PANTOPRAZOL PENSA 40 mg GASTRO-RESISTANT TABLETS

Introduction

Package Leaflet: Information for the User

Pantoprazole Pensa 40 mg Gastro-Resistant Tablets EFG

Read all of this leaflet carefully before you start taking this medicine.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you, do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any of the side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Contents of the pack:

1. What Pantoprazole Pensa is and what it is used for
2. Before taking Pantoprazole Pensa
3. How to take Pantoprazole Pensa
4. Possible side effects
5. Storage of Pantoprazole Pensa
6. Further information

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

Pantoprazole Pensa is a selective inhibitor of the "proton pump", a medicine that reduces the amount of acid produced in your stomach. It is used for the treatment of diseases related to stomach and intestine acid.

Pantoprazole Pensa is used for:

Adults and adolescents from 12 years:

• Reflux esophagitis. This is an inflammation of your esophagus (the tube that connects your throat to your stomach) accompanied by acid regurgitation from the stomach.

Adults:

• Infection with a bacterium called Helicobacter pyloriin patients with stomach and/or duodenal ulcers in combination with two antibiotics (eradication treatment). The goal is to get rid of the bacteria and thus reduce the likelihood of ulcer recurrence.

• Stomach and duodenal ulcers, and

• Zollinger-Ellison syndrome and other conditions in which too much acid is produced in the stomach.

2. Before taking Pantoprazole Pensa

Do not take Pantoprazole Pensa

• If you are allergic (hypersensitive) to pantoprazol or to any of the other components of Pantoprazole Pensa (see section 6).
• If you are allergic to medicines that contain other proton pump inhibitors (e.g., omeprazole, lansoprazole, rabeprazole, esomeprazole).

Be careful with Pantoprazole Pensa

• If you have serious liver problems. Tell your doctor if you have ever had liver problems. Your doctor will monitor your liver enzymes more frequently, especially when you are on long-term treatment with Pantoprazole Pensa. If there is an increase in liver enzymes, treatment should be discontinued.
• If you have reduced body stores of vitamin B12 or risk factors for this and receive treatment with pantoprazol for a long period. Like all acid-reducing medicines, pantoprazol may reduce the absorption of vitamin B12.
• Tell your doctor if you are taking any medicine that contains atazanavir (for HIV infection treatment) at the same time as pantoprazol.
• If you have ever had a skin reaction after treatment with a medicine similar to Pantoprazole Pensa to reduce stomach acid. If you get 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 discontinue treatment with Pantoprazole Pensa. Remember to mention any other symptoms you may notice, such as joint pain.
• It is planned that you will have a specific blood test (Chromogranin A).
• If you take pantoprazol for more than three months, you may suffer from a decrease in magnesium levels in the blood. The symptoms of low magnesium levels can include fatigue, involuntary muscle contractions, disorientation, dizziness, or increased heart rate. If you have any of these symptoms, tell your doctor immediately. Additionally, low magnesium levels can cause a decrease in potassium and calcium levels in the blood. Your doctor will decide whether to perform periodic blood tests to monitor magnesium levels.

Tell your doctor immediatelyif you notice any of the following symptoms:

• unintentional weight loss
• repeated vomiting
• difficulty swallowing
• blood in the vomit
• pale appearance and feeling of weakness (anemia)
• blood in your stools
• severe or persistent diarrhea, as pantoprazol has been associated with a small increase in infectious diarrhea.

Your doctor will decide if you need any additional tests to rule out a malignant disease because pantoprazol can alleviate the symptoms of cancer and may delay its diagnosis. If, despite treatment, your symptoms persist, complementary tests will be performed.

If you take Pantoprazole Pensa for a prolonged period (more than a year), your doctor may monitor you regularly. You should tell your doctor about any new symptoms and/or events each time you visit your doctor.

Use of other medicines

Pantoprazole Pensa may affect the efficacy of other medicines, for this reason, tell your doctor if you are taking:

• Medicines such as ketoconazole, itraconazole, and posaconazole (used to treat fungal infections) or erlotinib (used to treat certain types of cancer), as Pantoprazole Pensa may cause these and other medicines to not work properly.

• Warfarin and phenprocoumon, which affect blood coagulation. You may need additional checks.

• Atazanavir (used to treat HIV infection).

Tellyour doctor or pharmacist if you are using or have recently used other medicines, includingthose obtained without a prescription.

Pregnancy and breastfeeding

There is not enough data on the use of pantoprazol in pregnant women. It has been reported that in humans, pantoprazol is excreted in breast milk. If you are pregnant, or think you may be pregnant, or if you are breastfeeding, you should only use this medicine if your doctor considers that the benefit to you is greater than the potential risk to the fetus or baby.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

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

Important information about some of the components of Pantoprazole Pensa

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 Pensa

Follow the administration instructions of Pantoprazole Pensa indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

When and how should you take Pantoprazole Pensa?

Take the tablets whole, without chewing or crushing, with a little water, 1 hour before a meal.

Unless your doctor has indicated otherwise, the normal dose is:

Adults and adolescents from 12 years:

For the treatment of reflux esophagitis:

The usual dose is one tablet per day. Your doctor may indicate an increase to 2 tablets per day. The treatment time for reflux esophagitis is usually between 4 and 8 weeks. Your doctor will indicate how long you should take this medicine.

Adults:

For the treatment of an infection with a bacterium called Helicobacter pyloriin patients with stomach and/or duodenal ulcers in combination with two antibiotics (eradication treatment):

One tablet twice a day plus the two antibiotic tablets, either amoxicillin, clarithromycin, and metronidazole (or tinidazole), each to be taken twice a day with your pantoprazole tablet. Take the first pantoprazole tablet 1 hour before breakfast and the second 1 hour before dinner. Follow your doctor's instructions and make sure to read the package leaflets of the antibiotics.

