0.91 mg/ml solution for injection in a pre-filled syringe
Naloxone hydrochloride
Due to your condition, it may not be possible for you to read this information before receiving Prenoxad. The package leaflet has been given to you to provide information that you and the person helping you should receive.
– Save this information, you may need to read it again.
What Prenoxad is and what it is used for
Prenoxad contains the drug naloxone. Naloxone belongs to a group of medicines that are converted to counteract the effects of opioids. This medicine is used to eliminate the effects of opioids, e.g. if you have received, taken, or suspect an overdose of these medicines or drugs.
The medicine is designed to be used in emergencies by trained people as a life-saving treatment, but you should still seek emergency care as soon as possible.
Prenoxad is given to adults and adolescents 16 years of age or older.
What you need to know before using Prenoxad
Do not use Prenoxad
This medicine is often used in emergencies where it is necessary to act very quickly. You should ONLY be given an injection of this medicine if it is under the circumstances explained when you were prescribed Prenoxad.
Prenoxad will only be available for use by trained persons under appropriate conditions according to local guidelines for use at home or outside the healthcare facility.
You should not be given Prenoxad :
if you are allergic to naloxone or any of the other ingredients of this medicine (listed in section 6).
Warnings and cautions
Before you are given Prenoxad, your doctor and the person who has been trained to give Prenoxad will have considered whether special care must be taken. This applies if:
- you have kidney or liver problems
- you have heart or circulation problems
- Prenoxad is not effective in overdosing on drugs other than opioids
If you have any of these problems, you should talk to your doctor or healthcare professional.
Other medicines and Prenoxad
If possible, tell your doctor or the person trained to prescribe Prenoxad if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Pregnancy, breastfeeding, and fertility
Prenoxad should not be used if you are pregnant unless necessary.
If Prenoxad is used during pregnancy, caution should be exercised as it may cause high blood pressure ( hypertension ), irregular heartbeat ( arrhythmia ), fluid in the lungs ( pulmonary edema ), and myocardial infarction (cardiac arrest).
Breast-feeding should be avoided for the first 24 hours after treatment with Prenoxad.
Driving and using machines
If you have used Prenoxad, do not drive or use machines. As the effect of opioids, may recur, do not get into traffic or use machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Prenoxad contains excipients
Prenoxad contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per 2 ml dose, ie it is essentially ‘sodium-free’.
How to use Prenoxad
You or the person trained to give the medicine will inject a dose (0.4 ml) of solution for injection, if necessary, into the outer thigh muscle or the upper arm muscle ( intramuscularly ). The number of times your injection with 0.4 ml is repeated depends on your individual needs and how you react to the treatment. The syringe contains a total of 5 doses of 0.4 ml.
The package contains two needles. The second needle is used if the first needle is damaged or contaminated due to, for example, being dropped on the floor.
Use for adults and adolescents over 16 years
Known or suspected opiate overdose:
Prenoxad should only be given if it is known or suspected that an opiate overdose has occurred.
The following procedure must be followed:
See the diagram to help the person giving the injections
IF THE PATIENT BREATHES NORMALLY BUT CAN NOT BE AWAKENED OR UNCONSCIOUS
When the patient is breathing normally or has regained consciousness, the patient is placed in a supine position (lying on one side, with his mouth open and facing the ground). Monitor continuously.
The Prenoxad pack is intended for one patient only and the unused solution for injection should be discarded according to the instructions in section 5.
Use for children and adolescents
This medicine should not be used by children under the age of 16 or by newborns in a home environment or outside a healthcare facility.
If your child has had or has taken an opiate overdose, you should call an ambulance, tel. 112, immediately and start doing chest compressions and breaths if necessary.
If you have received too much or too little Prenoxad
If you think you have received too much or too little Prenoxad, tell your doctor or paramedic on the spot. The following symptoms have been observed if too much Prenoxad has been given: seizures, too high or too low blood pressure, too slow heart rate, and memory disorders.
If you have ingested too much medicine or if e.g. a child ingested the medicine accidentally contact a doctor or hospital for risk assessment and advice.
Possible side effects
Like all medicines, Prenoxad can cause side effects, although not everybody gets them.
Possible side effects include:
Very common (may affect more than 1 in 10 people): nausea
Common (may affect up to 1 in 10 people): dizziness, headache, palpitations, low blood pressure, high blood pressure, vomiting, or pain.
Uncommon (may affect up to 1 in 100 people): tremors, sweating, irregular heartbeat, slow heartbeat, diarrhea, dry mouth, local irritation, inflammation, and rapid or deep breathing.
Rare (may affect up to 1 in 1,000 people): seizures, nervous tension, fluid in the lungs ( pulmonary edema ).
Very rare (may affect up to 1 in 10,000 people): allergic reactions ( hives, runny nose, difficulty breathing, swelling of the face), anaphylactic shock, rapid and irregular heartbeat (flicker), cardiac arrest, redness of the bladder or ulcers (erythema multiforme).
Not known frequency (can not be calculated from the available data): fever, nervousness, restlessness, irritability, runny nose, sneezing, yawning, goosebumps, weakness, chills, high blood pressure when the opioid effect ceases, death when the opioid effect ceases.
How to store Prenoxad
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiration date is the last day of the specified month.
You should not be given Prenoxad after the expiry date which is stated on the carton and syringe. Your doctor, pharmacist, nurse, or prescriber will check the expiry date on the carton and syringe before you receive this medicine.
Medicines should not be disposed of via wastewater or household waste. Ask your doctor, pharmacist, or nurse how to dispose of medicines, including used and leftover unused needles. After use, unused drugs, including used and unused needles, can be given to ambulance personnel. These measures will help to protect the environment.
Store in the original package. This medicine does not require any special temperature instructions. Store the syringe in the plastic box. Sensitive to light. Do not use a solution for injection if it is discolored.
Contents of the pack and other information
Content declaration
The active substance is naloxone hydrochloride.
1 ml solution for injection contains 1 mg naloxone hydrochloride dihydrate equivalent to 0.91 mg naloxone hydrochloride.
2 ml solution for injection in a pre-filled syringe contains 2 mg naloxone hydrochloride dihydrate equivalent to 1.82 mg naloxone hydrochloride.
The other ingredients are sodium chloride, dilute hydrochloric acid (for pH adjustment ), and water for injections. 2 ml of solution contains 0.018 g of sodium chloride.
What the medicine looks like and the contents of the pack
The injection is provided in a 2 ml pre-filled syringe containing 2 ml of clear, colorless solution together with two needles. The syringe and needles are in a yellow plastic box.
Marketing Authorization Holder and Manufacturer
Ethypharm
194, Bureaux de la Colline
Building D 92213
Saint-Cloud Cedex
France
Manufacturer
Macarthys Laboratories Limited T / A Martindale Pharma
Bampton Road Harold Hill, Romford, Essex,
RM3 8UG
UK
For any information about this medicine, please contact the local representative of the Marketing Authorization Holder:
Unimedic Pharma AB
Box 6216
102 34 Stockholm
Tel: 08-1309950
Email: medinfo@unimedicpharma.se