MODALINA 1 mg Coated Tablet

Зміст інструкції

1. What is MODALINA and what is it 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

MODALINA 1 mg coated tablets
MODALINA 2 mg coated tablets
trifluoperazine

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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you take 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 is MODALINA and what is it used for

MODALINA contains trifluoperazine hydrochloride, which belongs to the group of medicines called “antipsychotics”. It works by regulating certain chemicals in the brain (neurotransmitters) and thereby causing calming effects.
This medicine is used for:

• treating disturbances of mental balance (psychotic disorders);
• controlling feelings of anxiety, tension and agitation in people suffering from: o mental disorders (neuroses); o mental disorders that lead to physical discomfort without any underlying bodily disease (psychosomatic disorders).

2. What you need to know before taking MODALINA

Do not take MODALINA

• if you are allergic to the active ingredient or to any of the other ingredients of this medicine (listed in section 6);
• if you have liver problems;
• if you have abnormalities of the blood cells;
• if you have problems involving the bone marrow (bone marrow depression);
• if you are in a coma;
• if you experience depression of the central nervous system caused by antidepressant drugs.

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

• if you have had problems with hypersensitivity (excessive reaction of the body) to medicines called “phenothiazines” in the past. Hypersensitivity problems manifest, for example, with abnormalities of the blood cells (blood dyscrasias) or yellowing of the skin and the white of the eye (jaundice);
• if you or a family member suffers from a disease involving the heart and blood vessels (cardiovascular diseases) including chest pain (angina) and irregular heartbeat (cardiac arrhythmias, e.g. prolonged QT syndrome);
• if you have eye problems (retinal alterations), because this medicine may worsen them;
• if you suffer from a disease that reduces your ability to remember, speak and reason (dementia);
• if you are elderly;
• if you or a family member has suffered from problems related to the formation of blood clots (thrombi), because this medicine may promote their formation;
• if you have had a stroke or if you are predisposed to stroke, such as heart problems, high blood pressure, diabetes, excess cholesterol, a family history of stroke, if you smoke or drink too much alcohol.

Tell your doctor immediatelyif:

• after taking this medicine you experience a combination of symptoms such as fever, severe muscle stiffness, severe difficulty in movements (akinesia), excessive sweating, if you feel your heartbeat accelerating, your blood pressure changing or if you lose consciousness. These are symptoms of a very serious and potentially fatal condition called “neuroleptic malignant syndrome”. In this case, therapy must be discontinued and immediate medical attention is required.

If your therapy with this medicine is long-lasting and with high doses, your doctor
will need to check you periodically to verify your health status, as
this medicine can accumulate in your body.

Other medicines and MODALINA
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines.
It is particularly important that you tell your doctor or pharmacist if you are taking or have
recently taken:

• medicines that have an effect on the heart rhythm, because this increases the risk of heart rhythm disturbances;
• medicines that can affect the levels of salts (potassium, magnesium) in the blood, because they should not be taken with MODALINA;
• other medicines that act on the central nervous system, such as other psychotropic drugs (used to treat schizophrenia), sedatives (used to treat insomnia), tranquilizers (used to treat anxiety), anesthetics (used for anesthesia) or alcohol, because they can increase the effects of this medicine on the brain.

MODALINA with alcohol
Do not drink alcoholduring therapy with Modalina.

Pregnancy and breastfeeding
Avoid taking this medicine if you are pregnant, if you suspect or are
planning a pregnancy, or if you are breastfeeding with breast milk unless your doctor has
considered it necessary and is under his control. Always ask your doctor or
pharmacist for advice 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 carefully monitored by the doctor, as they may
manifest: tremors, stiffness and/or muscle weakness, drowsiness, agitation, breathing problems and difficulty feeding. If you notice any of these symptoms in your baby contact your
doctor(see section 4 “Additional adverse effects in children”).

Driving and using machines
This medicine can alter your ability to drive vehicles or use
machinery. Modalina, especially at the beginning of treatment, may make you feel drowsy and
dizzy. These effects can compromise your ability to drive vehicles or
use machinery.

