Modalina

Patient Information Leaflet: Information for the patient

MODALINA 1 mg film-coated tablets, 2 mg film-coated tablets

trifluoperazine
Please read this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What MODALINA is and what it is used for
2. What you need to know before taking MODALINA
3. How to take MODALINA
4. Possible side effects
5. How to store MODALINA
6. Contents of the pack and other information

1. What MODALINA is and what it is used for

MODALINA contains trifluoperazine hydrochloride, which belongs to a group of medicines called
"antipsychotics". It works by regulating certain chemical substances in the brain (neurotransmitters),
thus producing a calming effect.
This medicine is used to:

• treat disturbances of mental equilibrium (psychotic disorders);
• control feelings of anxiety, tension, and agitation in individuals affected by:
  o mental disorders (neuroses);
  o mental disorders leading to physical discomfort without any underlying physical illness (psychosomatic disorders).

2. What you need to know before taking MODALINA

Do not take MODALINA

• if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6);
• if you have liver problems;
• if you have blood cell disorders;
• if you have conditions affecting the bone marrow (bone marrow depression);
• if you are in a coma;
• if you have central nervous system depression caused by antidepressant medicines.

Warnings and precautions
Talk to your doctor or pharmacist before taking MODALINA:

• if you have previously had hypersensitivity reactions (excessive body response) to medicines called "phenothiazines". Hypersensitivity reactions may, for example, include changes in blood cells (haematological dyscrasias) or yellowing of the skin and whites of the eyes (jaundice);
• if you or a family member has a disease affecting the heart and blood vessels (cardiovascular diseases), including chest pain (angina) and irregular heartbeat (cardiac arrhythmias, e.g. long QT syndrome);
• if you have eye problems (retinal disorders), as this medicine may worsen them;
• if you suffer from a disease that reduces your ability to remember, speak, and think (dementia);
• if you are elderly;
• if you or a family member has had problems related to blood clot formation (thrombi), as this medicine may increase the risk;
• if you have had a stroke or are at risk of stroke, such as due to heart problems, high blood pressure, diabetes, high cholesterol, family history of stroke, smoking, or excessive alcohol consumption.

Contact your doctor immediately if:

• after taking this medicine you experience a combination of symptoms such as fever, severe muscle stiffness, severe movement difficulties (akinesia), excessive sweating, rapid heartbeat, altered blood pressure, or loss of consciousness. These are symptoms of a very serious and potentially fatal condition called neuroleptic malignant syndrome. In this case, treatment must be stopped and immediate medical attention must be sought.

If your treatment with this medicine is long-term and involves high doses, your doctor
will need to monitor your health periodically, as this medicine may accumulate in your body.
Other medicines and MODALINA
Inform your doctor or pharmacist if you are currently taking, have recently taken, or might
take any other medicines.
It is particularly important that you inform your doctor or pharmacist if you are taking or have
recently taken:

• medicines that affect heart rhythm, as they may increase the risk of cardiac arrhythmias;
• medicines that may affect levels of electrolytes (potassium, magnesium) in the blood, as these should not be taken with MODALINA;
• other medicines acting on the central nervous system, such as other psychotropic drugs (used to treat schizophrenia), sedatives (used to treat insomnia), tranquilizers (used to treat anxiety), anaesthetics (used for anaesthesia), or alcohol, as they may enhance the effects of this medicine on the brain.

MODALINA and alcohol
Do not drink alcohol during treatment with Modalina.
Pregnancy and breastfeeding
Avoid taking this medicine if you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, unless your doctor has deemed it necessary and you are under medical supervision. Always consult your doctor or pharmacist before taking this medicine.
It is particularly important to avoid taking this medicine during the first three months of pregnancy.
Newborns of mothers who have taken this medicine during the last three months of pregnancy
must be closely monitored by a doctor, as they may develop: tremors, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties, and feeding problems. If you notice any of these symptoms in your baby, contact your doctor (see section 4 “Additional undesirable effects in children”).
Driving and using machines
This medicine may impair your ability to drive or operate machinery. MODALINA, especially at the beginning of treatment, may cause drowsiness and dizziness. These effects may affect your ability to drive or use machinery.
MODALINA contains sucrose. If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.

3. How to take MODALINA

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Use in adults
Anxiety and agitation
The recommended dose is 1 to 4 mg daily, taken in divided doses throughout the day as prescribed by your doctor.
Psychiatric disorders
The recommended starting dose is 5 to 10 mg daily. This may then be increased by 5 mg every 2 or 3 days, always following your doctor's instructions and dosage recommendations.
Use in children
Children with mild behavioural disorders
The recommended dose is 1 mg daily.
Hospitalised children with complex disorders
The recommended dose is 3 to 6 mg daily, according to the doctor's prescription.
If you take more MODALINA than you should
If you have taken more MODALINA than prescribed, inform your doctor immediately or go to the nearest hospital. Take this leaflet and the medicine package with you, even if empty.
If you have taken an excessive dose of this medicine, you may experience severe involuntary muscle contractions such as spasmodic torticollis, clenched jaw due to jaw muscle contraction (trismus), or protrusion of the tongue from the mouth (tongue protrusion).
In some cases, you may develop muscle rigidity, slowed movements, and tremors (parkinsonism).
If you forget to take MODALINA
Do not take a double dose to make up for a forgotten dose.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If any of the following serious side effects occur, stop treatment and contact your doctor immediately:

• fever, severe muscle stiffness, severe movement difficulties (akinesia), excessive sweating, rapid heartbeat, altered blood pressure, or loss of consciousness. These are symptoms of a condition called "neuroleptic malignant syndrome", which may require immediate medical treatment;
• involuntary rhythmic movements of the face, mouth, cheeks, and tongue (sometimes accompanied by similar movements of the limbs). These are signs of a condition called "persistent tardive dyskinesia", which may appear even after stopping treatment. The first symptom is often an involuntary (vermicular) movement of the tongue. This syndrome particularly affects elderly women;
• chest pain and breathing difficulties, as these may be caused by blood clots forming in the veins (venous thrombosis), which may travel through the bloodstream to the lungs (pulmonary embolism);
• rarely, the heart may beat irregularly (prolonged QT interval, ventricular arrhythmias, torsades de pointes, tachycardia, fibrillation). In extreme cases, the heart may stop (cardiac arrest);
• slow and difficult movements, muscle stiffness, and muscle weakness (similar to symptoms seen in Parkinson's disease), excessive fatigue;
• drowsiness, dizziness, insomnia;
• skin rashes;
• dry mouth, loss of appetite (anorexia);
• absence of menstruation (amenorrhea), abnormal milk secretion from the nipples (galactorrhea);
• vision disturbances.

Very rarely, sudden death has been reported.
Additional side effects in children
Newborns of mothers who took this medicine during the last three months of pregnancy may experience: neonatal withdrawal syndrome and extrapyramidal symptoms such as tremors, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties, and feeding problems (frequency of which is unknown). If your baby shows any of these symptoms, contact your doctor immediately.
Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the website:
http://www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store MODALINA

This medicine does not require any special storage conditions.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after "Exp.". The expiry date refers to the last day of that month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What MODALINA contains
MODALINA 1 mg coated tablets:

• The active substance is trifluoperazine. Each coated tablet contains 1.18 mg of trifluoperazine hydrochloride (equivalent to 1 mg of trifluoperazine);
• The other components are corn starch, calcium sulfate dihydrate, calcium carbonate, talc, magnesium stearate, gelatin, acacia gum, ethylcellulose, indigotine (E132), powdered sugar, macrogol 6000, sucrose.

MODALINA 2 mg coated tablets:

• The active substance is trifluoperazine. Each coated tablet contains 2.36 mg of trifluoperazine hydrochloride (equivalent to 2 mg of trifluoperazine);
• The other components are corn starch, calcium sulfate dihydrate, calcium carbonate, talc, magnesium stearate, gelatin, acacia gum, ethylcellulose, powdered sugar, macrogol 6000, sucrose.

Description of the appearance of MODALINA and package contents
MODALINA 1 mg coated tablets are supplied in a box containing 30 tablets in blister packs.
MODALINA 2 mg coated tablets are supplied in a box containing 30 tablets in blister packs.

Marketing Authorization Holder and Manufacturer
Laboratorio Farmaceutico SIT Specialità Igienico Terapeutiche S.r.l. - Via Cavour 70 – 27035
Mede (PV).