99.9%, 3 ml inhalation vapor, liquid
methoxyflurane
What Penthrox is and what it is used for
Penthrox contains an active substance called methoxyflurane. It is a drug used to reduce pain. It is inhaled through the specially designed Penthrox inhaler.
Penthrox is intended to reduce the severity of the pain, rather than stop it completely.
What you need to know before you use Penthrox
Do not use Penthrox
- if you are allergic to methoxyflurane, inhaled anesthetics (inhalation anesthetics), or any of the other ingredients of this medicine (listed in section 6)
- if you or someone in your family has had malignant hyperthermia; Malignant hyperthermia is a condition in which symptoms such as very high fever, rapid and irregular heartbeat, muscle spasms, and breathing problems have occurred after you or a family member, have been given anesthetic
- if you or a family member have previously had severe side effects from inhaled anesthetics
- if you have a history of liver damage after using methoxyflurane or any inhaled anesthetic
- if you have impaired kidney function and your doctor thinks that Penthrox is not suitable.
- if you have altered consciousness for any reason including head injury, drugs, or alcohol
- if you have heart or circulation problems
- if you have shallow breathing or difficulty breathing.
This medicine must not be used as an anesthetic.
If you are not sure if you should get this medicine, talk to your healthcare provider.
Warnings and cautions
Talk to your healthcare provider before using Penthrox if you:
- have liver or kidney problems
- have a medical condition that can cause kidney problems
- is older.
Children
Do not give this medicine to children.
Other medicines and Penthrox
Tell your healthcare provider if you are taking or have recently taken any other medicines. In particular, tell your healthcare provider if you are taking any of the following:
- Isoniazid to treat tuberculosis
- Phenobarbital or carbamazepine to treat epilepsy
- Rifampicin or other antibiotics to treat infection
- Drugs or illicit drugs that have a calming effect on the nervous system such as strong painkillers ( opioids ), sleeping pills, anesthetics (general anesthesia ), phenothiazines, sedatives, muscle relaxants, and sedative antihistamines
- Antibiotics and other drugs that can damage the kidneys, such as tetracycline, gentamicin, colistin, polymyxin B, amphotericin B, and contrast agents
- Efavirenz or nevirapine for the treatment of HIV
Ask your healthcare provider if you are unsure.
If you need treatment in a hospital that requires general anesthesia, tell the doctor treating you that you have used this medicine.
Penthrox with food, drink, and alcohol
Do not drink alcohol while taking this medicine as it may increase its effect.
You can eat and drink as usual while taking this medicine unless your healthcare provider has given you other instructions.
Pregnancy, breastfeeding, and fertility
Tell your healthcare provider before taking this medicine if you are pregnant, planning to have a baby, breastfeeding, or planning to breastfeed. Healthcare professionals will discuss the possible risks and benefits of receiving this medicine.
Driving and using machines
Penthrox can cause drowsiness or dizziness.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Penthrox contains butylhydroxytoluene (E321)
This medicine contains a stabilizing agent called butylhydroxytoluene (E321). Butylhydroxytoluene may cause local skin reactions (eg contact dermatitis ), or irritation of the eyes and mucous membranes.
How to use Penthrox
Always take this medicine exactly as your healthcare professional has told you. If you are unsure, consult your healthcare provider.
Adults:
One or two bottles containing 3 ml of Penthrox can be used per administration. The maximum dose is two bottles of 3 ml per administration. Do not inhale more than the maximum dose.
How to use Penthrox
Do not give this medicine to anyone else, even if they show signs of illness similar to yours.
If you use more Penthrox than you should
The healthcare professionals who give the medicine have experience with its use, so it is very unlikely that you will get too much of it. You should not use more than 2 bottles at the same time. If the maximum dose is exceeded, Penthrox can cause kidney damage. Tell your healthcare provider immediately if you think you have been given too much of this medicine.
If you have any further questions on the use of this product, ask your healthcare professional.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects are
If you have any of the following, tell your healthcare provider immediately:
- Severe allergic reactions with symptoms such as difficulty breathing and/or swelling of the face.
- Liver problems, such as decreased appetite, nausea, vomiting, jaundice (yellowing of the skin and/or eyes), dark urine, pale stools, pain/aches, or tenderness when touching the right abdomen (below the ribs).
- Kidney problems such as decreased or heavy urination or swelling of the feet or lower legs.
The above side effects can be life-threatening, so talk to your healthcare provider immediately.
Other side effects are
Very common side effects ( may affect more than 1 user in 10)
- Dizziness
Common side effects ( may affect up to 1 in 10 people)
- Drowsiness
- Headache or nausea
- The feeling of extreme happiness
- Feeling of drunkenness
- Taste disorders
- Cough
Uncommon side effects ( may affect up to 1 in 100 people)
- Anxiety or depression
- Attention Deficit Hyperactivity Disorder
- Inappropriate feelings or actions
- Repetition of words or speech difficulties
- Memory loss
- Tingling in the skin of hands and feet
- Numbness
- Impaired vision
- Redness of the skin
- Low or high blood pressure
- Dry mouth
- Discomfort or itchy feeling in the mouth
- Increased salivation
- Increased appetite
- Vomiting
- Sweating
- Fatigue
- Feeling of abnormality
- Overindulge
- Relaxed feeling
Has been reported (occurs in an unknown number of users)
- Hypersensitivity
- Mood swings
- Restlessness or anxiety
- Feeling we have ‘Run out of gas’ emotionally
- Confusion
- Changed level of consciousness
- Feeling of suffocation
- Respiratory distress
- Uncontrolled eye movements
How to store Penthrox
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiration date is the last day of the specified month.
No special temperature instructions.
The healthcare professional disposes of any remaining liquid of the Penthrox inhaler appropriately.
Contents of the pack and other information
Content declaration
The active substance is methoxyflurane. Each sealed bottle contains 3 ml of 99.9% methoxyflurane. The other ingredients are butylhydroxytoluene (E321).
What the medicine looks like and the contents of the pack
Penthrox is a clear, almost colorless, volatile liquid, with a characteristic fruity odor that becomes a vapor or gas when used with the Penthrox inhaler.
Penthrox is available in the following packages:
- A bottle of Penthrox 3 ml with a tear-off safety seal (packs of 10 x 3 ml), or
- Combination pack with a bottle of Penthrox 3 ml, a Penthrox‑ inhaler, and a container of activated carbon (pack of 1 x 3 ml or 10 x 3 ml)
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Medical Developments NED BV
411 Strawinskylaan, WTC Tower A
1077 XX Amsterdam
Netherlands
Manufacturer
MIAS Pharma Limited
Suite 2, Stafford House
Strand Road
Portmarnock, Co. Dublin
Ireland