Pantoprazole aptapharma

Package leaflet: Information for the user

Pantoprazole AptaPharma, 40 mg, powder for solution for injection
pantoprazole
Please read all of this leaflet carefully before using this medicine, because it contains
important information for the patient.
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 experience any side effects, including any not listed in this leaflet, please inform your doctor,
pharmacist or nurse. See section 4.
Contents of the leaflet
What Pantoprazole AptaPharma is and what it is used for
What you need to know before using Pantoprazole AptaPharma
How to use Pantoprazole AptaPharma
Possible side effects
How to store Pantoprazole AptaPharma
Contents of the pack and other information
What Pantoprazole AptaPharma is and what it is used for
Pantoprazole AptaPharma contains the active substance pantoprazole. Pantoprazole AptaPharma is a
selective "proton pump inhibitor", a medicine which reduces the secretion of hydrochloric acid in the
stomach. It is used in the treatment of stomach and intestinal disorders associated with 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 administration of pantoprazole in tablet
form. The intravenous medicine will be switched to tablets as soon as the doctor considers it appropriate.
Pantoprazole AptaPharma is used in adults for the treatment of:
Gastro-oesophageal reflux disease. Inflammation of the oesophagus (the tube connecting the throat
to the stomach) associated with the backflow of hydrochloric acid from the stomach.
Stomach and duodenal ulcers.
Zollinger-Ellison syndrome and other conditions associated with excessive hydrochloric acid
secretion in the stomach.
What you need to know before using Pantoprazole AptaPharma
When not to use Pantoprazole AptaPharma
If the patient is allergic to pantoprazole or to 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 Pantoprazole AptaPharma, please inform your doctor, pharmacist or
nurse:
if the patient has severe liver function disorders. Please inform the doctor if there has ever been
any history of liver function disorders. The doctor may order 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, please ask the doctor for detailed advice.
the use of a proton pump inhibitor such as pantoprazole, especially for periods longer than 1 year,
may slightly increase the risk of fractures of the hip, wrist or spine. Please 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 is taking Pantoprazole AptaPharma for longer than three months, the patient may
develop low magnesium levels in the blood, which may consequently lead to fatigue, tetany,
disorientation, seizures, dizziness and ventricular arrhythmias. If the patient experiences any of
these symptoms, please inform the doctor. Low magnesium levels in the blood may also lead to
reduced potassium and calcium levels in the blood. The doctor may decide to carry out periodic
blood magnesium level tests.
if the patient has ever experienced a skin reaction due to taking a medicine similar to Pantoprazole
AptaPharma which reduces hydrochloric acid secretion in the stomach.
if the patient has ever developed a skin rash, especially in areas exposed to sunlight, please inform
the doctor as soon as possible, as it may be necessary to discontinue treatment with Pantoprazole
AptaPharma. You should also report any other adverse reactions, such as joint pain.
serious skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis (TEN),
drug reaction with eosinophilia and systemic symptoms (DRESS) and erythema multiforme, have
been reported with the use of pantoprazole. You must stop taking pantoprazole and seek immediate
medical advice if you notice any symptoms related to these serious skin reactions described in
section 4.
about a planned specific blood test (chromogranin A level).
Please inform the doctor immediately, before starting or during treatment, if any of the
following symptoms occur, as they may indicate another, more serious illness:
unintentional weight loss;
vomiting, particularly recurrent vomiting;
vomiting blood, which may look like dark coffee grounds;
blood in the stool, 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 slight increase
in the risk of infectious diarrhoea.
The doctor may decide to perform tests to rule out an underlying malignant disease, as treatment
with Pantoprazole AptaPharma may alleviate symptoms of cancer and delay its diagnosis. If symptoms
persist despite treatment, further investigations should be considered.
Children and adolescents
Pantoprazole AptaPharma is not recommended for use in children, as its effects have not been studied
in children under 18 years of age.
Pantoprazole AptaPharma and other medicines
Please inform your doctor or pharmacist about all medicines currently or recently taken, as well as
any medicines the patient plans to take, including those available without a prescription.
Since Pantoprazole AptaPharma may affect the efficacy of other medicines, please 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), as Pantoprazole AptaPharma may inhibit the proper
action of these and other medicines.
warfarin and phenprocoumon, which affect blood clotting and prevent thrombosis. Further testing
