What is in this leaflet
1. What Pantoprazole pensavital is and what it is used for
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.
2. What you need to know before you take Pantoprazole pensavital
Do not take Pantoprazole pensavital:
Warnings and precautions
Talk to your doctor or pharmacist before taking 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:
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:
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:
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.
3. How to take Pantoprazole pensavital
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.
4. Possible side effects
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.
- Tingling, prickling, paraesthesia (tingling), burning or numbness (frequency not known).
The frequency of the possible side effects described below is classified as follows:
Benign polyps in the stomach.
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.
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).
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).
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.
5. How to store Pantoprazole pensavital
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.
6. Contents of the pack and other information
What Pantoprazole pensavital contains
What Pantoprazole pensavital look like and contents of the pack
Ochre-yellow, elongated, coated tablets.
Packs:
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