REAGILA 1.5 MG Hard capsule

Зміст інструкції

1. Reagila 1.5 mg hard capsules, 3 mg hard capsules, 4.5 mg hard capsules, 6 mg hard capsules
   1. What is Reagila and what is it used for
   2. What you need to know before taking Reagila
   3. How to take Reagila
   4. Possible side effects
   5. How to store Reagila
   6. Contents of the pack and other information
2. Reagila 1.5 mg orodispersible tablets, 3 mg orodispersible tablets, 4.5 mg orodispersible tablets, 6 mg orodispersible tablets
   1. What is Reagila and what is it used for
   2. What you need to know before you take Reagila
   3. How to take Reagila
   4. Possible side effects
   5. How to store Reagila
   6. Package contents and other information

Reagila 1.5 mg hard capsules, 3 mg hard capsules, 4.5 mg hard capsules, 6 mg hard capsules

cariprazina

Read this leaflet carefully before you start taking this medicine as 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 their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor. See section 4.

Contents of this leaflet

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

1. What is Reagila and what is it used for

Reagila contains the active substance cariprazine and belongs to a group of medicines called
antipsychotics. It is used to treat adults with schizophrenia.
Schizophrenia is an illness characterized by symptoms such as hearing, seeing or perceiving things that are not
present (hallucinations), suspicious behavior, false beliefs, incoherent speech and behavior, emotional flatness. People with this condition may also feel depressed,
guilty, anxious or tense, or unable to start or continue planned activities, without a desire
to talk, with a lack of emotional responses to situations that would normally stimulate feelings
in others.

2. What you need to know before taking Reagila

Do not take Reagila

• if you are allergic to cariprazine or any of the other ingredients of this medicine (listed in section 6).
• if you are taking medicines used to treat:
• hepatitis caused by the hepatitis C virus (medicines containing boceprevir and telaprevir)
• bacterial infections (medicines containing clarithromycin, telithromycin and nafcillin)
• tuberculosis (medicines containing rifampicin)
• human immunodeficiency virus (HIV) infections (medicines containing cobicistat, indinavir, nelfinavir, ritonavir, saquinavir, efavirenz and etravirine)
• fungal infections (medicines containing itraconazole, posaconazole and voriconazole)
• Cushing's syndrome - when the body produces an excess of cortisol (medicines containing ketoconazole)
• depression (herbal therapy containing St John's wort (Hypericum perforatum) and medicines containing nefazodone)
• epilepsy and seizures (medicines containing carbamazepine, phenobarbital and phenytoin)
• insomnia (medicines containing modafinil)
• high blood pressure in the lungs (medicines containing bosentan).

Warnings and precautions
Tell your doctor immediately:

• if you have thoughts or feelings about harming yourself or committing suicide. Suicidal thoughts and behaviors are more likely at the beginning of treatment.
• if you experience a combination of fever, sweating, rapid breathing, muscle rigidity and confusion or drowsiness (these may be signs of neuroleptic malignant syndrome).

Consult your doctor or pharmacist before taking Reagila, or during treatment, if you have:

• experienced or start to experience agitation and inability to sit still. These symptoms may occur early during treatment with Reagila. Tell your doctor if this happens.
• experienced or start to experience abnormal, involuntary movements, most commonly of the tongue or face. Tell your doctor if this happens.
• decreased vision. Your doctor may advise you to see an eye doctor.
• irregular heartbeats or if someone in your family has a history of irregular heartbeats (including the so-called prolongation of the QT interval seen with an electrocardiogram (ECG), and tell your doctor if you are taking other medicines, because they may cause or worsen this change in the ECG.
• high or low blood pressure, cardiovascular disease. Your doctor will need to check your blood pressure regularly.
• dizziness when getting up due to a drop in blood pressure that can cause fainting.
• a history of blood clots, or if someone in your family has a history of blood clots, as drugs for schizophrenia have been associated with the formation of blood clots.
• a history of stroke, especially if you are elderly or if you know you have other risk factors for stroke. Tell your doctor immediately if you notice signs of a stroke.
• dementia (memory loss and other mental abilities) especially if you are elderly.
• Parkinson's disease.
• if you have diabetes or risk factors for diabetes (e.g. obesity or someone in your family has diabetes). Your doctor will need to check your blood sugar regularly as Reagila may increase it. Signs of high blood sugar are excessive thirst, passing large amounts of urine, increased appetite and feeling weak.
• a history of seizures or epilepsy.