may be necessary.
medicines used to treat HIV infection, such as atazanavir.
methotrexate (used to treat rheumatoid arthritis, psoriasis and cancer diseases); in case of
methotrexate use, the doctor may temporarily discontinue Pantoprazole AptaPharma, as pantoprazole
may increase methotrexate blood levels.
fluvoxamine (used to treat depression and other psychiatric disorders) – if the patient is taking
fluvoxamine, the doctor may prescribe a lower dose.
rifampicin (used to treat infections).
St John's wort ( Hypericum perforatum ) (used to treat mild depression).
Before starting pantoprazole, please discuss this with the doctor if the patient is scheduled for a specific
urine test [for tetrahydrocannabinol (THC)].
Pregnancy, breastfeeding and fertility
Experience with use in pregnant women is limited. It has been established that the active substance
passes into human milk.
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a
child, she should consult a doctor or pharmacist before using this medicine.
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 using machines
Pantoprazole AptaPharma has no effect or a negligible effect on the ability to drive and use machines.
Do not drive or operate machinery if the patient experiences adverse reactions such as dizziness or
visual disturbances.
Pantoprazole AptaPharma contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per vial, meaning that the medicine is
considered "sodium-free".
How to use Pantoprazole AptaPharma
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 stomach and duodenal ulcers and gastro-oesophageal reflux disease
One vial (40 mg pantoprazole) per day.
For long-term treatment of Zollinger-Ellison syndrome and other conditions associated with
excessive hydrochloric acid secretion in the stomach
Two vials (80 mg pantoprazole) per day.
The dose may be adjusted by the doctor according to the amount of acid secreted. Daily doses higher
than 2 vials (80 mg) should be administered in two equal doses. The doctor may recommend periodic
increases in 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
Use in children and adolescents under 18 years of age is not recommended.
Missed dose of Pantoprazole AptaPharma
Since the medicine will be administered under strict medical supervision, it is unlikely that a dose will
be missed. However, if there is suspicion that a dose has been missed, please inform the doctor or
pharmacist.
Overdose of Pantoprazole AptaPharma
The doctor or nurse carefully checks the dosage, so overdose is unlikely. Symptoms of overdose are not
known.
If you have any further questions about the use of this medicine, please consult your doctor, pharmacist
or nurse.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone will experience them.
If any of the following side effects occur, please inform the doctor immediately or contact the nearest
hospital emergency department:
Severe allergic reactions (rare: may affect up to 1 in 1,000 people): swelling of the
tongue and (or) throat, difficulty swallowing, urticaria (rash resembling nettle stings),
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 determined from
available data): the patient may notice one or more of the following symptoms –
formation of skin blisters and sudden worsening of general condition, erosion (with mild
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, swelling of glands
(e.g. under the arms) may also occur, and blood tests may show changes in certain white
blood cells or liver enzymes.
red, target-shaped or round spots 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 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 enlarged kidneys, sometimes with pain during
urination and pain in the lower back (severe kidney inflammation), which may lead to kidney
failure.
Other side effects:
Common (may affect up to 1 in 10 people)
inflammation of blood vessel walls and thrombosis (phlebitis) 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 flatulence (wind);
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 (may affect up to 1 in 1,000 people)
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 the limbs (peripheral oedema);
allergic reactions;
depression;
breast enlargement in men.
Very rare (may affect up to 1 in 10,000 people)
disorientation.
Frequency unknown (frequency cannot be determined from available data)
hallucinations,
confusion (particularly in patients who have previously experienced such symptoms);
tingling, pricking, burning or numbness sensations, rash accompanied by joint pain,
inflammation of the large intestine causing persistent watery diarrhoea.
Side effects detected 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 fat levels;
fever-related sudden decrease in granulocyte count in the blood (white blood cells).
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 predispose to more frequent
infections; concurrent abnormal reduction in red blood cells, white blood cells and platelets.
Frequency unknown (frequency cannot be determined from available data) – reduced sodium,
magnesium, calcium or potassium levels in the blood (see section 2).

