Propofol Farmak

Leaflet attached to the packaging: information for the user

Propofol Farmak, 10 mg/mL, emulsion for injection/infusion

Propofol

Please read carefully the contents of the leaflet before using the medicine, as it contains important information for the patient.

• Please keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, please consult a doctor, pharmacist, or nurse.
• If the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

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

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

Propofol Farmak contains the active substance propofol. Propofol Farmak belongs to a group of medicines called general anesthetics. General anesthetics are used to induce unconsciousness (sleep) to enable surgery or other procedures to be performed. These medicines can also be used to induce sedation (a state in which the patient is drowsy but not completely asleep).

Propofol Farmak will be administered to the patient by injection or infusion by a doctor.

Propofol Farmak 10 mg/mL is used for:

• induction and maintenance of general anesthesia 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, as a single medicinal product or in combination with other medicinal products used to induce local or regional anesthesia.

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 under 16 years of age requiring intensive medical care.

Warnings and precautions

Please consult a doctor or anesthesiologist before using Propofol Farmak, and if any of the following situations apply or have applied to the patient in the past.

Propofol Farmak should be used with caution and under close monitoring in patients:

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

In elderly and debilitated patients, Propofol Farmak should be used with caution.

Before using Propofol Farmak, please inform the anesthesiologist or doctor in the intensive care unit if the patient has:

• heart disease
• lung disease
• kidney disease
• liver disease
• seizures (epilepsy)
• increased intracranial pressure (increased pressure inside the skull), combined with decreased blood pressure, which may reduce blood flow to the brain
• altered blood lipid levels, if the patient is totally parenterally fed (fed through a vein), blood lipid levels should be monitored
• significant water loss from the body (dehydration).

Before using 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:

• seizures
• nerve reflex slowing down heart rate (vagotonia, bradycardia)
• changes in blood flow to the patient's organs (hemodynamic effects on the cardiovascular system) if the patient is overweight and receives high doses of Propofol Farmak.

During sedation with Propofol Farmak, the patient may experience involuntary movements.

The doctor will consider how this may affect the surgical procedure being performed under sedation and will take necessary precautions.

Very rarely, after anesthesia, a postoperative loss of consciousness with accompanying increased muscle tension may occur. The patient should be monitored, but this does not require additional treatment. The patient will recover spontaneously.

The injection of Propofol Farmak can be painful. To reduce pain, a locally acting anesthetic can be used, but its use may cause side effects.

The patient will be able to leave the hospital when they have fully recovered consciousness.

If the patient is to return home soon after receiving propofol, they should be accompanied by another person.

Children and adolescents

Propofol Farmak, 10 mg/mL, emulsion for injection/infusion, is not recommended for use in newborns and children under 1 month of age.

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

Propofol Farmak with other medicines

Please inform the doctor about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take, including those available without a prescription.

In particular, please inform the doctor, anesthesiologist, 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 and relieve anxiety and tension).

Special caution is required if the patient is taking or receiving any of the following medicines:

• premedication drugs (the anesthesiologist will know which drugs may interact with Propofol Farmak)
• other anesthetics, including general, regional, and local anesthetics, as well as inhalation anesthetics (the anesthesiologist may decide to reduce the dose of Propofol Farmak)
• analgesics (pain relievers)
• strong analgesics (fentanyl or opioids)
• parasympatholytic drugs (used to treat spasms, asthma, and Parkinson's disease)
• benzodiazepines (sedatives)
• suxamethonium (a muscle relaxant)
• drugs that may affect the body's internal functions, such as heart rate, e.g., atropine
• drinks containing alcohol
• neostigmine (a medicine used to treat muscle weakness)
• cyclosporin (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 receiving Propofol Farmak, the patient should not eat, drink, or consume alcohol until they have fully recovered consciousness.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult a doctor before using this medicine.

The safety of propofol during pregnancy has not been established. Animal studies have shown a toxic effect on reproduction.

Propofol Farmak should not be used during pregnancy, unless it is absolutely necessary.

However, Propofol Farmak can be used during induced abortion.

Propofol Farmak passes through the placenta and may cause neonatal depression (neonatal depression syndrome). For 24 hours after receiving Propofol Farmak, breastfeeding should be interrupted, and all milk expressed during this period should be discarded.

Driving and using machines

For some time after receiving propofol, drowsiness may occur. The patient should not drive, operate machinery, or use appliances until they are sure that the effect of the medicine has worn off.

If the patient is to return home soon after receiving propofol, they should not drive or return home without an accompanying person.

The patient should ask their doctor when they 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, they should not use this medicine.

This medicine contains less than 1 mmol (23 mg) of sodium per 100 mL, which means that 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 a suitable therapeutic unit by an anesthesiologist or a doctor specialized in intensive care medicine, or under their direct supervision.

Dosage

The dose of Propofol Farmak varies depending on the patient. The dose administered will depend on the patient's age, weight, and condition. The doctor will administer the appropriate dose to induce and maintain anesthesia or achieve the required level of sedation, carefully monitoring the patient's reactions and vital signs (pulse, blood pressure, breathing, etc.).

It may be necessary to use other medicines to induce relaxation or deep sleep, relieve pain, ensure proper breathing, and maintain blood pressure at a stable level. The doctor will decide which medicines to use and when to administer them to the patient.

Use in children and adolescents

Propofol Farmak, 10 mg/mL, emulsion for injection/infusion, is intended for use in children and adolescents over 1 month of age

Propofol Farmak, 10 mg/mL, emulsion for injection/infusion, is not recommended for use in children under 1 month of age.

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

Method of administration

Propofol Farmak is intended for intravenous administration. The anesthesiologist may use a needle or cannula. Propofol Farmak will be injected intravenously manually or using an electric pump.

Before use, the rubber membrane should be cleaned with alcohol spray or a swab moistened with alcohol.

Duration of treatment

When using Propofol Farmak for sedation, it should not be used for more than 7 days.

Use of a higher than recommended dose of Propofol Farmak

If the patient receives more propofol than recommended, they may experience circulatory and respiratory depression. In case of respiratory arrest, artificial respiration is required; in case of low blood pressure, standard measures should be taken, such as placing the patient's head low, possibly using blood substitutes (volume expanders) and, if necessary, vasoconstrictor drugs.

The doctor will ensure that the patient receives the appropriate dose of propofol depending on the procedure being performed. However, different patients require different doses of the medicine. If the patient receives too high a dose of the medicine, the anesthesiologist will take appropriate action to ensure proper heart and respiratory function.

In case of any further doubts about the use of this medicine, please consult a doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Propofol Farmak can cause side effects, although not everybody gets them.

Side effects occurring during anesthesia

During anesthesia (during injection and when the patient is drowsy or completely asleep), the following side effects may occur. The doctor will be aware of this. If such side 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 heart rate
• low blood pressure
• change in breathing pattern (low breathing rate, respiratory arrest)
• hiccups
• cough (may also occur during recovery from anesthesia)

Uncommon (may affect less than 1 in 100 patients)

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

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

• body tremors or convulsions (may also occur during recovery from anesthesia)

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

• severe allergic reaction causing breathing difficulties, swelling, and redness of the skin, flushing. Fluid accumulation in the lungs, which can make breathing very difficult (may also occur during recovery from anesthesia)
• change in urine color (may also occur during recovery from anesthesia)

Frequency not known (cannot be estimated from the available data)

• involuntary movements
• severe skin and tissue reactions after accidental administration of the medicine outside the vein
• prolonged, often painful erection (priapism)

Side effects that may occur after recovery from anesthesia

The following side effects may occur after recovery from anesthesia (during recovery or when the patient is already awake)

Common (may affect less than 1 in 10 patients)

• headache
• nausea, vomiting
• cough

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 recovered consciousness without problems)
• pancreatitis, which causes severe abdominal pain (no causal relationship has been established)

Frequency not known (cannot be estimated from the available data)

• euphoria
• sexual arousal
• irregular heartbeat
• changes in ECG recording (corresponding to Brugada syndrome)
• liver enlargement
• kidney failure
• muscle damage (rhabdomyolysis), increased blood acidity, high potassium levels in the blood, high fat levels in the blood, heart failure
• drug abuse, mainly by medical personnel
• 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 (indicated as pain under the front part of the ribcage, on the right side of the body), sometimes with loss of appetite].

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

• dizziness
• vomiting
• drowsiness
• convulsions
• slow heart rate (bradycardia)
• irregular heartbeat (arrhythmia)
• shock.

Reporting side effects

If side effects occur, including any side effects not listed in the leaflet, the patient should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Pharmacovigilance 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

Side effects can also be reported to the marketing authorization holder.

By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Propofol Farmak

The medicine should be stored out of sight and reach of children.

Do not use this medicine after the expiry date stated on the ampoule/vial and carton after "EXP". The expiry date refers to the last day of the month stated. Do not store above 25°C. Do not freeze.

After first opening, the medicine should be used immediately.

Medicines should not be disposed of via wastewater or household waste. Please ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Propofol Farmak contains

• The active substance of the medicine is propofol. 1 mL of the emulsion contains 10 mg of propofol. 1 ampoule/vial of 20 mL contains 200 mg of propofol. 1 vial of 50 mL contains 500 mg of propofol. 1 vial of 100 mL 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/infusion.

Propofol Farmak is a white or almost white, homogeneous emulsion.

Propofol Farmak 10 mg/mL is available in:

• 20 mL colorless glass (type I) ampoule, in packs of 5 ampoules
• 20 mL colorless glass (type I) vial with a bromobutyl rubber stopper and an aluminum seal, in packs of 5 vials
• 50 mL and 100 mL colorless glass (type I) vial with a bromobutyl rubber stopper and an aluminum seal, in packs of 1 vial.

Not all pack sizes may be marketed.

Marketing authorization 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 medicine is authorized in the Member States of the European Economic Area under the following names:

Germany: Propofol Farmak

Poland: Propofol Farmak

Spain: Propofol Farmak 10 mg/ml emulsión inyectable y para perfusión EFG

Date of last revision of the leaflet:

----------------------------------------------------------------------------------------------

Information intended for healthcare professionals only:

Detailed information on this medicine can be found in the Summary of Product Characteristics available on the website of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: www.urpl.gov.pl