Torecan

Package Leaflet: Information for the Patient

Torecan, 6.5 mg, Coated Tablets

Thiethylperazine

Read the Leaflet Carefully Before Taking the Medication, 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 medication 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 or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Torecan and What is it Used For
• 2. Important Information Before Taking Torecan
• 3. How to Take Torecan
• 4. Possible Side Effects
• 5. How to Store Torecan
• 6. Package Contents and Other Information

1. What is Torecan and What is it Used For

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

• after anticancer chemotherapy,
• after radiotherapy,
• after taking medications with emetic effects,
• after surgical procedures.

2. Important Information Before Taking Torecan

When Not to Take Torecan

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

Torecan should not be taken by children under 15 years of age and by 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:

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

Like other antiemetic medications, Torecan may mask the symptoms of certain gastrointestinal and central nervous system disorders, as well as the adverse effects of other medications.
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, during treatment with Torecan, involuntary movements may occur, so treatment should not last more than 2 months.

Torecan and Other Medications

Tell your doctor or pharmacist about all medications you are currently taking or have recently taken, as well as any medications you plan to take.
Taking Torecan and certain other medications at the same time may lead to interactions between them, which can reduce or increase the effect of each medication.
Inform your doctor especially if you are taking:

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

Pregnancy, Breastfeeding, and Fertility

If you are pregnant, breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medication.
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, so 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 was observed only at doses higher than recommended, indicating little clinical significance.

Driving and Operating Machines

Torecan may significantly impair your ability to drive and operate machines, especially when taken with sedatives, sleeping pills, or alcohol. Therefore, caution is advised when driving vehicles and operating machines.

Torecan Contains Lactose and Sucrose

If you have been diagnosed with an intolerance to some sugars, consult your doctor before taking the medication.

3. How to Take Torecan

Always take this medication exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
Usually, the dose is 1 tablet per day. Your doctor may increase the dose to 2 or 3 tablets.
Swallow the tablet with water or another suitable liquid. The duration of treatment depends on the course of the underlying disease. Your doctor will determine the duration of treatment.
If you feel that the effect of the medication is too strong or too weak, talk to your doctor or pharmacist.
Special Populations
Kidney Function Disorders
No studies have been conducted in patients with kidney function disorders.
Liver Function Disorders
In patients with liver function disorders, when taking Torecan in high doses or for a long time, liver function should be monitored.
Children and Adolescents
Dosing in children has not been established, so the product is not recommended for children under 15 years of age.
Elderly Patients
Caution is advised when treating elderly patients (75 years and older).

Overdose of Torecan

Taking too much of the medication may cause dry mouth, dizziness, confusion, involuntary movements, and fainting due to decreased blood pressure. After taking more tablets than recommended, severe disturbances of consciousness, seizures, and other symptoms of impaired central nervous system function may also occur. Inform your doctor or medical personnel immediately if any of these symptoms occur.

Missed Dose of Torecan

Do not take a double dose to make up for a missed dose. If you miss a dose, take the next dose at the scheduled time.
If you have any doubts about taking the medication, ask your doctor or pharmacist.

4. Possible Side Effects

Like all medications, 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);
• increased 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 medication, tardive dyskinesia (involuntary movements) may occur. These symptoms usually disappear after stopping the medication or reducing its dose;
• blurred vision and cataract formation (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 or pharmacist. Side effects can be reported directly to the Department of Medicinal Product Monitoring, 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: ndl@urpl.gov.pl.
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medication.

5. How to Store Torecan

Keep the medication 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 that month.
Store in a temperature below 25°C.
Medications should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medications no longer required. This will help protect the environment.

6. Package Contents and Other Information

What Torecan Contains

• The active substance is thiethylperazine. Each coated tablet contains 6.5 mg of thiethylperazine in the form of thiethylperazine dimaleinate.
• The other ingredients are: tablet core - lactose monohydrate, corn starch, talc, stearic acid, gelatin. Coating - sucrose, arabic gum, talc, titanium dioxide (E 171). See section 2.

What Torecan Looks Like and Contents of the Package

Round, biconvex, white coated tablets.
The package contains 50 coated tablets of 6.5 mg each, in a bottle, in a carton.

Marketing Authorization Holder and Manufacturer

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

Date of Last Revision of the Leaflet: