Patient leaflet - Phenylephrine 0.1 mg/ml, solution for injection
1. What Phenylephrine is and what it is used for
This drug belongs to a group called adrenergic or dopaminergic agents. Phenylephrine is used to treat low blood pressure that can occur during different types of anesthesia.
2. What you need to know before you use Phenylephrine
Do not use Phenylephrine if:
- you are allergic (hypersensitive) to phenylephrine or any of the other ingredients of this medicine (listed in section 6).
- you suffer from hypertension (increased blood pressure)
- you are suffering from a peripheral vascular disease (poor blood circulation)
- you take a non-selective monoamine oxidase inhibitor (MAO) (or within 2 weeks of their withdrawal) for treatment of depression (iproniazide, nialamide).
- you suffer from a severe overactive thyroid gland (hyperthyroidism)
Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Phenylephrine; - if you are elderly
- if you have an overactive thyroid gland
- if you suffer from heart problems as a slow pulse, heart block (partial), heart muscle disease, poor blood circulation in the heart, non-severe peripheral vascular insufficiency, heart rhythm disorders, tachycardia (high heart rate), bradycardia (low heart rate), angina pectoris
- if you have poor blood circulation in the brain
- if you have atherosclerosis (hardening and thickening of the blood vessel walls)
- if you have diabetes mellitus
- if you are treated with oxytocin as the effect on the blood vessels can be enhanced and cause very high blood pressure and stroke in the period immediately after childbirth
- if you suffer from arterial hypertension
- if you suffer from a closed angle glaucoma
In patients with serious heart failure phenylephrine may worsen the heart failure as a consequence of blood vessel constriction.
The blood pressure in your arteries will be monitored during treatment. If you have heart disease, additional monitoring of vital functions will be performed.
Children
The medicine is not recommended for use in children due to insufficient data on efficacy, safety and dosage recommendations.
Other medicines and Phenylephrine
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines.
Do not use Phenylephrine with:
- iproniazide, nialamide (for depression)
The following medicines may affect or be affected by concomitant use:
- dihydroergotamine, ergotamine, methylergometrine, methysergide (for migraine) - linezolid (an antibiotic)
- bromocriptine, cabergoline, lisuride, pergolide (for Parkinson's disease)
- desipramine, imipramine, nortriptyline, moclobemide, toloxatone, minalcipram, venlafaxine (for depression)
- anaesthetics that are inhaled (desflurane, enflurane, halothane, isoflurane, methoxyflurane, sevoflurane)
- medicine used to treat high blood pressure (guanethidine)
- medicines used to treat heart failure and certain irregular heartbeats (cardiac glycosides) - medicine used to treat abnormal heart rhythm (quinidine) - medicine used during labour (oxytocin).
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor, pharmacist or nurse for advice before taking this medicine.
Pregnancy
This medication should not be used during pregnancy unless absolutely necessary.
Breast-feeding
This medication should not be used during breast-feeding unless it is absolutely necessary. However, in the event of a single administration during childbirth, breast-feeding is possible.
Driving and using machines
Not relevant.
Phenylephrine contains sodium
- Each 10 ml ampoule contains 1.6 mmol (36.8 mg) sodium. This is equivalent to 1,8% of the recommended maximum daily intake of sodium for an adult.
- Each 5 ml ampoule contains 0.8 mmol (18.4 mg) sodium per dose. This means that it contains less than 1 mmol sodium (23 mg), that is to say essentially “sodium-free”.
3. How to take Phenylephrine
The administration will be performed by a health-care professional with appropriate training and relevant experience.
Use in Adults
Your doctor or nurse will give you Phenylephrine into a vein (intravenously). Your doctor will decide the right dose for you and when and how it should be injected.
Use in patients with impaired renal function
Lower doses of phenylephrine may be needed in patients with impaired renal function.
Use in patients with impaired liver function
Higher doses of phenylephrine may be needed in patients with cirrhosis of the liver.
Use in older people
Treatment in older people should be carried out with care.
Use in children
It is not recommended for use in children due to insufficient data on efficacy, safety and dosage recommendations.
If you use more Phenylephrine than you should
Signs that indicates that you have received too much Phenylephrine is a faster and irregular heart beat, headache, nausea, vomiting, paranoid psychosis, hallucinations and hypertension. It is unlikely that this will happen because you will get this medicine at a hospital.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following adverse reactions have been reported:
Some side effects may be serious. Tell your doctor straight away if you get any of the following:
- chest pain or pain due to the angina
- irregular heartbeat
- feeling the heart pumping in the chest
- bleeding in the brain (speech disorder, dizziness, paralysis of one side of the body)
- psychosis (loosing contact with reality)
Other side effects may include (frequencies are not known):
- reaction of hypersensitivity (allergy)
- excessive dilation of the pupils
- increased pressure in the eye (aggravation of glaucoma)
- excitability (excessive sensitivity of an organ or body part)
- agitation (restlessness)
- anxiety
- confusion
- headache
- nervousness,
- insomnia (difficulty falling or staying asleep)
- shaking (tremor)
- burning of the skin
- prickling of the skin
- itching or tingling skin sensation (paraesthesia)
- slow or high heart rate
- high blood pressure
- difficulty in breathing
- fluids in the lung
- nausea
- vomiting
- sweating
- pallor or skin blanching (pale colour of the skin)
- goose flesh
- tissue damage at the site of the injection
- muscle weakness
- difficulty in passing urine or urine retention
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: Website: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Phenylephrine
Keep the ampoules in the outer carton in order to protect from light.
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 expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Phenylephrine contains
- The active substance is phenylephrine as phenylephrine hydrochloride 0.1 mg/ml
- The other ingredients are sodium chloride, sodium citrate, citric acid, water for injection and hydrochloric acid and sodium hydroxid for pH adjustment.
What Phenylephrine looks like and contents of the pack
Clear and colourless solution.
Phenylephrine 0.1 mg/ml, solution for injection, is available in glass ampoules of 5 ml and 10 ml.
The ampoules are packaged in trays of plastic and then in cartons of 5, 10, 20, 50 and 100 ampoules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Unimedic Pharma AB
PO Box 6216
SE-102 34 Stockholm
Sweden
Manufacturer
Unimedic AB
Storjordenvägen 2
SE-864 31 Matfors Sweden