PANTOPRAZOL DURBAN 40 mg GASTRO-RESISTANT TABLETS

Introduction

Package Leaflet: Information for the Patient

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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, as it may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet.

Contents of this leaflet

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

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

Pantoprazol Durban contains the active substance pantoprazol.

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

Pantoprazol Durban is used in adults and adolescents from 12 years of age to treat:

• Reflux esophagitis. This is an inflammation of your esophagus accompanied by acid regurgitation 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 stomach ulcers in combination with the indicated antibiotics as eradication therapy. The goal is to get rid of the bacterium and thus reduce the likelihood of ulcer recurrence.
• Gastric 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 taking Pantoprazol Durban:

Do not take Pantoprazol Durban:

• if you are allergic to pantoprazol or to 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

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. In case of increased liver enzymes, treatment should be discontinued.

?

? If you have a decrease in organic reserves of vitamin B12 or risk factors for vitamin B12 deficiency and receive prolonged treatment with pantoprazol. Like all antacids, pantoprazol may decrease 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 pantoprazol.

? Taking a proton pump inhibitor, such as pantoprazol, 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 may increase the risk of osteoporosis).

• If you are taking pantoprazol for more than 3 months, it is possible that low magnesium levels in the blood may decrease. Low magnesium levels can cause fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, and increased heart rate. If you have any of these symptoms, go to the doctor immediately. Low magnesium levels can also produce a decrease in potassium and calcium levels 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 acid.
• If you suffer a skin rash, especially in areas of 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 other serious diseases:

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

? vomiting, especially if it is repeated

?

? vomiting blood (dark coffee grounds in your vomit)

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

? you look pale and feel weak (anemia)

• ? chest pain

stomach pain

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

Your doctor will decide if you need some tests to rule out a malignant disease, as Pantoprazol also relieves symptoms of cancer and could delay its diagnosis. If your symptoms continue despite treatment, further studies will be considered.

If you take Pantoprazol Durban for long-term treatment (more than 1 year), your doctor will probably perform regular check-ups. Inform your doctor if you have any new or exceptional symptoms when you go to the medical consultation.

Children and adolescents

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 effectiveness of other medicines, so 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 to treat certain types of cancer), as Pantoprazol Durban may make them not work properly.

? Warfarin and Fenprocoumon, which affect blood coagulation (thickening) or anticoagulation (thinning). Your doctor may need to perform more tests.

? 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 because pantoprazol 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 the dose.

• Rifampicin (used to treat infections)

St. John's Wort (Hypericum perforatum) used for mild depression.

Pregnancy, breastfeeding, and fertility

There is not enough data on the use of pantoprazol in pregnant women.

Pantoprazol has been reported to be 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 influence or insignificant influence on the ability to drive or use machines.

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

3. How to take Pantoprazol Durban

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

The recommended dose is:

Adults and adolescents from 12 years of age and older:

For the treatment of reflux esophagitis

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

Adults:

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

One tablet twice a day plus the two antibiotic tablets, either amoxicillin, clarithromycin, and metronidazole (or tinidazole), each to be taken twice a day with your pantoprazol tablet. Take the first pantoprazol tablet one hour before breakfast and the second one hour before dinner. Follow your doctor's instructions and make sure to read the leaflets of the antibiotics. The duration of treatment is usually one to two 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 indicate how long you should take this medicine. The treatment time for stomach ulcers is usually between 4 and 8 weeks. The treatment time for duodenal ulcers is usually between 2 and 4 weeks.

For long-term treatment of Zollinger-Ellison syndrome and other conditions in which there is an increase in gastric acid secretion:

The initial recommended dose is two tablets per day. Take the two tablets one hour before a meal. Later, your doctor may adjust the dose, depending on the amount of acid secretion you produce. If you are prescribed more than two tablets per day, you should take the tablets divided into two doses per day. If you are prescribed more than four tablets per day, you will be told exactly when you should finish the 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. No symptoms are known for overdose.

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 medicine and the amount ingested.

If you forget to take Pantoprazol Durban

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

If you stop taking Pantoprazol Durban

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

If you have any further questions about the use of this medicine, 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 have 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);can affect up to 1 in 1,000 people: swelling of the tongue and/or throat, difficulty swallowing, hives, difficulty breathing, swelling of the face of allergic origin (Quincke's edema/angioedema), severe dizziness with very rapid heartbeats and profuse 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: 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, particularly 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)), and photosensitivity.

Other serious conditions (frequency not known;frequency cannot be estimated from the available data):yellowing of the skin and the whites of the eyes (severe liver cell damage, jaundice), or fever, rash, increased kidney size, sometimes with pain when urinating, and pain in the lower back (severe kidney inflammation).

Other side 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; diarrhea; nausea, vomiting; bloating and 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 fractures.

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);,decrease in magnesium levels in the blood (see section 2),sensation of tingling, pinching, numbness, burning sensation, or numbness; 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)

Increased liver enzymes

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

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

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

Reduction in the number of platelets that could cause bleeding or more bruising than usual; 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.

-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 they are not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: http://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Pantoprazol Durban

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

Do not take this medicine after 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 above 25°C.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE point of your usual pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

What does Pantoprazol Durban contain?

The active ingredientis pantoprazol. One tablet contains 40 mg of pantoprazol (as sodium sesquihydrate).

The other ingredientsare:

Core:Mannitol (E421), crospovidone 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).

Appearance of Pantoprazol Durban and Package Contents

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

Pantoprazol Durban is available in the following package sizes:

Box of blisters with 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 Last Revision of this Leaflet:

May 2022

Detailed and updated information on this medicinal product is available on the

website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/