Prospecto: information for the user

Propofol Lipuro 5mg/ml injectable emulsion and for perfusion

Propofol

Read this prospectus carefully before starting to usethismedication, because it contains important information for you.

• Conserve this prospectus, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• If you experience adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospectus.See section4.

1. What isPropofol Lipuroand for what it is used

2. What you need to know before starting to usePropofol Lipuro

3. How to usePropofol Lipuro

4. Possible adverse effects

5. Conservation ofPropofol Lipuro

6. Contents of the package and additional information

Propofol Lipuro belongs to a group of medicines called general anesthetics. General anesthetics are used to produce unconsciousness (sleep) so that surgical operations or other procedures can be performed. They can also be used to sedate you (so that you are drowsy but not completely asleep).

Propofol Lipuro is used for:

• inducing general anesthesia in adults and children over 1 month of age,
• sedating adult patients during diagnostic and surgical procedures for a short period of time, alone or in combination with local or regional anesthesia,

inducing sedation in adults and children over 1 month of age during diagnostic and surgical procedures

What you need to know before starting to use Propofol Lipuro

Do not use Propofol Lipuro

• If you are allergic to propofol, soy, peanuts, or any of the other components of this medication (listed in section6).
• For maintenance of general anesthesia or sedation in diagnostic procedures and surgical interventions in children
• For sedation in intensive care.

Warnings and precautions

Consult your doctor or pharmacist before starting to receive Propofol Lipuro.

Special care should be taken

• if you have severe head injuries,
• if you have mitochondrial disease, if you suffer from any disorder in which your body does not handle fats properly,
• if you suffer from any other health problem that requires careful use of fatty emulsions,
• if your blood volume is too low (hypovolemia),
• if you have a low concentration of proteins in your blood (hypoproteinemia),
• if you are very weak or suffer from any cardiac, renal, or hepatic problems,
• if you have high pressure in the skull,
• if you have any respiratory problems,
• if you suffer from epilepsy,
• if you are undergoing some procedures in which spontaneous movements are undesirable.

Inform your doctor if you suffer from any of these diseases or disorders.

If you are receiving other lipids by infusion in your vein simultaneously, your doctor will pay special attention to your total daily fat intake.

Propofol will be administered by a specialist doctor in anesthesia or intensive care.You will be constantly monitored during anesthesia and the recovery period.

If you experience signs of the so-called "propofol infusion syndrome" (see section4, "Possible adverse effects", "Call a doctor immediately if any of the following effects occur") your doctor will stopimmediatelythe administration of propofol.

See also in the section "Driving and operating machines" the precautions you should take after using propofol.

Children and adolescents

The use of Propofol Lipuro is not recommended in newborns.

Other medications and Propofol Lipuro

Inform your doctor or pharmacist if you are taking or have taken recently or may need to take any other medication.

Propofol has been used with efficacy for different regional anesthesia techniques, which numb only a part of the body (epidural and spinal anesthesia).

It has also been demonstrated to be safe in combination with

• medications you receive before surgery,
• other medications, such as muscle relaxants,
• inhalable anesthetics,
• analgesics.

However, your doctor may administer lower doses of propofol if general anesthesia or sedation is necessary as a supplement to regional anesthesia techniques.

Your doctor should take into account that the administration of propofol with other medications that inhibit the central nervous system may increase the effects of propofol.You may develop a deep drop in blood pressure if you receive rifampicin-containing antibiotics simultaneously.

Your doctor may reduce the dose if you are also receiving valproate (anticonvulsant) treatment.

Use ofPropofol Lipuro and alcohol

Your doctor will inform you about alcohol consumption before and after using Propofol Lipuro.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Propofol Lipuro should not be used during pregnancy unless absolutely necessary. It crosses the placenta and can depress the vital functions of the baby.

However, propofol can be used during induced abortion.

If you are breastfeeding, you should interrupt and discard breast milk for 24hours after receiving Propofol Lipuro. Studies in lactating women have shown that propofol passes in small amounts to breast milk.

Driving and operating machines

Do not drive or operate machines for a time after receiving an injection or infusion of Propofol Lipuro.

Your doctor will indicate

• if you should be accompanied when leaving,
• when you can drive and use machines again,
• the use of other tranquilizing medications (e.g., tranquilizers, potent analgesics, alcohol).

Propofol Lipuro contains sodium and soy oil

This medication contains less than 1mmol of sodium (23mg) per 20ml; it is essentially "sodium-free".

Propofol Lipuro contains soy oil.Do not use this medication in case of allergy to peanuts or soy.

Propofol Lipuro will only be administered by individuals who have received training in anesthesia administration or by specially trained doctors in a hospital or day treatment unit that is properly equipped.

Dosage

The dose you receive will vary, depending on your age, body weight, and physical condition. The doctor will administer the correct dose to start anesthesia or to achieve the desired level of sedation, by carefully observing your responses and vital signs (pulse, blood pressure, breathing, etc.).

The doctor will observe the maximum administration time, if necessary.

Propofol Lipuro will only be administered for a maximum of 1 hour.

Administration Form

You will receive Propofol Lipuro by intravenous injection or infusion, that is, through a small needle or a small tube placed in one of your veins. If administered by infusion, it may be previously diluted.

Your circulation and breathing will be constantly monitored while you receive the injection or infusion.

If you have received more Propofol Lipuro than you should

This is unlikely to happen, because the doses you receive are carefully controlled.

However, if you accidentally receive an overdose, this could lead to cardiac and respiratory depression. In this case, your doctor will immediately administer the necessary treatment.

If you have any further questions about the use of this product, ask your doctor or pharmacist.

.

Like all medications, Propofol Lipuro 5mg/ml, may cause adverse effects, although not everyone will experience them.

