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NEOSTIGMINE METHYLSULFATE INJECTION BP 2.5MG IN 1ML

Active substance(s): NEOSTIGMINE METHYLSULFATE

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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.
2.
3.
4.
5.
6.

What Neostigmine Methylsulfate Injection is and what it is used for
What you need to know before you are given Neostigmine Methylsulfate Injection
How to use Neostigmine Methylsulfate Injection
Possible side effects
How to store Neostigmine Methylsulfate Injection
Contents of the pack and other information

1. What Neostigmine Methylsulfate Injection
is and what it is used for

Other medicines and
Methylsulfate Injection

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.

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.

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
a controlled low sodium diet (this medicinal
product contains approximately 3.54 mg sodium
per ml)

Neostigmine

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 information is intended for healthcare professionals only:
PREPARATION GUIDE:

hameln

Neostigmine Methylsulfate Injection BP 2.5 mg in 1ml
Please refer to the Summary of Product
Characteristics for full prescribing and other
information.

Administration
Neostigmine Methylsulfate may be administered
by IV, IM or SC injection.

Therapeutic indications
• Indications: Myasthenia Gravis, antagonist to
non-depolarizing neuromuscular blockade,
Paralytic Ileus, Post-operative Urinary
Retention;
Paroxysmal
Supraventricular
Tachycardia.

Incompatibilities
Neostigmine may be diluted with Water for
Injections. Stability of the injection cannot be
guaranteed once it has been diluted.

The following side effects have also been
reported:

The marketing authorisation number of this
medicine is: PL 01502/0023

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

Marketing Authorisation Holder

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.

This leaflet was last revised in January 2018

hameln pharmaceuticals ltd
Gloucester, United Kingdom

Manufacturer
Siegfried Hameln GmbH
Langes Feld 13, 31789 Hameln, Germany
hameln rds a.s.
Horná 36, 900 01 Modra, Slovak Republic
HBM Pharma s.r.o.
03680 Martin, Sklabinská 30, Slovak Republic

For
any
information
about
this
medicine, please contact the Marketing
Authorisation Holder

Reporting of side effects

43849/03/18

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
Injection contains

Methylsulfate

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 following information is intended for healthcare professionals only:
(Continued from overleaf)

Neostigmine Methylsulfate Injection BP 2.5 mg in 1ml
Shelf life
36 Months.
Special precautions for storage
Protect from light and store at less than 25°C.

hameln

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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