PATIENT INFORMATION LEAFLET Pancuronium Injection 4mg in 2ml

Pancuronium Bromide BP

READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE.

However, please be aware that this may not always be possible because of your medical condition.

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

If you have any further questions, ask your doctor.

If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.

In this leaflet:

1.    What Pancuronium Injection is and what it is used for

2.    Before you are given Pancuronium Injection

3.    How Pancuronium Injection is given to you

4.    Possible side effects

5.    How to store Pancuronium Injection

6.    Further information

1.    WHAT PANCURONIUM INJECTION IS AND WHAT IT IS USED FOR

Pancuronium Injection belongs to a group of medicines called muscle relaxants.

Their effect is to block the connection between the nerves and certain muscles, which relaxes these muscles by temporarily paralysing them. This effect helps surgeons when performing a wide range of operations.

This medicine can also be used when a patient is put on a ventilator to control breathing. During this procedure, it is necessary for the muscles used for breathing to be paralysed.

2.    BEFORE YOU ARE GIVEN PANCURONIUM INJECTION You should not be given Pancuronium Injection if:

•    you know that you are allergic to Pancuronium or to any of the other ingredients (see Section 6 of this leaflet)

•    your doctor intends to give you another type of blocking agent, such as Suxamethonium.

Make sure your doctor knows if this applies to you.

Your doctor will take special care if any of the following situations apply to you:

•    you have a disease of the liver, gall bladder or kidneys or, if you have been passing a lot of urine • you have a heart problem or if you suffer from poor circulation

•    you have problems with water retention which may cause your ankles or tummy to be swollen or breathlessness

•    you suffer from myasthenia gravis (which causes severe weakness of the muscles) or from any other disease of nerves or muscles

•    you have been told that you have an electrolyte disorder (imbalance of salts in your blood) or acidosis (too much acid in your tissues). This may be caused by severe vomiting, diarrhoea and dehydration or weight loss

•    you have widespread cancer like lung cancer or disease of the lungs

•    you have jaundice (yellowish discoloration of the skin or whites of eyes)

•    you are ill or malnourished

•    you have altered plasma protein levels in your blood

•    you suffer from high blood pressure

•    the patient treated is a young infant.

Make sure your doctor is aware of these situations if it is not already obvious, before you are given this Injection.

Taking other medicines

Please tell your doctor if you are taking, or have recently taken, any other medicines. This includes medicines obtained without a prescription. This is extremely important because some medicines can strengthen or weaken the effects of others.

In particular, tell your doctor if you are taking any of the following:

•    antibiotics, including metronidazole, piperacillin, clindamycin, polymixins, aminoglycosides or polypeptide antibiotics which are used to treat infection

•    diuretics (to help you pass more water), e.g. hydrochlorthiazide

•    a beta-blocking medicine, which may be used to treat various conditions including high blood pressure, angina and irregular heart beats, e.g. propranolol or atenolol

•    calciumchannel blockers, used in the treatment of high blood pressure, e.g. verapamil

•    thiamine (also known as Vitamin B1)

•monoamine oxidase inhibitor (MAOI) e.g. isocarboxazid, and tricyclic antidepressants, e.g. amitriptyline, which are drugs for depression

•    phenytoin (for epilepsy)

•    quinidine (used to treat irregular heart beats)

•    protamine (a drug used to treat bleeding due to an overdose of heparin)

•    alpha-adrenergic blocking drugs (which have many uses, including management of high blood pressure and of enlargement of the prostate gland)

•    imidazole drugs (used to treat fungus infections, e.g. micronazole)

•    nitroglycerin (a drug used to treat angina and heart failure)

•    diazepam (a drug used to relieve anxiety and muscle spasm)

•    carbamazepine (used to treat epilepsy or fits)

•    donepzil (used to treat alzheimer's disease)

•    anticancer medicines belonging to a group called ‘alkylating agents’ (including medicines known as ‘nitrogen mustards’)

