Fentanyl Basi 50 micrograms/ml solution for injection EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Fentanil Basi 50 micrograms/ml injectable solution EFG

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

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

Leaflet contents

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

2. What you need to know before you are given Fentanil Basi

3. How Fentanil Basi is administered

4. Possible adverse effects

5. How to store Fentanil Basi

6. Contents of the pack and other information

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

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

Fentanil is used:

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

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

Do not use Fentanilo Basi

• if you are allergic to fentanyl or to any of the other ingredients of this medicine (listed in section 6),
• if you are allergic to medicines called morphine-like opioids.

Warnings and precautions

Talk to your doctor or nurse before starting to use fentanyl.

Talk to your doctor or nurse before receiving Fentanilo Basi if:

• you are pregnant, planning to become pregnant, or breastfeeding,
• you have an underactive thyroid gland,
• you suffer from a lung disease,
• you suffer from a muscle disorder known as myasthenia gravis,
• you suffer from liver or kidney disease,
• you are receiving treatment with opioids 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 reduced blood volume,
• you have pain in the upper right side of your abdomen (biliary tract),
• if administered during childbirth, injectable fentanyl may affect the newborn's breathing,
• you or a family member has ever abused or been dependent on alcohol, prescription medicines, or illegal drugs (“addiction”),
• you are a smoker,

• you have ever had problems with your mood (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.

Repeated use of opioid painkillers may cause the medicine to lose effectiveness (you may become accustomed to it). It may also lead to dependence and abuse, which could result in potentially fatal overdose. If you are concerned about becoming dependent on fentanyl, it is important to talk to your doctor.

In particular, inform your doctor or pharmacist if you are taking:

• Certain painkillers for nerve pain (gabapentin and pregabalin).

If treatment is stopped, withdrawal symptoms may occur. Inform your doctor or nurse if you think this is happening to you (see also section 4. Possible side effects).

Special monitoring:

• Your doctor must exercise particular care when administering this medicine if you are elderly, in a generally weak condition, or in labor.
• Fentanyl may cause slower than normal breathing or may cause difficulty breathing. This medicine will only be administered where you can be carefully monitored until your breathing returns to normal.
• Monitoring of blood pressure and heart rate is also advised.

Children and adolescents

Techniques involving analgesia in a spontaneously breathing child should only be used as part of an anesthetic technique or administered as part of a sedation/analgesia technique, with experienced personnel in a setting capable of managing sudden thoracic wall rigidity requiring intubation, or apnea requiring airway support.

Other medicines and Fentanilo Basi

Tell your doctor or nurse if you are using, have recently used, or might need to use any other medicines.

Drugs such as barbiturates, benzodiazepines, neuroleptics, general anesthetics, gabapentinoids (gabapentin and pregabalin), and other non-selective CNS depressants (e.g., alcohol) may enhance opioid-induced respiratory depression. When patients have received such medicines, the required dose of fentanyl should be lower than usual.

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

When patients have received such medicines, the required dose of fentanyl should be lower than usual.

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

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

When fentanyl is used as a single dose, concomitant administration of 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 fentanyl exposure.

With continuous treatment, a reduction in the fentanyl dose may be necessary to avoid accumulation, which could increase the risk of prolonged or delayed respiratory depression.

Generally, monoamine oxidase inhibitors (MAOIs) should be discontinued two weeks before any surgical or anesthetic procedure.

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

Effects of fentanyl on other medicines

After administration of fentanyl, the dose of other CNS depressants should be reduced.

The total plasma clearance and volume of distribution of etomidate decrease (by a factor of 2–3), with no change in half-life, when combined with fentanyl, resulting in a substantial increase in plasma concentration of etomidate. Simultaneous administration of fentanyl and intravenous midazolam produces an increase in the terminal plasma half-life and a reduction in the plasma clearance of midazolam. When these medicines are administered together with fentanyl, their dose may need to be reduced.

Concomitant use of fentanyl and sedative medicines such as benzodiazepines or related drugs increases the risk of drowsiness, difficulty breathing (respiratory depression), coma, and may be life-threatening. For this reason, concomitant use should only be considered when no other treatment options are possible.

If your doctor still prescribes fentanyl together with sedative medicines, the dose and duration of concomitant treatment should be limited.

Inform your doctor about all sedative medicines you are taking and strictly follow your doctor’s recommendations regarding dosage. It may be helpful to inform friends or family members so they can recognize the signs and symptoms mentioned above. If you experience these symptoms, contact your doctor.

Fentanilo Basi and alcohol

Alcohol may increase or prolong fentanyl-induced respiratory depression.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or nurse before using this medicine.

Fentanyl should not be used during childbirth, as it may affect the newborn's breathing.

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

Driving and using machines

You must not drive or operate machinery until sufficient time has passed after administration of fentanyl.

Use in athletes

Athletes are advised that this medicine contains a component that may lead to a positive analytical finding in doping controls.

Fentanilo Basi contains sodium

This medicine contains 3.54 mg of sodium (a main component of table/cooking salt) per unit volume of injectable solution. This corresponds to 0.18% of the maximum daily recommended sodium intake for an adult.

3. How Fentanilo Basi is administered

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

• Fentanil may be administered as an intravenous infusion or injection into a vein or muscle.
• Fentanil will be injected into a vein just before surgery. This medicine will help you fall asleep and prevent you from feeling pain during the operation.
• You may be given anesthetics and/or other medicines to prevent certain adverse effects of fentanyl, such as slower heartbeats and muscle rigidity.
• Your doctor will decide how much fentanil you need. This will depend on your age, body weight, general health, existing medical conditions, use of other drugs, and the type and duration of the surgery you will undergo.

Use in children and adolescents

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

If you are given more Fentanilo Basi than you should

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

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

4. Possible adverse effects

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

Possible adverse effects may occur especially during surgery and will be managed by your doctor. However, some may also occur shortly afterwards; therefore, postoperative monitoring will be carried out.

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

• Feeling unwell (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 movements of the body,
• Drowsiness, dizziness,
• Visual disturbances,
• Fast or slow heartbeat,
• Irregular heartbeat,
• High or low blood pressure,
• Pain in the veins,
• Choking due to spasm (cramp) of the throat muscles,
• Difficulty breathing or wheezing,
• Brief periods of breathing stopping (apnea) (your doctor has medication available to prevent this),
• Skin rash,
• Confusion after surgery.

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

• Elevated mood,
• Headache,
• Inflammation and clotting in a vein (phlebitis),
• Irregular changes in blood pressure,
• Faster than normal breathing,
• Hiccups,
• Decreased body temperature or chills,
• Airway complications due to anaesthesia,
• 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),
• Hives (urticaria),
• Seizures,
• Loss of consciousness,
• Muscle contractions,
• Cardiac arrest (your doctor has medication available to prevent this),
• Respiratory depression,
• Itching of the skin,
• Delirium (symptoms may include a combination of agitation, restlessness, disorientation, confusion, fear, seeing or hearing things that are not real, sleep disturbances, nightmares),
• Withdrawal syndrome symptoms (may manifest as the appearance of the following adverse effects: nausea, vomiting, diarrhoea, anxiety, chills, tremor, and sweating).

If fentanyl is used together with other medicines called neuroleptics, which are given before an operation to cause drowsiness, additional effects may occur, such as chills and/or tremors, agitation; after surgery – hallucinations, tremors, pronounced muscle rigidity or spasm, slowness of movement, and excessive salivation.

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish System for Pharmacovigilance of Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Fentanyl Basi Storage Instructions

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

Do not store above 25 °C.

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

Do not use this medicine after the expiry date stated on the label and carton following “EXP”. The expiry date refers to the last day of the month indicated.

Once the ampoule has been opened, the product must be used immediately.

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

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

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging no longer required. This will help protect the environment.

6. Contents of the pack and other information

Composition of Fentanilo Basi

• The active substance is fentanyl (as citrate).

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

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

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

A 10 ml vial 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 injections (see the end of Section 2 for more information).

Appearance of the medicinal product and contents of the container

Clear, colourless injectable solution.

Fentanilo Basi is available in colourless glass vials containing 3 ml, 5 ml, or 10 ml.

Pack sizes: 10 or 50 vials.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

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

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 European Economic Area member states under the following names:

Denmark: Fentanyl Basi

Finland: Fentanyyli Basi

Norway: Fentanyl Basi

Portugal: Fentanilo Medlink

Spain: Fentanilo Basi 50 microgramos/ml solución inyectable EFG

Sweden: Fentanyl Basi

Date of the most recent revision of this summary: May 2024

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.

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This information is intended for healthcare professionals only:

Dosage

The dose should be individually determined based on age, body weight, physical condition, underlying pathological state, concomitant use of other drugs, and type of surgical procedure and anesthesia.

• As an analgesic adjunct in general anesthesia

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

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

High doses during major surgery: 20–50 micrograms/kg of fentanyl. The duration of effect depends on the dose. During major surgery, administration of 20–50 micrograms/kg of fentanyl with nitrous oxide/oxygen has been shown to provide attenuation.

When these doses are used during surgery, postoperative ventilation and patient monitoring are required due to prolonged respiratory depression in the postoperative period.

Supplemental doses of 20–250 micrograms (0.5–5 ml) of fentanyl may be administered according to patient needs and duration of surgery.

• As an anesthetic agent

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

Use in elderly or debilitated patients

The initial dose in this patient group 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 dose titration of fentanyl is recommended in patients with hepatic impairment.

Use in patients with renal impairment

Careful dose titration of fentanyl 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 recommendations for adults.

Instructions for opening ampoules with the OPC (One-Point-Cut) break point:

1. Hold the body of the ampoule between the thumb and index finger, with the break point facing upward;
2. Place the index finger of the other hand on the top of the ampoule and place the thumb over the break point;
3. With index fingers close together, press on the break point area to open the ampoule.

Incompatibilities

If necessary, fentanyl may be mixed with sodium chloride 9 mg/mL (0.9%) or glucose 50 mg/mL (5%) for intravenous infusion. These dilutions are compatible with the plastic materials commonly 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: administer oxygen, assisted or controlled ventilation.

Respiratory depression: a specific narcotic 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 the antagonist may be required.

Muscle rigidity: administer an intravenous neuromuscular blocking agent to facilitate assisted or controlled ventilation.

The patient must be carefully monitored; adequate body temperature and fluid intake should be maintained. If hypotension is severe or persistent, hypovolemia should be considered and, if necessary, corrected by appropriate parenteral fluid administration.