Leaflet: information for the user

Reagila 1.5 mg hard capsules

Reagila 3 mg hard capsules

Reagila 4.5 mg hard capsules

Reagila 6 mg hard capsules

cariprazine

This medicine is subject to additional monitoring, which will speed up the detection of new information about its safety. You can contribute by reporting any adverse effects you may experience. The final part of section 4 includes information on how to report these adverse effects.

Read this leaflet carefully before starting to take 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, consult your doctor or pharmacist.

• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.

• If you experience adverse effects, consult your doctor, even if they are not listed in this leaflet. See section 4.

1. Storage of Reagila

1. Contents of the pack and additional information

Reagila contains the active ingredient cariprazine and belongs to a group of medicines called antipsychotics. It is used to treat adult patients with schizophrenia.

Schizophrenia is a disease characterized by symptoms such as hearing, seeing or feeling things that do not exist (hallucinations), distrust, false beliefs, incoherent and inexplicable speech and behavior, and emotional unresponsiveness. People who suffer from this disorder may feel depressed, anxious, guilty, tense, or unable to initiate or maintain planned activities, unwilling to talk, or lacking an emotional response to a situation that would normally evoke feelings in others.

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 hepatitis C virus (medicines containing boceprevir or telaprevir)

ritonavir, saquinavir, efavirenz, and etravirine)

• fungal infections (medicines containing itraconazole, posaconazole, voriconazole, and fluconazole)

• Cushing's syndrome, where 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 convulsions (medicines containing carbamazepine, phenobarbital, and phenytoin)

• heart diseases (medicines containing diltiazem and verapamil)
• drowsiness (medicines containing modafinil)
• pulmonary hypertension (medicines containing bosentan).

Warnings and precautions

Consult your doctor immediately:

• if you have thoughts or feelings of harming yourself or committing suicide. Suicidal thoughts and behaviors occur more frequently at the beginning of treatment.
• if you experience a combination of fever, sweating, rapid breathing, muscle stiffness, and lethargy or drowsiness (which may be signs of malignant neuroleptic syndrome).

Consult your doctor or pharmacist before starting to take Reagila or during treatment, if:

• you have experienced or are starting to experience agitation and inability to remain still. These symptoms may occur early during Reagila treatment. Inform your doctor if this happens.
• you have experienced or are starting to experience abnormal and involuntary movements, more frequently of the tongue or face. Inform your doctor if this happens.

• visual impairment. Your doctor will recommend that you visit an ophthalmologist.
• you have irregular heartbeats or if any other family member has a history of irregular heartbeats (including the called prolongation of the QT interval that is observed with ECG control), and inform your doctor if you are taking other medicines, because they may cause or worsen this ECG change.
• you suffer from high or low blood pressure, cardiovascular disease. Your doctor will have to check your blood pressure regularly.

• you suffer from dizziness when standing up due to a drop in blood pressure, which may cause fainting
• you have a history of blood clots, or any other family member has a history of blood clots, as antipsychotic medicines have been associated with blood clot formation

• you have a history of stroke, especially if you are elderly or know that you have other risk factors for stroke. Inform your doctor immediately if you notice any signs of stroke.
• you have dementia (loss of memory and other mental abilities), especially if you are elderly
• you have Parkinson's disease
• you have diabetes or risk factors for diabetes (e.g., obesity, or any other family member has diabetes). Your doctor will have to check your blood sugar level regularly as Reagila may increase it. Signs of high blood sugar are excessive thirst, increased urine production, increased appetite, and feeling weak.
• you have a history of seizures or epilepsy.

Weight gain

Reagila may cause significant weight gain that may affect your health. Your doctor will check your weight regularly.

Contraception

Women of childbearing age must use effective contraceptive methods while taking Reagila and for at least 10 weeks after stopping treatment. If you are using hormonal contraceptives, you must also use a barrier method (i.e., condom or diaphragm). See section “Pregnancy and breastfeeding”).

Children and adolescents

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

Other medicines and Reagila

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine. You cannot take certain medicines with Reagila (see section “Do not take Reagila”).

When taking Reagila with some medicines, you may need to adjust the dose of Reagila or the other medicine. These are medicines used to treat heart diseases that contain digoxin, anticoagulants that contain dabigatran, or medicines that affect mental functions.

If you are using hormonal contraceptives, you must also use a barrier method (see section “Pregnancy and breastfeeding” below).

Taking Reagila with food, drinks, and alcohol

Do not drink grapefruit juice during Reagila treatment.

Do not drink alcohol while taking Reagila.

Pregnancy and breastfeeding

Women of childbearing age

Women of childbearing age must use effective contraceptive methods while taking Reagila. Even if treatment is stopped, contraceptives must be used for at least 10 weeks after the last dose of Reagila. This is because the medicine will remain in the body for some time after the last dose. If you are using hormonal contraceptives, you must also use a barrier method (i.e., condom or diaphragm). Consult your doctor about suitable contraceptive options.

Pregnancy

Do not take this medicine during pregnancy unless your doctor has told you to.

