Adrenalina Vzf

Leaflet attached to the packaging: patient information

ADRENALINA WZF, 300 micrograms/0.3 ml, solution for injection

In a pre-filled syringe
Adrenalinum

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

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Adrenalina WZF and what is it used for
• 2. Important information before using Adrenalina WZF
• 3. How to use Adrenalina WZF
• 4. Possible side effects
• 5. How to store Adrenalina WZF
• 6. Package contents and other information

1. What is Adrenalina WZF and what is it used for

Adrenalina WZF contains adrenaline as the active substance.
Adrenalina WZF is intended for use in life-threatening conditions, in the treatment of severe allergic reactions, anaphylactic shock, and spontaneous anaphylaxis.
These conditions may be caused by contact with an allergen (e.g., insect stings and bites, foods, medicines, latex) or may result from other causes (e.g., physical exertion). Symptoms of these reactions may include: rash; skin itching; swelling of the face, throat, mouth, tongue, hands, and feet; shortness of breath; wheezing; nausea; vomiting; and in some cases, loss of consciousness. Adrenaline alleviates these symptoms, favorably affecting blood pressure, heart function, and breathing.
After using the medicine, the patient should immediately consult a doctor, as further treatment may be necessary.

2. Important information before using Adrenalina WZF

When not to use Adrenalina WZF:

• if the patient is allergic to adrenaline or any of the other ingredients of this medicine (listed in section 6). In life-threatening conditions, there are no absolute contraindications to the use of the medicine.

Warnings and precautions

Before starting treatment with Adrenalina WZF, discuss it with your doctor, pharmacist, or nurse.
The doctor will thoroughly instruct the patient on when and how to use the medicine.
If the patient has asthma, they may be at increased risk of severe allergic reactions.
Every patient who has experienced an anaphylaxis episode should consult a doctor to perform tests to determine which substances may cause allergies and should be strictly avoided in the future. It is essential to be aware that an allergy to one substance can lead to the development of allergies to multiple similar substances.
If the patient has a food allergy, it is crucial to check the ingredients of all products they consume (including medicines), as even small amounts can cause severe reactions.
Particularly, patients with:

• heart diseases and blood circulation disorders (symptoms such as chest pain, accelerated or irregular heartbeat, shortness of breath, high blood pressure);
• hyperthyroidism;
• chromaffin tumor of the adrenal gland (a tumor located in the glands above the kidneys);
• increased eye pressure;
• prostate diseases;
• increased calcium levels in the blood;
• decreased potassium levels in the blood;
• increased blood sugar levels;
• severe kidney failure. Patients with these diseases should inform their doctor.

Caution should be exercised in elderly patients.

Children

Children with a body weight below 30 kg should not be given a suitable dose of the medicine due to the design of the pre-filled syringe. It is not recommended to use smaller doses of the medicine, except in life-threatening situations and under medical supervision.
Patient with a risk of severe allergic reactions or anaphylactic shock should always carry the medicine with them (at home, at work, during vacation). Adrenalina WZF is packaged in a pre-filled syringe that is ready for immediate use.

Adrenalina WZF and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.
Medicines that affect the action of Adrenalina WZF include:

• medicines used to treat depression (e.g., venlafaxine, sibutramine, milnacipran, and monoamine oxidase inhibitors, e.g., selegiline);
• medicines used to treat Parkinson's disease (e.g., levodopa);
• thyroid hormones (triiodothyronine, thyroxine);
• anti-asthmatic medicines (e.g., theophylline);
• oxytocin (a hormonal medicine used during childbirth);
• parasympatholytics (e.g., atropine);
• antihistamines (e.g., diphenhydramine, chlorpheniramine);
• inhalation medicines that dilate the bronchi (e.g., formoterol);
• medicines used to treat high blood pressure and heart rhythm disorders (e.g., propranolol, sotalol);
• medicines used to treat heart diseases (digitalis glycosides, quinidine);
• inhalation anesthetics used for general anesthesia;
• medicines used to treat colds (ephedrine, pseudoephedrine);
• medicines used to treat diabetes (e.g., insulin).