Weight gain
Reagila can cause significant weight gain, which can affect your health. Your doctor
will therefore check your weight regularly.

Children and adolescents
This medicine is not recommended for children and adolescents under 18 years of age due to
lack of data in these patients.

Other medicines and Reagila
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines. You cannot take certain medicines together with Reagila (see section
“Do not take Reagila”).

• Taking Reagila together with other medicines may require an adjustment of the dose of Reagila or the other medicine. These include medicines used for the treatment of:
• heart conditions (e.g., digoxin, verapamil, diltiazem),
• blood clotting (anticoagulants (medicines that prevent blood clots), e.g., dabigatran),
• bacterial infections (e.g., erythromycin),
• fungal infections (e.g., fluconazole). Reagila should be used with caution in combination with other medicines that affect mental functions. Reagila with food, drinks and alcoholDo not drink grapefruit juice during treatment with Reagila. Consumption of alcohol should be avoided when taking Reagila.

Pregnancy and breastfeeding
Women of childbearing potential/Contraception
Women of childbearing potential must use effective contraception during treatment with
Reagila. Even after stopping treatment, the contraceptive method must be used for
at least 10 weeks after your last dose of Reagila. This is because the medicine will continue to
remain in your body after you take the last dose.
Pregnancy
Do not take this medicine during pregnancy unless your doctor has told you to do so.
If your doctor decides that you must take this medicine during pregnancy, your doctor will monitor
your baby closely after birth. This is because the following symptoms may occur in
newborns of mothers who have used this medicine in the last trimester (the last three months) of
pregnancy.

• tremors, stiffness and/or muscle weakness, drowsiness, agitation, breathing problems, difficulty feeding. If your baby develops any of these symptoms, you should contact your doctor.

Breastfeeding
Do not breastfeed while taking Reagila because a risk to the baby cannot be excluded. Ask
your doctor for advice.

Driving and using machines
There is a slight or moderate risk that this medicine may affect your ability to drive and
use machines. Drowsiness, dizziness and vision problems may occur during treatment
with this medicine (see section 4). Do not drive or use any tools or machinery
until you are sure that this medicine does not affect you negatively.

Reagila 3 mg, 4.5 mg, 6 mg hard capsules contain Allura Red AC (E 129).
Allura Red AC is a coloring agent that can cause allergic reactions.

3. How to take Reagila

Take this medicine following exactly the instructions of your doctor. If you have any doubts, ask your
doctor or pharmacist.
The recommended starting dose is 1.5 mg once a day by mouth. Afterwards, your doctor may slowly
adjust the dose, in steps of 1.5 mg, depending on how the treatment works for
you.
The maximum dose should not exceed 6 mg once a day.
Take Reagila at the same time each day with or without food.
If you were taking another medicine to treat schizophrenia before starting Reagila, your doctor
will decide on the gradual or immediate discontinuation of the previous antipsychotic and the adjustment of the
Reagila dose. Your doctor will also inform you about how to act if you switch from Reagila to another medicine.
Patients with kidney or liver problems
If you have severe kidney or liver problems Reagila may not be suitable for you. Consult your
doctor.
Elderly patients
Your doctor will carefully choose the appropriate dose according to your needs.
Reagila should not be used in elderly patients with dementia (memory loss).

If you take more Reagila than you should
If you take more Reagila than your doctor has recommended or if, for example, a child has
taken it by mistake, contact your doctor or go to the nearest hospital immediately and bring with you the
package of the medicine. You may experience dizziness due to low blood pressure, or have
irregular heartbeats, you may feel sleepy, tired, or have abnormal body movements and
find it difficult to stand or walk.

If you forget to take Reagila
If you forget to take a dose, take it as soon as you remember. However, if it is almost time for
your next dose, skip the missed dose and continue as usual.
Do not take a double dose to make up for a missed dose.
If you forget two or more doses, contact your doctor.

