Ipp 40

Package Leaflet: Information for the Patient

IPP 40, 40 mg, Gastro-Resistant Tablets

Pantoprazole

Read the package leaflet carefully before taking the medicine, as it contains important information for you.

• You should keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet:

• 1. What IPP 40 is and what it is used for
• 2. Important information before taking IPP 40
• 3. How to take IPP 40
• 4. Possible side effects
• 5. How to store IPP 40
• 6. Contents of the pack and other information

1. What IPP 40 is and what it is used for

IPP 40 contains the active substance pantoprazole. Pantoprazole is a selective proton pump inhibitor, a medicine that reduces the amount of acid produced in the stomach. It is used to treat conditions where the stomach produces too much acid, such as reflux oesophagitis.

IPP 40 is used in adults and adolescents aged 12 years and above for the treatment of:

reflux oesophagitis. This is a condition in which the acid in the stomach flows back up into the oesophagus (the food pipe), causing pain and discomfort.

IPP 40 is used in adults for the treatment of:

infection with a bacterium called Helicobacter pylori in patients with duodenal and gastric ulcers, in combination with two antibiotics (eradication therapy). The goal of the treatment is to kill the bacteria and reduce the risk of ulcers returning.

gastric and duodenal ulcers.

Zollinger-Ellison syndrome and other conditions where the stomach produces too much acid.

2. Important information before taking IPP 40

When not to take IPP 40

if you are allergic to pantoprazole or any of the other ingredients of this medicine (listed in section 6);

if you are allergic to other proton pump inhibitors.

Warnings and precautions

Before taking IPP 40, tell your doctor or pharmacist if:

you have severe liver problems. You should also tell your doctor if you have ever had problems with your liver in the past. Your doctor may need to monitor your liver function during treatment with IPP 40, especially if you are taking it for a long time.

you have a reduced level of vitamin B12 or have been treated for vitamin B12 deficiency. Low levels of vitamin B12 can occur in patients taking acid-reducing medicines for a long time, such as pantoprazole.

you have ever had a skin reaction after treatment with a medicine similar to IPP 40.

If you get a rash on your skin, especially in areas exposed to the sun, tell your doctor as soon as possible. This may be a sign of an allergic reaction. You should also tell your doctor if you notice any other symptoms, such as joint pain.

If you experience any of the following symptoms, tell your doctor immediately, as they may be signs of a more serious condition:

• unintentional weight loss;
• vomiting, especially if it is repeated;
• blood in your vomit or black tarry stools;
• difficulty swallowing;
• paleness, weakness, or feeling tired;
• chest pain or pain in your stomach;
• severe and/or persistent diarrhea.
• severe skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and erythema multiforme. If you experience any of these symptoms, stop taking pantoprazole and seek medical attention immediately.

Your doctor may decide to perform some tests to rule out malignant disease, as pantoprazole may mask the symptoms of cancer and delay its diagnosis. If your symptoms persist, your doctor will decide whether you need further tests.

Children

IPP 40 should not be used in children under 12 years of age, as there is no experience with this medicine in this age group.

IPP 40 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.

IPP 40 may influence the effectiveness of other medicines, so tell your doctor if you are taking:

medicines such as ketoconazole, itraconazole, or posaconazole (used to treat fungal infections) or erlotinib (used to treat certain types of cancer), as IPP 40 may reduce their effectiveness;

warfarin or phenprocoumon (used to thin the blood). Your doctor may need to monitor your blood clotting time;

medicines used to treat HIV, such as atazanavir;

methotrexate (used to treat rheumatoid arthritis, psoriasis, or cancer). If you are taking methotrexate, your doctor may need to temporarily stop your treatment with IPP 40;

fluvoxamine (used to treat depression and other mental health conditions). Your doctor may need to reduce your dose;

rifampicin (used to treat infections);

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

Pregnancy, breastfeeding, and fertility

There is limited experience with the use of pantoprazole during pregnancy. Pantoprazole has been detected in breast milk.

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Do not take IPP 40 if you are pregnant or breastfeeding unless your doctor considers it essential.

Driving and using machines

IPP 40 has no or negligible influence on the ability to drive and use machines. However, if you experience dizziness or blurred vision, do not drive or operate machinery.

IPP 40 contains sodium and a colorant

This medicine contains a colorant called erythrosine (E124), which may cause allergic reactions.

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

3. How to take IPP 40

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Method of administration

Take the tablets 1 hour before a meal, swallow them whole with a glass of water, and do not chew or crush them.

Recommended dose:

Adults and adolescents aged 12 years and above:

Treatment of reflux oesophagitis

Usually, one tablet per day is taken. Your doctor may increase the dose to two tablets per day. The treatment of reflux oesophagitis usually lasts for 4 to 8 weeks. Your doctor will decide how long you need to take the medicine.

Adults:

Treatment of Helicobacter pylori infection in patients with duodenal and gastric ulcers, in combination with two antibiotics (eradication therapy)

One tablet twice a day, plus two antibiotics (among amoxicillin, clarithromycin, and metronidazole or tinidazole), which are taken twice a day together with the pantoprazole tablet. Take the first tablet of IPP 40 1 hour before breakfast and the second 1 hour before dinner. Follow the instructions for the antibiotics and read the package leaflets for these medicines. The treatment usually lasts for 1 to 2 weeks.