Adrenalina WZF with alcohol

Alcohol may enhance the effect of Adrenalina WZF.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before using this medicine.
The decision to use the medicine during pregnancy will be made by your doctor.
It is unlikely that adrenaline used by a breastfeeding woman will affect the breastfed child.

Driving and using machines

After using the medicine, the patient should not drive vehicles or operate machines until the symptoms of severe allergic reactions have subsided.

Adrenalina WZF contains sodium metabisulfite (E 223) and sodium

The medicine may rarely cause severe hypersensitivity reactions and bronchospasm.
Adrenalina WZF contains less than 1 mmol (23 mg) of sodium per pre-filled syringe, which means the medicine is considered "sodium-free".

3. How to use Adrenalina WZF

This medicine should always be used according to the doctor's recommendations. In case of doubts, consult a doctor or pharmacist.
Adrenalina WZF is intended for use in emergency situations in life-threatening conditions. After using Adrenalina WZF, the patient should immediately seek medical attention.
Call the emergency number 112, ask for an ambulance, and say that you have "anaphylaxis", even if the symptoms seem to be subsiding. Hospitalization may be necessary for observation and further treatment. This is due to the possibility of recurrence of severe allergic reaction symptoms after some time.
While waiting for the ambulance, lie down with your legs elevated, and if you experience breathing difficulties in this position, sit up. Ask someone to stay with you until the ambulance arrives, in case you feel unwell again.
Unconscious patients should be placed on their side in a safe position.

• -Adrenalina WZF should be administered immediately after the onset of severe allergic reaction symptoms, which may occur within a few minutes of exposure to the allergen.
• -Adrenalina WZF should be injected only intramuscularly, into the muscle located in the anterior-lateral part of the thigh (see section Administration).
• -Adrenalina WZF should not be injected into the buttocks.
• -Administering adrenaline into the hand or fingers may cause blood flow to be cut off to these areas. If accidental needle stick or injection of the medicine into these parts of the body occurs, seek medical attention immediately.
• -The pre-filled syringe is for single-dose administration.
• -The pre-filled syringe contains 1 ml of solution. After administering the dose, 0.7 ml of solution remains in the pre-filled syringe, but it is not suitable for reuse. Ask your pharmacist how to dispose of the medicine safely.
• -The solution in the pre-filled syringe should be colorless or almost colorless and clear. Do not use the medicine if you notice a change in the color of the solution.

Adults and children with a body weight above 30 kg

• -Usually, 300 micrograms (0.3 ml) are administered.
• Sometimes, a single dose of adrenaline is not enough to completely alleviate the symptoms of a severe allergic reaction. Therefore, the doctor may prescribe more than one pre-filled syringe of Adrenalina WZF. If the symptoms do not subside or worsen within 5-15 minutes after the first injection, the patient should administer a second injection or ask someone to do it for them. For this reason, it is essential to always carry more than one pre-filled syringe of Adrenalina WZF in its original packaging.

Children with a body weight below 30 kg
It is not possible to administer a dose smaller than 300 micrograms with sufficient accuracy due to the design of the pre-filled syringe. Therefore, smaller doses may only be used in life-threatening situations and under medical supervision.

Administration method

Adrenalina WZF is a medicine used in life-threatening conditions. Therefore, it is essential to carefully read the following instructions immediately after purchasing the medicine, so that the patient is prepared to use it in case of an emergency.

It is recommended that family members, caregivers, or teachers of the patient also be trained in the proper use of Adrenalina WZF.

In case of doubts, consult a doctor or pharmacist.

• 1. Before use, remove the pre-filled syringe from the blister pack.
• 2. Remove the needle cap. Do not touch the needle. Do not remove the lock on the plunger of the pre-filled syringe.

