Pantoprazole Pensavital 20 mg gastro-resistant tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Pantoprazole pensavital 20 mg gastro-resistant tablets EFG

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

Follow exactly the instructions for use provided in this leaflet or those given by your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, consult your pharmacist.
• If you experience any 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 condition worsens or if you do not improve after 14 days.

Contents of this leaflet:

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

1. What Pantoprazol pensavital is and what it is used for

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

Pantoprazol pensavital is used for the short-term treatment of reflux symptoms (for example: heartburn and acid regurgitation) in adults.

Reflux is the backward flow of acid from the stomach into the throat (esophagus), which can cause inflammation and pain. This may cause symptoms such as a painful burning sensation in the chest, which may rise up to the throat (heartburn), and a sour taste in the mouth (acid regurgitation).

You may notice relief from acid reflux and heartburn symptoms after one day of treatment with Pantoprazol pensavital, but this does not mean the medicine provides immediate relief. It may be necessary to take the tablets for 2–3 consecutive days before symptom relief occurs.

• You should consult a doctor if your symptoms worsen or do not improve after 14 days.

2. What you need to know before starting to take Pantoprazol pensavital

Do not take Pantoprazol pensavital:

• If you are allergic (hypersensitive) to pantoprazol, lactose, or any of the other ingredients of this medicine (listed in section 6).
• If you are taking any medicine containing atazanavir (used to treat HIV infection).
• If you are under 18 years of age.
• 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 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 frequently visit your doctor due to severe discomfort or illnesses.
• If you are scheduled to undergo an endoscopy or a test called a urea breath test.
• If you have ever had a skin reaction after treatment with a medicine similar to Pantoprazol pensavital used to reduce stomach acid.
• If you develop a skin rash, especially in areas of skin exposed to sunlight, consult your doctor as soon as possible, as it may be necessary to discontinue treatment with Pantoprazol pensavital. Remember to mention any other symptoms you may notice, such as joint pain.

If you take Pantoprazol pensavital for prolonged periods, additional risks may occur, such as a decrease in blood magnesium levels (possible symptoms: fatigue, involuntary muscle spasms, confusion, seizures, dizziness, or increased heart rate). Additionally, low magnesium levels may lead to reduced levels of potassium and calcium in the blood. You should consult your doctor if you have been taking this medicine for more than 4 weeks. Your doctor may decide to perform periodic blood tests to monitor magnesium levels.

Inform your doctor immediately before or after taking this medicine if you experience any of the following symptoms, which could be signs of a more serious condition:

• Unintentional weight loss (not related to diet or exercise).
• Vomiting, especially if repeated.
• Difficulty swallowing or pain when swallowing.
• Blood in vomit, which may appear as dark coffee-ground-like material.
• You look pale or feel weak (anemia).
• Chest pain.
• Stomach pain.
• You notice blood in your stools, which may appear black or tar-like.
• Severe and/or persistent diarrhea, as Pantoprazol pensavital has been associated with a slight increase in the risk of infectious diarrhea.

Your doctor may decide that further tests are necessary.

If you are scheduled for a blood test, inform your doctor that you are taking this medicine.

You may notice relief from acid reflux and heartburn symptoms after just one day of treatment with Pantoprazol pensavital, but this does not mean the medicine provides immediate relief. Do 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.

Before taking this medicine, inform your doctor if:

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

Use of Pantoprazol pensavital with other medicines

Pantoprazol pensavital may interfere with the effectiveness of other medicines.

Inform your doctor if you are taking any medicine containing any of the following active substances:

• Ketoconazole (used to treat fungal infections).
• Warfarin or phenprocoumon (used to make the blood less likely to clot and prevent clot formation). You may require additional blood tests.
• Atazanavir (used to treat HIV infection). You must not take Pantoprazol pensavital if you are taking atazanavir.

Do not take Pantoprazol pensavital with other medicines that reduce stomach acid production, such as other proton pump inhibitors (e.g., omeprazole, lansoprazol, or rabeprazol) or H2 antagonists (e.g., ranitidine, famotidine).

However, if necessary, Pantoprazol pensavital may be taken together with antacids (e.g., magaldrate, alginic acid, sodium bicarbonate, aluminum hydroxide, magnesium carbonate, or combinations).

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Taking Pantoprazol pensavital with food and drinks

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

Pregnancy, breastfeeding, and fertility

Do not take Pantoprazol pensavital if you are pregnant or breastfeeding, think you might 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 operate machinery if you experience adverse effects such as dizziness or blurred vision.

Pantoprazol pensavital contains lactose

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him or her before taking this medicine.

