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Below is a text only representation of the Patient Information Leaflet (ePIL).
The text only version may be available in large print, Braille or audio CD.
For further information call emc accessibility on
0800 198 5000.
The product code(s) for this leaflet is: PL 01502/0023.
Neostigmine Methylsulfate Injection BP 2.5mg in 1ml
Package Leaflet: Information for the user
Neostigmine Methylsulfate Injection BP 2.5 mg in 1ml
Neostigmine Methylsulfate
Read all of this leaflet carefully before you start using 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, please ask your doctor or your pharmacist.
What is in this leaflet
1. What Neostigmine Methylsulfate Injection is and what it is used for 2. What you need to know before you are given Neostigmine Methylsulfate Injection 3. How to use Neostigmine Methylsulfate Injection 4. Possible side effects 5. How to store Neostigmine Methylsulfate Injection 6. Contents of the pack and other information
1. What Neostigmine Methylsulfate Injection is and what it is used for
Neostigmine injection belongs to a group of medicines used to:
Treat abnormally tired and weak muscles (myasthenia gravis).
Reverse the effects of muscle relaxants.
Improve movement in the small intestine.
Reduce urine retention after surgical procedures.
2. What you need to know before you are given Neostigmine Methylsulfate Injection
Do not use Neostigmine Methylsulfate Injection if you:
are allergic to neostigmine or any of the other ingredients in this medicine (listed in section 6).
have an intestinal obstruction or cannot urinate.
have peritonitis (an infection or inflammation of the outer layer of your stomach or intestines).
have a condition where your bowel may no longer be functioning.
you are receiving certain muscle relaxants (e.g. Suxamethonium).
Warning and precautions
Talk to your doctor or nurse before being given the injection if you have:
asthma
epilepsy
a slow pulse
any heart disease
vagotonia (you may suffer from sweating, constipation and involuntary movements)
an overactive thyroid gland
a stomach ulcer
Parkinson’s Disease
an anastomosis (an opening created by surgery, trauma, or disease) in your intestine
Other medicines and Neostigmine Methylsulfate Injection
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is especially important with the following medicines as they may interact with your Neostigmine Methylsulfate Injection :
you are receiving antibiotics known as aminoglycosides.
This medicine contains 3.54 mg (0.15 mmol) sodium (main component of cooking/table salt) per 1 ml ampoule, that is to say essentially ‘sodium-free’.
Pregnancy or breast feeding
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.
Driving and using machines
You should not drive or use machinery if you are affected by the administration of Neostigmine Methylsulfate Injection.
3. How to use Neostigmine Methylsulfate Injection
Your nurse or doctor will give you the injection.
Your doctor will decide the correct dosage for you and how and when the injection will be given.
Since the injection will be given to you by a doctor or nurse, it is unlikely that you will be given too much. If you think you have been given too much, you must tell the person giving you the injection.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact a doctor right away if you notice any of the following symptoms - you may need urgent medical treatment:
Swelling of the face, lips or throat which makes it difficult to swallow or breathe, rash, itching, hives and dizziness.
This could be a sign of an angioedema or a severe allergic reaction (frequency not known, cannot be estimated from the available data).
The following side effects have also been reported:
You may (frequency not known, cannot be estimated from the available data):
feel or actually be sick
produce more saliva than usual
produce more tears than usual
suffer from bronchial spasm and increased bronchial secretion
suffer from diarrhoea and stomach cramps
have constricted (pin-point) pupils in your eye
suffer from urinary incontinence (you pass urine when you do not mean to)
suffer from excessive sweating
have a slow pulse
suffer from hypotension (blood pressure that is much lower than usual)
suffer from muscle spasms
If you experience any of the side effects listed this may mean that you have been given an overdose and you should tell a doctor immediately.
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: 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 Neostigmine Methylsulfate Injection
Your injection will be stored at less than 25°C and protected from light. The nurse or doctor will check that the injection is not past its expiry date before giving you the injection.
6. Contents of the pack and other information
What Neostigmine Methylsulfate Injection contains
The active ingredient is Neostigmine Methylsulfate. Each 1 ml of solution contains 2.5 mg neostigmine methylsulfate.
The other ingredients are Sodium Chloride, Sterile Water for Injections.
What Neostigmine Methylsulfate Injection looks like and contents of the pack
Neostigmine Methylsulfate Injection is a clear colourless solution in clear glass ampoules containing 2.5 mg neostigmine methylsulfate in 1 ml. 10 ampoules are supplied in each carton.
The marketing authorisation number of this medicine is: PL 01502/0023
Marketing Authorisation Holder
hameln pharma ltd Nexus Gloucester Business Park Gloucester GL3 4AG United Kingdom
Manufacturer
Siegfried Hameln GmbH Langes Feld 13 31789 Hameln Germany
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