Naloxone hydrochloride wzf

Package leaflet: Information for the patient

Warning! Keep this leaflet! Information on the immediate packaging is in a foreign language.
Naloxonum Hydrochloricum WZF (Naloxone Polpharma)
400 micrograms/ml, solution for injection
Naloxoni hydrochloridum
Naloxonum Hydrochloricum WZF and Naloxone Polpharma are different trade names of the
same medicinal product.
Please read carefully the entire leaflet before using the medicine, as it contains
important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are similar.
• If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform the doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

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

1. What Naloxonum hydrochloricum WZF is and what it is used for

Naloxonum hydrochloricum WZF contains naloxone as the active substance and belongs to a group of medicines called opioid antagonists.
Naloxonum hydrochloricum WZF reverses (blocks) the unwanted effects of strong painkillers – opioids (e.g. morphine), such as breathing difficulties and drowsiness.
Naloxonum hydrochloricum WZF is used:

• in cases of overdose of strong painkillers (opioids) resulting in severe breathing difficulties;
• to reverse the effects of opioids administered during surgery;
• to treat breathing difficulties in newborns whose mothers received opioids during childbirth;
• to determine whether opioids are the cause of poisoning.

Naloxonum hydrochloricum WZF is always administered by medical personnel.

2. Important information before using Naloxonum hydrochloricum WZF

When not to use Naloxonum hydrochloricum WZF:

• if the patient is allergic to naloxone or to any of the other ingredients of this medicine (listed in section 6.).

Warnings and precautions
Before starting treatment with Naloxonum hydrochloricum WZF, discuss this with a doctor or pharmacist.
The doctor will exercise particular caution when administering Naloxonum hydrochloricum WZF and will take appropriate measures:

• if the patient has taken an excessive dose of opioids or is opioid-dependent, acute withdrawal symptoms may occur, such as high blood pressure, rapid heartbeat, severe breathing difficulties or cardiac arrest, which may occasionally lead to death;
• if withdrawal symptoms occur, such as nausea, vomiting, diarrhoea, weakness, rapid heartbeat, elevated blood pressure, fever, nasal discharge, sneezing, piloerection (so-called "goosebumps"), sweating, yawning, nervousness, restlessness, irritability, tremors, cramping abdominal pain, body aches; in newborns, seizures, excessive crying, and increased reflexes may occur;
• if Naloxonum hydrochloricum WZF is to be administered to a newborn whose mother took opioids before delivery or is opioid-dependent, as severe withdrawal symptoms may occur in the newborn;
• if the patient has heart disease or circulatory disorders, or is taking cardiac medications, or medications with adverse effects on the cardiovascular system, as these patients are at higher risk of adverse reactions such as irregular heartbeat, hypertension or hypotension, or breathing difficulties;
• if the patient has used a potent painkiller—buprenorphine or pentazocine—since the effectiveness of Naloxonum hydrochloricum WZF may be limited in such cases;
• if breathing difficulties occur after administration of Naloxonum hydrochloricum WZF, as this may be due to the shorter duration of action of naloxone compared to opioids;
• if Naloxonum hydrochloricum WZF is administered after surgery during which opioids were used, as symptoms such as nausea, vomiting, tremors, hypertension, and rapid heartbeat may occur (see section 4);
• if the patient has liver or kidney disease.

Naloxonum hydrochloricum WZF and other medicines
Inform the doctor about all medicines currently used or recently taken, as well as any medicines the patient plans to use.
Inform the doctor if the patient has used or is using:

• strong painkillers (e.g. morphine, codeine, buprenorphine, pentazocine);
• sleeping pills and/or sedatives;
• medicines that may affect the heart or circulatory system (e.g. antihypertensives, tricyclic antidepressants, calcium antagonists, beta-blockers, digoxin, clonidine, cocaine, methamphetamine). Severe hypertension has been reported during administration of hydrochloride naloxone in cases of coma induced by clonidine overdose.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult a doctor before using this medicine.
Inform the doctor if the patient:

• is pregnant;
• suspects she is pregnant;
• plans pregnancy;
• is breastfeeding. The decision to use Naloxonum hydrochloricum WZF during pregnancy or breastfeeding is made by the doctor. Naloxonum hydrochloricum WZF may cause withdrawal symptoms in newborns (see information above).