If you stop taking Reagila
If you stop taking this medicine you will lose the effects of the medicine. Even if you feel better,
do not change or stop your daily dose of Reagila unless you are told to do so by your
doctor as symptoms may reappear.
If you have any doubts about the use of this medicine, ask your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Tell your doctor immediatelyif you have:

• a severe allergic reaction which shows itself as fever, swelling of the mouth, face, lips or tongue, shortness of breath, itching, skin rash and sometimes a drop in blood pressure. ( Rare undesirable effect)
• a combination of fever, sweating, muscle rigidity, and drowsiness. These may be signs of a so-called neuroleptic malignant syndrome. ( Undesirable effect with frequency notknown)
• unexplained muscle pain, muscle cramps or muscle weakness. These can be signs of muscle damage, which can cause very serious kidney problems. (Rare undesirable effect)
• symptoms related to blood clots in the veins, especially in the legs (symptoms include swelling, pain and redness of the leg), which can travel through the blood vessels to the lungs causing chest pain and difficulty breathing. ( Undesirable effect withfrequency not known)
• thoughts or feelings of wanting to harm yourself or commit suicide, attempt to commit suicide. (Uncommon undesirable effect)

Other side effects

Very common undesirable effects (may affect more than 1 in 10 people)

• feeling restless and unable to stay still
• Parkinsonism, a medical condition with many and varied symptoms including decreased or slow movements, slowness of thought, resistance when bending the limbs (cogwheel rigidity), shuffling gait, tremors, little or no facial expression, muscle stiffness, drooling.

Common undesirable effects (may affect up to 1 in 10 people)

• anxiety
• drowsiness, difficulty sleeping, abnormal dreams, nightmares, sleepwalking
• dizziness
• involuntary rotating movements and strange postures
• excessive teeth grinding or jaw clenching, increased saliva production, persistent blinking in response to touching the forehead (an abnormal reflex), problems with movement, disorder of tongue movement (these are called extrapyramidal symptoms)
• blurred vision
• high blood pressure
• fast, irregular heartbeats
• increased or decreased appetite
• nausea, vomiting, constipation
• weight gain
• fatigue
• the following effects may be observed in laboratory tests: ° increased liver enzymes ° increased level of creatine phosphokinase in the blood ° abnormal amounts of lipids (e.g. cholesterol and/or fat) in the blood

Uncommon undesirable effects (may affect up to 1 in 100 people)

• depression
• sudden and severe confusion
• feeling of faintness
• unpleasant, abnormal sensations to the touch
• drowsiness, lack of energy or lack of interest in doing things
• involuntary movements, most commonly of the tongue or face. This can appear after short or long-term use.
• increased or decreased sexual desire, erectile dysfunction
• eye irritation, high eye pressure, poor vision
• problems focusing when looking at things far away or close up
• low blood pressure
• abnormal ECG value, abnormal nerve impulses in the heart
• slow, irregular heartbeat
• hiccups
• heartburn
• thirst
• pain when urinating
• frequent and abnormally large amounts of urination
• itching, skin rash
• diabetes
• the following effects may be observed in laboratory tests: ° abnormal levels of sodium in the blood ° increased glucose in the blood (hyperglycemia), increased bilirubin in the blood ° anemia (reduced levels of red blood cells) ° increased number of a type of white blood cells ° decreased level of thyroid-stimulating hormone (TSH) in the blood

Rare undesirable effects (may affect up to 1 in 1,000 people)

• convulsions
• memory loss, speech disorder
• discomfort in the eye in bright light
• clouding of the lens in the eye causing a decrease in vision (cataract)
• difficulty swallowing
• reduced levels of a type of white blood cells, this can make you more susceptible to infections
• underactive thyroid gland.

Undesirable effects with frequency not known (frequency cannot be estimated from available data)

• inflammation of the liver (pain in the upper right side of the abdomen, yellowing of the eyes and skin, weakness, fever)

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side effects not listed in this leaflet. You can also report side effects directly
through the national reporting system indicated in Annex V. By reporting side effects you can help provide
more information on the safety of this medicine.

5. How to store Reagila

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the package after SCAD and on the
blister after EXP. The expiry date refers to the last day of that month.
Keep the container in the outer packaging to protect it from light.
This medicine does not require any particular storage conditions for temperature.
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 Reagila contains

• The active ingredient is cariprazine. Reagila 1.5 mg: Each hard capsule contains cariprazine hydrochloride corresponding to 1.5 mg of cariprazine. Reagila 3 mg: Each hard capsule contains cariprazine hydrochloride corresponding to 3 mg of cariprazine. Reagila 4.5 mg: Each hard capsule contains cariprazine hydrochloride corresponding to 4.5 mg of cariprazine. Reagila 6 mg: Each hard capsule contains cariprazine hydrochloride corresponding to 6 mg of cariprazine.
• The excipients are: Reagila 1.5 mg hard capsules: pregelatinized starch (corn), magnesium stearate, titanium dioxide (E 171), gelatin, black ink (shellac, black iron oxide (E 172), propylene glycol, potassium hydroxide).

