TORECAN

Patient Information Leaflet: Read this leaflet carefully before using the medicine, as it contains important information for you.

Torecan, 6.5 mg/ml, solution for injection
Thiethylperazine
Please read all of this leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of Contents

1. What Torecan is and what it is 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 Torecan is and what it is used for

Torecan belongs to a group of medicines known as phenothiazine derivatives. It acts on structures in the medulla oblongata that regulate physiological processes related to vomiting. In this way, it suppresses the body's response to stimuli that trigger nausea and vomiting.
The medicine is indicated for the treatment of nausea and vomiting in the following conditions:

• following antineoplastic chemotherapy,
• following radiotherapy,
• following administration of emetogenic drugs,
• following surgical procedures.

2. Important information before using Torecan

When Torecan must not be used

• if the patient is allergic to tiethylperazine, 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 the patient has very low blood pressure;
• if the patient is pregnant or breastfeeding.

Torecan must not be used in children under 15 years of age, and in children and adolescents presenting symptoms resembling acute severe brain disease associated with concurrent liver function disorders (Reye's syndrome).

Warnings and precautions

Before starting treatment with Torecan, consult your doctor if:

• you suffer from conditions related to low blood pressure;
• you are pregnant, particularly if you have a specific condition involving high blood pressure accompanied by swelling of the limbs (pre-eclampsia);
• you have impaired liver function;
• you have ever experienced involuntary body movements due to illness in the past;
• you are taking the medicine bromocriptine.

Like other antiemetic medicines, Torecan may mask symptoms of certain gastrointestinal and central nervous system disorders, as well as adverse effects of other medicines.

As a member of the phenothiazine group, Torecan may cause a group of symptoms known as neuroleptic malignant syndrome, characterized by high fever, muscle rigidity, altered mental status, and fluctuating blood pressure. In such cases, treatment must be stopped immediately and the doctor must be contacted or visited as soon as possible.

In elderly patients, involuntary movements may occur during treatment; therefore, treatment should not last longer than 2 months.

Torecan must never be administered into an artery.

Torecan and other medicines

Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.

Concurrent administration of Torecan and certain medicines may lead to drug interactions, which could reduce or increase the effect of either medicine.

Inform your doctor especially if you are taking any of the following medicines:

• medicines acting on the central nervous system (sedatives, opioid analgesics, tranquilizers, antidepressants);
• a medicine that inhibits the secretion of certain hormones (bromocriptine);
• a medicine 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, you should consult your doctor or pharmacist before using this medicine.

Pregnancy

There is only limited data on the use of tiethylperazine in pregnant women. Animal studies are insufficient to exclude teratogenic effects of tiethylperazine, especially since a possible association was observed in two observational studies. 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.

Effect on fertility

Tiethylperazine had no effect on male fertility in rats. The observed effect on pregnancy rate in female rats occurred only at doses higher than recommended, indicating minimal relevance in clinical practice.

Driving and operating machinery

While receiving Torecan injection solution, patients must not drive or operate machinery.

Torecan may significantly impair the ability to drive and operate machinery, especially when used concomitantly with sedatives, hypnotics, or alcohol. Therefore, caution is advised when driving or operating machinery.

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

If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

This medicine may rarely cause severe hypersensitivity 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 vials.
The injection is usually given intramuscularly. The patient should be in a lying position during administration of the medicine.
In exceptional cases, the doctor may decide to administer it intravenously.
To prevent vomiting after surgery under general anesthesia, one vial should be given intramuscularly approximately 30 minutes before the end of the procedure.
The duration of treatment depends on the course of the underlying disease. The doctor will determine how long the treatment should last.

Special populations
Renal function impairment
Studies have not been conducted in patients with renal function impairment.

Hepatic function impairment
In patients with hepatic function impairment, liver function should be monitored during treatment with Torecan when administered in high doses or for prolonged periods.

Children and adolescents
Dosage in children has not been established; therefore, use of the product is not recommended in children under 15 years of age.

Elderly patients
Particular caution should be exercised when treating elderly patients (75 years of age and older).

Use of a higher than recommended dose of Torecan
Excessive doses of the medicine may cause dry mouth, dizziness, confusion, involuntary movements, and fainting due to low blood pressure. After administration of a dose higher than recommended, severe disturbances of consciousness, seizures, and other symptoms of central nervous system dysfunction may additionally occur. If any of these symptoms occur, contact a doctor or medical personnel immediately.

Missed dose of Torecan
Inform the doctor or nurse if a dose of Torecan has not been administered.
If you have any doubts regarding the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.

Uncommon adverse reactions (may occur in no more than 1 in 100 patients)

• Headache, dizziness, drowsiness, motor restlessness.

Rare adverse reactions (may occur in no more than 1 in 1000 patients)

• Breast enlargement in men (after long-term treatment);
• Severe spasms and other symptoms of central nervous system disorders (cervical dystonia, opisthotonus, oculogyric crisis, muscle rigidity, and facial grimacing). In elderly patients, prolonged use of the medicine may lead to tardive dyskinesia (involuntary movements). These symptoms usually resolve after discontinuation or dose reduction of the medicine;
• Lens opacities and blurred vision (after long-term treatment);
• Fluid retention with swelling of limbs and face, decreased blood pressure;
• Dry mouth and loss of appetite.

Very rare adverse reactions (may occur in no more than 1 in 10,000 patients)

• Facial pain (trigeminal neuralgia);
• Tachycardia (increased heart rate);
• Jaundice.

Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, e-mail: [email protected]. Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store the medicine Torecan

Keep the medicine out of the sight and reach of children.
Do not use Torecan after the expiry date stated on the cardboard packaging after EXP. The expiry date refers to the last day of the stated month.
Store below 25°C.
Keep in the original packaging to protect from light.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. 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 injection solution (1 ampoule) contains 6.5 mg of thiethylperazine in the form of malate (Thiethylperazinum).
• Other ingredients: ascorbic acid, sorbitol (E420), sodium pyrosulfite (E223), water for injections. See section 2.

What Torecan looks like and contents of the pack
A clear, colourless or slightly yellow solution.
5 or 50 ampoules made of colourless glass type I with a brown ring, in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
KRKA, d.d., Novo mesto
Šmarješka cesta 6
8501 Novo mesto
Slovenia