Naloxone may be used in pregnant women only if, in the doctor's opinion, its use is absolutely necessary. Breastfeeding should be avoided for 24 hours after administration of the medicine.

Driving and operating machinery
Do not drive or operate machinery for at least 24 hours after administration of the medicine.

Naloxonum hydrochloricum WZF contains sodium
The medicine contains 3.36 mg of sodium (main component of table salt) in each ml of solution. This corresponds to 0.17% of the maximum recommended daily dietary sodium intake for adults.
The medicine contains 84 mg of sodium (main component of table salt) in the maximum daily dose of 10 mg naloxone (25 ml of solution). This corresponds to 4.2% of the maximum recommended daily dietary sodium intake for adults.
The solution may be diluted—see below "Information intended exclusively for healthcare professionals". When calculating the total sodium content in the prepared, diluted solution, the sodium content originating from the diluent must be taken into account. For accurate information on the sodium content in the diluent, refer to the product characteristics of the medicinal product used as the diluent.

3. How to use Naloxonum Hydrochloricum WZF

Naloxonum Hydrochloricum WZF is always administered by medical personnel.
The medicine may be given:

• intravenously – injected directly into a vein or administered via infusion;
• intramuscularly;
• subcutaneously.
  The dose of the medicine is determined by the doctor. The administered dose depends on body weight, the patient's condition, and the type and amount of opioid used.

Use of a higher than recommended dose of Naloxonum Hydrochloricum WZF

• After administration of higher naloxone doses, recurrence of pain and return of muscle rigidity may occur.
• The medicine is administered by medical personnel, therefore it is unlikely that a patient will receive more medicine than intended.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
All medicines can cause allergic reactions, but severe allergic reactions after using this medicine are very rare. If you experience wheezing, difficulty breathing, swelling of the eyelids, face or lips, rash or itching (especially affecting the whole body), seek immediate medical advice.

The following adverse reactions have been reported:

Very common (occurring in more than 1 in 10 patients):

• nausea.

Common (occurring in less than 1 in 10 patients):

• dizziness;
• headache;
• rapid heartbeat;
• hypotension or hypertension;
• vomiting;
• postoperative pain.

Uncommon (occurring in less than 1 in 100 patients):

• tremor, sweating;
• heart rhythm disorders, slow heartbeat;
• diarrhoea;
• dry mouth;
• irritation of blood vessel walls after intravenous administration;
• local irritation, burning and redness at the site of intramuscular injection;
• too rapid and deep breathing.

Rare (occurring in less than 1 in 1,000 patients):

• seizures;
• muscle tension.

Very rare (occurring in less than 1 in 10,000 patients):

• severe heart problems (ventricular fibrillation, cardiac arrest);
• pulmonary oedema (symptoms include fluid in the lungs, difficulty breathing, breathlessness);
• erythema multiforme (symptoms usually include widespread blistering skin lesions and rash, skin discoloration, and damage to mucous membranes and skin);
• allergic reactions (symptoms usually include urticaria, rhinitis, breathlessness, facial swelling), anaphylactic shock (severe allergic reaction).

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can also be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Naloxonum Hydrochloricum WZF

Keep this medicine out of the sight and reach of children.
Store below 25 ℃. Do not freeze. Store the ampoules in the outer packaging to protect from light.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the Package and Other Information

What Naloxonum Hydrochloricum WZF Contains

• The active substance is naloxone hydrochloride. Each ml of solution contains 400 micrograms of naloxone hydrochloride (as naloxone hydrochloride dihydrate).
• Other ingredients: sodium chloride, hydrochloric acid diluted (for pH adjustment), water for injections.

