Leaflet: information for the user

Pantoprazol pensa 20 mg gastro-resistant tablets EFG

Read this leaflet carefully before you start taking the 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. Do not pass it on to others even if their symptoms are the same. It may harm them.

-If you think you have suffered a side effect, you can report it directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

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

2.Before taking Pantoprazol Pensa

3.How to take Pantoprazol Pensa

4.Possible side effects

5.Storage of Pantoprazol Pensa

6.Further information

Pantoprazol Pensais a selective proton pump inhibitor, a medication that reduces the amount of acid produced in your stomach. It is used for the treatment of diseases related to stomach and intestinal acid.

Pantoprazol Pensais used for:

Adults and adolescents 12 years and older:

• Ttreatment of symptoms associated with gastroesophageal reflux disease (stomach burning, acid regurgitation, difficulty swallowing) caused by acid reflux from the stomach.

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

Adults:

• Prevention of gastroduodenal ulcers induced by nonsteroidal anti-inflammatory drugs (NSAIDs, for example, ibuprofen) in patients at risk who require continued treatment with this type of medication.

Do not take Pantoprazol Pensa

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

Be especially careful 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 when you are on long-term treatment with Pantoprazol Pensa. If liver enzyme levels increase, treatment should be interrupted.
• If you need to take nonsteroidal anti-inflammatory drugs (NSAIDs) continuously and take Pantoprazol Pensa, as there is a higher risk of developing complications in the stomach and intestines. Any increased risk will be evaluated based on individual risk factors such as age (65 years or older), history of stomach or duodenal ulcers, or gastrointestinal bleeding.
• If you have decreased vitamin B12 reserves or risk factors for it and receive long-term treatment with pantoprazole. Like all medications that reduce acid production, pantoprazole may reduce vitamin B12 absorption.
• Inform your doctor if you are taking a medication that contains atazanavir (for HIV treatment) at the same time as pantoprazole.
• If you have ever had a skin reaction after treatment with a similar medication to Pantoprazol Pensa for reducing stomach acid. If you experience a rash, especially on sun-exposed skin areas, consult your doctor as soon as possible, as it may be necessary to interrupt treatment with Pantoprazol Pensa. Remember to mention any other symptoms you may notice, such as joint pain.
• A specific blood test (chromogranin A) is planned.
• If you take pantoprazole 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 decreased potassium and calcium levels in the blood. Your doctor will decide to perform periodic blood tests to monitor magnesium levels.

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

• Unintentional weight loss
• Recurring vomiting
• Difficulty swallowing
• Blood in vomit
• Pale appearance and feeling of weakness (anemia)
• Blood in stool
• Severe or persistent diarrhea, as pantoprazole has been associated with a small increase in infectious diarrhea.

Your doctor will decide if you need additional testing to rule out a malignant disease, as pantoprazole may alleviate cancer symptoms and potentially delay diagnosis. If your symptoms persist despite treatment, further investigations will be performed.

If you take Pantoprazol Pensa for a prolonged period (more than one year), your doctor may perform regular follow-up. You should inform your doctor of any new or unexpected symptoms and/or events each time you attend your consultation.

Use of other medications

Pantoprazol Pensa may affect the efficacy of other medications, so inform your doctor if you are taking,

• Medications such as ketoconazole, itraconazole, and posaconazole (used for fungal infections) or erlotinib (used for certain types of cancer), as Pantoprazol Pensa may make these and other medications less effective.

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

• Atazanavir (used for HIV treatment).

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

Pregnancy and breastfeeding

There is insufficient data on the use of pantoprazole in pregnant women. Pantoprazole has been detected in human milk. If you are pregnant, or think you may be pregnant, or if you are breastfeeding, you should only use this medication if your doctor considers the benefits for you to be greater than the potential risk to the fetus or baby.

Consult your doctor or pharmacist before using any medication.

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 components of Pantoprazol Pensa

This medication contains lactose. If your doctor has indicated that you have an intolerance to certain sugars, consult with them before taking this medication.

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

When and how should you take Pantoprazol Pensa?