The duration of treatment is usually one to two weeks.

For the treatment of stomach and duodenal ulcers:

The usual dose is one tablet per day. The dose may be doubled by your doctor.

Your doctor will indicate how long you should take this medicine. The duration of treatment for stomach ulcers is usually between 4 and 8 weeks. The duration of treatment for duodenal ulcers is usually between 2 and 4 weeks.

For long-term treatment of Zollinger-Ellison syndrome and other conditions in which there is an increase in stomach acid secretion:

The recommended initial dose is two tablets per day. Take the two tablets 1 hour before a meal. Later, your doctor may adjust the dose, depending on the amount of acid secretion you produce. If you are prescribed more than two tablets per day, you should take the tablets divided into two doses per day. If you are prescribed more than four tablets per day, you will be told exactly when to finish the treatment.

Special groups of patients:

• If you have kidney problems or moderate to severe liver problems, you should not take Pantoprazole Pensa for the elimination of Helicobacter pylori.

• If you have severe liver problems, you should not take more than one 20 mg pantoprazole tablet per day (for this case, 20 mg pantoprazole tablets are available).

• Children (under 12 years): the use of these tablets is not recommended in children under 12 years.

If you take more Pantoprazole Pensa than you should

If you have taken more Pantoprazole Pensa than you should, consult your doctor or pharmacist immediately, or call the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount used. It is recommended to take the package and the package leaflet of the medicine to the healthcare professional.

There are no known symptoms of overdose.

If you forget to take Pantoprazole Pensa

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

If you stop taking Pantoprazole Pensa

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.

4. Possible side effects

Like all medicines, Pantoprazole Pensa can cause side effects, although not everybody gets them.

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 the available data).

If you experience any of the following side effects, stop taking these tablets and tell your doctor immediately or contact the emergency department of the nearest hospital.

• Severe allergic reactions (rare frequency): swelling of the tongue and/or throat, difficulty swallowing, hives (urticaria), difficulty breathing, swelling of the face of allergic origin (Quincke's edema/angioedema), intense dizziness with very rapid heartbeat and profuse sweating.

• Severe skin reactions (frequency not known): blisters on the skin and rapid deterioration of general conditions, erosion (including slight bleeding) of eyes, nose, mouth/lips, or genitals (Stevens-Johnson syndrome, Lyell syndrome, erythema multiforme), and sensitivity to light.

• Other serious conditions (frequency not known): yellowing of the skin and the whites of the eyes (severe liver cell damage, jaundice), or fever, rash, increase in kidney size with occasional pain when urinating, and pain in the lower back (severe kidney inflammation).

Other side effects are:

• Common(affects between 1 and 10 patients in 100): benign stomach polyps
• Uncommon(affects between 1 and 10 patients in 1,000): headache; dizziness; diarrhea; feeling of dizziness, vomiting; swelling and flatulence (gas); constipation; dry mouth; abdominal pain and discomfort; skin rash, exanthema, eruption; tingling; feeling of weakness, fatigue, or general malaise; sleep disturbances.
• Rare(affects between 1 and 10 patients in 10,000): vision disturbances such as blurred vision; hives; joint pain; muscle pain; weight changes; increased body temperature; swelling in the extremities (peripheral edema); allergic reactions; depression; breast enlargement in men.
• Very rare(affects less than 1 patient in 10,000): disorientation
• Frequency not known(cannot be estimated from the available data): hallucination, confusion (especially in patients with a history of these symptoms), feeling of tingling, pricking, paresthesia (tingling), burning, or numbness, decreased sodium levels in the blood, skin rash, possibly with joint pain, inflammation of the large intestine that causes persistent watery diarrhea.

If you are taking Pantoprazole Pensa for more than three months, it is possible that your 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, go to the 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 Pensa, 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).

Side effects identified through blood tests:

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

Increased liver enzymes

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

Increased bilirubin; increased blood fat levels

• Very rare(affects less than 1 patient in 10,000):

Reduction of the number of platelets that could cause bleeding or more bruising than usual; reduction of the number of white blood cells that could lead to more frequent infections.

If any of the side effects worsen or if you notice any other reaction not described in this package leaflet, consult your doctor or pharmacist.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that is not listed in this package 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 Pensa

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

Do not store above 30°C. Store in the original package.

Do not use Pantoprazole Pensa after the expiration date stated on the package. The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Place the packages and medicines you no longer need in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packages and medicines you no longer need. This way, you will help protect the environment.

6. Further information

Composition of Pantoprazole Pensa

The active ingredient is pantoprazole. Each gastro-resistant tablet contains 40 mg of pantoprazole (present as 45.10 mg of pantoprazole sodium sesquihydrate).

The other components (excipients) are: microcrystalline cellulose (E-460i), lactose monohydrate, sodium croscarmellose, anhydrous colloidal silica, magnesium stearate (E-572), color mixture (Opadry II 85F32029 yellow, containing partially hydrolyzed polyvinyl alcohol, titanium dioxide (E-171), macrogol/PEG 3350, talc (E-553b), and yellow iron oxide (E-172)), methacrylic acid-ethyl acrylate copolymer (1:1) dispersion 30%, triethyl citrate (E-1505), talc (E-553b).

Appearance of the product and package contents

Oval, yellow-ochre film-coated tablets. Pantoprazole Pensa 40 mg gastro-resistant tablets are available in bottles or blisters of 14, 28, or 56 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/ de Sant Martí 75-97

08107 Martorelles (Barcelona)

Spain

This package leaflet was approved in August 2019.

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