This medicine contains ketamine hydrochloride which belongs to a group of medicines called anaesthetic agents, which are used to put you to sleep during an operation. Tekam may be used in both routine and emergency surgery.

Tekam is used in adults, the elderly and children. Tekam can be given alone or in combination with other anaesthetic agents.

You should not be given Tekam:

• If you are allergic to ketamine hydrochloride or any of the other ingredients of this medicine (listed in section 6).
• If you are suffering from any condition in which an increase in blood pressure may be harmful to you or have suffered in the past from a medical condition which may have been caused/made worse by an increase in blood pressure.
• If you have been pregnant and during your pregnancy you have suffered from a condition called eclampsia or pre-eclampsia which causes an increase in your blood pressure.
• If you have recently suffered a stroke or serious head or brain injury.
• If you have severe heart disease.
• If you are pregnant, trying to become pregnant or breast-feeding. However, ketamine may safely be used in caesarean section surgery or vaginal delivery.

Warnings and precautions
Talk to your doctor or nurse if any of the following apply to you, to help them decide if Tekam is suitable for you. If you:

• Drink large amounts of alcohol
• Have a history of drug abuse or addiction
• Have a history of or have current mental health problems
• Have a chest infection or problems breathing
• Have problems with your liver
• Have increased pressure in the eye (glaucoma)
• Have an inherited disease that affects the blood (porphyria)
• Have ever had seizures
• Are receiving treatment for your thyroid gland
• Have had any injury to your head or abnormal growth in the brain

If before your operation the pressure in your spinal cord is raised, your anaesthetist will pay special attention to this during the operation.

Ketamine administration is associated with hepatobiliary dysfunction (most often a cholestatic pattern) with recurrent use. (e.g., misuse/abuse or medically supervised unapproved indications). Biliary duct dilatation with or without evidence of biliary obstruction has also been reported with recurrent use.

The doctor will obtain baseline liver function tests, including alkaline phosphatase and gamma glutamyl transferase, in patients receiving ketamine as part of a treatment plan that utilizes recurrent dosing. The doctor will monitor those receiving recurrent ketamine at periodic intervals during treatment.

Other medicines and Tekam
Tell your doctor if you are taking, have recently taken or might take any other medicines.

Ketamine is usually given together with other medicines during surgery.

• Tell your doctor if you are taking barbiturates (e.g. thiopental) and narcotics (morphine-like drugs) since use with ketamine may slow your recovery from anaesthesia. Otherwise, ketamine may be used with all other general and local anaesthetics.
• Diazepam can increase the effects of Tekam so dose adjustments may be needed.
• Using sympathomimetics (for example adrenaline or noradrenaline) or vasopressin with Tekam may lead to an increase in blood pressure and heart rate.
• Using Tekam with ergometrine may lead to an increase in blood pressure.
• Using Tekam with theophylline or aminophylline may lead to an increased likelihood of seizures.
• Concomitant use of medicines used to treat high blood pressure carries the risk of developing hypotension (low blood pressure).
• When given to patients already on thyroid hormone tablets, there is an increased risk of developing a fast heart rate and high blood pressure.

Tekam with food and drink
It is normal not to eat or drink for at least six hours before an operation; therefore ketamine is usually given when your stomach is empty. If in an emergency, this is not possible, ketamine may still be used.

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

Driving and using machines
Caution should be taken when driving or operating machines following treatment with Tekam. You should not drive or operate machines in the first 24 hours after your operation.

The medicine can affect your ability to drive as it may make you sleepy or dizzy.

• Do not drive while taking this medicine until you know how it affects you.
• It is an offence to drive if this medicine affects your ability to drive.
• However, you would not be committing an offence if:
  • The medicine has been prescribed to treat a medical or dental problem and
  • You have taken it according to the instructions given by the prescriber or in the information provided with the medicine and
  • It was not affecting your ability to drive safely

Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while taking this medicine.

Tekam contains sodium
Tekam contains sodium. Each 20 ml of Tekam 200 mg/20 ml Solution for Injection/Infusion contains 59.11 mg sodium (main component of cooking/table salt). This is equivalent to 2.95% of the recommended maximum daily dietary intake of sodium for an adult.

Tekam contains sodium. Each 10 ml of Tekam 500 mg/10 ml Solution for Injection/Infusion contains 6.21 mg sodium. This medicine contains less than 1 mmol sodium (23 mg) per 10 ml, that is to say essentially ‘sodium-free’.

