• New

Reagila 1.5 mg. 28 capsules

€69

Reagila contains the active substance cariprazine, which belongs to a group of medicines called antipsychotics. It is used to treat adults with schizophrenia.

Quantity

What Reagila is and what it is used for

Reagila contains the active substance cariprazine, which belongs to a group of medicines called antipsychotics. It is used to treat adults with schizophrenia.

Schizophrenia is a disease characterized by symptoms such as hearing, seeing or feeling non-existent things (hallucinations), suspicion, misconceptions, incoherent speech, behavioral and emotional alignment.

People with this condition may also feel depressed, feel guilty, anxious, tense or unable to start or complete planned actions, unwilling to speak, lack of emotional response in a situation that causes emotions in other people. .

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, erythromycin and nafcillin);

tuberculosis (medicines containing rifampicin);

HIV infection (medicines containing cobicistat, indinavir, nelfinavir, ritonavir, saquinavir, efavirenz and etravirine);

fungal infections (medicines containing intraconazole, posaconazole, voriconazole and fluconazole);

Cushing's syndrome - when the body produces excess cortisol (medicines containing ketoconazole)

depression (treatment with herbs containing St. John's wort (Hypericum perforatum) and drugs containing nefazodone);

epilepsy and seizures (medicines containing carbamazepine, phenobarbital and phenytoin);

heart disease (medicines containing diltiazem and verapamil)

drowsiness (medicines containing modafinil);

high blood pressure in the lungs (medicines containing bosentan).

Warnings and precautions

Consult your doctor immediately:

if you think or feel that you will injure yourself or kill yourself. Thoughts of suicide and committing suicide are more likely at the beginning of treatment.

if you have a combination of fever, sweating, shortness of breath, muscle stiffness, dizziness or drowsiness (may be signs of neuroleptic malignant syndrome).

Ask your doctor or pharmacist for advice before taking Reagila or during treatment if:

you have ever felt or are beginning to feel anxious or unable to stand still. These symptoms may occur soon after starting treatment with Reagila. Tell your doctor if this happens;

you have ever had or now have unusual, involuntary movements, mainly of the tongue or face. Tell your doctor if this happens;

visual impairment. Your doctor will advise you to consult an ophthalmologist;

You have or have someone in your family who has had a heart rhythm disorder (including the so-called QT prolongation seen on the ECG), tell your doctor if you are taking other medicines, as they may cause or worsen this change in your heart rate. ECG;

you have high or low blood pressure, you have cardiovascular disease. Your doctor will need to check your blood pressure regularly;

you have dizziness when standing up due to a sharp drop in blood pressure, which can lead to fainting;

You or someone in your family has had blood clots in the past because medicines for schizophrenia have been linked to blood clots;

you have had a 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;

you have dementia (memory loss and other mental problems) especially if you are elderly;

you have Parkinson's disease;

if you have diabetes or risk factors for diabetes (eg obesity or someone close to you has diabetes). Your doctor will check your blood sugar regularly, as it may rise when you take Reagila. Signs of high blood levels include excessive thirst, large amounts of urine, increased appetite and a feeling of weakness;

you have had seizures or epilepsy in the past.

Weight gain

Reagila can cause significant weight gain, which may affect your health. Therefore, your doctor will check your weight regularly.

Contraception

Women of childbearing potential must use effective contraception while taking Reagila and for at least 10 weeks after stopping treatment. If you are taking hormonal contraceptives, you should also use one of the so-called barrier methods of contraception (eg condom or diaphragm) (see also section "Pregnancy and breast-feeding").

Children and adolescents

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

Other medicines and Reagila

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. You should not 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 dose of other medicines. These are medicines used to treat heart disease that contain digoxin, medicines to thin the blood that contain dabigatran, or medicines that affect mental function.

If you use hormonal contraception, you must also use one of the so-called barrier methods of contraception (see section "Pregnancy and breast-feeding" below).

Reagila with food, drink and alcohol

You should not consume grapefruit juice during treatment with Reagila.

Alcohol should be avoided when taking Reagila.

