PACKAGE LEAFLET: INFORMATION FOR THE USER

HYGIGAL

10 mg/ml solution for infusion
Paracetamol
Equivalent medicine
Read this leaflet carefully before using this medicine

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, because it could be harmful.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or nurse. See section 4.

Contents of this leaflet

What HYGIGAL 10 mg/ml solution for infusion is and what it is used for
What you need to know before using HYGIGAL 10 mg/ml solution for infusion
How to use HYGIGAL 10 mg/ml solution for infusion
Possible side effects
How to store HYGIGAL 10 mg/ml solution for infusion
Contents of the pack and other information

1. WHAT HYGIGAL 10 mg/ml INFUSION SOLUTION IS AND WHAT IT IS USED FOR

This medicinal product contains the active substance paracetamol, which is an analgesic (relieves pain) and an antipyretic (reduces fever).
It is indicated for the short-term treatment of moderate pain, particularly following surgical procedures, and for the short-term treatment of fever.
The 100 ml vial is intended for use only in adults, adolescents, and children with a body weight above 33 kg.

2. WHAT YOU SHOULD KNOW BEFORE USING HYGIGAL 10 mg/ml solution for infusion

Do not use HYGIGAL 10 mg/ml solution for infusion

if you are allergic (hypersensitive) to paracetamol or to any of the excipients of Hygigal;
if you are allergic (hypersensitive) to propacetamol (another analgesic for infusion and a precursor of paracetamol);
if you have severe liver disease.

Warnings and precautions
Talk to your doctor or pharmacist before using HYGIGAL 10 mg/ml solution for infusion
Exercise special caution with HYGIGAL 10 mg/ml solution for infusion

use appropriate oral analgesic treatment as soon as this route of administration becomes possible;
if you have liver or kidney disease or alcohol abuse;
if you are taking other medicines containing paracetamol;
in case of nutritional problems (malnutrition) or dehydration;
if you have a hereditary condition presenting with yellowish skin discoloration (Gilbert's syndrome);
if you have a rare hereditary disorder characterized by low levels of an enzyme known as glucose-6-phosphate dehydrogenase.

Inform your doctor before treatment if you fall into any of the above conditions.
During treatment with HYGIGAL 10 mg/ml solution for infusion, inform your doctor immediately if:
you have serious illnesses, including severe renal impairment or sepsis (when bacteria and their toxins circulate in the blood causing organ damage), or malnutrition, chronic alcoholism, or if you are also taking flucloxacillin (an antibiotic). In patients with these conditions, a serious condition called metabolic acidosis (an abnormality in blood and body fluids) has been reported when paracetamol is used at regular doses over a prolonged period or when paracetamol is taken concomitantly with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties with deep, rapid breathing, drowsiness, nausea, and vomiting.

Taking HYGIGAL 10 mg/ml solution for infusion with other medicines
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
This medicine contains paracetamol, which must be taken into account when using other medicines containing paracetamol or propacetamol, to avoid exceeding the recommended daily dose (see next section). Inform your doctor if you are taking other medicines containing paracetamol or propacetamol.
If you are being treated concomitantly with probenecid, a reduction in the dose of paracetamol should be considered.
Inform your doctor or pharmacist if you are taking oral anticoagulants. More frequent monitoring of the anticoagulant effect may be required.
Inform your doctor or pharmacist if you are taking

flucloxacillin (an antibiotic), due to a serious risk of blood and fluid abnormalities (called high anion gap metabolic acidosis) that require urgent treatment (see section 2 “Warnings and precautions”).

Pregnancy and breastfeeding
Pregnancy
Inform your doctor if you are pregnant. If necessary, HYGIGAL may be used during pregnancy. You should use the lowest possible dose that reduces pain and/or fever, and use it for the shortest possible time.
Contact your doctor if pain and/or fever do not improve or if you need to take the medicine more frequently.
Ask your doctor or pharmacist for advice before taking any medicine.

Breastfeeding
HYGIGAL may be used during breastfeeding.
Ask your doctor or pharmacist for advice before taking any medicine.

Important information about some excipients of HYGIGAL 10 mg/ml solution for infusion
This medicine contains less than 1 millimole of sodium (23 mg) per 100 ml of Hygigal, i.e. it is practically “sodium-free”.

