Paracetamol Accord

Leaflet accompanying the packaging: patient information

Paracetamol Accord, 10 mg/mL, solution for infusion

Paracetamol
For children and adults with a body weight of 33 kg or more

Read the 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 need advice or additional information, consult a doctor, pharmacist, or nurse.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, tell the doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

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

1. What is Paracetamol Accord and what is it used for

This is a pain-relieving (pain-relieving) and antipyretic (fever-reducing) medicine.
It is used for short-term treatment of moderate pain, especially in the postoperative period, and for short-term treatment of fever.
The packaging containing 100 mL is intended for adults, adolescents, and children with a body weight of more than 33 kg.

2. Important information before using Paracetamol Accord

When not to use Paracetamol Accord

Warnings and precautions

Before starting to use Paracetamol Accord, discuss it with your doctor, pharmacist, or nurse:

During the use of Paracetamol Accord, immediately inform the doctor:

It is recommended that this medicine be used only until the patient can take pain-relieving medicines orally again.

Paracetamol Accord and other medicines

Tell the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as medicines the patient plans to take.
This medicine contains paracetamol and should be considered if the patient is taking other medicines containing paracetamol or propacetamol to avoid overdose (see the next point). Tell the doctor about taking other medicines containing paracetamol or propacetamol.
In case of concomitant use with probenecid, consider reducing the dose.
Tell the doctor or pharmacist if the patient is taking oral anticoagulant medicines. Closer monitoring of their effect may be necessary.
Tell the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, even those that are available without a prescription.
Inform the doctor or pharmacist if the patient is taking flucloxacillin (an antibiotic), due to a serious blood and fluid disorder (called metabolic acidosis), which requires emergency treatment (see section 2).

Pregnancy and breastfeeding

Paracetamol Accord can be given to pregnant women if necessary. Use the smallest effective dose to relieve pain or reduce fever and take the medicine for as short a time as possible. If the pain is not relieved or the fever does not decrease, or if it is necessary to increase the frequency of taking the medicine, consult a doctor.
Paracetamol Accord can be used during breastfeeding.

Driving and using machines

Paracetamol does not affect the ability to drive and use machines.

Paracetamol Accord contains sodium

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

3. How to use Paracetamol Accord

Paracetamol Accord will be administered to the patient by qualified medical personnel.
The dose will be individually adjusted by the doctor based on the patient's body weight and overall condition.
This medicine is administered by qualified medical personnel by intravenous infusion (intravenous administration).
In case of a feeling that the effect of the medicine is too strong or too weak, contact a doctor.
To withdraw the solution from a 100 mL vial, use a 0.8 mm (21G) needle by puncturing the stopper vertically at the designated place.

Using a higher dose of Paracetamol Accord than recommended

In case of taking a higher dose of the medicine than recommended, immediately inform a doctor or pharmacist.
In case of overdose, symptoms usually occur within the first 24 hours and include: nausea, vomiting, loss of appetite, paleness of the skin, abdominal pain, as well as the risk of liver damage.
In case of any further doubts about the use of this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Possible side effects are listed below:

• Rarely (may occur more often than 1 in 10,000 and less often than 1 in 1,000 patients): malaise, decreased blood pressure, or changes in laboratory test results: abnormally high liver enzyme activity detected during blood tests. In case of this abnormality, inform the doctor, as regular blood tests may be required.
• Very rarely (may occur less often than 1 in 10,000 patients, including single reports): severe skin reactions or allergic reactions (in the form of anaphylactic shock, urticaria, flushing). Stop taking the medicine immediately and consult a doctor.
• Very rarely, cases of other changes in blood test results have been reported, requiring regular monitoring: abnormally low numbers of certain types of blood cells (platelets, white blood cells), which led to nosebleeds or gum bleeding. In case of such symptoms, inform the doctor.
• Reports of skin redness, hot flashes, itching, and abnormally rapid heart rate have been made.
• Frequent cases of pain and burning at the injection site have been reported. Cases of unknown frequency (frequency cannot be estimated from available data) of a serious condition that can make the blood more acidic (called metabolic acidosis), in patients with severe disease taking paracetamol (see section 2).

Reporting side effects

If you experience any side effects, including any side effects not listed in the leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products Al. Jerozolimskie 181C 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. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Paracetamol Accord

Store out of sight and reach of children.
Do not use this medicine after the expiry date stated on the label after EXP. The expiry date refers to the last day of the month.
Glass vials: Do not store in the refrigerator or freeze. Store in the original packaging to protect from light.
Polyolefin bags: Do not store at a temperature above 25°C. Do not store in the refrigerator or freeze. Store in the original packaging to protect from light.
For single use only. The product should be used immediately after opening.
Unused portions of the product should be disposed of.
Before administration, check visually. Do not use the product if the solution contains visible particles or discoloration.
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 packaging and other information

What Paracetamol Accord contains

• The active substance of the medicine is paracetamol. One mL contains 10 mg of paracetamol, the packaging contains 1000 mg of paracetamol in 100 mL.
• Other ingredients of the medicine are: mannitol, sodium dihydrogen phosphate dihydrate, povidone K-12, sodium hydroxide (to adjust pH), water for injections.

What Paracetamol Accord looks like and what the packaging contains

The solution is clear, colorless, or slightly brownish in color without visible particles.
The product is supplied in packaging containing 1, 10, 12, 20 glass vials containing 100 mL of solution or 10, 12, or 50 polyolefin plastic bags containing 100 mL of solution.
Not all pack sizes may be marketed.

Marketing authorization holder

Accord Healthcare Polska Sp. z o.o.
ul. Taśmowa 7
02-677 Warsaw
Tel: +48 22 577 28 00

Manufacturer

Industria Farmaceutica Galenica S.r.l.
Via Cassa Nord, 351
53014, Monteroni d’Arbia (SI)
Italy

This medicinal product is authorized in the Member States of the European Economic Area and the United Kingdom (Northern Ireland) under the following names:

Date of last revision of the leaflet: January 2025

The following information is intended for healthcare professionals only:

Below is a summary of information on dosing, dilution, administration, and storage conditions for Paracetamol Accord, 10 mg/mL, solution for infusion. For full information on prescribing the medicine, refer to the Summary of Product Characteristics.
Intravenous administration.
The product is intended only for adults, adolescents, and children with a body weight of more than 33 kg.
Close monitoring is required before the end of the infusion.
Dosing

*Maximum daily dose:
The maximum daily dose listed in the table above applies to patients who are not taking other medicinal products containing paracetamol. It should be reduced accordingly, taking into account the use of these products.
**Patients with a lower body weight are given proportionally smaller volumes.
The minimum interval between consecutive doses must be at least 4 hours. Do not administer more than 4 doses in 24 hours.
The minimum interval between consecutive doses in patients with severe renal impairment must be at least 6 hours.
Renal impairment

In patients with renal impairment, the minimum interval between consecutive administrations should be modified according to the following scheme:

Elderly patients
In elderly patients, dose modification is usually not required.
Method of administration
RISK OF DOSING ERRORS
Caution should be exercised to avoid dosing errors due to confusion between milligrams (mg) and milliliters (mL). These errors can lead to unintentional overdose and patient death.
This medicine is administered by intravenous infusion (intravenous administration). It takes about 15 minutes.