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NALPAIN 10 MG/ML SOLUTION FOR INJECTION

Active substance(s): NALBUPHINE HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
NALPAIN 10 mg/ml solution for injection
nalbuphine hydrochloride
Read all of this leaflet carefully before you start using this medicine.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you. Do not pass it on to others. It may harm
them, even if their symptoms are the same as yours.
If any of the side effects gets serious, or if you notice any side effects not listed in
this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1.
What NALPAIN 10 mg/ml solution for injection is and what it is used for
2.
Before you use NALPAIN 10 mg/ml solution for injection
3.
How to use NALPAIN 10 mg/ml solution for injection
4.
Possible side effects
5.
How to store NALPAIN 10 mg/ml solution for injection
6.
Further Information

1.

WHAT NALPAIN 10 MG/ML SOLUTION FOR INJECTION IS AND WHAT IT
IS USED FOR

NALPAIN 10 mg/ml solution for injection is a medicinal product that belongs to a group of
pain killers (analgesics) with opioid properties.
It is used for short-term treatment of moderate to severe pain. It can also be used
before or after an operation.

2.

BEFORE YOU USE NALPAIN 10 MG/ML SOLUTION FOR INJECTION

Do not use NALPAIN 10 mg/ml solution for injection
- if you are allergic (hypersensitive) to nalbuphine hydrochloride or any of the other
ingredients of NALPAIN 10 mg/ml solution for injection (see section 6)
- if you have severe renal impairment
- if you have hepatic impairment
- if you use other opioids
Take special care with NALPAIN 10 mg/ml solution for injection
- if you suffer from head injury, inner head injury or already existing increased
intracranial pressure, NALPAIN 10 mg/ml solution for injection might intensify this. It
is also possible that the use of NALPAIN 10 mg/ml solution for injection in patients
with head injury can disguise symptoms. if you suffer from a deranged kidney
function, the dosage of NALPAIN 10 mg/ml solution for injection must then be
reduced.
- if NALPAIN 10 mg/ml solution for injection is administered to the mother during
labour and delivery. Newborns should be monitored for respiratory depression and
arrhythmias if NALPAIN 10 mg/ml solution for injection has been used.if you suffer
from impaired breathing or if you get difficulties with your breathing during the
treatment, your doctor may have to monitor you closely.
- if you suffer with heart failure, paralysed gut, gallbladder pains, epilepsy or reduced
function of the thyroid.
- Abuse of NALPAIN 10 mg/ml solution for injection can lead to psychical and physical
addiction and habituation.

-

if you are addicted on heroine, methadone or other opioid substances. NALPAIN 10
mg/ml solution for injection cannot be used as a replacement. In these cases the
acute withdrawal symptoms can be considerably intensified.

Ask your doctor, if one of the above mentioned warnings applies to you or has applied to
you in the past.
Using other medicines
Other medicines can have an influence on the effect of NALPAIN 10 mg/ml solution for
injection.
Please tell your doctor or pharmacist if you are taking or have recently taken any other
medicines, including medicines obtained without a prescription, herbal medicines or
natural products.
-

Combination with specific narcotics (opioids) is not indicated. The painkilling effect
might be reduced.
Alcohol and medicinal products containing alcohol must be avoided.
The use of NALPAIN 10 mg/ml solution for injection in combination with other
medicines that diminish fear and anxiety (anxiolytics) or the concurrent use of
NALPAIN 10 mg/ml solution for injection with narcotic analgesics (pain killers),
phenothiazines (medicines used for schizophrenia) or other sedative, sleep enhancing
or similar medication that affect the central nervous system can show worsening of
the side effects. Your doctor must adapt the dosage of NALPAIN 10 mg/ml solution
for injection or the other medicinal product.

Pregnancy and breast-feeding
There are insufficient data on the possible harmful effects in humans with the use of
NALPAIN 10 mg/ml solution for injection in pregnancy. If NALPAIN 10 mg/ml solution for
injection is administered to the mother during labour and delivery, newsborns should be
monitored for respiratory depression and arrhythmias (see section 4 possible side
effects).
NALPAIN 10 mg/ml solution for injection is excreted in the breast-milk. Lactation should
be discontinued for 24 hours during treatment with NALPAIN 10 mg/ml solution for
injection.
Ask your doctor or nurse for advice before taking any medicine.
Driving and using machines
NALPAIN 10 mg/ml solution for injection reduces your ability to react quickly. You should
therefore avoid driving and using machines while you are treated with NALPAIN 10
mg/ml solution for injection. Other side effects that may occur are listed in section 4.
Important information about some of the ingredients of NALPAIN 10 mg/ml
solution for injection
This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. it is
essentially `salt-free´.

3.

HOW TO USE NALPAIN 10 MG/ML SOLUTION FOR INJECTION

NALPAIN 10 mg/ml solution for injection is only used by the physician or nurse.
Posology
Adults
The common used dose for adults is 10 to 20 mg for persons with 70 kg body weight:
intravenous, intramuscular or subcutaneous administration. This dose can be repeated
after 3 to 6 hours, if necessary. The dosage must be adapted according to the intensity
of the pain and the condition of the patient.

Children and adolescents
The usual dosage for children is 0,1 to 0,2 mg/kg body weight: intravenous,
intramuscular or subcutaneous administration. This dose can be repeated after 3 to 6
hours, if necessary. The single maximum dose is defined with 0,2 mg NALPAIN
hydrochloride per kilogram body weight.
Duration of treatment
The duration of treatment is specified by your doctor.
If you notice that the effect of NALPAIN 10 mg/ml solution for injection is too strong or
even too weak, please ask your doctor or nurse for advice.
If you get more NALPAIN 10 mg/ml solution for injection than you should
The usage of a high dosage of NALPAIN 10 mg/ml solution for injection can cause
symptoms such as respiratory depression, drowsiness or unconsciousness.
As this medicine will be given to you whilst you are in hospital, it is unlikely that you will
be given too much.
If you have any further questions on the use of this product, ask your doctor or nurse.

4.

POSSIBLE SIDE EFFECTS

Like all medicines, NALPAIN 10 mg/ml solution for injection can cause side effects,
although not everybody gets them.
The possible side effects are ranked according to their frequency:
very common (more than 1 out of 10 persons)
common (more than 1 out of 100 persons and less than 1 out of 10 persons)
uncommon (more than 1 out of 1,000 persons and less than 1 out of 100 persons)
rare (more than 1 out of 10,000 persons and less than 1 out of 1,000 persons)
very rare (less than 1 out of 10,000 persons)
The following side effects may appear:
Very common: Sedation
Common: Sweating, sleepiness, dizziness, Dry mouth, Headache, Vomiting, sickness,
decreased feeling of happiness
Rare: Light numbness in the head, nervousness, shiver, Withdrawal symptoms, disturbed
feeling of the skin, Respiratory difficulties
Very rare: illusions, n, personality disorder trait, slow heartbeat, rapid heartbeat, fluid
retention in the Lung, increased feeling of happiness, low blood pressure, high blood
pressure, Watery eyes, Blurred vision, Allergic reaction, Pain in the puncture, reddened
skin, nettle-rash, respiratory depression in newborn children, retarded circulation in
newborn children
If any of the side effects gets serious, or if you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.

5.

HOW TO STORE NALPAIN 10 MG/ML SOLUTION FOR INJECTION

Keep out of the reach and sight of children.

Do not use NALPAIN 10 mg/ml solution for injection after the expiry date which is stated
on the ampoule and carton.The expiry date refers to the last day of that month.
Do not store above 25°C.
Keep the ampoules in the outer carton, in order to protect from light.
The product has to be used immediately after first opening.
This medicinal product is for single use only. Discard any unused solution.
Do not use Nalpain 10 mg/ml if you notice discolouration, cloudiness or particles in the
solution.
Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose medicines no longer required. These measures will help to
protect the environment.

6.

FURTHER INFORMATION

What NALPAIN 10 mg/ml solution for injection contains
-

The active substance is nalbuphine hydrochloride.
1 ml of solution contains 10 mg nalbuphine hydrochloride.
1 ampoule of 2 ml contains 20 mg nalbuphine hydrochloride.
The other ingredients are
citric acid, anhydrous
sodium citrate
sodium chloride
hydrochloric acid (for pH adjustment)
water for injection

What NALPAIN 10 mg/ml solution for injection looks like and contents of the
pack
One ampoule contains 2 ml of a clear and colourless solution for injection.
NALPAIN 10 mg/ml solution for injection is available in packs with 10 ampoules.
Marketing Authorisation Holder
Orpha-Devel Handels und Vertriebs GmbH
Wintergasse 85/1B
3002 Purkersdorf
Austria
Manufacturer
HIKMA Italia S.P.A.
Italy
G.L. Pharma GmbH
Austria
Amomed Pharma GmbH
Austria
This medicinal product is authorised in the Member States of the EEA under the following names:

Belgium: PAINAFIN 10 mg/ml oplossing voor injectie
Czech Republic: Nalbuphin OrPha 10 mg/ml injekční roztok

Denmark: NALPAIN 10 mg/ml injektionsopløsning
Germany: NALPAIN 10 mg/ml Injektionslösung
Estonia: NALPAIN 10 mg/ml süstelahus
Finland: NALPAIN 10 mg/ml injektioneste, liuos
France: NALPAIN 20 mg/2 ml solution injectable
Greece: NALPAIN 10 mg/ml ενέσιμο διάλυμα
Hungary: NALPAIN 10 mg/ml oldatos injekció
Ireland: LAPAINOL 10 mg/ml solution for injection
Italy: NALPAIN 10 mg/ml soluzione iniettabile
Latvia: NALPAIN 10 mg/ml injekcinis tirpalas
Lithuania: NALPAIN 10 mg/ml injekcinis tirpalas
Luxemburg: NALPAIN 10 mg/ml solution injectable
Netherlands: Nalbufine HCl OrPha 10 mg/ml oplossing voor injectie
Poland: NALPAIN 10 mg/ml roztwór do iniekcji
Sweden: NALPAIN 10 mg/ml injektionsvätska, lösning
Slovenia: NALPAIN 10 mg/ml raztopina za injiciranje
UK: NALPAIN 10 mg/ml solution for injection
This leaflet was last approved in 07/02/2014

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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