Reagila 3 mg hard capsules: pregelatinized starch (corn), magnesium stearate, allura red AC (E 129), brilliant blue FCF (E 133), titanium dioxide (E 171), yellow iron oxide (E 172), gelatin, black ink (shellac, black iron oxide (E 172), propylene glycol, potassium hydroxide) (see also paragraph 2- Reagila 3 mg, 4.5 mg, 6 mg hard capsules contain allura red AC (E 129)).
Reagila 4.5 mg hard capsules: pregelatinized starch (corn), magnesium stearate, allura red AC (E 129), brilliant blue FCF (E 133), titanium dioxide (E 171), yellow iron oxide (E 172), gelatin, white ink (shellac, titanium dioxide (E 171), propylene glycol, simeticone) (see also paragraph 2- Reagila 3 mg, 4.5 mg, 6 mg hard capsules contain allura red AC (E 129)).
Reagila 6 mg hard capsules: pregelatinized starch (corn), magnesium stearate, brilliant blue FCF (E 133), allura red AC (E 129), titanium dioxide (E 171), gelatin, black ink (shellac, black iron oxide (E 172), propylene glycol, potassium hydroxide) (see also paragraph 2- Reagila 3 mg, 4.5 mg, 6 mg hard capsules contain allura red AC (E 129)).

Description of the appearance of Reagila and contents of the pack

• Reagila 1.5 mg hard capsules: Hard gelatin capsule of 'Size 4' (approximately 14.3 mm in length) with an opaque white cap and an opaque white body imprinted with "GR 1.5" on the capsule body with black ink. The capsules are filled with powder from white to white- yellowish.
• Reagila 3 mg hard capsules: Hard gelatin capsule of 'Size 4' (approximately 14.3 mm in length) with an opaque green cap and an opaque white body imprinted with "GR 3" on the capsule body with black ink. The capsules are filled with powder from white to white- yellowish.
• Reagila 4.5 mg hard capsules: Hard gelatin capsule of 'Size 4' (approximately 14.3 mm in length) with an opaque green cap and an opaque green body imprinted with "GR 4.5" on the capsule body with white ink. The capsules are filled with powder from white to white- yellowish.
• Reagila 6 mg hard capsules: Hard gelatin capsule of 'Size 3' (approximately 15.9 mm in length) with an opaque purple cap and an opaque white body imprinted with "GR 6" on the capsule body with black ink. The capsules are filled with powder from white to white- yellowish. .

Reagila 1.5 mg and Reagila 3 mg hard capsules are available in packs containing 7, 14, 21, 28, 30, 49, 56, 60, 84, 90 or 98 hard capsules.
Reagila 4.5 mg and Reagila 6 mg hard capsules are available in packs containing 7, 21, 28, 30, 49, 56, 60, 84, 90 or 98 hard capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Gedeon Richter Plc.
Gyömrői út 19-21.
1103 Budapest
Hungary
For further information on this medicine, contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien
Recordati BV
Tél/Tel: +32 2 461 01 36

Lietuva
Gedeon Richter Plc. atstovybė Lietuvoje
Tel: +370 5 261 01 54

България
ТП „Гедеон Рихтер АД”
Teл.: + 359 2 8129063

Luxembourg/Luxemburg
Recordati BV
Tél/Tel: + 32 2 461 01 36 (Belgique/Belgien)

Česká republika
Gedeon Richter Marketing ČR, s.r.o.
Tel: +420 261 141 200

Magyarország
Richter Gedeon Nyrt.
Tel.: +36 1 505 7032

Danmark
Recordati AB
Tlf: +46 8 545 80 230 (Sverige)

Malta
Recordati Ireland Limited
Tel: + 353 21 4379400 (Ireland)

Deutschland
Recordati Pharma GMBH
Tel: + 49 731 70470

Nederland
Recordati BV
Tel: + 32 2 461 01 36 (België)

Eesti
Richter Gedeon Eesti filiaal
Tel: +372 608 5301

Norge
Recordati AB
Tlf: + 46 8 545 80 230 (Sverige)

Ελλάδα
Recordati Hellas Pharmaceuticals S.A.
Τηλ: + 30 210-6773822

Österreich
Recordati Austria GmbH
Tel: + 43 676 353 0 262

España
Casen Recordati S.L.
Tel: + 34 91 659 15 50

Polska
GEDEON RICHTER POLSKA Sp. z o.o.
Tel.: + 48 (22)755 96 48

France
Bouchara-Recordati S.A.S.
Tél: + 33 1 45 19 10 00

Portugal
Jaba Recordati S.A.
Tel: + 351 21 432 95 00

Hrvatska
Gedeon Richter Croatia d.o.o.
Tel: + 385 1 5625 712

Ireland
Recordati Ireland Limited
Tel: + 353 21 4379400

România
Gedeon Richter România S.A.
Tel: +40-265-257 011

Slovenija
Gedeon Richter d.o.o.
Tel: + +386 8 205 68 70

Ísland
Recordati AB
Sími: +46 8 545 80 230 (Svíþjóð)

