Paracetamol S.A.L.F.

Package leaflet: Information for the user

PARACETAMOL S.A.L.F. 10 mg/ml infusion solution

Generic medicine
Read this leaflet carefully before using this medicine because it contains important information for you.
Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor, pharmacist, or nurse.
This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, because it could be harmful.
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:
1. What PARACETAMOL S.A.L.F. is and what it is used for
2. What you need to know before using PARACETAMOL S.A.L.F.
3. How to use PARACETAMOL S.A.L.F.
4. Possible side effects
5. How to store PARACETAMOL S.A.L.F.
6. Contents of the pack and other information

1. What PARACETAMOL S.A.L.F. is and what it is used for
PARACETAMOL S.A.L.F. contains the active substance paracetamol, which belongs to a group of medicines known as analgesics and antipyretics, as they act by relieving pain and inflammation (analgesic and anti-inflammatory action) and reducing body temperature in case of fever (antipyretic action).
PARACETAMOL S.A.L.F. is indicated for:

• Short-term treatment of mild to moderate pain, particularly following surgical procedures
• Short-term treatment of fever, when other routes of administration are impractical

2. What you need to know before using PARACETAMOL S.A.L.F.

Do not use PARACETAMOL S.A.L.F.:
if you are allergic to paracetamol, to other similar medicines (propacetamol) or to any of
the other ingredients of this medicine (listed in section 6)
if you have severe liver disease (hepatic insufficiency)
if the person to be treated with this medicine is a child weighing less than 33 kg

Warnings and precautions
Talk to your doctor, pharmacist or nurse before using PARACETAMOL S.A.L.F.
This medicine should be administered to you with caution:
if you have liver problems such as severe hepatic insufficiency, hepatocellular insufficiency or acute hepatitis, and if you are taking other medicines that affect liver function
if you have a hereditary condition causing yellowish discoloration of the skin (Gilbert's syndrome)
if you have severe kidney problems (renal insufficiency)
if you are a chronic alcohol abuser (chronic alcoholism)
if you suffer from malnutrition (body weight less than 50 kg) and dehydration
if you have a rare hereditary condition characterized by low levels of an enzyme known as glucose-6-phosphate dehydrogenase
if you have haemolytic anaemia, a condition characterized by a low number of red blood cells in the blood.
Avoid taking other medicines containing paracetamol or propacetamol during treatment with this medicine, to prevent overdose which may cause serious liver damage (see section "If you use more PARACETAMOL S.A.L.F. than you should").
Treatment with this medicine should be as short as possible. It is recommended to switch to oral therapy (by mouth) as soon as possible.

Other medicines and PARACETAMOL S.A.L.F.
Inform your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines.
This medicine should be administered to you with caution if you are taking the following medicines:
probenecid (a medicine used to treat gout)
medicines containing salicylamide, used to relieve pain and inflammation
medicines used to thin the blood (anticoagulants)
hormonal contraceptives and estrogens
medicines used to treat epilepsy (phenytoin, phenobarbital, methylphenobarbital, primidone, lamotrigine)
chloramphenicol, a medicine used to treat viral infections
medicines used to treat nausea (metoclopramide and domperidone)
drugs used to treat high blood pressure such as propranolol
rifampicin, a medicine used to treat tuberculosis
zidovudine, a medicine used to treat AIDS
The use of this medicine may alter the results of certain laboratory tests, such as measurements of uric acid levels (uricemia) or blood sugar (glycemia).

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant or are planning to become pregnant, or if you are breastfeeding, consult your doctor or pharmacist before this medicine is administered to you.
If necessary, PARACETAMOL S.A.L.F. may be used during pregnancy. It is advisable to use the lowest possible dose that relieves pain and/or fever, and to take it for the shortest possible time. Contact your doctor/midwife if pain and/or fever do not subside or if you need to take the medicine more frequently.
This medicine may be used during breastfeeding.

Driving and using machines
The use of PARACETAMOL S.A.L.F. does not affect the ability to drive or operate machinery.

PARACETAMOL S.A.L.F. contains sodium and glucose
This medicine contains less than 23 mg of sodium (1 mmol) per 100 ml of solution, i.e. it is practically sodium-free.
This medicine contains 33 mg of monohydrate glucose per ml. This should be taken into account in patients with diabetes mellitus.

3. How to use PARACETAMOL S.A.L.F.

This medicine will be administered to you by a doctor or other specialized medical personnel through direct injection into a vein (intravenous infusion). The administration will last approximately 15 minutes. You will be closely monitored during treatment.
The dose will be adjusted by the doctor according to your body weight.
This medicine is indicated for adults and children weighing more than 33 kg (approximately 11 years of age).

* Maximum daily dose: The maximum daily dose reported in the table above applies to
patients who are not taking other products containing paracetamol, and should be adjusted
accordingly, taking into account such products.
** Patients with lower body weight will require smaller volumes.
The minimum interval between each administration must be at least 4 hours. No more than 4 doses
should be administered within 24 hours.
In patients with severe renal impairment, the minimum interval between each administration must be
at least 6 hours.
Use in patients with liver problems, alcoholism, chronic malnutrition, or dehydration: The dose should be reduced.
Use in patients with kidney problems: the dosing interval should be prolonged.
Method of administration:
RISK OF THERAPEUTIC ERRORS
Take care to avoid dosing errors due to confusion between
milligrams (mg) and millilitres (mL), which may lead to accidental overdose
and death.
For 100 mL bottles, use a 0.8 mm needle (21 gauge) and pierce the stopper vertically at the exact point indicated.
If you use more PARACETAMOLO S.A.L.F. than you should
Overdose is unlikely, as the medicine will be administered by a healthcare professional.
However, if you think you have been given an excessive dose, inform your doctor or nurse immediately, even if you feel well, because there is a risk of severe liver damage.
In case of overdose, symptoms generally appear within the first 24 hours and include nausea, vomiting, anoressia (loss of appetite), pallor, abdominal pain, and risk of liver damage.
Doses exceeding the recommended amounts may cause severe liver damage (including fulminant hepatitis, severe hepatic failure, cholestatic hepatitis, cytolytic hepatitis, severe haemolytic anaemia), which mainly manifest 4–6 days after the start of administration.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
The following side effects may occur:

Rare (may affect up to 1 in 1,000 people):

• Low blood pressure
• Changes in platelet levels, disorders of stem cells
• Depression, confusion, hallucinations
• Tremor, headache (migraine)
• Blurred vision
• Fluid retention and swelling (edema)
• Bleeding (hemorrhage)
• Abdominal pain, diarrhea, nausea, vomiting
• Liver problems (impaired liver function, liver failure, hepatic necrosis)
• Abnormal increase in liver enzyme levels detected in blood tests. In this case, inform your doctor, as regular blood tests may be required thereafter
• Itching, skin rash, sweating, bruising (purpura)
• Swelling of the face, tongue and throat (angioedema), urticaria
• Dizziness, malaise, fever, drowsiness
• Drug interaction
• Overdose and poisoning

Very rare (may affect up to 1 in 10,000 people):

• Reduction in platelets (thrombocytopenia), white blood cells (leucopenia, neutropenia)
• Liver damage (hepatotoxicity)
• Yellowing of the skin and whites of the eyes (jaundice)
• Sterile pyuria (cloudy urine)
• Allergic reactions requiring discontinuation of treatment, such as skin rash, urticaria, anaphylactic shock. These symptoms require treatment to be stopped
• Severe skin reactions

Not known (frequency cannot be estimated from available data):

• Skin irritation (erythema)
• Redness and itching of the skin
• Increased heart rate (tachycardia)

Cases of pain and burning sensation at the site of administration have been reported.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the following website:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store PARACETAMOL S.A.L.F.

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "EXP". The expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from light. Do not store above 25°C. Do not refrigerate or freeze.
Keep the 100 ml bag in its outer aluminium packaging.
The product should be used immediately after opening for single administration; any remaining residue must be discarded. The solution is clear, colourless or slightly coloured, ranging from amber-yellow to pale pink-orange (the appearance may vary depending on the primary container). Do not use the medicine if it contains a precipitate or if it has turned dark in colour.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information What the package contains

PARACETAMOL S.A.L.F.
The active substance is paracetamol. 1 ml of solution contains 10 mg of paracetamol.
The other components are: glucose monohydrate, sodium citrate dihydrate, sodium acetate trihydrate, acetic acid, hydrochloric acid, sodium hydroxide, water for injections.

Description of the appearance of PARACETAMOL S.A.L.F. and package contents
Pack containing 1 glass or PP vial of 100 ml.
Pack containing 20 glass or PP vials of 100 ml.
Pack containing 30 glass or PP vials of 100 ml.
Pack containing 20 PVC-free bags of 100 ml.

Marketing Authorization Holder and Manufacturer
S.A.L.F. S.p.A. Laboratorio Farmacologico
Via Marconi, 2 - 24069 Cenate Sotto (BG) - Italy.

This instruction leaflet was last updated on:

Instruction leaflet: information for the physician

PARACETAMOL S.A.L.F. 10 mg/ml solution for infusion

The following information is intended exclusively for physicians or healthcare professionals
CLINICAL INFORMATION
Dosage and method of administration
Intravenous use.
The use of PARACETAMOL S.A.L.F. is restricted to adults, adolescents, and children weighing
more than 33 kg (approximately 11 years of age).
Dosage:
The dose is based on the patient's body weight. Please refer to the dosage table below:

| Patient weight | Dose per administration | Volume per administration (10 mg/mL) | Maximum volume per administration based on upper weight limit of group (mL)** | Maximum daily dose of Paracetamol S.A.L.F. | |--------------------|-----------------------------|----------------------------------------|--------------------------------------------------|---------------------------------------------| | > 33 kg and ≤ 50 kg | 60 mg/kg, not exceeding 3 g | 1.5 mL/kg | 75 mL | 3 g | | > 50 kg with additional risk factors for hepatotoxicity | 1 g | 100 mL | 100 mL | 3 g | | > 50 kg without additional risk factors for hepatotoxicity | 1 g | 100 mL | 100 mL | 4 g |

* Maximum daily dose: The maximum daily dose reported in the table above applies to patients who are not taking other products containing paracetamol and should be adjusted accordingly when such products are used.
** Patients with lower body weight will require smaller volumes.
The minimum interval between each administration must be at least 4 hours. No more than 4 doses should be administered within 24 hours.
In patients with severe renal impairment, the minimum interval between administrations must be at least 6 hours.

