Penthrop 99,9 %

PENTHROP is an inhalation anaesthetic. At the recommended dose, PENTHROP provides pain relief without producing general anaesthesia. PENTHROP is used to reduce pain in conscious patients with trauma and associated pain as well as in patients who require analgesia for surgical procedures such as the change of dressings. It is inhaled through the custom-built PENTHROP inhaler. Pain relief should start after 6 to 10 breaths. PENTHROP is intended to reduce the severity of pain, rather than completely eliminate it.

Do not use PENTHROP:

• If you are hypersensitive (allergic) to methoxyflurane, or other inhalation anaesthetics or any of the ingredients of PENTHROP. Symptoms of an allergic reaction may include:
• Shortness of breath, wheezing or difficulty to breathe
• Swelling of the face, lips, tongue or other parts of the body
• Rash, itching or hives on the skin.
• If you have, or are suspected of having, an inherited tendency for a condition called malignant hyperthermia. This is a condition where, when you or a related family member has been given an anaesthetic, symptoms such as a very high fever, fast irregular heartbeat, muscle spasms and breathing problems have occurred.
• If you have a heart disease.
• If you have a kidney disease or reduced function of your kidneys.
• If you have liver impairment.
• If you have difficulty breathing.
• If you have a change in the level of consciousness due to any cause including a head injury.
• If you have porphyria.

PENTHROP must not be used as an anaesthetic.

Warnings and precautions

Take special care with PENTHROP:

Before using PENTHROP, tell your doctor if you have, or have had, any medical conditions, especially the following:

• Liver problems.
• Diabetes mellitus. Diabetic patients have an increased likelihood of developing kidney problems.
• Have a medical condition which may cause kidney problems, your doctor will prescribe the lowest effective dose.
• If you are an elderly patient, your doctor will prescribe the lowest dose that is effective, and you should use PENTHROP with caution because of a possible reduction in heart rate or blood pressure.
• If you have chronic pain conditions or repeated episodes of trauma related pain.

Children

Limited data is available regarding the use of PENTHROP in children. The minimum effective dose to reduce pain should be administered to children.

Other medicines and PENTHROP

Always tell your healthcare provider if you are taking any other medicine. (This includes all complementary or traditional medicines.) Tell your doctor if you are using any of the following medicines:

• Antibiotics or other medicines that may interact with PENTHROP, such as tetracycline, gentamycin, kanamycin, colistin, polymyxin B, cephaloridine, amphotericin B, isoniazid, rifampicin, efavirenz or nevirapine)
• β-blockers used in the treatment of high blood pressure
• Carbamazepine and barbiturates, such as phenobarbital to treat epilepsy
• Medicines, or illegal medicines, that have a dampening effect on the nervous system such as narcotics, pain killers, sedatives, sleeping pills, general anaesthetics, phenothiazines, tranquilisers, muscle relaxants and sedating antihistamines.

PENTHROP with food and drink

Do not drink alcohol whilst using PENTHROP as it may increase its effect.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, please consult your doctor, pharmacist or other healthcare provider for advice before using PENTHROP. PENTHROP crosses the placenta and carries the potential to produce central nervous system and respiratory depression in the new-born infant. Your healthcare provider will discuss the possible risks and benefits of being given PENTHROP during pregnancy and breastfeeding.

Driving and using machines

PENTHROP may make you feel drowsy. Do not drive a vehicle or operate a machine until you have completely recovered from the effects of PENTHROP.

PENTHROP contains butylated hydroxytoluene. PENTHROP contains another ingredient, butylated hydroxytoluene (E321), a stabiliser which may cause local skin reactions (e.g. contact dermatitis), or irritation to the eyes and mucous membranes (see section 6).

Do not share medicines prescribed for you with any other person. Always use PENTHROP exactly as your doctor or pharmacist has told you. Check with your doctor, pharmacist or nurse if you are not sure.

How much is given

One 3 ml bottle of PENTHROP provides approximately 20 to 25 minutes of pain relief. A second 3 ml bottle of PENTHROP can be given to extend the period of pain relief to approximately 50 to 55 minutes. The maximum recommended dosage is 6 ml per day or 15 ml per week in adolescents (12 to 17 years) and adults (18 years and older). In children (1 to 11 years), the maximum recommended dose is 3 ml per day and 15 ml per week. PENTHROP should not be used on consecutive days. You should not inhale more than the maximum dose, because PENTHROP may damage your kidneys and this effect depends on the amount you receive. Your doctor will tell you how long your treatment with PENTHROP will last. If you have the impression that the effect of PENTHROP is too strong or too weak, tell your doctor or pharmacist.