Slovenská republika
Gedeon Richter Slovakia, s.r.o.
Tel: +421 2 5020 5801

Italia
RECORDATI S.p.A.
Tel: + 39 02 487871

Suomi/Finland
Recordati AB
Puh/Tel: +46 8 545 80 230 (Ruotsi/Sverige)

Κύπρος
C.G. PAPALOISOU LTD.
Τηλ: + 357 22 490305

Sverige
Recordati AB
Tel: +46 8 545 80 230

LatvijaUnited Kingdom (Northern Ireland)
Recordati Pharmaceuticals Ltd.
Tel: + 44 1491 576336

Altre fonti d'informazioni
Detailed and up-to-date information on this medicine is available by scanning the
QR code below and on the outer packaging with a smartphone.
The same information is also available at the internet address: www.reagila.com
'QR code to be included' + www.reagila.com
More detailed information on this medicine is available on the website of the European
Medicines Agency, http://www.ema.europa.eu .
Gedeon Richter Plc. representation in Latvia
Tel: +371 67845338

Reagila 1.5 mg orodispersible tablets, 3 mg orodispersible tablets, 4.5 mg orodispersible tablets, 6 mg orodispersible tablets

cariprazina

Read this leaflet carefully before you start taking this medicine as 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 their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor. See section 4.

Contents of this leaflet

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

1. What is Reagila and what is it used for

Reagila contains the active substance cariprazine and belongs to a group of medicines called
antipsychotics. It is used to treat adults with schizophrenia.
Schizophrenia is an illness characterized by symptoms such as hearing, seeing or perceiving things that are not
present (hallucinations), suspicious behavior, false beliefs, incoherent speech and behavior, emotional flatness. People with this condition may also feel depressed,
guilty, anxious or tense, or unable to start or continue planned activities, without a desire
to speak, with a lack of emotional responses to situations that would normally stimulate feelings
in others.

2. What you need to know before you take Reagila

Do not take Reagila

• if you are allergic to cariprazine or any of the other ingredients of this medicine (listed in section 6).
• if you are taking medicines used to treat:
• hepatitis caused by the hepatitis C virus (medicines containing boceprevir and telaprevir)
• bacterial infections (medicines containing clarithromycin, telithromycin and nafcillin)
• tuberculosis (medicines containing rifampicin)
• human immunodeficiency virus (HIV) infections (medicines containing cobicistat, indinavir, nelfinavir, ritonavir, saquinavir, efavirenz and etravirine)
• fungal infections (medicines containing itraconazole, posaconazole and voriconazole)
• Cushing's syndrome - when the body produces an excess of cortisol (medicines containing ketoconazole)
• depression (herbal therapy containing St John's wort (Hypericum perforatum) and medicines containing nefazodone)
• epilepsy and seizures (medicines containing carbamazepine, phenobarbital and phenytoin)
• insomnia (medicines containing modafinil)
• high blood pressure in the lungs (medicines containing bosentan).

Warnings and precautions
Tell your doctor immediately:

• if you have thoughts or feelings about harming yourself or committing suicide. Suicidal thoughts and behaviours are more likely at the beginning of treatment.
• if you experience a combination of fever, sweating, rapid breathing, muscle rigidity and confusion or drowsiness (these could be signs of neuroleptic malignant syndrome).

Consult your doctor or pharmacist before taking Reagila, or during treatment, if you have:

