Pantoprazole Pensa 20 mg gastro-resistant tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Pantoprazol Pensa 20 mg gastro-resistant tablets EFG

Read the entire leaflet carefully before you start taking this medicine.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you and should not be given to other people, even if they have the same symptoms, as it may harm them.
• If you consider any of the side effects you experience to be severe, or if you notice any side effects not mentioned in this leaflet, inform your doctor or pharmacist.

Leaflet contents:

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

1. What is Pantoprazol Pensa and what is it used for?

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

Pantoprazol Pensa is used for:

Adults and adolescents aged 12 years and older:

• Treatment of symptoms associated with gastroesophageal reflux disease (heartburn, acid regurgitation, pain when swallowing) caused by reflux of acid 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, for example, ibuprofen) in patients at risk who require ongoing treatment with these types of medicines.

2. Before taking Pantoprazol Pensa

Do not take Pantoprazol Pensa

• If you are allergic (hypersensitive) to pantoprazol or to any of the other components of Pantoprazol Pensa (see section 6).
• If you are allergic to medicines containing other proton pump inhibitors (e.g., omeprazole, lansoprazol, rabeprazol, esomeprazol).

Take special care with Pantoprazol Pensa

• If you have severe liver problems. Inform your doctor if you have ever had liver problems. Your doctor will monitor your liver enzymes more frequently, especially if you are on long-term treatment with Pantoprazol Pensa. If liver enzymes increase, treatment should be discontinued.
• If you need to take non-steroidal anti-inflammatory drugs (NSAIDs) continuously while taking Pantoprazol Pensa, as there is an increased risk of developing stomach and intestinal complications. Any increased risk will be assessed according to personal risk factors such as age (65 years or older), history of stomach or duodenal ulcer, or gastrointestinal bleeding.
• If you have reduced body stores of vitamin B12 or risk factors for this, and you are receiving pantoprazol treatment over a long period. Like all medicines that reduce acid levels, pantoprazol may reduce the absorption of vitamin B12.
• Consult your doctor if you are taking a medicine containing atazanavir (for treatment of HIV infection) at the same time as pantoprazol.
• If you have ever had a skin reaction after treatment with a medicine similar to Pantoprazol Pensa used to reduce stomach acidity. If you develop a skin rash, especially in areas of skin exposed to sunlight, consult your doctor as soon as possible, as it may be necessary to discontinue treatment with Pantoprazol Pensa. Remember to mention any other symptoms you may notice, such as joint pain.
• If you are scheduled to have a specific blood test (chromogranin A).
• If you take pantoprazol for more than three months, you may experience a decrease in blood magnesium levels. Symptoms of low magnesium levels may include fatigue, involuntary muscle contractions, confusion, dizziness, or increased heart rate. If you experience any of these symptoms, inform your doctor immediately. In addition, low magnesium levels may lead to decreased levels of potassium and calcium in the blood. Your doctor may decide to perform periodic blood tests to monitor magnesium levels.

Contact your doctor immediately if you notice any of the following symptoms:

• Unintentional weight loss
• Repeated vomiting
• Difficulty swallowing
• Blood in vomit
• Pale appearance and feeling weak (anemia)
• Blood in your stools
• Severe or persistent diarrhoea, as pantoprazol has been associated with a small increased risk of infectious diarrhoea.

Your doctor will decide whether you need additional tests to rule out malignancy, as pantoprazol may relieve symptoms of cancer and could delay diagnosis. If your symptoms persist despite treatment, further investigations will be carried out.

If you take Pantoprazol Pensa for a prolonged period (more than one year), your doctor will likely monitor you regularly. You should inform your doctor of any new or unexpected symptoms and/or events at each visit.

Use of other medicines

Pantoprazol Pensa may affect the effectiveness of other medicines. Therefore, inform your doctor if you are taking:

• Medicines such as ketoconazole, itraconazole, and posaconazole (used to treat fungal infections) or erlotinib (used for certain types of cancer), as Pantoprazol Pensa may prevent these and other medicines from working properly.

• Warfarin and fenprocoumon, which affect blood clotting. You may require additional monitoring.

• Atazanavir (used for the treatment of HIV infection).

Inform your doctor or pharmacist if you are using or have recently used any other medicines, including those obtained without a prescription.

Pregnancy and breast-feeding

There are insufficient data on the use of pantoprazol in pregnant women. It has been reported that pantoprazol is excreted in human breast milk. If you are pregnant, think you may be pregnant, or are breast-feeding, you should only use this medicine if your doctor considers that the benefit to you outweighs the potential risk to the fetus or infant.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

Do not drive or operate machinery if you experience adverse effects such as dizziness or blurred vision.

Important information about some of the components of Pantoprazol Pensa

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.

3. How to take Pantoprazol Pensa

Follow exactly the administration instructions for Pantoprazol Pensa provided by your doctor. Consult your doctor or pharmacist if you have any doubts.

When and how should you take Pantoprazol Pensa?

