Patient Information Leaflet

Neostigmine Methylsulfate Injection BP 2.5 mg

Where to find information in this leaflet

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

2.    Before you are given Neostigmine Methylsulfate Injection

3.    How to use Neostigmine Methylsulfate Injection

4.    Possible side effects

5.    Storing Neostigmine Methylsulfate Injection

6.    Further 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.    Before you are given Neostigmine Methylsulfate Injection

You should NOT be given Neostigmine Methylsulfate Injection if you:

•    are sensitive or allergic to neostigmine or any of the other ingredients in this injection.

•    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).

Please tell 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)

Using other medicines:

medicines obtained without a prescription. This is especially important with the following medicines as they may interact with your Neostigmine Methylsulfate Injection :

•    you are receiving antibiotics known as aminoglycosides.

Pregnancy or breast feeding:

Please tell your doctor or nurse before being given this injection if you are pregnant or breast feeding. The doctor will then decide if the injection is suitable for you.

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, Neostigmine Methylsulfate Injection can cause side effects, although not everybody gets them. You may:

•    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.

If you think this injection is causing you any problems, or you are at all worried, talk to your doctor, nurse 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 at: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

5.    Storing 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.    Further information

What Neostigmine Methylsulfate Injection contains:

This injection contains the active ingredient Neostigmine Methylsulfate. Each 1 ml of solution contains 2.5 mg neostigmine methylsulfate.

This injection contains the following inactive ingredients: 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 pharmaceuticals ltd Gloucester, United Kingdom

Manufacturer:

hameln pharmaceuticals gmbh Langes Feld 13, 31789 Hameln, Germany

hameln rds a.s.

Horna 36, 900 01 Modra, Slovak Republic

HBM Pharma s.r.o.

03680 Martin, Sklabinska 30, Slovak Republic

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

This leaflet was last approved November 2014

43849/03/15

Patient Information Leaflet

Neostigmine Methylsulfate Injection BP 2.5 mg

•    Read all of this leaflet carefully before you start using this medicine. In some circumstances this may not be possible and this leaflet will be kept in a safe place should you wish to read it.

•    Keep this leaflet. You may need to read it again.

•    If you have any further questions, please ask your doctor or your pharmacist.

•    This medicine has been prescribed for you personally and you should not pass it on to others. It may harm them, even if their symptoms are the same as yours.

Where to find information in this leaflet

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

2.    Before you are given Neostigmine Methylsulfate Injection

3.    How to use Neostigmine Methylsulfate Injection

4.    Possible side effects

5.    Storing Neostigmine Methylsulfate Injection

6.    Further 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.    Before you are given Neostigmine Methylsulfate Injection

medicines obtained without a prescription. This is especially important with the following medicines as they may interact with your Neostigmine Methylsulfate Injection :

• you are receiving antibiotics known as aminoglycosides.

Pregnancy or breast feeding:

Please tell your doctor or nurse before being given this injection if you are pregnant or breast feeding. The doctor will then decide if the injection is suitable for you.

Driving and using machines:

You should NOT be given Neostigmine

Methylsulfate Injection if you:

•    are sensitive or allergic to neostigmine or any of the other ingredients in this injection.

•    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).

Please tell 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

¹ a controlled low sodium diet (this medicinal product contains approximately 3.54 mg sodium per ml)

Using other medicines:

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, Neostigmine Methylsulfate Injection can cause side effects, although not everybody gets them. You may:

•    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.

If you think this injection is causing you any problems, or you are at all worried, talk to your doctor, nurse 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 at: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

5.    Storing 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.    Further information

What Neostigmine Methylsulfate Injection contains:

This injection contains the active ingredient Neostigmine Methylsulfate. Each 1 ml of solution contains 2.5 mg neostigmine methylsulfate.

This injection contains the following inactive ingredients: 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 pharmaceuticals ltd Gloucester, United Kingdom

Manufacturer:

hameln pharmaceuticals gmbh Langes Feld 13, 31789 Hameln, Germany

hameln rds a.s.

Horna 36, 900 01 Modra, Slovak Republic HBM Pharma s.r.o.

03680 Martin, Sklabinska 30, Slovak Republic

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

This leaflet was last approved November 2014

58175/03/15