Adrenalina wzf

Package leaflet: Information for the patient

ADRENALINA WZF, 300 micrograms/0.3 ml, solution for injection
in an ampoule-syringe
Adrenalinum
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any doubts, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Table of contents

1. What Adrenalina WZF is and what it is 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. Contents of the pack and other information

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

Adrenalina WZF contains adrenaline as the active substance.
Adrenalina WZF is intended for use in life-threatening conditions, for the treatment of
sudden, severe allergic reactions, anaphylactic shock, and idiopathic anaphylaxis.
These conditions may be triggered by exposure to 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, lips, tongue, hands, and feet; shortness of breath; wheezing; nausea; vomiting; and in some cases, loss of consciousness. Adrenaline relieves these symptoms by beneficially affecting blood pressure, heart function, and breathing.
After administration of the medicine, the patient should immediately seek medical advice, as further treatment may be necessary.

2. Information before using Adrenalina WZF

When not to use Adrenalina WZF:

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

Warnings and precautions
Before using Adrenalina WZF, discuss it with your doctor, pharmacist, or nurse.
Your doctor will provide detailed instructions on when and how to use the medicine.
If the patient has asthma, they may be at increased risk of severe allergic reactions.
Any patient who has experienced an episode of anaphylaxis should consult a doctor to undergo tests to identify substances that may cause allergy and which must be strictly avoided in the future. It is important to be aware that allergy to one substance may lead to allergy to several similar substances.
If the patient has food allergy, it is important to check the ingredients of all products consumed (including medicines), as even small amounts may cause severe reactions.
In particular, consult a doctor in patients with:

• heart diseases and circulatory disorders (symptoms such as chest pain, rapid or irregular heartbeat, shortness of breath, high blood pressure);
• hyperthyroidism;
• pheochromocytoma (a tumor located in the glands above the kidneys);
• increased intraocular pressure;
• prostate gland diseases;
• elevated calcium levels in the blood;
• decreased potassium levels in the blood;
• elevated blood glucose levels;
• severe kidney failure. Patients with any of the above conditions should inform their doctor.

Caution is advised in elderly patients.
Children
Children weighing less than 30 kg cannot receive an appropriate dose of the medicine due to the design of the pre-filled syringe. Use of lower doses is not recommended except in life-threatening situations and under medical supervision.
Patients at risk of severe allergic reaction or anaphylactic shock should always keep the medicine with them (at home, at work, during holidays). Adrenalina WZF is packed in a pre-filled syringe ready for immediate use.
Adrenalina WZF and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Medicines that may affect the action of Adrenalina WZF include:

• medicines used to treat depression (e.g. venlafaxine, sibutramine, milnacipran, and monoamine oxidase inhibitors such as selegiline);
• medicines used to treat Parkinson's disease (e.g. levodopa);
• thyroid hormones (triiodothyronine, thyroxine);
• anti-asthma medicines (e.g. theophylline);
• oxytocin (a hormonal medicine used during childbirth);
• parasympatholytics (e.g. atropine);
• antiallergic medicines (e.g. diphenhydramine, chlorpheniramine);
• inhaled bronchodilators (e.g. formoterol);
• medicines used for hypertension and cardiac arrhythmias (e.g. propranolol, sotalol);
• medicines used for heart diseases (cardiac glycosides, quinidine);
• inhaled anesthetics used for general anesthesia;
• medicines used for colds (ephedrine, pseudoephedrine);
• medicines used for diabetes (e.g. insulin).

Adrenalina WZF and alcohol
Alcohol may intensify the effect of Adrenalina WZF.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
The decision to use the medicine during pregnancy will be made by the doctor.
It is unlikely that adrenaline administered to a breastfeeding woman will have any effect on the breastfed infant.
Driving and operating machinery
After administration of the medicine, the patient should not drive or operate machinery until symptoms of severe allergic reaction 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; therefore, the medicine is considered "sodium-free".

3. How to use Adrenalina WZF

This medicine should always be used according to the doctor's instructions. If in doubt, consult your doctor or pharmacist.
Adrenalina WZF is intended for emergency use in life-threatening situations. After using Adrenalina WZF, immediate medical assistance must always be sought.
Call 112, request an ambulance, and state that anaphylaxis has occurred, even if symptoms appear to be improving. Hospitalization may be necessary for observation and further treatment, as symptoms of severe allergic reaction may recur after some time.
While waiting for the ambulance, lie down with legs elevated. If breathing becomes difficult in this position, sit down. Ask someone to stay with the patient until the ambulance arrives, in case the patient's condition worsens again.
Unconscious patients should be placed in the recovery position on their side.

