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, 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 – 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)
  • heart disease (medicines containing diltiazem and verapamil)
  • sleepiness (medicines containing modafinil)
  • high blood pressure in the lungs (medicines containing bosentan).

 

Warnings and precautions

Tell your doctor immediately:

• if you are having any thoughts or feelings about harming yourself. Suicidal thoughts and behaviours are more likely at the beginning of the treatment.
• if you experience a combination of fever, sweating, faster breathing, muscle stiffness and drowsiness or sleepiness (may be signs of neuroleptic malignant syndrome).

 

Talk to your doctor or pharmacist before taking this medicine, or during treatment, especially if you have:

• ever experienced or start to experience restlessness and inability to sit still. These symptoms may occur early during treatment with Reagila. Tell your doctor if this happens.
• ever experienced or start to experience abnormal, involuntary movements, most commonly of the tongue or face. Tell your doctor if this happens
• visual impairment. Your doctor will advise you to visit an ophthalmologist.
• irregular heartbeat or if someone else in your family has a history of irregular heartbeat (including so called QT prolongation seen with ECG monitoring), and tell your doctor if you are taking other medicines, because they might cause or worsen this ECG change.
• high or low blood pressure, cardiovascular disease. Your doctor will need to check your blood pressure regularly.
• dizziness on standing up due to a drop in your blood pressure, which may cause fainting
• a history of blood clots, or if someone else in your family has a history of blood clots, as medicines for schizophrenia have been associated with formation of blood clots
• a history of stroke, especially if you are elderly or know that you have other risk factors for stroke. Tell your doctor immediately if you notice any signs of a stroke.
• dementia (loss of memory 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 else in your family has diabetes). Your doctor will need to check your blood sugar regularly since it may be increased by Reagila. Signs of high blood sugar level are excessive thirst, passing of large amounts of urine, increase in appetite and feeling weak.
• a history of seizures (fits) or epilepsy.

 

Weight increase

Reagila may cause significant weight increase which may 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 due to the 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 some medicines may require a dose adjustment of Reagila or the other medicine. These are medicines used to treat heart diseases containing digoxin, blood thinners containing dabigatran, or medicines affecting your mental functions. 

 

Reagila with food, drink and alcohol

You should not drink grapefruit juice during treatment with Reagila.

Alcohol should be avoided when taking Reagila.

 

Pregnancy and breast-feeding

 

Women of childbearing / Contraception

 

Women of childbearing potential must use effective contraception during Reagila treatment. Even after treatment is stopped, contraception must be used for at least 10 weeks after your last dose of Reagila. This is because the medicine will stay in your body for some time after the last dose was taken. 

 

Pregnancy

 

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

 

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

• shaking, muscle stiffness and/or weakness, sleepiness, agitation, breathing problems, and difficulty in feeding.

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

 

Breast-feeding

 

Do not breast-feed if you are taking Reagila because a risk for the baby cannot be excluded. Contact your doctor for advice.

 

Driving and using machines

There is a small risk that the medicine affects the ability to drive and use machines. Sedation, dizziness and vision problems may occur during treatment with this medicine (see section 4). Do not drive or use any tools or machines until you know that this medicine does not affect you in a negative way.

 

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

Allura red AC is a coloring agent, which may cause allergic reactions.