Leaflet: information for the patient

Pantoprazol Durban 40mg gastro-resistant EFG tablets

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, consult your doctor or pharmacist.

-This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, 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.

Contents of this leaflet

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", which reduces the amount of acid produced by your stomach. It is used for the treatment of diseases related to stomach and intestinal acid.

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

-Gastroesophageal reflux esophagitis.It is an inflammation of your esophagus accompanied by regurgitation of acid from your stomach.

Pantoprazol Durban is used in adults to treat:

-Infection caused by a bacteria called Helicobacter pylori (H. pylori)in patients with duodenal and stomach ulcers in combination with the indicated antibiotics as eradication therapy. The goal is to get rid of the bacteria and thus reduce the likelihood of ulcers reappearing.

-Peptic ulcers.

-Zollinger-Ellison syndrome and other conditions in which too much acid is produced in the stomach.

Do not take Pantoprazol Durban:

-if you are allergic to pantoprazole or any of the othercomponents of this medication (listed in section6)

-if you are allergic to medications that contain other proton pump inhibitors.

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 probably check your liver enzymes, especially when you are on long-term treatment with Pantoprazol Durban. If liver enzyme levels increase, treatment should be discontinued.

?

?If you have a decrease in your body's reserves of vitamin B12 or are at risk of vitamin B12 deficiency and are on long-term treatment with pantoprazole. Like all antacids, pantoprazole can decrease 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.

?Long-term use of a proton pump inhibitor, such as pantoprazole, may increase therisk of fractures of the hip, wrist, or spine. Inform your doctor if you have osteoporosis (reduced bone density) or are taking corticosteroids (which may increase the risk of osteoporosis).

• If you are taking pantoprazole for more than 3 months, it is possible that low levels of magnesium in the blood may decrease. Low levels of magnesium can cause fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, increased heart rate. If you experience any of these symptoms, see your doctor immediately. Low levels of magnesium can also cause a decrease in potassium and calcium levels in the blood. Your doctor may decide to perform regular blood tests to monitor magnesium levels.

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• If you have ever had a skin reaction after treatment with a similar medication to Pantoprazol Durban to reduce stomach acid.
• If you have a skin rash, especially in sun-exposed areas, consult your doctor as soon as possible, as treatment with Pantoprazol Durban may need to be discontinued. 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 other serious diseases:

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

?vomiting, particularly if repeated

?

?vomiting with blood (coffee ground-like appearance in your vomit)

• if you notice blood in your stool, which may appear black or melena
• difficulty swallowing, or pain when swallowing

?appears pale and feels weak (anemia)

• ?chest pain

stomach pain

?severe and/or persistent diarrhea, as pantoprazole has been associated with a small increase in infectious diarrhea

Your doctor will decide if you need any tests to rule out cancer because Pantoprazol also alleviates cancer symptoms and may delay its diagnosis. If your symptoms persist despite treatment, further studies will be considered.

If you are on long-term treatment with Pantoprazol Durban (more than 1 year), your doctor will probably perform regular check-ups. Inform your doctor if you have any new or unusual symptoms when you attend the medical consultation.

Children and adolescents

Pantoprazol Durban is not recommended for 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 need to take any other medication, including medications purchased without a prescription.

Pantoprazol Durban may affect the efficacy of other medications, so inform your doctor if you are taking or have taken recently:

?Medications such as ketoconazole, itraconazole, and posaconazole (used for fungal infections) orerlotinib(used for certain types of cancer) because Pantoprazol Durban may make them less effective.

?WarfarinandFenprocumon, which affect blood clotting (thickening) or anticoagulation (thinning). Your doctor may need to perform additional tests.

?Medications used to treat HIV infection, such asatazanavir

?Metotrexate(used to treat rheumatoid arthritis, psoriasis, and cancer), your doctor may temporarily discontinue treatment with Pantoprazol Durban because pantoprazole may increase metotrexate 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 for mild depression.

Pregnancy, lactation, and fertility

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

Pantoprazole has been reported to be excreted in breast milk.

If you are pregnant or breastfeeding, consult your doctor or pharmacist before using this medication. You should only use this medication if your doctor considers that the benefit for you is greater than the potential risk to the fetus or baby.

Driving and operating machinery

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

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

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

The recommended dose is:

Adults and adolescents 12 years and older:

For the treatment of gastroesophageal reflux disease (GERD)

The usual dose is one tablet per day. Your doctor may indicate an increase of up to 2 tablets per day. The treatment duration for GERD usually ranges from 4 to 8 weeks. Your doctor will inform you for how long you should take this medication.

Adults:

For the treatment of an infection caused by a bacteria calledHelicobacter pyloriin patients with stomach and/or duodenal ulcers in combination with two antibiotics (eradication treatment)

One tablet twice a day, plus two antibiotic tablets, either amoxicillin, clarithromycin, and metronidazole (or tinidazole), each taken twice a day, should be taken 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 antibiotic leaflets. 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. Your doctor may increase the dose.

Your doctor will inform you for how long you should take this medication. The treatment duration for stomach ulcers is usually 4 to 8 weeks, and for duodenal ulcers, it is usually 2 to 4 weeks.

For long-term treatment of Zollinger-Ellison syndrome and other conditions characterized by excessive stomach acid production:

The initial recommended dose is two tablets per day. Take the two tablets one hour before a meal. Your doctor may adjust your dose based on the amount of stomach acid you produce. If you are prescribed more than two tablets per day, you should take the tablets twice a day. If you are prescribed more than four tablets per day, you will be told exactly when to stop treatment.

Patients with kidney problems:

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

Patients with liver problems

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

Use in children and adolescents

This medication is not recommended for use in children under 12 years old.

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. No symptoms of overdose are known.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Pantoprazol Durban

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

If you interrupt treatment with Pantoprazol Durban

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

If you have any other questions about the use of this medication, 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 immediately inform your doctor, or contact the nearest hospital's emergency service.

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, allergic swelling of the face (Quincke's edema/angioedema), intense dizziness with very rapid heartbeats and excessive sweating.

Severe skin alterations (unknown frequency);its frequency cannot be estimated with the available data): you may notice one or more of the following effects: blisters on the skin and a rapid deterioration of overall conditions, erosion (including mild bleeding) of the eyes, nose, mouth/lips, or genitals, or skin sensitivity/eruption, particularly in areas of exposed skin 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, multiform erythema, acute cutaneous lupus erythematosus, pharmacological reaction with eosinophilia, and systemic symptoms (DRESS)), and photosensitivity.

Other serious conditions (unknown frequency;its frequency cannot be estimated with the available data):yellow discoloration of the skin and the white of the eyes (severe liver cell damage, jaundice), or fever, hives, increased kidney size sometimes with painful urination and lower back pain (severe kidney inflammation).

Other side effects are:

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

Benign polyps in the stomach.

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

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

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

Alteration or complete loss 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.

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

Disorientation.

Unknown frequency(cannot be estimated from the available data)

Illusion, confusion (especially in patients with a history of these symptoms);,decrease in blood magnesium levels (see section 2),tingling, pins and needles, numbness, burning sensation, or numbness; rash, possibly with joint pain. Inflammatory bowel disease causing persistent watery diarrhea.

Side effects identified through blood tests:

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

Increased liver enzymes

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

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

-Muy raras(may affect up to 1 in 10,000 patients)

Reduction in the number of platelets that could cause bleeding or more frequent bruising; reduction in the number of white blood cells that could lead to more frequent infections; abnormal reduction in the balance between the number of red and white blood cells, as well as platelets.

-Unknown frequency(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 type of side effect, consult your doctor, 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 Pharmacovigilance of Medicines for Human Use: htpp://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not takethis medicationafter the expiration date, which appears on the box and on the packaging. The expiration date refers to the last day of that month.

Do not store at a temperature above 25°C.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medicines you no longer need at your local SIGRE collection point. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

What is contained in Pantoprazol Durban?

The active principle is pantoprazole. A tablet contains 40 mg of pantoprazole (as sesquihydrate of sodium).

The other components are:

Core:Mannitol (E421), crospovidone type A (E1202), anhydrous sodium carbonate, calcium stearate.

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

Appearance of Pantoprazol Durban and contents of the packaging

Yellow, oval, biconvex tablets with enteric coating and smooth on both sides.

Pantoprazol Durban is available in the following packaging sizes:

Blister pack with 14, 28, 30, 56, 60, 90, and 100 enteric-coated tablets.

Marketing Authorization Holder

Laboratorios Francisco Durbán S.A.

Industrial Park 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, UK

Netpharmalab Consulting Services

Carretera de Fuencarral, 22

28108 – Alcobendas, Madrid

Spain

Synoptis Industrial Sp. z.o.o.

Ul. Rabowicka 15

62-020 Swarzedz

Poland

Last review date of this leaflet:

May 2022

Detailed and updated information on this medicine is available on the

website of the Spanish Agency for Medicines and Medical Devices (AEMPS)

(http://www.aemps.gob.es/)