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

Unless your doctor has instructed otherwise, the usual dosage is:

Adults and adolescents aged 12 years and older:

For the treatment of symptoms associated with gastroesophageal reflux disease (heartburn, acid regurgitation, painful swallowing)

The usual dose is one tablet per day.

This dose generally provides relief within 2–4 weeks, and if not, at most within the following 4 weeks. Your doctor will advise you on how long you should continue taking the medicine.

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

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 your dose; in this case, you may take Pantoprazol Pensa 40 mg once daily. After healing, the dose may be reduced again to one 20 mg tablet per day.

Adults:

For the prevention of duodenal and gastric ulcers in patients requiring ongoing treatment with NSAIDs

The usual dose is one tablet per day.

Special patient groups:

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

If you take more Pantoprazol Pensa than you should

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

Symptoms of overdose are not known.

If you forget to take Pantoprazol Pensa

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

If you stop taking Pantoprazol Pensa

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

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

4. Possible adverse effects

Like all medicines, Pantoprazole Pensa may produce adverse effects, although not everyone experiences them.

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

very common (affects more than 1 in 10 patients)
common (affects between 1 and 10 patients in 100)
uncommon (affects between 1 and 10 patients in 1,000)
rare (affects between 1 and 10 patients in 10,000)
very rare (affects less than 1 in 10,000 patients)
frequency not known (cannot be estimated from available data)

If you experience any of the following adverse effects, stop taking these tablets immediately and inform your doctor or contact the nearest hospital emergency service.

• Severe allergic reactions (rare frequency): swelling of the tongue and/or throat, difficulty swallowing, rash (urticaria), difficulty breathing, facial swelling of allergic origin (Quincke's edema/angioedema), severe dizziness with rapid heartbeat and excessive sweating.

• Severe skin disorders (frequency not known): skin blisters and rapid deterioration of general condition, erosion (including slight bleeding) of eyes, nose, mouth/lips or genitals (Stevens-Johnson syndrome, Lyell's syndrome, erythema multiforme), and photosensitivity.

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

Other adverse effects are:

• Common (affects between 1 and 10 out of every 100 patients): benign gastric polyps
• Uncommon (affects between 1 and 10 patients in 1,000): headache; dizziness; diarrhoea; sensation of dizziness, vomiting; bloating and flatulence; constipation; dry mouth; pain and discomfort in the abdomen; skin rash, exanthema, eruption; tingling; feeling of weakness, tiredness or general malaise; sleep disturbances.
• Rare (affects between 1 and 10 patients in 10,000): vision 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 in 10,000 patients): disorientation
• Frequency not known (cannot be estimated from available data): hallucination, confusion (especially in patients with a history of these symptoms), sensation of tingling, pricking, paresthesia (tingling), burning or numbness, decreased sodium levels in blood, skin rash possibly accompanied by joint pain, inflammation of the large intestine causing persistent watery diarrhoea.

If you are taking Pantoprazole Pensa for more than three months, your blood magnesium levels may decrease. Low magnesium levels can cause fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, and increased heart rate. If you experience any of these symptoms, consult your doctor immediately. Low magnesium levels may also lead to decreased levels of potassium and calcium in the blood. Your doctor may decide to perform periodic blood tests to monitor your magnesium levels.

If you are taking proton pump inhibitors such as Pantoprazole Pensa, especially for a period longer than one year, there may be a slight increase in the risk of fractures of the hip, wrist, and spine. Inform your doctor if you have osteoporosis or if you are taking corticosteroids (which may increase the risk of osteoporosis).

Adverse 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 levels of blood fats

• Very rare (affects less than 1 in 10,000 patients):
  Reduction in platelet count, which could lead to bleeding or unusual bruising; reduction in white blood cell count, which could lead to more frequent infections.

If any of the adverse effects worsen or if you notice any other reactions not listed in this leaflet, consult your doctor or pharmacist.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse 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.

Vial: No special storage conditions are required. Keep the vial tightly closed.

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

Do not use Pantoprazole Pensa after the expiry date stated on the packaging. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Additional Information

Composition of Pantoprazol Pensa

• The active substance is pantoprazole. Each gastro-resistant tablet contains 20 mg of pantoprazole (as sodium sesquihydrate).

The other components (excipients) are: microcrystalline cellulose (E-460i), lactose monohydrate, sodium croscarmellose, colloidal anhydrous silica, magnesium stearate (E-572), colour mixture (Opadry II 85F32081 yellow containing partially hydrolyzed polyvinyl alcohol, polyethylene glycol/PEG 3350, titanium dioxide, talc, yellow iron oxide, quinoline yellow aluminum lake (E-104)), methacrylic acid and ethyl acrylate copolymer (1:1), 30% dispersion, triethyl citrate (E-1505), talc (E-553b).

Appearance of the product and contents of the pack

Yellowish, elongated coated tablets.

Pantoprazol Pensa 20 mg is available in packs of 14, 28 or 56 tablets, in blister packs 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

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

This leaflet was last approved in August 2019

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/