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

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

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

Naloxone hydrochloride

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet as 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 and must not be given to other people, even if they have the same symptoms as you. It could harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet:

1. What Naloxone B. Braun is and what it is used for
2. What you need to know before using Naloxone B. Braun
3. How to use Naloxone B. Braun
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 reverse the effects of opioid overdose, for example, overdose due to morphine.

Naloxone B. Braun is used to reverse the unwanted effects of opioids, counteracting central nervous system and respiratory depression (difficulty breathing), which can be life-threatening.

Naloxone B. Braun is also used to diagnose acute opioid overdose or poisoning. If a woman has received analgesic medications during childbirth, the newborn may be treated with Naloxone B. Braun to reverse the unwanted effects of opioids, for example, if the newborn experiences respiratory problems or central nervous system depression.

2. What you need to know before using Naloxona B. Braun

Do not use Naloxona B. Braun

• If you are allergic (hypersensitive) to naloxone hydrochloride or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before taking Naloxona B. Braun.

Special caution is needed

• If you have physical dependence on opioids (e.g. morphine), or if you have received high doses of these drugs (you may experience severe withdrawal symptoms after receiving Naloxona B. Braun due to too rapid reversal of the opioid effect; these symptoms may include excessively high blood pressure, palpitations, severe breathing difficulties, or cardiac arrest).
• If you have any heart or circulatory problems (because side effects such as high or low blood pressure, palpitations, or severe breathing difficulties are more likely to occur).

Use of Naloxona B. Braun with other medicines

Inform your doctor or pharmacist if you are using or have recently used any other medicines.

• If you are taking analgesic medication such as buprenorphine. The analgesic effect may become even stronger while receiving treatment with Naloxona B. Braun. However, reversal of undesirable effects, such as respiratory depression caused by buprenorphine, is limited.
• If you are taking sedatives, since Naloxona B. Braun may act more slowly.
• If you are taking any medicine that may affect your heart or circulation (e.g. antihypertensives such as clonidine), including non-prescription medicines.

Use of Naloxona B. Braun with alcohol

Inform your doctor if you have consumed alcohol. In patients with multiple intoxication (opioids and sedatives or alcohol), Naloxona B. Braun may act more slowly.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

Adequate information regarding the use of Naloxona B. Braun in pregnant women is not available. During pregnancy, your doctor will weigh the benefits of Naloxona B. Braun against the potential risks to the unborn child. Naloxona B. Braun may cause withdrawal syndrome in the newborn.

Breastfeeding

It is unknown whether Naloxona B. Braun passes into breast milk, and it has not been determined whether infants who consume breast milk are affected by Naloxona B. Braun. Therefore, breastfeeding is not recommended for 24 hours after treatment.

Driving and use of machines

After receiving Naloxona B. Braun to reverse the effects of opioids, you must not drive, operate machinery, or engage in any other activity requiring physical or mental effort for at least 24 hours, as the effects of opioids may recur.

Patients on low-sodium diets should be aware that this medicine contains 88.5 mg (3.8 mmol) of sodium per maximum daily dose.

3. How to use Naloxone B. Braun

The recommended doses to be administered are:

To reverse unwanted effects of opioids:

Adults: 0.1 to 0.2 mg; if necessary, additional injections of 0.1 mg may be given.

Children: 0.01 to 0.02 mg per kg of body weight; if necessary, additional injections of the same dose may be given.

Diagnosis and treatment of opioid overdose or poisoning:

Adults: 0.4 mg to 2 mg; if necessary, injections may be repeated at intervals of 2 to 3 minutes. The maximum dose of 10 mg should not be exceeded.

Children: 0.01 mg per kg of body weight; if an additional dose is needed, the dose may be increased in the next injection to 0.1 mg per kg.

Reversal of unwanted opioid effects in newborns whose mothers have received opioids:

0.01 mg per kg of body weight; if necessary, additional injections may be administered.

To reverse unwanted opioid effects (in adults, children, and also in newborns), patients will be monitored to ensure the desired effect of Naloxone B. Braun is achieved. If necessary, additional doses may be administered every one to two hours.

