Torecan

Package leaflet: Information for the patient

Torecan, 6.5 mg, suppositories
Thiethylperazinum
Please read all of this leaflet carefully before using this medicine, because it contains
important information for the patient.

• 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 give it to others. This medicine may harm others, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform the doctor or pharmacist. See section 4.

Table of contents of the leaflet

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. The drug 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 provoke nausea and vomiting.
The medicine is indicated for the treatment of nausea and vomiting in the following conditions:

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

2. Important information before using Torecan

When not to use Torecan

• 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, or 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 low blood pressure;
• you are pregnant, particularly if you have a specific condition involving high blood pressure with 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 or 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 medical advice must be sought or a doctor contacted as soon as possible.

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

Torecan with other medicines

Inform your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.

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

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

• medicines acting on the central nervous system (sleeping pills, opioid analgesics, sedatives, 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, suspect you may be pregnant, or are planning to have a child, consult your doctor or pharmacist before using this medicine.

Pregnancy

There is only limited data available 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. A slight effect on pregnancy rate in female rats was observed only at doses higher than recommended, suggesting minimal relevance in clinical practice.

Driving and operating machinery

Torecan may significantly impair the ability to drive vehicles and operate machinery, especially when taken together with sedatives, sleeping medicines, or alcohol. Therefore, caution is advised when driving motor vehicles or operating machinery.

3. How to use Torecan

This medicine should always be used according to the instructions given by your doctor or pharmacist. If you have any doubts,
please consult your doctor or pharmacist.
The usual dose is 1 suppository per day. 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 how long the treatment should last.
If you feel that the medicine's effect is too strong or too weak, please consult your doctor or
pharmacist.

Special populations
Renal impairment
Studies have not been conducted in patients with renal impairment.
Hepatic impairment
In patients with hepatic impairment, liver function should be monitored when Torecan is administered in high doses or for prolonged periods.
Children and adolescents
Dosage in children has not been established; therefore, use of this product is not recommended in children under 15 years of age.
Elderly patients
Particular caution should be exercised when treating elderly patients (aged 75 years 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 reduced blood pressure. After administration of a dose higher than recommended, severe disturbances in consciousness, seizures, and other symptoms of central nervous system dysfunction may additionally occur. You should immediately contact your doctor or medical personnel if any of these symptoms occur.

Missed dose of Torecan
Do not use a double dose to make up for a missed dose. If a patient forgets to use the medicine, they should take the next dose at the scheduled time.
If you have any doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences 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 (torticollis, 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 of the medicine or dose reduction;
• 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 any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw, Poland
Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309
Email: [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 Torecan

Keep the medicine out of 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.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This helps protect the environment.

6. Contents of the pack and other information

What Torecan contains

• The active substance is tiethylperazine. Each suppository contains 6.5 mg of tiethylperazine in the form of tiethylperazine dimaleate.
• Other ingredients are: lactose monohydrate, solid fat.

What Torecan looks like and contents of the pack
White to slightly yellow suppositories.
Carton box containing 6 suppositories in blisters made of Aluminium/LDPE/LDPE/Aluminium foil in a cardboard box.
Marketing Authorisation Holder and Manufacturer
KRKA, d.d., Novo mesto
Šmarješka cesta 6
8501 Novo mesto
Slovenia