Prospecto: information for the user

Fentanilo Basi 50 micrograms/ml injectable solution EFG

Read this prospect carefully before starting to use this medicine, because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or nurse.
• This medicine has been prescribed only for you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or nurse, even if they do not appear in this prospect. See section 4.

1.What is Fentanilo Basi and for what it is used

2.What you need to know before Fentanilo Basi is administered to you

3.How Fentanilo Basi is administered

4.Possible adverse effects

1. Storage of Fentanilo Basi

6.Contents of the package and additional information

Fentanilo Basi injectable solution contains the active ingredient fentanilo (as citrate). It belongs to a group of medicines called opioid analgesics. These medicines prevent and relieve pain.

Fentanilo is used:

• as a narcotic analgesic supplement in general or local anesthesia;
• in combination with a neuroleptic (for example, droperidol) in the neuroleptoanalgesia technique;
• for the induction of anesthesia, and as an adjunct in the maintenance of general and local anesthesia.

No use Fentanilo Basi

-if you are allergic to fentanyl or any of the other components of this medication (listed in section 6).

-if you are allergic to medications called morphinomimetics.

Advertencias y precauciones

Consult your doctor or nurse before starting to use fentanyl.

Consulte a su médico o enfermero antes de recibir Fentanilo Basi si:

• you are pregnant, intend to become pregnant, or are breastfeeding,

• you have a less active thyroid gland,

• you suffer from a lung disease,

• you suffer from a muscle disease known as myasthenia gravis,

• you suffer from liver or kidney disease,

• you are receiving opioid treatment or have a history of opioid abuse,

• you suffer from alcoholism,

• you have severe, undiagnosed headaches or have recently suffered a head injury,

• you have been told you have a decrease in blood volume,

• you have pain in the upper right side of your abdomen (bile duct),

• fentanyl injectable may affect the breathing of the newborn when administered during delivery,

• you or a family member has ever abused or been dependent on alcohol, prescription medications, or illegal drugs (“addiction”),

• you are a smoker,

• you have ever had mood problems (depression, anxiety, or a personality disorder) or have been treated for your mood (depression, anxiety, or a personality disorder) or have been treated by a psychiatrist for other mental disorders.

The repeated use of opioid analgesics may make the medication less effective (you may become accustomed to it). It may also produce dependence and abuse that can result in potentially fatal overdose. If you are concerned that you may become dependent on fentanyl, it is essential to consult your doctor.

Particularly, inform your doctor or pharmacist if you are taking:

• Some pain-relieving medications for nerve pain (gabapentin and pregabalin).

If treatment is interrupted, withdrawal symptoms may occur. Inform your doctor or nurse if you believe you are experiencing this (see also section 4. Possible side effects).

Monitorización especial:

• Your doctor will need to take special care in administering this medication if you are an elderly person, have a weak overall health status, or are in labor.

• Fentanyl may cause slower-than-normal breathing or difficulty breathing. This medication will only be administered where you can be closely monitored until your breathing returns to normal.

• It is also recommended to monitor blood pressure and heart rate.

Niños y adolescentes

Anesthesia techniques involving analgesia in a child who breathes spontaneously should only be used as part of an anesthetic technique, or administered as part of a sedation/analgesia technique, with experienced personnel in an environment that can handle sudden rigidity of the thoracic wall requiring intubation, or apnea requiring airway support.

Otros medicamentos y Fentanilo Basi

Inform your doctor or nurse if you are using, have used recently, or may need to use any other medication.

Medications such as barbiturates, benzodiazepines, neuroleptics, general anesthetics, gabapentinoids (gabapentin and pregabalin), and other non-selective central nervous system depressants (e.g., alcohol) may potentiate the respiratory depression of opioids. When patients have received these medications, the dose of fentanyl required should be less than usual.

Inform your doctor if you are using other central nervous system depressants, such as a selective serotonin reuptake inhibitor (SSRI) or a serotonin and norepinephrine reuptake inhibitor (SNRI).

When patients have received these medications, the dose of fentanyl required should be less than usual.