PARACETAMOL S.A.L.F. must not be used in children weighing less than 33 kg (approximately under 11 years of age) for safety reasons.

Severe renal impairment
When administering paracetamol to patients with severe renal impairment (creatinine clearance ≤30 mL/min), the minimum interval between administrations should be increased to 6 hours (see section 5.2 of the Summary of Product Characteristics).

In adults with hepatic impairment, chronic alcoholism, chronic malnutrition (low hepatic glutathione reserves), or dehydration:
the maximum daily dose must not exceed 3 g (see section 4.4 of the Summary of Product Characteristics).

Method of administration:
RISK OF THERAPEUTIC ERRORS
Take care to avoid dosing errors due to confusion between milligrams (mg) and milliliters (mL), which may lead to accidental overdose and death.

Paracetamol solution is administered by intravenous infusion over 15 minutes. Before administration, the product must be visually inspected for particulate matter and discoloration. Single-use only.
For 100 mL vials, use a 0.8 mm (21 gauge) needle and puncture the stopper vertically at the exact point indicated.

As with all infusion solutions contained in vials, close monitoring is required, especially at the end of the infusion, regardless of the route of administration. This end-of-infusion monitoring is particularly important in the case of central line infusions to prevent gas embolism.

For instructions on dilution of the medicinal product before administration, see section 6.6 of the Summary of Product Characteristics.

Overdose
There is a risk of liver damage (including fulminant hepatitis, hepatic failure, cholestatic hepatitis, cytolytic hepatitis), particularly in elderly patients, underweight children, patients with liver disease, chronic alcoholics, chronically malnourished patients, and those receiving enzyme inducers. In these cases, overdose may be fatal.
Symptoms usually appear within the first 24 hours and include nausea, vomiting, anorexia, pallor, and abdominal pain. Immediate emergency measures are required, even in the absence of symptoms.

Overdose (7.5 g or more of paracetamol in a single dose in adults, or 140 mg/kg body weight in a single dose in children) causes hepatic cytolytic necrosis, which may lead to complete and irreversible necrosis, resulting in hepatocellular failure, metabolic acidosis, and encephalopathy that may progress to coma and death.
Concurrently, increased levels of liver transaminases (AST, ALT), lactate dehydrogenase (LDH), and bilirubin are observed, along with decreased prothrombin levels, which may become evident 12 to 48 hours after ingestion. Clinical signs of liver damage typically become apparent after about two days and peak between 4 and 6 days.
Doses exceeding 20–25 g are potentially lethal.

Emergency measures
Immediate hospitalization.
Before starting treatment, and as soon as possible after overdose, collect a blood sample to determine plasma paracetamol levels.
Treatment includes administration of the antidote, N-acetylcysteine (NAC), given intravenously or orally, preferably within 10 hours. However, NAC may still provide some protective effect beyond 10 hours, although prolonged treatment is required in such cases.
Symptomatic treatment.
Liver enzyme tests should be performed at the start of treatment and repeated every 24 hours. In most cases, liver transaminases return to normal within one to two weeks, with full recovery of liver function. In very severe cases, liver transplantation may be necessary.

Interference with diagnostic tests
Paracetamol may affect the results of the following laboratory tests:
Blood: increased (biological) levels of transaminases (ALT and AST), alkaline phosphatase, ammonia, bilirubin, creatine, lactate dehydrogenase (LDH), and urea; increased (interference with assay) levels of glucose, theophylline, and uric acid; increased prothrombin time (in patients on maintenance warfarin therapy, but without clinical significance). Decreased (interference with assay) glucose levels when using the peroxidase-oxidase method.
Urine: false increases in metanephrine and uric acid levels may occur.
Bentiromide test for pancreatic dysfunction: paracetamol, like bentiromide, is metabolized to an arylamine, thus increasing the apparent amount of para-aminobenzoic acid (PABA) recovered. It is recommended that paracetamol be discontinued at least three days before bentiromide administration.
Urinary 5-hydroxyindoleacetic acid (5-HIAA) assays: paracetamol may cause false-positive results in qualitative screening tests using nitroso-naphthol as reagent. Quantitative tests remain unaffected.

Special precautions for disposal and handling
Before use, the product must be visually inspected for particulate matter and discoloration. Do not reuse. Unused solution must be discarded.
The diluted solution must be visually inspected and must not be used if opalescence, visible particles, or precipitates are present.
For further information, consult the Summary of Product Characteristics.