Pantoprazole pensavital contains the drug 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 reflux symptoms (e.g. heartburn and acid regurgitation) in adults.

Reflux is the backflow of acid from the stomach into the throat (oesophagus), 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 and heartburn symptoms after one day of treatment with Pantoprazole pensavital, but this does not mean that the medicine gives immediate relief. It may be necessary to take the tablets for 2-3 consecutive days to produce relief of symptoms.

You must talk to a doctor if you do not feel better or if you feel worse after 14 days.

Do not take Pantoprazole pensavital:

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

Warnings and precautions

Talk to your doctor or pharmacist before taking Pantoprazole pensavital

• If you have been treated for heartburn or dyspepsia continuously for 4 or more weeks.
• If you are over 55 years of age and take daily over-the-counter treatment for dyspepsia.
• If you are over 55 years of age 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 serious complaints or illnesses.
• If you are going to have an endoscopy or a test called a urea breath test.
• If you have ever had a skin reaction after treatment with a medicine like Pantoprazole pensavital to reduce stomach acid.
• If you develop a rash, especially on sun-exposed areas of the skin, consult your doctor as soon as possible, as it may be necessary to stop 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, additional risks may occur such as a decrease in blood magnesium levels, (possible symptoms: fatigue, involuntary muscle twitching, disorientation, seizures, dizziness or increased heart rate). In addition, low levels of magnesium can lead to decreased 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 do regular blood tests to monitor your magnesium levels.

Tell your doctor immediately before or after taking this medicine if you notice any of the following symptoms, which could be signs of another, more serious illness:

• 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 look like dark coffee grounds in the vomit.
• you are pale or feel weak (anaemia).
• chest pain.
• stomach pain.
• you notice blood in your stools, which may have a black or tar-like appearance.
• severe and/or persistent diarrhoea, as Pantoprazole pensavital has been associated with a slight increase in the occurrence of diarrhoea of infectious origin.

Your doctor may decide that some tests are necessary.

If you are having a blood test, tell your doctor that you are taking this medicine. You may notice relief from acid reflux and heartburn symptoms after one day of treatment with Pantoprazole pensavital, but this does not mean that the medicine gives immediate relief. You should not take it as a preventive treatment.

If you have had repeated symptoms of dyspepsia or heartburn for some time, remember to see your doctor regularly.

Before taking this medicine, tell your doctor if:

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

Other medicines and Pantoprazole pensavital

Pantoprazole pensavital may stop other medicines from working properly.

Tell your doctor if you are using any medicines containing any of the following active substances:

• Ketoconazole (used for the treatment of fungal infections).
• Warfarin or phenprocoumon (used to make blood thinner and prevent blood clots). You may have additional blood tests.
• Atazanavir (used to treat HIV infection). You should 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 together with antacids (e.g. magaldrate, alginic acid, sodium bicarbonate, aluminium hydroxide, magnesium carbonate, or combinations).

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

Pantoprazole pensavital with food and drink

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

Pregnancy, breast-feeding and fertility

Do not take Pantoprazole pensavital if you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking 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 you have been told by your doctor that you have an intolerance to certain sugars, talk to your doctor before taking this medicine.

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The recommended dose is one tablet a day. Do not exceed the recommended dose of 20 mg 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 and heartburn symptoms after one day of treatment with Pantoprazole pensavital, but this does not mean that the medicine gives you immediate relief.

If you do not notice relief of symptoms after taking this medicine for 2 weeks in a row, consult your doctor.

Do not take Pantoprazole pensavital tablets for more than 4 weeks without consulting your doctor.

Take the tablet before one of your 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

This medicine should not be used in children and adolescents under 18 years of age.

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 Toxicological Information Service, telephone (+34) 91 562 04 20, indicating the medicine and the amount taken.

There are no known symptoms of overdose.

If you forget to take Pantoprazole pensavital

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

If you stop taking Pantoprazole pensavital

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

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

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

Tell your doctor immediately or 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 of the face, lips, mouth, tongue and/or throat, which may cause difficulty in swallowing or breathing, hives (urticaria), severe dizziness with very fast heartbeat and profuse sweating.
• Severe skin reactions (unknown frequency): rash with swelling, blistering or peeling of the skin, loss of skin and bleeding around the eyes, nose, mouth or genitals and rapid deterioration of your general health, or rash after sun exposure.
• Other serious side effects (unknown frequency): yellowing of the skin and eyes (due to severe liver damage), or kidney problems such as painful urination and lower back pain with fever.

- Tingling, prickling, paraesthesia (tingling), burning or numbness (frequency not known). 

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

• Very common (may affect more than 1 in 10 people).
• Common (may affect up to 1 in 10 people).
• Uncommon (may affect up to 1 in 100 people).
• Rare (may affect up to 1 in 1,000 people).
• Very rare (may affect up to 1 in 10,000 people).
• Not known (frequency cannot be estimated from the available data).

• 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; diarrhoea; dizziness, nausea, vomiting; bloating and flatulence (gas); constipation; dry mouth; stomach pain and discomfort; hives or rash; itching; feeling weak, tired or generally unwell; sleep disturbances; increased liver enzymes in blood tests.

• Rare side effects (may affect up to 1 in 1,000 people)

Distortion or complete absence of the sense of taste; vision disturbances such as blurred vision; hives; joint pain; muscle pain; weight changes; increased body temperature; swelling of the extremities (peripheral oedema); allergic reactions; depression; increased bilirubin and fat levels in the blood (detected in blood tests); enlarged breasts in men; high fever and a sharp decrease in circulating granular white blood cells (observed in blood tests).

• Very rare side effects (may affect up to 1 in 10,000 people)

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

• Not known (frequency cannot be estimated from the available data)

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

If you are taking Pantoprazole pensavital for more than three months, it is possible that your blood magnesium levels may drop. Low magnesium levels can cause fatigue, involuntary muscle contractions, disorientation, seizures, dizziness and increased heart rate. If you have any of these symptoms, see a doctor immediately. Low magnesium levels can also lead to a decrease in potassium and calcium levels in the blood. Your doctor may decide to do regular blood tests to check your magnesium levels.

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

Skin rash, possibly with joint pain.

Inflammation of the large intestine causing persistent watery diarrhoea.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Pharmacovigilance System for Medicinal Products for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

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

Do not use this medicine after the expiry date which is stated on the carton after CAD. The expiry date refers to the last day of that month.

Bottle: This medicine does not require any special storage conditions. Keep the bottle tightly closed.

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

Do not throw away any medicines via wastewater or household waste. Dispose of containers and medicines that you do not need at the SIGRE Point  in the pharmacy. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What Pantoprazole pensavital contains

• The active substance is pantoprazole. Each gastro-resistant tablet contains 20 mg pantoprazole (as pantoprazole sodium sesquihydrate).
• The other ingredients (excipients) are: microcrystalline cellulose (E-460), lactose monohydrate, croscarmellose sodium, 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, iron oxide yellow (E172) and quinoline yellow (E104) aluminium lake).

What Pantoprazole pensavital look like and contents of the pack

Ochre-yellow, elongated, coated tablets.

Packs:

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

Marketing authorisation 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

This leaflet was last revised in February 2021

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

Detailed and updated information on this product is available by scanning the QR code included in the outer carton with a smartphone. The same information is also available at the following URL: https://www.pensapharma.es/info/pensavital-pantoprazol-20mg-comprimidos/ and on the following website: https://cima.aemps.es/cima/dochtml/p/71225/P_71225.html