Martí 75-97

08107 – Martorelles (Barcelona)

Spain

Date of last revision of this leaflet:February 2021

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