If your doctor decides that you should take this medicine during pregnancy, your doctor will closely monitor your child after birth. This is because newborns of mothers who have used this medicine in the last trimester (last three months) of pregnancy may experience the following symptoms:

• shivering, stiffness, or muscle weakness, drowsiness, agitation, respiratory problems, and difficulty feeding.

Inform your doctor if your child experiences any of these symptoms.

Breastfeeding

Do not breastfeed your child while taking Reagila because it cannot be ruled out that there is a risk to the baby.

Consult your doctor.

Driving and operating machines

There is a small or moderate risk that the medicine may affect your ability to drive and use machines. You may experience drowsiness, dizziness, and vision problems during Reagila treatment (see section 4). Do not drive or operate tools or machinery until you know that this medicine does not affect you negatively.

Reagila 3 mg, 4.5 mg, 6 mg hard capsules contain red Allura AC (E 129).

Red Allura AC is a dye that may cause allergic reactions.

Follow exactly the administration instructions for this medication as indicated by your doctor.

If in doubt, consult your doctor or pharmacist again.

The recommended initial dose is 1.5 mg once a day taken orally. Your doctor may then gradually adjust the dose, at intervals of 1.5 mg, based on the effectiveness of the treatment for you.

The maximum dose should not exceed 6 mg once a day.

Take Reagila once a day at the same time with or without food.

If you were taking another medication for schizophrenia before starting Reagila, your doctor will decide whether to gradually discontinue or immediately discontinue the other medication and how to adjust the dose of Reagila. Your doctor will also inform you of how to act if you change from Reagila to another medication.

Patients with kidney or liver problems

If you have severe kidney or liver problems, Reagila may not be suitable for you. Consult your doctor.

Older patients

Your doctor will carefully select the appropriate dose for your needs.

Older patients with dementia (memory loss) should not use Reagila.

If you take more Reagila than you should

If you have taken more Reagila than your doctor recommended or if, for example, a child has taken it by mistake, contact your doctor or go immediately to the nearest hospital and bring the medication packaging with you. You may experience dizziness due to low blood pressure or abnormal heartbeats, feel drowsiness, fatigue, or have abnormal body movements and problems staying upright or walking.

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 to take the next dose, omit the missed dose and take the next dose at your usual time. Do not take a double dose to compensate for the missed doses.

If you forget two or more doses, consult your doctor.

If you interrupt treatment with Reagila

If you interrupt treatment with this medication, you will lose its effects. Although you may feel better, do not modify or interrupt your daily dose of Reagila unless your doctor tells you to, as symptoms may reappear.

If you have any other questions about the use of this medication, ask your doctor.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Consult your doctorimmediatelyif you notice any of the following symptoms:

• a severe allergic reaction consisting of fever, swelling of the mouth, face, lips, or tongue, shortness of breath, itching, skin rash, and sometimes a drop in blood pressure. (Rare adverse effect)

• a combination of fever, sweating, muscle stiffness, and drowsiness. These could be symptoms of the so-called malignant neuroleptic syndrome. (Adverse effect of unknown frequency)
• unexplained muscle aches, muscle cramps, or muscle weakness. They may be signs of muscle injury that can cause severe kidney problems.(Rare adverse effect)
• symptoms related to blood clots in the veins, especially in the legs (your symptoms are swelling, pain, and redness of the leg), which can move through the blood vessels to the lungs and cause chest pain and difficulty breathing. (Adverse effect of unknown frequency)

• thoughts or feelings of self-harm or suicide, suicide attempt(Rare adverse effect)

Other side effects

Very common side effects (can affect more than 1 in 10 people)

• feeling of restlessness and inability to stay still
• Parkinsonism: a disease with many symptoms that include slow or reduced body movements, slow thinking, tremors when moving the limbs (rigidity in dentate wheel), shuffling gait, agitation, little or no facial expression, muscle stiffness, drooling

Common side effects (can affect up to 1 in 10 people)

• anxiety
• drowsiness, difficulty sleeping, abnormal dreams, nightmares, sleepwalking
• dizziness
• involuntary movements of twisting and unusual postures
• excessive tooth grinding or jaw clenching, drooling, persistent blinking as a response to forehead taps (an abnormal reflex), movement problems, tongue movement disorder (these are called extrapyramidal symptoms)
• blurred vision
• high blood pressure
• rapid and irregular heartbeats
• decreased or increased 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 amount of lipids (e.g., cholesterol or fat) in the blood

Uncommon side effects (can affect up to 1 in 100 people)

• depression
• sudden and intense confusion
• sensation of everything spinning
• unpleasant and abnormal sense of touch
• drowsiness, lack of energy, or lack of interest in doing things
• involuntary movements, more frequently of the tongue or face. They may appear after short or long-term use.
• decreased or increased libido, erectile dysfunction
• eye irritation, high eye pressure, poor vision,
• problems with focus, seeing far to see near
• low blood pressure