Fentanyl, a high-clearance drug, is rapidly and extensively metabolized mainly by CYP3A4. Itraconazole (a potent CYP3A4 inhibitor) administered orally at 200 mg/day for 4 days had no significant effect on the pharmacokinetics of intravenous fentanyl.

Ritonavir administered orally (one of the most potent CYP3A4 inhibitors) reduced the clearance of intravenous fentanyl by two-thirds. However, the peak plasma concentrations after a single dose of intravenous fentanyl were not affected.

When fentanyl is used in single doses, concomitant administration with potent CYP3A4 inhibitors such as ritonavir requires special attention and observation of the patient.

Concomitant administration of fluconazole or voriconazole and fentanyl may result in increased exposure to fentanyl.

With continuous treatment, it may be necessary to reduce the dose of fentanyl to avoid accumulation, which may increase the risk of prolonged or delayed respiratory depression.

Generally, it is recommended to discontinue the administration of monoamine oxidase inhibitors (MAOIs) two weeks before any surgical or anesthetic procedure.

However, several reports describe the use of fentanyl during surgical or anesthetic procedures in patients with MAOIs without any interaction.

Efectos del fentanilo sobre otros medicamentos

After administration of fentanyl, the dose of other central nervous system depressants should be reduced.

The total plasma clearance and volume of distribution of etomidate decrease (by a factor of 2-3), without changes in the half-life, when combined with fentanyl, resulting in a significant increase in the plasma concentration of etomidate. Simultaneous administration of fentanyl and midazolam intravenously produces an increase in the terminal plasma half-life and a reduction in the plasma clearance of midazolam. When these medications are administered with fentanyl, it may be necessary to reduce their dose.

The concomitant use of fentanyl and sedatives such as benzodiazepines or related drugs increases the risk of drowsiness, difficulty breathing (respiratory depression), coma, and may put life at risk. For this reason, concomitant use should only be considered when other treatment options are not possible.

If your doctor still prescribes fentanyl with sedatives, you should limit the dose and duration of concomitant treatment.

Inform your doctor of all sedatives you are taking and strictly follow your doctor's recommendations regarding the dose. It may be helpful to inform friends or family members to recognize the signs and symptoms mentioned above. If you have these symptoms, contact your doctor.

Fentanilo Basi con alcohol

Alcohol may increase or prolong the respiratory depression of fentanyl.

Embarazo y lactancia

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

Fentanyl should not be used during delivery, as it may affect the breathing of the newborn.

Fentanyl is excreted in breast milk. Do not breastfeed or use breast milk that has been expressed within 24 hours after administration of fentanyl injectable.

Conducción y uso de máquinas

You should not drive or operate machinery until a sufficient amount of time has passed since the administration of fentanyl.

Uso en deportistas

It is reported to athletes that this medication contains a component that may establish a positive analytical result in doping control.

Fentanilo Basi contiene sodio

This medication contains 3.54 mg of sodium (main component of table salt/for cooking) in each unit of volume of injectable solution. This is equivalent to 0.18% of the recommended daily maximum sodium intake for an adult.

Follow exactly the administration instructions for this medication as indicated by your doctor. If in doubt, consult your doctor again.

- Fentanilo may be administered as an infusion or injection into a vein or muscle.

- Fentanilo will be injected into a vein just before the operation. This medication will help you fall asleep and prevent you from feeling pain during the operation.

- You may be administered anesthetics and/or other medications to prevent some adverse effects of fentanilo, such as slower heartbeats and stiff muscles.

- Your doctor will decide how much fentanilo you need. This will depend on your age, body weight, general state of health, existing disease, use of other medications, the type and duration of the operation you will undergo.

Use in children and adolescents

In children, the administered dose will always depend on their body weight.

If you are administered more Fentanilo Basi than you should

Since this medication will be administered by a doctor or nurse, it is unlikely that you will be administered too much. A fentanilo overdose can cause respiratory depression and a brain disorder (known as toxic leukoencephalopathy) (see Warnings and precautions).

If you have any other questions about the use of this medication, ask your doctor or nurse.

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

Side effects may occur especially during surgery and will be resolved by your doctor. However, some may also occur shortly after; therefore, post-operative observation will be performed.

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

- Feeling of discomfort (nausea), being sick (vomiting),

- Muscle stiffness (which may involve the muscles of the chest).

Common(may affect up to 1 in 10 people):

- Involuntary and repetitive body movements,

- Drowsiness, dizziness,

- Visual deterioration,

- Rapid or slow heart rate,

- Irregular heart rhythm,

- Low or high blood pressure,

- Pain in the veins,

- Asphyxia caused by muscle spasm (spasm) of the throat muscles,

- Difficulty breathing or wheezing,

- Temporary cessation of breathing (apnea) (the doctor has the medication to prevent it),

- Skin rash,

- Confusion after surgery.

Rare(may affect up to 1 in 100 people):

- Elevation of mood,

- Headache,

- Inflammation and coagulation in a vein (phlebitis),

- Irregular changes in blood pressure,

- Rapid breathing,

- Hiccup,

- Decrease in body temperature or chills,

- Respiratory tract complication due to anesthesia,

- Agitation after surgery.

- Difficulty swallowing.

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

- Severe allergic reaction with sudden drop in blood pressure, difficulty breathing, or skin rash (anaphylaxis),

- Urticarial hives,

- Convulsions,

- Loss of consciousness,

- Muscle contractions,

- Cardiac arrest (the doctor has the medication to prevent it),

- Respiratory depression,

- Itching on the skin,

- Delirium (symptoms may consist of a combination of agitation, restlessness, disorientation, confusion, fear, seeing or hearing things that do not exist, sleep disturbances, nightmares),

- Symptoms of withdrawal syndrome (may manifest by the appearance of the following side effects: nausea, vomiting, diarrhea, anxiety, chills, tremors, and sweating).

If fentanyl is used with other medications called neuroleptics, which are administered before surgery to induce drowsiness, other effects may be experienced, such as chills and/or tremors, agitation; after surgery – hallucinations, tremors, pronounced muscle stiffness or spasm, slowness of movement, and excessive saliva.

Reporting of side effects

If you experience any type of side effect, consult your doctor 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: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not store at a temperature above 25°C.

Store the ampoules in the outer packaging to protect it from light.

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

Once the ampoule is opened, the product must be used immediately.

Chemical and physical stability has been demonstrated for use over 24 hours at 25°C. From a microbiological standpoint, the medication must be used immediately. If not used immediately, storage times in use and storage conditions before use are the responsibility of the user and normally will not exceed 24 hours at 2 – 8°C, unless dilution has taken place in controlled and validated aseptic conditions.

Do not use this medication if you observe discoloration or the presence of particles. If only a part of the solution is used, the remainder must be discarded.

Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. This will help protect the environment.

Fentanyl Basi Composition

• The active principle is fentanyl (as citrate).

1 ml of solution contains fentanyl citrate equivalent to 50 micrograms of fentanyl.

A vial (3 ml) contains fentanyl citrate equivalent to 150 micrograms of fentanyl.

A vial (5 ml) contains fentanyl citrate equivalent to 250 micrograms of fentanyl.

A vial (10 ml) contains fentanyl citrate equivalent to 500 micrograms of fentanyl.

• The other components (excipients) are sodium chloride, hydrochloric acid (for pH adjustment), sodium hydroxide (for pH adjustment), and water for injectable preparations (see the end of Section 2 for more information).

Product appearance and packaging contents

Transparent and colorless injectable solution.

Fentanyl Basi is presented in colorless glass vials with 3ml, 5 ml, or 10 ml.

Packaging sizes: 10 or 50 vials.

Only some packaging sizes may be commercially available.

Marketing authorization holder and manufacturer responsible

Marketing authorization holder

Laboratórios Basi – Indústria Farmacêutica, S.A.

Parque Industrial Manuel Lourenço Ferreira, Lote 8,15 e 16

3450-232 Mortágua, Viseu

Portugal

Tel.: +351 231 920 250

Fax: +351 231 921 055

E-mail: [email protected]

Manufacturer responsible

Laboratórios Basi – Indústria Farmacêutica, S.A.

Parque Industrial Manuel Lourenço Ferreira Lote 8, 15 e 16

3450-232 Mortágua, Viseu

Portugal

Local representative

Laphysan, S.A.U.

Calle Anabel Segura 11,

Complejo Empresarial Albatros, Edificio A, Planta 4, puerta D,

28108 Alcobendas (Madrid)

This medicinal product is authorized in the member states of the European Economic Area with the following names:

Denmark: Fentanyl Basi

Finland: Fentanyyli Basi

Norway: Fentanyl Basi

Portugal: Fentanilo Medlink

Spain: Fentanilo Basi 50 micrograms/ml injectable solution EFG

Sweden: Fentanyl Basi

Last review date of this leaflet: May 2024

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

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This information is intended solely for healthcare professionals:

Dosage

The dose of medication should be determined individually according to age, body weight, physical condition, underlying pathological condition, concomitant use of other medications, and type of surgical and anesthesia intervention.

- As a supplementary analgesic in general anesthesia

In low doses for minor surgical procedures: 2 micrograms/kg of fentanyl.

Moderate dose: 2-20 micrograms/kg of fentanyl.

In high doses during major surgery: 20-50 micrograms/kg of fentanyl. The duration of the effect depends on the dose. During major surgery, it has been demonstrated that the administration of 20-50micrograms/kg of fentanyl with nitrous oxide/oxygen has an attenuating effect.

When these doses are used during surgery, it is necessary to provide postoperative ventilation and monitor the patient due to prolonged postoperative respiratory depression.

Complementary doses of 20-250 micrograms (0.5-5 ml) of fentanyl may be administered as needed and according to the duration of surgery.

- As an anesthetic agent

When the attenuation of the stress response to surgery is especially important, doses of 50-100 micrograms/kg of fentanyl with oxygen and a muscle relaxant may be administered. This technique provides anesthesia without the use of additional anesthetic agents. In certain cases, doses of up to 150 micrograms/kg of fentanyl may be necessary to produce an anesthetic effect. In this way, fentanyl is used in open-heart surgery and in other major surgical procedures in patients in whom myocardial protection against excessive oxygen demand is particularly indicated.

Use in elderly patients or debilitated patients

The initial dose in this group of patients should be reduced. The effect of the initial dose should be taken into account when determining additional doses. Administration of a small intravenous dose of an anticholinergic agent immediately before induction is recommended to prevent bradycardia. Droperidol may be administered to prevent nausea and vomiting.

Use in patients with hepatic impairment

Careful titration of the fentanyl dose is recommended in patients with hepatic impairment.

Use in patients with renal impairment

Careful titration of the fentanyl dose is recommended in patients with renal impairment.

Children aged 2 to 11 years

The usual dosage regimen in children is as follows:

Children aged 12 to 17 years

Follow the dosage for adults.

Instructions for opening vials with a one-point cut (OPC) point:

1. Hold the vial body between the thumb and index finger, with the point upwards;

2. Place the index finger of the other hand holding the top of the vial. Place the thumb on the point;

3. With the index fingers close together, press the area of the point to open the vial.

Incompatibilities

Fentanyl may be mixed with sodium chloride 9 mg/ml (0.9%) or glucose 50mg/ml (5%) for intravenous infusion. These dilutions are compatible with the plastic material used for infusions.

Overdose

Symptoms

Generally, the manifestations of fentanyl overdose are an extension of its pharmacological actions. Depending on individual sensitivity, the clinical picture is determined by the degree of respiratory depression, ranging from bradypnea to apnea.

Treatment

Hypoventilation or apnea: administration of oxygen, assisted or controlled ventilation.

Respiratory depression: a specific opioid antagonist (e.g., naloxone) should be administered. This does not exclude the use of immediate countermeasures.

Respiratory depression may persist longer than the effect of the antagonist; therefore, in some cases, additional doses of this may be necessary.

Muscle rigidity: an intravenous neuromuscular blocking agent should be administered to facilitate assisted or controlled ventilation.

The patient should be closely monitored; adequate body temperature and fluid intake should be maintained. If severe hypotension or persistent hypotension occurs, the possibility of hypovolemia should be considered and, if necessary, controlled by adequate parenteral fluid administration.