Vecuronium SUN 10 mg powder for solution for injection/infusion

• 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.

1. What Vecuronium is and what it is used for
2. What you need to know before you are given Vecuronium
3. How Vecuronium is used
4. Possible side effects
5. How to store Vecuronium
6. Contents of the pack and other information

• if you are allergic to vecuronium, the bromide ion or any of the other ingredients of this medicine (listed in section 6).

Talk to your doctor, pharmacist or nurse before you are given Vecuronium

• if you are allergic to any muscle relaxants
• if you have reduced renal function or a renal disease
• if you have a heart disease or a disease affecting your blood circulation
• if you have an accumulation of fluid beneath the skin (for example swelling of the ankles)
• if you have a liver or a gallbladder disease
• if you have diseases affecting nerves and muscles (for example polio (poliomyelitis), myasthenia gravis, Eaton-Lambert syndrome).

• low potassium levels in the blood (hypokalaemia; caused for example by severe vomiting or by severe diarrhoea)
• high magnesium levels in the blood (hypermagnesaemia)
• low calcium levels in the blood (hypocalcaemia; caused by blood transfusion)
• low levels of proteins in the blood (hypoproteinaemia)
• loss of too much water from the body (dehydration; caused for example by being sick, diarrhoea or sweating)
• over-breathing (hyperventilation) leading to too little carbon dioxide in the blood (alkalosis)
• too much acid in the blood or body tissue (acidosis)
• an increased level of carbon dioxide in the blood (hypercapnia)
• general ill-health (cachexia)
• being very overweight (obesity)
• burns
• drop in body temperature (hypothermia) during anaesthesia.

If you have any of the conditions listed above, your doctor will take them into account when deciding the correct dose of Vecuronium for you.

Tell your doctor or pharmacist if you are taking, have recently taken, or might take, any other medicines. Vecuronium may affect other medicines or be affected by them.

Medicines which increase the effect of Vecuronium

• certain medicines used to make you sleep during surgery (anaesthetics; for example suxamethonium)
• certain medicines to treat bacterial infections (antibiotics; for example aminoglycosides, lincosamide and polypeptide antibiotics, acylamino-penicillin antibiotics)
• medicines which increase the amount of urine (diuretics or water tablets)
• medicines used for the treatment of heart disease or high blood pressure (calcium channel blockers, beta-blockers and quinidine)
• medicines used to treat mania, manic depressive illness or depression (lithium)
• certain medicines used to treat stomach ulcers, heartburn or acid reflux (cimetidine)
• some laxatives such as magnesium salts
• long-term concomitant use of certain anti-inflammatory medicines (corticosteroids)
• certain medicines for reducing pain (local anaesthetics; for example lidocaine)
• short-term concomitant use of certain medicines used for epilepsy (phenytoin).

Medicines which decrease the effect of Vecuronium

• certain medicines used for epilepsy (for example phenytoin or carbamazepine)
• calcium chloride and potassium chloride.

Medicines with variable effect

• other muscle relaxants.

Effect of Vecuronium on other drugs

• Vecuronium may make certain anaesthetics (for example lidocaine) work more quickly.

Your doctor will take this into account when deciding the correct dose of Vecuronium for you.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor, pharmacist or nurse for advice before you are given this medicine.

Your doctor may still give you Vecuronium, but you need to discuss it first. Vecuronium may be given to you if you are having a Caesarean section.

Do not drive or use machines until advised it is safe to do so. Because Vecuronium is given as part of a general anaesthetic, you may feel tired, weak or dizzy for some time afterwards. Your anaesthetist will be able to advise you on how long the effects are likely to last.

Vecuronium can be used in adults and children of all ages. The dose will be determined by the doctor. You will be given Vecuronium before or during a surgical procedure. The usual dose is 0.08 to 0.1 mg vecuronium bromide per kg body weight and the effect will last for 24 to 60 minutes. During the procedure it will be checked whether Vecuronium is still working.

You may be given additional doses if they are needed. The dose that you receive will depend on various factors. These include possible interactions with any other drugs you may have been given, the expected duration of the operation, your age and the state of your health.

Vecuronium will be given to you by your doctor. Vecuronium is given intravenously (into a vein), either as single injections or as a continuous infusion (a drip).

As your doctor will be monitoring your condition carefully it is unlikely that you will be given too much Vecuronium. However if this happens, your doctor will keep you breathing artificially (on a ventilator) until you can breathe on your own. It is possible to counteract the effects (too much) Vecuronium and speed-up your recovery by giving you a drug that reverses the effect of Vecuronium. You will be kept asleep while this takes place.

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.

• The active substance is vecuronium bromide. Each vial contains vecuronium as 10 mg vecuronium bromide.
• The other ingredients are citric acid anhydrous, disodium phosphate anhydrous, mannitol (E421), sodium hydroxide (for pH adjustment) and phosphoric acid concentrated (for pH adjustment).

Vecuronium is a white to off-white lyophilised powder, for solution for injection/infusion.

Vecuronium is supplied in packs containing 1, 4, 10 or 20 vials.

Not all pack sizes may be marketed.