Patient leaflet - Phenylephrine 10 mg/ml solution for injection or infusion
1.What Phenylephrine Injection is and what it is used for
- atomoxetine used to treat attention-deficit hyperactivity disorder (ADHD)
2.What you need to know before you are given Phenylephrine Injection
- lithium carbonate a drug used for depression or aggression.
3.How Phenylephrine Injection is given to you 4.Possible side effects
- monoamine oxidase inhibitors medications prescribed for the treatment of depression.
5.How to store Phenylephrine Injection 6.Contents of the pack and other information
- atropine or other antimuscarinics used to treat certain types of nerve agent
Pregnancy and breast-feeding
- 1.
WHAT PHENYLEPHRINE INJECTION IS AND WHAT IT IS USED FOR
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. The safety of phenylephrine during pregnancy and breast-feeding has not been established.
Phenylephrine Injection contains
phenylephrine hydrochloride, which belongs to a group of medicines known as adrenergic cardiac stimulants. It raises blood pressure by constricting blood vessels.
Driving and using machines
Phenylephrine Injection is used to treat low blood pressure, which may be caused by circulatory failure, spinal anaesthesia or certain medicines.
Phenylephrine Injection should not affect your ability to drive. As with all medicines, if you feel unwell you must speak to your doctor or nurse before driving or operating machinery.
- 2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN PHENYLEPHRINE INJECTION
Information on sodium content
This medicine contains less than 1 mmol sodium (23 mg) per ml, that is to say essentially ‘sodium free’.
You should NOT be given Phenylephrine Injection:
- 3. HOW PHENYLEPHRINE INJECTION IS GIVEN TO YOU
- •
if you are allergic (hypersensitive) to phenylephrine hydrochloride or any of the other ingredients (listed in section 6)
You will normally be given Phenylephrine Injection in a hospital or clinic.
- •
if you suffer from high blood pressure
Phenylephrine Injection can be given by an injection under the skin, into a muscle, or diluted and given by slow injection or infusion (drip) into a vein.
- • if you have an overactive thyroid
(hyperthyroidism)
if you are taking Monoamine Oxidase Inhibitors (MAOIs) used to treat depression, or have taken them in the last 14 days.
Dose for adults, including the elderly: When given under the skin or into a muscle the usual dose is 2 to 5 mg with further doses of 1 to 10 mg if necessary.
- if you suffer from prostatic enlargement
Warnings and precautions
Talk to your doctor, pharmacist or nurse before you are given Phenylephrine Injection:
When given as a diluted solution by slow injection into a vein the dose is 100 to 500 micrograms, repeated as necessary after at least 15 minutes.
- if the anterior part (anterior chamber) of your eye is shallow
if you have a history of acute increase of eye pressure (acute narrow angle glaucoma)
Alternatively, it may be infused as a diluted solution into a vein (drip), and the dose adjusted according to the response.
any heart problems or disease, including arrhythmias or angina
Dose for children:
a disease of your blood vessels, such as arteriosclerosis or aneurysms
The usual dose is 100 micrograms/kg bodyweight given as an injection under the skin or into a muscle.
- diabetes mellitus
Other medicines and Phenylephrine Injection
If you are given more Phenylephrine Injection than you should
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.
As you will be given Phenylephrine Injection in a hospital or clinic by a qualified healthcare professional, this will be unlikely.
In particular, if you are taking any of the following:
If you have any further questions on the use of this product, ask your doctor or nurse.
Package Leaflet: Information for the Healthcare Professional PHENYLEPHRINE 10MG/ML SOLUTION FOR INJECTION OR INFUSION
The following information is intended for medical or healthcare professionals only:
Adults:
Qualitative and quantitative composition
Phenylephrine hydrochloride Ph Eur 1.0% w/v. Each 1 ml ampoule contains 10 mg phenylephrine.
Therapeutic indications
For the treatment of hypotensive states, e.g. circulatory failure, during spinal anaesthesia or drug-induced hypotension.
Posology and method of administration
For subcutaneous, intramuscular or slow intravenous injection or by intravenous infusion. Inspect visually for particulate matter and discolouration prior to administration.
ACSXP223KPB Manufacturer
4. POSSIBLE SIDE EFFECTS
Altan Pharmaceuticals, S.A, Polígono Industrial de Bernedo s/n, 01118 Bernedo (Álava), Spain.
Like all medicines, Phenylephrine Injection can cause side effects, although not everybody gets them.
Altan Pharmaceuticals, S.A. (CSR plant) Avda. de la Constitución, 198-199,
Tell your doctor or nurse if you experience other side effects of Phenylephrine Injection which may include:
21100190-00 Product: Phenylephrine 10mg x 1ml ampoules - PIL PL Number: PL 51463/0121
Polígono Industrial Monte Boyal,
Casarrubios del Monte, 45950 Toledo, Spain
This leaflet was last revised in April 2023
Not known: frequency cannot be estimated from the available data
- allergic reaction (symptoms such as itching/rash, swelling of your face, lips or throat or difficulty in breathing/wheeziness)
- a change in your heart rate and rhythm (speeding up, slowing down or cessation, palpitations)
- an irregular heart beat (arrhythmias)
- chest pain or pain due to angina
- an increase in blood pressure with headache and vomiting, which may cause bleeding in the brain or fluid in the lungs
- a decrease in blood pressure with dizziness
- difficulty in passing urine or urine retention (inability to empty bladder completely)
- fainting or flushing
- nervousness
- enlarged pupils, which may make your vision blurry
- difficulty sleeping
- injection site skin reactions.
- angle-closure glaucoma (when pressure rises quickly inside the eyes)
- sweating
- excessive production of saliva
- a feeling of fullness in the head
- tingling or coolness of the skin
- altered metabolism including glucose metabolism.
Reporting of side effects
If you get any side effects, talk to your doctor, nurse or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE PHENYLEPHRINE INJECTION
Keep out of the sight and reach of children.
Store below 25ºC. Store in the original package.
Do not use after the expiry date, which is stated on the carton and ampoule.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Phenylephrine Injection contains
- Each 1ml ampoule contains 10mg of the active substance phenylephrine hydrochloride
- The other ingredients are sodium hydroxide, hydrochloric acid and water for injections. What Phenylephrine Injection looks like and contents of the pack
Phenylephrine Injection is a clear, colourless, sterile solution in a glass ampoule, available in packs of 10 ampoules.
Marketing Authorisation Holder
Kent Pharma UK Limited, 2nd Floor, Connect 38, 1 Dover Place, Ashford, Kent, England, TN23 1FB.
21100190-00
ACSXP223KPB
Incompatibilities
Children:
Phenylephrine Injection has been stated to be incompatible with alkalis, ferric salts, phenytoin sodium and oxidising agents.
100 micrograms/kg bodyweight subcutaneously or intramuscularly.
Elderly:
There is no need for dosage reduction in the elderly.
For full prescribing information please refer to the Summary of Product
Characteristics
Pharmacokinetic properties
When injected subcutaneously or
intramuscularly, phenylephrine takes 10 to 15 minutes to act. Intravenous injections are effective for up to about 20 minutes, whereas subcutaneous injections are effective for up to one hour and intramuscular injections for up to two hours.
Dimensions: 165mm x 440mm
Code: ACSXP223KPB
Date: 19/04/2023