• Except in an emergency, ketamine should only be used in hospitals by experienced anaesthetists with resuscitation equipment available.
• Before your operation you will usually be given a medicine such as atropine or hyoscine to dry up your secretions (body fluids like saliva and tears) and another medicine called a benzodiazepine. The benzodiazepine will help you to relax and help to prevent a side effect known as "emergence reaction".
• The dose of ketamine depends on its use and varies from person to person. When injected directly into a vein at a dose of 2 mg for every kg of your bodyweight, ketamine produces unconsciousness within 30 seconds and this lasts for 5 to 10 minutes. Because it works so quickly, it is important to be lying down, or supported in some other way when the drug is given. When ketamine is injected into a muscle, at a dose of 10 mg for every kg of bodyweight, it takes longer to work (3 to 4 minutes) but lasts 12 to 25 minutes.
• Your anaesthetist will then keep you anaesthetised with either:
  • Another anaesthetic
  • More ketamine given by injection into a muscle or vein, or in a drip (infusion)
  • Ketamine together with another anaesthetic.
• When it is injected directly into a vein, ketamine is given over at least a minute so that it does not slow your breathing too much. If breathing is slowed, it can be helped mechanically.
• While you are anaesthetised, your anaesthetist will watch over you constantly, paying particular attention to your breathing, airways, reflexes, the degree of anaesthesia and the condition of your heart.
• You should not be released from hospital until you have completely recovered from the anaesthetic. If you are discharged on the same day as the operation, you should be accompanied by another adult (see also the section on ‘Driving and using machines’).

If you are given more Tekam than you should
If you are given more Tekam than you should you may experience breathing difficulties. Your doctor or nurse may provide you with equipment to help you breath.

If you have any further questions on the use of this medicine, ask your doctor or nurse.

Like all medicines, this medicine can cause side effects although not everyone gets them.

Tell your doctor immediately if you notice pain, inflammation of the skin or rash at the injection site.

Ketamine can sometimes cause allergic symptoms (‘anaphylaxis’) such as breathing problems, swelling and rash. Some people have hallucinations, vivid dreams, nightmares, feel ill at ease, confused, anxious or behave irrationally while recovering from anaesthesia with ketamine. These side effects are collectively known as an ‘emergence reaction’. You will be allowed to recover from the anaesthetic in a quiet place and this helps to prevent the reaction (see section 3 under ‘How Tekam is given’).

Common: may affect up to 1 in 10 people

• The following, while recovering from anaesthesia (these are collectively known as an ‘emergence reaction’): hallucinations (which may include flashbacks or floating sensation), vivid dreams, nightmares, feeling ill at ease, confused, anxious and irrational behaviour.
• Unusual eye movements, increased muscle tone and muscle twitches (which may resemble ‘fits’ or convulsions).
• Double vision.
• Increased blood pressure and increased pulse rate.
• Breathing more quickly.
• Nausea, vomiting.
• Skin inflammation/rash.

Uncommon: may affect up to 1 in 100 people

• Loss of appetite, feeling anxious.
• Slowing of heart rate, changes in heart rhythm.
• Lowering of blood pressure.
• Breathing more slowly, narrowing of the voice-box leading to difficulty in breathing.
• Pain, inflammation of the skin or rash at the injection site.

Rare: may affect up to 1 in 1000 people

• Allergic symptoms (‘anaphylaxis’) such as breathing problems, swelling and rash.
• Drifting in and out of consciousness (with feeling of confusion and hallucinations), flashbacks, feeling ill at ease, sleeplessness, feeling disorientated.
• Effect on the reflexes which keep your airways clear, resulting in temporary inability to breathe.
• Increase in salivation.
• Inflammation of the bladder and/or pain when urinating (‘cystitis’). The appearance of blood in the urine may also occur.

Not known: frequency cannot be estimated from the available data

• Raised pressure in the eyes.
• Abnormal results to liver function tests.
• Drug-induced liver injury (when taken for more than 3 days).
• Hepatobiliary dysfunction and biliary duct dilatation.

Keep this medicine out of the sight and reach of children.

Store below 30°C. Avoid freeze.

Store in the original package in order to protect from light.

Do not use this medicine after the expiry date which is stated on the package after “EXP”. The expiry date refers to the last day of that month.

Do not use this medicine if you notice any visible signs of deterioration.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.