Prospect: information for the user

Diprivan 20 mg/ml emulsion for infusion

Propofol

Read this prospect carefully before starting to use the medicine, because it contains

important information for you

• Keep this prospect, as you may have to read it again.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• If you experience adverse effects, consult with your doctor, pharmacist, or nurse, even if they are not listed in this prospect. See section 4.

Diprivan belongs to a group of medications known as “general anesthetics”. General anesthetics are used to produce unconsciousness (sleep) during surgical operations or other procedures. It can 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 anesthesia in adults and children over 3 years of age.
• sedating patients over 16 years of age with assisted respiration in intensive care units.
• sedating adults and children over 3 years of age during diagnostic and surgical interventions, alone or in combination with local or regional anesthesia.

Before administering the anesthetic, the anesthesiologist, surgeon, or intensive care physician will evaluate your clinical status and any treatment you are currently receiving.

Do not use Diprivan

• If you are allergic (hypersensitive) to propofol or to any of the other components of this medication (listed in section 6).
• If you are allergic to soy or peanuts. This is because Diprivan contains soy oil.
• In patients 16 years of age 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 a seizure or convulsion,
• You have ever been told that you have very high levels of fat in your blood or that you have problems with fat absorption. In these cases, your doctor may need to determine your fat levels in the blood,
• You have any other health problem, such as heart, respiratory, kidney, or liver problems or if you have been feeling unwell for some time,
• You are taking any other medication, even those you have purchased without a prescription
• Your body has lost a large amount of water (hypovolemia),
• You have prolonged and/or intense diarrhea,
• You have ever been told that you have a disease called “mitochondrial disease”,
• You are elderly or debilitated,
• You have had a head disease along with a high pressure in your head.

Before undergoing surgery or another procedure that requires the administration of any type of anesthesia, it is essential to inform your doctor if you have a disease called “hereditary predisposition to acute porphyria”.

In rare cases, if you are administered propofol for a long time, you may develop a disease called propofol infusion syndrome (SIP). This disease can damage the heart, muscles, or kidneys, cause other serious problems, and even lead to death. However, your doctor will closely monitor you and take necessary measures to prevent this from happening.

Children and adolescents

Diprivan is not recommended for use in newborns.

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

Other medications and Diprivan

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

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

• Strong tranquilizers (opioid analgesics) to relieve intense pain
• Medications called “parasympatholytics” (e.g., medications used to treat cramps, asthma, Parkinson's disease, and other medications in this group)
• Benzodiazepines (medications used to treat anxiety)
• Neostigmine (medication used to treat a disease called myasthenia gravis)
• Ciclosporin (medication used to prevent rejection in organ transplants)
• Rifampicin (medication used to treat tuberculosis)
• Glucocorticoids (medications to treat asthma, arthritis, immune system diseases, skin diseases, and other diseases)
• Medications that strengthen the heart, such as digoxin (for the treatment of heart failure)
• Medications to treat epilepsy, such as phenytoin, phenobarbital, and others.
• Suxamethonium (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 the administration of Diprivan.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor, pharmacist, or nurse before Diprivan is administered.

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

If you are breastfeeding, do not breastfeed while Diprivan is being administered and discard breast milk for 24 hours after Diprivan administration.

Driving and operating machines

Diprivan may affect your reaction time. Your doctor or anesthesiologist will indicate how long you should wait before driving or operating machines and will tell you to go accompanied to return home. Generally, the effects of propofol disappear 12 hours after the end of its administration.

Diprivan contains soy oil

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

Diprivan contains sodium

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

• Diprivan will be administered by, or under the supervision of your anesthesiologist or intensive care physician.
• Diprivan is administered through infusion (drip) in 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 administration speed.

The dose of Diprivan will vary depending on your age, body weight, and physical condition. Your doctor will provide the correct dose to initiate and maintain anesthesia or to achieve the required level of sedation, closely monitoring your responses and vital signs (pulse, blood pressure, breathing, etc.).

You may need to use several medications to make you sleep or feel drowsy, without pain, breathing normally, and maintaining stable blood pressure. Your anesthesiologist or intensive care physician will decide which medication to use and when, and will adjust the dose of Diprivan based on the medications used.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

During the induction and maintenance of anesthesia or sedation with Diprivan, the following side effects may occur (while the injection or infusion is being administered or when you are drowsy or asleep). Your doctor will be monitoring the occurrence of side effects and, if they occur, will administer the 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 100 patients

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

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

• Thrombosis and phlebitis.
• Coughing during anesthesia maintenance.

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

• Tics and muscle contractions or spasms that may occur during induction, maintenance, and recovery of anesthesia.

• Coughing during anesthesia induction.

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

• Severe allergic reaction, including anaphylactic shock.
• Postoperative unconsciousness.
• Pulmonary edema.
• Pancreatitis (inflammation of the pancreas).
• Urine discoloration.
• Sensation of sexual excitement.
• Fever, postoperative.
• Tissue damage (necrosis) at the injection site.

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

• Metabolic acidosis, increased potassium levels, increased blood lipid levels.
• Euphoria, abuse, and dependence on the medication.
• Involuntary movements.
• Alteration of heart rhythm, heart failure, alteration of cardiac nerve signal detected on the electrocardiogram.
• Enlargement of the liver.
• Rhabdomyolysis (breakdown of muscle cells).
• Difficulty breathing.
• Prolonged and often painful erection (priapism).
• Pain and inflammation at the injection site, when Diprivan is administered outside the vein.
• Renal function failure.
• Hepatitis (inflammation of the liver), acute liver failure (symptoms may include yellow skin and eyes, itching, dark urine, stomach pain, and liver sensitivity, indicated by pain under the front of the ribcage on the right side), sometimes with loss of appetite).

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es/. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Do not store at a temperature above 25°C. Do not freeze.

Keep out of sight and reach of children.

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

After dilution: Use within a period of 6 hours.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medicines at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medicines. By doing so, you will help protect the environment.

Composition of Diprivan 20 mg/ml

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

Appearance of the product and contents of the package

This medication is presented in boxes of a vial with 50 ml of emulsion.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Aspen Pharma Trading Limited

3016 Lake Drive,

Citywest Business Campus,

Dublín 24, Ireland

Tel: +34 952 010 137

Responsible for manufacturing:

Corden Pharma S.P.A.

Caponago

Milan (Italy)

Local representative:

ASPEN PHARMACARE ESPAÑA, S.L.

Avenida Diagonal, 512,

Ground Floor 1, Office 4,

Barcelona, 08006, Spain

Last review date of this leaflet: 08/2024

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