Torecan

Package Leaflet: Information for the User

Torecan, 6.5 mg/ml, Solution for Injection

Thiethylperazinum

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet

• 1. What is Torecan and what is it used for
• 2. Important information before using Torecan
• 3. How to use Torecan
• 4. Possible side effects
• 5. How to store Torecan
• 6. Contents of the pack and other information

1. What is Torecan and what is it used for

Torecan belongs to a group of phenothiazine derivatives. The medicine affects the structures in the brainstem that regulate physiological processes related to vomiting. In this way, it inhibits the body's reaction to stimuli that induce nausea and vomiting.
The medicine is intended for the treatment of nausea and vomiting in the following conditions:

• after anticancer chemotherapy,
• after radiotherapy,
• after the use of emetic drugs,
• after surgical procedures.

2. Important information before using Torecan

When not to use Torecan

• if you are allergic to thiethylperazine, phenothiazines, or any of the other ingredients of this medicine (listed in section 6);
• in severe disturbances of consciousness or other symptoms of impaired central nervous system function;
• if you have very low blood pressure;
• if you are pregnant or breastfeeding.

Torecan should not be used in children under 15 years of age and in children and adolescents with symptoms similar to those of Reye's syndrome (a rare but serious condition that causes swelling in the liver and brain).

Warnings and precautions

Before starting treatment with Torecan, discuss with your doctor if you have:

• low blood pressure;
• pregnancy, especially if you have a history of high blood pressure with swelling of the limbs (pre-eclampsia);
• liver function disorders;
• a history of involuntary body movements;
• are taking bromocriptine.

Like other antiemetic medicines, Torecan may mask the symptoms of certain gastrointestinal and central nervous system disorders, as well as the adverse effects of other medicines.
Torecan, as a representative of the phenothiazine group, may cause the occurrence of a group of symptoms known as malignant neuroleptic syndrome, which is characterized by high fever, muscle stiffness, changes in mental state, and fluctuations in blood pressure. In such cases, treatment should be discontinued immediately and a doctor should be informed as soon as possible.
In elderly patients, involuntary movements may occur during treatment with Torecan, therefore, treatment should not last more than 2 months.
Torecan should never be administered intrarterially.

Torecan and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
Taking Torecan with certain other medicines may lead to interactions between them, which may reduce or increase the effect of each medicine.
Your doctor should be informed, especially if you are taking:

• medicines that act on the central nervous system (sedatives, opioid analgesics, tranquilizers, antidepressants),
• medicines that inhibit the secretion of certain hormones (bromocriptine),
• medicines used in the treatment of cancer (procarbazine).

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
There is limited data on the use of thiethylperazine in pregnant women. Animal studies are insufficient to exclude teratogenic effects of thiethylperazine, especially since two observational studies suggested a possible association. As a precautionary measure, Torecan should not be used during pregnancy.
Breastfeeding
Phenothiazines pass into breast milk, therefore, Torecan should not be used during breastfeeding.
Fertility
Thiethylperazine had no effect on fertility in male rats. The effect on the pregnancy rate in female rats observed only at doses higher than recommended indicates little clinical significance.

Driving and using machines

Do not drive vehicles or operate machines while using Torecan solution for injection.
Torecan may significantly impair your ability to drive vehicles and operate machines, especially when used with sedatives, hypnotics, or alcohol. Therefore, caution is advised when driving vehicles and operating machines.

Torecan contains sorbitol (E420), sodium metabisulfite (E223), and sodium.

If you have previously been diagnosed with an intolerance to some sugars, you should consult your doctor before taking the medicine.
The medicine may rarely cause severe allergic reactions and bronchospasm.
This medicine contains less than 1 mmol of sodium (23 mg) per dose, i.e., the medicine is considered "sodium-free".

3. How to use Torecan

This medicine will be administered by a doctor or nurse.
The daily dose is one to three ampoules.
Usually, the injection is given intramuscularly. During administration, the patient should be in a lying position. In exceptional cases, the doctor may decide to administer the medicine intravenously.
To prevent vomiting after surgery under general anesthesia, one ampoule is administered intramuscularly about 30 minutes before the end of the procedure.
The duration of treatment depends on the course of the underlying disease. The doctor will determine the duration of treatment.
Special populations
Renal impairment
No studies have been conducted in patients with renal impairment.
Hepatic impairment
In patients with hepatic impairment, liver function should be monitored when using Torecan in high doses or for a long time.
Children and adolescents
Dosing in children has not been established, therefore, the product is not recommended for use in children under 15 years of age.
Elderly patients
Caution should be exercised when treating elderly patients (75 years and older).

Overdose of Torecan

Taking too much of the medicine may cause dry mouth, dizziness, confusion, involuntary movements, and fainting due to decreased blood pressure. After taking a higher dose than recommended, severe disturbances of consciousness, seizures, and other symptoms of impaired central nervous system function may also occur. If any of these symptoms occur, a doctor or medical personnel should be informed immediately.

Missed dose of Torecan

Tell your doctor or nurse if you miss a dose of Torecan.
If you have any doubts about using the medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Torecan can cause side effects, although not everybody gets them.
Uncommon side effects (may affect up to 1 in 100 people)

• headache, dizziness, drowsiness, restlessness.

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

• enlargement of the breasts in men (after long-term treatment);
• seizures and other symptoms of impaired central nervous system function (torticollis, opisthotonus, oculogyric crisis, muscle stiffness, and facial grimacing). In elderly patients, after long-term use of the medicine, tardive dyskinesia (involuntary movements) may occur. These symptoms usually disappear after discontinuation of the medicine or reduction of the dose;
• clouding of the lens and blurred vision (after long-term treatment);
• fluid retention with swelling of the limbs and face, decreased blood pressure;
• dry mouth and loss of appetite.

Very rare side effects (may affect up to 1 in 10,000 people)

• facial pain (trigeminal neuralgia);
• tachycardia (rapid heart rate);
• jaundice.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Pharmacovigilance, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, e-mail: [email protected].
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Torecan

Keep the medicine out of the sight and reach of children.
Do not use Torecan after the expiry date stated on the carton after EXP. The expiry date refers to the last day of the month.
Store in a temperature below 25°C.
Store in the original package to protect from light.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Torecan contains

• The active substance is thiethylperazine. 1 ml of the solution for injection (1 ampoule) contains 6.5 mg of thiethylperazine in the form of thiethylperazine maleate.
• The other ingredients are: ascorbic acid, sorbitol (E420), sodium metabisulfite (E223), water for injections. See section 2.

What Torecan looks like and contents of the pack

Clear, colorless or slightly yellowish solution.
5 or 50 ampoules made of colorless glass type I with a brown ring, in a carton box.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

KRKA, d.d., Novo mesto
Šmarješka cesta 6
8501 Novo mesto
Slovenia

Date of last revision of the leaflet: