Phenylephrine 10 mg/ml, concentrate for solution for injection/infusion

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

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

• 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)

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.

The medicine is not recommended for use in children due to insufficient data on efficacy, safety and dosage recommendations.

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)

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.

Not relevant.

• Each 2 ml ampoule (containing 1 ml solution) contains 0,2 mmol (3,7 mg) per ampoule. This means that it contains less than 1 mmol sodium (23 mg) per ampoule, which means that it is almost free from sodium.

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 (headache, shortness of breath, tiredness).

It is unlikely that this will happen because you will get this medicine at a hospital

• 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 (losing 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 (headache, shortness of breath, tiredness)
• 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

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.

• The active substance is phenylephrine. Phenylephrine contains phenylephrine hydrochloride equivalent to 10 mg/ml phenylephrine.
• The other ingredients are sodium chloride, sodium citrate, citric acid, water for injection and hydrochloric acid and sodium hydroxid for pH adjustment

Clear and colourless solution.

Phenylephrine 10 mg/ml, concentrate for solution for injection/infusion is available in glass ampoules of 2 ml (containing 1 ml solution).

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.