Package leaflet: Information for the user

Argipressin Farmak, 20 IU/mL, solution for injection
Argipressinum
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, ask your doctor, pharmacist or nurse.
This medicine has been prescribed for you personally. 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 leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of the leaflet

What Argipressin Farmak is and what it is used for
What you need to know before you are given Argipressin Farmak
How to use Argipressin Farmak
Possible side effects
How to store Argipressin Farmak
Contents of the pack and other information

1. What Argipressin Farmak is and what it is used for

Argipressin Farmak contains argipressin, which is similar to a hormone naturally present in the body. It is an antidiuretic agent that helps prevent excessive loss of water through urine, and also constricts certain blood vessels in the body.
Argipressin Farmak is used in adults with septic shock who have low blood pressure despite adequate prior therapy with other appropriate treatments aimed at achieving the target blood pressure values set by the physician (i.e. fluid resuscitation and catecholamine vasopressors).

2. Important information before using Argipressin Farmak

When not to use Argipressin Farmak

if the patient is allergic to argipressin or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to a doctor or nurse before receiving Argipressin Farmak.
Special caution is required when Argipressin Farmak is used in patients who:

have asthma or other allergic diseases,
suffer from migraine,
suffer from epilepsy (seizures),
have heart or vascular disease,
have coronary vessel obstruction (e.g. coronary artery),
have kidney disease,
have goitre (enlarged thyroid) and the heart is not functioning properly,
have any other condition in which a sudden increase in extracellular water volume poses a risk to an already overloaded system,
have a condition called polyuria (excretion of abnormally large volumes of urine),
have any disease that may cause low blood sodium levels,
are taking other medicines that may reduce blood sodium levels,
if the patient is pregnant or may be pregnant (see section "Pregnancy and breastfeeding" below).

Patients receiving Argipressin Farmak should be closely monitored.
Children and adolescents
The safety and efficacy of Argipressin Farmak in children with vasodilatory shock (shock caused by excessive blood vessel dilation) have not been established. Therefore, the use of Argipressin Farmak in children is not recommended.
Argipressin Farmak with other medicines
Inform the doctor about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to use.
Special caution is required when taking any of the following medicines:

anticonvulsant drugs (carbamazepine),
drugs used in diabetes treatment (chlorpropamide),
lipid-lowering drug (clofibrate),
certain drugs used to treat depression (tricyclic antidepressants, e.g. amitriptyline),
drugs suspected of causing nephrogenic diabetes insipidus, e.g. antibiotics (demeclocycline),
drugs used to treat psychiatric disorders (lithium, clozapine), viral infections (foscarnet),
the anti-inflammatory drug indomethacin used to treat painful conditions such as arthritis,
furosemide (a diuretic) used to treat fluid retention (edema) in patients with congestive heart failure, liver disease or kidney disease, such as nephrotic syndrome,
fludrocortisone (a steroid drug used to treat adrenal insufficiency or syndromes involving excessive urinary sodium loss),
drugs that increase or decrease blood pressure,
heparin (a drug used to prevent blood clots from forming or growing larger),
tolvaptan (a drug used to treat low blood salt (sodium) levels, which may result from conditions such as heart failure and certain hormonal imbalances),
urea (carbamide).

Argipressin Farmak and alcohol
Argipressin Farmak must not be used in combination with alcohol.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.
The use of Argipressin Farmak during pregnancy and breastfeeding is not recommended unless the doctor considers it necessary.
Argipressin Farmak may cause uterine contractions and increased intrauterine pressure during pregnancy and may reduce uterine blood flow.
It is unknown whether Argipressin Farmak passes into human milk. Breastfeeding should be discontinued during treatment with Argipressin Farmak and for 1.5 hours after receiving the medicine. Breast milk should be expressed and discarded.
Driving and operating machinery
Argipressin Farmak may affect the ability to drive and operate machinery; the patient may experience dizziness after injection. Consult the doctor for further advice.