• abnormal ECG reading, abnormal nerve impulses in the heart
• slow and irregular heart rhythm
• hypophagia
• gastric acidity
• thirst
• painful urination
• abnormally frequent and abundant urination
• itching, rash
• diabetes
• The following effects may be observed in laboratory tests:
• • abnormal sodium level in the blood
  • increase in blood glucose (blood sugar), increase in bilirubin pigment in the blood
  • anemia (reduction of red blood cell levels)
  • increase in a type of white blood cell
  • reduction of thyroid-stimulating hormone (TSH) levels in the blood

Rare side effects (can affect up to 1 in 1,000 people)

• seizures
• memory loss, loss of speech
• eye discomfort in bright light
• opacity of the crystalline lens that causes a decrease in vision (cataracts)
• difficulty swallowing
• reduction of a type of white blood cell, which can make you more prone to infections
• underactive thyroid gland

Adverse effects of unknown frequency (frequency cannot be estimated from available data)

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

Reporting of adverse effects

If you experience any type of side effect, consult your doctor, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through thenational notification system included in theAppendix V. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the box and on the blister pack after CAD and EXP. The expiration date is the last day of the month indicated.

Store the blister pack in the outer packaging to protect it from light.

This medication does not require any special storage temperature.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. This will help protect the environment.

Composition of Reagila

• The active ingredient is cariprazine.

Reagila 1.5 mg: Each hard capsule contains cariprazine hydrochloride equivalent to 1.5 mg of cariprazine.

Reagila 3 mg: Each hard capsule contains cariprazine hydrochloride equivalent to 3 mg of cariprazine.

Reagila 4.5 mg: Each hard capsule contains cariprazine hydrochloride equivalent to 4.5 mg of cariprazine.

Reagila 6 mg: Each hard capsule contains cariprazine hydrochloride equivalent to 6 mg of cariprazine.

• The other components are:

Reagila 1.5 mg hard capsules: Maize pregelatinised starch, magnesium stearate, titanium dioxide (E 171), gelatin, black ink (lacquer, iron oxide black (E 172), propylene glycol, potassium hydroxide).

Reagila 3 mg hard capsules: Maize pregelatinised starch, magnesium stearate, Allura Red AC (E 129), Brilliant Blue FCF (E 133), titanium dioxide (E 171), iron oxide yellow (E 172), gelatin, black ink (lacquer, iron oxide black (E 172), propylene glycol, potassium hydroxide).

Reagila 4.5 mg hard capsules: Maize pregelatinised starch, magnesium stearate, Allura Red AC (E 129), Brilliant Blue FCF (E 133), titanium dioxide (E 171), iron oxide yellow (E 172), gelatin, white ink (lacquer, titanium dioxide (E 171), propylene glycol, simethicone).

Reagila 6 mg hard capsules: Maize pregelatinised starch, magnesium stearate, Brilliant Blue FCF (E 133), Allura Red AC (E 129), titanium dioxide (E 171), gelatin, black ink (lacquer, iron oxide black (E 172), propylene glycol, potassium hydroxide).

Appearance of the product and contents of the pack

• Reagila 1.5 mg hard capsules: Hard gelatin capsule, size 4 (approximately 14.3 mm in length), with a white opaque cap and body, printed with "GR 1.5" in black on the body of the capsule. The capsules contain a white to pale yellow powder.

• Reagila 3 mg hard capsules: Hard gelatin capsule, size 4 (approximately 14.3 mm in length), with a green opaque cap and white opaque body, printed with "GR 3" in black on the body of the capsule. The capsules contain a white to pale yellow powder.

• Reagila 4.5 mg hard capsules: Hard gelatin capsule, size 4 (approximately 14.3 mm in length), with a green opaque cap and body, printed with "GR 4.5" in white on the body of the capsule. The capsules contain a white to pale yellow powder.

• Reagila 6 mg hard capsules: Hard gelatin capsule, size 3 (approximately 15.9 mm in length), with a violet opaque cap and white opaque body, printed with "GR 6" in black on the body of the capsule. The capsules contain a white to pale yellow powder.

The capsules are packed in a transparent PVC/PE/PVDC hard blister sealed in hot on a hard aluminium foil. The blisters are packed in a cardboard box.

Reagila 1.5 mg and Reagila 3 mg hard capsules are available in pack sizes 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 pack sizes containing 21, 28, 30, 49, 56, 60, 84, 90 or 98 hard capsules.

Only some pack sizes may be marketed.

Marketing authorisation holder and responsible person for manufacturing

Gedeon Richter Plc.

Gyömroi út 19-21

1103 Budapest

Hungary

For further information about this medicinal product, please contact the local representative of the marketing authorisation holder:

Last update of this leaflet: <{MM/AAAA}> Other sources of information

You can access detailed and updated information about this medicinal product by scanning the QR code below and on the outer carton with a smartphone.

The same information is also available on the following URL: www.reagila.com“Se debe incluir un código QR”+ www.reagila.com

Detailed information about this medicinal product is available on the website of the European Medicines Agency:http://www.ema.europa.eu.