In elderly patients with heart or circulatory problems, or in those receiving medications that may cause circulatory or heart disorders (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 rapid heartbeat (ventricular tachycardia) and fibrillation have been reported.

If you feel that the effect of Naloxone B. Braun is too strong or too weak, tell your doctor.

Method of administration

Naloxone B. Braun will always be administered by intravenous or intramuscular injection (into a vein or into a muscle), or, after dilution, as an intravenous infusion (over a prolonged period). Naloxone B. Braun will be administered by your anaesthetist or by a doctor with experience.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

It may be difficult to know which adverse effects are due to Naloxone B. Braun, as it is always administered after other medicines have been used.

The following adverse effects may be serious. If you experience any of these, consult a doctor immediately.

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

• Rapid heartbeat

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

• Changes in the way your heart beats, slow heart rate

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

• Seizures

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

• Allergic reactions (hives, nasal congestion or cold-like symptoms, difficulty breathing, angioedema (severe swelling)), anaphylactic shock
• Fibrillation, cardiac arrest
• Fluid in the lungs (pulmonary edema)

Other adverse effects include:

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

• Nausea

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

• Dizziness, headache
• Increased or decreased blood pressure (you may have headache or feel dizzy)
• Vomiting
• If a very high dose is administered after surgery, you may feel agitated and experience pain (because the analgesic effects of the medicines received will have been reversed, as well as their effects on your breathing)

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

• Involuntary tremors, sweating
• Diarrhea, dry mouth
• Overbreathing (hyperventilation)
• Irritation of the blood vessel walls (after IV administration); local irritation and inflammation (after IM administration)

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

• Tension

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

• Skin discoloration and lesions (erythema multiforme)

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Naloxone B. Braun

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the ampoule and packaging. The expiry date is the last day of the month indicated.

Store the ampoules in the outer packaging to protect them from light.

Store below 25 °C.

Store diluted solutions below 25 °C.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Naloxone B. Braun

The active substance is naloxone hydrochloride.

Each 1 ml ampoule contains 0.4 mg of naloxone hydrochloride (as naloxone hydrochloride dihydrate).

The other components are sodium chloride, diluted hydrochloric acid (for pH adjustment), and water for injections.

Appearance of the product and contents of the pack

Naloxone B. Braun is a clear, colourless solution in colourless glass ampoules containing 1 ml of injectable or infusion solution.

Pack sizes: 5 and 10 ampoules

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

• Braun Melsungen AG
  Carl-Braun-Strasse 1
  34212 Melsungen
  Germany
  Telephone: +49/5661/71-0
  Fax: +49/5661/71-4567

Manufacturer:

Hameln Pharmaceuticals GmbH
Langes Feld 13
31789 Hameln
Germany

or

B. BRAUN MEDICAL S.A.
Ronda de los Olivares, Parcela 11, Polígono Industrial Los Olivares
23009 Jaén (Jaén)
Spain

Further information on this medicinal product is available from the local representative of the Marketing Authorisation Holder:

• BRAUN MEDICAL, S.A.
  Ctra. de Terrassa, 121
  08191 Rubí (Barcelona)
  Spain

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

Date of the last revision of this leaflet: March 2018.

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products: http://www.aemps.gob.es/

This information is intended for healthcare professionals only:

Shelf-life after first opening of the container

After the first opening of the container, the medicinal product should be used immediately.

Shelf-life after dilution

The physical and chemical stability of the diluted product 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 in-use storage times and conditions prior to use are the responsibility of the user and normally should not exceed 24 hours at a temperature of 2 to 8 °C, unless the dilution has been carried out under strictly controlled and validated aseptic conditions.

For intravenous infusion, Naloxone B. Braun should be diluted only with 0.9% sodium chloride or 5% glucose. 5 ampoules of Naloxone B. Braun (2 mg) in 500 ml yield a concentration of 4 μg/ml.

It is recommended not to mix infusions of Naloxone B. Braun with preparations containing bisulfite, metabisulfite, long-chain or high molecular weight anions, or alkaline pH solutions.

This medicinal product is for single use only.

Please inspect the medicinal product visually before use (also after dilution). Use only clear, colourless solutions that are practically free from particles.