Pantoprazole PensA 40 mg gastro-resistant tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Pantoprazol Pensa 40 mg gastro-resistant tablets EFG

Read all of this 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 you should not give it 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 listed 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 Pantoprazol Pensa is and what it is 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 acid-related diseases of the stomach and intestine.

Pantoprazol Pensa is used for:

Adults and adolescents from 12 years of age:

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

Adults:

• Infection with a bacterium called Helicobacter pylori in patients with gastric and/or duodenal ulcer, in combination with two antibiotics (eradication therapy). The aim is to eliminate the bacteria and thereby reduce the likelihood of ulcer recurrence.

• Gastric and duodenal ulcers, and

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

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 have reduced body stores of vitamin B12 or risk factors for this, and 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 any medicine containing atazanavir (used to treat 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 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. 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 of weakness (anemia)
• Blood in your stools
• Severe or persistent diarrhea, as pantoprazol has been associated with a small increased risk of infectious diarrhea.

Your doctor will decide whether additional tests are needed to rule out malignancy, as pantoprazol may relieve cancer symptoms 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 may 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 cause these and other medicines to be less effective.

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

• Atazanavir (used to treat 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 breastfeeding

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 breastfeeding, 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 operating machinery

You should 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 with 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 you otherwise, the usual dose is:

Adults and adolescents aged 12 years and older:

For the treatment of reflux esophagitis:

The usual dose is one tablet per day. Your doctor may instruct you to increase the dose to 2 tablets per day. The treatment duration for reflux esophagitis is usually between 4 and 8 weeks. Your doctor will advise you on how long to take this medicine.

Adults:

For the treatment of infection with a bacterium called Helicobacter pylori in patients with gastric and/or duodenal ulcer, in combination with two antibiotics (eradication therapy):

One tablet twice daily, together with two antibiotic tablets—either amoxicillin, clarithromycin, and metronidazole (or tinidazole)—each to be taken twice daily along 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 normally one to two weeks.

For the treatment of gastric and duodenal ulcers:

The usual dose is one tablet daily. Your doctor may double the dose.

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

For long-term treatment of Zollinger-Ellison syndrome and other conditions associated with increased gastric acid secretion:

The recommended initial dose is two tablets daily. Take both tablets 1 hour before a meal. Subsequently, your doctor may adjust your dose depending on the amount of gastric acid secreted. If you are prescribed more than two tablets daily, you should take the tablets divided into two doses per day. If you are prescribed more than four tablets daily, you will be specifically informed when to stop treatment.

Special patient groups:

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

• If you have severe liver impairment, 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 of age.

If you take more Pantoprazol Pensa than you should

If you have taken more Pantoprazol Pensa than you should, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medication and amount taken. It is recommended to bring the medication packaging and leaflet to the healthcare professional.

There are no known symptoms of overdose.

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 cause 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 people)
common (affects between 1 and 10 in 100 people)
uncommon (affects between 1 and 10 in 1,000 people)
rare (affects between 1 and 10 in 10,000 people)
very rare (affects fewer than 1 in 10,000 people)
frequency not known (cannot be estimated from available data).

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

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

• Severe skin disorders (frequency not known): skin blisters and rapid deterioration in 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 include:

• Common (affects between 1 and 10 in 100 patients): benign gastric polyps
• Uncommon (affects between 1 and 10 in 1,000 patients): headache; dizziness; diarrhoea; sensation of dizziness, vomiting; bloating and flatulence; constipation; dry mouth; abdominal pain and discomfort; skin rash, exanthema, eruption; tingling; feeling of weakness, tiredness or general malaise; sleep disturbances.
• Rare (affects between 1 and 10 in 10,000 patients): visual disturbances such as blurred vision; urticaria; joint pain; muscle pain; weight changes; increased body temperature; swelling of the limbs (peripheral oedema); allergic reactions; depression; breast enlargement in men.
• Very rare (affects fewer than 1 in 10,000 patients): disorientation
• Frequency not known (cannot be estimated from available data): hallucinations, confusion (especially in patients with a history of these symptoms), sensation of tingling, pricking, paraesthesia (tingling), burning or numbness, decreased levels of sodium in the 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 reduced 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 are taking corticosteroids (which may increase the risk of osteoporosis).

Adverse effects identified through blood tests:

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

• Rare (affects between 1 and 10 in 10,000 patients):
  Increased bilirubin; increased blood lipid levels

• Very rare (affects fewer than 1 in 10,000 patients):
  Reduction in platelet count, which could lead to bleeding or bruising more easily than usual; 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 adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can 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 Pantoprazol Pensa

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

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

Do not use Pantoprazol Pensa after the expiry date stated on the container. 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 containers and medicines at the SIGRE Point in your pharmacy. If in doubt, ask your pharmacist how to dispose of unused containers and medicines. This will help protect the environment.

6. Additional Information

Composition of Pantoprazol Pensa

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

The other components (excipients) are: microcrystalline cellulose (E-460i), lactose monohydrate, sodium croscarmellose, colloidal anhydrous silica, magnesium stearate (E-572), colouring mixture (Opadry II 85F32029 yellow, containing partially hydrolysed 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) 30% dispersion, triethyl citrate (E-1505), talc (E-553b).

Appearance of the product and contents of the container

Yellowish-ochre oval coated tablets. Pantoprazol Pensa 40 mg gastro-resistant tablets are available in bottles or blisters containing 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 leaflet was 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/