Paracetamol accord

Package leaflet: Information for the patient

Paracetamol Accord, 10 mg/mL, infusion solution
Paracetamolum
For children and adults with body weight of 33 kg or more
Please read this leaflet carefully before using this medicine, because it contains important
information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, please consult your doctor, pharmacist, or nurse.
• If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Leaflet contents:

1. What Paracetamol Accord is and what it is 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 pack and other information

1. What Paracetamol Accord is and what it is used for
This is an analgesic (relieves pain) and antipyretic (reduces fever).
It is used for short-term treatment of mild to moderate pain, particularly in the postoperative period, and for short-term treatment of fever.
The pack containing 100 mL is intended for adults, adolescents, and children with body weight greater than 33 kg.

2. Important information before using Paracetamol Accord

When not to use Paracetamol Accord

• if the patient is allergic (hypersensitive) to paracetamol or to any of the other ingredients of this medicine,
• if the patient is allergic (hypersensitive) to propacetamol (another analgesic for infusion, which is converted in the body to paracetamol),
• if the patient has severe liver disease.

Warnings and precautions
Before starting treatment with Paracetamol Accord, discuss with your doctor, pharmacist, or nurse:

• if the patient has liver disease or severe kidney disease, or if the patient chronically abuses alcohol,
• if the patient is taking other medicines (prescription and over-the-counter) containing paracetamol,
• in case of dehydration or malnutrition,
• in case of glucose-6-phosphate dehydrogenase deficiency (which may lead to haemolytic anaemia), or blood disorders.

During treatment with Paracetamol Accord, inform the doctor immediately:

• if the patient has serious conditions, including severe renal dysfunction or sepsis (when bacteria and their toxins circulate in the blood, leading to organ damage), malnutrition, chronic alcoholism, or if the patient is also taking flucloxacillin (an antibiotic). Cases of a serious condition called metabolic acidosis (a blood and fluid imbalance) have been reported in patients who take paracetamol regularly for a prolonged period or who take paracetamol together with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties, including rapid deep breathing, drowsiness, nausea, and vomiting.

It is recommended that this medicine be used only until the patient can resume oral analgesics.
Paracetamol Accord and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
This medicine contains paracetamol, and this should be taken into account if the patient is taking other medicines containing paracetamol or propacetamol, to avoid overdose (see next section). Inform your doctor about taking other medicines containing paracetamol or propacetamol.
If used concomitantly with probenecid, dose reduction should be considered.
Tell your doctor or pharmacist if the patient is taking oral anticoagulants. Closer monitoring of their effect may be necessary.
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, including those available without a prescription.
Inform your doctor or pharmacist if the patient is taking flucloxacillin (an antibiotic), due to a serious blood and fluid imbalance (called metabolic acidosis), which requires urgent treatment (see section 2).
Pregnancy and breastfeeding
Paracetamol Accord may be administered to pregnant women if necessary. The lowest effective dose that adequately relieves pain or reduces fever should be used, and the medicine should be taken for as short a duration as possible. If pain is not relieved or fever does not subside, or if increased dosing frequency becomes necessary, consult a doctor.
Paracetamol Accord may be used during breastfeeding.
Driving and operating machinery
Paracetamol has no influence on the ability to drive or operate machinery.
Paracetamol Accord contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per single unit volume, meaning 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 physician according to the patient's body weight and general condition.
This medicine is administered by qualified medical personnel as an intravenous infusion (intravenous administration).
If you feel that the effect of the medicine is too strong or too weak, contact your doctor.
To withdraw the solution from the 100 mL vial, use a 0.8 mm (21G) needle, piercing the stopper vertically at the marked site.
Use of a higher than recommended dose of Paracetamol Accord
In case of administration of a dose higher than recommended, inform a doctor or pharmacist immediately.
Symptoms of overdose usually occur within the first 24 hours and may include: nausea, vomiting, anorexia (loss of appetite), pallor, abdominal pain, and risk of liver damage.
If you have any further doubts concerning the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will get them.
The possible adverse reactions are listed below:

• Rare (may occur in more than 1 in 10,000 and less 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. If this abnormality occurs, inform your doctor, as regular blood tests may be required.
• Very rare (may occur in less than 1 in 10,000 patients, including single reports): severe skin reactions or allergic reactions (such as anaphylactic shock, urticaria, erythema). The medicine must be discontinued immediately and medical advice sought.
• Very rare cases of other changes in blood laboratory test results requiring regular monitoring have been reported: abnormally low number of certain types of blood cells (platelets, white blood cells), leading to nose or gum bleeding. If such symptoms occur, inform your doctor.
• Cases of skin redness, hot flushes, itching, and abnormally rapid heartbeat have been reported.
• Frequent cases of pain and burning at the injection site have been reported. Cases with unknown frequency (frequency cannot be estimated from available data) of a serious condition causing blood to become more acidic (so-called metabolic acidosis) have been reported in patients with severe illness receiving paracetamol (see section 2).

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department for Monitoring of Adverse Drug Reactions of the 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Paracetamol Accord

Keep out of the 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 stated 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 temperatures 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.
Any unused portion should be discarded.
Visually inspect before administration. Do not use the product if the solution contains visible solid 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 pack and other information

What Paracetamol Accord contains

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

What Paracetamol Accord looks like and contents of the pack
The solution is clear, colourless or slightly brownish, without visible solid particles.
The product is supplied in packs containing 1, 10, 12, or 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 Authorisation Holder
Accord Healthcare Polska Sp. z o.o.
Taśmowa Street 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 authorised in the Member States of the European Economic Area and the United Kingdom (Northern Ireland) under the following names:

The following information is intended for medical personnel only:

Below is a summary of dosing, dilution, administration, and storage instructions for Paracetamol Accord 10 mg/mL, infusion solution. For complete prescribing information, refer to the Summary of Product Characteristics.
Intravenous administration.
This product is intended only for adults, adolescents, and children with body weight above 33 kg.
Close monitoring is required until completion of the infusion.

Dosing
Dosing is based on the patient's body weight (see dosing table below).

*Maximum daily dose:
The maximum daily dose indicated in the table above applies to patients who are not receiving
other medicinal products containing paracetamol. This dose should be appropriately reduced
taking into account the use of these products.
** Smaller volumes should be administered to patients with lower body weight.
The minimum interval between individual doses must be at least 4 hours. Do not administer more
than 4 doses within 24 hours.
The minimum interval between individual doses in patients with severe renal impairment must be
at least 6 hours.
Renal function disorders
In patients with impaired renal function, the minimum interval between individual doses should be modified according to the following scheme:

Liver function disorders
Patients with chronic or stable active liver disease, liver failure, chronic alcoholism, chronic
malnutrition (low hepatic glutathione reserves), dehydration, Gilbert's syndrome, or body weight below 50 kg:
The maximum daily dose must not exceed 3 g.
There are no contraindications for using paracetamol at therapeutic doses in patients with
chronic stable liver disease.
Elderly patients
In elderly patients, dosage adjustment is usually not required.
Method of administration
RISK OF DOSING ERRORS
Caution must be exercised to avoid dosing errors due to confusion between milligrams (mg) and milliliters (ml). Such errors may lead to unintentional overdose and patient death.
This medicinal product is administered by intravenous infusion (intravenous administration). It takes approximately 15 minutes.