Leaflet: information for the user

Pantoprazol pensa 40 mg gastro-resistant tablets EFG

Read this leaflet carefully before starting to take the medicine

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for you and should not be given to others, even if they have the same symptoms, as it may harm them.
• If you consider that any of the side effects you are experiencing is serious or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

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. Additional information

Pantoprazol Pensa is 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 acid and intestine.

Pantoprazol Pensa is used for:

Adults and adolescents 12 years and older:

• Esophagitis caused by reflux. It is an inflammation of your esophagus (the tube that connects your throat to your stomach) accompanied by regurgitation of acid from your stomach.

Adults:

• Infection caused by a bacteria called Helicobacter pylori in 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 ulcers reappearing

• Stomach and duodenal ulcers, and

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

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 have reduced vitamin B12 reserves or risk factors for it and receive pantoprazole treatment for a long period. Like all medications that reduce acid levels, pantoprazole may reduce vitamin B12 absorption.
• Consult your doctor if you are taking any 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 to reduce 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 Pantoprazol Pensa treatment. Remember to mention any other symptoms you may notice, such as joint pain.
• A specific blood test (Cromogranin A) is planned.
• If you take pantoprazole 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, 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 blood potassium and calcium levels. Your doctor will 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 your 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, additional investigations will be performed.

If you take Pantoprazol Pensa for a prolonged period (more than one year), your doctor may perform regular follow-ups. 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),asPantoprazol Pensa may make these and other medications not work correctly.

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

• Atazanavir (used for HIV treatment).

Informyour doctor or pharmacist if you are using or have recently used other medications,includingthose purchasedwithout a prescription.

Pregnancy and breastfeeding

There is insufficient data on the use of pantoprazole in pregnant women.Pantoprazole is excreted in human breast 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 benefit 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 of the 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 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:

Treatment of esophagitis by reflux:

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

Adults:

Treatment of an infection with a bacteria calledHelicobacter 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),eachone to be taken twice a daywith your pantoprazole tablet. Take thefirstpantoprazole tablet 1 hour before breakfast and thesecond1 hour before dinner. Follow your doctor's instructions and make sure to read the antibiotic prospectuses.

The usual treatment duration is 1 to 2 weeks.

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 tell you for how long you should take this medication. The usual treatment duration for stomach ulcers is 4 to 8 weeks, and for duodenal ulcers is 2 to 4 weeks.

Long-term treatment of Zollinger-Ellison Syndrome and other conditions in which there is an increase in stomach acid production:

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

Special patient groups:

• If you have kidney problems, or moderate or severe liver problems,you should not take Pantoprazol Pensa for the elimination ofHelicobacter 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 Pantoprazol Pensa than you should

If you have taken morePantoprazol Pensathan you should, consult your doctor or pharmacist immediately, or call the Toxicological Information Service, phone91 562 04 20indicating the medication and the amount used. It is recommended to bring the packaging and the medication prospectus to the healthcare professional.

No known symptoms of overdose.

If you forgot 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 doubts about the use of this product, ask your doctor or pharmacist.

Like all medications,Pantoprazol Pensamay 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 1 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 disorders (frequency not known):skin blisters and rapid deterioration of general condition, erosion (including light 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 patients in every 100): 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, convulsions, 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 may 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 Medicines 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.

Do not store at a temperature above30°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. Dispose of the packaging and medicines you no longer need at the SIGRE collection pointofthe pharmacy. Incase of doubt, ask your pharmacist how to dispose of the packaging and medicines 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 40 mg of pantoprazol (present in the form of 45.10 mg of pantoprazol 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)), acid methacrylic copolymer (1:1) dispersion at 30%, triethyl citrate (E-1505), talc (E-553b).

Appearance of the product and contents of the package

Oval-shaped tabletscoatedwith yellow-brown color.Pantoprazol Pensa 40 mg gastro-resistant tablets are presented in a bottle or blister pack of 14, 28 or 56 tablets.

Holder of the marketing authorization

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

This leaflet was approved in August 2019.

The detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/