Ipp 20

Package Leaflet: Information for the Patient

IPP 20, 20 mg, gastro-resistant tablets

Pantoprazole

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

• Keep this package 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 experience any side effects, including any not listed in this package leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of the package leaflet:

• 1. What is IPP 20 and what is it used for
• 2. Important information before taking IPP 20
• 3. How to take IPP 20
• 4. Possible side effects
• 5. How to store IPP 20
• 6. Contents of the pack and other information

1. What is IPP 20 and what is it used for

IPP 20 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 stomach and gut conditions caused by acid.

IPP 20 is used in adults and adolescents aged 12 years and above:

to treat symptoms (such as heartburn, acid regurgitation, pain when swallowing) related to gastro-oesophageal reflux disease (GORD) caused by stomach acid flowing back into the gullet;

for long-term treatment of reflux oesophagitis (inflammation of the gullet caused by stomach acid flowing back into the gullet) and to prevent its return.

IPP 20 is used in adults:

to prevent stomach and duodenal ulcers caused by non-steroidal anti-inflammatory drugs (NSAIDs, such as ibuprofen) in patients at risk who require continuous NSAID treatment.

2. Important information before taking IPP 20

When not to take IPP 20

if you are allergic to pantoprazole or 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

Before taking IPP 20, tell your doctor, pharmacist, or nurse if:

you have severe liver problems. You should also tell your doctor if you have ever had liver problems in the past. Your doctor will closely monitor your liver function, especially if you are taking IPP 20 for a long time. If your liver function increases, you should stop taking the medicine.

you have to take NSAIDs continuously and are also taking IPP 20, as this may increase the risk of gastrointestinal side effects. The risk will be assessed by your doctor based on individual risk factors, such as your age (65 years or older), a history of stomach or duodenal ulcers or bleeding in the gut.

you have a reduced vitamin B12 level or have risk factors for a reduced vitamin B12 level, as pantoprazole, like all medicines that reduce stomach acid, may reduce the absorption of vitamin B12.

Tell your doctor if you notice any of the following symptoms, which could be signs of a low vitamin B12 level:

• extreme tiredness or lack of energy,
• numbness or tingling,
• pain or redness of the tongue, mouth ulcers,
• muscle weakness,
• vision problems,
• memory problems, disorientation, depression.

If you are taking HIV inhibitors such as atazanavir, tell your doctor, as IPP 20 may reduce their effectiveness.

If you are taking IPP 20 for a long time (more than one year), your doctor will probably keep a regular check on your health.

Children

IPP 20 is not recommended for children under 12 years of age, as there is no data on its use in this age group.

IPP 20 and other medicines

Tell your doctor or pharmacist about all the medicines you are taking, have recently taken, or might take, including those obtained without a prescription.

Pantoprazole may affect 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 cancers), as IPP 20 may reduce their effectiveness;

warfarin or phenprocoumon, which affect blood clotting. Further tests may be necessary;

HIV treatment medicines such as atazanawir;

methotrexate (used to treat rheumatoid arthritis, psoriasis, and cancer). If you are taking methotrexate, your doctor may advise you to stop taking IPP 20 temporarily, as pantoprazole may increase the level of methotrexate in your blood;

fluvoxamine (used to treat depression and other mental health conditions); your doctor may reduce the dose of fluvoxamine;

rifampicin (used to treat infections);

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

Before taking IPP 20, tell your doctor if you are going to have a specific urine test (for tetrahydrocannabinol - THC).

Pregnancy, breastfeeding, and fertility

There is not enough data on the use of pantoprazole in pregnant women. There are reports of pantoprazole passing into 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.

The medicine should only be used if the benefits to the mother outweigh the risks to the fetus or baby.

Driving and using machines

IPP 20 has no or negligible influence on the ability to drive and use machines. If you experience dizziness or blurred vision, do not drive or operate machinery.

IPP 20 contains a colorant and sodium

This medicine contains the colorant cochineal red A (E124), which may cause allergic reactions.

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

3. How to take IPP 20

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

Method of administration

Take the tablets 1 hour before a meal, swallow them whole (do not chew or break them), with a small amount of water.

