Package leaflet: Information for the user

Pantoprazole Genoptim, 40 mg, powder for solution for injection
Pantoprazolum
Please read all of this leaflet carefully before this medicine is administered, because it contains
important information for you.

Keep this leaflet, as you may need to read it again.
If you have any further questions, please ask your doctor, pharmacist, or nurse.
If you get any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

List of contents of the leaflet

What Pantoprazole Genoptim is and what it is used for
What you need to know before using Pantoprazole Genoptim
How to use Pantoprazole Genoptim
Possible side effects
How to store Pantoprazole Genoptim
Contents of the pack and other information

1. What Pantoprazole Genoptim is and what it is used for

Pantoprazole Genoptim contains the active substance pantoprazole. Pantoprazole Genoptim is a selective "proton pump inhibitor", a medicine which reduces the production of acid in the stomach. 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.
Pantoprazole Genoptim is used to treat:

Gastro-oesophageal reflux disease. Oesophagitis (inflammation of the tube connecting the throat to the stomach) is associated with the backflow of hydrochloric acid from the stomach.
Gastric and/or duodenal ulcer disease.
Zollinger-Ellison syndrome and other conditions associated with excessive gastric acid secretion.

2. Important information before using Pantoprazole Genoptim

When not to use Pantoprazole Genoptim

If the patient is allergic to pantoprazole or any of the other ingredients of this medicine (listed in section 6).
If the patient has previously experienced an allergic reaction to medicines containing other proton pump inhibitors.

Warnings and precautions
Before starting treatment with Pantoprazole Genoptim, the patient should inform the doctor,
pharmacist or nurse:

If the patient has severe liver function disorders. The doctor should be informed if the patient has ever had liver problems. The doctor may recommend more frequent monitoring of liver enzyme activity. If liver enzyme activity increases, 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 seek detailed advice from the doctor.
Use of a proton pump inhibitor such as pantoprazole, especially for more than 1 year, may slightly increase the risk of fractures of the hip, wrist or spine. The patient should inform the doctor if they have osteoporosis or if they are taking corticosteroids (which may increase the risk of osteoporosis).
If the patient takes Pantoprazole Genoptim for longer than three months, blood magnesium levels may decrease, which may lead to fatigue, tetany, disorientation, seizures, dizziness, and ventricular arrhythmias. If any of these symptoms occur, the patient should inform the doctor. Low blood magnesium levels may also lead to reduced potassium and calcium levels in the blood. The doctor may decide that periodic monitoring of blood magnesium levels is necessary.
If the patient has ever had a skin reaction to a medicine similar to Pantoprazole Genoptim that reduces gastric acid secretion.
About planned specific blood tests (chromogranin A levels).

If the patient develops a skin rash, especially in areas exposed to sunlight, they should inform the doctor as soon as possible, as discontinuation of Pantoprazole Genoptim may be necessary. The patient should also report any other adverse effects, such as joint pain.
The patient should immediately inform the doctor before starting or during treatment
if any of the following symptoms occur, as they may indicate another, more serious condition:

Unintentional weight loss;
Vomiting, particularly recurrent;
Vomiting blood, which may look like dark coffee grounds;
Blood in stools, black or tarry stools;
Difficulty swallowing or pain when swallowing;
Pallor and weakness (anaemia);
Chest pain;
Abdominal pain;
Severe and/or persistent diarrhoea, as use of this medicine is associated with a slightly increased risk of infectious diarrhoea.

The doctor may decide that further investigations are necessary to exclude an underlying tumour, as treatment with pantoprazole may relieve symptoms of tumour-related disease and delay diagnosis. If symptoms persist despite treatment, further investigations should be considered.
Children and adolescents
Pantoprazole Genoptim is not recommended for use in children, as its effects have not been studied in patients under 18 years of age.
Pantoprazole Genoptim and other medicines
The patient should inform their doctor or pharmacist about all medicines currently or recently taken, as well as any medicines they plan to take.
Since Pantoprazole Genoptim may affect the effectiveness of other medicines, the patient should inform the doctor if they are taking:

Medicines such as ketoconazole, itraconazole and posaconazole (used to treat fungal infections) or erlotinib (used in certain types of cancer), because Pantoprazole Genoptim may inhibit the proper action of these and other medicines.
Warfarin and phenprocoumon, which affect blood clotting and prevent thrombosis. Further testing may be required.
Medicines used in the treatment of HIV infection, such as atazanavir.
Methotrexate (used in the treatment of rheumatoid arthritis, psoriasis and cancer). In case of methotrexate treatment, the doctor may temporarily discontinue Pantoprazole Genoptim, 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).

Pregnancy, breastfeeding and fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to become pregnant, 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.
This medicine may be used in pregnant women, women who may be pregnant, or breastfeeding women only if the doctor considers that the benefit to the woman outweighs the risk to the unborn child or infant.
Animal studies have not shown any impairment of fertility after administration of pantoprazole.
Driving and operating machinery
Pantoprazole Genoptim has no effect or has a negligible effect on the ability to drive and operate machinery.
Patients should not drive or operate machinery if they experience adverse effects such as dizziness or visual disturbances.
Sodium content
This medicine contains less than 1 mmol (23 mg) of sodium per vial, meaning the medicine is considered "sodium-free".

