Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Naloxone 400 micrograms/ml solution for injection
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Naloxone hydrochloride may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
for Naloxone 400 micrograms/ml solution for injection/infusion is a drug used to counter the effects of opioid overdose, for example morphine overdose. Naloxone 400 micrograms/ml solution for injection/infusion is used for reversal of unwanted effects of opioids for countering life-threatening depression of the central nervous system and respiratory system (breathing difficulties). Naloxone 400 micrograms/ml solution for injection/infusion is also used to diagnose an acute opioid overdose or intoxication. If a woman was given analgetic drugs during labour, a newborn child can be treated with Naloxone 400 micrograms/ml solution for injection/infusion for reversal of unwanted effects of opioids, e.g. if he/she suffers from breathing problems or depression of central nervous system. 2. What you need to know before Naloxone 400 micrograms/ml solution for injection/infusion is administered to you Naloxone 400 micrograms/ml solution for injection/infusion must not be administered If you are allergic (hypersensitive) to naloxone hydrochloride or to any of the ingredients of this medicine (listed in section 6). Warnings and precautions Talk to your doctor or pharmacist before Naloxone 400 micrograms/ml solution for injection/infusion is administered to you. Special care will be taken
If you are physically dependent to opioids (for example morphine) or have received high doses of these drugs (you may get strong withdrawal symptoms after receiving Naloxone 400 micrograms/ml solution for injection/infusion because of a too rapid reversal of the opioid effect; these symptoms may be high blood pressure, palpitations, severe difficulties in breathing or cardiac arrest). If you have any heart or circulation problems (because side effects like high or low blood pressure, palpitations or severe difficulties in breathing may appear more likely).
Other medicines and Naloxone 400 micrograms/ml solution for injection/infusion Tell your doctor or pharmacist if you are taking or have recently taken any other medicines. If you are taking painkilling medication like buprenorphine. The painkilling effect may even become stronger while you are treated with Naloxone 400 micrograms/ml solution for injection/infusion. However, the reversal of unwanted effects, like respiratory depression caused by buprenorphine is limited. If you are taking sedatives, as Naloxone 400 micrograms/ml solution for injection/infusion may possibly have a less rapid effect. If you are taking any medication that may affect your heart or circulation (e.g. antihypertensive drugs e.g. clonidine), even those not prescribed. Naloxone 400 micrograms/ml solution for injection/infusion with alcohol Please inform your doctor if you drank alcohol. In patients with multi-intoxication (with opioids and sedatives or alcohol) Naloxone 400 micrograms/ml solution for injection/infusion may have a less rapid effect. Pregnancy and breast-feeding If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Pregnancy There is no adequate information available regarding the use of Naloxone 400 micrograms/ml solution for injection/infusion in pregnant women. During pregnancy, your doctor will outweigh the benefit of Naloxone 400 micrograms/ml solution for injection/infusion against possible risks to the unborn baby. Naloxone 400 micrograms/ml solution for injection/infusion can cause withdrawal symptoms in the newborn baby. Breastfeeding It is not known whether Naloxone 400 micrograms/ml solution for injection/infusion passes into breast milk and it has not been established whether infants who are breast-fed are affected by Naloxone 400 micrograms/ml solution for injection/infusion. Therefore, breastfeeding is not recommended for 24 hours after treatment Driving and using machines After receiving Naloxone 400 micrograms/ml solution for injection/infusion for the reversal of the effects of opioids you must not take part in road traffic, operate machinery or engage in any other physically or mentally demanding activity for at least 24 hours since the effects of opioids may possibly recur. Naloxone 400 micrograms/ml solution for injection/infusion contains sodium This medicinal product contains 3.8 mmol (88.5 mg) sodium per maximum daily dose. Please tell your doctor, if you are on low sodium diet, he/she will take it into account. 3. How Naloxone 400 micrograms/ml solution for injection/infusion is administered The recommended doses given to you are
