Ipp 20

Package leaflet: information for the patient

IPP 20, 20 mg, enteric-coated tablets
Pantoprazolum
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any doubts, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents:

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

IPP 20 contains the active substance pantoprazole. Pantoprazole is a selective proton pump inhibitor, a medicine that reduces the amount of hydrochloric acid produced in the stomach. It is used in the treatment of stomach and intestinal disorders caused by hydrochloric acid.
IPP 20 is used in adults and adolescents aged at least 12 years:
for the treatment of symptoms (such as heartburn, acid regurgitation, pain on swallowing) associated with gastro-oesophageal reflux disease (GORD), caused by the backflow of acidic stomach contents into the oesophagus;
for long-term treatment of reflux oesophagitis (inflammation of the oesophageal mucosa due to backflow of acidic stomach contents into the oesophagus) and prevention of its recurrence.
IPP 20 is used in adults:
for the prevention of gastric and duodenal ulcers induced by non-steroidal anti-inflammatory drugs (NSAIDs, e.g. ibuprofen) in patients at risk who require ongoing NSAID treatment.

2. Important information before using IPP 20

When not to use IPP 20
if the patient is allergic to pantoprazole or to any of the other ingredients of this medicine
(listed in section 6);
if the patient is allergic to medicines containing other proton pump inhibitors.

Warnings and precautions
Before starting treatment with IPP 20, consult a doctor, pharmacist, or nurse if:

• the patient has severe liver function disorders. Inform the doctor if the patient has ever had liver disease in the past. The doctor will monitor liver enzyme activity more frequently, especially if the patient is taking IPP 20 for a prolonged period. If enzyme activity increases, administration of the drug should be discontinued.

• the patient is continuously taking NSAIDs and is receiving IPP 20, as this increases the risk of gastrointestinal complications. The extent of risk will be assessed by the doctor based on individual risk factors such as the patient's age (65 years or older), history of gastric or duodenal ulcer disease, or gastrointestinal bleeding.

• vitamin B₁₂ stores in the body of a patient undergoing long-term pantoprazole treatment are reduced, or there are risk factors for decreased absorption. As with all drugs that inhibit gastric acid production, pantoprazole may reduce vitamin B₁₂ absorption. Contact the doctor if any of the following symptoms occur, which may indicate low vitamin B₁₂ levels:

  • extreme fatigue or lack of energy,
  • numbness or tingling sensations,
  • pain or redness of the tongue, oral ulcers,
  • muscle weakness,
  • vision disturbances,
  • memory problems, disorientation, depression.

• the patient is taking HIV protease inhibitors such as atazanavir (a medicine used to treat HIV infection) at the same time as pantoprazole; the patient should seek medical advice.

• the patient is taking a proton pump inhibitor (such as pantoprazole), especially for longer than one year, as there may be a slight increase in the risk of fractures of the hip, wrist, or spine. Inform the doctor if the patient has osteoporosis (reduced bone density) or has been informed of an increased risk of developing osteopor游戏副本

3. How to take IPP 20

This medicine should always be taken as directed by a doctor or pharmacist. If in doubt,
consult a doctor or pharmacist.
Method of administration
The tablets should be taken 1 hour before a meal. Swallow them whole (without chewing or
breaking) with a small amount of water.
Recommended dose:
Adults and adolescents aged at least 12 years
Treatment of gastro-oesophageal reflux disease (GERD) symptoms (i.e. heartburn, acid regurgitation,
swallowing pain)
One tablet per day is usually recommended. This dose generally relieves symptoms within 2 to 4 weeks,
and no later than after an additional 4 weeks. Your doctor will inform you how long you should take
the medicine. After symptoms have resolved, any recurrence can be managed by taking one tablet per day as needed.
Long-term treatment to prevent recurrence of reflux oesophagitis
One tablet per day is usually recommended. If symptoms recur, your doctor may double the dose.
In such a case, IPP 40 tablets may be used, one tablet per day. After resolution of inflammation,
you may return to taking 1 tablet of IPP 20 per day.
Adults
Prevention of gastric and duodenal ulcers in patients requiring continuous use of NSAIDs
One tablet per day is usually recommended.
Liver function impairment
If the patient has severe liver function impairment, no more than one 20 mg tablet per day should be taken.
Use in children
These tablets are not recommended for use in children under 12 years of age.
Taking more IPP 20 than recommended
Contact a doctor or pharmacist. Symptoms of overdose are not known.
Missed dose of IPP 20
Do not take a double dose to make up for a missed dose. Take the next tablet at the usual time.
Stopping IPP 20 treatment
Do not stop treatment without consulting a doctor or pharmacist.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
If any of the adverse effects listed below occur, stop taking IPP 20 tablets immediately and contact your doctor or the emergency department of the nearest hospital without delay:
Severe allergic reactions (rare: may occur in fewer than 1 in 1,000 people): swelling
of the tongue and (or) throat, difficulty swallowing, urticaria (hives), difficulty breathing, allergic
swelling of the face (angioedema/Quincke's edema/vascular edema), severe dizziness with very
rapid heartbeat and excessive sweating.
Severe skin reactions (frequency unknown: cannot be estimated from available
data): The patient may notice one or more of the following symptoms:

• blistering of the skin with sudden deterioration in general health, erosions (with slight bleeding) in the eyes, nose, oral cavity/lips or genital organs, or skin hypersensitivity/rash, particularly on areas of skin exposed to light/sunlight. Joint pain or flu-like symptoms, fever, swollen lymph nodes (e.g. under the arms) may also occur, and blood tests may show changes in certain types of white blood cells or liver enzymes.
• red, flat, disc-shaped or circular spots on the trunk, often with centrally located blisters, skin peeling, ulceration of the mouth, throat, nose, genital organs and eyes. These severe skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• widespread rash, high body temperature, swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome) and photosensitivity.

Other severe conditions (frequency unknown): yellowing of the skin or whites of the eyes (severe
liver cell damage, jaundice) or fever, rash and enlarged kidneys, sometimes with pain during urination and pain in the lower back (severe kidney inflammation, which
may progress to kidney failure).
Other adverse effects:
Common (may occur in fewer than 1 in 10 people)
benign gastric polyps.
Uncommon (may occur in fewer than 1 in 100 people)
headache; dizziness; diarrhoea; nausea; vomiting; feeling of fullness and bloating (gas);
constipation; dryness of the mouth; abdominal pain and discomfort; skin rash; eruption;
erosions; itching; feeling of weakness, fatigue or general malaise; sleep disturbances,
fracture of the hip, wrist or spine.
Rare (may occur in fewer than 1 in 1,000 people)
disturbances or complete loss of taste; visual disturbances, such as blurred vision;
urticaria; joint pain; muscle pain; changes in body weight; increased body temperature; swelling
of the limbs (peripheral oedema); allergic reactions; depression; breast enlargement in males.
Very rare (may occur in fewer than 1 in 10,000 people)
disorientation.
Frequency unknown (cannot be estimated from available data)
hallucinations, confusion (particularly in patients who have previously experienced these symptoms);
tingling, pricking, numbness, burning or stinging sensations; rash which may
be accompanied by joint pain; inflammation of the large intestine causing persistent watery diarrhoea.
Adverse effects detected in blood tests:
Uncommon (may occur in fewer than 1 in 100 people)
increased liver enzyme activity.
Rare (may occur in fewer than 1 in 1,000 people)
increased bilirubin concentration; increased blood lipid levels; sudden decrease
in granulocyte count (white blood cells) in blood, accompanied by high fever.
Very rare (may occur in fewer than 1 in 10,000 people)
decreased platelet count, which may lead to bleeding or easier bruising than usual; decreased white blood cell count, which may result in more frequent
infections; abnormal decrease in red blood cells, white blood cells and platelets.
Frequency unknown (cannot be estimated from available data)
reduced concentrations of sodium, magnesium, calcium or potassium in blood (see section 2).
Reporting of adverse effects
If any adverse effects occur, including any possible adverse effects not listed in this leaflet, consult your doctor, pharmacist or nurse. Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions at the 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.
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps 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 pack and the cardboard
box after "EXP". The expiry date refers to the last day of the stated month.
No special storage precautions are required.
Do not use IPP 20 more than 6 months after first 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. Such measures will help
protect the environment.

6. Contents of the packaging and other information

What IPP 20 contains
The active substance is pantoprazole. Each enteric-coated tablet contains 20 mg of pantoprazole
(in the form of pantoprazole sodium sesquihydrate).
Other ingredients: anhydrous sodium carbonate, microcrystalline cellulose, crospovidone (type A),
hypromellose (type EXF), anhydrous colloidal silicon dioxide, calcium stearate.
Coating: hypromellose, titanium dioxide (E171), polyethylene glycol 400, quinoline yellow (E104),
yellow iron oxide (E172), carmine red (E124), methacrylic acid and ethyl acrylate copolymer (1:1),
polysorbate 80, sodium lauryl sulfate, triethyl citrate.

What IPP 20 looks like and contents of the pack
IPP 20 enteric-coated tablets are yellow, oval-shaped (coated with a special coating), with approximate dimensions of 8.9 x 4.6 mm. They are available in blisters (28, 56, 84 and 168 tablets) or in containers (28 and 56 tablets).

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Sandoz GmbH
Biochemiestrasse 10
6250 Kundl, Austria

Manufacturers
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 about the medicinal product and its names in other European Economic Area countries, please contact:
Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warsaw, Poland
tel. 22 209 70 00