• experienced or start to experience agitation and inability to sit still. These symptoms may occur early during treatment with Reagila. Tell your doctor if this happens.
• experienced or start to experience abnormal, involuntary movements, most commonly of the tongue or face. Tell your doctor if this happens.
• decreased vision. Your doctor may advise you to visit an eye doctor.
• irregular heartbeats or if someone in your family has a history of irregular heartbeats (including the so-called prolongation of the QT interval seen on an electrocardiogram (ECG), and tell your doctor if you are taking other medicines, because they may cause or worsen this change in the ECG.
• high or low blood pressure, cardiovascular disease. Your doctor will need to check your blood pressure regularly.
• dizziness when getting up due to a drop in blood pressure that can cause fainting.
• a history of blood clots, or if someone in your family has a history of blood clots, as medicines for schizophrenia have been associated with the formation of blood clots.
• a history of stroke, especially if you are elderly or if you know you have other risk factors for stroke. Tell your doctor immediately if you notice signs of a stroke.
• dementia (memory loss and other mental abilities) especially if you are elderly.
• Parkinson's disease.
• if you have diabetes or risk factors for diabetes (e.g. obesity or someone in your family has diabetes). Your doctor will need to check your blood sugar regularly as Reagila may increase it. Signs of high blood sugar are excessive thirst, passing large amounts of urine, increased appetite and feeling weak.
• a history of seizures or epilepsy.

Weight gain
Reagila can cause significant weight gain, which can affect your health. Your doctor
will therefore check your weight regularly.

Children and adolescents
This medicine is not recommended for children and adolescents under the age of 18 due to
lack of data in these patients.

Other medicines and Reagila
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines. You cannot take certain medicines together with Reagila (see section
“Do not take Reagila”).

• Taking Reagila together with other medicines may require an adjustment of the dose of Reagila or the other medicine. These include medicines used for the treatment of:
• heart conditions (e.g., digoxin, verapamil, diltiazem),
• blood clotting (anticoagulants (medicines that prevent blood clots), e.g., dabigatran),
• bacterial infections (e.g., erythromycin),
• fungal infections (e.g., fluconazole). Reagila should be used with caution in combination with other medicines that affect mental function. Reagila with food, drinks and alcoholDo not drink grapefruit juice during treatment with Reagila. Consumption of alcohol should be avoided when taking Reagila.

Pregnancy and breastfeeding
Women of childbearing potential/Contraception
Women of childbearing potential must use effective contraception during treatment with
Reagila. Even after stopping treatment, the contraceptive method must be used for
at least 10 weeks after your last dose of Reagila. This is because the medicine will continue to
remain in your body after you take the last dose.
Pregnancy
Do not take this medicine during pregnancy unless your doctor has told you to do so.
If your doctor decides that you need to take this medicine during pregnancy, your doctor will monitor
your baby closely after birth. This is because the following symptoms may occur in
newborns of mothers who have used this medicine in the last trimester (the last three months) of
pregnancy.

• tremors, stiffness and/or muscle weakness, drowsiness, agitation, breathing problems, difficulty feeding. If your baby develops any of these symptoms, you should contact your doctor.

Breastfeeding
Do not breastfeed while taking Reagila because a risk to the baby cannot be excluded. Seek
advice from your doctor.

Driving and using machines
There is a slight or moderate risk that this medicine may affect your ability to drive and
use machines. Drowsiness, dizziness and vision problems may occur during treatment
with this medicine (see section 4). Do not drive or use any tools or machinery
until you are sure that this medicine does not affect you negatively.

Reagila orodispersible tablets contain sodium
This medicine contains less than 1 mmol of sodium (23 mg) per orodispersible tablet, i.e.
it is essentially “sodium-free”.

3. How to take Reagila

Take this medicine following exactly the instructions of your doctor. If you have any doubts, ask your
doctor or pharmacist.
The recommended starting dose is 1.5 mg once a day by mouth. Afterwards, your doctor may slowly
adjust the dose, in steps of 1.5 mg, depending on how the treatment works for you.
The maximum dose should not exceed 6 mg once a day.
Take Reagila at the same time each day with or without food.
Do not open the blister until the time of administration. Separate one unit from the blister from the entire
blister by detaching it along the perforated lines and peel off the foil to expose the tablet. Do not
push the tablet through the foil to avoid damaging it.

After opening the blister, immediately take the tablet with dry hands and place the entire
orodispersible tablet on your tongue. The tablet disintegrates rapidly with saliva. Do not chew or
swallow the tablet whole, but wait for it to dissolve in your mouth.
Alternatively, disperse the tablet in water and drink the resulting suspension. In this case, the
contents of the glass must be thoroughly mixed to prevent any undissolved residues from
settling.
If you were taking another medicine to treat schizophrenia before starting Reagila, your doctor
will decide on the gradual or immediate discontinuation of the previous antipsychotic and the modification
of the Reagila dose. Your doctor will also inform you about how to proceed if you switch from Reagila
to another medicine.
Patients with kidney or liver problems
If you have severe kidney or liver problems, Reagila may not be suitable for you. Consult your
doctor.
Elderly patients
The doctor will carefully choose the appropriate dose according to your needs.
Reagila should not be used in elderly patients with dementia (memory loss).