Take the whole tablets, 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 12 years and older:

For treating symptoms associated with gastroesophageal reflux disease (stomach burning, acid regurgitation, difficulty swallowing)

The usual dose is 1 tablet per day.

This dose usually provides relief within 2-4 weeks, and if not, within a maximum of 4 weeks. Your doctor will tell you how long you should continue taking the medication.

Any recurring symptoms can be controlled as needed by taking 1 tablet per day.

For long-term treatment and prevention of esophagitis relapses

The usual dose is 1 tablet per day. If the disease recurs, your doctor may double the dose, in which case you can take Pantoprazol Pensa 40 mg once a day. After recovery, you can reduce the dose again to 1 tablet of 20 mg per day.

Adults:

For preventing duodenal and stomach ulcers in patients requiring long-term treatment with NSAIDs

The usual dose is 1 tablet per day.

Special patient groups:

• If you have severe liver problems, do not take more than 1 tablet of 20 mg per day.
• These tablets are not recommended for children under 12 years old.

If you take more Pantoprazol Pensa than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone91 562 04 20, indicating the medication and the amount taken.

No symptoms of overdose are known.

If you forget to take Pantoprazol Pensa

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

If you interrupt treatment with Pantoprazol 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.

Like all medications,Pantoprazol Pensacan cause side effects, although not everyone will experience them.

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

Very common (affects more than one in 10 patients)

Common (affects between 1 and 10 patients in every 100)

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

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

Very rare (affects fewer than 1 in 10,000 patients)

Frequency not known (cannot be estimated from available data).

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

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

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

• Other severe conditions (frequency not known):yellowing of the skin and white of the eyes (severe liver cell damage, jaundice), or fever, hives, increased kidney size with occasional pain while urinating, and lower back pain (severe kidney inflammation)

Other side effects are:

• Common(affects between 1 and 10 in every 100 patients): benign stomach polyps
• Uncommon(affects between 1 and 10 patients in every 1,000): headache; dizziness; diarrhea; sensation of dizziness, vomiting; bloating and flatulence (gas); constipation; dry mouth; abdominal pain and discomfort; skin hives, exanthema, rash; tingling; feeling of weakness, fatigue, or general discomfort; sleep disturbances.
• Rare(affects between 1 and 10 patients in every 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; gynecomastia in men.
• Very rare(affects fewer 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, prickling, paresthesia (tingling), burning, or numbness, decreased sodium levels in the blood, skin rash, possibly with joint pain, inflammatory bowel disease causing persistent watery diarrhea.

If you are taking Pantoprazol Pensa for more than three months, it is possible that magnesium levels in the blood may decrease. Low magnesium levels can cause fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, increased heart rate. If you experience any of these symptoms, see your doctor immediately. Low magnesium levels can also cause decreased 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 such as Pantoprazol Pensa, especially for a period of more than one year, it may slightly increase the risk of hip, wrist, and spinal 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 patients in every 1,000):

Increased liver enzymes

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

Increased bilirubin; increased levels of fats in the blood

• Very rare(affects fewer than 1 in 10,000 patients):

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

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

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

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

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

Blister: Store below30°C. Store in the original packaging

Do not usePantoprazol Pensaafter the expiration date that appears on the packaging. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash.Deposit the packaging and medicines that you no longer need at the SIGRE collection pointofthe pharmacy. Incase of doubtask your pharmacist how to dispose of the packaging and medicines that you no longer need. By doing so, you will help protect the environment.

Composition of Pantoprazol Pensa

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

Appearance of the product and contents of the package

Yellow ochre-coated elongated tablets.

Pantoprazol Pensa 20 mg is presented in packages of 14, 28 or 56 tablets, in blister or bottle.

Marketing Authorization Holder

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Responsible for Manufacturing

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, arepresented in packages of 14, 28 and 56 tablets.

This prospectus was approved in August 2019

The detailed information of this medicine is available on the webpage of the Spanish Agency of Medicaments and Sanitary Products (AEMPS)http://www.aemps.gob.es/