PATIENT INFORMATION LEAFLET

Pantoprazol Durban 20 mg gastro-resistant tablets EFG

Pantoprazol

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

• 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 only. Do not give it to others even if they have similar symptoms, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Table of Contents

1. What Pantoprazol Durban is and what it is used for.
2. What you need to know before you start taking Pantoprazol Durban.
3. How to take Pantoprazol Durban.
4. Possible side effects.
5. Storage of Pantoprazol Durban.

6. Contents of the pack and additional information.

Pantoprazol Durban contains the active substance pantoprazol.

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

Pantoprazol Durbanis used inadults and adolescents aged 12 years and older to treat:

• 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).

Pantoprazol Durban is used in adults to treat:

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 Durban

• If you are allergic (hypersensitive) to pantoprazole or to any of the other components of this medication (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 or pharmacist before starting to take Pantoprazol Durban.

• 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 Durban. If liver enzyme levels increase, treatment should be discontinued.
• If you need to take nonsteroidal anti-inflammatory drugs (NSAIDs) continuously and take Pantoprazol Durban, as there is a higher risk of developing complications in the stomach and intestines.

Any increased risk will be evaluated in accordance with 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.
• Consult your doctor if you are taking HIV protease inhibitors such as atazanavir (for HIV treatment) at the same time as pantoprazole.
• Taking a proton pump inhibitor like pantoprazole, especially for more than a year, may increase the risk of fractures of the hips, wrists, or spine. Inform your doctor if you have osteoporosis (reduced bone density) or if you are taking corticosteroids (which may increase the risk of osteoporosis).
• If you are taking pantoprazole for more than three months, it is possible that blood magnesium levels 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 have ever had a skin reaction after treatment with a similar medication to Pantoprazol Durban to reduce stomach acid.
• If you suffer from a skin rash, especially in sun-exposed areas, consult your doctor as soon as possible, as it may be necessary to discontinue treatment with Pantoprazol Durban. Remember to mention any other symptoms you may notice, such as joint pain.
• If you are scheduled to have a specific blood test (Cromogranin A).

Inform your doctor immediatelybefore or after taking this medication, if you notice any of the following symptoms, which may be signs of more serious underlying diseases:

• Unintentional weight loss
• Vomiting, particularly if repeated
• Blood in the vomit, which may appear as a dark brown powder in your vomit
• Notice blood in your stool, which may appear black or melena
• Difficulty swallowing or pain when swallowing
• Pale appearance and feeling of weakness (anemia)
• Chest pain
• Stomach pain
• Severe or persistent diarrhea, as this medication has been associated with a small increase in infectious diarrhea.

Your doctor will decide if you need additional testing to rule out cancer, 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 Durban for a prolonged period (more than a year), your doctor may regularly monitor you. You should inform your doctor of any new or unexpected symptoms each time you attend your appointment.

Children and adolescents

The use of Pantoprazol Durban is not recommended in children, as it has not been tested in children under 12 years old.

Taking Pantoprazol Durban with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may take any other medication, including over-the-counter medications.

Pantoprazol Durban 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 to treat certain types of cancer), as Pantoprazol Durban may make these and other medications less effective.
• Warfarin and phenprocoumon, which affect blood clotting.

You may need additional monitoring.

• Medications used to treat HIV infection, such as atazanavir.
• Methotrexate (used to treat rheumatoid arthritis, psoriasis, and cancer), if you are taking

Your doctor may temporarily discontinue treatment with Pantoprazol Durban because pantoprazole may increase methotrexate levels in the blood.

• Fluvoxamine (used to treat depression and other psychiatric disorders), if you are taking fluvoxamine, your doctor may reduce your dose.
• Rifampicin (used to treat infections)
• St. John's Wort (Hypericum perforatum) (used to treat mild depression)

Pregnancy, breastfeeding, and fertility

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

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

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.

Driving and operating machinery

Pantoprazol Durban has no influence or insignificant influence on the ability to drive or operate machinery.

You should not drive or operate machinery if you experience side effects such as dizziness or blurred vision.

Pantoprazol Durban contains sodium

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

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

Administration Form

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

The recommended 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 one 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 symptom can be controlled as needed by taking one tablet per day.one tablet per day.

• For long-term treatment and prevention of relapses of esophagitis due to reflux

The usual dose is one tablet per day. If the disease reappears, your doctor may double the dose, in which case you can take Pantoprazol Durban 40 mg once a day. After healing, you can reduce the dose again to one 20 mg tablet per day.

Adults:

• For the prevention of duodenal and stomach ulcers in patients requiring continued treatment with NSAIDs

The usual dose is one tablet per day.

Patients with liver problems

• If you have severe liver problems, do not take more than one 20 mg tablet per day.

Use in children and adolescents

• These tablets are not recommended for use in children under 12 years old.

