PANTOPRAZOL OPKO 40 mg GASTRO-RESISTANT TABLETS

Introduction

Package Leaflet: Information for the User

Pantoprazole OPKO 40 mg Gastro-Resistant Tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

1. What is Pantoprazole OPKO and what is it used for
2. What you need to know before you take Pantoprazole OPKO
3. How to take Pantoprazole OPKO
4. Possible side effects
5. Storage of Pantoprazole OPKO
6. Contents of the pack and other information

1. What is Pantoprazole OPKO and what is it used for

Pantoprazole OPKO contains the active substance pantoprazole. Pantoprazole is a "proton pump inhibitor", a medicine that reduces the amount of acid produced in your stomach. It is used to treat diseases related to stomach acid and intestine acid.

Pantoprazole OPKO is used in adults and adolescents aged 12 years and above to treat:

• Reflux esophagitis. This is an inflammation of your esophagus (the tube that connects your throat to your stomach) accompanied by acid reflux.

Pantoprazole OPKO is used in adults to treat:

• Infection by a bacterium called Helicobacter pyloriin patients with duodenal ulcers and stomach ulcers in combination with two antibiotics (eradication treatment). The goal is to get rid of the bacterium and thus reduce the likelihood of these ulcers coming back.
• Stomach and duodenal ulcers.
• Zollinger-Ellison syndrome and other conditions in which too much acid is produced in the stomach.

2. What you need to know before you take Pantoprazole OPKO

Do not take Pantoprazole OPKO

• If you are allergic to pantoprazole or any of the other ingredients of this medicine (listed in section 6).
• If you are allergic to medicines that contain other proton pump inhibitors.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting to take pantoprazole:

• If you have severe liver problems. Tell your doctor if you have ever had liver problems in the past. Your doctor will monitor your liver enzymes more frequently, especially when you are taking pantoprazole as long-term treatment. If there is an increase in liver enzymes, treatment should be stopped.
• If you have low levels of vitamin B12 or risk factors for this and are receiving long-term treatment with pantoprazole. Like all medicines that reduce acid, pantoprazole may reduce the absorption of vitamin B12.

Tell your doctor if you notice any of the following symptoms, which could indicate low levels of vitamin B12:

• Extreme tiredness or lack of energy
• Tingling sensation
• Sore or inflamed tongue, mouth ulcers
• Muscle weakness
• Vision problems
• Memory problems, confusion, depression
• Tell your doctor if you are taking HIV protease inhibitors such as atazanavir (for the treatment of HIV infection) at the same time as pantoprazole.
• Taking a proton pump inhibitor like pantoprazole, especially for a period of more than one year, may slightly increase the risk of hip, wrist, or spine fractures. Tell your doctor if you have osteoporosis (reduced bone density) or if you have been told you are at risk of osteoporosis (for example, if you are taking steroids).
• If you take pantoprazole for more than three months, you may suffer from a decrease in magnesium levels in your blood. Symptoms of low magnesium levels can include fatigue, muscle contractions, disorientation, dizziness, or increased heart rate. If you experience any of these symptoms, tell your doctor immediately. Additionally, low magnesium levels can lead to decreased potassium and calcium levels in the blood. Your doctor will decide whether to perform periodic blood tests to monitor magnesium levels.
• If you have ever had a skin reaction after treatment with a medicine similar to pantoprazole to reduce stomach acid.
• If you get a skin rash, especially in areas exposed to the sun, tell your doctor as soon as possible, as you may need to stop your treatment with pantoprazole. Also, mention any symptoms you may notice, such as joint pain.
• Severe skin reactions have been reported in relation to treatment with pantoprazole, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug rash with eosinophilia and systemic symptoms (DRESS), and erythema multiforme. Stop taking pantoprazole and call your doctor immediately if you experience any of the symptoms related to severe skin reactions described in section 4.
• If you need to have a specific blood test (Chromogranin A).

Tell your doctor immediately, before or after taking this medicine, if you notice any of the following symptoms, which could be signs of a more serious disease:

• Unintentional weight loss
• Vomiting, especially if it is repeated
• Vomiting blood; this may appear as dark coffee grounds in the vomit
• If you notice blood in your stool; it may appear black or tarry
• Difficulty swallowing or pain when swallowing
• Pale appearance and feeling of weakness (anemia)
• Chest pain
• Stomach pain
• Severe and/or persistent diarrhea, as this medicine has been associated with a small increase in infectious diarrhea.

Your doctor will decide if you need any additional tests to rule out a malignant disease because pantoprazole can alleviate the symptoms of cancer and could delay its diagnosis. If, despite treatment, your symptoms persist, additional tests will be performed.

If you take pantoprazole for a prolonged period (more than 1 year), your doctor may perform regular follow-up. You should tell your doctor about any new or unexpected symptoms or events each time you visit your doctor.

Children and Adolescents

Pantoprazole is not recommended for use in children, as it has not been tested in children under 12 years of age.

Other Medicines and Pantoprazole OPKO

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

This is because pantoprazole may affect the efficacy of other medicines, so tell 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 pantoprazole may prevent these and other medicines from working properly.
• Warfarin and phenprocoumon, which affect blood coagulation. You may need additional checks.
• Medicines used to treat HIV infection, such as atazanavir.
• Methotrexate (used to treat rheumatoid arthritis, psoriasis, and cancer): if you are taking methotrexate, your doctor may temporarily stop treatment with pantoprazole because this medicine can increase methotrexate levels in the blood.
• Fluvoxamine (used to treat depression and other psychiatric disorders): if you are taking fluvoxamine, your doctor may reduce the dose.
• Rifampicin (used to treat infections).
• St. John's Wort (Hypericum perforatum) (used to treat mild depression).

Consult your doctor before taking pantoprazole if you need to have a specific urine test (for THC; tetrahydrocannabinol).

Pregnancy, Breast-feeding, and Fertility

There is not enough data on the use of pantoprazole in pregnant women. It has been reported that it is excreted in breast milk.

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

You should use this medicine only if your doctor considers that the benefit for you is greater than the potential risk to the fetus or baby.

Driving and Using Machines

Pantoprazole has no or negligible influence on the ability to drive and use machines.

If you experience side effects such as dizziness or blurred vision, do not drive or use machines.

Pantoprazole OPKO contains Sodium and Propylene Glycol

This medicine contains less than 1 mmol of sodium (23 mg) per tablet, which is essentially "sodium-free".

This medicine contains 3.72 mg of propylene glycol in each gastro-resistant tablet.

3. How to take Pantoprazole OPKO

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist.

Method of Administration

Take the tablets 1 hour before a meal without chewing or breaking them and swallow them whole with a little water.

The recommended dose is:

Adults and Adolescents aged 12 years and above

For the treatment of reflux esophagitis

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

Adults

For the treatment of an infection by a bacterium called Helicobacter pylori in patients with duodenal ulcers and stomach ulcers in combination with two antibiotics (eradication treatment).

One tablet twice a day plus two tablets of antibiotics, either amoxicillin, clarithromycin, and metronidazole (or tinidazole), each to be taken twice a day with your pantoprazole tablet. Take the first pantoprazole tablet 1 hour before breakfast and the second pantoprazole tablet 1 hour before dinner. Follow your doctor's instructions and make sure to read the package leaflets of these antibiotics. The treatment duration is usually 1 to 2 weeks.

For the 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 how long to take this medicine. The treatment duration for stomach ulcers is usually between 4 and 8 weeks. The treatment duration for duodenal ulcers is usually between 2 and 4 weeks.

For long-term treatment of Zollinger-Ellison syndrome and other diseases 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. Afterwards, your doctor may adjust the 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 divided into two doses per day.

If your doctor prescribes more than four tablets per day, he will tell you exactly when to stop treatment.

Patients with Kidney Problems

If you have kidney problems, you should not take pantoprazole for the eradication of Helicobacter pylori.

Patients with Liver Problems

If you have severe liver problems, you should not take more than one 20 mg pantoprazole tablet per day (20 mg pantoprazole tablets are available for this purpose).

If you have moderate or severe liver problems, you should not take pantoprazole for the eradication of Helicobacter pylori.

Use in Children and Adolescents

These tablets are not recommended for use in children under 12 years of age.

If you take more Pantoprazole OPKO than you should

Talk to your doctor or pharmacist. There are no known symptoms of overdose.

In case of overdose or accidental ingestion, talk to your doctor or pharmacist immediately or call the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Pantoprazole OPKO

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

If you stop taking Pantoprazole OPKO

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

If you have any further questions on the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

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

• Severe allergic reactions (rare frequency:may affect up to 1 in 1,000 people):swelling of the tongue and/or throat, difficulty swallowing, hives (urticaria), breathing difficulties, swelling of the face of allergic origin (Quincke's edema/angioedema), intense dizziness with very rapid heartbeats and profuse sweating.

• Severe skin conditions (unknown frequency: their frequency cannot be estimated from the available data): you may notice one or more of the following: blisters on the skin and rapid deterioration of your general condition, erosion (including slight bleeding) of the eyes, nose, mouth/lips or genitals, or sensitivity/skin rash, especially in areas of the skin exposed to light or sun. You may also experience joint pain or symptoms similar to those of the flu, fever, swollen glands (e.g., in the armpit), and blood tests may show changes in certain white blood cells or liver enzymes.