Do not press the plunger (e.g., to remove an air bubble).

• 3. With a firm motion, insert the entire needle at a right angle (90°) into the muscle located in the anterior-lateral part of the thigh. If necessary, the injection can be performed through light clothing. Press the plunger until it stops.

If necessary, the injection can be performed through light clothing. Press the plunger until it stops.

• 4. Remove the needle and put the cap back on.
• 5. Massage the injection site gently for 10 seconds.
• 6. Dispose of the used pre-filled syringe safely.

Overdose of Adrenalina WZF

In case of overdose or accidental injection of the medicine into a blood vessel, there may be a sudden increase in blood pressure, vasoconstriction, and cardiac stimulation. There may be slowing, acceleration, or disturbances of heart function and breathing difficulties. In such cases, seek medical attention immediately.
In case of any further doubts about the use of this medicine, consult a doctor or pharmacist, or nurse.

4. Possible side effects

Like all medicines, Adrenalina WZF can cause side effects, although not everybody gets them.
The occurrence of side effects depends on the patient's sensitivity to adrenaline and the administered dose.
Frequent side effects, even after administration of small doses of adrenaline:

• palpitations (feeling of strong or rapid heartbeat);
• accelerated heart rate;
• excessive sweating;
• nausea, vomiting;
• breathing difficulties;
• pallor;
• dizziness, headache;
• weakness;
• tremors;
• anxiety, feeling of unease;
• nervous excitement;
• cold extremities.

Rarely reported side effects:

• hallucinations;
• fainting;
• increased blood glucose levels;
• decreased potassium levels in the blood;
• decreased blood pH (metabolic acidosis);
• pupil dilation;
• urination difficulties, including urinary retention;
• muscle tremors.

Side effects that have occurred after administration of higher doses of adrenaline or in sensitive individuals:

• heart rhythm disorders (atrial fibrillation or cardiac arrest);
• sudden increase in blood pressure (sometimes leading to stroke);
• vasoconstriction (e.g., of the skin, mucous membranes, kidneys).

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, inform your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring, 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
e-mail: ndl@urpl.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Adrenalina WZF

Store in a refrigerator (2°C - 8°C).
Within the validity period, the medicine can be stored outside the refrigerator for a period of 6 months at a temperature below 25°C (the correct date should be written in the space marked on the carton "Date of removal from the refrigerator"), after 6 months from this date, the medicine is no longer suitable for use. Store in the outer packaging to protect from light. Do not freeze.
Store the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and pre-filled syringe. The expiry date stated on the carton is the last day of the given month.
The inscription on the packaging after the abbreviation EXP means the expiry date, and after the abbreviation Lot means the batch number.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Adrenalina WZF contains

• The active substance of the medicine is adrenaline. Each ml of solution contains 1 mg of adrenaline in the form of adrenaline tartrate.
• The other ingredients are: sodium metabisulfite (E 223), sodium chloride, water for injections.

What Adrenalina WZF looks like and what the package contains

Adrenalina WZF is a colorless or almost colorless, clear solution.
One pre-filled syringe contains 1 ml of solution, with a needle length of 1.27 cm. The pre-filled syringe has a lock that allows for the administration of a single dose of 300 micrograms of adrenaline (0.3 ml of solution).
The pre-filled syringe is packaged in a blister pack with PVC foil and paper; the carton contains 1 or 2 pre-filled syringes.

Marketing authorization holder

Pharmaceutical Works POLPHARMA S.A.
Pelplińska 19, 83-200 Starogard Gdański
phone: +48 22 364 61 01

Manufacturer

Warsaw Pharmaceutical Works Polfa S.A.
Karolkowa 22/24; 01-207 Warsaw
Detailed and up-to-date information about this product is available after scanning the QR code below with a smartphone. The same information is also available on the website www.adrenalinawzf.pl

Date of last revision of the leaflet: