Label: Information for the User

Tiobarbital B. Braun 0.5 g Powder for Injection

Thiopental Sodium

This medication contains the active ingredient thiopental sodium in the form of thiopental sodium and sodium carbonate. It is a thiobarbiturate with rapid onset for intravenous administration.

Thiobarbital B. Braun is used in adults:

• in short-duration surgical interventions as a single anesthetic agent for the induction and maintenance of anesthesia.
• in combination with other agents used in general anesthesia for the induction and maintenance of anesthesia.
• to control seizures that may occur with some types of anesthesia or due to other causes.
• to induce emergency coma during a prolonged epileptic crisis (refractory status epilepticus).
• to induce and maintain barbiturate coma to reduce intracranial pressure in patients where pressure increases and other therapeutic measures have failed.

Thiobarbital B. Braun is used in children:

• in short-duration surgical interventions as a single anesthetic agent for the induction and maintenance of anesthesia.
• in combination with other agents used in general anesthesia for the induction and maintenance of anesthesia.
• to control seizures that may occur with some types of anesthesia or due to other causes.

to induce emergency coma during a prolonged epileptic crisis (refractory status epilepticus).

Do not use Tiobarbital B. Braun:

• if you are allergic to barbiturates or any of the components of this medication (listed in section 6).
• if you have a respiratory tract obstruction.
• if you have acute asthma (severe asthma attack).
• if you suffer from hereditary muscular dystrophy.
• if you have severe shock.
• if you have a metabolic disorder called porphyria (hereditary disease caused by deficiency in enzymes involved in the synthesis of a component of hemoglobin found in red blood cells).

Warnings and precautions:

Consult your doctor or pharmacist before starting to use Tiobarbital B. Braun, especially if you have:

• increased intracranial pressure.
• asthma or other severe respiratory disease.
• inflammation in the mouth, jaw, and throat, which could lead to respiratory problems during the use of thiopental.
• any heart or blood vessel disease or high blood pressure.
• inflammation of the sac around the heart.
• dehydration or decreased total blood volume circulating in the body (hypovolemia).
• severe bleeding or burns.
• myasthenia gravis (condition in which muscles fatigue easily and weaken).
• reduced function of the adrenal gland, even when treated with cortisone.
• weakness, malnutrition, and weight loss.
• increased levels of urea, toxins, or potassium in the blood.
• severe anemia.
• shock.
• liver or kidney problems.
• any metabolic disorder, such as hyperthyroidism, mixedema, and diabetes.
• alcohol or drug addiction.

Use of Tiobarbital B. Braun with other medications:

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

The medications that may affect or interact with thiopental are the following:

• Aminophylline (for asthma treatment).

• Midazolam (a sedative medication).
• Opioid analgesics (medications for severe pain).
• Probenecid (a medication for gout treatment).
• Fentanyl (pain medication).
• Muscle relaxants.
• MAO inhibitors and tricyclic antidepressants (medications used for depression treatment), for example, citalopram, amitriptyline.
• Substances that depress the central nervous system.
• Metoclopramide and droperidol (medications for nausea and vomiting treatment).
• Medications containing St. John's Wort or valerian.
• Androgens (for male infertility treatment).
• Medications for epilepsy treatment.
• Corticosteroids (medications that reduce inflammation and allergic reactions).

• Medications for bacterial infections such as metronidazole, sulfafurazol, isoniazid, and vancomycin.
• Estradiol (for menopause treatment).

Oral medications for diabetes treatment

• Antihypertensive medications (medications administered to lower blood pressure), for example, captopril, enalapril, terazosin, felodipine, bisoprolol, hydralazine, losartan, metildopa, moxonidine, nitrates, and diuretics.
• Acetylsalicylic acid (aspirin) and other pain medications.
• Antipsychotic medications such as lithium, promethazine, or quetiapine.
• Diazoxide (for low blood sugar treatment).
• Oral anticoagulants (medications that thin the blood and prevent clot formation).

Use of Tiobarbital B. Braun with alcohol

Do not consume any beverage or food containing alcohol in any case before and even after anesthesia.

If you suffer from alcohol dependence or regularly consume large amounts of alcohol, it may be necessary to increase the dose of thiopental.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or think you may be pregnant or plan to become pregnant, consult your doctor before using this medication.

Pregnancy

Thiopental crosses the placental barrier. There are some data in pregnant women indicating that thiopental does not cause malformations or fetal/neonatal toxicity. If you are pregnant, you will receive this medication only if your doctor considers it appropriate.

Breastfeeding

Thiopental is excreted in breast milk, therefore breastfeeding should be suspended temporarily (at least 12 hours after thiopental use) or breast milk should be expressed before using this medication.

Fertility

There are no data on the effect of thiopental on human fertility.

Driving and operating machinery

The influence of thiopental on the ability to drive and operate machinery is important. You may experience dizziness, disorientation, and sedation. Do not drive or operate machinery, especially during the first 24 to 36 hours after injection.

Tiobarbital B. Braun contains sodium

This medication contains 46 mg of sodium per vial equivalent to 2.3% of the maximum daily intake of 2 g of sodium recommended by the WHO for an adult.

Follow exactly the administration instructions of the medication contained in this leaflet or those indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

This medication will be administered by specialized personnel in the use of general anesthetics, who will be constantly available during administration, as well as the resuscitation team.

This medication will be administered directly into one of the blood vessels, a vein (intravenously).

You will be given a test dose of 25 to 75 mg, to adjust the dose according to your needs.

Adults

General anesthesia

Your individual dose will be determined by your doctor and will be based on your age, sex, body weight, and general condition. You will receive a dose to initiate anesthesia of 50 to 75 mg in intervals of 20 to 40 seconds and additional injections to maintain anesthesia of 25 to 50 mg.

Seizure crisis

The thiopental injection is 50 to 125 mg and should be administered as soon as possible after the seizure begins. You may need additional doses to control the seizures.

Cerebral hypertension

You will receive a dose of 1.5 to 3.5 mg per kg of body weight to reduce intracranial pressure (providing controlled ventilation).

Alteration of renal or hepatic function

Your doctor may reduce the dose of the thiopental injection if you have altered renal or hepatic function.

Geriatric patients

A greater effect is expected in elderly patients, so the dose should be reduced.

Pediatric population

General anesthesia

The individual dose is adjusted according to age, maturity, and general condition of the pediatric patient. You will receive a dose to initiate anesthesia of approximately 3 to 6 mg per kg of body weight and additional injections to maintain anesthesia of 1 mg per kg of body weight.

Seizure crisis

A initial dose of 2 mg per kg of body weight is administered, and then individualized until the desired effect is achieved. Do not exceed the maximum dose of 5 mg/kg/h.

Cerebral hypertension

The safety and efficacy of thiopental in pediatric populations for treating increased intracranial pressure have not been established.

If you use more Tiobarbital B. Braun than you should

This is unlikely to happen, as your doctor will determine the necessary dose for you.

The most severe symptoms of overdose may occur between six hours and five days after sudden discontinuation of the drug. These symptoms are as follows:

• severe drop in blood pressure

• severe difficulty breathing
• severe slow or irregular breathing

There are other less severe effects that may appear between eight and twelve hours after the last dose, which have a less frequent incidence:

• prolonged drowsiness,
• headache,
• nausea, vomiting, and constipation.

If these effects appear, your doctor will immediately discontinue use and treat you according to the symptoms that appear.

The most indicated treatment for overdose is to maintain proper ventilation with assisted breathing and even administering oxygen if necessary. It is advisable to monitor vital signs and, if renal function allows, a diuresis can be induced, alkalizing the urine to eliminate the drug.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

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

Consult your doctor immediately if you experience any of the following symptoms, as you may need urgent medical treatment:

Unknown frequency(cannot be estimated from available data)

• Difficulty breathing, wheezing, skin rashes, itching, urticaria, and dizziness. This could be a severe allergic reaction.

Other side effects that may occur:

Frequent(may affect up to 1 in 100 people)

• Cardiac arrhythmias (alteration of the normal heart rhythm).
• Cardiac problems (such as myocardial depression).
• Low blood pressure.
• Drowsiness.
• Delayed awakening from anesthesia.
• Respiratory difficulties.
• Slow or inadequate breathing.
• Difficulty swallowing, breathing, or speaking (laryngospasm).
• Coughing.
• Snoring.
• Stifling.
• Chills.
• Formation of blood clots within blood vessels.
• Phlebitis (inflammation of a vein).
• Pain at the injection site.

