Pantoprazole Durban 40 mg gastro-resistant tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Pantoprazol Durban 40mg gastro-resistant tablets EFG

Read this entire leaflet carefully before you start taking this medicine, as 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 pass it on to others, even if they have the same symptoms as you, since it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet.

Contents of this leaflet

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

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

Pantoprazol Durban contains the active substance pantoprazol.

Pantoprazol Durban is a "selective proton pump inhibitor" that reduces the amount of acid produced by your stomach. It is used to treat acid-related disorders of the stomach and intestine.

Pantoprazol Durban is used in adults and adolescents aged 12 years and older to treat:

• Reflux esophagitis. This is inflammation of your esophagus accompanied by regurgitation of acid from the stomach.

Pantoprazol Durban is used in adults to treat:

• Infection with a bacterium called Helicobacter pylori (H. pylori) in patients with duodenal and gastric ulcers, in combination with the antibiotics indicated as eradication therapy. The aim is to eliminate the bacteria and thereby reduce the likelihood of ulcer recurrence.
• Gastric and duodenal ulcers.
• Zollinger-Ellison syndrome and other conditions in which excessive acid is produced in the stomach.

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

Do not take Pantoprazol Durban:

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

Warnings and precautions

Talk to your doctor or pharmacist before taking Pantoprazol Durban:

? If you have severe liver problems. Inform your doctor if you have ever had liver problems. Your doctor will likely monitor your liver enzymes, especially if you are undergoing long-term treatment with Pantoprazol Durban. If liver enzymes increase, treatment should be discontinued.

?

? If you have reduced body stores of vitamin B12 or risk factors for vitamin B12 deficiency and are receiving prolonged treatment with pantoprazole. Like all antacids, pantoprazole may reduce the absorption of vitamin B12.

• Consult your doctor if you are taking protease inhibitors for HIV, such as atazanavir (for treatment of HIV infection), at the same time as pantoprazole.

? Taking a proton pump inhibitor, such as pantoprazole, especially for more than one 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 may increase the risk of osteoporosis).

• If you are taking pantoprazole for more than 3 months, magnesium levels in the blood may decrease. Low magnesium levels can cause fatigue, involuntary muscle contractions, confusion, seizures, dizziness, and increased heart rate. If you experience any of these symptoms, contact your doctor immediately. Low magnesium levels may also lead to decreased levels of potassium and calcium in the blood. Your doctor may decide to perform periodic blood tests to monitor magnesium levels.

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• If you have ever had a skin reaction after treatment with a medicine similar to Pantoprazol Durban to reduce stomach acidity.
• If you develop a skin rash, especially in areas of skin exposed to sunlight, 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)

Contact your doctor immediately before or after taking this medicine, if you notice any of the following symptoms, which may be signs of other serious conditions:

? unintentional weight loss (not related to diet or exercise program)

? vomiting, especially if recurrent

?

? vomiting blood (dark, coffee-ground-like material in your vomit)

• if you notice blood in your stools, which may appear black or tarry (melena)
• difficulty swallowing, or pain when swallowing

? you look pale and feel weak (anemia)

• ?chest pain

stomach pain

? severe and/or persistent diarrhea, as pantoprazole has been associated with a slightly increased risk of infectious diarrhea

Your doctor will decide whether you need certain tests to rule out serious diseases, because Pantoprazol can also relieve symptoms of cancer and might delay its diagnosis. If your symptoms persist despite treatment, further investigations will be considered.

If you are taking Pantoprazol Durban for long-term treatment (more than 1 year), your doctor will likely perform regular check-ups. Inform your doctor of any new or unusual symptoms during medical visits.

Children and adolescents

Pantoprazol Durban is not recommended in children, as it has not been studied in children under 12 years of age.

Taking Pantoprazol Durban with other medicines

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

Pantoprazol Durban may affect the effectiveness of other medicines; therefore, inform your doctor if you are taking or have recently taken:

? Medicines such as ketoconazole, itraconazole, and posaconazole (used to treat fungal infections) or erlotinib (used for certain types of cancer), because Pantoprazol Durban may reduce their effectiveness.

? Warfarin and Phenprocoumon, which affect blood clotting (thickening) or anticoagulation (thinning). Your doctor may need to perform additional monitoring.

? Medicines used to treat HIV infection, such as atazanavir

? Methotrexate (used to treat rheumatoid arthritis, psoriasis, and cancer); your doctor may temporarily discontinue treatment with Pantoprazol Durban, as pantoprazole may increase methotrexate levels in the blood.

? Fluvoxamine (used to treat depression and other psychiatric conditions); if you are taking fluvoxamine, your doctor may reduce your dose.

• Rifampicin (used to treat infections)

St. John’s wort (Hypericum perforatum), used for mild depression.

Pregnancy, breastfeeding, and fertility

There are insufficient data on the use of pantoprazole in pregnant women.

It has been reported that pantoprazole is excreted in breast milk.

If you are pregnant or breastfeeding, think you might be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine. This medicine should only be used if your doctor considers that the benefit to you outweighs the potential risk to the fetus or baby.

Driving and Use of Machines

Pantoprazole Durban has no influence or has negligible influence on the ability to drive or operate machinery.

If you experience adverse effects such as dizziness or visual disturbances, you should not drive or use machinery.

3. How to take Pantoprazol Durban

Follow exactly the dosing instructions for this medicine as provided by your doctor. If you are unsure, consult your doctor or pharmacist again.

