Fentanyl Ethypharm

Package leaflet: Information for the user

Fentanil Ethypharm 50 micrograms/ml, Injectable Solution

(fentanyl)
Generic medicine
Read this leaflet carefully before Fentanil Ethypharm is administered to you.

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

Contents of this leaflet:

1. What Fentanil Ethypharm is and what it is used for
2. What you need to know before Fentanil Ethypharm is administered
3. How Fentanil Ethypharm is administered
4. Possible side effects
5. How to store Fentanil Ethypharm
6. Contents of the pack and other information

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

Fentanil belongs to a group of medicines called opioid analgesics, often used in anesthesia or as pain relievers.
Fentanil Injection can be used in the following situations:

• At low doses, it is used to relieve pain during short surgical procedures
• In cases requiring assisted respiration, it is used at higher doses as an anesthetic and analgesic
• To relieve pain
• For the treatment of severe pain.

2. What you should know before Fentanil Ethypharm is administered

Do not receive Fentanil Ethypharm if:

• you are allergic (hypersensitive) to fentanyl, to other opioid medicines, or to any of the other ingredients of this medicine (listed in section 6)
• you suffer from asthma, shallow breathing, or other breathing difficulties
• you are taking or have recently taken (within the last two weeks) any medicine for depression known as a monoamine oxidase inhibitor (MAOI) (see "Taking other medicines")

Warnings and precautions
Talk to your doctor or nurse before receiving Fentanil Ethypharm if:

• you are pregnant, planning a pregnancy, or breastfeeding
• your thyroid gland activity is lower than normal
• you suffer from lung disease
• you suffer from a muscle disorder called myasthenia gravis
• you suffer from liver or kidney disease
• you are currently undergoing opioid therapy or have previously abused opioids
• you suffer from alcoholism
• you suffer from severe undiagnosed headache or have recently suffered a head injury
• you have been informed that you have low blood volume (hypovolemia)
• you experience pain in the upper right side of your abdomen (biliary tract)
• you have been administered Fentanil Injection during labour, as it may cause breathing problems in the newborn
• you or someone in your family has ever abused or been dependent on alcohol, prescription medicines, or illegal substances ("dependence")
• you are a smoker
• you have ever had problems with your mood (depression, anxiety, or a personality disorder) or have ever received treatment from a psychiatrist for another mental illness

Repeated use of opioid painkillers may make the medicine less effective (you become accustomed to it). It may also lead to dependence and abuse, which can result in a potentially life-threatening overdose. If you are concerned about becoming dependent on [fentanyl-containing medicine], it is important to consult your doctor.
If any of these restrictions may apply to you or your child, please consult your doctor.
Special monitoring

• With repeated use of fentanyl, tolerance and dependence may develop.
• Your doctor will pay particular attention when administering this medicine if you are elderly or debilitated due to illness, or if you are in labour.
• Fentanil Injection may cause slower-than-normal breathing or shortness of breath. This medicine will only be administered to you in a setting where you can be closely monitored until normal breathing is restored.
• Your blood pressure and heart rate may also be monitored.

If treatment is stopped, withdrawal symptoms may occur. Inform your doctor or nurse if you think this is happening to you (also see section 4. Possible side effects).
Other medicines and Fentanil Ethypharm:
Concomitant use of fentanyl and sedative medicines, such as benzodiazepines or related drugs, increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be potentially fatal. Therefore, concomitant use should only be considered when no other therapeutic options are available. In any case, if your doctor prescribes fentanyl together with sedative medicines, they must limit the dose and duration of concomitant treatment. Inform your doctor about any sedative medicines you are taking and strictly follow the dose recommended by your doctor. It may be helpful to ask friends or family members to watch for the signs and symptoms listed above. Contact your doctor if these symptoms occur. Inform your doctor or nurse if you are using or have recently used any other medicine, including those without a prescription.
Fentanil Injection must not be used with medicines for the treatment of severe depression, such as phenelzine or moclobemide, or if you have stopped taking such medicines within the last 2 weeks. These medicines are known as monoamine oxidase inhibitors (MAOIs).
Inform your doctor or nurse if:

• you are taking selective serotonin reuptake inhibitors (SSRIs) or serotonin-noradrenaline reuptake inhibitors (SNRIs) for depression (including citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, venlafaxine)
• you are taking any major tranquilizers (antipsychotics)
• you are taking certain nerve pain medicines (gabapentin and pregabalin)

Medicines that may interact with Fentanil Ethypharm include:

• CNS depressants (medicines that act on the brain and cause drowsiness or weakness). These include sleeping pills, antihistamines (medicines used to treat allergies) that cause drowsiness, medicines used to treat certain mental disorders, other painkillers, or general anaesthetics such as etomidate
• ritonavir (a medicine used to treat or prevent viral infections, including HIV) and other protease inhibitors such as indinavir and saquinavir
• droperidol (a medicine used to treat anxiety and nausea)
• muscle relaxants
• medicines used to treat fungal infections, such as fluconazole or voriconazole
• midazolam (a medicine used to promote relaxation and sedation before surgery)

It may be necessary to reduce the dose of etomidate and midazolam if administered together with Fentanil Ethypharm.
Inform your doctor if you are taking any of the medicines listed above, as Fentanil Injection may increase the effects of these medicines or impair their proper functioning.
Taking Fentanil Injection with food, drinks, and alcohol:
You must not drink alcohol during treatment with Fentanil Ethypharm.
Pregnancy and breastfeeding:
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or nurse before using this medicine.
Fentanil Injection must not be used during childbirth, as it may cause breathing problems in the newborn.
Fentanyl is excreted in breast milk. You must not breastfeed or use expressed milk for 24 hours after administration of Fentanil Injection.
Driving and using machines:
Do not drive or operate machinery for at least 24 hours after administration of Fentanil Ethypharm, as this medicine reduces alertness. This medicine may affect your ability to drive because it may cause drowsiness or dizziness.

• Do not drive while taking this medicine until you have determined how it affects you.

Consult your doctor or pharmacist to find out whether it is safe for you to drive while taking this medicine.
Fentanil Injection contains sodium
If you need to monitor your salt intake (low-sodium diet), you should be aware that:

• Fentanil Ethypharm contains 3.5 mg of sodium per ml of solution, equivalent to 0.18% of the recommended maximum daily dietary sodium intake for an adult.
• The contents of the vial may be diluted in a saline solution before administration. Saline solution also contains sodium.

For those engaged in sports: using this medicine without a therapeutic need constitutes doping and may result in a positive anti-doping test.

3. How to administer Fentanil Ethypharm

This medicine is an injection and will be administered to you by your doctor. Your doctor will decide the dose you need based on your age, body weight, your health condition, and any other medicines you are taking.
Fentanil Ethypharm is administered into a vein by injection or infusion (intravenous infusion). In certain circumstances, your doctor may prescribe a dose higher than the one indicated here.
Adults and children aged 12 to 17 years:
During surgery with spontaneous breathing
The usual initial dose ranges between 50 and 200 micrograms, followed by an additional dose of 50 micrograms if needed.
During surgery with assisted breathing
The usual initial dose ranges between 300 and 3500 micrograms, followed by an additional dose of 100–200 micrograms if needed.
For infusion (intravenous infusion)
The usual initial dose is 1 microgram per kilogram per minute for the first 10 minutes, followed by a further dose of 0.1 microgram per kilogram per minute for the duration of the surgery. The infusion is normally stopped 40 minutes before the end of the procedure.
Elderly patients:
If you are elderly, you will be given a reduced dose.
Use in children aged 2 to 11 years:
During surgery if your child is able to breathe spontaneously
The usual initial dose ranges between 1 and 3 micrograms per kilogram of body weight, followed by an additional dose of 1–1.25 micrograms per kilogram of body weight if needed.
During surgery if your child is under assisted ventilation
The usual initial dose ranges between 1 and 3 micrograms per kilogram of body weight, followed by an additional dose of 1–1.25 micrograms per kilogram of body weight if needed.
If you receive more Fentanil Ethypharm than you should:
Since Fentanil Ethypharm will be administered to you in a hospital setting by a doctor, overdose is unlikely; however, inform your doctor or nurse if you think you have received too much of this medicine or if you begin to experience breathing difficulties, dizziness, symptoms of low blood pressure, or muscle rigidity. An overdose may also cause a brain disorder known as toxic leukoencephalopathy.

4. Possible side effects

Like all medicines, Fentanil Injection can cause side effects, although not everybody gets them.
Contact your doctor or nurse immediately if you experience any of the following symptoms, as they may indicate a severe allergic reaction:

• sudden onset of wheezing or chest tightness
• swelling of the eyelids, face or lips
• skin lumps or hives
• skin rash (red spots), itching, fever
• collapse

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

• muscle stiffness
• feeling unwell (nausea) or being unwell (vomiting)

Common side effects (may affect less than 1 in 10 people):

• feeling restless
• jerky or uncoordinated movements
• drowsiness
• dizziness
• blurred vision, blind spots, or halos around bright objects (visual disturbances)
• slow or irregular heartbeat
• unusually low or high blood pressure
• pain in the veins
• choking caused by spasms (cramps) of the throat muscles
• wheezing or breathing difficulties
• temporary cessation of breathing. If necessary, your breathing may be supported by a machine (ventilator).
• skin rash accompanied by itching or redness of the skin
• confusion

Uncommon side effects (may affect less than 1 in 100 people) include:

• excessive feeling of happiness (euphoria)
• headache
• swelling and clot in a vein
• changes in blood pressure
• breathing faster than normal
• hiccups
• lowering of body temperature or chills
• respiratory complications

Other side effects (frequency not known) include:

• severe allergic reaction (see symptoms listed above)
• seizures (fits or convulsions)
• loss of consciousness
• muscle spasms
• cessation of heartbeat (cardiac arrest)
• slow or shallow breathing
• skin itching
• withdrawal syndrome symptoms (may occur with the onset of the following side effects: nausea, vomiting, diarrhoea, anxiety, chills, tremor, and sweating)
• delirium (symptoms may include a combination of agitation, restlessness, disorientation, confusion, fear, seeing or hearing things that are not there, sleep disturbances, nightmares)

Other side effects may occur when Fentanil Injection is used together with a type of medicine called neuroleptics. These side effects include:

• chills or tremors
• restlessness
• sensation of seeing or hearing unreal things (hallucinations)
• unusual movements, including trembling and agitation of hands and fingers, body twisting, shuffling gait, and stiffness of arms and legs

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Fentanil Ethypharm

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the outer carton and on the vial label after 'Exp./'. The expiry date refers to the last day of the month.
Do not use this medicine if you notice any changes in colour or the presence of particles. If used only partially, discard any remaining solution.
Do not store above 25°C and keep the container in the outer packaging to protect from light.

6. Package contents and other information

What Fentanil Ethypharm contains
Active substance: fentanyl citrate 78.5 micrograms equivalent to 50 micrograms of fentanyl.
Other components: sodium chloride, sodium hydroxide (for pH adjustment), water for injectable preparations.

Description of the appearance of Fentanil Ethypharm and package contents
The clear, colourless solution is contained in 2 ml or 10 ml glass vials, in packages containing 10 vials.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Ethypharm
194 Bureaux de la Colline, Bâtiment D
92213 Saint-Cloud CEDEX
France

Manufacturer:
Macarthys Laboratories Limited T/A Martindale Pharma
Bampton Road
Romford
Essex, RM3 8UG
United Kingdom
ETHYPHARM,
Chemin de la Poudriere, GRAND QUEVILLY,
76120, France

This medicinal product is authorised in the European Economic Area Member States under the following names:
Denmark: Fentanyl Ethypharm
Finland: Fentanyl Ethypharm 50 mikrog /ml injektioneste, liuos
France: Fentanyl Ethypharm 50 microgrammes/mL, solution injectable
Germany: Fentanyl Ethypharm 50 Mikrogramm / ml Injektionslösung
Italy: Fentanil Ethypharm
Norway: Fentanyl Ethypharm
Spain: Fentanilo Ethypharm 50 mcg/ml solución para inyección EFG
Sweden: Fentanyl Ethypharm 50 mikrogram /ml injektionsvätska, lösning
United Kingdom: Fentanyl 50 mcg/ml solution for injection