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MercuryPharma

PATIENT INFORMATION LEAFLET

Naloxone Hydrochloride 20micrograms/ml Solution for Injection/Infusion

§ Naloxone Hydrochloride 400micrograms/ml Solution for Injection/Infusion

The name of your medicine is Naloxone Hydrochloride 20micrograms/ml Solution for Injection/Infusion, Naloxone Hydrochloride 400 micrograms/ml Solution for Injection/Infusion. It will be referred to as Naloxone Injection/Infusion for ease hereafter.

In this leaflet:

1.    What Naloxone Injection/Infusion is and what it is used for

2.    Before you are given Naloxone Injection/Infusion

3.    How Naloxone Injection/Infusion is given to you

4.    Possible side effects

5.    How to store Naloxone Injection/Infusion

6.    Further information

1. WHAT NALOXONE INJECTION/INFUSION IS AND WHAT IT IS USED FOR

Naloxone belongs to a group of medicines known as opioid antagonists. Opioid medicines are strong painkillers such as morphine and codeine. In high doses these painkillers can result in side effects which cause difficulty in breathing and drowsiness. These effects can be reversed by an opioid antagonist (blocks the effects of opioids).

Naloxone Injection/Infusion may be used:

•    to treat the breathing problems caused by these opioid painkillers

•to help determine whether a patient has taken or received an overdose of opioid drugs

•    to reverse the depressant effects on breathing and on other parts of the brain and spinal cord in newborn infants (resulting from the use of opioid painkillers in the mother during childbirth).

2. BEFORE YOU ARE GIVEN NALOXONE INJECTION/INFUSION

You should not be given this medicine if you know that you are allergic to naloxone, or to any of the other ingredients (listed in Section 6 at the end of this leaflet).

Speak to your doctor if this applies to you before you are given this medicine.

Your doctor will take special care if:

•    you have received large doses of opioid drugs or if you have a drug-dependence (drug addiction) problem

•    you suffer from any heart or circulatory problems

•you suffer from high blood pressure, irregular heart beat or difficulty in breathing

•    you have a newborn baby who requires this injection/infusion; tell the doctor beforehand if you received large doses of opioid drugs before you gave birth or if you have a drug-dependence problem

•    you are suffering from diseases of the kidney, liver or lung.

Speak to your doctor if one of these applies to you before you are given this medicine.

Taking other medicines:

Tell your doctor before you are given this medicine if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

A number of medicines can interact with Naloxone Injection/Infusion which can significantly alter their effects. In particular, tell your doctor if you are taking

•    Strong pain killer medicines like buprenorphine and pentazocine.

•    Sleeping pills

•    Medicines that may affect your heart or blood circulation (e.g. antihypertensive drugs, cocaine, methamphetamine, cyclic antidepressants, calcium channel blockers, beta-blockers, digoxin and clonidine) even those not prescribed.

Pregnancy and breast-feeding

Tell your doctor before you are given this medicine if you are pregnant, think you may be pregnant or are planning to become pregnant, or are breast-feeding.

The potential risk for humans is unknown. Naloxone injection/infusion should not be used during pregnancy unless clearly necessary.

Naloxone Injection/Infusion must be used with caution in breast feeding mothers. Breast-feeding should be avoided for 24 hours after treatment.

Driving and using machines:

After receiving Naloxone Injection/Infusion, you must not drive a vehicle, operate machinery or engage in any other physically or mentally demanding activity for at least 24 hours, as the effect of opioids may possibly recur.

Important information about some of the ingredients of Naloxone Injection/Infusion

Naloxone Hydrochloride 400micrograms/ml Solution for Injection/Infusion contains 3.8 mmol (88.2 mg) sodium per maximum daily dose of 10mg naloxone hydrochloride and Naloxone Hydrochloride 20micrograms/ml Solution for Injection/Infusion contains 77.2 mmol(1.78 g) sodium per maximum daily dose of 10mg naloxone hydrochloride. Ask your doctor about this if you are on a strict sodium controlled diet.

3. HOW NALOXONE INJECTION/INFUSION IS GIVEN TO YOU

Naloxone Injection/Infusion is always given by a doctor or nurse.

It may be injected into a vein, a muscle, or the tissue just under the skin. It may also be given by a drip into a vein.

The dose of the injection/infusion will be calculated by your doctor. This will depend upon your weight and the circumstances that require treatment.

For adults:

• To treat an overdose or suspected overdose of opioids, between 400 and 2000 micrograms may be given every 2-3 minutes.

•After an operation 100-200 micrograms may be given every 2-3 minutes.

For children:

•The usual dose is 10 micrograms for each kilogram they weigh increased to 100 micrograms per kg to achieve the desired response.

For new born babies:

•The usual starting dose is 10 micrograms per kg body weight every 2-3 minutes. Or a single dose of 200 micrograms may be given at birth.

If you think you have been given more Naloxone Injection/Infusion than you should have

This is unlikely as your injection/infusion will be administered by a doctor or nurse. If you are concerned about the dose, discuss it with your doctor.

If you have any further questions on the use of this product ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Naloxone Injection/Infusion can sometimes cause side-effects, although not everybody gets them.

All medicines can cause allergic reactions although serious allergic reactions are rare. Any sudden wheeziness, difficulty in breathing, swelling of the eyelids, face or lips, rash or itching (especially affecting your whole body) should be reported to a doctor immediately.

Other side effects may include:

Very common: (probably occuring in more than 1 in 10 people)

•    Feeling sick

Common: (probably occurring in less than 1 in 10 people)

•    Dizziness

•    Headache

•    Fast Heart beat

•    Increased or decreased blood pressure •Vomiting

•    Post-operative pain

If too large a dose is given after an operation, you may become excited and feel pain (because the pain killing effects of medicines you were given will have been counteracted as well as the effects on your breathing).

Uncommon: (probably occurring in less than 1 in 100 people)

•    Tremors

•    Sweating

•    Changes in the way your heart beats

•    Slow heart rate

•    Over breathing (hyperventilation)

•    Diarrhoea

•    Dry mouth

•    Irritation of the walls of the veins has been reported after intravenous administration.

•    Local irritation, burning and redness have been reported after the intra-muscular administration.

Rare: (probably occurring in less than 1 in 1000 people)

•    Fits (seizures)

•    Tension

Very Rare: (probably less than 1 in 10000 people)

•    Severe problems with the heart (Fibrillation and cardiac arrest)

•    Fluid in the lungs

•    Discolouration and lesions of the skin.

•Allergic reactions (urticaria, rhinitis, dyspnoea, Quincke's oedema), anaphylactic shock

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

5. HOW TO STORE NALOXONE INJECTION/INFUSION

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 and ampoule label after ‘Exp’. The expiry date refers to the last day of that month.

Do not store above 25°C.

Keep the ampoules (small bottles) in the outer carton in order to protect from light.

If only part used, discard the remaining solution.

Do not use the ampoule if the contents are discoloured in any way. For single use only.

6. FURTHER INFORMATION

The active substance is naloxone hydrochloride dihydrate.

The other ingredients are sodium chloride, dilute hydrochloric acid in water for injections.

What Naloxone Hydrochloride Injection/Infusion looks like and contents of pack

Naloxone Hydrochloride 20micrograms/ml Solution for Injection/Infusion (0.02 mg/ml) is a clear, colourless, sterile solution containing 40 micrograms (0.04 mg) naloxone hydrochloride present as naloxone hydrochloride dihydrate in 2ml clear glass ampoules (small bottles).

Naloxone Hydrochloride 400micrograms/ml Solution for Injection/Infusion (0.4 mg/ml) is a clear, colourless, sterile solution containing 400 micrograms (0.4mg) naloxone hydrochloride present as naloxone hydrochloride dihydrate in 1ml clear glass ampoules (small bottles).

Pack size: 3, 5 or 10 ampoules may be packaged together in cardboard cartons. All pack sizes may not be marketed.

Marketing authorisation holder: Mercury Pharma International Ltd, 4045, Kingswood Road, City West Business Park, Co Dublin, Ireland.

Manufacturer: Delpharm Tours, La Baraudiere, 37170, Chambray-Les-Tours, France.

This leaflet was last revised in April 2012

100117/LF/2, 100488/LF/2

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