Argipressin Farmak

Package Leaflet: Information for the User

Argipressin Farmak, 20 IU/mL, Solution for Injection

Argipressinum

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, 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 only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

• 1. What is Argipressin Farmak and what is it used for
• 2. Important information before using Argipressin Farmak
• 3. How to use Argipressin Farmak
• 4. Possible side effects
• 5. How to store Argipressin Farmak
• 6. Contents of the pack and other information

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

Argipressin Farmak contains argipressin, which is similar to a naturally occurring hormone in the body. It is an antidiuretic medicine that helps prevent excessive water loss in the urine and also constricts some blood vessels in the body.
Argipressin Farmak is used in adults with septic shock, who have low blood pressure after ineffective use of other appropriate methods to achieve target blood pressure values set by the doctor (i.e., fluid and catecholamine therapy).

2. Important information before using Argipressin Farmak

When not to use Argipressin Farmak

• if you are allergic to argipressin or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before taking Argipressin Farmak, talk to your doctor or nurse.
Special care should be taken when Argipressin Farmak is used to treat patients who:

• have asthma or other allergic diseases,
• have migraine,
• have epilepsy (seizures),
• have heart or blood vessel disease,
• have coronary artery disease (e.g., coronary artery disease),
• have kidney disease,
• have thyroid disease and heart problems,
• have any other disease where a sudden increase in extracellular water volume poses a risk to an already overloaded system,
• have a condition called polyuria (excessive urine production),

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• have any disease that may cause low sodium levels in the blood,
• are taking other medicines that may decrease sodium levels in the blood,
• if you are or may be pregnant (see "Pregnancy and breastfeeding" below).

Patients taking Argipressin Farmak should be closely monitored.

Children and adolescents

The safety and efficacy of Argipressin Farmak in children with vasodilatory shock (shock caused by increased dilation of blood vessels) have not been established. Therefore, the use of Argipressin Farmak in children is not recommended.

Argipressin Farmak with other medicines

Tell your doctor about all medicines you are taking, or have recently taken, and any medicines you plan to take.
Special care should be taken when taking any of the following medicines:

• seizure control medicines (carbamazepine),
• diabetes medicines (chlorpropamide),
• a lipid-lowering medicine (clofibrate),
• certain antidepressants (tricyclic antidepressants, e.g., amitriptyline),
• medicines suspected of causing diabetes insipidus, such as antibiotics (demeclocycline),
• medicines used to treat mental disorders (lithium, clozapine), viral infections (foscarnet),
• an anti-inflammatory medicine indomethacin used to treat painful conditions such as arthritis,
• furosemide (a diuretic) used to treat fluid retention (edema) in people with congestive heart failure, liver disease, or kidney disease, such as nephrotic syndrome,
• fludrocortisone (a steroid medicine used to treat adrenal insufficiency or conditions where there is excessive loss of sodium in the urine),
• medicines that increase or decrease blood pressure,
• heparin (a medicine used to prevent blood clots from forming or growing),
• tolvaptan (a medicine used to treat low sodium levels in the blood, which can be caused by conditions such as heart failure and certain hormonal imbalances),
• urea (a medicine used to treat certain conditions, such as high blood pressure and certain types of edema).

Argipressin Farmak with alcohol

Do not use Argipressin Farmak with alcohol.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Argipressin Farmak should not be used during pregnancy and breastfeeding, unless your doctor considers it necessary.
Argipressin Farmak may cause uterine contractions and increased uterine pressure during pregnancy and may decrease blood flow to the uterus.
It is not known whether Argipressin Farmak passes into breast milk. Breastfeeding should be discontinued during treatment with Argipressin Farmak and for 1.5 hours after administration of Argipressin Farmak. Breast milk should be expressed and discarded.
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Driving and using machines

Argipressin Farmak may affect your ability to drive or use machines, you may feel dizzy after injection. Talk to your 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 suitable dose and method of administration based on your symptoms.

Using more than the recommended dose of Argipressin Farmak

Since the injection will be given by a doctor, it is unlikely that you will receive a dose larger than necessary. If you think you have been given too much Argipressin Farmak, talk to your doctor immediately.
If you have any further questions on the use of this medicine, ask your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
All medicines can cause allergic reactions. If you experience any sudden wheezing, difficulty breathing, swelling of the eyelids, face, or lips, rash, or itching (especially all over the body), seek medical help immediately, as this could also lead to a heart attack if not treated immediately.
The following side effects may occur:

• low sodium levels in the blood (hyponatremia),
• heart rhythm disorders (arrhythmia),
• chest pain caused by angina pectoris,
• disorders of blood circulation in the heart muscle (myocardial ischemia),
• pallor,
• peripheral vasoconstriction,
• tissue necrosis, including skin necrosis,
• abdominal pain,
• insufficient blood supply to the small intestine (intestinal ischemia),
• limited blood flow to the fingertips (finger ischemia), including tissue death (gangrene) in individual cases.

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

• headache,
• dizziness (feeling of spinning),
• tremor,
• life-threatening arrhythmia,
• loss of heart function (cardiac arrest),
• decreased cardiac output (insufficient blood pumped by the heart to meet the body's needs),
• breathing difficulties due to bronchospasm,
• bloating,
• nausea,

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• vomiting,
• intestinal tissue necrosis,
• increased bilirubin levels (a breakdown product of red blood cells) in the blood,
• increased levels of aminotransferases (liver enzymes) in the blood,
• decreased platelet count (blood cells that help with blood clotting) in the blood.

Frequency not known (cannot be estimated from the available data):

• decreased oxygen levels in tissues due to insufficient blood or fluid (hypovolemic shock),
• uncontrolled bleeding,
• allergic reactions, anaphylactic reactions (including anaphylactic shock) may occur in sensitive patients,
• heart failure,
• sudden decrease in blood flow to the heart (acute coronary syndrome),
• irregular and rapid heart rhythm (atrial fibrillation),
• slow heart rhythm (bradycardia),
• high blood pressure,
• diarrhea,
• urge to defecate,
• excessive sweating,
• hives,
• skin changes due to blocked blood flow (ischemic skin ulcers),
• edema (fluid retention),
• changes in certain blood test parameters (increased cortisol levels, increased growth hormone levels),
• excess water in the body,
• blood clots in the veins,
• nausea,
• uterine contractions,
• a condition where the kidneys are unable to retain water (diabetes insipidus).

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse.
Side effects can be reported directly to the Department of Drug Safety Monitoring of 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
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this 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), store in the original packaging to protect from light. Do not freeze.
After first opening: use the medicine 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 carton after: "EXP". The expiry date refers to the last day of the month stated.
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Medicines should 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 pack and other information

What Argipressin Farmak contains

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

What Argipressin Farmak looks like and contents of the pack

Argipressin Farmak is a clear, colorless solution, free from visible particles.
Each ampoule contains 1 ml or 2 ml solution. The carton contains 10 ampoules.
Not all pack sizes may be marketed.

Marketing authorization 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. Piłsudskiego 141
92-318 Łódź

This medicine is authorized in the Member States of the European Economic Area under the following names:

Germany:
Argipressin Farmak 20 IU/ml Injektionslösung
Poland:
Argipressin Farmak

Date of last revision of the leaflet:

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