3. How to use Pantoprazole Genoptim

The medicine is administered intravenously as a single daily dose over 2–15 minutes by a nurse or doctor.
Recommended dose:
Adults
For the treatment of gastric and/or 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 hydrochloric 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 is possible to temporarily increase the pantoprazole dose to more than four vials (160 mg) per day. To achieve 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 (½ vial).
Use in children and adolescents
Pantoprazole Genoptim is not recommended for use in children and adolescents under 18 years of age.
Use of a higher than recommended dose of Pantoprazole Genoptim
The dose is carefully checked by the doctor or nurse; therefore, overdose is unlikely. Symptoms of overdose are unknown.
If you have any further doubts regarding the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If any of the following adverse reactions occur, you should immediately inform your doctor or
contact the nearest hospital providing emergency care:

Severe allergic reactions (rare: occur no more frequently than in 1 out of 1,000 patients): swelling of the tongue and/or throat, difficulty swallowing, hives (rash resembling stinging nettle burns), difficulty breathing, allergic swelling of the face (Quincke's oedema/angioedema), severe dizziness with rapid heartbeat and profuse sweating.
Severe skin reactions (frequency unknown: frequency cannot be estimated from available data): formation of skin blisters and sudden deterioration in general condition, erosion (with slight bleeding) of the eyes, nose, oral cavity and/or lips or genital organs (Stevens-Johnson syndrome, Lyell's syndrome, erythema multiforme), photosensitivity.
Other severe reactions (frequency unknown: frequency cannot be estimated from available data): 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), which may lead to kidney failure.

Other known adverse reactions occurring:

Common (occur no more frequently than in 1 out of 10 patients): inflammation of blood vessel walls and blood clots (thrombophlebitis) at the injection site; benign gastric polyps.
Uncommon (occur no more frequently than in 1 out of 100 patients): headache; dizziness; diarrhoea; nausea, vomiting; feeling of fullness in the abdomen and bloating with flatulence; constipation; dry mouth; abdominal pain and discomfort; skin rash, erythema, skin eruptions; itching of the skin; weakness, exhaustion or general malaise; sleep disturbances; fractures of the hip, wrist or spine.
Rare (occur no more frequently than in 1 out of 1,000 patients): 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 men.
Very rare (occur no more frequently than in 1 out of 10,000 patients): disorientation.
Frequency unknown (frequency cannot be estimated from available data): hallucinations, disorientation (particularly in patients who have previously experienced such symptoms); decreased sodium levels in blood, decreased magnesium levels in blood (see section 2), tingling, pricking, burning or numbness sensations, rash possibly accompanied by joint pain, inflammation of the large intestine causing persistent watery diarrhoea.

Adverse reactions identified by blood tests occurring:

Uncommon (occur no more frequently than in 1 out of 100 patients): increased liver enzyme activity.
Rare (occur no more frequently than in 1 out of 1,000 patients): increased bilirubin levels; increased blood lipid levels; fever-related sudden decrease in circulating granulocytes – white blood cells.
Very rare (occur no more frequently than in 1 out of 10,000 patients): decreased platelet count, which may lead to more frequent bleeding and bruising; decreased white blood cell count, which may predispose to more frequent infections; concurrent abnormal decrease in red blood cells, white blood cells, and platelets.

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed in this leaflet, you should inform your doctor, pharmacist, or nurse.
Adverse reactions 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, phone: +48 22 4921 301, fax: +48 22 4921 309, website: https://smz.ezdrowie.gov.pl.
Adverse reactions can also be reported to the marketing authorisation holder. By reporting adverse reactions, more information on the safety of the medicine can be collected.

5. How to store Pantoprazole Genoptim

Keep this medicine out of 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 stated month.
Store below 30°C in the original packaging to protect from light.
The solution after reconstitution should be used within 12 hours.
The solution after reconstitution and dilution should be used within 12 hours.
Due to the need to maintain microbiological purity, the solution should be used immediately after preparation. If the solution is not used immediately after preparation, the responsibility for the storage duration and conditions prior to use lies with the user. Storage of the solution for longer than 12 hours at 25°C is not recommended.
Do not use Pantoprazole Genoptim 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. This will help protect the environment.

6. Contents of the packaging and other information

What the medicine Pantoprazole Genoptim contains

The active substance is pantoprazole. Each vial contains 40 mg of pantoprazole.
The other ingredients are: disodium edetate, nitrogen.

What Pantoprazole Genoptim looks like and contents of the pack
Pantoprazole Genoptim is a white to off-white, porous "disc" or powder for solution for injection.
A 10 ml vial made of colourless glass (type I), closed with a chlorobutyl rubber stopper and secured with an aluminium seal, containing 40 mg of powder for solution for injection, in a cardboard box.
Pantoprazole Genoptim is available in the following pack sizes:

Pack containing 1 vial.
Pack containing 10 vials.

Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Synoptis Pharma Sp. z o.o.
ul. Krakowiaków 65
02-255 Warsaw
Manufacturer
LABORATORIOS NORMON, S.A.
Ronda de Valdecarrizo, 6
28760 Tres Cantos, Madrid
Spain

Information intended exclusively for healthcare professionals

The ready-to-use solution is prepared by injecting 10 ml of 0.9% sodium chloride solution for injection (9 mg/ml concentration) into the vial containing the lyophilized powder. The resulting solution may be administered directly or after dilution with 100 ml of 0.9% sodium chloride solution for injection (9 mg/ml concentration) or 100 ml of 5% glucose solution for injection (55 mg/ml concentration). Glass or plastic containers should be used for dilution.
Pantoprazole Genoptim must not be prepared or mixed with solvents other than those specified above.
After preparation, the solution must be used within 12 hours. For microbiological safety reasons, the solution should be used immediately after preparation. If the solution is not used immediately, responsibility for storage conditions and duration prior to use lies with the user. Storage of the solution for longer than 12 hours at 25°C is not recommended.
The medicinal product should be administered intravenously over 2–15 minutes.
The content of the vial is intended for single use only. Any unused medicinal product or solution showing visible changes (e.g. cloudiness or precipitation) must be discarded.