Torecan

Package Leaflet: Information for the Patient

Torecan, 6.5 mg, Suppositories

Thiethylperazine

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 only. 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 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 using medicines that induce vomiting,
• 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 severe brain disease with concurrent liver function disorders (Reye's syndrome).

Warnings and precautions

Before starting to use Torecan, discuss it with your doctor, especially if you have:

• low blood pressure;
• pregnancy, with a special form of high blood pressure with concurrent swelling of the limbs (pre-eclampsia);
• liver function disorders;
• a history of involuntary body movements;
• using 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 manifests as high fever, muscle stiffness, change in mental state, and blood pressure fluctuations. In such a case, treatment should be stopped immediately and a doctor should be informed or consulted as soon as possible.
In elderly patients, during the use of the medicine, involuntary movements may occur, therefore, treatment should not last more than 2 months.

Torecan and other medicines

Tell your doctor or pharmacist about all the medicines you are taking now or have recently taken, as well as the medicines you plan to take.
Concomitant administration of Torecan and certain medicines may lead to interactions between them, which may reduce or increase the effect of each of these medicines.
Inform your doctor especially if you are using 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 plan to have a child, consult your doctor or pharmacist before using this medicine.
Pregnancy
There are only 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 precaution, 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

Torecan may significantly impair the ability to drive and use machines, especially when used concomitantly with sedatives, hypnotics, or alcohol. Therefore, caution is recommended when driving vehicles and operating machines.

3. How to use Torecan

Always use this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
Usually, a dose of 1 suppository per day is used. Your doctor may increase the dose to two or three suppositories.
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 medicine 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 using Torecan in high doses or for a longer period, liver function should be monitored.
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
Special caution should be exercised when treating elderly patients (75 years and older).

Using more than the recommended dose of Torecan

Too high doses of the medicine may cause dry mouth, dizziness, confusion, involuntary movements, and fainting due to decreased blood pressure. After using a dose higher than recommended, severe disturbances of consciousness, seizures, and other symptoms of central nervous system disorders may also occur. Inform your doctor or medical staff immediately if any of these symptoms occur.

Missing a dose of Torecan

Do not use 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 using the medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine 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 central nervous system disorders (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 stopping the medicine or reducing its 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 rareside 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 Monitoring of Adverse Reactions to Medicinal Products, 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 below 25°C.
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. Each suppository contains 6.5 mg of thiethylperazine in the form of thiethylperazine dimaleinate.
• The other ingredients are: lactose monohydrate, solid fat.

What Torecan looks like and contents of the pack

White to light yellow suppositories.
A carton containing 6 suppositories in aluminum/LDPE/LDPE/aluminum blisters 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: