Pantoprazole Durban 20 mg gastro-resistant tablets EFG

Patient Information Leaflet

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Pantoprazol Durban 20 mg gastro-resistant tablets EFG

Pantoprazole

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 and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Leaflet Contents

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", a medicine that reduces the amount of acid produced in your stomach. It is used for the treatment of conditions related to stomach and intestinal acid.

Pantoprazol Durban is used in adults and adolescents from 12 years of age 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 at-risk patients who require ongoing treatment with these types of medicines.

2. What you need to know before starting to take Pantoprazole Durban

Do not take Pantoprazole Durban

• If you are allergic (hypersensitive) to pantoprazole or to any of the other ingredients of this medicine (see section 6).
• If you are allergic to medicines containing other proton pump inhibitors (e.g., omeprazole, lansoprazole, rabeprazole, esomeprazole).

Warnings and precautions

Talk to your doctor or pharmacist before taking Pantoprazole 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 if you are on long-term treatment with Pantoprazole Durban. If liver enzymes increase, treatment should be discontinued.
• If you need to take non-steroidal anti-inflammatory drugs (NSAIDs) continuously while taking Pantoprazole Durban, as there is an increased risk of developing stomach and intestinal complications.

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

• If you have reduced body stores of vitamin B12 or risk factors for this and are receiving long-term treatment with pantoprazole. Like all medicines that reduce acid, pantoprazole may reduce the absorption of vitamin B12.
• Consult your doctor if you are taking HIV protease inhibitors 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 three months, your blood magnesium levels may decrease. Low magnesium levels can cause fatigue, involuntary muscle contractions, disorientation, 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.
• If you have ever had a skin reaction after treatment with a medicine similar to Pantoprazole Durban used to reduce stomach acid.
• 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 Pantoprazole 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 could be signs of more serious conditions:

• Unintentional weight loss
• Vomiting, particularly if repeated
• Blood in vomit, which may appear as dark coffee-ground material
• Blood in stools, which may appear black or tarry (melena)
• Difficulty swallowing or pain when swallowing
• Pale appearance and feeling weak (anemia)
• Chest pain
• Stomach pain
• Severe or persistent diarrhea, as this medicine has been associated with a small increased risk of infectious diarrhea.

Your doctor will decide whether additional tests are needed to rule out a malignant condition, as pantoprazole may relieve cancer symptoms and could delay diagnosis.

If your symptoms persist despite treatment, further investigations will be carried out.

If you take Pantoprazole Durban for a prolonged period (more than one year), your doctor will likely monitor you regularly. You should inform your doctor of any new or unexpected symptoms or events at each visit.

Children and adolescents

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

Taking Pantoprazole Durban with other medicines

Tell 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.

Pantoprazole Durban may affect the effectiveness of other medicines; therefore, inform your doctor if you are taking:

• Medicines such as ketoconazole, itraconazole, and posaconazole (used to treat fungal infections) or erlotinib (used for certain types of cancer), as Pantoprazole Durban may cause these and other medicines to be less effective.
• Warfarin and phenprocoumon, which affect blood clotting.

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 Pantoprazole Durban, as 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 are insufficient data on the use of pantoprazole in pregnant women. It has been reported that pantoprazole is excreted in human breast milk.

If you are pregnant or breastfeeding, think you may be pregnant, or are planning 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 outweighs the potential risk to the fetus or baby.

Driving and using machines

Pantoprazole Durban has no effect or an insignificant effect on the ability to drive or operate machinery.

However, you should not drive or operate machinery if you experience adverse effects such as dizziness or blurred vision.

Pantoprazole 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 instructions for use of this medicine given 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, swallowing them whole with water.

The recommended dose is:

Adults and adolescents aged 12 years and older:

To treat symptoms associated with gastroesophageal reflux disease (heartburn, acid regurgitation, painful swallowing):

The usual dose is one tablet daily. This dose generally provides relief within 2–4 weeks, and if not, at the latest within the following 4 weeks. Your doctor will advise you on how long you should continue taking the medicine. Afterwards, any recurring symptoms may be managed as needed, by taking one tablet per day.

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

The usual dose is one tablet daily. If the disease recurs, your doctor may double your dose, in which case you may take Pantoprazol Durban 40 mg once daily. After healing, the dose may be reduced again to one 20 mg tablet daily.

Adults:

• For prevention of duodenal and gastric ulcers in patients requiring ongoing treatment with NSAIDs:

The usual dose is one tablet daily.

Patients with liver problems

• If you have severe liver problems, you must 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 at telephone number 91 562 04 20, indicating the medicine and the amount ingested. Symptoms of overdose are not known.

If you forget to take Pantoprazol Durban

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

If you stop taking Pantoprazol Durban

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

If you have any further questions about the use of this product, 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 right away, or contact the emergency department of your nearest hospital:

• 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 (Quincke's edema/angioedema), severe dizziness with very rapid heartbeat and excessive sweating.
• Severe skin disorders (frequency not known: frequency cannot be estimated from available data): you may notice one or more of the following: blisters on the skin and rapid deterioration in general condition, erosion (including slight bleeding) of eyes, nose, mouth/lips or genitals, or skin sensitivity/rash, mainly in areas of skin exposed to light/sun. There may also be 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's 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 available data): yellowing of the skin and whites of the eyes (severe liver cell damage, jaundice), or fever, rash, enlarged kidneys with occasional pain when urinating and lower back pain (severe kidney inflammation), which could possibly lead to kidney failure.

Other adverse effects are:

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

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

Headache; dizziness; diarrhoea; feeling of dizziness, vomiting; bloating and flatulence (gas); constipation; dry mouth; pain and discomfort in the abdomen; skin rash, exanthema, eruption; tingling; feeling of weakness, tiredness or general malaise; sleep disturbances, hip, wrist and vertebral fractures.

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

Disturbance 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 limbs (peripheral edema); 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 available data)

Hallucination, confusion (especially in patients with a history of these symptoms), sensation of tingling, pricking, numbness, burning or tingling; skin 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)

increase in liver enzymes

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

increase in bilirubin; increase in blood fat 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 the number of platelets, which could lead to bleeding or more bruising than usual; reduction in the number of white blood cells, which could lead to more frequent infections; abnormal reduction in the balance between the number of red blood cells, white blood cells, and platelets.

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

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

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://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 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 refers to the last day of the month indicated.

Do not store above 30°C.

Medicines must not be disposed of via wastewater drains or household waste. Dispose of containers and unused medicines at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and unused medicines. This way, you will help protect the environment.

6. Contents of the pack and other information

Composition of Pantoprazol Durban 20 mg

The active substance is pantoprazole. Each gastro-resistant tablet contains 20 mg of pantoprazole (as 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 pack contents

Yellow, oval, biconvex gastro-resistant coated tablet with a smooth surface on both sides (approximately 8.45 mm x 4.2 mm).

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

Blister packs 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

España

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

Rabowicka 15,

Swaredz

Polonia

STM Group SRL

Strada Provinciale Pianura 2

80078, Pozzuoli

Italia

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

Rabowicka 15,

Swaredz

Polonia

Date of the most recent review of this leaflet: May 2022

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