Pantoprazole zentiva

Package leaflet: Information for the user

Pantoprazol Zentiva, 40 mg, powder for solution for injection/infusion
pantoprazole
Read the entire leaflet carefully before using this medicine, as it contains important information for you.
Keep this leaflet so that you can read it again if necessary.
If you have any further questions, ask your doctor, pharmacist or nurse.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. See section 4.
Leaflet contents
What Pantoprazol Zentiva is and what it is used for
What you need to know before using Pantoprazol Zentiva
How to use Pantoprazol Zentiva
Possible side effects
How to store Pantoprazol Zentiva
Contents of the pack and other information

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

Pantoprazol Zentiva contains the active substance pantoprazole. Pantoprazol Zentiva is a selective
proton pump inhibitor, a medicine that reduces gastric acid secretion. It is used in the treatment of stomach and intestinal disorders related to hydrochloric acid secretion.
This medicine is administered intravenously and is used only when, in the opinion of the doctor, this route of administration is more beneficial for the patient than oral pantoprazole tablets. Intravenous treatment will be switched to oral tablets as soon as the doctor considers it appropriate.
Pantoprazol Zentiva is used in adults for the treatment of:
Gastroesophageal reflux disease. Inflammation of the oesophagus (the tube connecting the throat to the stomach) associated with the backflow of hydrochloric acid from the stomach.
Peptic ulcer disease of the stomach and duodenum.
Zollinger-Ellison syndrome and other pathological conditions associated with excessive hydrochloric acid secretion in the stomach.

2. Important information before using Pantoprazol Zentiva

When not to use Pantoprazol Zentiva
If the patient is allergic to pantoprazole or any of the other ingredients
of this medicine (listed in section 6).
If the patient has had an allergic reaction to medicines containing other proton pump inhibitors.

Warnings and precautions
Before starting treatment with Pantoprazol Zentiva, inform your doctor,
pharmacist, or nurse:
if the patient has severe liver function disorders. Inform the
doctor if there has ever been a history of liver problems. The doctor may order more frequent monitoring of liver enzyme activity. If liver enzyme levels increase, treatment with this medicine should be discontinued.
if the patient is taking HIV protease inhibitors such as atazanavir (used in the treatment of HIV infection) concomitantly with pantoprazole, the patient should consult the doctor for specific advice.
the use of a proton pump inhibitor such as pantoprazole, especially for a period longer than 1 year, may slightly increase the risk of fractures of the hip, wrist, or spine. Inform the doctor if the patient has osteoporosis (reduced bone density) or if the doctor has informed the patient that they are at risk of developing osteoporosis (for example, if the patient is taking steroid medicines).
if the patient takes Pantoprazol Zentiva for longer than three months, there may be a decrease in magnesium levels in the blood, which may subsequently cause fatigue, tetany, disorientation, seizures, dizziness, and ventricular arrhythmias. If any of these symptoms occur, inform the doctor immediately. Low magnesium levels in the blood may also lead to reduced potassium and calcium levels in the blood. The doctor may decide that periodic monitoring of magnesium levels in the patient's blood is necessary.
if the patient has ever experienced a skin reaction due to taking a medicine similar to Pantoprazol Zentiva that reduces gastric acid secretion.
if the patient has ever developed a skin rash, especially in areas exposed to sunlight, they should inform the doctor as soon as possible, as it may be necessary to discontinue treatment with Pantoprazol Zentiva. The patient should also report any other adverse reactions occurring, such as joint pain.
serious skin reactions have been reported with the use of pantoprazole, including Stevens-Johnson syndrome, toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and erythema multiforme. The patient should stop taking pantoprazole and seek immediate medical advice if any symptoms suggestive of these serious skin reactions occur, as described in section 4.
about a planned specific blood test (chromogranin A levels).

Contact the doctor immediately before starting or during treatment if any of the following symptoms appear, as they may indicate another, more serious condition:
unintentional weight loss;
vomiting, especially if recurrent;
vomiting blood, which may look like dark coffee grounds;
blood in the stool, black or tarry stools;
difficulty swallowing or pain during swallowing;
pallor and weakness (anaemia);
chest pain;
abdominal pain;
severe and/or persistent diarrhoea, as use of this medicine is associated with a small increased risk of infectious diarrhoea.