3. How to use Argipressin Farmak

Argipressin Farmak is administered by a doctor in a hospital.
The medicine is diluted in a glucose solution and slowly infused through a needle into a vein. The doctor will decide on the most appropriate dose and method of administration depending on the symptoms.
Use of a higher than recommended dose of Argipressin Farmak
Since the injection will be given by a doctor, it is unlikely that the patient will receive a higher than necessary dose. If the patient thinks they have been given too high a dose of the medicine, they should immediately contact the doctor.
If the patient has any further questions about the use of this medicine, they should consult their doctor.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
All medicines can cause allergic reactions. If you experience sudden wheezing,
difficulty breathing, swelling of the eyelids, face or lips, rash or itching
(particularly affecting the whole body), you should contact your doctor immediately, as this
could also lead to myocardial infarction if not treated immediately.
The following adverse reactions may occur:

Common (may occur in up to 1 in 10 people):

low blood sodium levels (hyponatremia),
heart rhythm disorders (arrhythmia),
chest pain caused by angina pectoris,
circulatory disturbances in the heart muscle (myocardial ischemia),
pallor,
peripheral vasoconstriction,
tissue necrosis, including skin tissue,
abdominal pain,
insufficient blood supply to the small intestine (intestinal ischemia),
reduced blood flow to fingertips (digital ischemia), including tissue death (gangrene) in isolated cases.

Uncommon (may occur in up to 1 in 100 people):

headache,
dizziness (sensation of spinning),
tremor,
life-threatening arrhythmia,
cardiac arrest (cessation of heart function),
reduced cardiac output (insufficient amount of blood pumped by the heart to meet the body's needs),
breathing difficulties caused by airway constriction,
bloating,
nausea,
vomiting,
intestinal tissue necrosis,
increased bilirubin levels (a breakdown product of red blood cells) in blood,
increased aminotransferase levels (liver enzymes) in blood,
decreased platelet count (blood cells that help with clotting).

Unknown frequency (cannot be estimated from available data):

reduced oxygen levels in tissues due to insufficient blood or fluid volume (hemorrhagic shock),
uncontrolled bleeding,
allergic reactions, anaphylactic reactions (including anaphylactic shock) may occur in sensitive patients,
heart failure,
sudden reduction in blood flow to the heart (acute coronary syndrome),
irregular and rapid heart rhythm (atrial fibrillation),
slow heart rate (bradycardia),
high blood pressure,
diarrhea,
urge to defecate,
excessive sweating,
urticaria,
skin lesions caused by blocked blood supply (ischemic skin ulcers),
edema (fluid retention),
changes in certain blood laboratory parameters (increased cortisol levels, increased growth hormone levels),
excess water in the body,
blood clot in veins,
belching,
uterine contractions,
a condition in which the kidneys are unable to retain water (diabetes insipidus).

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse effects 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 at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Argipressin Farmak

Keep the medicine out of the sight and reach of children.
Unopened packaging: Store in a refrigerator (2°C - 8°C). Keep in the original packaging to protect from light. Do not freeze.
After first opening, the medicine must be used immediately.
After dilution: The diluted solution should be discarded after 18 hours at room temperature or after 24 hours at 2°C – 8°C.
Do not use this medicine after the expiry date stated on the label and the cardboard box after: "EXP". The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the package and other information

What Argipressin Farmak contains

The active substance is argipressin. One ampoule containing 1 ml of solution contains 20 IU of argipressin (as acetate).
The other ingredients are: glacial acetic acid, water for injections.

What Argipressin Farmak looks like and contents of the pack
Argipressin Farmak is a clear, colourless liquid free from visible particles.
Each ampoule contains 1 ml or 2 ml of solution. The cardboard box contains 10 ampoules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Farmak International Sp. z o.o.
ul. Koszykowa 65
00-667 Warsaw
tel. +48 22 822 93 06
Importer
Farmak International Sp. z o.o.
ul. Chełmżyńska 249
04-458 Warsaw
This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Germany: Argipressin Farmak 20 IU/ml Injektionslösung
Poland: Argipressin Farmak