How PENTHROP is given

PENTHROP is poured into the base of the PENTHROP inhaler by the healthcare provider and is absorbed into the wick. You will inhale PENTHROP directly from the custom built PENTHROP inhaler. The administration will be supervised by your healthcare provider.

If you use more PENTHROP than you should

The healthcare provider giving you PENTHROP will be experienced in its use, so it is extremely unlikely that you will be given too much. The dose of PENTHROP is limited by the amount contained in each bottle. You should not use more than 2 bottles in one day and not more than 5 bottles in one week. Children 11 years and younger should not be given more than 1 bottle in one day and not more than 3 bottles in one week. If the maximum dose is exceeded PENTHROP may cause irreversible damage to your kidneys. In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison control centre.

If you forget to use PENTHROP

Do not receive a double dose to make up for forgotten individual doses. Since a healthcare provider will administer PENTHROP, it is unlikely that the dose will be missed.

Things you must do while being given PENTHROP

You should breathe in through the mouthpiece, initially ensuring that the “dilutor hole” of the PENTHROP inhaler is not covered. Accustom yourself to the characteristic fruity smell of the PENTHROP by inhaling gently for the first two breaths through the PENTHROP inhaler. You may breathe out through the PENTHROP inhaler or through your nose. If further relief is required, you may cover the “dilutor hole” for a higher inhaled concentration of PENTHROP. Use PENTHROP intermittently as required to provide you pain relief. You are in control of the level of your relief by directly inhaling PENTHROP from the custom-built PENTHROP inhaler. The aim of PENTHROP is to relieve pain until you feel comfortable. Relief will commence after approximately 6 to 10 breaths. Relief will continue for several minutes after ceasing use of PENTHROP. PENTHROP has a characteristic fruity smell.

PENTHROP can have side effects. Not all side effects reported for PENTHROP are included in this leaflet. Should your general health worsen or if you experience any untoward effects while receiving PENTHROP, please consult your healthcare provider for advice. If any of the following happens, stop using PENTHROP and tell your doctor immediately, or go to the casualty department at your nearest hospital:

• You experience any symptoms of liver problems, such as loss of appetite, nausea, vomiting, jaundice (yellowing of the skin and/or eyes), dark coloured urine, pale coloured stools, pain/ache or sensitivity to touch in your right abdominal area (below your ribs).
• You experience any symptoms of kidney problems such as reduced or excess urination or swelling of feet or lower legs. These are all very serious side effects. If you have them, you may have had a serious allergic reaction to PENTHROP. You may need urgent medical attention or hospitalisation.

Tell your doctor if you notice any of the following:

PENTHROP may frequently cause:

• Dizziness
• Headache
• Drowsiness
• Dysfunction of the sense of taste
• Happy mood
• Coughing (usually in the first few breaths)
• Nausea
• Feeling drunk

PENTHROP less frequently causes:

• Increased appetite
• Pins and needles (paraesthesia), weakness, numbness and pain, usually in your hands and feet
• Memory loss
• Difficulty speaking
• Depression
• Anxiety, nervousness
• Inappropriate emotions or actions
• Attention disturbances
• Repetition of words
• Vision impairment
• Flushing of the skin
• Low blood pressure
• High blood pressure
• Mouth discomfort or itch
• Dry mouth
• Increased salivation
• Vomiting
• Excessive sweating
• Tiredness
• Chills
• Feeling abnormal
• Feeling of relaxation

Side effects reported with unknown frequency after PENTHROP was marketed:

• Hypersensitivity
• Mood swings
• Restlessness or agitation
• Feeling of being disconnected from reality
• Feeling confused
• Altered state of consciousness
• Uncontrolled eye movement
• Choking
• Shortness of breath (hypoxia)
• Liver problems, such as loss of appetite, nausea, vomiting, jaundice (yellowing of the skin and/or eyes), dark coloured urine, pale coloured stools, pain/ache or sensitivity to touch in your right stomach area (below your ribs)
• Kidney problems such as reduced or excessive urination or swelling of feet or lower legs
• Laboratory findings that increased, namely the liver function tests, blood urea, blood creatinine and blood uric acid

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects

If you get side effects, talk to your doctor, pharmacist or nurse. You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of PENTHROP.

Store PENTHROP at or below 30 °C in its original container. Do not freeze. Keep the product in the original container until required for use in order to protect from light. Keep the container tightly closed. STORE ALL MEDICINES OUT OF REACH OF CHILDREN. Do not use PENTHROP if the package is damaged. Do not use after the expiry date stated on the bottle. Your healthcare provider will dispose of any excess PENTHROP liquid and the PENTHROP inhaler in the appropriate way.