Naloxone B.Braun

PATIENT INFORMATION LEAFLET: INFORMATION FOR THE PATIENT

Naloxone B. Braun 0.4 mg/ml injection/infusion solution

naloxone hydrochloride
Please read this leaflet carefully before receiving this medicine,
as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Never give it to others. It may be harmful to other people, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist.

Contents of this leaflet:

1. What Naloxone B. Braun is and what it is used for
2. What you need to know before you are given Naloxone B. Braun
3. How Naloxone B. Braun is administered
4. Possible side effects
5. How to store Naloxone B. Braun
6. Contents of the pack and other information

1. WHAT NALOXONE B. BRAUN IS AND WHAT IT IS USED FOR

Naloxone B. Braun is a medicine used to counteract the effects of opioid overdose, for example, morphine overdose.
Naloxone B. Braun is used to reverse the adverse effects of opioids in order to counteract depression of the central nervous system and respiratory system (breathing difficulties), which may be life-threatening.
Naloxone B. Braun is also used for the diagnosis of opioid intoxication or acute opioid overdose.
If a woman has taken analgesics during labour, the newborn will be treated with Naloxone B. Braun to reverse the unwanted effects of opioids, for example, if the newborn has breathing problems or central nervous system depression.

2. WHAT YOU SHOULD KNOW BEFORE NALOXONE IS ADMINISTERED TO YOU

B.BRAUN
Naloxone B. Braun must not be administered to you

• if you are allergic (hypersensitive) to naloxone hydrochloride or to any of the excipients of this medicinal product (listed in section 6). Warnings and precautions
  Talk to your doctor or pharmacist before Naloxone B. Braun is administered to you.
  Pay particular attention:

• If you are physically dependent on opioids (e.g. morphine), or have taken high doses of these substances (you may experience severe withdrawal symptoms after administration of Naloxone B. Braun 0.4 mg/ml due to too rapid reversal of opioid effects; such symptoms may include high blood pressure, palpitations, severe breathing difficulties, or cardiac arrest).

• If you suffer from heart or circulatory problems (because side effects such as high or low blood pressure, palpitations, or severe breathing difficulties may be more likely to occur in such cases). Other medicines and Naloxone B. Braun

Inform your doctor or pharmacist if you are taking or have recently taken any other
medicinal product.
If you are taking analgesics such as buprenorphine, whose pain-relieving effect may
be intensified during treatment with Naloxone B. Braun. However, the reversal of undesirable effects,
such as respiratory depression caused by buprenorphine, is limited.

• If you are taking sedatives, as they may delay the effect of Naloxone B. Braun.
• If you are taking medicinal products that may affect your heart or circulation (e.g. antihypertensive medicines such as clonidine), including those without a prescription. Naloxone B. Braun and alcohol
  Inform your doctor if you have consumed alcohol. Naloxone B. Braun may act less rapidly in patients with multiple intoxication (from opioids and sedatives or alcohol). Pregnancy and breastfeeding
  If you are pregnant, suspect you may be pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicinal product. Pregnancy
  There is insufficient information available regarding the use of Naloxone B. Braun in pregnant women. During pregnancy, your doctor must weigh the benefits of Naloxone B. Braun against the potential risks to the fetus. Naloxone B. Braun may cause withdrawal symptoms in the newborn. Breastfeeding
  It is not known whether Naloxone B. Braun passes into breast milk, and it has not been established whether breastfed infants are affected. Therefore, breastfeeding is not recommended for 24 hours after treatment. Driving and using machines
  After receiving Naloxone B. Braun to reverse the effects of opioids, do not drive vehicles or operate machinery, or engage in any other activities requiring physical or mental effort for at least 24 hours, as the effects of opioids may reappear. Naloxone B. Braun contains sodium
  This medicinal product contains approximately 3.8 mmol (88.5 mg) of sodium per maximum daily dose. If you are on a low-sodium diet, inform your doctor, who will take this into account.

3. HOW NALOXONE B. BRAUN IS ADMINISTERED TO YOU

The recommended doses to be administered are as follows:
Reversal of undesirable effects of opioids
Adults: 0.1 – 0.2 mg; if necessary, additional injections of 0.1 mg may be given
Children: 0.01 – 0.02 mg per kg of body weight; if necessary, additional injections of the same dosage may be given
Diagnosis of opioid intoxication or overdose
Adults: 0.4 – 2 mg; if necessary, injections may be repeated at 2-3 minute intervals. It is recommended not to exceed a maximum dose of 10 mg.
Children: 0.01 mg per kg of body weight; if necessary, additional injections of 0.1 mg per kg may be given.
Reversal of opioid-induced adverse effects in the newborn whose mother has taken opioids:
0.01 mg per kg of body weight; if necessary, additional injections may be given.
To reverse the undesirable effects of opioids (in adults, children, and also newborns), patients are monitored to ensure the desired effect of Naloxone B. Braun is achieved. If necessary, additional doses may be administered every 1–2 hours.
In elderly patients with heart or circulatory problems, or in patients who have taken medicines that may cause cardiac or circulatory disturbances (e.g. cocaine, methamphetamine, cyclic antidepressants, calcium channel blockers, beta-blockers, digoxin), Naloxone B. Braun should be used with caution, as serious adverse effects such as increased heart rate (ventricular tachycardia) and fibrillation have been reported.