• Adrenalina WZF should be administered immediately after symptoms of a severe allergic reaction appear, which may occur within minutes of exposure to the allergen.
• Adrenalina WZF must be injected intramuscularly only, into the muscle on the anterolateral aspect of the thigh (see Administration instructions).
• Adrenalina WZF must not be injected into the buttock.
• Injecting adrenaline into the hand or fingers may cause loss of blood flow to these areas. If accidental injection into these areas occurs, seek immediate medical attention.
• The pre-filled syringe is intended for single-dose administration only.
• The pre-filled syringe contains 1 ml of solution. After administration, 0.7 ml of solution remains in the syringe, but the syringe must not be reused. Ask your pharmacist how to dispose of the medicine safely.
• The solution in the pre-filled syringe should be colourless or almost colourless and clear. Do not use the medicine if discolouration or particles are observed.

Adults and children weighing over 30 kg

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

Children weighing less than 30 kg
Due to the design of the pre-filled syringe, doses smaller than 300 micrograms cannot be accurately administered. Therefore, lower doses may only be used in life-threatening situations and under medical supervision.

Administration instructions
Adrenalina WZF is a medicine used in life-threatening emergencies. Therefore, carefully read the instructions below immediately after obtaining the medicine, so that the patient is adequately prepared to use it when necessary.
It is recommended that family members, caregivers, or teachers of the patient also be trained in the proper use of Adrenalina WZF.
If in doubt, consult your doctor, pharmacist, or nurse.

1. Remove the pre-filled syringe from the blister pack.

2. Remove the needle cap. Do not touch the needle. Do not remove the safety block on the plunger. Do not press the plunger (e.g. to expel air bubbles).

3. With a firm motion, insert the entire needle at a 90º angle into the muscle on the anterolateral aspect of the thigh. The injection can be administered through light clothing if necessary. Press the plunger fully.

4. Remove the needle and replace the needle cap.
5. Gently massage the injection site for 10 seconds.
6. Dispose of the used pre-filled syringe safely.

Use of a higher than recommended dose of Adrenalina WZF
If a higher than recommended dose of adrenaline is administered or if the medicine is accidentally injected intravascularly, a sudden increase in blood pressure, vasoconstriction, and cardiac stimulation may occur. Slowing, rapidity, or disturbances in heart function and breathing difficulties may occur. In such cases, seek immediate medical attention.
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 everybody will experience them.
The occurrence of adverse reactions depends on the patient's sensitivity to adrenaline and on the dose administered.

Adverse reactions that are common, even after administration of small doses of adrenaline:

• palpitations (awareness of a strong or rapid heartbeat);
• increased heart rate;
• excessive sweating;
• nausea, vomiting;
• breathing difficulties;
• pallor;
• dizziness, headache;
• weakness;
• tremor;
• anxiety states, feeling of restlessness;
• nervous hyperexcitability;
• cold extremities.

Rarely reported adverse reactions:

• hallucinations;
• fainting;
• increased blood glucose concentration;
• decreased blood potassium concentration;
• decreased blood pH (metabolic acidosis);
• pupil dilation;
• urinary difficulties including urinary retention;
• muscle tremor.

Adverse reactions occurring after administration of higher adrenaline doses or in sensitive individuals:

• cardiac arrhythmias (atrial fibrillation or cardiac arrest);
• sudden increase in arterial blood pressure (sometimes leading to cerebral haemorrhage);
• vasoconstriction (e.g. of the skin, mucous membranes, kidneys).

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor, pharmacist, or nurse.
Adverse reactions can be reported directly to the Department for Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: +48 22 4921 301
Fax: +48 22 4921 309
e-mail: [email protected]
Adverse reactions can also be reported to the marketing authorization holder.
Reporting of adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Adrenalina WZF

Store in a refrigerator (2°C - 8°C).
During the valid shelf life, storage outside the refrigerator for a period of 6 months at a temperature below 25°C is permitted (enter the appropriate date in the space marked on the carton “Date of removal of the package from the refrigerator”). After 6 months from this date, the medicinal product is no longer suitable for use. Store in the outer packaging to protect from light. Do not freeze.
Keep the medicinal product out of sight and reach of children.
Do not use this medicinal product after the expiry date stated on the carton and the ampoule-syringe. The expiry date refers to the last day of the stated month.
The marking on the packaging following EXP indicates the expiry date, and following LOT indicates the batch number.
Medicinal products must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the pack and other information

What Adrenalina WZF contains

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

What Adrenalina WZF looks like and contents of the pack
Adrenalina WZF is a colourless or almost colourless, clear liquid.
Each glass pre-filled syringe contains 1 ml of solution, with a needle 1.27 cm in length. The syringe
has a lock mechanism allowing administration of a single dose of 300 micrograms of adrenaline
(0.3 ml of solution).
The pre-filled syringe is packaged in a blister made of PVC foil and paper; the cardboard carton contains 1 or
2 pre-filled syringes.
Marketing Authorisation Holder
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
tel. +48 22 364 61 01
Manufacturer
Warszawskie Zakłady Farmaceutyczne Polfa S.A.
ul. Karolkowa 22/24; 01-207 Warszawa
Detailed and up-to-date information on this product is available by scanning with a smartphone
the QR code located in the leaflet below. The same information is also available on the website
www.adrenalinawzf.pl