•    strong pain relieving medicines, e.g. codeine

•magnesium sulphate which has various uses including the treatment of some heart disorders

• neostigmine, pyridostigmine and edrophonium (used in the treatment or diagnosis of myasthenia gravis, or used to reverse the effects of muscle relaxants)

•    steroids, including corticosteroids for the treatment of asthma and other inflammatory conditions • adrenaline (used in emergency reactions for severe allergic reactions) and noradrenaline (to treat severe low blood pressure)

• azathioprine (used to suppress the immune response) and anti-cancer drugs, e.g. cyclophosphamide

•    theophylline (for asthma or wheezing)

•    heparin (to prevent blood clots)

•medicines containing the salts potassium chloride, sodium chloride or calcium chloride

•    tricyclic antidepressants.

Your doctor will take care when using these.

Pregnancy and breast feeding

There is not enough information available about the use of Pancuronium in pregnant women. Therefore, it should only be used during pregnancy when your doctor decides the benefits outweigh any possible risk.

There is insufficient information to say whether this medicine passes in to breast milk. It is recommended not to breast feed for at least 24 hours following administration of Pancuronium. Ask your doctor for advice before taking any medicine.

3.    HOW PANCURONIUM INJECTION IS GIVEN TO YOU

The anaesthetist will decide on the most appropriate dose.

It may be administered as an injection. The anaesthetist will make sure that you are asleep before this muscle relaxant is administered.

If you are given more Pancuronium Injection than you should

As the injection will be administered by an anaesthetist, it is unlikely that you will be given more than is necessary. In case of an overdose, the muscle will stay relaxed for longer than required.

If you have any further questions on the use of this product ask your doctor.

4.    POSSIBLE SIDE EFFECTS

Like all medicines Pancuronium Injection can sometimes cause side-effects, although not everybody gets them.All medicines can cause allergic reactions although severe allergic reactions are very rare. Any sudden wheeziness, difficulty in breathing, swelling of the eyelids, face or lips, rash or itching (especially affecting your whole body) should be reported to a doctor immediately.

The following side effects have also been reported:

• slight rise in blood pressure and pulse rate with a lowering of the pressure in the eye and constriction of the pupil. These effects are minimal and should not cause any noticeable symptoms

•    soreness at the site of injection

•    rarely, spasm of the air passages in the lungs or the windpipe causing difficulty in breathing and very high temperature

•    irregular heart beats

•    increased salivation.

When you wake up after the anaesthetic, if you notice any of the side effects becoming serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.

5.    HOW TO STORE PANCURONIUM INJECTION

Your doctor or nurse will know how to store this medicine properly.

The ampoules containing the injection solution are stored in their original packaging at a temperature between 2°C and 8°C. The expiry date (EXP) is printed on the label and the carton. The first 2 digits indicate the month and the remaining digits indicate the year of expiry. The drug should not be used after this date. Once opened, any unused liquid should be discarded.

6. FURTHER INFORMATION

The active substance is Pancuronium Bromide. There is 4mg of Pancuronium in 2ml of the injection.

Other ingredients of the solution are sodium acetate, sodium chloride, glacial acetic acid, water for injections and nitrogen.

What Pancuronium Injection looks like and contents of pack

Pancuronium Injection BP 4mg in 2ml is a colourless, sterile solution. Each glass ampoule (small bottle) contains 2ml with 4mg respectively of the active ingredient, Pancuronium Bromide. These ampoules are then packed in to cardboard boxes. Each box contains 10 ampoules and one information leaflet for the patient.

Marketing authorization holder

Mercury Pharma International Ltd., 4045, Kingswood Road, City West Business Park, Co Dublin, Ireland

Manufacturer

Mercury Pharmaceuticals (Ireland) Ltd., 4045, Kingswood Road, City West Business Park, Co Dublin, Ireland

This leaflet was last revised in March 2012.