1.5 mg, 3 mg, 4.5 mg, 6 mg hard capsules
cariprazine
What Reagila is and what it is 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 a disease characterized by symptoms such as hearing, seeing, or perceiving something that does not exist (hallucinations), suspicion, delusions, incoherent speech and behavior, and emotional numbness. People with this disease may also feel depressed, anxious, tense, feel guilty, be unable to start or continue planned activities, be reluctant to talk, and have no emotional reaction to a situation that would normally evoke emotions in others.
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 is caused by the hepatitis C virus (medicines containing boceprevir or telaprevir)
- bacterial infections (medicines containing clarithromycin, telithromycin, erythromycin, or nafcillin)
- tuberculosis (medicines containing rifampicin)
- HIV infections (medicines containing cobicistat , indinavir, nelfinavir, ritonavir, saquvinavir, efavirenz or etravirine)
- fungal infections (medicines containing itraconazole, posaconazole, voriconazole or fluconazole )
- Cushing’s syndrome – when the body produces an excess of cortisol (drugs containing ketoconazole )
- depression (herbal medicines containing St. John’s wort, Hypericum perforatum, and medicines containing nefazodone)
- epilepsy and seizures (medicines containing carbamazepine, phenobarbital, or phenytoin )
- heart disease (medicines containing diltiazem or verapamil)
- drowsiness (medicines containing modafinil)
- high blood pressure in the lungs (medicines containing bosentan ).
Warnings and cautions
Tell your doctor immediately:
- if you have thoughts or feelings of wanting to hurt yourself or take your life. Suicidal thoughts and behaviors are more likely at the beginning of treatment.
- if you get a combination of fever, sweating, shortness of breath, muscle stiffness, and drowsiness or drowsiness (may be a sign of malignant neuroleptic syndrome).
Talk to your doctor or pharmacist before taking Reagila, or during treatment, if you:
- have ever experienced or are beginning to experience restlessness or inability to sit still. These symptoms may occur early in treatment with Reagila. Tell your doctor if this happens.
- have ever experienced or are beginning to experience abnormal, involuntary movements, usually in the tongue or face. Tell your doctor if this happens.
- get impaired vision. Your doctor will advise you to visit an ophthalmologist.
- have irregular heartbeats or if someone else in your family has or has had irregular heartbeats (including so-called QT prolongation seen in ECG examinations). Tell your doctor if you are taking other medicines, as they may cause or aggravate this ECG change.
- have high or low blood pressure or cardiovascular disease. Your doctor will need to check your blood pressure at regular intervals
- experiencing dizziness, due to a drop in blood pressure, which can make you faint when you stand up.
- have had blood clots before, or if someone else in your family has had blood clots because medicines for schizophrenia are associated with the formation of blood clots.
- have had a stroke before, especially if you are elderly or know you have other risk factors for stroke. Tell your doctor immediately if you notice any signs of stroke.
- have dementia (loss of memory and other mental abilities), especially if you are older.
- have Parkinson’s disease.
- have diabetes or risk factors for diabetes (eg obesity, or if someone else in your family has diabetes ). Your doctor will need to check your blood sugar at regular intervals as Reagila may cause an increase. Signs of high blood sugar are excessive thirst, large amounts of urine, increased appetite, and feeling weak.
- have previously had seizures or epilepsy.
Weight gain
Real can cause significant weight gain which can affect your health. Your doctor will therefore check your weight at regular intervals.
Contraceptive
Women of childbearing potential must use a very effective contraceptive during treatment with Reagila and for at least 10 weeks after stopping treatment. If you use hormonal contraceptives, you should also use a so-called barrier method (eg condoms or diapers ). (See section “Pregnancy and breastfeeding”).
Children and young people
This medicine is not recommended for children and adolescents under 18 years of age because of a lack of information in this group of patients.
Other medicines and Regalia
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. You must not take certain medicines with Reagila (see section “Do not take Reagila”).
If you are taking Reagila with certain medicines, the dose of one of Reagila or the other medicine may need to be adjusted. These are medicines used to treat heart disease and which contain digoxin (a blood thinner containing dabigatran) or medicines that affect your mental functions.
If you use hormonal contraceptives, you should also use a so-called barrier method (see the section “Pregnancy and breastfeeding” below).
Reagila with food, drink, and alcohol
You should not drink grapefruit juice while you are being treated with Regalia.
You should not drink alcohol while you are being treated with Regalia.
Pregnancy and breastfeeding
Women of childbearing potential
Women of childbearing potential must use effective contraception during treatment with Reagila. Even after stopping treatment, you must continue to use the contraceptive method for at least 10 weeks after the last dose of one of Regina. This is because the medicine stays in the body for a while after you take the last dose. If you use hormonal contraceptives, you should also use a so-called barrier method (eg condoms or diapers ). Ask your doctor about suitable contraceptives.
Pregnancy
You should not use this medicine during pregnancy unless your doctor tells you to.
If your doctor has advised you to take this medicine during pregnancy, he/she will closely monitor your baby after birth. This is because the following symptoms may occur in newborns of mothers who have used this medicine during the last trimester of pregnancy (the last three months):
- tremors, muscle stiffness and/or muscle weakness, drowsiness, anxiety, difficulty breathing, and difficulty eating.
Contact a doctor if your child has any of these symptoms.
Breast-feeding
Do not breastfeed if you are taking Reagila as there may be a risk to the baby. Consult your doctor.
Driving and using machines
There is a small or moderate risk that the medicine will affect the 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 machines until you know that this medicine will not adversely affect you.
Reagila 3 mg, 4.5 mg, 6 mg hard capsules contain allura red AC (E129)
Allura Red AC is a dye that can cause allergic reactions.
How to take Reagila
Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
The recommended starting dose is 1.5 mg once a day. The capsule should be swallowed. Then the dose can be slowly adjusted by the doctor, in steps of 1.5 mg, depending on how the treatment works for you.
The maximum dose is 6 mg once daily.
Take Reagila at the same time each day with or without food.
If you are taking another medicine for schizophrenia before starting Reagila, your doctor will decide if you should stop taking the other medicine gradually or immediately, and how to adjust one dose of Reagila. Your doctor will also tell you how to proceed if you are switching 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. Talk to your doctor.
Elderly patients
Your doctor will carefully select the appropriate dose for your needs.
Regalia should not be used in elderly patients with dementia (memory loss).
If you take more Reagila than you should
If you have taken too much Reagila, or if e.g. If a child has accidentally ingested the medicine, contact a doctor immediately or go to the nearest hospital and take the medicine pack with you. You may experience dizziness due to low blood pressure or abnormal heartbeat, drowsiness, fatigue, abnormal body movements, and difficulty standing and 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 your next dose, skip the missed dose and continue as usual.
Do not take a double dose to make up for a forgotten dose.
Contact a doctor if you miss two or more doses .
If you stop taking Reagila
If you stop taking this medicine you will lose the effect the medicine. Even if you feel better, do not change or stop taking your daily dose of Reagila unless your doctor tells you to. If you change or stop taking Reagila, your symptoms may return.
If you have any further questions on the use of this product, ask your doctor.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you notice any of the following symptoms, contact your doctor immediately :
- severe allergic reaction with symptoms such as fever, swelling of the mouth, face, lips, or tongue, shortness of breath, itching, rash and sometimes a drop in blood pressure (rare side effect )
- a combination of fever, sweating, muscle stiffness, and drowsiness or drowsiness. These symptoms may be signs of a condition called neuroleptic malignant syndrome ( side effect in an unknown number of users)
- unexplained muscle pain, muscle cramps, or muscle weakness. These symptoms can be signs of muscle damage that can cause very serious kidney problems (rare side effect )
- if you get blood clots, especially in the legs (symptoms are swelling, pain and redness on the leg), which can be transported to the lungs and cause chest pain and difficulty breathing ( side effect with unknown frequency)
- thoughts or feelings about harming yourself or committing suicide, suicide attempt (less common side effect ).
Other side effects are
Very common (may affect more than 1 user in 10)
- restlessness and inability to sit still
- Parkinsonism is a medical condition that has many different symptoms, including diminished or slow body movements, slowness of thought, twitching of arms and legs (gear rigidity), hasty steps, tremors, decreased or lack of facial expressions, muscle stiffness, and drooling.
Common (may affect up to 1 in 10 people)
- anxiety
- drowsiness, difficulty sleeping, abnormal dreams, nightmares, sleepwalking
- dizziness
- involuntary twisting movements and strange postures
- severe gnashing of teeth or squeezing of the jaws, drooling, persistent blinking in response to knocks on the forehead (abnormal reflex), movement problems, movement disorders in the tongue (these are called extrapyramidal symptoms)
- dimsyn
- high blood pressurefast, irregular heartbeat
- decreased or increased appetite
- nausea, vomiting, constipation
- weight gain
- fatigue
- the following can be seen in laboratory tests:
- increased amount of liver enzymes
- increased levels of creatine phosphokinase in the blood
- abnormal amount of lipids (eg cholesterol and / or fat) in the blood.
Uncommon (may affect up to 1 in 100 people)
- Depression
- sudden and severe confusion
- feeling that it is spinning
- unpleasant, abnormal feeling of touch
- drowsiness, lack of energy, or a lack of interest in doing things
- involuntary movements, usually in the tongue or face. This can show up after short-term or long-term use
- decreased or increased sex drive, erection problems
- eye irritation, high pressure in the eye, impaired vision
- problems to focus on when looking from afar or up close
- low blood pressure
- abnormal ECG , abnormal nerve impulses in the heart
- slow, irregular heart rate
- hiccup
- heartburn
- thirst
- pain when urinating
- to urinate abnormally often and a lot
- itching , rash
- diabetes
- the following can be seen in laboratory tests:
- abnormal sodium content in the blood
- increased blood glucose (blood sugar), increased bile pigment ( bilirubin ) in the blood
- anemia (decreased amount of red blood cells )
- increased amount of a type of white blood cell
- decreased levels of thyroid-stimulating hormone ( TSH ) in the blood.
Rare (may affect up to 1 in 1,000 people)
- seizures
- memory loss, loss of speech
- eye problems in bright light
- cloudiness of the lens of the eye leading to impaired vision (cataracts)
- difficulty swallowing
- the decreased amount a type of white blood cells, which can make you more susceptible to infection you
- impaired thyroid function.
Has been reported (occurs in an unknown number of users)
- hepatitis (pain in the upper right part of the abdomen, yellowing of the eyes and skin, weakness, fever).
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 carton and blister after EXP. and EXP. The expiration date is the last day of the specified month.
Store the blister in the outer carton. Sensitive to light.
No special temperature instructions.
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 to protect the environment.
Contents of the pack and other information
Content declaration
- The active substance is cariprazine. Reagle 1.5 mg: One hard capsule contains cariprazine hydrochloride equivalent to 1.5 mg of cariprazine.
Reagle 3 mg: One hard capsule contains cariprazine hydrochloride equivalent to 3 mg cariprazine.Reagle 4.5 mg: One hard capsule contains cariprazine hydrochloride equivalent to 4.5 mg cariprazine.Reagle 6 mg: One hard capsule contains cariprazine hydrochloride equivalent to 6 mg cariprazine. - Other ingredients are Reagile 1.5 mg hard capsules: pregelatinised starch (maize), magnesium stearate, titanium dioxide (E 171), gelatin, black ink (shellac, black iron oxide (E 172), propylene glycol, potassium hydroxide).
Reagile 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).
Reagle 4.5 mg hard capsules: pregelatinized starch (maize), 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, simethicone).
Reagle 6 mg hard capsules: pregelatinised starch (maize), 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).
What the medicine looks like and the contents of the pack
- Reagile 1.5 mg hard capsules: Size 4 (length approx. 14.3 mm) hard gelatin capsule with white opaque upper part and white opaque lower part marked with “GR 1.5” in black on the capsule part. The capsules are filled with white to off-white powder.
- Reagle 3 mg hard capsules: Size 4 (length approx. 14.3 mm) hard gelatin capsule with green opaque top and white opaque bottom marked with “GR 3” in black on the capsule part. The capsules are filled with white to off-white powder.
- Reagle 4.5 mg hard capsules: Size 4 (length approx. 14.3 mm) hard gelatin capsule with green opaque top and green opaque bottom marked with “GR 4.5” in white on the capsule part. The capsules are filled with white to off-white powder.
- Regalia 6 mg hard capsules: Size 3 (length about 15.9 mm) hard gelatin capsule with purple opaque top and white opaque bottom marked with “GR 6” in black on the capsule part. The capsules are filled with white to off-white powder.
The capsules are packed in transparent hard PVC / PE / PVDC blisters, heat-sealed with a hardback of the aluminum foil. Blisters are packed in a box of cardboard.
Reagila 1.5 mg and Reagila 3 mg hard capsules are available in pack sizes of 7, 14, 21, 28, 30, 49, 56, 60, 84, 90 or 98 hard capsules.
Regalia 4.5 mg and Reagila 6 mg hard capsules are available in pack sizes of 7, 21, 28, 30, 49, 56, 60, 84, 90 or 98 hard capsules.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Gedeon Richter Plc.
Gyömrői out 19-21
1103 Budapest
Hungary
Contact the representative of the marketing authorization holder to find out more about this medicine:
| Belgium / Belgique / BelgienRecorded by BVBATel: +32 2 46101 36 | LithuaniaGedeon Richter Plc. atstovybė LietuvojeTel: +370 5 261 01 54 |
| BulgariaTP “Gideon Richter AD”Tel: + 359 2 8129063 | Luxembourg / LuxemburgRecorded by BVBATel: + 32 2 46101 36 (Belgium / Belgium) |
| Czech RepublicGedeon Richter Marketing Cr, sroTel: +420 261 141 200 | HungaryJudge Gedeon Nyrt.Tel .: +36 1 505 7032 |
| DenmarkRecordati ABTel: +46 8 545 80 230 (Sweden) | MaltaRecordati Ireland LimitedTel: + 353 21 4379400 (Ireland) |
| GermanyRecordati Pharma GMBHTel: + 49 731 70470 | The NetherlandsRecorded by BVBATel: + 32 2 46101 36 (Belgium) |
| EestiJudge Gedeon Eesti BranchTel: +372 608 5301 | NorwayRecordati ABTel: + 46 8 545 80 230 (Sweden) |
| GreeceRecordati Hellas Pharmaceuticals SA:Ηλ: + 30 210-6773822 | AustriaRecordati Austria GmbHTel: + 43 676 353 0 262 |
| SpainCasen Recordati SLTel: + 34 91 659 15 50 | PolandGEDEON JUDGE POLSKA Sp. z ooTel .: + 48 (22) 755 96 48 |
| FranceBouchara-Recordati SASTel: + 33 1 45 19 10 00 | PortugalJaba Recordati SATel: + 351 21 432 95 00 |
| CroatiaGedeon Richter Croatia dooTel: + 385 1 5625 712 | RomaniaGedeon Richter România SATel: + 40-265-257 011 |
| IrelandRecordati Ireland LimitedTel: + 353 21 4379400 | SloveniaGedeon Richter dooTel: + +386 8 205 68 70 |
| IcelandRecordati ABPhone: +46 8 545 80 230 (Sweden) | Slovak RepublicGedeon Richter Slovakia, sroTel: +421 2 5020 5801 |
| ItalyRECORDATI SpATel: + 39 02 487871 | Finland / FinlandRecordati ABPuh / Tel: +46 8 545 80 230 (Ruotsi / Sweden) |
| .ΠροςCG PAPALOISOU LTD.:Ηλ: + 357 22 490305 | SwedenRecordati ABTel: +46 8 545 80 230 |
| LatviaGedeon Richter Plc. pārstāvniecība LatvijāTel: +371 67845338 |