Rare(may affect up to 1 in 1,000 people)

• Severe allergic reaction.

Unknown frequency(cannot be estimated from available data)

• Hyperkalemia (elevated potassium levels in the blood).
• Hypokalemia (low potassium levels in the blood).
• Anorexia (loss of appetite).
• General malaise.
• Fatigue.
• Headache.
• Dizziness.
• Confusion.
• Memory loss.
• Allergic reactions, skin reactions, hypersensitivity.

Initially, when this medicine is administered, it may cause laryngospasm, coughing, and sneezing. After the operation and use of this medicine, vomiting is uncommon but may cause persistent drowsiness, confusion, memory loss (amnesia), and chills.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use: www.notificaRAM.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

No special storage conditions are required. Store in the original packaging to protect it from light.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

The contents of the vials must be used immediately after opening. Once the packaging is opened, discard any unused portion.

Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

Composition of Tiobarbital B. Braun 0.5 g

• The active ingredient is thiopental sodiumin the form of thiopental sodium and sodium carbonate. Each vialcontains 0.5 g of thiopental sodium in the form of thiopental sodium and sodium carbonate.

Aspect of the product and contents of the packaging

Tiobarbital B. Braun 0.5 g is a powder for injectable solution. It is a white or yellowish white crystalline powder conditioned in glass vials.

It is presented packaged in boxes of 1 and 50 vials.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

B. Braun Medical, S.A.

Ctra. de Terrassa, 121

08191-Rubí (Barcelona)

Spain

Responsible for manufacturing:

B. Braun Medical, S.A.

Ronda de los Olivares, Parcela 11

Polígono Industrial Los Olivares

23009-Jaén (Jaén)

Spain

Last review date of this leaflet: April 2021

The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).

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This information is intended solely for doctors or healthcare professionals:

Solutions must be prepared aseptically with one of the following three diluents:

- sterile water for injectable preparations

- sodium chloride solution 0.9%

- 5% dextrose solution

Used clinical concentrations for intravenous intermittent administration vary between 2.0% and 5.0%.

A 2.0% or 2.5% solution is used most frequently. A 3.4% concentration in sterile water for injection is isotonic; concentrations below 2.0% in this diluent are not used because they cause hemolysis. For continuous intravenous infusion, concentrations of 0.2% or 0.4% are used. Solutions can be prepared by adding thiopental to a 5% dextrose solution or a 0.9% sodium chloride solution.

CALCULATIONS FOR VARIOUS CONCENTRATIONS

The dissolution of Tiobarbital B. Braun must be performed extemporaneously and aseptically.

Once the extemporaneous solution is prepared, it must be administered within a maximum period of 24 hoursbetween 2°C and 8°C. Discard the residual volume of solution.

This medicine is administered only by intravenous route. Avoid extravasation or intraarterial injection. A qualified person in the use of anesthetics must be constantly available during the administration of the medication. Have available endotracheal intubation equipment, oxygen, and resuscitation equipment.

The following corrective measures have been suggested in case of intraarterial injection:

1. Dilute the injected thiopental by removing the tourniquet and any restrictive clothing.

2. Leave the intravenous cannula in place, if possible.

3. Inject a diluted solution of papaverine, or lidocaine, into the artery to inhibit smooth muscle spasm.

4. If necessary, perform a sympathetic block of the brachial plexus and/or the stellate ganglion to relieve pain and help open collateral circulation. Papaverine can be injected into the subclavian artery, if desired.

5. Unless contraindicated, treat with heparin to prevent thrombus formation.

6. Consider local infiltration of an alpha-adrenergic blocking agent such as fentolamine in the vasospastic area.

7. Provide additional symptomatic treatment as needed.

Only use the solution if the closure of the container is not damaged and the solution is clear.

Incompatibilities

This medicine should not be mixed with other medications, except those mentioned in section 6.6 of the technical data sheet.

The reconstituted solutions with Tiobarbital may cause an alkaline reaction and are incompatible with volume substitution solutions and acidic anesthetic adjuvant solutions, as this may lead to precipitation and blockage of the injection needle; similarly, chemical changes in the resulting solution cannot be ruled out.