The recommended dose is:

Adults and adolescents aged 12 years and older:

For the treatment of reflux esophagitis

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

Adults:

For the treatment of an infection with a bacterium calledHelicobacter pyloriin patients with gastric and/or duodenal ulcer, in combination with two antibiotics (eradication therapy)

One tablet twice daily, together with two antibiotic tablets—either amoxicillin, clarithromycin, and metronidazole (or tinidazole)—each to be taken twice daily along with your pantoprazole tablet. Take the first pantoprazole tablet one hour before breakfast and the second one hour before dinner. Follow your doctor's instructions and make sure to read the package leaflets of the antibiotics. The duration of treatment is normally one to two weeks.

For the treatment of gastric and duodenal ulcers:

The usual dose is one tablet daily. Your doctor may double the dose.

Your doctor will tell you how long to take this medicine. The treatment duration for gastric ulcers is usually between 4 and 8 weeks. The treatment duration for duodenal ulcers is normally between 2 and 4 weeks.

For long-term treatment of Zollinger-Ellison syndrome and other conditions with increased gastric acid secretion:

The recommended initial dose is two tablets daily. Take both tablets one hour before a meal. Subsequently, your doctor may adjust your dose depending on the amount of gastric acid you produce. If you are prescribed more than two tablets daily, you should take them in two divided doses. If you are prescribed more than four tablets daily, you will be given specific instructions on when to stop treatment.

Patients with kidney problems:

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

Patients with liver problems:

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

Use in children and adolescents

This medicine is not recommended for use in children under 12 years of age.

Method of administration

Take the tablets one hour before meals. Do not chew or break the tablets; swallow them whole with a little water.

If you take more Pantoprazol Durban than you should

Consult your doctor or pharmacist. Symptoms of overdose are not known.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Pantoprazol Durban

Do not take a double dose to make up for missed doses. Take your next dose at the usual scheduled time.

If you stop taking Pantoprazol Durban

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

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

If you experience any of the following adverse effects, stop taking these tablets immediately and contact your doctor or go to the nearest hospital emergency department without delay.

Severe allergic reactions (rare frequency); may affect up to 1 in 1,000 people: swelling of the tongue and/or throat, difficulty swallowing, rash (urticaria), difficulty breathing, allergic swelling of the face (angioedema/Quincke's edema), severe dizziness with very rapid heartbeat and excessive sweating.

Severe skin disorders (frequency not known); frequency cannot be estimated from the available data: you may notice one or more of the following effects: skin blisters and rapid deterioration of general condition, erosion (including slight bleeding) of eyes, nose, mouth/lips or genitals, or skin sensitivity/rash, particularly in areas of skin exposed to light/sun. You may also experience joint pain or flu-like symptoms, 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)), and 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, enlarged kidneys sometimes with pain when urinating and lower back pain (severe kidney inflammation).

Other adverse effects are:

Frequent (may affect more than 1 in 10 patients):

Benign polyps in the stomach.

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

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

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

Altered or complete loss of taste sensation; vision disorders such as blurred vision; urticaria; joint pain; muscle pain; weight changes; increased body temperature; high fever; swelling of the limbs (peripheral oedema); allergic reactions; depression; enlargement of the breasts in men.

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

Disorientation.

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

Hallucination, confusion (especially in patients with a history of these symptoms); decrease in blood magnesium levels (see section 2); tingling sensation, prickling, numbness, burning or stinging sensation; rash, possibly with joint pain. Inflammation of the large intestine causing persistent watery diarrhoea.

Adverse effects identified through blood tests:

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

Increased liver enzymes

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

Increased bilirubin; increased 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 which could lead to bleeding or unusual bruising; reduction in white blood cell count which could lead to more frequent infections; abnormal imbalance in the levels of red blood cells, white blood cells, and platelets.

-Frequency not known (cannot be estimated from the available data): Decrease in blood levels of sodium, magnesium, calcium or potassium (see section 2).

Reporting of adverse effects

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

5. Storage of Pantoprazole Durban

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date, which is stated on the carton and on the container. The expiry date refers to the last day of that month.

Do not store above 25°C.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE Point in your usual pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

What Pantoprazol Durban contains

The active substance is pantoprazole. One tablet contains 40 mg of pantoprazole (as sodium sesquihydrate).

The other components are:

Core: Mannitol (E421), cross-linked polyvinylpyrrolidone type A (E1202), anhydrous sodium carbonate, calcium stearate.

Coating: hypromellose 5cP (E464), povidone K-25 (E1201), propylene glycol (E1520), titanium dioxide (E171), yellow iron oxide (E172), 30% dispersion of methacrylic acid-ethyl acrylate copolymer (1:1), triethyl citrate (E1505).

What Pantoprazol Durban looks like and contents of the pack

Yellow, oval, biconvex enteric-coated tablets, smooth on both sides.

Pantoprazol Durban is available in the following pack sizes:

Blister packs containing 14, 28, 30, 56, 60, 90 and 100 gastro-resistant tablets.

Marketing Authorization Holder

Laboratorios Francisco Durbán S.A.

Polígono Ind. La Redonda, c/ IX, nº 2

04710 El Ejido ALMERÍA. Spain

Manufacturer

Macleods Pharma UK Limited

Wynyard Park House,

Wynyard Avenue,

Wynyard, Billingham,

TS22 5TB, United Kingdom

Netpharmalab Consulting Services

Carretera de Fuencarral, 22

28108 – Alcobendas, Madrid

Spain

Synoptis Industrial Sp. z.o.o.

Ul. Rabowicka 15

62-020 Swarzedk

Poland

Date of the most recent review of this leaflet:

May 2022

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