3. HOW TO USE HYGIGAL 10 mg/ml infusion solution

Hygigal will be administered to you by a healthcare professional through infusion into one of your veins.
The dose will be individually adjusted by the doctor, according to your body weight and general condition.
If you feel that the effect of HYGIGAL 10 mg/ml infusion solution is too strong or too weak, consult your doctor.
If you use more HYGIGAL 10 mg/ml infusion solution than you should, contact your doctor or pharmacist immediately.
In case of overdose, symptoms generally appear within the first 24 hours and include: nausea, vomiting, anorexia, pallor, abdominal pain and risk of liver damage.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, HYGIGAL 10 mg/ml infusion solution can cause adverse reactions, although
not everyone experiences them.
The following adverse reactions may occur:

Rare (may affect up to 1 in 1,000 people): malaise, drop in blood pressure, or changes in laboratory test results (abnormal increase in liver enzyme levels detected in blood tests). In this case, inform your doctor, as regular blood tests may subsequently be required.
Very rare (may affect up to 1 in 10,000 people): severe allergic reactions (such as skin rash, urticaria, anaphylactic shock). In these cases, stop treatment immediately and inform your doctor.
Very rare (may affect up to 1 in 10,000 people): abnormal decrease in levels of certain types of blood cells (platelets, white blood cells), possibly leading to bleeding from the nose or gums. In these cases, inform your doctor.
Not known (frequency cannot be estimated from the available data): severe condition causing the blood to become excessively acidic (called metabolic acidosis), in patients with serious underlying illness using paracetamol (see section 2).

Cases of skin flushing, redness, itching, and abnormally rapid heartbeat have been reported.
Cases of pain and burning sensation at the site of administration have also been reported.

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

5. HOW TO STORE HYGIGAL 10 mg/ml infusion solution

Keep this medicine out of the sight and reach of children.
Do not use HYGIGAL 10 mg/ml infusion solution after the expiry date stated on the packaging after "Exp.".
The expiry date refers to the last day of the month.
Store in the original packaging to protect the medicine from light. Do not refrigerate or freeze.
Before administration, the solution should be inspected visually. HYGIGAL must not be used if particles or discoloration are observed.
For single use only. The medicine must be used immediately after opening. Any unused solution must be discarded.

6. PACKAGING CONTENTS AND OTHER INFORMATION

What HYGIGAL 10 mg/ml infusion solution contains

The active substance is paracetamol. 1 ml contains 10 mg of paracetamol.
The excipients are: cisteine hydrochloride monohydrate, disodium phosphate dihydrate, hydrochloric acid, mannitol, sodium hydroxide, water for injections, nitrogen.

Description of the appearance of HYGIGAL 10 mg/ml infusion solution and contents of the pack
100 ml vial
HYGIGAL 10 mg/ml infusion solution is a clear, slightly yellowish solution.
HYGIGAL 10 mg/ml infusion solution is available in packs of 1 vial or 20 vials.
It is possible that not all pack sizes or presentations are marketed.

Marketing Authorization Holder
Industria Farmaceutica Galenica Senese S.r.l., Via Cassia Nord 351 - 53014 Monteroni d’Arbia (Siena)

Responsible person for batch release
Industria Farmaceutica Galenica Senese S.r.l., Via Cassia Nord 351 - 53014 Monteroni d’Arbia (Siena)

Other sources of information

The following information is intended for healthcare professionals
For intravenous use.
The 100 ml vial is intended for adults, adolescents, and children with a body weight above 33 kg.
Close monitoring is required before the end of the infusion.

Dosage
The dose is determined according to the patient's body weight (refer to the table below)

Patient weight >33 kg to ≤50 kg >50 kg with additional risk factors for hepatotoxicity >50 kg without additional risk factors for hepatotoxicity	Dose per administration	Volume per administration	Maximum volume of Hygigal (10 mg/mL) per administration based on upper weight limit of group (mL)**	Maximum daily dose ***
	15 mg/kg	1.5 mL/kg	75 mL	60 mg/kg up to a maximum of 3 g
	1 g	100 mL	100 mL	3 g
	1 g	100 mL	100 mL	4 g

**Patients with lower body weight require reduced volumes.
The minimum interval between each administration must be at least 4 hours. No more than 4 doses should be
administered within 24 hours.
The minimum interval between each administration in patients with severe renal impairment must be
at least 6 hours.
***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.
Method of administration
RISK OF THERAPEUTIC ERRORS
Take care to avoid dosing errors due to confusion between milligrams (mg) and millilitres (mL), which
can lead to accidental overdose and death.
Paracetamol in solution is administered as a 15-minute intravenous infusion.
The diluted solution should be inspected visually and must not be used if it is opalescent, contains visible particles or precipitates.