Diprivan 20 mg/ml emulsion for infusion

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Diprivan 20 mg/ml emulsion for infusion

Propofol

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet:

1. What Diprivan is and what it is used for
2. What you need to know before using Diprivan
3. How to use Diprivan
4. Possible side effects
5. How to store Diprivan
6. Further information

1. What Diprivan is and what it is used for

Diprivan belongs to a group of medicines called "general anaesthetics". General anaesthetics are used to produce unconsciousness (sleep) while surgical operations or other procedures are being performed. It may also be used to sedate you (make you feel drowsy but not completely asleep).

Diprivan 20 mg/ml is used for:

• inducing and maintaining general anaesthesia in adults and children over 3 years of age.
• sedating patients over 16 years of age who are on assisted ventilation in intensive care.
• sedating adults and children over 3 years of age during diagnostic and surgical procedures, either alone or in combination with local or regional anaesthesia.

2. What you need to know before using Diprivan

Before administering the anesthetic, the anesthetist, surgeon, or intensive care physician will assess your clinical condition and any treatments you are currently receiving.

Do not use Diprivan

• If you are allergic (hypersensitive) to propofol or to any of the other components of this medicine (listed in section 6).
• If you are allergic to soy or peanuts. This is because Diprivan contains soybean oil.
• In patients aged 16 years or younger for sedation in intensive care.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to use Diprivan if:

• you have ever had an epileptic seizure or convulsion,
• you have ever been told you have very high levels of fat in your blood or have fat metabolism disorders. In these cases, your doctor may need to monitor your blood fat levels,
• you have any other health problems, such as heart, respiratory, kidney, or liver problems, or if you have been unwell for some time,
• you are taking any other medicines, including those purchased without a prescription,
• your body has lost a large amount of fluid (hypovolemia),
• you have prolonged and/or severe diarrhea,
• you have ever been told you have a condition called “mitochondrial disease”,
• you are elderly or frail,
• you have had a brain disorder along with increased pressure inside the skull.

Before undergoing surgery or any procedure requiring anesthesia, it is important to inform your doctor if you have a condition called “hereditary predisposition to acute porphyria.”

In rare cases, if propofol is administered for a prolonged period, you may develop a condition known as propofol infusion syndrome (PRIS). This condition may damage the heart, muscles, or kidneys, cause other serious problems, and may even lead to death. However, your doctor will closely monitor you and take necessary measures to prevent this from occurring.

Children and adolescents

The use of Diprivan is not recommended in newborns.

The use of Diprivan 20 mg/ml is not recommended in children under 3 years of age.

Other medicines and Diprivan

Inform your doctor, pharmacist, or nurse if you are taking, have recently taken, or might need to take any other medicines.

Inform your doctor before using Diprivan if you are taking any of the following medicines:

• strong painkillers (opioid analgesics) for severe pain relief,
• medicines called “parasympatholytics” (e.g., medicines used to treat cramps, asthma, Parkinson’s disease, and other medicines in this group),
• benzodiazepines (medicines used to treat anxiety),
• neostigmine (a medicine used to treat a condition called myasthenia gravis),
• cyclosporine (a medicine used to prevent organ transplant rejection),
• rifampicin (a medicine used to treat tuberculosis),
• dexmedetomidine (used to induce sedation [a very relaxed state of calmness, drowsiness, or sleep]),
• steroids (medicines used to treat asthma, arthritis, immune system disorders, skin diseases, and other conditions),
• medicines that strengthen the heart, such as digoxin (used to treat heart failure),
• medicines to treat epilepsy, such as phenytoin, phenobarbital, and others,
• suxamethonium (a muscle relaxant),
• midazolam (used to induce sedation [a very relaxed state of calmness, drowsiness, or sleep] and to relieve anxiety and muscle tension).

Use of Diprivan with food, drinks, and alcohol

You should avoid consuming alcohol at least 8 hours before and after administration of Diprivan.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor, pharmacist, or nurse before receiving Diprivan.

Diprivan should not be administered to pregnant women unless absolutely necessary.

If you are breastfeeding, you must not breastfeed while receiving Diprivan, and you should discard breast milk for 24 hours after administration of Diprivan.

Driving and using machines

Diprivan may affect your reaction ability. Your doctor or anesthetist will advise you how long you should wait before driving or operating machinery, and will instruct you to be accompanied when returning home. Generally, the effects of propofol wear off within 12 hours after administration ends.

