Propofol farmak

Patient Information Leaflet

Propofol Farmak, 10 mg/mL, emulsion for injection / for infusion
Propofolum
Please read all of this leaflet carefully before the medicine is administered, because it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, 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.

Table of contents:

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

1. What Propofol Farmak is and what it is used for

Propofol Farmak contains the active substance propofol. Propofol Farmak belongs to a group of medicines called general anaesthetics. General anaesthetics are used to induce loss of consciousness (sleep) to allow surgery or other procedures to be performed. These medicines may also be used to achieve sedation (a state in which the patient is sleepy but not fully unconscious).
Propofol Farmak will be administered to the patient as an injection or infusion by a doctor.
Propofol Farmak 10 mg/mL is used for:

• induction and maintenance of general anaesthesia in adults, adolescents and children over 1 month of age;
• sedation of mechanically ventilated patients over 16 years of age in intensive care units;
• sedation of adults, adolescents and children over 1 month of age undergoing diagnostic and surgical procedures, either as a single medicinal product or in combination with other medicinal products used to induce local or regional anaesthesia.

2. Important information before using Propofol Farmak

When not to use Propofol Farmak:

• if the patient is allergic to propofol, peanuts, soy, or any of the other ingredients of this medicine (listed in section 6),
• for sedation of patients aged 16 years or younger requiring intensive medical care.

Warnings and precautions
Please consult a doctor or anaesthesiologist before administering Propofol Farmak, and if any of the conditions listed below apply or have previously applied to the patient.
Propofol Farmak must be administered with special caution and under intensive monitoring in patients:

• with advanced heart failure
• with other severe heart diseases
• undergoing electroconvulsive therapy (electroconvulsive therapy used in psychiatric treatment).

Propofol Farmak should be used with caution in elderly and debilitated patients.
Before administering Propofol Farmak, inform the anaesthesiologist or intensive care physician if the patient has:

• heart disease
• lung disease
• kidney disease
• liver disease
• seizures (epilepsy)
• increased intracranial pressure (increased intracranial pressure); in combination with low blood pressure, blood flow to the brain may be reduced
• altered blood lipid levels; if the patient is receiving total parenteral nutrition (nutrition via a vein), blood lipid levels should be monitored
• significant fluid loss from the body (dehydration).

Prior to administration of Propofol Farmak, the following conditions must be treated in the patient:

• heart failure
• inadequate tissue perfusion (circulatory failure)
• severe breathing difficulties (respiratory failure)
• dehydration (hypovolemia)
• seizures (epilepsy).

Propofol Farmak may increase the risk of:

• epileptic seizures
• vagal reflex causing slowed heart rate (vagotonia, bradycardia)
• changes in organ perfusion (haemodynamic effects on the cardiovascular system) if the patient is overweight and receives high doses of Propofol Farmak.

During sedation with Propofol Farmak, involuntary movements may occur in the patient.
The doctor will consider how this may affect the surgical procedure performed under sedation and take necessary precautions.
Very rarely, after anaesthesia, a postoperative period of unconsciousness with associated increased muscle tone may occur. The patient should be monitored, but no additional treatment is required. Recovery of consciousness occurs spontaneously.
Injection of Propofol Farmak may be painful. To reduce pain, a local anaesthetic may be used, but its use may cause adverse reactions.
The patient may leave the hospital only after full recovery of consciousness.
If the patient is discharged soon after propofol administration, another person should accompany them home.

Children and adolescents
Use of Propofol Farmak 10 mg/mL, emulsion for injection/infusion is not recommended in neonates and children under 1 month of age.
Propofol Farmak must not be used for sedation in children and adolescents under 16 years of age in intensive care units, as the safety of propofol use for this indication has not been established in this age group.

Propofol Farmak and other medicines
Inform the doctor about all medicines currently taken or recently taken by the patient, as well as any medicines the patient plans to use, including those available without a prescription.
In particular, inform the attending physician, anaesthesiologist, or nurse if the patient is taking any of the following medicines:

• rifampicin (a medicine used to treat tuberculosis)
• midazolam (a medicine used to induce sedation (a deep state of calmness, drowsiness, or sleep), relieve anxiety symptoms, and reduce muscle tension).