The doctor may decide to perform tests to rule out an underlying malignant condition, as treatment with pantoprazole may alleviate symptoms of malignancy and delay diagnosis. If symptoms persist despite treatment, further investigations should be considered.

Children and adolescents
Pantoprazol Zentiva is not recommended for use in children, as its efficacy and safety have not been established in children under 18 years of age.

Pantoprazol Zentiva and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take, including those available without a prescription.

Since Pantoprazol Zentiva may affect the effectiveness of other medicines, inform the doctor if the patient is taking:
medicines such as ketoconazole, itraconazole, and posaconazole (used to treat fungal infections) or erlotinib (used in certain types of cancer), because Pantoprazol Zentiva may impair the proper action of these and other medicines.
warfarin and phenprocoumon, which affect blood clotting and prevent thrombosis. Additional monitoring may be required.
medicines used to treat HIV infection, such as atazanavir.
methotrexate (used in the treatment of rheumatoid arthritis, psoriasis, and cancerous diseases); when methotrexate is used, the doctor may temporarily discontinue Pantoprazol Zentiva, as pantoprazole may increase methotrexate blood levels.
fluvoxamine (used in the treatment of depression and other psychiatric disorders); if the patient is taking fluvoxamine, the doctor may recommend a lower dose.
rifampicin (used to treat infections).
St John’s wort (Hypericum perforatum) (used in the treatment of mild depression).

Before starting pantoprazole, discuss this with the doctor if the patient is scheduled for a specific urine test [for tetrahydrocannabinol (THC)].

Pregnancy, breastfeeding, and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
Experience with use in pregnant women is limited. It has been shown that the active substance passes into human milk.
The medicine may be used only if the doctor considers that the benefit of treatment outweighs the potential risk to the unborn child or infant.

Driving and operating machinery
Pantoprazol Zentiva has no effect or has a negligible effect on the ability to drive and operate machinery.
Do not drive or operate machinery if the patient experiences adverse effects such as dizziness or visual disturbances.

Pantoprazol Zentiva contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per vial, meaning that the medicine is considered "sodium-free".

3. How to take Pantoprazol Zentiva

The medicine is administered intravenously as a single daily dose over 2–15 minutes by a nurse or
doctor.
The recommended needle size is 21G.
Recommended dose:
Adults
For the treatment of gastric and duodenal ulcer, and reflux esophagitis
One vial (40 mg of pantoprazole) per day.
For long-term treatment of Zollinger-Ellison syndrome and other conditions associated with
excessive gastric acid secretion
Two vials (80 mg of pantoprazole) per day.
The dosage may be adjusted appropriately by the physician depending on the amount of acid secreted. Daily doses exceeding two vials (80 mg) should be administered in two equal doses.
It may be possible to temporarily increase the pantoprazole dose to more than four vials (160 mg) per day.
For rapid control of acid secretion, an initial dose of 160 mg (4 vials) should be sufficient to reduce acid secretion.
Patients with impaired liver function
In severe liver disease, the daily dose should be only 20 mg (half a vial).
Use in children and adolescents
Pantoprazol Zentiva is not recommended for use in children and adolescents under 18 years of age.
Use of a higher than recommended dose of Pantoprazol Zentiva
The doctor or nurse carefully checks the dosage; therefore, overdose is unlikely. Symptoms of overdose are unknown.
If you have any further questions regarding the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

If any of the following side effects occur, you must immediately inform your doctor or contact the nearest hospital providing emergency care:

Severe allergic reactions (rare: may affect up to 1 in 1,000 people): swelling of the tongue and/or throat, difficulty swallowing, hives (a rash similar to nettle rash), difficulty breathing, angioedema (Quincke's oedema/angio-oedema), severe dizziness with rapid heartbeat and excessive sweating.

Severe skin reactions (frequency unknown: frequency cannot be estimated from available data): the patient may notice one or more of the following symptoms – formation of skin blisters and sudden worsening of general condition, erosions (with slight bleeding) of the eyes, nose, mouth/oral cavity or genital organs, or rash, particularly in areas of skin exposed to sunlight. Joint pain or flu-like symptoms, fever, and swollen glands (e.g. under the arms) may also occur, and blood tests may show changes in certain white blood cells or liver enzymes.

Reddish, non-elevated spots or circular lesions on the trunk, often with blisters in the centre, skin peeling, ulceration of the mouth, throat, nose, genital organs and eyes. The appearance of such a severe skin rash may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).

Widespread rash, high body temperature and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

Other severe reactions (frequency unknown): yellowing of the skin and eyes (severe liver cell damage, jaundice), or fever, rash and kidney problems manifested by their enlargement, sometimes with pain during urination and pain in the lower back (severe kidney inflammation), possibly leading to kidney failure.

Other side effects:

Common (may affect up to 1 in 10 people)
inflammation of the walls of blood vessels and blood clots (thrombophlebitis) at the injection site;
benign gastric polyps.

Uncommon (may affect up to 1 in 100 people)
headache;
dizziness;
diarrhoea;
nausea;
vomiting;
feeling of fullness in the abdomen and bloating with passing wind (flatulence);
constipation;
dry mouth;
abdominal pain and discomfort;
skin rash, erythema, skin eruptions;
itching of the skin;
weakness, fatigue or general malaise;
sleep disorders;
fractures of the hip, wrist or spine.

Rare (may affect up to 1 in 1,000 people)
taste disturbances or complete loss of taste sensation;
visual disturbances such as blurred vision;
urticaria;
joint pain;
muscle pain;
changes in body weight;
elevated body temperature;
high fever;
swelling of limbs (peripheral oedema);
allergic reactions;
depression;
breast enlargement in males.

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

Frequency unknown (frequency cannot be estimated from available data)
hallucinations;
confusional state (particularly in patients who have previously experienced such symptoms);
tingling, pricking, burning or numbness sensations; rash possibly associated with joint pain; inflammation of the large intestine causing persistent watery diarrhoea.

Side effects identified by 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 levels; increased blood lipid levels; sudden decrease in circulating granulocytes – white blood cells, associated with high fever.

Very rare (may affect up to 1 in 10,000 people) – reduced platelet count, which may lead to more frequent bleeding and bruising; reduced white blood cell count, which may increase susceptibility to infections; concurrent abnormal reduction in red blood cells, white blood cells and platelets.

Frequency unknown (frequency cannot be estimated from available data)
decreased blood concentrations of sodium, magnesium, calcium or potassium (see section 2).

Reporting of side effects

If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse.

Side effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.

Side effects can also be reported to the marketing authorisation holder.

Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Pantoprazol Zentiva

Keep out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and vial after EXP. The expiry date refers to the last day of the specified month.
Store below 30°C.
Keep the vial in the outer packaging to protect from light.
The solution after reconstitution or after reconstitution and dilution must be used within 12 hours.
For microbiological safety, the solution should be used immediately after preparation. If the solution is not used immediately after preparation, the user is responsible for storage conditions and duration prior to use. Storage of the solution for longer than 12 hours is not recommended at temperatures not exceeding 25°C.
Do not use Pantoprazol Zentiva if there is any visible change in its appearance (e.g. cloudiness or precipitation in the solution).
Medicines must 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 Pantoprazol Zentiva contains
The active substance is pantoprazole (in the form of sodium pantoprazole hemihydrate). Each vial contains 40 mg of pantoprazole.
The other ingredients are: disodium edetate and sodium hydroxide (for pH adjustment).

What Pantoprazol Zentiva looks like and contents of the pack
Pantoprazol Zentiva is a white or almost white porous lyophilisate.
Pantoprazol Zentiva is supplied in 10 ml vials made of colourless glass (type I), closed with a grey chlorobutyl rubber stopper and sealed with an aluminium cap. The pack is contained in a cardboard carton.
Pack sizes: 1, 10, 50 vials.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Zentiva, k.s.
U kabelovny 130
Dolní Měcholupy
102 37 Prague 10
Czech Republic

Manufacturer
Laboratorios Normon, S.A.
Ronda de Valdecarrizo 6
28760 Tres Cantos, Madrid
Spain

For further information on this medicinal product, please contact the local representative of the Marketing Authorisation Holder in Poland:
Zentiva Polska Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw
Tel.: +48 22 375 92 00

This medicinal product is authorised in the European Economic Area member states under the following names:
France, Czech Republic: Pantoprazole Zentiva
Bulgaria: Пантопразол Зентива
Poland, Germany: Pantoprazol Zentiva
Italy: Pantoprazol Zentiva Lab
Hungary: Pantacid Flux
Romania: Zencopan
Slovak Republic: Ozzion