If you take more Pantoprazol Durban than you should

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

If you forget to take Pantoprazol Durban

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

If you interrupt treatment with Pantoprazol Durban

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 medicines, this medicine may cause side effects, although not everyone will experience them.

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

• 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), 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: cannot be estimated with available data):You may notice one or more of the following: blisters on the skin and rapid deterioration of overall condition, erosion (including mild bleeding) of eyes, nose, mouth/lips, or genitals, or skin sensitivity/eruption, mainly in exposed skin areas to light/sun. You may also experience joint pain or symptoms similar to the flu, fever, swollen lymph nodes (e.g., in the armpit), and blood tests may show changes in certain white blood cells or liver enzymes (Stevens-Johnson syndrome, Lyell syndrome, erythema multiforme, acute cutaneous lupus erythematosus, pharmacological reaction with eosinophilia and systemic symptoms (DRESS)), photosensitivity.
• Other severe conditions (unknown frequency: cannot be estimated with available data):yellow discoloration of the skin and white of the eyes (severe liver cell damage, jaundice), or fever, hives, occasional kidney enlargement with painful urination, and lower back pain (severe kidney inflammation)possibly leading to renal failure

Other side effects are:

Frequent: (may affect up to 1 in 10 patients):Benign polyps in the stomach.

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

Headache; dizziness; diarrhea; sensation of dizziness, vomiting; bloating and flatulence (gas); constipation; dry mouth; abdominal pain and discomfort; hives on the skin, exanthema, eruption; tingling; feeling of weakness, fatigue, or general malaise; sleep disturbances; fracture of the hip, wrist, and spine.

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

Loss or complete absence of taste; visual disturbances such as blurred vision; urticaria; joint pain; muscle pain; weight changes; increased body temperature; high fever; swelling in the extremities (peripheral edema); allergic reactions; depression; gynecomastia in men.

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

Disorientation.

• Unknown frequency(cannot be estimated from available data)

Illusion, confusion (especially in patients with a history of these symptoms),sensation of tingling, pinching, numbness, burning, or numbness,skin eruption, possibly with joint pain.Protracted watery diarrhea due to inflammation of the large intestine.

Side effects identified through blood tests:

-Infrequent(may affect up to 1 in 100 patients)

increase in liver enzymes

-Rare(may affect up to 1 in 1,000 patients)

increase in bilirubin; increase in blood lipid levels; sudden drop in granular white blood cells in circulation, associated with high fever.

-Very rare(may affect up to 1 in 10,000 patients)

reduction in platelet count that could cause bleeding or more frequent bruising than usual; reduction in white blood cell count that could lead to more frequent infections; abnormal imbalance between red and white blood cell counts, as well as platelet counts.

-Unknown frequency (cannot be estimated from available data)

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

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, 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 medicine.

Keep out of sight and reach of children.

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

Do not store above 30°C.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medicines at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medicines. By doing so, you will help protect the environment.

Composition of Pantoprazol Durban 20 mg

The active ingredient is pantoprazol. Each gastro-resistant tablet contains 20 mg of pantoprazol (in the form of sodium sesquihydrate).

The other components are:

Core: mannitol (E421), crospovidone (type A), anhydrous sodium carbonate, calcium stearate.

Covering: Hydroxypropylmethyl cellulose 5 cP (E464), povidone K25 (E1201), propylene glycol (E1520), titanium dioxide (E171), yellow iron oxide (E172), ethyl acrylate-methacrylic acid copolymer (1:1), [polysorbate 80, sodium lauryl sulfate], triethyl citrate (E1505).

Black opacode ink: [shellac (E904), black iron oxide (E172), propylene glycol (E1520) ammonium hydroxide].

Appearance of Pantoprazol Durban and packaging content

Gastro-resistant tablet of yellow color, oval, biconvex, smooth coated on both sides (approximately 8.45 mm x 4.2 mm).

Pantoprazol Durban 20 mg is available in the following packaging sizes:

Blister pack of 14, 28, 30, 56, 60, 90, and 100 gastro-resistant tablets.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Francisco Durbán S.A.

Industrial Park La Redonda, c/ IX, nº 2

04710 El Ejido (Almería)

Responsible manufacturer

Macleods Pharma UK Limited

Wynyard Park House,

Wynyard Avenue,

Wynyard, Billingham,

TS22 5TB, United Kingdom

IDIFARMA DESARROLLO FARMACÉUTICO, S.L.

Poligono Mocholi

C/Noain, 1

31110 NOAIN (NAVARRA)

SPAIN

Netpharmalab Consulting Services

Carretera de Fuencarral, 22

28108 – Alcobendas, Madrid

Spain

Synoptis Industrial Sp. z.o.o. ul.

Rabowicka 15,

Swaredz

Poland

STM Group SRL

Strada Provinciale Pianura 2

80078, Pozzuoli

Italy

Synoptis Industrial Sp. z.o.o. ul.

Rabowicka 15,

Swaredz

Poland

Last review date of this leaflet: May 2022

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