Propofol farmak

Patient Information Leaflet

Propofol Farmak, 20 mg/mL, emulsion for injection/infusion
Propofolum
Please read all of this leaflet carefully before this medicine is administered, because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the leaflet:

1. What Propofol Farmak is and what it is used for
2. What you need to know before Propofol Farmak is administered
3. How Propofol Farmak is administered
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 cause loss of consciousness (sleep) so that surgery or other procedures can 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 20 mg/mL will be given to you by infusion, administered by a doctor.
Propofol Farmak 20 mg/mL is used:

• for induction and maintenance of general anaesthesia in adults, adolescents, and children over 3 years of age;
• for sedation of artificially ventilated patients over 16 years of age in intensive care units;
• for sedation of adults, adolescents, and children over 3 years 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 care.

Warnings and precautions
Consult a doctor or anaesthesiologist before administering Propofol Farmak, and if any of the following conditions apply or have previously applied to the patient.
Propofol Farmak must be used with special caution and 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 physician in the intensive care unit if the patient has:

• heart disease,
• lung disease,
• kidney disease,
• liver disease,
• seizures (epilepsy),
• increased intracranial pressure (elevated intracranial pressure); in combination with low blood pressure, cerebral blood flow 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).

The following conditions must be treated prior to administration of Propofol Farmak:

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

Propofol Farmak may increase the risk of:

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

Involuntary movements may occur in the patient during sedation with Propofol Farmak.
The physician will consider how this may affect the surgical procedure performed under sedation and will take necessary precautions.
Very rarely, postoperative unconsciousness with associated increased muscle tone may occur after anaesthesia. The patient should be monitored, but no additional treatment is required. Consciousness returns 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 be discharged from hospital only after full recovery of consciousness.
If the patient is discharged home shortly after receiving propofol, another person should accompany them.

Children and adolescents
Use of Propofol Farmak 20 mg/mL, emulsion for injection/infusion, is not recommended in children under 3 years 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 the patient is currently taking or has recently taken, including those obtained without a prescription, as well as any medicines the patient plans to use.
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).

Special caution is required 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 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 with food, drink, and alcohol
After administration of Propofol Farmak, the patient must not eat, drink, or consume alcohol until full consciousness is regained.

Pregnancy, breastfeeding, and effects on fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her 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 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 is discharged home shortly after receiving propofol, they should not drive or return home unaccompanied.
Ask your doctor when it is safe to resume these activities and return to work.

Propofol Farmak contains soy oil and sodium
Propofol Farmak contains soy 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 it 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 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 other medications to provide calming effects or full sleep, relieve pain perception, ensure proper breathing, and maintain stable arterial blood pressure. The physician will decide which medications should be used and when to administer them to the patient.
Use in children and adolescents
Propofol Farmak, 20 mg/mL, emulsion for injection/infusion is intended for use in children and adolescents above three years of age.
Use of Propofol Farmak, 20 mg/mL, emulsion for injection/infusion is not recommended in children under 3 years 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 for this indication has not been established in this age group.
Method of administration
Propofol Farmak is intended for intravenous administration. The 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 stopper 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.
Administration of a higher than recommended dose 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, possibly administering plasma substitutes (blood volume expanders), and, if necessary, 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 drug, the anaesthesiologist will initiate appropriate interventions to ensure proper cardiac and respiratory function.
If you have any further doubts regarding the use of this medicinal product, 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 completely unconscious), the adverse effects listed below may occur. The doctor will monitor for these. If such 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 less than 1 in 10 patients)

• slow or fast heartbeat
• low blood pressure
• changes in breathing (reduced breathing rate, respiratory arrest)
• hiccups
• coughing (may also occur during emergence from anaesthesia)

Uncommon (may affect less than 1 in 100 patients)

• swelling and redness along the vein where the medicine was administered or blood clots

Rare (may affect less than 1 in 1,000 patients)

• body tremors, shaking or convulsions (may also occur during emergence from anaesthesia)

Very rare (may affect less than 1 in 10,000 patients)

• severe allergic reaction causing breathing difficulties, skin swelling and redness, hot flushes. Fluid accumulation in the lungs, which makes breathing very difficult (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 less than 1 in 10 patients)

• headache
• nausea, vomiting
• coughing

Rare (may affect less than 1 in 1,000 patients)

• dizziness, shivering and feeling cold
• agitation

Very rare (may affect less than 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 (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, mainly by healthcare professionals
• prolonged, often painful erection (priapism)
• hepatitis, acute liver failure [symptoms may include yellowing of the skin and eyes, 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
• convulsions
• slow heartbeat (bradycardia)
• irregular heartbeat (arrhythmia)
• shock.

Reporting of adverse effects
If any adverse effects occur, including any 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 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
Adverse effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps provide more information on the safety of the medicine.

5. How to store Propofol Farmak

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the vial and the outer cardboard
box 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 must not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. These measures will help protect
the environment.

6. Contents of the pack and other information

What Propofol Farmak contains

• The active substance is propofol. 1 mL of emulsion contains 20 mg of propofol. One 20 mL vial contains 400 mg of propofol. One 50 mL vial contains 1000 mg of propofol. One 100 mL vial contains 2000 mg of propofol.
• 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
Injectable emulsion / for infusion.
Propofol Farmak is a white or almost white, homogeneous emulsion.
Propofol Farmak 20 mg/mL is available in:

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

Not all pack sizes may be marketed.
Marketing Authorisation Holder
Farmak International Sp. z o.o.
ul. Koszykowa 65
00-667 Warsaw
tel. +42 22 822 93 06
Importer
Farmak International Sp. z o.o.
ul. Piłsudskiego 141
92-318 Łódź
This medicinal product is authorised in the European Economic Area countries under the following names:
Germany: Propofol Aspire Pharma
Poland: Propofol Farmak
Spain: Propofol Farmak 20 mg/ml emulsión inyectable y para perfusión EFG

Information intended exclusively for medical 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