REAGILA 4.5 mg HARD CAPSULES

Introduction

Package 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 allow for quick identification of new safety information. You can help by reporting any side effects you may get. The last section of this leaflet includes information on how to report side effects.

Read all of this leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. Storage of Reagila

1. 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 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 speech and behavior, and emotional unresponsiveness. People suffering from this disorder may feel depressed, anxious, guilty, tense, or unable to initiate or maintain planned activities, unwilling to speak, lacking emotional response to a situation that would normally evoke 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 C virus infection (medicines containing boceprevir or telaprevir)

• bacterial infections (medicines containing clarithromycin, telithromycin, erythromycin, and nafcillin)
• tuberculosis (medicines containing rifampicin)
• HIV infections (medicines containing cobicistat, indinavir, nelfinavir, ritonavir, saquinavir, efavirenz, and etravirine)

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

• Cushing's syndrome, where the body produces excess 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 suicidal thoughts. Suicidal thoughts and behaviors occur more frequently at the start of treatment.
• if you experience a combination of fever, sweating, rapid breathing, muscle stiffness, and drowsiness or somnolence (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 started to experience agitation and inability to stay still. These symptoms may occur early during treatment with Reagila. Inform your doctor if this happens.
• you have experienced or started 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 so-called QT interval prolongation observed with ECG control), and inform your doctor if you are taking other medicines, as they may cause or worsen this ECG change.
• you suffer from high or low blood pressure, cardiovascular disease. Your doctor will need to regularly check your blood pressure.

• you suffer from dizziness when standing up due to a drop in blood pressure, which can cause you to faint
• 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 the formation of blood clots

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

Weight gain

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

Contraception

Women of childbearing age must use very 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 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 with Reagila (see section "Do not take Reagila").

When taking Reagila with some medicines, it may be necessary to adjust the dose of Reagila or the other medicine. These include medicines used to treat heart diseases containing digoxin, anticoagulants containing dabigatran, or medicines affecting 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 treatment with Reagila.

Do not drink alcohol while taking Reagila.

Pregnancy and breastfeeding

Women of childbearing age

Women of childbearing age must use effective contraceptive methods during treatment with 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 taking 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 baby after birth. This is because in newborns of mothers who have used this medicine in the last trimester (last three months) of pregnancy, the following symptoms may appear:

• tremors, muscle stiffness or weakness, drowsiness, agitation, breathing problems, and difficulty feeding.

If your baby has any of these symptoms, you should contact your doctor.

Breastfeeding

Do not breastfeed your baby if you are taking Reagila, as it cannot be excluded that there is a risk to the baby.

Consult your doctor.

Driving and using machines

There is a small or moderate risk that this medicine may affect your ability to drive or use machines. It can cause drowsiness, dizziness, and vision problems during treatment with this medicine (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 colorant that may cause allergic reactions.

3. How to take Reagila

Follow exactly the administration instructions of this medicine given by your doctor.

In case of doubt, consult your doctor or pharmacist again.

The recommended initial dose is 1.5 mg once daily by mouth. Afterwards, your doctor may slowly adjust the dose, at intervals of 1.5 mg, depending on the efficacy of the treatment for you.

The maximum dose should not exceed 6 mg once daily.

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

If you were taking another medicine for treating schizophrenia before starting Reagila, your doctor will decide whether to gradually stop or immediately stop the other medicine and how to adjust the dose of Reagila. 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

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

Elderly 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 take the medicine package with you. You may experience dizziness due to low blood pressure or abnormal heartbeats, you may feel drowsy, tired, or have abnormal body movements and problems standing 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 for your next dose, skip the missed dose and take the next dose at the usual time. Do not take a double dose to make up for forgotten doses.

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

If you stop taking Reagila

If you stop taking this medicine, you will lose its effects. Although you may feel better, do not change or stop your daily dose of Reagila unless your doctor tells you to, as symptoms may recur.

If you have any other questions 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.

Consult your doctor immediatelyif you notice any of the following symptoms:

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

• a combination of fever, sweating, muscle stiffness, and drowsiness. These could be symptoms of malignant neuroleptic syndrome. (Frequency not known)
• muscle pain, muscle cramps, or unexplained muscle weakness. These can be signs of muscle damage that can cause serious kidney problems. (Rare side effect)
• symptoms related to blood clots in the veins, especially in the legs (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. (Frequency not known)

• thoughts or feelings of harming yourself or suicidal thoughts, attempted suicide (Uncommon side effect)

Other side effects

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

• feeling of restlessness and inability to stay still
• Parkinsonism: a disease with many symptoms including slow or reduced body movements, slow thinking, jerky movements when moving limbs (cogwheel rigidity), shuffling gait, agitation, little or no facial expression, muscle stiffness, drooling

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

• anxiety
• drowsiness, difficulty sleeping, abnormal dreams, nightmares, sleepwalking
• dizziness
• involuntary movements of twisting and abnormal postures
• excessive teeth grinding or jaw clenching, drooling, persistent blinking as a response to tapping on the forehead (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 creatine phosphokinase levels in the blood
  • abnormal lipid levels (e.g., cholesterol or fat) in the blood

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

• depression
• sudden and severe confusion
• feeling that everything is 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. These can appear after short-term or long-term use.
• decreased or increased sexual desire, erection problems
• eye irritation, high eye pressure, poor vision,
• problems with focusing, seeing from far to near
• low blood pressure

• abnormal ECG reading, abnormal nerve impulses in the heart
• slow and irregular heartbeat
• hypo
• heartburn
• thirst
• pain when urinating
• abnormal and frequent urination
• itching, rash
• diabetes
• the following effects may be observed in laboratory tests:
• • abnormal sodium levels in the blood
  • increased glucose levels in the blood (blood sugar), increased bilirubin levels in the blood
  • anemia (reduced red blood cell levels)
  • increased levels of a type of white blood cell
  • reduced levels of thyroid-stimulating hormone (TSH) in the blood

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

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

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

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

Reporting of side effects

If you experience 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 listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of 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 carton and blister after EXP. The expiry date refers to the last day of the month shown.

Store the blister in the outer carton to protect from light.

This medicine does not require any special storage temperature.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Package Contents and Additional Information

Reagila Composition

• 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: pregelatinized corn starch, magnesium stearate, titanium dioxide (E 171), gelatin, black ink (lacquer, black iron oxide [E 172], propylene glycol, potassium hydroxide).

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

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

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

Product Appearance and Package Contents

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

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

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

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

The capsules are packaged in a transparent hard PVC/PE/PVDC blister pack sealed with a hard aluminum foil. The blisters are packaged in a cardboard box.

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

Not all package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Gedeon Richter Plc.

Gyömroi út 19-21

1103 Budapest

Hungary

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

Date of Last Revision of this Leaflet: <{MM/AAAA}> Other Sources of Information

Detailed and up-to-date information on this medicinal product can be accessed by scanning the QR code below and on the outer packaging with a smartphone.

The same information is also available at the following URL: www.reagila.com "A QR code should be included" + www.reagila.com

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