Exercise special caution if the patient is taking and/or concurrently receiving any of the following medicines:

• medicines used for premedication (the anaesthesiologist will know which medicines may interact with Propofol Farmak)
• other anaesthetics, including general, regional, and local anaesthetics, and inhaled anaesthetic agents (the anaesthesiologist may decide to reduce the dose of Propofol Farmak)
• analgesics (painkillers)
• strong analgesics (fentanyl or opioids)
• parasympatholytic medicines (used for painful spasms, asthma, and Parkinson's disease)
• benzodiazepines (sedative medicines)
• suxamethonium (a muscle relaxant)
• medicines that may affect internal body functions such as heart rhythm, e.g. atropine
• medicines and beverages containing alcohol
• neostigmine (a medicine used to treat muscle weakness)
• cyclosporine (a medicine used to prevent transplant rejection)
• valproate (a medicine used to treat epilepsy and psychiatric disorders).

Propofol Farmak, food, drink, and alcohol
After administration of Propofol Farmak, the patient should not eat, drink, or consume alcohol until full consciousness is regained.

Pregnancy, breastfeeding, and fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor before using this medicine.
The safety of propofol use during pregnancy has not been established. Animal studies have shown reproductive toxicity.
Propofol Farmak should not be used during pregnancy unless absolutely necessary.
However, Propofol Farmak may be used during induced abortion.
Propofol Farmak crosses the placenta and may cause neonatal depression (neonatal drug-induced depression syndrome). Breastfeeding should be interrupted for 24 hours after receiving Propofol Farmak, and all milk collected during this period should be discarded.

Driving and operating machinery
Drowsiness may occur for some time after receiving propofol. Do not drive, operate equipment, or machinery until you are certain that the effects of the medicine have completely worn off.
If the patient returns home soon after propofol administration, they should not drive or return home unaccompanied.
Ask your doctor when you can resume these activities and return to work.

Propofol Farmak contains soybean oil and sodium
Propofol Farmak contains soybean oil. If the patient is allergic to peanuts or soy, this medicine should not be used.
This medicine contains less than 1 mmol (23 mg) of sodium per 100 mL, meaning the medicine is considered "sodium-free".

3. How to use Propofol Farmak

Propofol Farmak will be administered to the patient only in a hospital or on an appropriate therapeutic ward by an anaesthesiologist or a physician specialized in intensive care medicine, or under their direct supervision.

Dosage
The dose of Propofol Farmak varies depending on the patient. The administered dose will depend on the patient's age, body weight, and general condition. The physician will administer the appropriate dose to induce and maintain anaesthesia or achieve the required level of sedation, carefully monitoring the patient's responses and vital signs (pulse, blood pressure, respiration, etc.).

It may be necessary to use additional medications to provide calming effects or full sleep, relieve pain perception, ensure proper respiration, and maintain stable arterial blood pressure. The physician will decide which medications should be used and when they should be administered to the patient.

Use in children and adolescents
Propofol Farmak, 10 mg/mL, emulsion for injection / for infusion is intended for use in children and adolescents above the age of 1 month.
The use of Propofol Farmak, 10 mg/mL, emulsion for injection / for infusion is not recommended in children under 1 month of age.

Propofol Farmak must not be used for sedation in children and adolescents aged 16 years or younger in intensive care units, as the safety of propofol use for this indication has not been established in this age group.

Method of administration
Propofol Farmak is intended for intravenous administration. An anaesthesiologist may use a needle or cannula. Propofol Farmak will be administered intravenously either manually or by means of an electric pump.

Before use, the rubber membrane should be cleaned with alcohol spray or an alcohol-soaked swab.

Duration of treatment
When Propofol Farmak is used for sedation, it must not be administered for longer than 7 days.

Overdose of Propofol Farmak
If a patient receives more propofol than recommended, circulatory and respiratory depression may occur. In case of respiratory arrest, artificial ventilation is required; in case of low blood pressure, standard measures should be applied, such as positioning the patient's head low, and if necessary, administration of plasma substitutes (blood volume expanders) and vasoconstrictor drugs.

The physician will ensure that the patient receives an appropriate dose of propofol according to the procedure being performed. However, different patients require different doses of the drug. If a patient receives too high a dose of the medication, the anaesthesiologist will initiate appropriate interventions to ensure adequate cardiac and respiratory function.

If you have any further questions regarding the use of this medicine, please consult your physician, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Adverse effects occurring during anaesthesia

During anaesthesia (during injection and when the patient is drowsy or fully unconscious), the adverse effects listed below may occur. The doctor will monitor for these. If any of these adverse effects occur, the doctor will provide appropriate treatment.

Very common (may affect more than 1 in 10 patients)

• Pain at the injection site (during injection, before the patient falls asleep)

Common (may affect up to 1 in 10 patients)

• Slow or fast heartbeat
• Low blood pressure
• Changes in breathing pattern (shallow breathing, apnoea)
• Hiccups
• Cough (may also occur during emergence from anaesthesia)

Uncommon (may affect up to 1 in 100 patients)

• Swelling, redness along the vein where the medicine was administered, or blood clots

Rare (may affect up to 1 in 1,000 patients)

• Body tremors, shaking, or seizures (may also occur during emergence from anaesthesia)

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

• Severe allergic reaction causing breathing difficulties, skin swelling and redness, hot flushes. Fluid accumulation in the lungs, leading to severe breathing difficulties (may also occur during emergence from anaesthesia)
• Change in urine colour (may also occur during emergence from anaesthesia)

Frequency not known (cannot be estimated from available data)

• Involuntary movements
• Severe skin and tissue reactions following accidental extravasation (injection outside the vein)
• Prolonged, often painful erection (priapism)

Adverse effects that may occur after emergence from anaesthesia

The following adverse effects may occur after emergence from anaesthesia (during waking up or once the patient is awake):

Common (may affect up to 1 in 10 patients)

• Headache
• Nausea, vomiting
• Cough

Rare (may affect up to 1 in 1,000 patients)

• Dizziness, chills, and feeling cold
• Agitation

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

• Postoperative loss of consciousness (in such cases, patients returned to consciousness without complications)
• Pancreatitis, causing severe abdominal pain (causal relationship not established)
• Postoperative fever

Frequency not known (cannot be estimated from available data)

• Euphoria
• Sexual arousal
• Irregular heartbeat
• Changes in ECG pattern (corresponding to Brugada syndrome)
• Liver enlargement
• Kidney failure
• Muscle damage (rhabdomyolysis), increased blood acidity, high potassium levels in blood, high blood lipid levels, heart failure
• Misuse of the medicine, primarily by healthcare professionals
• Prolonged, often painful erection (priapism)
• Hepatitis, acute liver failure [symptoms may include yellowing of the skin and eyes (jaundice), itching, dark urine, abdominal pain, and liver tenderness on palpation (indicated as pain under the front part of the rib cage on the right side of the body), sometimes with loss of appetite]

When Propofol Farmak is administered in combination with lidocaine (a local anaesthetic used to reduce injection site pain), the following adverse effects may rarely occur:

• Dizziness
• Vomiting
• Drowsiness
• Seizures
• Slow heartbeat (bradycardia)
• Irregular heartbeat (arrhythmia)
• Shock

Reporting of adverse effects

If any adverse effects occur, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse effects can 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

Adverse effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps to provide more information on the safety of this medicine.

5. How to store Propofol Farmak

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the ampoule/vial and the cardboard
pack after "EXP". The expiry date refers to the last day of the stated month. Do not store above
25°C. Do not freeze.
After first opening, the medicine must be used immediately.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the package and other information

What Propofol Farmak contains

• The active substance is propofol. 1 mL of emulsion contains 10 mg of propofol. One 20 mL ampoule/vial contains 200 mg of propofol. One 50 mL vial contains 500 mg of propofol. One 100 mL vial contains 1000 mg of propofol.
• The other ingredients are: purified soybean oil, egg phospholipids, glycerol, sodium hydroxide, disodium edetate, water for injections.

What Propofol Farmak looks like and contents of the pack
Emulsion for injection/for infusion.
Propofol Farmak is a white or almost white, homogeneous emulsion.
Propofol Farmak 10 mg/mL is available in:

• 20 mL ampoules made of colourless glass (type I), with 5 ampoules in a cardboard box
• 20 mL vials made of colourless glass (type I) with a bromobutyl rubber stopper and aluminium seal, with 1 vial or 5 vials in a cardboard box
• 50 mL and 100 mL vials made of colourless glass (type I) with a bromobutyl rubber stopper and aluminium seal, with 1 vial or 10 vials in a cardboard box.

Not all pack sizes may be marketed.
Marketing Authorisation Holder
Farmak International Sp. z o.o.
Koszykowa 65
00-667 Warsaw
tel. +42 22 822 93 06
Importer
Farmak International Sp. z o.o.
Piłsudskiego 141
92-318 Łódź
This medicinal product is authorised for marketing in the European Economic Area countries under the following names:
Germany: Propofol Aspire Pharma
Poland: Propofol Farmak
Spain: Propofol Farmak 10 mg/ml solution for injection and infusion EFG

Information intended exclusively for healthcare professionals:

Detailed information about this medicinal product is available in the Product Characteristics, accessible on the website of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: www.urpl.gov.pl