MODALINA contains sucrose.If your doctor has diagnosed you with an intolerance to some
sugars, contact him before taking this medicine.

3. How to take MODALINA

Take this medicine following the instructions of your doctor or pharmacist exactly. If you have any doubts, consult your doctor or pharmacist.

Use in adults

Anxiety and agitation
The recommended dose is from 1 to 4 mg per day, to be taken divided throughout the day according to the doctor's prescription.

Psychiatric disorders
The recommended initial dose is from 5 to 10 mg per day, and may then be increased by 5mg every 2 or 3 days, always following the methods and prescription of the doctor.

Use in children

Children with mild behavioral disorders
The recommended dose is 1 mg per day.

Children with complex disorders hospitalized in hospital
The recommended dose is from 3 to 6 mg per day according to the doctor's prescription.

If you take more MODALINA than you should
If you have ingested a dose of MODALINA higher than that prescribed, immediately notify your doctoror go to the nearest hospital. Bring this leaflet and the medicine box with you, even if it is empty.
If you have taken an excessive dose of this medicine, you may experience strong involuntary muscle contractions such as spasmodic torticollis, tight mouth due to contraction of the jaw muscles (trismus), tongue protruding from the mouth (tongue protrusion).
In some cases, you may experience muscle rigidity, slowed movements and tremors (Parkinsonian syndrome).

If you forget to take MODALINA
Do not take a double dose to make up for a missed dose.
If you have any doubts about the use of 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 treatmentand immediately inform your doctor:

• fever, severe muscle rigidity, severe difficulty in movements (akinesia), excessive sweating, if you have a fast heartbeat, altered blood pressure or if you lose consciousness. These are symptoms of a disease called “neuroleptic malignant syndrome” and immediate medical care may be necessary;
• rhythmic involuntary movements of the face, mouth, cheeks and tongue (sometimes accompanied by similar movements of the limbs). These are signs of the syndrome called “persistent tardive dyskinesia” which may appear even after stopping treatment. The first symptom is an involuntary (vermiform) movement of the tongue. The syndrome especially affects elderly women;
• chest pain and difficulty breathing because they may be caused by the formation of blood clots in the veins that can travel through the blood to the lungs (pulmonary embolism, venous thrombosis);
• rarely, the heart may beat with an irregular rhythm (prolongation of the QT interval, ventricular arrhythmias, torsade de pointes, tachycardia, fibrillation). The heart may even stop (cardiac arrest);
• slowed and difficult movements, rigidity and weakness of the muscles (as in subjects affected by Parkinson's disease), excessive feeling of fatigue;
• drowsiness, dizziness, insomnia;
• skin rashes;
• dry mouth, loss of appetite (anorexia);
• absence of menstruation (amenorrhea), abnormal secretion of milk from the nipples (galactorrhea);
• visual disturbances.

Very rarely, sudden death has occurred.

Additional side effects in children
Newborns of mothers who have taken this medicine during the last three months of
pregnancy have shown: neonatal withdrawal syndrome and extrapyramidal symptoms,
such as: tremors, rigidity and/or muscle weakness, drowsiness, agitation, breathing problems
and difficulty feeding (whose frequency is unknown). If any of these symptoms occur in
your child contact your doctor immediately.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet,
tell 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 particular storage conditions.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is reported on the pack after
“Exp.”. The expiry date refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What MODALINA contains
MODALINA 1 mg coated tablets:

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

MODALINA 2 mg coated tablets:

• The active ingredient is trifluoperazine. Each coated tablet contains 2.36 mg of trifluoperazine hydrochloride (corresponding to 2 mg of trifluoperazine);
• The other ingredients are corn starch, calcium sulfate dihydrate, calcium carbonate, talc, magnesium stearate, gelatin, gum arabic, ethylcellulose, powdered sugar, macrogols 6000, sucrose.

Description of the appearance of MODALINA and contents of the pack
MODALINA 1 mg coated tablets are presented in a box containing 30 tablets in
blisters.
MODALINA 2 mg coated tablets are presented in a box containing 30 tablets in
blisters.

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