What Naloxonum Hydrochloricum WZF Looks Like and Contents of the Pack
Naloxonum Hydrochloricum WZF, solution for injection, is a colorless,
transparent liquid.
Ampoules made of colorless glass containing 1 ml of solution are packed in a cardboard box.
Each cardboard box contains 10 ampoules.
For more detailed information, please contact the marketing authorization holder or the parallel importer.
Marketing Authorization Holder in the Czech Republic, country of export:
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19
83-200 Starogard Gdański
Poland
Manufacturer:
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19
83-200 Starogard Gdański
Poland
Parallel Importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing Authorization Number in the Czech Republic, country of export: 19/228/90-C
Parallel Import Authorization Number: 382/25
Information intended exclusively for healthcare professionals:
Naloxonum hydrochloricum WZF (Naloxone Polpharma)
400 micrograms/ml, solution for injection
Naloxoni hydrochloridum
Naloxonum Hydrochloricum WZF and Naloxone Polpharma are different trade names for the same medicinal product.
How to Administer Naloxonum Hydrochloricum WZF
The medicine is administered intravenously, intramuscularly, or subcutaneously, or by intravenous infusion after prior dilution.
When administering by intravenous infusion, the solution should be diluted with 0.9% sodium chloride solution or 5% glucose solution as follows: 2000 micrograms (5 ml of solution containing 400 micrograms/ml naloxone) in 500 ml of diluent. The resulting diluted solution contains 4 micrograms of naloxone per 1 ml. The solution should be prepared immediately before administration.
Warning: Naloxonum Hydrochloricum WZF must not be administered in the same intravenous infusion with other medicinal products.
During treatment, oxygen therapy and resuscitation measures must be readily available, along with equipment necessary for cardiopulmonary resuscitation.
Instructions for Opening the Ampoule
Before opening the ampoule, ensure that all the solution is in the lower part of the ampoule. Gently shake the ampoule or tap it with your finger to help the solution flow down.
Each ampoule has a colored dot (see Figure 1) indicating the score line located beneath it.

• To open the ampoule, hold it vertically in both hands, with the colored dot facing toward you – see Figure 2. The upper part of the ampoule should be gripped so that the thumb is positioned above the colored dot.
• Press in the direction of the arrow shown in Figure 3. Ampoules are intended for single use only and should be opened immediately before use. Any unused portion of the medicinal product must be discarded according to applicable regulations.

Figure 1.

Figure 2.

Figure 3.

Dosage of Naloxonum Hydrochloricum WZF
The dose of naloxone and the route of administration depend on the patient's condition, the type, and the amount of opioid administered.
Opioid Poisoning
Adults
Typically, an initial intravenous dose of 400 to 2000 micrograms is administered.
If necessary, the intravenous dose may be repeated every 2 to 3 minutes until consciousness returns and regular, steady respiration is established. If no improvement in respiratory function or return of consciousness occurs after administration of 10 mg, the symptoms are likely not due to opioid overdose.
The medicine may also be administered intramuscularly or subcutaneously. In life-threatening situations, the medicine should be given intravenously.
Children
Typically, the initial intravenous dose is 10 micrograms per kg body weight. If necessary, an additional dose of 100 micrograms per kg body weight may be given.
If naloxone cannot be administered intravenously, it should be given intramuscularly or subcutaneously in divided doses.
Reversal of Opioid-Induced Anesthesia
Adults
Typically, 100 to 200 micrograms intravenously, i.e., 1.5–3 micrograms per kg body weight.
In some cases, especially when a long-acting opioid has been used, an additional intramuscular dose of naloxone may be required within 1–2 hours. The medicine may also be administered by intravenous infusion.
Children
Intravenous dose of 10 micrograms per kg body weight. If necessary, an additional dose of 100 micrograms per kg body weight may be given.
If intravenous administration is not possible, administer the medicine intramuscularly or subcutaneously in divided doses. The medicine may also be administered by intravenous infusion.
Reversal of Respiratory Depression in Neonates Due to Maternal Administration of Opioid Analgesics During Labor
Neonates
In case of apnea, ensure airway patency before administering the medicine.
Administer intravenously, intramuscularly, or subcutaneously at a dose of 10 micrograms per kg body weight. The dose may be repeated after 2–3 minutes if necessary.
An intramuscular single dose of 200 micrograms of naloxone (approximately 60 micrograms per kg body weight) may also be administered.
Differential Diagnosis of Opioid Poisoning
Intravenous administration of a dose of 0.5 micrograms per kg body weight of naloxone allows confirmation of whether respiratory depression or urinary tract spasm is caused by opioids. The naloxone dose may then be gradually increased, avoiding excessively high doses. High doses eliminate all opioid effects, including analgesia, and may also cause sympathetic and cardiovascular system stimulation.