Adrenaline 1 mg/1 ml

Adrenaline (epinephrine) belongs to a group of medicines called sympathomimetic substances. ADRENALINE (EPINEPHRINE) 1 mg/1 ml (1:1 000) FRESENIUS is used in life-threatening emergencies, such as acute allergic reactions. It is an active chemical produced in the body. Epinephrine (adrenaline) acts on receptors in the body and can increase the speed and force of heart muscle contractions, relieve narrowing of the lung passages to help breathing and relieve some of the symptoms of acute allergic reaction.

ADRENALINE (EPINEPHRINE) 1 mg/1 ml (1:1 000) FRESENIUS should not be administered to you:

• if you are hypersensitive (allergic) to sympathomimetic medicines, including epinephrine (adrenaline), or any of the other ingredients of ADRENALINE (EPINEPHRINE) 1 mg/1 ml (1:1 000) FRESENIUS (see section 6.);
• if you are taking, or have taken within the last 14 days, medicines used for depression known as monoamine oxidase inhibitors (MAOIs).

ADRENALINE (EPINEPHRINE) 1 mg/1 ml (1:1 000) FRESENIUS should not be administered in your fingers, toes, ears, nose or genitalia.

Warnings and precautions

Tell your doctor or health care provider before being given ADRENALINE (EPINEPHRINE) 1 mg/1 ml (1:1 000) FRESENIUS:

• if you have Parkinson’s disease;
• if you have an overactive thyroid;
• if you suffer from any psychological disorders;
• if you have phaeochromocytoma (a tumour on your adrenal gland);
• if you have or are at risk of developing glaucoma (high pressure in your eye);
• if you have diabetes mellitus (high blood sugar);
• if you have been diagnosed with low levels of potassium or high blood levels of calcium in your body;
• if you have severe kidney problems;
• if you are male and your prostate is enlarged;
• if you have difficulty urinating;
• if you are suffering from any disease of the brain, or you have suffered any brain damage;
• if you have been told that you have atherosclerosis (narrowing and hardening of your blood vessels);
• if you have had a spinal cord injury and are suffering from over-activity of the involuntary nervous system which causes your blood pressure to be uncontrolled;
• if you are in shock or have lost a lot of blood;
• if you suffer from a heart disease, heart failure, chest pains or you have an abnormal heart beat;
• if you have high blood pressure;
• if you are elderly;
• if you suffer from asthma or emphysema;
• if you are going to have surgery under general anaesthesia;
• if you are in labour (you are having your baby).

You will not be expected to give yourself ADRENALINE (EPINEPHRINE) 1 mg/1 ml (1:1 000) FRESENIUS. It will be given to you by a person who is qualified to do so. ADRENALINE (EPINEPHRINE) 1 mg/1 ml (1:1 000) FRESENIUS will be injected into a muscle or under the skin. Your doctor will decide on the dose and will determine how many injections of ADRENALINE (EPINEPHRINE) 1 mg/1 ml (1:1 000) FRESENIUS he/she will give you. If you have the impression that the effect of ADRENALINE (EPINEPHRINE) 1 mg/1 ml (1:1 000) FRESENIUS is too strong or too weak, tell your doctor or pharmacist. If you receive more ADRENALINE (EPINEPHRINE) 1 mg/1 ml (1:1 000) FRESENIUS than you should. Since a health care provider will administer ADRENALINE (EPINEPHRINE) 1 mg/1 ml (1:1 000), he/she will control the dosage. However, in the event of overdosage your doctor will manage the overdosage.

ADRENALINE (EPINEPHRINE) 1 mg/1 ml (1:1 000) FRESENIUS can have side effects. Not all side effects reported for ADRENALINE (EPINEPHRINE) 1 mg/1 ml (1:1 000) FRESENIUS are included in this leaflet. Should your general health worsen or if you experience any untoward effects while receiving ADRENALINE (EPINEPHRINE) 1 mg/1 ml (1:1 000) FRESENIUS, please consult your health care provider for advice. If any of the following happens, stop receiving ADRENALINE (EPINEPHRINE) 1 mg/1 ml (1:1 000) FRESENIUS and tell your doctor immediately:

• swelling of your hands, feet, ankles, face, lips, mouth or throat, which may cause difficulty in swallowing or breathing;
• rash or itching;
• fainting.

These are all very serious side effects. If you have them, you may have had a serious allergic reaction to ADRENALINE (EPINEPHRINE) 1 mg/1 ml (1:1 000) FRESENIUS. You may need urgent medical attention or hospitalisation. Tell your doctor immediately if you notice any of the following:

• changes in the way your heart beats (such as beating faster, or skipping a beat);
• chest pain;
• heart attack (pressure, tightness, pain, or a squeezing or aching sensation in your chest or arms that may spread to your neck, jaw or back, indigestion, shortness of breath);
• increased blood pressure which causes bleeding around the brain and paralysis;
• gangrene if ADRENALINE (EPINEPHRINE) 1 mg/1 ml (1:1 000) FRESENIUS is injected into your fingers or toes (red/black, swollen and foul-smelling tissue);
• bowel necrosis (reduced blood flow to your bowels causing pain, tenderness, cramping, blood in your stools, diarrhoea);
• shortness of breath;
• difficulty urinating or emptying your bladder.

These are all serious side effects. You may need urgent medical attention. Tell your doctor if you notice any of the following:

• metabolic acidosis (an imbalance of certain constituents in your blood);
• changes in your metabolism, such as increased sugar levels in your blood or the breakdown of fat in your body;
• abnormal thinking and perceptions (psychotic states);
• feeling anxious, scared, confused, irritated or restless;
• difficulty sleeping (insomnia);
• headache, dizziness, uncontrolled shaking (tremors);
• increased rigidity and tremor if you suffer from Parkinson’s disease;
• coldness of your hands or feet;
• low blood pressure (dizziness or fainting);
• flushing;
• dry mouth, reduced appetite, nausea (feeling sick), vomiting (being sick), increased saliva;
• increased sweating, weakness or paleness of your skin;
• tissue damage at the site of injection after repeated injections of ADRENALINE (EPINEPHRINE) 1 mg/1 ml (1:1 000), and elsewhere in the body (for example; in the fingers and toes, liver and kidney).

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 or pharmacist. You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reactions Reporting Form”, found online under SAHPRA’s publications: http://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of ADRENALINE (EPINEPHRINE) 1 mg/1 ml (1:1 000) FRESENIUS. Health care providers are asked to report any suspected adverse drug reactions to the Holder of the Certificate of Registration at the following email address: [email protected], and to the relevant medicine’s regulatory authority in the country where the product is marketed.

• Store at or below 25 °C.
• Protect from light.
• Store all medicines out of reach of children.
• Do not use after the expiry date printed on the container.
• Return all unused medicine to your pharmacist.
• Do not dispose of unused medicine in drains and sewerage systems (e.g. toilets).