PANTOPRAZOL PENSA 20 mg GASTRO-RESISTANT TABLETS

Introduction

Package Leaflet: Information for the User

Pantoprazole Pensa 20 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 following side effects, or any other side effects not mentioned in this leaflet, inform your doctor or pharmacist.

Contents of the Package Leaflet:

1. What is Pantoprazole Pensa and what is it 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 is Pantoprazole Pensa and what is it 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:

• Treatment of symptoms associated with gastroesophageal reflux disease (heartburn, acid regurgitation, pain when swallowing) caused by acid reflux from the stomach.

• Long-term treatment and prevention of relapses of reflux esophagitis (inflammation of the esophagus accompanied by acid regurgitation from the stomach).

Adults:

• Prevention of gastroduodenal ulcers induced by non-steroidal anti-inflammatory drugs (NSAIDs, e.g., ibuprofen) in patients at risk who require continued treatment with these types of drugs.

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 cautious when taking Pantoprazole Pensa

• If you have severe liver problems. Inform your doctor if you have ever had liver problems. Your doctor will perform more frequent monitoring of liver enzymes, especially when you are on long-term treatment with Pantoprazole Pensa. In case of an increase in liver enzymes, treatment should be discontinued.
• If you need to take non-steroidal anti-inflammatory drugs (NSAIDs) continuously and take Pantoprazole Pensa, as there is a higher risk of developing complications in the stomach and intestine. Any increased risk will be assessed according to personal risk factors such as age (65 years or older), history of stomach or duodenal ulcers or stomach or intestinal bleeding.
• If you have decreased body reserves of vitamin B12 or risk factors for it and receive long-term treatment with pantoprazol. Like all medicines that reduce acid, pantoprazol may reduce the absorption of vitamin B12.
• Consult your doctor if you are taking any medication containing 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 experience 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.
• A specific blood test (Chromogranin A) is scheduled.
• If you take pantoprazol for more than three months, you may experience a decrease in magnesium levels in the blood. Symptoms of low magnesium levels may include fatigue, involuntary muscle contractions, disorientation, dizziness, or increased heart rate. If you experience any of these symptoms, inform your doctor immediately. Additionally, low magnesium levels may cause a decrease in potassium and calcium levels in the blood. Your doctor may decide to perform periodic blood tests to monitor magnesium levels.

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

• unintentional weight loss
• repeated vomiting
• difficulty swallowing
• blood in vomit
• pale appearance and feeling of weakness (anemia)
• blood in 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, as pantoprazol may alleviate symptoms of cancer and could 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 one year), your doctor may perform regular follow-up. You should inform your doctor of any new symptoms and/or unexpected events each time you visit your doctor.

Use of other medicines

Pantoprazole Pensa may affect the efficacy of other medicines, so inform 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 controls.

• Atazanavir (used to treat HIV infection).

Inform your doctor or pharmacist if you are using or have recently used other medicines, including those 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 instructions for administration 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 usual dose is:

Adults and adolescents from 12 years:

To treat symptoms associated with gastroesophageal reflux disease (heartburn, acid regurgitation, pain when swallowing)

The usual dose is one tablet per day.

This dose usually provides relief within 2-4 weeks, and if not, within a maximum of 4 weeks. Your doctor will indicate how long you should take the medicine.

Subsequently, any recurring symptoms can be controlled by taking one tablet per day as needed.

For long-term treatment and prevention of relapses of reflux esophagitis

The usual dose is one tablet per day. If the disease recurs, your doctor may double the dose, in which case you can take Pantoprazole Pensa 40 mg once a day. After healing, you can reduce the dose back to one 20 mg tablet per day.

Adults:

To prevent duodenal and stomach ulcers in patients who require continuous treatment with NSAIDs

The usual dose is one tablet per day.

Special patient groups:

• If you have severe liver problems, you should not take more than one 20 mg tablet per day.
• It is not recommended to use these tablets in children under 12 years of age.

If you take more Pantoprazole Pensa than you should

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

No symptoms of overdose are known.

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 further 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 person in 10,000)

frequency not known (cannot be estimated from the available data).

If you experience any of the following side effects, stop taking these tablets and inform 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), severe dizziness with rapid heartbeats and excessive sweating.

• Severe skin disorders (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 severe conditions (frequency not known): yellowing of the skin and the whites of the eyes (severe liver cell damage, jaundice), or fever, rash, increased 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 people in 100): benign stomach polyps
• Uncommon(affects between 1 and 10 people in 1,000): headache; dizziness; diarrhea; feeling of dizziness, vomiting; bloating 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 people in 10,000): 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; breast enlargement in men.
• Very rare(affects less than 1 person 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), tingling, prickling, 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, or increased heart rate. If you experience any of these symptoms, consult your doctor immediately. Low magnesium levels may 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. Inform 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 people in 1,000):

Increased liver enzymes

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

Increased bilirubin; increased blood fat levels

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

Reduced platelet count, which could lead to bleeding or more bruising than usual; reduced white blood cell count, which could lead to more frequent infections.

If any of the side effects worsen or if you notice any other reaction not described in this 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 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 contribute to providing more information on the safety of this medicine.

5. Storage of Pantoprazole Pensa

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

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

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

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

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medicines in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Further information

Composition of Pantoprazole Pensa

• The active ingredient is pantoprazole. Each gastro-resistant tablet contains 20 mg of pantoprazole (in the form of 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 85F32081 yellow containing polyvinyl alcohol, partially hydrolyzed, macrogol/PEG 3350, titanium dioxide, talc, yellow iron oxide, aluminum quinoline yellow lake (E-104)), methacrylic acid copolymer and ethyl acrylate (1:1), 30% dispersion, triethyl citrate (E-1505), talc (E-553b).

Appearance of the product and packaging content

Yellow-ochre, elongated, coated tablets.

Pantoprazole Pensa 20 mg is available in packs of 14, 28, or 56 tablets, in blisters or bottles.

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

Other presentations

Pantoprazole Pensa 40 mg gastro-resistant tablets EFG, available in packs of 14, 28, and 56 tablets.

This leaflet was approved in August 2019

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