PANTOPRAZOL DURBAN 20 mg GASTRO-RESISTANT TABLETS

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

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. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. Contents of the pack and other information.

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

Pantoprazol Durban contains the active substance pantoprazole.

Pantoprazol Durban is a selective inhibitor of the "proton pump", a medicine that reduces the amount of acid produced in your stomach. It is used to treat diseases related to stomach and intestine acid.

Pantoprazol Durbanis used inadults and adolescents from 12 years to treat:

• Symptoms associated with gastroesophageal reflux disease (heartburn, acid regurgitation, pain when swallowing) caused by acid reflux from the stomach.
• Long-term treatment and prevention of relapses of reflux esophagitis (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 non-steroidal anti-inflammatory drugs (NSAIDs, e.g., ibuprofen) in patients at risk who require continued treatment with these types of drugs.

2. What you need to know before you take Pantoprazol Durban

Do not take Pantoprazol Durban

• If you are allergic (hypersensitive) to pantoprazole or any of the other ingredients of this medicine (see section 6).
• If you are allergic to medicines 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 serious liver problems. Inform your doctor if you have ever had liver problems. Your doctor will perform more frequent monitoring of liver enzymes, especially when you are on long-term treatment with Pantoprazol Durban. If there is an increase in liver enzymes, treatment should be discontinued.
• If you need to take non-steroidal anti-inflammatory drugs (NSAIDs) continuously and take Pantoprazol Durban, as there is a greater risk of developing complications in the stomach and intestine.

Any increased risk will be assessed according to personal risk factors such as age (65 years or older), history of stomach or duodenal ulcers or stomach and intestinal bleeding.

• If you have decreased body reserves of vitamin B12 or risk factors for it and receive long-term treatment with pantoprazole. Like all acid-reducing medicines, pantoprazole may reduce the absorption of vitamin B12.
• Consult your doctor if you are taking HIV protease inhibitors such as atazanavir (for HIV infection 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 hip, wrist, or spine. Inform your doctor if you have osteoporosis (reduced bone density) or if you are taking corticosteroids (which can increase the risk of osteoporosis).
• If you are taking pantoprazol for more than three months, it is possible that your blood magnesium levels may decrease. Low magnesium levels can cause fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, increased heart rate. If you have any of these symptoms, go to the doctor immediately. Low magnesium levels can also produce a decrease in blood potassium and calcium levels. 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 medicine similar to Pantoprazol Durban to reduce stomach acidity.
• If you suffer a skin rash, especially in areas of the skin exposed to the sun, 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 (Chromogranin A)

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

• unintentional weight loss
• vomiting, particularly if it is repeated
• blood in the vomit, which may appear as a dark coffee grounds-like substance in your vomit
• if you notice blood in your stools, which may appear black or tarry
• difficulty swallowing or pain when swallowing
• pale appearance and feeling of weakness (anemia)
• chest pain
• stomach pain
• severe 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 may alleviate the symptoms of cancer and could delay its diagnosis.

If, despite treatment, your symptoms persist, complementary tests will be performed.

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

Children and adolescents

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

Taking Pantoprazol Durban with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.

Pantoprazol Durban may affect the efficacy of other medicines, so inform your doctor if you are taking:

• Medicines 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 medicines not work properly.
• Warfarin and phenprocoumon, which affect blood coagulation.

You may need additional monitoring.

• 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 discontinue treatment with Pantoprazol Durban because pantoprazole may increase methotrexate levels in the blood.

Pregnancy, breastfeeding, and fertility

There is not enough data on the use of pantoprazole in pregnant women. It has been reported that in humans, pantoprazole is excreted in 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 medicine.

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

Driving and using machines

Pantoprazol Durban has no or negligible influence on the ability to drive or use machines.

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

Pantoprazol Durban contains sodium

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

3. How to take Pantoprazol Durban

Follow exactly the administration instructions of this medicine indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Method of administration

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 from 12 years:

To treat symptoms associated with gastroesophageal reflux disease (heartburn, acid regurgitation, pain when swallowing)

The usual dose is one tablet per day. This dose usually provides relief within 2-4 weeks, and if not, at most, within the following 4 weeks. Your doctor will indicate how long you should continue taking the medicine. Subsequently, any recurring symptoms can be controlled as needed, taking one tablet per day.

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

The usual dose is one tablet per day. If the disease recurs, 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 back to one 20 mg tablet per day.

Adults:

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

The usual dose is one tablet per day.

Patient with liver problems

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

Use in children and adolescents

• The use of these tablets is not recommended in children under 12 years of age.

If you take more Pantoprazol Durban than you should

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

If you forget to take Pantoprazol Durban

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

If you stop taking Pantoprazol Durban

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

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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:may affect up to 1 in 1,000 people):swelling of the tongue and/or throat, difficulty swallowing, hives (urticaria), difficulty breathing, swelling of the face of allergic origin (Quincke's edema/angioedema), intense dizziness with very rapid heartbeats and profuse sweating.
• Severe skin reactions (frequency not known: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 general conditions, erosion (including slight bleeding) of eyes, nose, mouth/lips, or genitals, or sensitivity/skin rash, mainly in areas of skin exposed to light/sun. You may also have 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 (Stevens-Johnson syndrome, Lyell syndrome, erythema multiforme, subacute cutaneous lupus erythematosus, drug reaction with eosinophilia and systemic symptoms (DRESS)), photosensitivity.
• Other serious conditions (frequency not known:frequency cannot be estimated from the available data):yellowing of the skin and whites of the eyes (severe liver cell damage, jaundice), or fever, rash, increased kidney size with occasional pain when urinating, and pain in the lower back (severe kidney inflammation) possibly leading to kidney failure.

Other side effects are:

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

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

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

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

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 in the limbs (peripheral edema); allergic reactions; depression; breast enlargement in men.

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

Disorientation.

• Frequency not known(cannot be estimated from the available data)

Hallucinations, confusion (especially in patients with a history of these symptoms), feeling of tingling, pinching, numbness, burning, or tingling, skin rash, possibly with joint pain. Inflammation of the large intestine that causes persistent watery diarrhea.

Side effects identified through blood tests:

• Uncommon (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 fat levels; sharp drop in white blood cell count, associated with high fever.

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

reduction in platelet count, which could lead to bleeding or more bruising than usual; reduction in white blood cell count, which could lead to more frequent infections; abnormal reduction in the balance between red and white blood cell and platelet counts.

-Frequency not known (cannot be estimated from the available data)

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

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Pantoprazol Durban

Keep out of sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Do not store above 30°C.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Container Content and Additional Information

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), sodium carbonate (anhydrous), calcium stearate.

Coating: 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 Container 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 package sizes:

Box of blisters of 14, 28, 30, 56, 60, 90 and 100 gastro-resistant tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorios Francisco Durbán S.A.

Polígono Ind. La Redonda, c/ IX, nº 2

04710 El Ejido (Almería)

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

Date of the Last Revision of this Prospectus: May 2022

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