PACKAGE LEAFLET: INFORMATION FOR THE USER. ADRENALINE (TARTRATE) STEROP 1 mg/1 ml Solution for injection. Adrenaline (Levorenine, Epinephrine)

PACKAGE LEAFLET: INFORMATION FOR THE USER ADRENALINE (TARTRATE) STEROP 1 mg/1 ml

Solution for injection

Adrenaline (Levorenine, Epinephrine) Read all of this leaflet carefully before you start using this medicine.

- Keep this leaflet. You may need to read it again.

- If you have any further questions, ask your doctor or pharmacist.

- This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1. What ADRENALINE (TARTRATE) STEROP is and what it is used for 2. Before you use ADRENALINE (TARTRATE) STEROP

3. How to use ADRENALINE (TARTRATE) STEROP 4. Possible side effects

5. How to store ADRENALINE (TARTRATE) STEROP 6. Further information

1.

WHAT ADRENALINE (TARTRATE) STEROP IS AND WHAT IT IS USED FOR Pharmacotherapeutic group

Alpha and beta sympathomimetic. Treatment for hypotension.

Therapeutic indications

Epinephrine for injection is indicated:

- in case of extreme emergency following cardiac arrest in order to restart the heart.

- in the treatment of severe allergic reactions caused by insect stings or bites, medicines, food or other substances.

2. BEFORE YOU USE ADRENALINE (TARTRATE) STEROP Do not use ADRENALINE (TARTRATE) STEROP

- In case of hypersensitivity or suspicion of hypersensitivity to epinephrine or any of the ingredients of the medicine. In any other emergency situation, the doctor must consider the potential beneficial effect/potential risk ratio when chosing the medicine to administer or prescribe.

- If you are pregnant, except if the doctor prescribes this medicine for you. They will explain to you the risks and benefits of using epinephrine during pregnancy.

- If you are giving birth: epinephrine can stop the contractions of the uterus during labour.

- If you are breast-feeding: epinephrine is excreted in breast milk.

- If the solution is pink or brown coloured or if it contains particles.

Take special care with ADRENALINE (TARTRATE) STEROP

Epinephrine must be used with extreme caution:

- if you are allergic to any of the ingredients of the medicine, especially sodium metabisulphite.

- cardiac or blood vessel disorders, - angina pectoris or chest pain, - high blood pressure,

- rapid heartbeat, myocardial infarction, - high eye pressure (glaucoma),

- diabetes, - stroke,

- hyperactive thyroid, - pulmonary diseases, - chronic asthma,

- psychoneurotic disorders,

- it is recommended to avoid any extravasation (= passage of the medicine outside of the vessels) during intravenous administration since it could lead to the destruction of the surrounding tissue.

Always tell your doctor if you have allergies to other medicines, to food, to preservatives or dyes.

If you are already taking other medicines, please also read the section, “Using other medicines”.

Please consult your doctor if one of the warnings listed below is applicable to you, or if it has been in the past.

Using other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Some medicines that can be affected by epinephrine or can affect its action:

- certain medicines to treat chills and cough, - certain medicines treating high blood sugar, - general anaesthetics,

- medicines to treat depression such as monoamine oxidase inhibitor (MAOI), - medicines that affect potassium levels such as diuretics and theophylline,

- medicines used for hypertension and cardiac disorders (alpha and beta blockers).

You may then need another dosage of your medicine or use another medicine. Your doctor and your pharmacist have more information about medicines for which the combination can be used with caution or cannot be used.

Incompatibilities

Since epinephrine is quickly destroyed in an alkaline medium or in the presence of oxidative agents, any mixture with other medicines for injection, and particularly with alkaline solutions (for example, bicarbonate solutions), is to be avoided.

Epinephrine is compatible with sodium chloride solutions at 0.9% (isotonic) but incompatible with solutions at higher concentrations.

Using ADRENALINE (TARTRATE) STEROP with food and drink

Not applicable

In case of use during pregnancy, epinephrine can lead to an insufficient concentration of oxygen for the foetus.

In all cases, epinephrine is to be used during pregnancy only if, in the practitioner’s opinion, the expected benefit justifies the possible risks for the foetus.

Epinephrine is excreted in breast milk. Its use in women who are breast-feeding can lead to serious adverse reactions in the infant. In case of treatment with epinephrine, breast-feeding could be suspended. Your doctor can discuss with you the risks and benefits of use during breast-feeding.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

No contraindication is known at this time.

Important information about some of the ingredients of ADRENALINE (TARTRATE) STEROP

ADRENALINE (TARTRATE) STEROP contains sodium metabisulphite, which can, in rare cases, cause hypersensitivity reactions (allergy).

3. HOW TO USE ADRENALINE (TARTRATE) STEROP

In terms of treatment of shock due to heightened sensitivity to a foreign substance or in

intensive care, the administration of ADRENALINE (TARTRATE) STEROP is not to be used alone but as a part of a highly specific protocol. The administration of epinephrine is

normally performed by a doctor or trained nurse.

If you must inject epinephrine, carefully follow your doctor’s instructions. They will tell you which dose to use. This may differ from the information in this leaflet.

The injection is to be administered just below the skin; nevertheless, it can also be administered in the muscle or directly in a vein.

Children receive a lower dose depending on their weight.

For patients using epinephrine as emergency treatment for an allergic reaction:

- if you have an allergic reaction as described by your doctor, use ADRENALINE (TARTRATE) STEROP immediately.

- keep the medicine close at hand at all times.

ADRENALINE (TARTRATE) STEROP is solely intended for injection.

If you administer the injections to yourself or to another person, be sure you know the correct technique. In case of doubt, ask for your doctor’s advice.

If you must use ADRENALINE (TARTRATE) STEROP as emergency treatment, talk to your doctor immediately or go to the nearest hospital emergency room. You may need hospital assistance.

If you use more ADRENALINE (TARTRATE) STEROP than you should

The doctor or nurse who administers ADRENALINE (TARTRATE) STEROP to you will be

experienced in its use; it is therefore extremely rare that you would receive too much.

If you must inject ADRENALINE (TARTRATE) STEROP, be sure to administer it exactly as your doctor has indicated to you. This will make an overdose unlikely.

If you think that you have used or administered too much ADRENALINE (TARTRATE) STEROP, immediately contact your doctor, your pharmacist or the Anti-poison Centre (070/245.245). Call even if no sign of discomfort or poisoning appears.

You may need emergency medical follow-up.

Symptoms:

The symptoms of overdose may include discomfort, redness or pallor, chills, difficulty breathing, abnormal heartbeats and headache.

Treatment:

Since epinephrine is quickly eliminated by the body, the treatment of an acute overdose should be mainly symptomatic.

If you forget to use ADRENALINE (TARTRATE) STEROP Not applicable

If you stop using ADRENALINE (TARTRATE) STEROP Not applicable

4. POSSIBLE SIDE EFFECTS

Like all medicines, ADRENALINE (TARTRATE) STEROP can cause side effects, although not everybody gets them.

Do not be alarmed by the list of side effects below. You may not experience any of them.

Epinephrine can cause:

- Sweating, stiffness, tremor, dizziness, black out, fainting, nervousness, anxiety, insomnia, excitability, weakness, very high sugar level, palpitations, rapid heart beat, headache, cold extremities and modifications on electrocardiograms, even at low doses.

- High blood pressure.

- Worsening or triggering of angina pectoris in patients with coronary heart disease or heart disease by insufficient blood flow.

- Potentially fatal ventricular arrhythmias including fibrillation, particularly in patients presenting with a congenital cardiomyopathy or receiving other substances that may disturb cardiac

rhythm.

- Increase in rigidity and tremor in patients presenting with Parkinsonism.

- Nausea, vomiting, perspiration, pallor, difficulty breathing and apnoea.

- Repeated or high dose injections of epinephrine can cause necrosis at the injection site.

- Prolonged use or overdose of epinephrine can cause metabolic acidosis. Drug tolerance can develop after prolonged or excessive administration of epinephrine. This tolerance disappears when treatment is suspended for a few days.

- Very low potassium level.

Immediately tell your doctor or go to the closest hospital emergency room if you notice the

following side effects:

- abnormal heart beats or palpitations These side effects are rare.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5. HOW TO STORE ADRENALINE (TARTRATE) STEROP Keep out of the reach and sight of children.

Store in the refrigerator (between 2°C and 8°C) away from light. Store the solution at a temperature not to exceed 25°C for a period not to exceed 6 months.

Do not store the solution in the freezer.

Do not use if the solution is pinkish or brownish, if it is not clear or if it contains particles.

Do not use ADRENALINE (TARTRATE) STEROP after the expiry date which is stated on the box and the ampoule after the EX(MM/YYYY) listed. The expiry date refers to the last day of that month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. FURTHER INFORMATION

What ADRENALINE (TARTRATE) STEROP contains

The active substance is epinephrine in the form of epinephrine tartrate: 1mg of epinephrine base equivalent to 1.8 mg of epinephrine tartrate.

The other ingredients are sodium chloride, sodium metabisulphite, water for injection.

What ADRENALINE STEROP looks like and contents of the pack Solution for injection by subcutaneous, intramuscular and intravenous route.

1 mL glass ampoules, packaged in 1 or 5 ampoules (home use) and 10, 50, 100 ampoules (hospital use).

Dispensing: by medical prescription Registration number: BE325701

Marketing Authorisation Holder and Manufacturer

Laboratoires STEROP, avenue de Scheut 46-50, 1070 Brussels, Belgium.

This leaflet was last approved in October 2008.