Zenziket 10 mg/50 mg Solution

ZENZIKET belongs to a group of medicines called anaesthetics. When injected, it causes sedation, loss of mobility and will make you go to sleep and lose consciousness. It has powerful pain blocking properties. It acts on the brain, and the nerve pathways and networks within your brain.

ZENZIKET is used:

• For the induction of anaesthesia, or it may be used on its own or in combination with other anaesthetics, to maintain general anaesthesia.
• In children for the management of minor surgical and diagnostic procedures or procedures that require intense analgesia, such as changing burn dressings.

ZENZIKET should not be given to you if you:

• Are hypersensitive (allergic) to ketamine hydrochloride or to any of the other ingredients of ZENZIKET (listed in section 6).
• Are suffering from any condition in which an increase of 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.
• Previously suffered a stroke.
• Have or recently had a serious head or brain injury.
• Have developed high blood pressure during pregnancy (where your blood pressure was previously normal) called eclampsia or pre-eclampsia.
• Have severe heart disease.
• Suffer from high pressure in your eye or have an object penetrating your eye.
• Are pregnant or breastfeeding.

Warnings and precautions

Tell your doctor or healthcare professional before being given ZENZIKET if you:

• Recently had a heart attack or suffer from any heart disease or condition.
• Suffer from increased pressure on your brain.
• Have increased pressure in the eye (glaucoma).
• Have an eye injury, where the eye has been perforated (pierced).
• Drink large amounts of alcohol.
• Have problems with your liver or kidneys.
• Are dehydrated.
• Have a history of or have current mental health problems.
• Have an inherited disease that affects the blood, called porphyria.
• Have or ever had seizures (fits).
• Are receiving treatment for your thyroid gland.
• Have a chest infection or problems breathing.
• Have had any injury of your head or abnormal growth in the brain.
• Have a history of drug abuse or addiction.

Some people have hallucinations, vivid dreams, nightmares, feel ill at ease, confused, anxious or behave irrationally while recovering from anaesthesia with ZENZIKET. These side effects are collectively known as an “emergence reaction”. You will be allowed to recover from the anaesthetic in a quiet place, which helps to prevent the reaction (see section “Possible side effects”).

If you are receiving ZENZIKET on a long-term basis, you may experience bladder and liver complications. Speak to your doctor, since ZENZIKET is not intended for long-term use.

Children and adolescents

ZENZIKET must not be used in children aged less than 3 months due to potential respiratory complications.

Other medicines and ZENZIKET

Always tell your healthcare professional if you are taking any other medicine (This includes complementary or traditional medicines). Some medicines and ZENZIKET may interfere with each other.

Do not share medicines prescribed for you with any other person. You will not be expected to give yourself ZENZIKET. It will be given to you by a person who is qualified to do so. Your doctor will decide what your dose is and for how long you will receive ZENZIKET. This will vary from patient to patient. It will depend on your condition and other factors, such as your physical condition, weight, age, as well as other medicines that you are taking at the time or afterwards.

ZENZIKET is given as a single dose injection or on a continuous basis for the duration of the operation. ZENZIKET injection is administered either:

• directly into the muscle (intramuscular);
• as a slow injection directly into the vein (intravenous) over 60 seconds; or
• as a slow intravenous infusion directly into the vein until surgery is complete.

If you are given more ZENZIKET than you should

Since a health care provider will administer ZENZIKET, he / she will control the dosage. However, in the event of overdosage your doctor will manage the overdosage.

ZENZIKET can have side effects. Not all side effects reported for ZENZIKET are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking ZENZIKET, please consult your health care provider for advice.

If any of the following happens, stop receiving ZENZIKET and tell your doctor immediately or go to the casualty department at your nearest hospital:

• Swelling of the hands, feet, ankles, face, lips, mouth or throat, which may cause difficulty in swallowing or breathing.
• Severe rash or itching.
• Fainting.

These are all very serious side effects. If you have them, you may have had a serious allergic reaction to ZENZIKET. You may need urgent medical attention or hospitalisation.

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of 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 and irrational behaviour (see section “Warnings and precautions”).
• Increased pressure in the skull, which will present as a bad headache.
• Unusual eye movements, increased muscle tone and muscle twitches (which may resemble fits or convulsions).
• Double vision or involuntary rapid eye movement.
• Raised pressure in the eyes.
• Increased blood pressure and increased pulse rate.
• Slowing of heart rate, changes in heart rhythm.
• Breathing faster, or more slowly, narrowing of the voice box leading to difficulty in breathing, stop breathing while you are asleep (apnoea).
• Effect on the reflexes which keep your airways clear, resulting in temporary inability to breathe.
• Medicine-induced liver injury (see section “Warnings and precautions”). You may experience symptoms such as loss of appetite, nausea, vomiting, fever, weakness, abdominal pain, and yellowing of the eyes and skin.
• Measle-like skin rash.
• Inflammation of the bladder and/or pain when urinating. The appearance of blood may also occur.

These are all serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following:

Frequent side effects:

• Nausea and vomiting.

Less frequent side effects:

• Feeling anxious.
• Drifting in and out of consciousness (with a feeling of confusion and hallucinations), flashbacks, feeling uneasy, sleeplessness, feeling disorientated.
• Feeling dizzy (vertigo).
• Lowering of blood pressure.
• Loss of appetite and weight (anorexia).
• Drooling.
• Pain, inflammation of the skin or rash at the site of injection.

Frequency unknown:

• Increase in the production of tears.
• Temporary skin rashes.

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects

If you get side effects, talk to your doctor, pharmacist or nurse. You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of ZENZIKET.

Store at or below 30 °C. Do not refrigerate or freeze. Store in original package in order to protect from light. Diluted solutions for infusion should be used immediately and should not be stored. Keep out of the sight and reach of children. Do not use after the expiry date printed on the carton. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains and sewerage systems (e.g., toilets).