Package Insert: Information for the Patient

Pantoprazol Tarbis 20 mg Gastrorresistant Tablets EFG

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed for you only and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

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

2. What you need to know before starting to take Pantoprazol Tarbis

3. How to take Pantoprazol Tarbis

4. Possible adverse effects

5. Storage of Pantoprazol Tarbis

6. Contents of the package and additional information

Pantoprazol Tarbisis 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 Tarbisis used for:

Adults and adolescents 12 years and older:

• Treatment 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 recurrences 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 takePantoprazol Tarbis

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

Warnings and precautions

Consult your doctor before starting to take Pantoprazol Tarbis:

• 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 pantoprazole. If liver enzyme levels increase, treatment should be interrupted.
• If you need to take nonsteroidal anti-inflammatory drugs (NSAIDs) continuously and take pantoprazole, as there is a higher risk of developing complications in the stomach and intestine. 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 treatment with pantoprazole for a long period of time. Like all medications that reduce acid production, pantoprazole may reduce vitamin B12 absorption.

-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 Tarbis to reduce stomach acid.

• If you are scheduled to have a specific blood test (Cromogranin A).
• 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 a decrease in potassium and calcium levels in the blood. Your doctor will decide to perform periodic blood tests to monitor magnesium levels.

If you experience a skin rash, especially in sun-exposed areas, consult your doctor as soon as possible, as it may be necessary to interrupt treatment with Pantoprazol Tarbis. Remember to mention any other symptoms you may notice, such as joint pain.

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

• Unintentional weight loss
• Repeated vomiting
• Difficulty swallowing
• Blood in the vomit
• Pale appearance and feeling of weakness (anemia)
• Blood in your stools

-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 pantoprazole for a prolonged period (more than one year), your doctor may regularly monitor you. You should inform your doctor of any new or unexpected symptoms and/or events each time you attend your consultation.

Consult your doctor or pharmacist before starting to take Pantoprazol Tarbis.

Use of Pantoprazol Tarbis with other medications

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

• Medications such as ketoconazole, itraconazole, and posaconazole (used to treat fungal infections) or erlotinib (used for certain types of cancer), as Pantoprazol Tarbis may make these and other medications not work correctly.

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

• Atazanavir (used to treat HIV infection).

Inform your doctor or pharmacist about any medications you are using, have used recently, or may need to use.

Pregnancy and breastfeeding

There is insufficient data on the use of pantoprazole in pregnant women. Pantoprazole has been excreted in human breast milk.

If you are pregnant, breastfeeding, believe you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medication.

Driving and operating machinery

Pantoprazol Tarbis is unlikely to affect your ability to drive or use tools or machines. However, side effects such as dizziness and visual disturbances (see section 4) may occur. If they do, you should not drive or operate machinery.

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor again.

When and how should you take Pantoprazol Tarbis?

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. Subsequently, 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 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.

- Children under 12 years: These tablets are not recommended for children under 12 years.

If you take morePantoprazol Tarbisthan you should

Inform your doctor or pharmacist or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested. No symptoms of overdose are known.

If you forget to takePantoprazol Tarbis

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

If you interrupt treatment withPantoprazol Tarbis

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

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

Like all medicines, Pantoprazol Tarbis may 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 patient in every 10)

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 one patient in every 10,000)

Frequency unknown (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 emergency department of the nearest hospital:

-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 (unknown frequency):blistering of the skin and rapid deterioration of general condition, erosion (including slight bleeding) of eyes, nose, mouth/lips or genitals (Stevens-Johnson syndrome, Lyell syndrome, erythema multiforme), and sensitivity to light,skin rash, possibly with joint pain.

• Other severe conditions (unknown frequency):yellowing of the skin and the white of the eyes (severe liver cell damage, jaundice), or fever, hives, increased size of the kidneys 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 polyps in the stomach.

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

headache; dizziness; diarrhea; sensation of dizziness, vomiting; swelling and flatulence (gas); constipation; dry mouth; abdominal pain and discomfort; skin rash, exanthema, eruption; feeling of weakness, fatigue or general malaise; 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; breast enlargement in men.

-Very rare(affects fewer than one patient in every 10,000)

disorientation

• Unknown frequency(cannot be estimated from available data)

hallucination, confusion (especially in patients with a history of these symptoms), decreased sodium levels in the blood, sensation of tingling, numbness, paresthesia (tingling), burning or numbness,inflammatory bowel disease that causes persistent watery diarrhea.

Side effects identified through blood tests:

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

increase in liver enzymes

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

increase in bilirubin; increase in blood fats

-Very rare(affects fewer than one patient in every 10,000)

reduction in platelet count that could cause bleeding or more frequent bruising; reduction in white blood cell count that could lead to more frequent infections.

Unknown frequency

If you are taking Pantoprazol Tarbis 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 recommend periodic blood tests to monitor magnesium levels.

If you are taking proton pump inhibitors such as Pantoprazol Tarbis, especially for a period of more than one year, you may have a slightly increased 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).

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Vigilance 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.

Do not usethis medicationafter the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

PantoprazolTarbis in a Polyethylene bottle, does not require special storage conditions.

PantoprazolTarbis inAluminum/Aluminum blister:store below30°C

Medicines should not be disposed of through drains or in the trash.Deposit the packaging and unused medications at the SIGRE collection pointof the pharmacy. In case of doubtask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition ofPANTOPRAZOL TARBIS

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:

Core:Dihydrate sodium phosphate anhydrous (E-339), Mannitol (E-421), Microcrystalline cellulose (E-460), Sodium croscarmellose, Magnesium stearate (E-470)

Coating:Hydroxypropyl methylcellulose, Triethyl citrate, Sodium carboxymethyl starch from potato, Copolymer of methacrylic acid-ethyl acrylate (1:1), 30% dispersion

Printing ink:Yellow iron oxide (E-172)

Appearance of the product and contents of the packaging

Gastro-resistant tablet of yellow color, oval, concave, and smooth.

Containers:

Bottles (high-density polyethylene container with a polyethylene screw cap) and blisters (Alu/Alu blisters)

Containers with 28 or 56 gastro-resistant tablets

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Tarbis Farma, S.L.

Gran Vía Carlos III, 94

08028 Barcelona- Spain

Responsible for manufacturing

Teva Pharma S.L.U.

Malpica industrial estate c/ C, 4.

50016 Zaragoza

Spain

Last review date of this leaflet:August 2019

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