Reversal of the unwanted 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 body weight, if necessary additional injections of the same dose may be given Diagnosis of opioid overdose or intoxication Adults: 0.4 – 2 mg, if necessary the injections can be repeated at intervals of 2-3 minutes. The maximum dose of 10 mg should not be exceeded. Children: 0.01 mg per kg body weight, if necessary an additional injection of 0.1 mg per kg may be given Reversal of the unwanted effects of opioids in neonates whose mothers have received opioids 0.01 mg per kg body weight, if necessary additional injections may be given For reversal of the unwanted effects of opioids (in adults, children and also in neonates) patients are monitored to ensure that the desired effect of Naloxone 400 micrograms/ml solution for injection/infusion occurs. Additional doses may be given every 1 – 2 hours if necessary. In elderly patients with heart or circulation problems or in those receiving medicines that can produce heart or circulation disorders (e.g. cocaine, methamphetamine, cyclic antidepressants, calcium channel blockers, beta-blockers, digoxin) Naloxone 400 micrograms/ml solution for injection/infusion will be used with caution since serious side effects such as fast heart beat (ventricular tachycardia) and fibrillation have occurred. If you have the impression that the effect of Naloxone 400 micrograms/ml solution for injection/infusion is too strong or too weak, talk to your doctor. Method of administration Naloxone 400 micrograms/ml solution for injection/infusion will be given to you always by intravenous or intramuscular injection (into a vein or into a muscle) or, after dilution, as intravenous infusion (over a longer period). Naloxone 400 micrograms/ml solution for injection/infusion will be given by your anaesthetist or experienced physician. If you have any further questions on the use of this product, ask your doctor or pharmacist. 4.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. It may be difficult to know what side effects Naloxone 400 micrograms/ml solution for injection/infusion has, because it is always given after other drugs have also been used. The following side effects may be serious. If any of the following side effects occur, consult a doctor immediately: Common (may affect up to 1 in 10 people):
- Fast heart beat 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 (nettle rash, nasal catarrh or a cold, difficult breathing, Quincke's oedema (giant swelling)), allergic shock
- Fibrillation, cardiac arrest
- Fluids on the lungs (pulmonary oedema) Other 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
- Increased or decreased blood pressure (you may have a headache or feel faint)
- Vomiting
- If a too large dose is given after an operation, you may become excited and feel pain (because the painkilling effects of the medicines you were given will have been counteracted as well as the effects on your breathing). Uncommon (may affect up to 1 in 100 people)
- Involuntary trembling or quivering (tremor), sweating
- Diarrhoea, dry mouth
- Over breathing (hyperventilation)
- Irritation of vessel wall has been reported after i.v. administration; local irritation and inflammation have been reported after i.m. administration. Rare (may affect up to 1 in 1,000 people):
- Tension Very rare (may affect up to 1 in 10,000 people):
- Discoloration and lesions of the skin (erythema multiforme) Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any
Possible side effects
not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine. 5.
How to store it
Naloxone 400 micrograms/ml solution for injection/infusion
Keep this medicine out of the sight and reach of children. This medicine must not be administered after the expiry date, which is stated on the ampoule label and the carton. The expiry date refers to the last day of that month. Keep the ampoules in the outer carton in order to protect from light. Store below 25°C. Store diluted solutions below 25°C. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the
environment. 6.
Contents of the pack and other information
What Naloxone 400 micrograms/ml solution for injection/infusion contains The active substance is naloxone hydrochloride. Each ampoule with 1 ml contains 0.4 mg naloxone hydrochloride (as naloxone hydrochloride dihydrate). The other ingredients are sodium chloride, hydrochloric acid diluted (for pH adjustment) and water for injections. What Naloxone 400 micrograms/ml solution for injection/infusion looks like and contents of the pack Naloxone 400 micrograms/ml solution for injection/infusion is a clear and colourless solution in colourless glass ampoules containing 1 ml solution for injection/infusion. Pack sizes: 5 and 10 ampoules Not all pack sizes may be 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 Tel.: +49 5151/581-0 Fax: +49 5151/581-258 and B. Braun Medical S.A. Carretera de Terrassa, 121 08191 Rubí (Barcelona) Spain
This medicinal product is authorised in the Member States of the EEA under the following names: Austria
Naloxon B. Braun 0,4 mg/ml Injektions-/Infusionslösung
Belgium
Naloxon B. Braun 0,4 mg/ml oplossing voor injectie/infusie
Denmark
Naloxon B. Braun injektions-/infusionsvæske, opløsning
Finland
Naloxon B. Braun 0,4 mg/ml injektio-/infuusioneste, liuos
Germany
Naloxon B. Braun 0,4 mg/ml Injektions-/Infusionslösung
Greece
Naloxon B. Braun 0,4 mg/ml ενέσιμο διάλυμα/διάλυμα για έγχυση
Iceland
Naloxon B. Braun 0,4 mg/ml stungulyf/innrennslislyf, lausn
Italy
Naloxone B. Braun 0,4 mg/ml soluzione iniettabile/per infusione
Luxembourg
Naloxon B. Braun 0,4 mg/ml Injektions-/Infusionslösung
Norway
Naloxon B. Braun 0,4 mg/ml injeksjons-/infusjonsvæske, oppløsning
Portugal
Naloxona B. Braun 0,4 mg/ml solução injetável/para perfusão
Spain
Naloxona B. Braun 0,4 mg/ml solución para inyección/perfusión
Sweden
Naloxon B. Braun 0,4 mg/ml injektions-/infusionsvätska, lösning
The Netherlands
Naloxon HCl B. Braun 0,4 mg/ml, oplossing voor injectie/infusie
United Kingdom
Naloxone 400 micrograms/ml solution for injection/infusion
This leaflet was last revised in 07/2024. ——————————————————————————————————————–Blue box content The following information is intended for healthcare professionals only: Shelf-life after first opening: After first opening the medicinal product should be used immediately. Shelf-life after dilution Chemical and physical in-use stability has been demonstrated for 24 hours below 25°C. From the microbiological point of view, the dilutions should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8 °C, unless dilution has taken place in controlled and validated aseptic conditions. For i.v. infusion Naloxone 400 micrograms/ml solution for injection/infusion is diluted only with sodium chloride 0.9 % or glucose 5 %. 5 ampoules of Naloxone 400 micrograms/ml solution for injection/infusion (2 mg) per 500 ml give 4 μg/ml. It is recommended that infusions of Naloxone 400 micrograms/ml solution for injection/infusion should not be mixed with preparations containing bisulphite, metabisulphite, long-chain or high-molecular-weight anions, or solutions with an alkaline pH. This medicinal product is for single use only. Please inspect the medicinal product visually prior to use (also after dilution). Use only clear and colourless solutions practically free from particles.
Frequently asked questions about Naloxone 400 micrograms/ml solution for injection
How do I take Naloxone 400 micrograms/ml solution for injection?
Naloxone 400 micrograms/ml solution for injection comes as injection containing 400micrograms/ml. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Naloxone 400 micrograms/ml solution for injection?
The active substance in Naloxone 400 micrograms/ml solution for injection is naloxone hydrochloride.
Are there equivalent medicines to Naloxone 400 micrograms/ml solution for injection?
Medicines with the same active substance, strength and form include: Naloxone 400 micrograms/ml solution for Injection/Infusion. They are interchangeable only if your prescriber or pharmacist says so.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Naloxone 400 micrograms/ml solution for injection, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Naloxone 400 micrograms/ml solution for injection without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: naloxone hydrochloride
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
• Complete or partial reversal of CNS and especially respiratory depression, caused by natural or synthetic opioids.
• Diagnosis of suspected acute opioid overdose or intoxication.
• Complete or partial reversal of respiratory and other CNS depression in the neonate whose mothers have received opioids.
4.2. Posology and method of administration
General
The medicinal product can be injected intravenously (i.v.) or intramuscularly (i.m.) or can be given via intravenous infusion.
For incompatibilities and instructions on dilution of the product before administration, see sections 6.2 and 6.6.
The i.m. administration of Naloxone 400 micrograms/ml should only be used in cases where an i.v. administration is not possible.
The most rapid effect is obtained by means of i.v. administration, which is why this method of administration is recommended in acute cases.
When Naloxone 400 micrograms/ml is administered i.m., it is necessary to remember that the onset of action is slower than following i.v. injection; however, i.m. administration has a longer action than i.v. administration. The duration of action is dependent upon the dose and route of administration of naloxone hydrochloride, varying between 45 minutes and 4 hours.
Furthermore, it has to be considered that necessary i.m. dosages are generally higher than i.v. dosages and that dosage has to be adapted to the individual patient.
As it is possible that the duration of effect of some opioids (e.g. dextropropoxyphene, dihydrocodeine, methadone) is longer than that of naloxone hydrochloride, the patients must be kept under continuous supervision, and repeated doses must be given if necessary.
Complete or partial reversal of CNS and especially respiratory depression, caused by natural or synthetic opioids
Adults
Dosage is determined for each patient in order to obtain optimum respiratory response while maintaining adequate analgesia. An i.v. injection of 0.1 to 0.2 mg naloxone hydrochloride (approx. 1.5-3 µg/kg) is usually sufficient. If necessary, additional i.v. injections of 0.1 mg can be administered at 2 minute intervals until satisfactory respiration and consciousness are obtained. An additional injection can again be necessary within 1 to 2 hours, depending on the type of active substance to be antagonised (short-term effect or slow release), the amount administered and time and mode of administration. Naloxone 400 micrograms/ml can alternatively be administered as an i.v. infusion.
Infusion: The duration of action for some opioids is longer than that of the naloxone hydrochloride i.v. bolus. Therefore, in situations where depression is known to be induced by such substances or there is a reason to suspect this, naloxone hydrochloride should be administered as a continuous infusion. The infusion rate is determined according to the individual patient, depending on the response of the patient to the i.v. bolus and on the reaction of the patient to the i.v. infusion. The use of the continuous intravenous infusion should be carefully considered and respiratory assistance should be applied if necessary.
Children
Initially, 0.01-0.02 mg naloxone hydrochloride per kg i.v. at intervals of 2-3 minutes until satisfactory respiration and consciousness are obtained. Additional doses may be necessary at 1- to 2-hours intervals depending on the response of the patient and the dosage and duration of action of the opiate administered.
Diagnosis and treatment of suspected acute opioid overdose or intoxication
Adults
The initial dose is usually 0.4-2 mg naloxone hydrochloride i.v. If the desired improvement in the respiratory depression is not obtained immediately after i.v. administration, the injections can be repeated at intervals of 2-3 minutes. Naloxone 400 micrograms/ml can also be injected intramuscularly (initial dose usually 0.4-2 mg) if intravenous administration is not possible. If 10 mg naloxone hydrochloride does not produce a significant improvement, this suggests that the depression is wholly or partially caused by other pathological conditions or active substances other than opioids.
Children
The usual starting dose is 0.01 mg naloxone hydrochloride per kg i.v. If the satisfactory clinical response is not achieved, the dose can be increased in the next injection to 0.1 mg/kg injection. Depending on the individual patient, an i.v. infusion may also be necessary. If i.v. administration is not possible, Naloxone 400 micrograms/ml can also be injected i.m. (initial dose 0.01 mg/kg), divided into several doses.
Reversal of respiratory and other CNS depression in the neonate whose mothers have received opioids
The usual dosage is 0.01 mg naloxone hydrochloride per kg i.v. If the respiratory function is not reversed to a satisfactory level with this dosage, the injection can be repeated at 2 to 3 minute intervals. If i.v. administration is not possible, Naloxone 400 micrograms/ml can also be injected i.m. (initial dose 0.01 mg/kg).
Elderly
In elderly patients with pre-existing cardiovascular disease or in those receiving potentially cardiotoxic drugs, Naloxone 400 micrograms/ml should be used with caution since serious adverse cardiovascular effects such as ventricular tachycardia and fibrillation have occurred in postoperative patients following administration of naloxone hydrochloride.
4.3. Contraindications
Naloxone 400 micrograms/ml is contraindicated in patients with hypersensitivity to naloxone hydrochloride or to any of the excipients of this medicinal product listed in section 6.1.
4.4. Special warnings and precautions for use
Naloxone 400 micrograms /ml must be given with caution to patients who have received high doses of opioids or are physically dependent on opioids. Too rapid reversal of the opioid effect can cause an acute withdrawal syndrome in such patients. Hypertension, cardiac arrhythmias, pulmonary oedema and cardiac arrest have been described. This also applies to newborn infants of such patients.
Patients who respond satisfactorily to naloxone hydrochloride must be closely monitored. The effect of opioids can be longer than the effect of naloxone hydrochloride and new injections may be necessary.
Naloxone hydrochloride is not effective in central depression caused by agents other than opioids. Reversal of buprenorphine-induced respiratory depression may be incomplete. If an incomplete response occurs respiration should be mechanically assisted.
Following the use of opioids during surgery, excessive dosage of naloxone hydrochloride should be avoided, because it may cause excitement, increase in blood pressure and clinically important reversal of analgesia. A reversal of opioid effects achieved too rapidly may induce nausea, vomiting, sweating or tachycardia.
Naloxone hydrochloride has been reported to induce hypotension, hypertension, ventricular tachycardia, fibrillation and pulmonary oedema. These adverse effects have been observed postoperatively most often in patients who have cardiovascular diseases or who have used medicines with similar cardiovascular adverse effects. Although no direct causative relations have been shown, caution should be used in administering Naloxone 400 micrograms /ml to patients with heart diseases or to patients who are taking relatively cardiotoxic drugs causing ventricular tachycardia, fibrillation and cardiac arrest (e.g. cocaine, methamphetamine, cyclic antidepressants, calcium channel blockers, beta-blockers, digoxin).
See section 4.8.
This medicinal product contains 3.8 mmol (88.5 mg) sodium per maximum daily dose of 10 mg naloxone hydrochloride. This should be taken into consideration by patients on a controlled sodium diet.
4.5. Interaction with other medicinal products and other forms of interaction
The effect of naloxone hydrochloride is due to the interaction with opioids and opioid agonists. When administered to subjects dependent on opioids, in some subjects the administration of naloxone hydrochloride can cause pronounced withdrawal symptoms. Hypertension, cardiac arrhythmias, pulmonary oedema and cardiac arrest have been described.
With a standard naloxone hydrochloride dose there is no interaction with barbiturates and tranquillizers.
Data on interaction with alcohol are not unanimous. In patients with multi-intoxication as a result of opioids and sedatives or alcohol, depending on the cause of the intoxication, one may possibly observe a less rapid result after administration of naloxone hydrochloride.
When administering naloxone hydrochloride to patients who have received buprenorphine as an analgesic complete analgesia may be restored. It is thought that this effect is a result of the arch-shaped dose-response curve of buprenorphine with decreasing analgesia in the event of high doses. However, reversal of respiratory depression caused by buprenorphine is limited.
Severe hypertension has been reported on administration of naloxone hydrochloride in cases of coma due to a clonidine overdose.
4.6. Fertility, pregnancy and lactation
Pregnancy
For Naloxone hydrochloride insufficient clinical data on exposed pregnancies are available. Animal studies have shown reproductive toxicity (see section 5.3). The potential risk for humans is unknown. The medicinal product should not be used during pregnancy unless clearly necessary. Naloxone hydrochloride can cause withdrawal symptoms in new-born infants (see section 4.4).
Breast-feeding
It is not known whether naloxone hydrochloride passes into breast milk and it has not been established whether infants who are breast-fed are affected by naloxone hydrochloride. Therefore, breast-feeding should be avoided for 24 hours after treatment.
4.7. Effects on ability to drive and use machines
Patients who have received naloxone hydrochloride to reverse the effects of opioids should be warned not to take part in road traffic, to operate machinery or to engage in other activities demanding physical or mental exertion for at least 24 hours, since the effect of the opioids may return.
4.8. Undesirable effects
The following frequency terminology is used:Very common: ≥ 1/10;Common: ≥ 1/100, < 1/10;Uncommon: ≥ 1/1,000, < 1/100;Rare: ≥ 1/10,000, < 1/1,000;Very rare: < 1/10,000;Not known (cannot be estimated from the available data)
Immune system disorders
Very rare: Allergic reactions (urticaria, rhinitis, dyspnoea, Quincke's oedema), anaphylactic shock
Nervous system disorders
Common: Dizziness, headache Uncommon: Tremor, sweating Rare: Seizures, tension
Seizures have occurred rarely following administration of naloxone hydrochloride; however, a causal relationship to the drug has not been established. Higher than recommended dosage in postoperative use can lead to tension.
Cardiac disorders
Common: Tachycardia Uncommon: Arrhythmia, bradycardia Very rare: Fibrillation, cardiac arrest
Vascular disorders
Common: Hypotension, hypertension
Hypotension, hypertension and cardiac arrhythmia (including ventricular tachycardia and fibrillation) have also occurred with the postoperative use of naloxone hydrochloride. Adverse cardiovascular effects have occurred most frequently in postoperative patients with a pre-existing cardiovascular disease or in those receiving other drugs that produce similar adverse cardiovascular effects.
Respiratory, thoracic and mediastinal disorders
Very rare: Pulmonary oedema
Pulmonary oedema has also occurred with the postoperative use of naloxone hydrochloride.
Gastrointestinal disorders
Very common: Nausea Common: Vomiting Uncommon: Diarrhoea, dry mouth
Nausea and vomiting have been reported in postoperative patients who have received doses higher than recommended. However, a causal relationship has not been established, and the symptoms may be signs of too rapid antagonisation of the opioid effect.
Skin and subcutaneous tissue disorders
Very rare: Erythema multiforme
One case of erythema multiforme cleared promptly after naloxone hydrochloride was discontinued.
General disorders and administration site conditions
Common: Postoperative pain Uncommon: Hyperventilation, irritation of vessel wall (after i.v. administration); local
irritation and inflammation (after i.m. administration)
Higher than recommended dosage in postoperative use can lead to the return of pain. A fast reversal of opioid effect can induce hyperventilation.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via Yellow Card Scheme www.mhra.gov.uk/yellowcard.
4.9. Overdose
In view of the indication and the broad therapeutic margin overdose is not to be expected. Single doses of 10 mg naloxone hydrochloride i.v. have been tolerated without any adverse effects or changes in laboratory values. Higher than recommended dosage in postoperative use can lead to the return of pain and tension.
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