Treatment of gastric and duodenal ulcers

Usually, one tablet per day is taken. The dose can be doubled after consulting your doctor. Your doctor will decide how long you need to take the medicine. The treatment of gastric ulcers usually lasts for 4 to 8 weeks, and for duodenal ulcers, it usually lasts for 2 to 4 weeks.

Long-term treatment of Zollinger-Ellison syndrome and other conditions with excessive acid production

The recommended starting dose is usually two tablets per day. Take both tablets 1 hour before breakfast. Your doctor may adjust the dose later, depending on the amount of acid produced by your stomach. If your doctor has prescribed more than two tablets per day, take them twice a day. If your doctor has prescribed more than four tablets per day, you will be given more detailed instructions.

Renal impairment

If you have kidney problems, you should not take IPP 40 for the eradication of Helicobacter pylori.

Hepatic impairment

If you have severe liver problems, you should not take more than one 20 mg tablet of pantoprazole per day (IPP 20 tablets are available).

Use in children

IPP 40 should not be used in children under 12 years of age.

Overdose

Consult your doctor or pharmacist. There are no known symptoms of overdose.

Missed dose

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

Stopping treatment

Do not stop treatment without consulting 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 IPP 40 and contact your doctor or go to the emergency department immediately:

Severe allergic reactions (rare, may affect up to 1 in 1,000 people):swelling of the tongue and/or throat, difficulty swallowing, hives, difficulty breathing, allergic swelling of the face (Quincke's oedema/anaphylactic shock), severe dizziness with a very fast heartbeat and profuse sweating.

Severe skin reactions (frequency not known):you may notice one or more of the following symptoms: blisters on the skin, sudden unexplained high fever, a severe skin reaction called Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), or erythema multiforme.

Other severe conditions (frequency not known):yellowing of the skin or the whites of the eyes (severe liver damage, jaundice) or fever, rash, and swollen kidneys, sometimes with painful urination and lower back pain (severe kidney problems, which may lead to kidney failure).

Other side effects:

Common (may affect up to 1 in 10 people):mild polyps in the stomach.

Uncommon (may affect up to 1 in 100 people):headache; dizziness; diarrhea; nausea; vomiting; feeling bloated and swollen (gases); constipation; dry mouth; stomach pain and discomfort; skin rash; itching; feeling weak, tired, or generally unwell; sleep disorders.

Rare (may affect up to 1 in 1,000 people):changes in taste or vision, such as blurred vision; hives; joint pain; muscle pain; changes in body weight; increased body temperature; swelling of the limbs (peripheral oedema); allergic reactions; depression.

Very rare (may affect up to 1 in 10,000 people):disorientation.

Frequency not known (cannot be estimated from the available data):hallucinations, confusion (especially in patients who have had these symptoms before); feeling of tingling, pricking, burning, or numbness; skin rash, which may be accompanied by joint pain; inflammation of the colon, which can cause persistent watery diarrhea.

Side effects detected in blood tests:

Uncommon (may affect up to 1 in 100 people):increased liver enzymes.

Rare (may affect up to 1 in 1,000 people):increased bilirubin; increased fat levels in the blood; sudden reduction in the number of white blood cells, which may cause fever.

Very rare (may affect up to 1 in 10,000 people):reduction in the number of platelets, which may cause bleeding or bruising; reduction in the number of white blood cells, which may cause infections; abnormal reduction in the number of blood cells, including red and white blood cells and platelets.

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

Reporting side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in the package leaflet.

5. How to store IPP 40

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 blister and carton after EXP. The expiry date refers to the last day of that month.

No special precautions for storage are necessary.

Do not use IPP 40 after 6 months of first opening the container.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What IPP 40 contains

The active substance is pantoprazole. Each gastro-resistant tablet contains 40 mg pantoprazole (as pantoprazole sodium sesquihydrate).

The other ingredients are: sodium carbonate, microcrystalline cellulose, crospovidone (type A), hypromellose (type EXF), colloidal anhydrous silica, calcium stearate.

Coating: hypromellose, titanium dioxide (E171), macrogol 400, quinoline yellow (E104), iron oxide yellow (E172), erythrosine (E124), methacrylic acid-ethyl acrylate copolymer (1:1), polysorbate 80, sodium lauryl sulfate, triethyl citrate.

What IPP 40 looks like and contents of the pack

IPP 40 gastro-resistant tablets are yellow, oval (film-coated), approximately 11.7 x 6.0 mm in size. They are available in blisters (28, 56, 84, and 168 tablets) or containers (28 and 56 tablets).

Marketing authorisation holder and manufacturer

Marketing authorisation holder: Sandoz GmbH, Biochemiestrasse 10, 6250 Kundl, Austria

Manufacturer: Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, 39179 Barleben, Germany

Lek S.A., ul. Domaniewska 50 C, 02-672 Warsaw, Poland

Lek Pharmaceuticals d.d., Verovškova 57, 1526 Ljubljana, Slovenia

Lek Pharmaceuticals d.d., Trimilini 2D, 9220 Lendava, Slovenia

Sandoz S.R.L., Str. Livezeni nr. 7A, 540472 Targu-Mures, Romania

Lek S.A., ul. Podlipie 16, 95-010 Stryków, Poland

For further information on this medicine, please contact:

Sandoz Polska Sp. z o.o., ul. Domaniewska 50 C, 02-672 Warsaw, Poland, tel. 22 209 70 00

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