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THIOPENTAL SODIUM 500 MG POWDER FOR SOLUTION FOR INJECTION

Active substance(s): THIOPENTAL SODIUM / THIOPENTAL SODIUM / THIOPENTAL SODIUM

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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.
– Please keep this leaflet. You may need to read it again.
– If you have any further questions, ask the doctor or nurse.
– If you suffer from any side effect that gets serious, or if you notice
any side effects not listed in this leaflet, please tell the doctor or
nurse.
In this leaflet:
1. What Thiopental injection is and what it is used for
2. Before Thiopental injection is given
3. How Thiopental injection is given
4. Possible side effects
5. How to store Thiopental injection
6. Further information










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




antihypertensives (used to treat high blood pressure or heart
problems), such as ACE inhibitors, angiotensin-II receptor
antagonists, alpha blockers, beta-blockers, calcium antagonists,
diuretics, vasodilating anti-hypertensives, alpha adrenergic
neurone blockers
nitrates (used to treat angina)
antidepressants (used to treat depression), such as monoamine
oxidase inhibitors (MAOIs) and tricyclic antidepressants
benzodiazepines, such as midazolam, to treat anxiety
lithium (used to treat mania, manic depressive illness or
depression)
analgesics (used to treat pain) such as aspirin
opioid analgesics (strong pain relievers) such as morphine,
fentanyl and pethidine
phenothiazines (used to treat psychosis and nausea) such as
promethazine
drugs that have an effect on the gastrointestinal tract (gut), such
as metoclopramide or droperidol
drugs that have an effect on the central nervous system (CNS)
cyclizine (used to treat dizziness, nausea and vomiting)
drugs to treat high blood pressure, such as diazoxide,
methyldopa, moxonidine, hydralazine, minoxidil and
nitroprusside
probenecid (used to treat gout and high uric acid in the blood)
oral anticoagulants (to thin your blood)
oestrogens (oral contraceptives or hormone replacement
therapy)
herbal medicines, such as valerian and St John’s Wort.

Thiopental injection contains the active ingredient thiopental sodium
which is also known as thiopentone sodium. It is an anaesthetic agent,
which may be given:
• as a general anaesthetic or to make you sleepy before using
another anaesthetic agent
• before using agents to prevent pain or to relax muscles
• to control fits
• to reduce intracranial pressure.





This injection is usually given to you by a doctor directly into a vein.



2. BEFORE THIOPENTAL INJECTION IS GIVEN

Thiopental sodium with alcohol
The effect of alcohol may be increased in the period after treatment
with thiopental sodium (at least the first 24 hours).

You MUST NOT be given Thiopental if you:
• are allergic to thiopental sodium or have had reactions to
thiopental or to other barbiturates (such as some anaesthetics)
• have any respiratory abnormalities (difficulty in breathing),
such as an obstruction in your lungs or in the tubes leading to
them
• have acute asthma (short term)
• are in severe shock
• have myotonic dystrophy - a muscular disease
• have the condition known as porphyria - a metabolic disorder.
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:
• heart disease or circulatory problems, as these can suddenly
be made more severe by Thiopental
• severe anaemia, blood pressure problems (high blood
pressure or low blood pressure), raised blood potassium,
increased blood urea, bacterial infection in the blood, severe
bleeding
• liver or kidney disease
• increased pressure in the brain
• muscle weakness or degeneration (such as myasthenia gravis
or muscular dystrophies)
• thyroid gland problems
• diabetes
• dehydration, malnutrition or wasting
• underproduction of steroid hormones by the adrenal
gland (even when controlled by cortisone)
• a metabolic disorder caused by an underactive
thyroid gland (a reduced dose may be required)
• asthma
• burns
• shock
• hypovolaemia – a low level of fluids in the body
• are elderly (a reduced dose may be required)
• are taking opioid analgesics - strong pain relievers.
• are on a sodium controlled diet as this product
contains 53.5mg sodium per vial.
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:
• antibiotics (used to treat infections), such as vancomycin,
isoniazid and sulphonamides
• sulphafurazole (an antibiotic) - smaller doses of thiopental given
more frequently may be required

Kyowa Kirin Limited
Galabank Business Park,
Galashiels, UK, TD1 1QH
Tel: +44 (0) 1896 664 000
Fax: +44 (0) 1896 664 001
Please tick the appropriate box:
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Pregnancy and breast-feeding
If you are pregnant, planning to become pregnant or breast-feeding,
your doctor will consider the risks and benefits of giving Thiopental 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.
Dose
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.
Anaesthesia:
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).
Convulsions (fits):
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:
• liver disease (including jaundice), shock, dehydration,
severe anaemia, high blood level of potassium, infection
in your blood

Product No:

LFT-THI-GB-002 (Pg 1 of 2)

Product Name:

THIOPENTAL SODIUM 500 mg

Colours Used
Black
Keyline

Item Description:
Cutter Ref:

-

Pharmacode:

-

Manufacturer Code:

-

Actual Size:

165 x 280 mm

Market:

United Kingdom

Language:

English

Proof No:

2

Date Issued:

10-Jun-16

Issued by:

-

Font Size

7pt

Font Type:

Helvetica World and Helvetica World Bold

Reason for Change:

-





myxoedema (a metabolic disorder caused by an
underactive thyroid gland).
received morphine or similar medicines before you are given
Thiopental
received a medicine called sulfafurazole – your doctor may need
to give you smaller and more frequent doses of Thiopental.

United Kingdom: Yellow Card Scheme.
Website: www.mhra.gov.uk/yellowcard.
Ireland: HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2.
Tel: +353 1 6764971, Fax: +353 1 6762517
Website: www.hpra.ie
E-mail: medsafety@hpra.ie.

Increased doses may be needed if you:
• are a heavy and frequent drinker of alcohol
• regularly take non-prescribed drugs.

5. HOW TO STORE THIOPENTAL INJECTION

The dose of Thiopental may need to be increased or given with
another medicine to increase its effect.

Before reconstitution:
The vials should be kept in the outer carton and not stored above
25°C.

Keep out of the sight and reach of children.

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 product, ask your
doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Thiopental can cause side effects, although not
everybody gets them. Seek medical help immediately if you have
any of the following allergic reactions:
• difficulty breathing or swallowing, swelling of the face, lips,
tongue or throat
• skin rashes and other allergic reactions, such as itching.
When it is injected, Thiopental can cause the following:
• coughing, sneezing or spasm of the airways; difficulty in
breathing
• fall in blood pressure - often seen when thiopental is first given
• drowsiness, nausea with or without vomiting, anorexia
(poor appetite), malaise (general sense of unwellness),
fatigue, dizziness, headache
• delirium (sudden severe confusion) - may occur in
elderly patients
• shivering, low body temperature and severely reduced
brain function can occur with excessive doses of thiopental.
Other effects include:
• confusion, amnesia (loss or disruption of memory)
• reduced pumping action of the heart or irregular heartbeats
• low blood pressure or other circulatory effects
• Thiopental has been associated with reports of decreased
potassium blood levels during infusion and increased potassium
blood levels after stopping thiopental infusion.
• tissue damage if the injection leaks into surrounding tissue.
If you experience severe pain at the site of injection, inform
your doctor immediately.
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, pharmacist 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.

After reconstitution:
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. If the solution is discoloured it must not be used.
Thiopental should not be used after the expiry date printed on each
vial and the pack. The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household
waste. Your healthcare professional will dispose of this medicine
once no longer required. These measures will help to protect the
environment.
6. FURTHER INFORMATION
What Thiopental Injection contains
Each vial contains 500mg of the active substance Thiopental Sodium
(as Thiopental Sodium and Sodium Carbonate Ph. Eur.)
What Thiopental injection looks like and contents of the pack
The product is a dry, yellow-white powder contained in 20ml glass
vials with rubber closures. Each vial contains 500mg thiopental
sodium. This powder needs to be dissolved in Water for Injections
before use.
Thiopental injection is packed in 10 or 25 x 20ml glass vials.
Marketing Authorisation Holder
Archimedes Pharma UK Ltd,
Galabank Business Park,
Galashiels,
TD1 1QH,
United Kingdom.
Manufacturer
Inresa Arzneimittel GmbH,
Obere Hardtstraβe 18,
79114 Freiburg,
Germany.
PL 12406/0014 PA 0757/004/001
The leaflet was revised: 05/2016

LFT-THI-GB-002

Kyowa Kirin Limited
Galabank Business Park,
Galashiels, UK, TD1 1QH
Tel: +44 (0) 1896 664 000
Fax: +44 (0) 1896 664 001
Please tick the appropriate box:
Amend &
Re-Submit

Approved
& Proceed

Approved
for Print Only

Signature
Date

This Proof has been ‘enabled for commenting’ in
Acrobat. Please review, add comments if
appropriate then click the ‘Send Comments’ button on the
toolbar. Return to artwork@prostrakan.com

Product No:

LFT-THI-GB-002 (Pg 2 of 2)

Product Name:

THIOPENTAL SODIUM 500 mg

Colours Used
Black
Keyline

Item Description:
Cutter Ref:

-

Pharmacode:

-

Manufacturer Code:

-

Actual Size:

165 x 280 mm

Market:

United Kingdom

Language:

English

Proof No:

2

Date Issued:

10-Jun-16

Issued by:

-

Font Size

7pt

Font Type:

Helvetica World and Helvetica World Bold

Reason for Change:

-

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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