Diprivan contains soybean oil

Diprivan contains soybean oil. Do not use this medicine if you are allergic to peanuts or soy.

Diprivan contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per dose; therefore, it is essentially “sodium-free.”

3. How to use Diprivan

• Diprivan will be administered by, or under the supervision of, your anaesthetist or intensive care doctor.
• Diprivan is given by intravenous infusion (drip) into a vein, usually in the back of the hand or forearm. A needle or a thin plastic tube called a cannula may be used. For long surgical procedures and in intensive care, an electric pump may be used to control the rate of administration.

The dose of Diprivan will vary depending on your age, body weight, and physical condition. Your doctor will administer the appropriate dose to induce and maintain anaesthesia or to achieve the required level of sedation, carefully monitoring your responses and vital signs (pulse, blood pressure, respiration, etc.).

It may be necessary to use several medications to make you fall asleep or feel drowsy, relieve pain, maintain healthy breathing, and keep your blood pressure stable. Your anaesthetist or intensive care doctor will decide which medications to use and when they are needed, and will adjust the dose of Diprivan accordingly depending on the medications used.

4. Possible adverse effects

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

The following adverse effects may occur during induction and maintenance of anaesthesia or sedation with Diprivan (while the injection or infusion is being administered, or when you are drowsy or asleep). Your doctor will monitor you for any adverse effects and, if they occur, will provide appropriate treatment.

Very common: may affect more than 1 in 10 patients

Pain at the injection site (while the injection is being administered, before falling asleep).

Common: may affect 1 to 10 in every 100 patients

• Headache during the recovery phase.
• Slower heart rate.
• Decreased blood pressure (hypotension).
• Changes in your breathing pattern during induction.
• Nausea and vomiting during the recovery phase.

Uncommon: may affect 1 to 10 in every 1,000 patients

• Thrombosis and phlebitis.
• Coughing during maintenance of anaesthesia.

Rare: may affect 1 to 10 in every 10,000 patients

• Twitches, body contractions, or spasms that may occur during induction, maintenance, and recovery from anaesthesia.
• Coughing during induction of anaesthesia.

Very rare: may affect less than 1 in every 10,000 patients

• Severe allergic reaction, including anaphylactic shock.
• Unconsciousness after surgery.
• Fluid accumulation in the lungs.
• Inflammation of the pancreas (pancreatitis).
• Discoloration of urine.
• Sensation of sexual excitement.
• Fever after surgery.
• Tissue damage (necrosis) at the injection site.

Frequency not known (frequency cannot be estimated from available data):

• Metabolic acidosis, increased potassium levels, increased blood fat levels.
• Euphoria, drug abuse, and dependence.
• Involuntary movements.
• Changes in heart rhythm, loss of strength in heartbeats (heart failure), alteration in the nerve signal of the heart detected on electrocardiogram.
• Enlargement of the liver.
• Breakdown of muscle cells (rhabdomyolysis).
• Difficulty breathing.
• Prolonged and often painful erection (priapism).
• Pain and inflammation at the injection site when Diprivan is administered outside the vein.
• Kidney function failure.
• Hepatitis (liver inflammation), acute liver failure (symptoms may include yellowing of the skin and eyes, itching, dark urine, stomach pain, and liver tenderness (indicated by pain below the front of the rib on the right side), sometimes with loss of appetite).

Reporting of adverse effects

If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es/. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Diprivan

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

Keep out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the container following EXP. The expiry date refers to the last day of the month indicated.

After dilution: Use within 6 hours.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Additional information

Composition of Diprivan 20 mg/ml

• The active substance is propofol.
• The other components are refined soybean oil, purified egg phosphatide, glycerol, sodium hydroxide, nitrogen, water for injection, and disodium edetate.

Presentation of the product and contents of the pack

This medicinal product is presented in boxes containing one 50 ml vial of emulsion.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Aspen Pharma Trading Limited
3016 Lake Drive,
Citywest Business Campus,
Dublin 24, Ireland
Tel: +34 952 010 137

Manufacturer:

Corden Pharma S.P.A.
Caponago
Milan (Italy)

Local representative:

ASPEN PHARMACARE ESPAÑA, S.L.
Avenida Diagonal, 512,
Planta Interior 1, Oficina 4,
Barcelona, 08006, Spain

Date of the most recent review of this leaflet: 04/2025

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/