Reporting of side effects
If any side effects occur, including any not listed in this leaflet, please inform your doctor,
pharmacist or nurse.
Side effects can be reported directly to the Department of Monitoring of 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.
By reporting side effects, you can help provide more information on the safety of this medicine.
How to store Pantoprazole AptaPharma
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 the EXP. The expiry
date refers to the last day of that month.
Store below 30°C.
Keep the vial in the outer packaging to protect from light.
The reconstituted solution should be used within 24 hours; the reconstituted and diluted solution should
be used within 12 hours.
From a microbiological point of view, the solution should be used immediately after preparation. If the
solution is not used immediately after preparation, the responsibility for storage conditions and duration
before use lies with the user and should usually not exceed 24 hours at 2-8 °C, unless reconstitution and
dilution were carried out under controlled and validated aseptic conditions.
Do not use Pantoprazole AptaPharma if any change in appearance is visible (e.g. cloudiness of the
solution or precipitation of sediment).
Medicines should not be disposed of via wastewater or household waste. Please ask the pharmacist
how to dispose of medicines no longer in use. This will help protect the environment.
Contents of the pack and other information
What Pantoprazole AptaPharma contains
The active substance is pantoprazole (as sodium pantoprazole sesquihydrate). Each vial contains
40 mg of pantoprazole.
The other ingredients are: edetate disodium and sodium hydroxide (for pH adjustment).
What Pantoprazole AptaPharma looks like and contents of the pack
Powder for solution for injection.
Pantoprazole AptaPharma is a white or almost white porous "tablet" or powder. The medicine is
packaged in a 10 mL vial made of colourless glass (type I) with a 20 mm neck, closed with a grey
bromobutyl rubber stopper with a 20 mm diameter and sealed with an aluminium seal with a
polypropylene disc.
Pack sizes: 1, 5, 10 and 20 vials.
Not all pack sizes may be marketed.
Marketing authorisation holder and manufacturer/importer
Marketing authorisation holder
Apta Medica Internacional d.o.o.
Likozarjeva ulica 6
1000 Ljubljana
Slovenia
Tel.: 00386 51 615 015
e-mail: [email protected]
Manufacturer/Importer
APL Swift Services (Malta) Limited
Hf26, Hal Far Industrial Estate
Qasam Industrijali Hal Far
BBG 3000 Birzebbuga
Malta
This medicine is authorised for sale in the European Economic Area countries under the
following names:

Information intended exclusively for healthcare professionals

Reconstituted solution
The ready-to-administer solution is prepared by injecting 10 mL of 0.9% sodium chloride solution for injection (concentration 9 mg/mL) into a vial containing the lyophilisate. The resulting solution may be administered directly. After preparation, the solution is chemically and physically stable for 24 hours at a temperature not exceeding 25°C.

Reconstituted and diluted solution
The ready-to-administer solution is prepared by injecting 10 mL of 0.9% sodium chloride solution for injection (concentration 9 mg/mL) into a vial containing the lyophilisate, followed by dilution by mixing with 100 mL of 0.9% sodium chloride solution for injection (concentration 9 mg/mL) or 50 mg/mL (5%) glucose solution for injection (final concentration approximately 0.4 mg/mL). After reconstitution and dilution, the solution is chemically and physically stable for 12 hours in 0.9% sodium chloride solution for injection (concentration 9 mg/mL) and 50 mg/mL (5%) glucose solution for injection, stored at a temperature not exceeding 25°C. Plastic containers should be used for dilution.

Pantoprazole AptaPharma must not be prepared or mixed with solvents other than those listed above.

The reconstituted and diluted solution must be used within 12 hours, or within 24 hours if no further dilution has been performed.

From a microbiological standpoint, the solution should be used immediately after preparation. If the solution is not used immediately, the user is responsible for storage conditions and duration, which should generally not exceed 24 hours at 2–8°C, unless reconstitution and dilution were performed under controlled and validated aseptic conditions.

The medicinal product is administered intravenously over 2–15 minutes.

The vial content is for single use only. Any unused medicinal product remaining in the vial, or any solution that has changed in appearance (e.g. solution becoming cloudy or precipitation occurring), must be discarded.

The reconstituted solution is a clear, colourless to yellowish solution.