Pregnancy and lactation

Women of childbearing potential

Women of childbearing potential must use effective contraception during treatment with Reagila. Even after stopping treatment, contraception should be used for at least 10 weeks after taking the last dose of Reagila. The reason is that the medicine stays in your body for some time after taking the last dose. If you are using hormonal contraceptives, you must also use one of the so-called barrier methods of contraception (eg a condom or diaphragm). Ask your doctor about the appropriate choice of contraceptives.

Pregnancy

Do not take this medicine during pregnancy unless instructed to do so by your doctor.

If your doctor decides that you should take this medicine during pregnancy, he will monitor your baby after birth, as the following symptoms may occur in newborns whose mothers have been taking this medicine in the last trimester (last three months) from pregnancy:

tremor, muscle stiffness and / or weakness, drowsiness, agitation, breathing problems, difficulty eating.

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

Breastfeeding

You should not breast-feed while taking Reagila, as a risk to the baby cannot be ruled out. Talk to your doctor.

Driving and using machines

There is minimal or moderate risk of this medicine affecting your ability to drive and use machines. You may experience drowsiness, dizziness and vision problems during treatment (see section 4). Do not drive or use any tools or machines until you know if this medicine is affecting you.

Reagila 3 mg, 4.5 mg, 6 mg hard capsules contain Alura red AC (E129).

Alura red AC is a colorant that can cause allergic reactions.

3. How to take Reagila

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, talk to your doctor or pharmacist.

The recommended starting dose is 1.5 mg once a day, taken orally. Your doctor may then gradually adjust your dose in 1.5 mg steps depending on how your treatment works.

The maximum daily dose should not exceed 6 mg.

Take Reagila at the same time each day, with or without food.

If you are taking the other medicine for schizophrenia before you start taking Reagila, your doctor will decide whether to stop taking the other medicine for schizophrenia gradually or immediately and what the dose of Reagila should be. Your doctor will also tell you what to do if you switch from Reagila to another medicine.

Patients with kidney or liver problems

If you suffer from serious kidney or liver problems, Reagila may not be right for you. Consult your doctor.

Old age

Your doctor will carefully choose the right dose for you.

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 prescribed or, for example, a child has taken Reagila by mistake, contact your doctor or go to the nearest hospital straight away, taking the medicine pack with you. You may feel dizzy due to low blood pressure

5. How to store Reagila

Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. And EXP. The expiry date refers to the last day of that month.

Keep the blister in the outer carton in order to protect from light.

This medicine does not require any special storage conditions.

Do not throw away any medicines via wastewater or household waste.

Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the package and additional information

What Reagila contains

The active substance is cariprazine.

Reagila 1.5 mg: each hard capsule contains cariprazine hydrochloride corresponding to 1.5 mg cariprazine.

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

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

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

The other ingredients are:

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

Reagila 3 mg hard capsules: pregelatinised (maize) starch, magnesium stearate, alura red AC (E 129), brilliant blue FCF (E 133), titanium dioxide (E 171), yellow iron oxide (E 172), gelatin, black printed ink (shellac, black iron oxide (E 172), propylene glycol, potassium hydroxide).

Reagila 4.5 mg hard capsules: pregelatinised (maize) starch, magnesium stearate, allura red AC (E 129), brilliant blue FCF (E 133), titanium dioxide (E 171), yellow iron oxide (E 172), gelatin, white printing ink (shellac, titanium dioxide (E 171), propylene glycol, simethicone).

Reagila 6 mg hard capsules: pregelatinised (corn) starch, magnesium stearate, brilliant blue FCF (E 133), allura red AC (E 129), titanium dioxide (E 171), gelatin, black printing ink (shellac, black iron oxide) E 172), propylene glycol, potassium hydroxide).

What Reagila looks like and contents of the pack

Reagila 1.5 mg hard capsules: hard gelatin capsule, “size 4” (approximately 14.3 mm long) with a white opaque cap and a white opaque body, imprinted with “GR 1.5” on the capsule body in black ink. The capsules are filled with a white to yellowish-white powder mixture.

1000 Items