Call a doctor immediately if any of the following effects occur

Frequent (may affect between 1 and 10 out of every 100people):

• Decrease in blood pressure that may occasionally require the administration of fluids and a reduction in the rate of propofol administration.
• Very slow heartbeats, which may be serious in rare cases.

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

• Seizures like those in epilepsy

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

• Allergic reactions up to anaphylactic shock, such as swelling of the face, tongue, or throat, hissing breathing, skin redness, and low blood pressure.

• There have been cases of postoperative loss of consciousness. Therefore, you will be closely monitored during the recovery period.
• Pulmonary edema after propofol administration.
• Pancreatitis inflammation.

Unknown frequency(cannot be calculated from available data):

• Isolated cases of adverse reactions have been reported, presenting as a combination of the following symptoms: muscle tissue degradation, accumulation of acidic substances in the blood, abnormally high potassium levels in the blood, high levels of fats in the blood, abnormal ECG (Brugada type), liver enlargement, irregular heartbeats, renal insufficiency, and heart failure. This has been called the“propofol infusion syndrome”. Some of the reported cases have had a fatal outcome. These effects have only been observed in intensive care patients, mainly in patients with severe head injuries and children with respiratory tract infections who received doses exceeding 4mg of propofol per kg of body weight and per hour. See also section2, "Warnings and precautions".
• Hepatitis (liver inflammation), acute liver failure (symptoms may include yellow skin and eyes, itching, dark urine, stomach pain, and hepatic sensitivity (indicated by pain below the front of the thoracic cage on the right side), sometimes with loss of appetite).

Other side effects are as follows:

Very frequent(may affect more than 1 in every 10people):

• Pain at the injection site, produced during the first injection. The pain can be reduced by injecting propofol into the large veins of the forearm. Simultaneous injection of lidocaine (a local anesthetic) and propofol also helps to reduce pain at the injection site.

Frequent(may affect up to 1 in every 10people):

• Brief interruption of breathing.

• Headache during the recovery period

• Nausea or vomiting during the recovery period

Infrequent(may affect up to 1 in every 100people):

• Thrombosis in veins or inflammation of veins at the injection site

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

• Loss of sexual control during recovery
• Abnormal urine color after prolonged administration of propofol
• Cases of fever after surgery
• Tissue damage after accidental injection of the medication outside the vein

Unknown (frequency cannot be calculated from available data):

• Involuntary movements
• Abnormally good mood
• Drug abuse and dependence
• Heart failure
• Cardiac arrest
• Shallow breathing
• Prolonged and painful erection of the penis
• Pain and/or swelling at the injection site after accidental injection of the medication outside the vein
• Very rarely, muscle tissue degradation has been reported in cases where propofol was administered in doses exceeding the recommended amounts for sedation in intensive care units.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through theSistema Español de Farmacovigilancia de Medicamentos de Uso Humano:www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the label and packaging. The expiration date is the last day of the month indicated.

Do not store above 25°C. Do not freeze.

Propofol Lipuro must be used immediately after opening/diluting.

Do not use Propofol Lipuro if two separate layers are observed after shaking the product or if it does not have a white milky color.

Composition of Propofol Lipuro

• The active principle is propofol.

Each milliliter of Propofol Lipuro 5mg/ml contains 5mg of propofol.

1 vial of 20ml contains 100mg propofol.

• The other components are:

Refined soybean oil,

Medium-chain triglycerides,

Egg phospholipids for injectable preparations,

Glycerol,

Sodium oleate,

Water for injectable preparations.

Appearance of Propofol Lipuro and packaging contents

It is an injectable and infusion emulsion.

It is a water-in-oil emulsion, white and milky in color.

It is presented in 20ml glass vials, available in packs of 5vials.

Marketing authorization holder, manufacturer and local representative

Marketing authorization holder and manufacturer

B. Braun Melsungen AG

Carl-Braun-Straße 1Postal address:

34212 Melsungen34209 Melsungen, Germany

Phone:+49/5661/71-0

Fax:+49/5661/71-4567

Local representative

B Braun Medical, SA

Ctra Terrasa, 121.

08191 Rubí (Spain)

This medicine is authorized in the member states of the European Economic Area and in the United Kingdom (Northern Ireland) with the following names:

GermanyPropofol-Lipuro 5mg/ml Emulsion for injection or infusion

AustriaPropofol-Lipuro 5mg/ml Emulsion for injection or infusion

DenmarkPropofol “B.Braun” 5mg/ml

SlovakiaPropofol Lipuro 0.5% (5mg/ml)

SpainPropofol Lipuro 5mg/ml

FinlandPropofol Lipuro 5mg/ml

FrancePropofol Lipuro 5mg/ml

HungaryPropofol Lipuro 5mg/ml

IrelandPropofol Lipuro 0.5% (5mg/ml)

ItalyPropofol B.Braun 0.5%

LuxembourgPropofol-Lipuro 5mg/ml Emulsion for injection or infusion

NorwayPropofol Lipuro 5mg/ml

PolandPropofol Lipuro 5mg/ml

PortugalPropofol Lipuro 0.5% (5mg/ml)

United Kingdom (Northern Ireland)Propofol Lipuro 0.5% (5mg/ml)

Czech RepublicPropofol Lipuro 0.5% (5mg/ml)

SwedenPropofol Lipuro 5mg/ml

Last review date of this leaflet:07/2024

The detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)

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This information is intended solely for healthcare professionals:

The containers are for single use, in a single patient.

The containers must be shaken before use.

Before use, the neck of the vial should be cleaned with medicinal alcohol (in a spray or with a cotton swab soaked in it).

Any unused emulsion should be discarded at the end of administration.The elimination of unused medication and all materials that have come into contact with it will be carried out in accordance with local regulations.

For complete information on this medicine, consult the product characteristics summary.