If you feel that the effect of Naloxone B. Braun is too strong or too weak, consult your doctor.
Method of administration
Naloxone B. Braun will always be administered by intravenous or intramuscular injection (into a vein or muscle), or, after dilution, by intravenous infusion (over a longer period than with injection). Naloxone B. Braun will be administered by an anaesthetist or experienced doctor.
If you have any doubts about the use of Naloxone B. Braun, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
It may be difficult to recognize side effects of Naloxone B. Braun, as it is always administered following the use of other drugs.

The following adverse reactions could be serious. If you experience any of the following, seek immediate medical attention:

Common (may affect up to 1 in 10 people):

• Rapid heartbeat

Uncommon (may affect up to 1 in 100 people):

• Changes in heartbeat, slowing of heart rate

Rare (may affect up to 1 in 1,000 people):

• Convulsions

Very rare (may affect up to 1 in 10,000 people):

• Allergic reactions (urticaria, nasal catarrh or cold-like symptoms, breathing difficulties, Quincke's edema [giant edema]), anaphylactic shock
• Fibrillation, cardiac arrest
• Fluid in the lungs (pulmonary edema)

Other adverse reactions include:

Very common (may affect more than 1 in 10 people):

• Nausea

Common (may affect up to 1 in 10 people):

• Dizziness, headache
• Increase or decrease in blood pressure (may result in headache or feeling faint)
• Vomiting
• If an excessive dose is administered after surgery, you may feel agitated and experience pain (because the effects of the pain-relieving medicines you were given, as well as their effects on your breathing, will have been reversed).

Uncommon (may affect up to 1 in 100 people):

• Involuntary tremors, sweating
• Diarrhea, dry mouth
• Shortness of breath (hyperventilation)
• Following intravenous administration, irritation of the blood vessel walls has been reported; following intramuscular administration, local inflammation and irritation have been reported.

Rare (may affect up to 1 in 1,000 people):

• Tension

Very rare (may affect up to 1 in 10,000 people):

• Changes in skin colour and skin lesions (erythema multiforme)

If you experience any adverse reaction, including those not listed in this leaflet, consult your doctor or pharmacist.

5. HOW TO STORE NALOXONE B. BRAUN

Keep this medicine out of the sight and reach of children.
This medicine must not be administered after the expiry date stated on the
vial label and carton. The expiry date refers to the last day of the month.
Keep the vials in the outer packaging to protect them from light.
Store below 25 °C.
Store diluted solutions below 25 °C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how
to dispose of medicines no longer required. This will help protect the environment.

6. PACKAGING CONTENTS AND OTHER INFORMATION

What Naloxone B. Braun contains
The active substance is naloxone hydrochloride.
Each 1 ml vial contains 0.4 mg of naloxone hydrochloride (as naloxone hydrochloride dihydrate).
The excipients are sodium chloride, diluted hydrochloric acid (for pH adjustment), and water for
injections.

Description of the appearance of Naloxone B. Braun and packaging contents
Naloxone B. Braun is a clear, colourless solution in neutral glass vials, each containing 1 ml of
injectable/infusion solution.
Pack sizes: 5 and 10 vials
It is possible that not all pack sizes are marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
B. Braun Melsungen AG
Carl-Braun-Strasse 1
34212 Melsungen, Germany
Postal address:
34209 Melsungen, Germany
Phone: +49 5661 71 0
Fax: +49 5661 71 4567

Manufacturer:
hameln pharmaceuticals gmbh
Langes Feld 13, 31789 Hameln
Germany

This medicinal product is authorised in the Member States of the European Economic Area under the following names:

This leaflet was last updated on:
09/2012

The following information is intended exclusively for physicians or healthcare professionals:
Period of validity after first opening:
After first opening, the medicinal product must be used immediately.
Period of validity after dilution:
Chemical and physical in-use stability has been demonstrated for 24 hours at temperatures below 25°C.
From a microbiological standpoint, diluted solutions should be used immediately. If not used immediately,
the period of in-use storage and conditions prior to use are the responsibility of the user and normally
should not exceed 24 hours at 2–8°C, unless dilution has been carried out under controlled and validated
aseptic conditions.
For intravenous infusion, Naloxone B. Braun must be diluted only with 0.9% sodium chloride or 5% glucose.
5 vials of Naloxone B. Braun (2 mg) in 500 ml provide 4 µg/ml.
It is recommended not to mix Naloxone B. Braun infusions with preparations containing bisulfite, metabisulfite,
long-chain anions or high molecular weight substances, or solutions with alkaline pH.
This medicinal product is for single use only.
Inspect the medicinal product visually before use (including after dilution). Use only a clear, colourless solution
that is practically free from particles.