If you take more Reagila than you should
If you take more Reagila than your doctor has recommended or if, for example, a child has
taken it by mistake, contact your doctor or go to the nearest hospital immediately and bring the
package of the medicine with you. You may experience dizziness due to low blood pressure, or have
irregular heartbeats, you may feel sleepy, tired, or have abnormal body movements and
find it difficult to stand or walk.

If you forget to take Reagila
If you forget to take a dose, take it as soon as you remember. However, if it is almost time for
your next dose, skip the missed dose and continue as usual.
Do not take a double dose to make up for a missed dose.
If you forget two or more doses, contact your doctor.

If you stop taking Reagila
If you stop taking this medicine you will lose the effects of the medicine. Even if you feel better,
do not change or stop your daily dose of Reagila unless your doctor tells you to do so, as symptoms
may return.
If you have any doubts about the use of this medicine, ask your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Inform your doctor immediatelyif you have:

• a severe allergic reaction that manifests as fever, swelling of the mouth, face, lips or tongue,

shortness of breath, itching, skin rash and sometimes a drop in blood pressure. ( Rare

undesirable effect)

• a combination of fever, sweating, muscle rigidity, and drowsiness. These may be signs of the so-called malignant neuroleptic syndrome. ( Undesirable effect with frequency notknown)
• unexplained muscle pain, muscle cramps, or muscle weakness. These may be signs of muscle damage, which can cause very serious kidney problems. (Rare undesirable effect)
• symptoms related to blood clots in the veins, especially in the legs (symptoms include swelling, pain, and redness of the leg), which can travel through the blood vessels to the lungs causing chest pain and difficulty breathing. ( Undesirable effect withfrequency not known)
• thoughts or feelings of wanting to harm yourself or commit suicide, attempted suicide. (Uncommon undesirable effect)

Other side effects

Very common undesirable effects (may affect more than 1 in 10 people)

• a feeling of restlessness and inability to stay still
• Parkinsonism, a medical condition with many and varied symptoms including decreased or slow movements, slowness of thought, resistance when bending the limbs (cogwheel rigidity), shuffling gait, tremors, little or no facial expression, muscle stiffness, drooling.

Common undesirable effects (may affect up to 1 in 10 people)

• anxiety
• drowsiness, difficulty sleeping, abnormal dreams, nightmares, sleepwalking
• dizziness
• involuntary twisting movements and strange postures
• excessive teeth grinding or jaw clenching, increased saliva, persistent blinking in response to touching the forehead (an abnormal reflex), movement problems, tongue movement disorder (these are called extrapyramidal symptoms)
• blurred vision
• high blood pressure
• fast, irregular heartbeats
• increased or decreased appetite
• nausea, vomiting, constipation
• weight gain
• fatigue
• the following effects may be observed in laboratory tests: ° increased liver enzymes ° increased level of creatine phosphokinase in the blood ° abnormal amounts of lipids (e.g. cholesterol and/or fat) in the blood

Uncommon undesirable effects (may affect up to 1 in 100 people)

• depression
• sudden and severe confusion
• feeling dizzy
• unpleasant, abnormal sensations to the touch
• drowsiness, lack of energy or lack of interest in doing things
• involuntary movements, most commonly of the tongue or face. This may appear after short-term or long-term use.
• increased or decreased sexual desire, erectile dysfunction
• eye irritation, high eye pressure, poor vision
• problems focusing when looking at distant or near objects
• low blood pressure
• abnormal ECG value, abnormal nerve impulses in the heart
• slow, irregular heartbeat
• hiccups
• heartburn
• thirst
• pain when urinating
• frequent and abnormally large urination
• itching, skin rash
• diabetes
• the following effects may be observed in laboratory tests: ° abnormal sodium levels in the blood ° increased glucose in the blood (hyperglycemia), increased bilirubin in the blood ° anemia (reduced levels of red blood cells) ° increased in a type of white blood cells ° decreased level of thyroid-stimulating hormone (TSH) in the blood

Rare undesirable effects (may affect up to 1 in 1,000 people)

• seizures
• memory loss, speech disorder
• discomfort in the eye in the presence of bright light
• clouding of the lens in the eye causing a decrease in vision (cataract)
• difficulty swallowing
• reduced levels of a type of white blood cells, this may make you more susceptible to infections
• hypothyroidism (underactive thyroid gland).

