Prospect: information for the user

Pantoprazol pensavital 20 mg gastro-resistant tablets EFG

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

Follow exactly the administration instructions of the medicine contained in this prospect or those indicated by your doctor or pharmacist

• Keep this prospect, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.
• You should consult a doctor if your symptoms worsen or do not improve after 14 days.

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

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

3.How to take Pantoprazol pensavital

4.Possible adverse effects

5.Storage of Pantoprazol pensavital

6.Contents of the package and additional information

Pantoprazol pensavitalcontains the active ingredient pantoprazol that blocksthe “pump” that produces acid in the stomach. Therefore, this medication reduces the amount of acid in the stomach.

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

Reflux is the backflow of acid from the stomach into the 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 day of treatment with Pantoprazol pensavital, but this does not mean that the medication will provide 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 symptoms worsen or do not improve after 14 days.

Do not take Pantoprazol pensavital:

• If you are allergic (hypersensitive) to pantoprazole, lactose, or any of the other components of this medication (listed in section 6).
• If you are taking any medication 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 take Pantoprazol pensavital for extended periods, there may be additional risks such as a decrease in blood magnesium levels, (possible symptoms: fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, or 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 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 may be signs of a more serious underlying condition:

• Unintentional weight loss (not related to any diet or exercise).
• Vomiting, especially if 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.
• Observe blood in your stool, which may appear black or tar-like.
• Severe and/or persistent diarrhea, as Pantoprazol pensavital has been associated with a slight increase in the occurrence of infectious diarrhea.

Your doctor may decide to perform some tests.

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

You may experience relief from heartburn and acid reflux symptoms after a single day of treatment with Pantoprazol pensavital, but this does not mean that the medication will provide immediate relief. Do not take it as a preventive measure.

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

Before taking this medication, inform your doctor if:

-This is planned for you to undergo a specific blood test (Cromogranin A).

Use of Pantoprazol pensavital with other medications

Pantoprazol pensavital may prevent other medications from working properly.

Inform your doctor if you are using any medication that contains any of the following active ingredients:

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

Do not take Pantoprazol pensavital with other medications 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 Pantoprazol pensavital with antacids (e.g. magaldrate, aluminum hydroxide, sodium bicarbonate, magnesium carbonate, or combinations).

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

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 may be pregnant, or plan to become pregnant. Consult your doctor or pharmacist before using this medication.

Driving and operating machinery

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

Pantoprazol pensavital contains lactose

This medication contains lactose. If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medication.

Follow exactly the administration instructions of the medication contained in this leaflet or those indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

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

You should take this medication 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 that the medication will provide immediate relief.

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

Do not take Pantoprazol pensavital tablets for more than four 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

Pantoprazol pensavital should not be used in children or individuals under 18 years old.

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 Toxicological Information Service, phone 91 562 04 20 , indicating the medication and the amount taken.

No symptoms of overdose are known.

If you forgot to take Pantoprazol pensavital

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

If you interrupt treatment with Pantoprazol pensavital

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

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

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

• Severe allergic reactions (rare): hypersensitivity reactions, also known as anaphylactic reactions, anaphylactic shock, and angioedema. Typical symptoms are: swelling in the face, lips, mouth, tongue, and/or throat, which may cause difficulty swallowing or breathing, hives (urticaria), intense dizziness with very rapid heartbeats, and excessive sweating.
• Severe skin reactions (unknown frequency):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 overall health, or skin rash after exposure to the sun.
• Other severe side effects (unknown frequency): yellow discoloration of the skin and eyes (due to severe liver damage), or kidney problems such as painful urination and lower back pain with fever.

- Tingling, numbness, paresthesia (tingling), burning, or numbness (unknown frequency).

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

Very frequent (affects more than 1 in 10 patients).

Frequent (affects between 1 and 10 patients in 100).

Infrequent (affects between 1 and 10 patients in 1,000).

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

Very rare (affects fewer than 1 in 10,000 patients).

Unknown frequency (cannot be estimated from available data).

Benign polyps in the stomach.

• Infrequent side effects(affects between 1 and 10 patients in 1,000)

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

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

Distortion or complete absence of the sense of taste; visual disturbances such as blurred vision; urticaria; joint pain; muscle pain; weight changes; increased body temperature; swelling in the extremities (peripheral edema); allergic reactions; depression;increased levels of bilirubin and triglycerides in the blood (detected in blood tests);increased breast size in men; high fever and sudden drop in granulocytes in the blood (observed in blood tests).

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

Disorientation; decrease in platelet count in the blood that may lead to bleeding or more frequent bruising than normal; decrease in white blood cell count that may lead to more frequent infections; coexistence of an abnormal reduction in red blood cell, white blood cell, and platelet counts (observed in blood tests).

• Unknown frequency(cannot be estimated from available data)

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

If you are taking Pantoprazol 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 experience any of these symptoms, see your 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 are taking proton pump inhibitors such as Pantoprazol pensavital, especially for a period of more than one year, it may slightly increase the risk of hip, wrist, and spinal fractures. Inform your doctor if you have osteoporosis or if you are taking corticosteroids (they may increase the risk of osteoporosis).

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

Reporting of side effects:

If you experienceany type ofside effect, consult your doctor, pharmacistor nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicinal Products for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

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

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

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

Medicines should not be disposed of through drains or in the trash. Deposit the packaging and medicines you no longer need at the SIGRE point of the pharmacy.Ask your pharmacist if you are unsure how to dispose of the packaging and medicines you no longer need. In this way, you will help protect the environment.

Composition of Pantoprazol pensavital

• The active ingredient is pantoprazol. Each gastro-resistant tablet contains 20 mg of pantoprazol (in the form of sodium sesquihydrate).
• The other components (excipients) are: microcrystalline cellulose (E-460), lactose monohydrate, sodium croscarmellose, anhydrous colloidal silica, magnesium stearate (vegetal). The coating contains acid methacrylic 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, yellow iron oxide (E172), and quinoline yellow lake (E-104)).

Appearance of the product and content of the packaging

Yellow ochre-coated elongated tablets.

Containers:

• HDPE bottles with a screw cap with a desiccant capsule (LDPE/HDPE) containing 14 tablets.
• Aluminum blister pack of 14 tablets.

Marketing authorization holder

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Responsible for manufacturing:

Towa Pharmaceutical Europe, S.L

C/ Sant Martí

75-97

08107 – Martorelles (Barcelona)

Spain

Last review date of this leaflet:

February 2021

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