Pharma – Q Adrenaline 1 mg Injection

The active substance of PHARMA - Q ADRENALINE INJECTION 1 mg/ml is: Adrenaline (epinephrine) belongs to a group of medicines called sympathomimetic substances. Each 1 ml contains 1 mg adrenaline (epinephrine) as the acid tartrate. PHARMA - Q ADRENALINE INJECTION 1 mg/ml is used in life-threatening emergencies, such as acute allergic reactions.

PHARMA - Q ADRENALINE INJECTION 1 mg/ml should not be administered to you:

• if you are hypersensitive (allergic) to adrenaline (epinephrine) or any of the other ingredients of PHARMA - Q ADRENALINE INJECTION 1 mg/ml (listed in section 6).
• If you are receiving mono - amine oxidase inhibitors as adrenaline (epinephrine) interacts with monoamine oxidase inhibitors and should not be given to patients receiving such treatment or within 14 days of its termination.
• PHARMA - Q ADRENALINE INJECTION 1 mg/ml should not be administered in your fingers, toes, ears, nose or genitalia owing to the risk of ischaemic tissue necrosis (the death of most or all of the cells in an organ or tissue due to disease, injury, or failure of the blood supply).

Warnings and precautions

Tell your doctor or health care provider before being given the injection:

Special care should be taken with PHARMA - Q ADRENALINE INJECTION 1 mg/ml if you suffer from the following:

• Parkinson’s disease
• Hyperthyroidism (overactive thyroid)
• Psychoneurosis, or any other psychological disorder
• Pheochromocytoma (a tumour on your adrenal gland)
• Narrow angle glaucoma (high pressure in your eyes)
• Diabetes mellitus (high blood sugar)
• Hypokalaemia or hypercalcaemia (low blood levels of potassium or high blood levels of calcium in your body)
• Severe renal impairment (kidney problems)
• Prostatic hypertrophy (enlarged prostate) or have difficulty urinating
• Any disease of the brain, or you have suffered any brain damage
• Arteriosclerosis (narrowing and hardening of your blood vessels)
• Autonomic dysreflexia (hyperreflexia), particularly in spinal cord injury (e.g., tetraplegics)
• Shock (other than anaphylactic shock) or have lost a lot of blood
• A heart disease, heart failure, chest pains or you have an abnormal heartbeat
• Hypertension (high blood pressure) as well as most patients with dysrhythmias
• If you are elderly
• Asthma or emphysema
• If you are going to have surgery under general anaesthesia
• If you are in labour (you are having your baby)
• Phenothiazine-induced circulatory collapse or hypotension

Your doctor will tell you how long your treatment with PHARMA - Q ADRENALINE INJECTION 1 mg/ml will last. If you have the impression that the effect of PHARMA - Q ADRENALINE INJECTION 1 mg/ml is too strong or too weak, tell your doctor or pharmacist. The usual dose is. By subcutaneous or intramuscular injection.

Adults: 0,2 to 0,5 ml

Children: 0,1 to 0,3 ml

If you are administered more PHARMA - Q ADRENALINE INJECTION 1 mg/ml than you should Since a health care provider will administer PHARMA - Q ADRENALINE INJECTION 1 mg/ml, he/she will control the dosage. However, in the event of overdosage your doctor will manage the overdosage.

If you forget to use PHARMA - Q ADRENALINE INJECTION 1 mg/ml Since a health care provider will administer PHARMA - Q ADRENALINE INJECTION 1 mg/ml, it is unlikely that the dose will be missed.

PHARMA - Q ADRENALINE INJECTION 1 mg/ml can have side effects. Not all side effects reported for PHARMA - Q ADRENALINE INJECTION 1 mg/ml are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking PHARMA - Q ADRENALINE INJECTION 1 mg/ml, please consult your health care provider for advice.

If any of the following happens, stop receiving PHARMA - Q ADRENALINE INJECTION 1 mg/ml and tell your doctor immediately or go to the casualty department at your nearest hospital:

• swelling of the hands, feet, ankles, face, lips, mouth, or throat which may cause difficulty in swallowing or breathing, rash or itching. These are all very serious side effects. If you have them, you may have had a serious reaction to PHARMA - Q ADRENALINE INJECTION 1 mg/ml. You may need urgent medical attention or hospitalisation.

