Patient Leaflet Updated 22-Dec-2017 | Kyowa Kirin Ltd
PACKAGE LEAFLET: INFORMATION FOR THE USER
THIOPENTAL SODIUM 500 mg
Powder for Solution for Injection
Read all of this leaflet carefully before receiving this medicine because it contains important information for you.
What is in this leaflet:
1. What Thiopental injection is and what it is used for
2. What you need to know before Thiopental injection is given
3. How Thiopental injection is given
4. Possible side effects
5. How to store Thiopental injection
6. Contents of the pack and other information
1. WHAT THIOPENTAL INJECTION IS AND WHAT IT IS USED FOR
Thiopental injection contains the active ingredient thiopental sodium (as thiopental sodium and sodium carbonate) which is also known as thiopentone sodium. It is an anaesthetic agent, which may be given:
This injection is usually given to you by a doctor directly into a vein.
2. WHAT YOU NEED TO KNOW BEFORE THIOPENTAL INJECTION IS GIVEN
You MUST NOT be given Thiopental Injection if you:
If any of these apply to you, tell the doctor or nurse, they will usually decide to use another medicine instead.
Take special care with Thiopental injection
Tell your doctor before you are given thiopental if you have any of the following, as your dose may need to be adjusted:
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
The following medicines can affect, or be affected by, this injection and may need to be adjusted before or after receiving this injection:
Thiopental sodium with alcohol
The effect of alcohol may be increased in the period after treatment with thiopental sodium (for at least the first 24 hours).
Pregnancy and breast-feeding
Breast-feeding should be temporarily stopped or breast milk expressed before being given Thiopental injection.
If you are pregnant or breast feeding, think you may be pregnant or are planning to become pregnant, your doctor will consider the risks and benefits of giving Thiopental injection to you.
Driving and using machines
You may experience dizziness (vertigo), disorientation and sedation; these will wear off quite quickly. Do not drive or operate machinery, especially during the first 24 to 36 hours after the injection.
3. HOW THIOPENTAL INJECTION IS GIVEN
This injection is usually given to you directly into a vein by a doctor, but can be given via a drip into a vein.
If thiopental is accidentally injected into an artery instead of a vein, it can cause damage to your tissues. Your doctor should treat these effects (a similar problem can occur if thiopental leaks from the vein into surrounding tissue). If you feel severe pain near where the drug was injected tell the doctor or nurse immediately so that treatment can be started quickly.
The sterile powder is made into a solution and must not be mixed with other acidic injections.
This solution should be discarded after 7 hours.
The dosage will be adjusted according to your age, sex, and weight as well as your response to the drug.
Adults: 100mg - 150mg, injected over 10 to 15 seconds.
Elderly: as for adults, although smaller doses may be required.
Children: the calculated dose will usually be 2 to 7mg/kg.
You will normally feel the effects within 30 seconds and be asleep within one minute. Further small doses will be given to you as necessary (you will normally be asleep during this process).
75mg to 125mg, given as soon as possible after the convulsion begins. Further doses may be required and your doctor will decide the best dose to give.
Neurological patients with raised intracranial pressure: Intermittent injections of 1.5 to 3mg/kg.
Reduced doses may be needed if you have:
Increased doses may be needed if you:
The dose of thiopental may need to be increased or given with another medicine to increase its effect.
If you are given more thiopental than you should
This product will be given to you under medical supervision, it is therefore unlikely that you will be given too much. However, if you feel unwell you should tell your doctor immediately. Symptoms could be: rapid shallow breathing or feeling faint or dizzy.
If you have any further questions on the use of this medicine, ask your doctor or nurse.
4. POSSIBLE SIDE EFFECTS
Like all medicines, thiopental can cause side effects, although not everybody gets them.
Tell your doctor right away if you notice any of the following symptoms - you may need urgent medical treatment:
Difficulty breathing, wheezing, rash, itching, hives, dizziness, difficulty swallowing, and swelling of the face, lips, tongue or throat, or any other allergic reaction. This could be a severe allergic reaction (frequency not known, cannot be estimated from the available data).
When it is injected, thiopental can cause the following (frequencies not known):
Other effects include (frequencies not known):
If any of these side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
Reporting of side effects
If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects you can help provide more information on the safety of this medicine.
United Kingdom: Yellow Card Scheme. Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
5. HOW TO STORE THIOPENTAL INJECTION
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the vial and the pack. The expiry date refers to the last day of that month.
Do not store above 25°C. Keep in outer carton.
This product contains no preservatives and should be used immediately. If the solution is stored, keep it upright and store between 2°C and 8°C. The reconstituted solution must be used within 7 hours. Use once following reconstitution and discard any residue.
Do not use this medicine if you notice that the solution is discoloured.
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 to protect the environment.
6. FURTHER INFORMATION
What Thiopental Injection contains
Each vial contains 500mg of thiopental sodium (as thiopental sodium and sodium carbonate).
What Thiopental injection looks like and contents of the pack
The product is a dry, yellow-white powder contained in a glass vial with a rubber closure. Each vial contains 500mg thiopental sodium (as thiopental sodium and sodium carbonate).
Thiopental injection is packed in 1, 10 or 25 glass vials.
Marketing Authorisation Holder
PL 16508/0062 PA 1049/014/001
The leaflet was revised: 10/2017