Nalpain 10 mg/ml

Package Leaflet: Information for the User

NALPAIN, 10 mg/ml, Solution for Injection

Nalbupine hydrochloride

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• 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 only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Contents of the Package Leaflet:

• 1. What is NALPAIN and what is it used for
• 2. Important information before using NALPAIN
• 3. How to use NALPAIN
• 4. Possible side effects
• 5. How to store NALPAIN
• 6. Contents of the pack and other information

1. What is NALPAIN and what is it used for

NALPAIN is a medicinal product belonging to the group of analgesic (anesthetic) medicines with opioid properties.
It is used for the short-term treatment of moderate to severe pain. It can also be used before and after surgery.

2. Important information before using NALPAIN

When not to use NALPAIN

• if you are allergic to nalbupine or any of the other ingredients of this medicine (listed in section 6)
• if you have severe kidney problems
• if you have liver problems
• if you are using other opioids

Warnings and precautions

When to be careful when using NALPAIN

• If you have a head injury, internal head injury, or increased intracranial pressure, NALPAIN may worsen these symptoms. It is also possible that the use of NALPAIN in patients with head injuries may mask their symptoms. If you have kidney problems, the dose of NALPAIN must be reduced.
• If NALPAIN is given to a mother during childbirth, it is necessary to monitor whether the newborns do not experience respiratory depression and heart rhythm disturbances. If you have difficulty breathing or if breathing difficulties occur during treatment with NALPAIN, it may be necessary to closely monitor your health by a doctor.
• If you have heart failure, intestinal paralysis, gallbladder pain, epilepsy, or decreased thyroid function.
• Abuse of NALPAIN can lead to psychological and physical dependence or addiction.
• If you are addicted to heroin, methadone, or other opioid substances, NALPAIN should not be used as a substitute. In these cases, withdrawal symptoms may be significantly worsened.

Ask your doctor if any of the above warnings apply to you or have applied to you in the past.

NALPAIN and other medicines

Other medicines may affect the action of NALPAIN.
Tell your doctor or pharmacist about all the medicines you are taking now or have recently taken, as well as any medicines you plan to take, including those without a prescription, herbal medicines, or natural supplements.

• Combination with specific narcotics (opioids) is not recommended. The analgesic effect may be reduced.
• Avoid alcohol and medicinal products containing alcohol.
• Using NALPAIN in combination with other medicines that reduce anxiety and anxiety (anxiolytics) or concomitant use of NALPAIN with opioid analgesics (painkillers), phenothiazines (medicines used in schizophrenia), or other sedatives, sleep-inducing, or similar medicines that affect the central nervous system, may cause an increase in side effects. The doctor must adjust the dose of NALPAIN 10 mg/ml solution for injection or another medicinal product.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor for advice before using this medicine.
There is no sufficient information on the possible harmful effects of NALPAIN on human pregnancy.
If NALPAIN is given to a mother during childbirth, it is necessary to monitor whether the newborns do not experience respiratory depression and heart rhythm disturbances (see section 4, Possible side effects).
NALPAIN passes into breast milk. Breastfeeding should be interrupted for 24 hours during treatment with NALPAIN.
Ask your doctor or nurse for advice before using any medicine.

Driving and using machines

NALPAIN reduces reaction speed. Therefore, you should avoid driving and using machines during treatment with NALPAIN. Other possible side effects are listed in section 4.

NALPAIN contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per dose unit, which means the medicine is considered "sodium-free".

3. How to use NALPAIN

Nalbupine will always be administered to you by medical staff. The dose you receive depends on your body weight.

Dosage

Adults
The recommended dose for adult patients with a body weight of 70 kg is 10-20 mg of nalbupine hydrochloride, which corresponds to 0.1-0.3 mg/kg of body weight. The maximum single dose per day should not exceed 20 mg.
The dose can be repeated if necessary after 3 to 6 hours, with a maximum total daily dose of 160 mg.
Dosage should be adjusted according to the intensity of pain and the patient's physical condition.
Children and adolescents
The recommended dose for children is 0.1-0.2 mg/kg of body weight. The maximum single dose is 0.2 mg of nalbupine hydrochloride per kilogram of body weight.
The dose can be repeated if necessary after 3 to 6 hours, with a maximum total daily dose of 1.6 mg/kg of body weight.

Duration of treatment

The duration of treatment is determined by the doctor.
If you find that the effect of NALPAIN is too strong or too weak, you should consult your doctor or nurse for advice.

Using a higher dose of NALPAIN than recommended

Using a higher dose of NALPAIN than recommended may cause symptoms of respiratory depression, drowsiness, or loss of consciousness.
However, since this medicine will be administered during your hospital stay, it is unlikely that too much of the medicine will be given.
If you have any further questions about the use of this medicine, ask your doctor or nurse.

4. Possible side effects

Like all medicines, NALPAIN can cause side effects, although not everybody gets them.
The following side effects may occur:
Very common (in more than 1 in 10 people): sedation
Common (in more than 1 in 100 people and less than 1 in 10 people): sweating, drowsiness, dizziness, dry mouth, headache, vomiting, nausea, decreased sense of well-being
Rare (in more than 1 in 10,000 people and less than 1 in 1,000 people): feeling of light numbness in the head, nervousness, tremors, withdrawal symptoms, disturbed skin sensation, breathing difficulties
Very rare (in less than 1 in 10,000 people): hallucinations, disorientation, personality disorders, slowed heart rate, accelerated heart rate, fluid accumulation in the lungs, increased sense of well-being, low blood pressure, high blood pressure, tearing, blurred vision, allergic reactions, pain at the injection site, redness of the skin, hives, respiratory depression in newborns, delayed development of the circulatory system in newborns
If any of these side effects worsen, or if you notice other side effects not listed in this leaflet, please inform your doctor or pharmacist.

Reporting side effects

If you experience any side effects, including those not listed in the leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, PL-02 222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store NALPAIN

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the ampoule and carton after "EXP". The expiry date refers to the last day of the month. The "Lot" abbreviation means batch number.
Do not store above 25°C.
Store the ampoules in the outer packaging to protect from light.
The product should be used immediately after opening.
The medicinal product is intended for single use only. Any unused solution should be discarded.
Do not use NALPAIN 10 mg/ml if you notice discoloration, turbidity, or solid particles in the solution.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What NALPAIN contains

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

What NALPAIN looks like and contents of the pack

One ampoule contains 2 ml of clear and colorless solution for injection.
NALPAIN is available in packs of 10 ampoules.

Marketing authorization holder and manufacturer

Marketing authorization holder

Orpha-Devel Handels und Vertriebs GmbH
Wintergasse 85/1B
3002 Purkersdorf
Austria

Manufacturer

AOP Orphan Pharmaceuticals GmbH
1190 Vienna, Austria

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

Czech Republic: Nalbuphin OrPha 10 mg/ml injekční roztok
Greece: NALPAIN 10 mg/ml ενέσιμο διάλυμα
Netherlands: Nalbufine HCl OrPha 10 mg/ml oplossing voor injectie
Ireland: LAPAINOL 10 mg/ml solution for injection
Germany: NALPAIN 10 mg/ml Injektionslösung
Poland: NALPAIN 10 mg/ml roztwór do wstrzykiwań
Slovenia: NALPAIN 10 mg/ml raztopina za injiciranje
Hungary: NALPAIN 10 mg/ml oldatos injekció

Date of last revision of the leaflet: 12/2024