Patient Leaflet Updated 09-Oct-2019 | ADVANZ Pharma
Prochlorperazine Injection BP 12.5mg/ml, 2ml
Package leaflet: Information for the user
Prochlorperazine Mesilate 12.5mg/ml Solution for Injection
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor, pharmacist or nurse. 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.
The name of your medicine is Prochlorperazine Mesilate 12.5mg/ml Solution for Injection. It will be referred to as Prochlorperazine Injection for ease hereafter.
What is in this leaflet:
1. What Prochlorperazine Injection is and what it is used for
2. What you need to know before you take Prochlorperazine Injection
3. How to take Prochlorperazine Injection
4. Possible side effects
5. How to store Prochlorperazine Injection
6. Contents of the pack and other information
1. WHAT PROCHLORPERAZINE INJECTION IS AND WHAT IT IS USED FOR
Prochlorperazine Injection belongs to a class of drugs called phenothiazine neuroleptics. It influences the activity of certain brain cells by decreasing the effect of dopamine, a natural chemical in the brain.
Prochlorperazine Injection may be used to improve the symptoms of major mental disorders such as in schizophrenia, acute mania, and short term treatment of anxiety. It may also be used to treat the symptoms of nausea (feeling sick) and vomiting (being sick), as well as symptoms of vertigo due to Menieres syndrome or labyrinthitis (inner ear disorders).
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PROCHLORPERAZINE INJECTION
Do not take Prochlorperazine Injection if:
Warnings and precautions
Talk to your doctor or pharmacist or nurse before taking Prochlorperazine Injection
Other medicines and Prochlorperazine Injection:
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. The effects of these medicines may change, especially if you are taking:
Prochlorperazine Injection with food, drink and alcohol:
You should not drink alcohol whilst you are taking this medicine.
Pregnancy breast feeding and fertility:
You should not be given Prochlorperazine Injection if you are pregnant, think you may be pregnant or are planning to become pregnant, or while breast feeding, unless your doctor decides that treatment is essential. It is particularly important not to take Prochlorperazine Injection during the first three months of pregnancy.
The following symptoms may occur in newborn babies, of mothers that have used Prochlorperazine in the last trimester (last three months of their pregnancy): shaking, muscle stiffness and/or weakness, sleepiness, agitation, breathing problems and difficulty in feeding. If your baby develops any of these symptoms you may need to contact your doctor.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines:
Prochlorperazine Injection may make you feel drowsy or dizzy or give you blurred vision. You should not drive or use machines when you are first given this medicine until you are certain that you are not getting these side effects. If in any doubt, speak to your doctor before you drive or use machines.
Prochlorperazine Injection contains sodium, sodium sulphite and sodium metabisulphite:
This medicinal product contains less than 1mmol sodium (23mg) per dose, i.e. is essentially “sodium-free”.
This medicine also contains the preservatives sodium sulphite (E221) and sodium metabisulphite (E223) which may rarely cause severe hypersensitivity reactions and bronchospasm.
3. HOW TO TAKE PROCHLORPERAZINE INJECTION
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Prochlorperazine Injection is only given in the hospital by a doctor.
Prochlorperazine Injection is usually given by injection deep into the muscle. Your doctor will decide on a suitable dose depending on your age, severity of the symptoms and previous responses to similar medicines.
For mood disorders and schizophrenia, it may take several weeks for you to feel the full benefit of this medicine.
A smaller starting dose should be given to elderly patients.
Use in children and adolescents
Prochlorperazine Injection is not for use in children.
If you are given more Prochlorperazine Injection than you should:
As Prochlorperazine Injection is administered by a healthcare professional it is unlikely that you will be given too much. If you are at all concerned, speak to your doctor.
In this event, you will be treated in the hospital and you will be given the necessary treatment.
If you miss a dose of Prochlorperazine Injection:
This is unlikely as the injection is given by a healthcare professional but if you are concerned about missing a dose, speak to your doctor.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them.
You should avoid:
Some patients may experience a local lump at the site of injection, difficulty in sleeping, stuffy nose or dry mouth, agitation.
Tell your doctor straight away if you notice any of the following:
If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
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 Website: 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 PROCHLORPERAZINE INJECTION
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 ampoule and carton. The expiry date refers to the last day of that month.
Do not store above 25°C. Keep ampoules in the outer carton in order to protect from light.
If only part of the solution is used, the remainder should be discarded.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
The active substance in Prochlorperazine Injection is prochlorperazine mesilate.
The other ingredients are anhydrous sodium sulphite (E221), sodium metabisulphite (E223) and ethanolamine in water for injections.
What Prochlorperazine Injection looks like and contents of the pack:
Prochlorperazine Injection is a colourless or almost colourless sterile solution. Each 1ml of solution contains 12.5mg of prochlorperazine mesilate. The solution is presented in 1ml and 2ml clear glass ampoules.
Each carton contains either 5 or 10 ampoules. Not all pack sizes may be marketed.
Marketing Authorisation Holder:
This leaflet was last revised in September 2019.
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