Undesirable effects with frequency not known (frequency cannot be estimated from available data)

• inflammation of the liver (pain in the upper right side of the abdomen, yellowing of the eyes and skin, weakness, fever)

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, please tell your
doctor. You can also report side effects directly through the national reporting system detailed in
Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Reagila

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the package after SCAD and on the
blister after EXP. The expiry date refers to the last day of that month.
Keep the tablets in the original packaging to protect them from moisture.
This medicine does not require any particular storage conditions for temperature.
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. Package contents and other information

What Reagila contains

• The active ingredient is cariprazine. Reagila 1.5 mg: Each orally disintegrating tablet contains cariprazine hydrochloride corresponding to 1.5 mg of cariprazine. Reagila 3 mg: Each orally disintegrating tablet contains cariprazine hydrochloride corresponding to 3 mg of cariprazine. Reagila 4.5 mg: Each orally disintegrating tablet contains cariprazine hydrochloride corresponding to 4.5 mg of cariprazine. Reagila 6 mg: Each orally disintegrating tablet contains cariprazine hydrochloride corresponding to 6 mg of cariprazine.
• The excipients are: Mannitol (E 421), corn starch, sodium starch glycolate (type A), malic acid (E 296), sodium stearyl fumarate (E 485), silicon dioxide (E 551) (See also section 2 - Reagila orally disintegrating tablets contain sodium).

Description of the appearance of Reagila and contents of the pack

• Reagila 1.5 mg orally disintegrating tablets: Triangular, biconvex tablet, white or off-white in color. The diameter of the tablet is approximately 8 mm and the thickness is approximately 3-4 mm. “C2” is engraved on one side, and there is no engraving on the other side.
• Reagila 3 mg orally disintegrating tablets: Round, biconvex tablet, white or off-white in color. The diameter of the tablet is approximately 7 mm and the thickness is approximately 3-4 mm. “C3” is engraved on one side, and there is no engraving on the other side.
• Reagila 4.5 mg orally disintegrating tablets: Square, biconvex tablet, white or off-white in color. The diameter of the tablet is approximately 7 mm and the thickness is approximately 3-4 mm. “C4” is engraved on one side, and there is no engraving on the other side.
• Reagila 6 mg orally disintegrating tablets: Oval, biconvex tablet, white or off-white in color. The width of the tablet is approximately 5 mm, the length is 8.5 mm and the thickness is approximately 3-4 mm. “CI” is engraved on one side, and there is no engraving on the other side.

Reagila 1.5 mg, 3 mg, 4.5 mg and 6 mg orally disintegrating tablets are available in packs
containing 28 or 30 orally disintegrating tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Gedeon Richter Plc.
Gyömrői út 19-21.
1103 Budapest
Hungary
For further information on this medicine, contact the local representative of the Marketing
Authorisation Holder:

België/Belgique/Belgien/Danmark/Deutschland
/Ελλάδα/España/France/Ireland/Ísland/Italia/
Κύπρος/Luxembourg/Luxemburg/
Magyarország/Malta/Nederland/Norge/
Österreich/Portugal/Suomi/Finland/Sverige/
United Kingdom (Northern Ireland)
Richter Gedeon Nyrt.
Tel: +36 1 505 7032

Lietuva
Gedeon Richter Plc. atstovybė Lietuvoje
Tel: +370 5 261 01 54

България
ТП „Гедеон Рихтер АД”
Тел.: + 359 2 8129063

Polska
GEDEON RICHTER POLSKA Sp. z o.o.
Tel.: + 48 (22)755 96 48

Česká republika
Gedeon Richter Marketing ČR, s.r.o.
Tel: +420 261 141 200

România
Gedeon Richter România S.A.
Tel: +40-265-257 011

Slovenija
Gedeon Richter d.o.o.
Tel: + +386 8 205 68 70

Hrvatska
Gedeon Richter Croatia d.o.o.
Tel: + 385 1 5625 712

Eesti
Richter Gedeon Eesti filiaal
Tel: +372 608 5301

Slovenská republika
Gedeon Richter Slovakia, s.r.o.
Tel: +421 2 5020 5801

Latvija
Gedeon Richter Plc. pārstāvniecība Latvijā
Tel: +371 67845338

Other sources of information
Detailed and up-to-date information on this medicine is available by scanning the
QR code below and on the outer pack with a smartphone.
The same information is also available at the internet address: www.reagila.com
'QR code to be included' + www.reagila.com
More detailed information on this medicine is available on the website of the European
Medicines Agency, http://www.ema.europa.eu .