-Red patches, not raised, target-like or circular on the trunk, often with blisters in the center, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin rashes can be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).

• Widespread skin rash, high body temperature, and enlarged lymph nodes (DRESS or drug hypersensitivity syndrome).

• Other severe conditions (unknown frequency):yellowing of the skin or the white part of the eyes (severe liver cell damage, jaundice) or fever, rash, and enlarged kidneys, sometimes with pain when urinating, and pain in the lower back (severe kidney inflammation), which can lead to kidney failure.

Other side effects are:

• Frequent(may affect up to 1 in 10 people)

Benign polyps in the stomach.

• Infrequent(may affect up to 1 in 100 people)

Headache; dizziness; diarrhea; feeling of dizziness, vomiting; swelling and flatulence (gas); constipation; dry mouth; abdominal pain and discomfort; skin rash, exanthema, rash; itching; feeling of weakness, fatigue, or general malaise; sleep disorders; fracture of the hip, wrist, or spine.

• Rare(may affect up to 1 in 1,000 people)

Alteration or complete loss of taste; vision disturbances such as blurred vision; hives; joint pain; muscle pain; weight changes; increased body temperature; high fever; swelling of the limbs (peripheral edema); allergic reactions; depression; increased breast size in men.

• Very rare(may affect up to 1 in 10,000 people)

Disorientation.

• Unknown frequency(frequency cannot be estimated from the available data)

Hallucination, confusion (especially in patients with a history of these symptoms); sensation of tingling, prickling, paresthesia (tingling), burning, or numbness, skin rash, possibly with joint pain, inflammation of the large intestine that causes persistent watery diarrhea.

Adverse effects identified through blood tests:

• Infrequent(may affect up to 1 in 100 people)

Increased liver enzymes.

• Rare(may affect up to 1 in 1,000 people)

Increased bilirubin; increased fat levels in the blood; sudden drop in circulating granular white blood cells associated with high fever.

• Very rare(may affect up to 1 in 10,000 people)

Reduction in the number of platelets in the blood, which can cause bleeding or more bruising than usual; reduction in the number of white blood cells that could lead to more frequent infections; coexistence of an abnormal decrease in the number of red and white blood cells, as well as platelets.

• Unknown frequency(frequency cannot be estimated from the available data)

Decrease in sodium, magnesium, calcium, or potassium levels in the blood (see section 2)

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 that does not appear in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Pantoprazol OPKO

Keep out of sight and reach of children.

Do not store above 30 ºC.

Do not use this medicine after the expiration date that appears on the box after CAD. The expiration date is the last day of the month indicated.

Medicines should not be thrown down the drain or into the trash. Deposit the containers and medicines you no longer need at the SIGRE point of the pharmacy. Ask your pharmacist how to dispose of the containers and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Pantoprazol OPKO Composition

The active ingredient is pantoprazol. Each gastro-resistant tablet contains 40 mg of pantoprazol (as pantoprazol sodium sesquihydrate).

The other components are:

Tablet core:

Manitol (E421),

Crospovidone,

Anhydrous sodium carbonate,

Hydroxypropylcellulose,

Calcium stearate

Tablet coating:

Hypromellose,

Titanium dioxide (E171),

Yellow iron oxide (E172),

Propylene glycol (E1520),

Eudragit L-30 D55 (Copolymer of methacrylic acid-ethyl acrylate (1:1) (The dispersion consists of approximately 97% (w/w) of methacrylic acid and ethyl acrylate copolymer (1:1), 2.3% (w/w) of polysorbate 80, and 0.7% (w/w) of sodium lauryl sulfate).

Triethyl citrate,

Talc

See section 2: Pantoprazol OPKO contains sodium and propylene glycol

Product Appearance and Package Contents

Yellow, oval, biconvex, gastro-resistant tablets (11.7 mm long, 6.0 mm wide), smooth on both sides.

Pantoprazol OPKO is available in packages of 28 gastro-resistant tablets; Al/Al blister pack

Marketing Authorization Holder

OPKO HEALTH ESPAÑA, S.L.U.

Pl. Europa 13-15, 08908

L'Hospitalet de Llobregat (Barcelona)

Spain

Manufacturer

Laboratori Fundació Dau

C/ C, 12-14 Pol. Ind. Zona Franca,

08040 Barcelona,

Spain

This medicine is authorized in the member states of the European Economic Area with the following names:

Denmark: Pantoprazol OPKO

Spain: Pantoprazol OPKO 40 mg gastro-resistant tablets EFG

Date of the last revision of this prospectus:August 2024.

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS): http://www.aemps.gob.es/