Torendo q-tab 2 mg

Package leaflet: Information for the patient

Torendo Q-Tab 1 mg, orodispersible tablets
Torendo Q-Tab 2 mg, orodispersible tablets
risperidone
Please read the entire leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, 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 other people, even if their symptoms are similar.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

1. What Torendo Q-Tab is and what it is used for
2. Important information before taking Torendo Q-Tab
3. How to take Torendo Q-Tab
4. Possible side effects
5. How to store Torendo Q-Tab
6. Contents of the pack and other information

1. What Torendo Q-Tab is and what it is used for

Torendo Q-Tab belongs to a group of medicines called antipsychotics.
Torendo Q-Tab is used:

• For the treatment of schizophrenia – a condition in which patients may see, hear, or feel things that do not exist, believe things that are not true, or experience extreme suspicion or confusion.
• For the treatment of manic episodes – a condition in which patients may feel intensely excited, stimulated, enthusiastic, or excessively active. Manic episodes occur in bipolar affective disorder.
• Short-term treatment (up to 6 weeks) of persistent aggression in patients with Alzheimer's dementia who are a danger to themselves or others. Before using this medicine, alternative non-pharmacological treatment methods should be considered.
• Short-term treatment (up to 6 weeks) of persistent aggression in intellectually disabled children (aged at least 5 years) and adolescents with behavioural disorders.

Torendo Q-Tab reduces disease symptoms and helps prevent their recurrence.

2. Important information before using Torendo Q-Tab

When not to use Torendo Q-Tab

• if the patient is allergic to risperidone or any of the other ingredients of this medicine (listed in section 6).

If the patient is unsure whether the above information applies to them, they should consult a doctor or
pharmacist before using Torendo Q-Tab.
Warnings and precautions
Before using Torendo Q-Tab, contact a doctor or pharmacist:

• If the patient has heart problems, for example irregular heartbeat, or if the patient has a tendency towards low blood pressure, or if the patient is taking medicines to control blood pressure. Torendo Q-Tab may cause a drop in blood pressure. Dose adjustment may be necessary.
• If the patient is aware of any risk factors that may predispose to stroke, such as high blood pressure, cardiovascular disorders, or cerebrovascular disorders.
• If the patient has ever experienced involuntary rhythmic movements of the tongue, mouth, or face.
• If the patient has ever had a condition characterized by fever, severe muscle stiffness, sweating, or decreased level of consciousness (also known as neuroleptic malignant syndrome).
• In patients with Parkinson's disease or dementia.
• If the patient has previously had a low white blood cell count (which may or may not have been caused by other medicines).
• In patients with diabetes.
• In patients with epilepsy.
• If the male patient has experienced prolonged or painful erection.
• If the patient has difficulty controlling body temperature or overheating.
• If the patient has kidney problems.
• If the patient has liver problems.
• If the patient has been diagnosed with abnormally high levels of the hormone prolactin in the blood or suspected prolactin-dependent tumor.
• If the patient or their family has a history of blood clots, as use of medicines such as Torendo Q-Tab is associated with blood clot formation.

If the patient is unsure whether any of the symptoms described above apply to them, they should
consult a doctor or pharmacist before using Torendo Q-Tab.
The doctor may order a white blood cell count test, as very rarely, patients taking
risperidone have been observed to have dangerously low levels of certain types of white blood cells
needed to fight infections.
Torendo Q-Tab may cause weight gain. Significant weight gain may negatively
affect the patient's health. The doctor should regularly monitor the patient's
body weight.
The doctor will monitor whether the patient develops symptoms of high blood sugar, as
cases of diabetes or worsening of existing diabetes have been reported in patients
taking Torendo Q-Tab. In patients with pre-existing diabetes, blood glucose levels should be monitored regularly.
Torendo Q-Tab often increases levels of a hormone called "prolactin". This may cause
adverse effects such as: menstrual disorders, fertility problems in women, breast swelling
in men (see Possible side effects). If such adverse effects occur, testing for blood prolactin levels is recommended.
During cataract removal surgery, the pupil may not dilate sufficiently. Also,
the iris of the eye may be flaccid during the procedure, which may result in eye damage. If the patient
is scheduled for eye surgery, they should inform the ophthalmologist about taking this medicine.
Elderly patients with dementia
In elderly patients with dementia, there is an increased risk of stroke. Patients
with dementia caused by stroke should not take risperidone.
During treatment with Torendo Q-Tab, the patient should frequently consult with their doctor.
Medical help should be sought immediately if the patient or caregiver observes a sudden change in mental state or sudden muscle weakness or numbness in the face, arms, or legs, especially on one side, or speech disturbances, even if they are brief. These symptoms may indicate a stroke.
Children and adolescents
Before starting treatment for behavioral disorders, other causes of aggressive behavior should be ruled out.
If the patient feels fatigued during treatment, timing of risperidone administration may be adjusted to improve concentration.
Before starting treatment, the doctor may check the patient's body weight and may regularly
monitor the patient's weight during treatment.
In a small study, increased growth was observed in children taking Torendo Q-Tab,
but it is not known whether this is due to the medicine or other causes.
Torendo Q-Tab and other medicines
Tell the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Patients should especially inform the doctor or pharmacist if they are taking any of the
following medicines:

• medicines acting on the brain, such as medicines to help calm down (benzodiazepines) or certain painkillers (opioids), antihistamines, as risperidone may enhance their calming effect,
• medicines that may cause changes in the heart's electrical activity, such as antimalarial medicines, antiarrhythmics, antihistamines, certain antidepressants, or other medicines used to treat psychiatric disorders,
• medicines that slow down heart rate,
• medicines that reduce potassium levels in the blood (e.g. certain diuretics),
• medicines used for high blood pressure, as Torendo Q-Tab may lower blood pressure,
• medicines used in Parkinson's disease (e.g. levodopa),
• medicines that increase central nervous system activity (psychostimulants, such as methylphenidate),
• diuretics used in heart disease or to relieve swelling in areas with excessive fluid accumulation (e.g. furosemide or chlorothiazide). Torendo Q-Tab, taken alone or in combination with furosemide, may increase the risk of stroke or death in elderly patients with dementia.

The following medicines may reduce the effect of risperidone:

• rifampicin (a medicine used to treat certain infections),
• carbamazepine, phenytoin (medicines for epilepsy),
• phenobarbital. When starting or stopping these medicines, a change in risperidone dose may be necessary.

The following medicines may enhance the effect of risperidone:

• quinidine (used in certain heart conditions),
• antidepressants such as paroxetine, fluoxetine, tricyclic antidepressants,
• medicines known as beta-blockers (used to treat high blood pressure),
• phenothiazines (e.g. used to treat psychosis or for calming),
• cimetidine, ranitidine (reducing stomach acid),
• itraconazole or ketoconazole (used in fungal infections),
• certain medicines used to treat HIV/AIDS, such as ritonavir,
• verapamil, used to treat high blood pressure and (or) heart rhythm disorders,
• sertraline and fluvoxamine, used to treat depression and other psychiatric disorders.

When starting or stopping these medicines, a change in risperidone dose may be necessary.
If the patient is unsure whether they have taken or are taking any of the medicines described above,
they should consult a doctor or pharmacist before using Torendo Q-Tab.
Torendo Q-Tab with food, drink, and alcohol
This medicine may be taken with or without food. Alcohol should be avoided during treatment with
Torendo Q-Tab.
Pregnancy, breastfeeding, and effects on fertility

• If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine. The doctor will decide whether the patient may take Torendo Q-Tab.
• Newborns whose mothers took risperidone during the third trimester of pregnancy (last 3 months) may experience the following symptoms: tremors, muscle stiffness and (or) muscle weakness, drowsiness, agitation, breathing difficulties, and feeding problems. If any of these symptoms occur in the baby, contact a doctor.
• Torendo Q-Tab may increase prolactin levels in the blood – a hormone that may affect fertility (see section "Possible side effects").

Driving and using machines
While taking Torendo Q-Tab, dizziness, tiredness, and
vision problems may occur. Therefore, do not drive or
operate machinery without first consulting a doctor.
Torendo Q-Tab contains aspartame (E 951)
This medicine contains 0.80 mg aspartame in each 1 mg orodispersible tablet and 1.60
mg aspartame in each 2 mg orodispersible tablet. Aspartame is a source of
phenylalanine. It may be harmful to patients with phenylketonuria. This is a rare
genetic disorder in which phenylalanine accumulates in the body due to improper
excretion.

3. How to use Torendo Q-Tab

This medicine should always be taken exactly as directed by your doctor or pharmacist. If you are
unsure, consult your doctor or pharmacist.
Please note that not all strengths of these medicinal products may be available on the market, or
not all recommended doses may be achievable with these products. Other pharmaceutical forms/strengths may be available by prescription.
Recommended doses are given below.
In the treatment of schizophrenia
Adults

• The usual starting dose is 2 mg once daily, which may be increased to 4 mg on the second day.
• Depending on the patient's response to treatment, the doctor may adjust the dose.
• For most patients, the optimal daily dose ranges from 4 mg to 6 mg.
• This total daily dose may be administered as a single dose or divided into two doses. Your doctor will inform you which dosing regimen is best for you.

Elderly patients

• The usual starting dose is typically 0.5 mg twice daily.
• The doctor may then gradually increase the dose to 1 mg to 2 mg twice daily.
• Your doctor will inform you which dosing regimen is best for you.

In the treatment of manic episodes
Adults

• The usual starting dose is typically 2 mg once daily.
• Depending on the patient's response to treatment, the doctor may gradually adjust the dose.
• For most patients, the optimal dose ranges from 1 mg to 6 mg once daily.

Elderly patients

• The usual starting dose is typically 0.5 mg twice daily.
• The doctor may then gradually adjust the dose up to 1 mg to 2 mg twice daily, depending on the patient's response to treatment.

In the treatment of persistent aggression in patients with Alzheimer's type dementia
Adults (including elderly patients)

• The usual starting dose is typically 0.25 mg twice daily.
• Depending on the patient's response to treatment, the doctor may gradually adjust the dose.
• For most patients, the optimal daily dose is 0.5 mg twice daily. Some patients may require a dose of 1 mg twice daily.
• The duration of treatment in patients with Alzheimer's type dementia should not exceed 6 weeks.

Children and adolescents

• Torendo Q-Tab should not be used in children and adolescents under 18 years of age for the treatment of mania associated with bipolar affective disorder.

In the treatment of behavioural disorders
The dose depends on the child's body weight:
In children with body weight below 50 kg

• The usual starting dose is 0.25 mg once daily.
• The dose may be increased every other day by 0.25 mg per day.
• The usual maintenance dose is typically between 0.25 mg and 0.75 mg once daily.

In children with body weight of 50 kg or more

• The usual starting dose is typically 0.5 mg once daily.
• The dose may be increased every other day by 0.5 mg per day.
• The usual maintenance dose is typically between 0.5 mg and 1.5 mg once daily.

The duration of treatment in patients with behavioural disorders should not exceed 6 weeks.
Torendo Q-Tab should not be used in children under 5 years of age for the treatment of behavioural
disorders.
Patients with renal or hepatic impairment
Regardless of the condition being treated, all initial and subsequent doses should be halved. Dose
escalation should be slower in these patients.
Risperidone should be used with caution in this patient group.
Method of administration
Oral administration
Torendo Q-Tab orally disintegrating tablets are fragile. Do not press them out of the foil blister, as this may damage the tablet. To remove the tablet from the packaging, follow these steps:

1. Hold the blister by the edges and carefully separate the square containing the tablet from the rest of the blister along the perforation.
2. Pull the edge of the foil and tear it off completely.
3. Shake the tablet onto your hand.
4. Place the tablet on your tongue immediately after removing it from the packaging.

Within a few seconds, the tablet will begin to disintegrate in the mouth and can be swallowed with or without water. Do not have anything in your mouth before placing the tablet on your tongue.
The tablet may also be placed in a glass or cup of water and taken immediately.
Taking more Torendo Q-Tab than recommended

• Seek medical advice immediately. Take the medicine package with you.
• In case of overdose, the patient may experience drowsiness or fatigue, abnormal body movements, difficulty standing or walking, dizziness due to low blood pressure, irregular heartbeat, or seizures may occur.

If you forget to take Torendo Q-Tab

• If you miss a dose, take it as soon as possible. However, if it is almost time for the next dose, skip the missed dose and take the next dose as scheduled. If you miss two or more doses, contact your doctor.
• Do not take a double dose (two doses at the same time) to make up for a missed dose.

Stopping Torendo Q-Tab
Do not stop taking this medicine unless instructed by your doctor. Symptoms of the illness may return. If your doctor decides to discontinue treatment, the dose may be gradually reduced over several days.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everybody will experience them.

Immediately inform your doctor if any of the following not very common adverse effects occur (may occur in up to 1 in 100 people):

• The patient with dementia experiences a sudden change in mental state, sudden weakness or numbness of the face or limbs, particularly on one side of the body, or speech disturbances, even if they occur for a short time. These symptoms may indicate a stroke.
• The patient develops tardive dyskinesia (involuntary, repetitive, jerking movements of the face, tongue or other body parts). Immediately consult a doctor if rhythmic, involuntary movements of the tongue, lips or face occur. It may be necessary to discontinue risperidone treatment.

Immediately inform your doctor if any of the following rare adverse effects occur (may occur in less than 1 in 1,000 people):

• The patient develops blood clots in the veins, especially in the legs (symptoms include leg pain and redness), which may travel through blood vessels to the lungs, causing chest pain and difficulty breathing. If such symptoms occur, seek immediate medical help.
• The patient develops fever, muscle stiffness, sweating or decreased level of consciousness (a condition known as neuroleptic malignant syndrome). Immediate treatment may be required.
• The male patient experiences prolonged or painful erection. This condition is known as priapism. Immediate treatment may be necessary.
• The patient develops a severe allergic reaction characterized by fever, swelling of the lips, face, tongue or mouth, shortness of breath, itching, skin rash or drop in blood pressure.

The following adverse effects may occur:

Very common adverse effects (may occur in more than 1 in 10 people):

• Difficulty falling asleep or waking up.
• Parkinsonism: This condition may include slow or abnormal movements, feelings of stiffness or muscle tension (causing uneven, jerky movements), and sometimes even a sensation of "freezing" of movements followed by sudden release. Other symptoms of parkinsonism include slow gait, resting tremor, increased salivation/drooling, and expressionless face.
• Drowsiness or reduced alertness.
• Headache.

Common adverse effects (may occur in less than 1 in 10 people):

• Pneumonia, bronchitis, cold symptoms, sinus infection.
• Urinary tract infection, ear infection, flu-like symptoms.
• Increased blood levels of the hormone prolactin (with or without symptoms). Symptoms of increased prolactin levels occur not very commonly and may include in men: breast swelling, difficulty achieving or maintaining erection, decreased sexual drive or other sexual disorders. In women, they may include breast discomfort, milk discharge from the breasts, absence of menstruation or other menstrual disorders, or fertility problems.
• Weight gain, increased appetite, decreased appetite.
• Sleep disturbances, irritability, depression, anxiety, restlessness.
• Dystonia: In this condition, slow or sustained involuntary muscle contractions occur. Although it may affect any part of the body (possibly resulting in abnormal posture), dystonia most commonly affects facial muscles, including abnormal eye, mouth, tongue or jaw movements.
• Dizziness.
• Dyskinesias: In this condition, involuntary muscle movements occur, including repetitive, spasmodic or twisting movements or jerks.
• Tremor.
• Blurred vision, eye infection or conjunctivitis.
• Rapid heartbeat, high blood pressure, shortness of breath (dyspnea).
• Sore throat, cough, nosebleed, nasal congestion.
• Abdominal pain, discomfort in the abdominal cavity, vomiting, nausea, constipation, diarrhea, indigestion, dry mouth, toothache.
• Rash, redness of the skin.
• Muscle cramps, bone or muscle pain, back pain, joint pain.
• Urinary incontinence.
• Swelling of the body, upper or lower limbs, fever, chest pain, weakness, fatigue, pain.
• Fall.

Uncommon adverse effects (may occur in less than 1 in 100 people):

• Respiratory tract infection, bladder infection, eye infection, tonsillitis, fungal nail infection, skin infection, localized skin infection, viral infection, skin inflammation caused by mites.
• Decreased number of white blood cells (including those that help protect against infections), decreased number of platelets (blood cells that help stop bleeding), anemia, decreased number of red blood cells, increased number of eosinophils (a type of white blood cell).
• Allergic reaction.
• Development of diabetes or worsening of existing diabetes, high blood sugar levels, excessive thirst and drinking.
• Weight loss, loss of appetite leading to malnutrition and low body weight.
• Increased cholesterol levels in the blood.
• Elevated mood (mania), confusion, decreased libido, nervousness, nightmares.
• Lack of response to stimuli, loss of consciousness, low level of consciousness.
• Seizures, fainting.
• Need to move body parts, balance disorders, impaired coordination, dizziness upon standing, difficulty concentrating, speech difficulties, loss or altered sense of taste, reduced sensation to pain and touch on the skin, tingling, prickling or numbness of the skin.
• Light sensitivity of the eyes, dry eyes, increased tearing, redness of the eyes.
• Dizziness, ringing in the ears, ear pain.
• Atrial fibrillation (irregular heartbeat), heart conduction block, abnormal conduction of electrical impulses in the heart, QT interval prolongation, slow heartbeat, abnormal electrocardiogram (ECG), palpitations.
• Low blood pressure, low blood pressure upon standing (postural hypotension) (as a result, some patients taking Torendo Q-Tab may faint, feel dizzy or lose consciousness when standing up suddenly or rising quickly), sudden flushing of the skin, especially of the face.
• Aspiration pneumonia (caused by food entering the airways), pulmonary congestion, engorgement of the respiratory tract, lung rales, wheezing, dysphonia (hoarseness), breathing difficulties.
• Stomach or intestinal infection, fecal incontinence, very hard stool, difficulty swallowing, excessive flatulence.
• Urticaria, itching, hair loss, skin thickening, skin eruptions, dry skin, skin depigmentation, acne, scaly and itchy scalp or other body parts, skin disorders, skin lesions.
• Increased CPK (creatine phosphokinase) activity in blood, an enzyme sometimes released from damaged muscles.
• Abnormal posture, joint stiffness, joint swelling, muscle weakness, neck pain.
• Frequent urination, urinary incontinence, painful urination.
• Erectile dysfunction, ejaculation disorders.
• Absence of menstrual bleeding, lack of menstruation and other menstrual cycle disorders (in women).
• Breast enlargement in men, milk discharge from the breasts, sexual disorders, breast pain, breast discomfort, vaginal discharge.
• Swelling of the face, lips, eyes or mouth.
• Chills, increased body temperature.
• Change in walking pattern.
• Thirst, malaise, chest discomfort, feeling unwell, discomfort.
• Increased aminotransferase activity in blood, increased GGTP (gamma-glutamyl transferase) enzyme activity in blood, increased liver enzyme activity in blood.
• Pain related to medical procedures.

Rare adverse effects (may occur in less than 1 in 1,000 people):

• Infections.
• Abnormal secretion of the hormone regulating urine production.
• Somnambulism (sleepwalking).
• Sleep-related eating disorders.
• Glucose in urine, low blood sugar levels, high triglyceride (fat) levels in blood.
• Lack of emotion, inability to achieve orgasm.
• Reduced motor activity and lack of response in a patient with preserved consciousness (catatonia).
• Cerebrovascular disorders.
• Coma due to uncontrolled diabetes.
• Trembling or nodding head movements.
• Glaucoma (increased intraocular pressure), eye movement disorders, rotary eye movements, eyelid margin ulcers.
• Eye complications during cataract surgery. During this procedure, intraoperative floppy iris syndrome (IFIS) may occur if the patient is currently or has previously taken Torendo Q-Tab. If cataract surgery is planned, inform the ophthalmologist about current or past use of this medicine.
• Dangerously low number of certain white blood cells responsible for fighting infections.
• Dangerously excessive water drinking.
• Irregular heartbeat.
• Breathing disorders during sleep (sleep apnea), rapid, shallow breathing.
• Pancreatitis, intestinal obstruction.
• Tongue swelling, dry lips, drug rash.
• Pityriasis.
• Muscle fiber breakdown and muscle pain (rhabdomyolysis).
• Delayed menstruation, enlargement of mammary glands, breast enlargement, breast discharge.
• Increased insulin levels in blood (a hormone regulating blood sugar levels).
• Skin sclerosis.
• Low body temperature, cold hands and feet.
• Withdrawal symptoms.
• Yellowing of the skin and eyes (jaundice).

Very rare (may occur in less than 1 in 10,000 people):

• Life-threatening complications related to uncontrolled diabetes.
• Severe allergic reaction with swelling, which may involve the throat and cause breathing difficulties.
• Loss of intestinal function leading to obstruction.

Adverse effects with unknown frequency: frequency cannot be estimated from available data:

• Severe or life-threatening rash with blisters and peeling skin, which may appear in the mouth, nose, eyes, genital areas and around these sites, and may spread to other parts of the body (Stevens-Johnson syndrome or toxic epidermal necrolysis).

Adverse effects observed during use of another medicine – paliperidone – very similar to risperidone, which may also occur during use of Torendo Q-Tab: rapid heartbeat upon standing.

Additional adverse effects in children and adolescents
It is generally expected that adverse effects in children will be similar to those in adults.
The following adverse effects have been observed more frequently in children and adolescents (aged 5 to 17 years) than in adults: drowsiness or reduced alertness, fatigue, headache, increased appetite, vomiting, cold symptoms, nasal congestion, abdominal pain, dizziness, cough, fever, tremor, diarrhea and urinary incontinence.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects 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
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Torendo Q-Tab

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
No special storage conditions are required.
Medicines must not be disposed of via the sewage system 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 Torendo Q-Tab contains

• The active substance is risperidone. Each orodispersible tablet contains 1 mg or 2 mg of risperidone.
• Other ingredients are: mannitol, basic butyl methacrylate copolymer, povidone, microcrystalline cellulose, low-substituted hydroxypropylcellulose, aspartame (E 951), crospovidone, iron oxide red (E 172), mint flavour, peppermint flavour, calcium silicate, magnesium stearate. See section 2 “Torendo Q-Tab contains aspartame (E 951)”.

What Torendo Q-Tab looks like and contents of the pack
Orodispersible tablets are round, slightly convex, pink marbled tablets.
Pack sizes: 20, 28, 30, 50, 56, 60, 98 or 100 orodispersible tablets in
blister packs, in a cardboard carton.
Marketing Authorisation Holder
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
Manufacturer
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
For more detailed information on the product names in other European Economic Area countries and the United Kingdom (Northern Ireland), please contact the local representative of the Marketing Authorisation Holder:
KRKA-POLSKA Sp. z o.o.
ul. Równoległa 5
02-235 Warszawa
Tel. 22 57 37 500