Thiopental powder for solution for injection

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or nurse.
• If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

The name of your medicine is Thiopental 0.5/1 g powder for solution for injection (called Thiopental Injection in this leaflet).

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

• if you are allergic to thiopental sodium, barbiturates or any of the other ingredients of this medicine (listed in section 6)
• in case of obstruction of the airways (respiratory obstruction)
• if you have acute asthma (severe asthma attack)
• if you suffer from hereditary muscle degeneration (myotonic dystrophy)
• if you are in severe shock
• if you have porphyria.

Talk to your doctor or nurse before you are given Thiopental Injection. The health care professionals should be extra careful and may have to adjust your dose, if you have/are:

• increased pressure in your skull
• asthma or other severe respiratory disease
• inflammation in the mouth, jaw and throat – this could lead to airway problems during the use of Thiopental Injection
• any heart or blood vessel disease or high blood pressure
• inflammation of the heart sac
• low levels of fluids in the body (hypovolaemia) or are dehydrated
• severe bleeding or burns
• myasthenia gravis (a disease which makes the muscles very weak)
• reduced function of the adrenocortical gland, even when treated with cortisone
• feeling generally ill, are undernourished and have lost weight
• increased level of urea, toxins or potassium in your blood
• severe anemia
• in shock
• liver or kidney impairment
• any metabolic disorder, such as thyrotoxicosis, myxedema and diabetes
• addicted to alcohol or drugs of abuse.

Tell your doctor or nurse if you are using, have recently used or might use any other medicines.

The following medicines can affect or can be affected by this injection and may need to be adjusted before or after receiving this injection:

• Aminophylline and theophylline (for the treatment of asthma)
• Midazolam (a sedative medicine)
• Opioid analgesics (strong painkillers)
• Probenecid (a gout medicine)
• Sufentanile (an anaesthetic medicine)
• Muscle relaxants
• MAO-inhibitors and tricyclic antidepressants (for the treatment of depression), e.g. citalopram, amitriptyline
• Medicines that have a depressive effect on the central nervous system (CNS)
• Metoclopramide and droperidol (for the treatment of nausea and vomiting)
• Medicines containing St John's Wort
• Androgens (for treatment of male infertility)
• Medicine for epilepsy
• Glucocorticoides (antiinflammatory agents)
• Medicines to treat bacterial infections such as metronidazole, sulphafurazole, isoniazid, vancomycin
• Estrogen (for the treatment of menopauses)
• Medicines for the treatment of diabetes, taken by mouth
• Medicines used for the treatment of high blood pressure e.g. captopril, enalapril, terazosin, felodipine, hydralazine, losartan, methyldopa, moxonidine and diuretics
• Acetylsalicylic acid (Aspirin) and other painkilling medications
• Antipsychotic medications such as promethazine or quetiapine; lithium
• Diazoxide (for the treatment of low blood sugar)
• Tablets or spray used for the treatment of angina pectoris
• Medicines used to thin the blood (anticoagulants taken by mouth).

The dose of Thiopental Injection may need to be increased if you are addicted to or regularly consume large amounts of alcohol.

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 taking this medicine.

Thiopental Injection should be given to a pregnant woman only if the doctor considers it to be clearly necessary.

Thiopental is excreted in breast milk; breastfeeding should be temporarily suspended (for at least 12 hours after the use of thiopental) or breast milk expressed before the use of Thiopental Injection.

Thiopental Injection has major influence on the ability to drive and use machines. Although recovery is relatively quick, you may experience periods of vertigo, disorientation and sedation. Patients therefore must not drive and use machines within 24 to 36 hours after the use of Thiopental Injection.

One vial of Thiopental Injection 0.5 g contains 51-56 mg (or 2.2-2.4 mmol) sodium (main component of cooking/table salt) and one vial of Thiopental Injection 1 g contains 102-112 mg (or 4.4-4.9 mmol) sodium. This is equivalent to 2.8% (0.5 g vial) and 5.6% (1 g vial) of the recommended maximum daily dietary intake of sodium for an adult.

It is unlikely that you receive an excessive dose, since healthcare personnel takes care of the administration of Thiopental Injection.

Overdose may occur from too many injections or if Thiopental Injection is administered too quickly. In the event of suspected or apparent overdose, the drug should be discontinued. Symptoms of overdose include: alarming fall in blood pressure, shock. In addition apnea, coughing and other breathing difficulties may occur (this however, can also be a sign of underdosing).

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 via the Yellow Card Scheme website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects you can help provide more information on the safety of this medicine.

• The active substance is thiopental sodium.
  Each vial of Thiopental 0.5 g powder for solution for injection contains 500 mg thiopental sodium (as thiopental sodium and sodium carbonate).
  Each vial of Thiopental 1 g powder for solution for injection contains 1000 mg thiopental sodium (as thiopental sodium and sodium carbonate).
• The other ingredient is sodium carbonate.

Glass vial with bromobutyl rubber stopper and aluminium seal, in a carton box.

Content of the pack:

Thiopental Injection powder for solution for injection 0.5 g: 1 x 1 vial, 10 x 1 vial, 20 x 1 vial or 50 x 1 vial

Thiopental Injection powder for solution for injection 1 g: 1 x 1 vial, 10 x 1 vial, 20 x 1 vial or 50 x 1 vial

Not all pack sizes may be marketed.