Tell your doctor if you notice any of the following:

Less frequent:

• Stress cardiomyopathy (a disease of the heart muscle that makes it harder for the heart to pump blood to the rest of the body)

Frequency unknown:

• Anaphylaxis (allergic reaction) possibly with severe bronchospasm (a cough with generalized wheezing)
• Hypokalaemia (when the amount of potassium in your blood is too low)
• Disturbances of glucose metabolism
• Inhibition of insulin secretion and hyperglycaemia (high blood sugar) even with low doses
• Gluconeogenesis (the reversal of the process in which glucose is broken down to produce energy)
• Lipolysis (the breakdown of fats and other natural oils to release fatty acids) and ketogenesis (a physiologically important process to produce an alternative metabolic source of energy)
• Metabolic acidosis (occurs when acid builds up or when bicarbonate is lost)
• Psychotic states anxiety, fear, confusion
• Insomnia (inability to sleep)
• Restlessness, irritability, hallucinations, nervousness.
• Headache, tremors, dizziness
• In patients with Parkinsonian syndrome, PHARMA - Q ADRENALINE INJECTION 1 mg/ml increases rigidity and tremor
• Syncope (fainting or passing out)
• Mydriases (dilation of the pupil of the eye)
• Palpitations (feelings or sensations that your heart is pounding or racing), cardiac arrest, rapid pulse, anginal pain, acute angina attacks
• Weakness and coldness of the extremities, even with small doses and especially when given in conjunction with local anaesthetics
• Tachycardia (a fast heartbeat)
• Reflex bradycardia (If blood pressure decreases, the heart beats faster in an attempt to raise it)
• Cardiac dysrhythmias (an abnormal or irregular heartbeat)
• Potentially fatal ventricular dysrhythmias (abnormal heart rhythms that make the lower chambers of your heart twitch instead of pump) including fibrillation, especially in patients with organic heart disease or those receiving other medicines that sensitise the heart to dysrhythmias (abnormality in a physiological rhythm)
• Myocardial ischaemia (occurs when blood flow to the heart muscle is obstructed by a partial or complete blockage of a coronary artery by a buildup of plaques) and myocardial infarction (heart attack) electrocardiogram (ECG) changes including a decrease in T-wave amplitude in all leads in normal subjects
• Subarachnoid haemorrhage (bleeding in the space that surrounds the brain) and hemiplegia (paralysis that affects only one side of your body) have resulted from hypertension, even following subcutaneous administration of usual doses of PHARMA - Q ADRENALINE INJECTION 1 mg/ml
• Bowel necrosis (the death of body tissue which occurs when too little blood flows to the tissue)
• Hypotension (low blood pressure) with dizziness, flushing and fainting
• Vasoconstriction (narrowing of blood vessels by small muscles in their walls) with resultant hypertension. The rise in blood pressure may produce cerebral haemorrhage (bleeding in the brain) and pulmonary oedema (too much fluid in the lungs), coldness of extremities may occur even with small doses.
• Reduced appetite, nausea, vomiting, hypersalivation, dry mouth.
• Difficulty in micturition (urinating), urinary retention.
• Dyspnoea (difficulty or laboured breathing), weakness, disturbances of glucose metabolism, sweating, extravasation of parenterally administered catecholamines (hormones made by your adrenal glands) may result in tissue necrosis and sloughing, pallor, necrosis may also occur in the extremities, kidneys and liver.

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects

If you get side effects, talk to your doctor, pharmacist or nurse. You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reactions Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of PHARMA - Q ADRENALINE INJECTION 1 mg/ml.

Store all medicines out of reach of children. Store at or below 25 °C. Protect from light. PHARMA - Q ADRENALINE INJECTION 1 mg/ml is not to be used if its colour is pinkish or darker than slightly yellow or if it contains a precipitate. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g., toilets).