3. How to take Pantoprazol pensavital

Follow exactly the instructions for use provided in this leaflet or those given by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

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

If you do not experience symptom relief after taking this medicine for 2 consecutive weeks, consult your doctor.

Do not take Pantoprazol pensavital tablets for longer than 4 weeks without consulting your doctor.

Take the tablet before one of the main meals, at the same time each day. Swallow the tablet whole with some water. Do not chew or break the tablet.

Use in children and adolescents

Pantoprazol pensavital must not be used in children or adolescents under 18 years of age.

If you take more Pantoprazol pensavital than you should

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

Symptoms of overdose are not known.

If you forget to take Pantoprazol pensavital

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

If you stop taking Pantoprazol pensavital

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

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Contact your doctor immediately or contact the nearest hospital emergency service if you notice any of the following adverse effects. Stop taking this medicine immediately, but bring this leaflet and/or the tablets with you.

• Severe allergic reactions (rare): hypersensitivity reactions, also called anaphylactic reactions, anaphylactic shock, and angioedema. Typical symptoms include: swelling of the face, lips, mouth, tongue, and/or throat, which may cause difficulty swallowing or breathing, hives (urticaria), severe dizziness with very 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, rapid deterioration in your general health, or skin rash after exposure to sunlight.

• Other serious adverse 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 accompanied by fever.

• Tingling sensation, prickling, paresthesia (tingling), burning, or numbness (frequency not known).

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

Very common (affects more than 1 in 10 people).
Common (affects between 1 and 10 in 100 people).
Uncommon (affects between 1 and 10 in 1,000 people).
Rare (affects between 1 and 10 in 10,000 people).
Very rare (affects fewer than 1 in 10,000 people).
Frequency not known (cannot be estimated from available data).

• Common adverse effects (may affect up to 1 in 10 patients)

Benign gastric polyps.

• Uncommon adverse effects (affects between 1 and 10 in 1,000 patients)

Headache; dizziness; diarrhoea; sensation of dizziness, nausea, vomiting; bloating and flatulence (gas); constipation; dry mouth; stomach pain and discomfort; rash or skin eruption; itching; feeling of weakness, tiredness or general malaise; sleep disorders; increased liver enzymes in blood tests.

• Rare adverse effects (affects between 1 and 10 in 10,000 patients)

Distortion or complete loss of taste; visual disturbances such as blurred vision; urticaria; joint pain; muscle pain; weight changes; increased body temperature; swelling in the extremities (peripheral oedema); allergic reactions; depression; increased levels of bilirubin and blood lipids (detected in blood tests); enlargement of the breasts in men; high fever and sudden drop in circulating granulocytes (observed in blood tests).

• Very rare adverse effects (affects fewer than 1 in 10,000 patients)

Disorientation; decreased number of platelets in the blood, which may lead to bleeding or bruising more frequently than normal; decreased number of white blood cells, which may lead to more frequent infections; concurrent abnormal reduction in the number of red blood cells, white blood cells, and platelets (observed in blood tests).

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

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

If you are taking Pantoprazol pensavital 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, seizures, dizziness, and increased heart rate. If you experience any of these symptoms, consult your doctor immediately. Low magnesium levels may also lead to decreased levels of potassium and calcium in the blood. Your doctor may decide to perform periodic blood tests to monitor your magnesium levels.

If you are taking proton pump inhibitors such as Pantoprazol pensavital, especially for more than one year, you may have a slightly increased risk of fractures of the hip, wrist, and spine. Inform your doctor if you have osteoporosis or if you are taking corticosteroids (which may increase the risk of osteoporosis).

Skin rash, possibly with joint pain. Inflammation of the large intestine causing persistent watery diarrhoea.

Reporting of adverse effects:

If you experience any adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse 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 expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Vial: No special storage conditions required. Keep the vial tightly closed.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Pantoprazole pensavital

• The active substance is pantoprazole. Each gastro-resistant tablet contains 20 mg of pantoprazole (as sodium sesquihydrate).
• The other components (excipients) are: microcrystalline cellulose (E-460), monohydrate lactose, 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 hydrolysed polyvinyl alcohol, titanium dioxide (E171), macrogol/PEG 3350, talc, yellow iron oxide (E172) and quinoline yellow aluminium lake (E-104)).

Appearance of the product and contents of the pack

Yellowish, elongated coated tablets.

Pack sizes:

• Bottles (HDPE container with screw cap and desiccant cap (LDPE/HDPE)) containing 14 tablets.
• Al/Al blister packs containing 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 the most recent review of this leaflet: February 2021

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es