Recommended dose:

Adults and adolescents aged 12 years and above

Treatment of gastro-oesophageal reflux disease symptoms (such as heartburn, acid regurgitation, pain when swallowing)

Usually, one tablet per day is taken. This dose usually leads to the disappearance of symptoms within 2 to 4 weeks, and at the latest within a further 4 weeks. Your doctor will tell you how long to take the medicine. After the symptoms have disappeared, any recurrence can be controlled by taking one tablet per day if necessary.

Adults

Prevention of stomach and duodenal ulcers in patients who need continuous NSAID treatment

Usually, one tablet per day is taken.

Impaired liver function

If you have severe liver problems, you should not take more than one 20 mg tablet per day.

Use in children

IPP 20 is not recommended for 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, IPP 20 can cause side effects, although not everybody gets them.

If you experience any of the following side effects, stop taking the tablets and contact your doctor or the emergency department of your nearest hospital 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 edema/anaphylactic shock), severe dizziness with a very fast heartbeat and excessive sweating.

Severe skin reactions (frequency not known, cannot be estimated from the available data):You may notice one or more of the following symptoms:

• blistering of the skin with a rapid deterioration of the general condition, erosions (with slight bleeding) in the eyes, nose, mouth/lips, or genitals, or increased sensitivity of the skin/skin rash, especially on areas of skin exposed to light/sun. You may also experience joint pain or flu-like symptoms, fever, swollen lymph nodes (e.g., under the arms), and changes in blood test results showing changes in certain types of white blood cells or liver enzymes.
• red, non-raised, target-like, or circular patches on the trunk, often with central blisters, peeling of the skin, mouth ulcers, genital ulcers, and eye inflammation. These severe skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• widespread skin rash, high fever, enlarged lymph nodes (DRESS or drug hypersensitivity syndrome), and sensitivity to light.

Other severe conditions (frequency not known, cannot be estimated from the available data):yellowing of the skin or the whites of the eyes (severe liver damage, jaundice) or fever, rash, and enlarged kidneys, sometimes with pain when urinating and pain in the lower back (severe kidney inflammation, which can lead to kidney failure).

Other side effects:

Common (may affect up to 1 in 10 people)

mild stomach polyps.

Uncommon (may affect up to 1 in 100 people)

headache; dizziness; diarrhea; nausea; vomiting; feeling of fullness and bloating (gas); constipation; dry mouth; stomach pain and discomfort; skin rash; itching; feeling of weakness, fatigue, or general malaise; sleep disorders; fractures of the hip, wrist, or spine.

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

disturbances or complete loss of taste; visual disturbances, such as blurred vision; hives; joint pain; muscle pain; changes in body weight; increased body temperature; swelling of the limbs (peripheral edema); allergic reactions; depression; breast enlargement in men.

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, prickling, 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 enzyme activity.

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

increased bilirubin level; increased fat level in the blood; sudden decrease in the number of white blood cells (granulocytes) in the blood, with a high fever.

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

decreased platelet count, which may cause bleeding or easy bruising; decreased white blood cell count, which may cause more frequent infections; abnormal decrease in the number of red and white blood cells and platelets.

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

decreased sodium, magnesium, calcium, or potassium level in the blood (see section 2).

Reporting side effects

If you experience any side effects, including any not listed in this package leaflet, tell your doctor, pharmacist, or nurse. You can also report side effects directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301/fax: +48 22 49 21 309/website: https://smz.ezdrowie.gov.pl.

You can also report side effects to the marketing authorization holder.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store IPP 20

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

Do not use this medicine after the expiry date 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 20 after 6 months of opening the HDPE container.

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

6. Contents of the pack and other information

What IPP 20 contains

The active substance is pantoprazole. Each gastro-resistant tablet contains 20 mg of pantoprazole (as pantoprazole sodium sesquihydrate).

The other ingredients are: anhydrous 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), cochineal red A (E124), methacrylic acid-ethyl acrylate copolymer (1:1), polysorbate 80, sodium lauryl sulfate, triethyl citrate.

What IPP 20 looks like and contents of the pack

IPP 20 gastro-resistant tablets are yellow, oval (film-coated), approximately 8.9 x 4.6 mm in size. They are available in blisters (28, 56, 84, and 168 tablets) or containers (28 and 56 tablets).

Marketing authorization holder and manufacturer

Marketing authorization 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

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

For more information about this medicine and its authorized names in other European Economic Area countries, please contact:

Sandoz Polska Sp. z o.o.

ul. Domaniewska 50 C

02-672 Warsaw

tel. 22 209 70 00