Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - reagila

Document Subject

Generated Narrative: MedicinalProductDefinition mpcbc8bd303ae5e6a2b05a1e976deb4928

identifier: http://ema.europa.eu/identifier/EU/1/17/1209/001-042

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Reagila 1.5 mg hard capsules

type: Full name

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part: nan

type: Invented name part

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part: nan

type: Scientific name part

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type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-cbc8bd303ae5e6a2b05a1e976deb4928

identifier: http://ema.europa.eu/identifier/EU/1/17/1209/001-042

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - reagila

Attesters

What is in this leaflet

1. What Reagila is and what it is used for
2. What you need to know before you take Reagila
3. How to take Reagila
4. Possible side effects
5. How to store Reagila
6. Contents of the pack and other information

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 characterised by symptoms such as hearing, seeing or sensing things which are not there (hallucination), suspiciousness, mistaken beliefs, incoherent speech and behaviour and emotional flatness. People with this condition may also feel depressed, guilty, anxious, tense, or not being able to start or keep up planned activities, unwillingness to speak, lack of emotional response to a situation that would normally stimulate 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 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 or to commit suicide. 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 Reagila, or during treatment 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 potential/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 minor or moderate risk that the medicine could 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 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.

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

The recommended starting dose is 1.5 mg once a day by mouth. Thereafter, the dose may be slowly adjusted by your doctor, in steps of 1.5 mg, depending on how the treatment works for you. The maximum dose should not exceed 6 mg once a day.

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

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

Patients with kidney or liver problems If you have serious kidney or liver problems Reagila may not be appropriate for you. Talk to your doctor.

Elderly patients Your doctor will carefully select the appropriate dose for your needs. Reagila should not be used by elderly patients with dementia (loss of memory).

If you take more Reagila than you should If you have taken more Reagila than your doctor has recommended or if, for example, a child has taken it by mistake, contact your doctor or go to the nearest hospital right away and take the pack of the medicine with you. You may experience dizziness from low blood pressure, or have abnormal heartbeats, you may feel sleepy, tired, or have abnormal body movements and find it difficult to stand or walk.

If you forget to take Reagila If you forget to take a dose, take it as soon as you remember it. However, if it is almost time for your next dose, skip the missed dose and continue as usual. Do not take a double dose to make up for a forgotten dose. If you miss two or more doses, contact your doctor.

If you stop taking Reagila If you stop taking this medicine you will lose the effects of the medicine. Even if you feel better, do not alter or stop your daily dose of Reagila unless told to do so by your doctor as your symptoms may return.

If you have any further questions on the use of this medicine, ask your doctor.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Tell your doctor immediately if you have:

• a severe allergic reaction seen as fever, swollen mouth, face, lip or tongue, shortness of breath, itching, skin rash and sometimes a drop in blood pressure. (Rare side effect)
• combination of fever, sweating, muscle stiffness, and drowsiness or sleepiness. These can be the signs of the so-called neuroleptic malignant syndrome. (Side effect with frequency not known)
• inexplicable muscle pains, muscle cramps or muscle weakness. These may be signs of muscle damage which can cause very serious kidney problems. (Rare side effect)
• symptoms related to blood clots in the veins especially in the legs (symptoms include swelling, pain and redness in the leg), which may travel through blood vessels to the lungs causing chest pain and difficulty in breathing. (Side effect with frequency not known)
• thoughts or feelings about harming yourself or to commit suicide, suicide attempt. (Uncommon side effect)

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

• feeling of restlessness and inability to sit still
• Parkinsonism - a medical condition with many various symptoms which include decreased or slow movements, slowness of thought, jerks when bending the limbs (cogwheel rigidity), shuffling, steps, shaking, little or no facial expression, muscle stiffness, drooling

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

• anxiety

• sleepiness, difficulty in sleeping, abnormal dreams, nightmare, sleepwalking

• dizziness

• involuntary twisting movements and strange postures

• excessive teeth grinding or jaw clenching, drooling, persistent blinking in response to tapping of the forehead (an abnormal reflex), movement problems, tongue movement disturbance (these are called extrapyramidal symptoms)

• blurred vision

• high blood pressure

• fast, irregular heartbeat

• decreased or increased appetite

• nausea, vomiting, constipation

• weight increased

• tiredness

• the following can be seen in laboratory tests: increases in liver enzymes increases in the level of creatine phosphokinase in the blood abnormal amount of lipids (e.g. cholesterol and/or fat) in the blood

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

• depression
• sudden and severe confusion
• spinning sensation
• unpleasant, abnormal sense of touch
• drowsiness, lack of energy or a lack of interest in doing things
• involuntary movements, most commonly of the tongue or face. This can appear after short or long-term use.
• decreased or increased sexual desire, erectile problems
• eye irritation, high pressure in the eye, poor vision
• focusing problems seeing at a distance to or seeing close-to
• low blood pressure
• abnormal ECG reading, abnormal nerve impulses in the heart
• slow, irregular heart rate
• hiccups
• heartburn
• thirst
• pain when passing urine
• abnormally frequent and large urinations
• itching, rash
• diabetes
• the following can be seen in laboratory tests: abnormal sodium level in the blood increased blood glucose (blood sugar), increased bile pigment (bilirubin) in the blood anaemia (reduced levels of red blood cells) increase in a type of white blood cells decreased level of thyroid stimulating hormone (TSH) in the blood

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

• seizure
• loss of memory, loss of speech
• eye discomfort in bright light
• clouding of the lens in the eye leading to a decrease in vision (cataract)
• difficulty in swallowing
• reduced levels of a type of white blood cells, this can make you more susceptible to infections
• underactive thyroid gland

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

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

Reporting of side effects If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V.

By reporting side effects you can help provide more information on the safety of this medicine.

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 the blister after 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 temperature storage conditions.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

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 3 mg cariprazine. 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 6 mg cariprazine.

• The other ingredients are: Reagila 1.5 mg hard capsules: pregelatinized (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: pregelatinized (maize) 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 (shellac, black iron oxide (E 172), propylene glycol, potassium hydroxide) (See also Section 2).

Reagila 4.5 mg hard capsules: pregelatinized (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 ink (shellac, titanium dioxide (E 171), propylene glycol, simeticone).

Reagila 6 mg hard capsules: pregelatinized (maize) starch, 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 Reagila looks like and contents of the pack

• Reagila 1.5 mg hard capsules: Size 4 (approximately 14.3 mm in length) hard gelatin capsule with white opaque cap and white opaque body imprinted with GR 1.5 on the capsule body with black ink. The capsules are filled with white to yellowish white powder.

• Reagila 3 mg hard capsules: Size 4 (approximately 14.3 mm in length) hard gelatin capsule with green opaque cap and white opaque body imprinted with GR 3 on the capsule body with

black ink. The capsules are filled with white to yellowish white powder.

• Reagila 4.5 mg hard capsules: Size 4 (approximately 14.3 mm in length) hard gelatin capsule with green opaque cap and green opaque body imprinted with GR 4.5 on the capsule body with white ink. The capsules are filled with white to yellowish white powder.

• Reagila 6 mg hard capsules: Size 3 (approximately 15.9 mm in length) hard gelatin capsule with purple opaque cap and white opaque body imprinted with GR 6 on the capsule body with black ink. The capsules are filled with white to yellowish white powder.

The capsules are packed in transparent hard PVC/PE/PVDC blister heat-sealed with hard aluminium foil backing. The blisters are packed in a folded carton 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 7, 21, 28, 30, 49, 56, 60, 84, 90 or 98 hard capsules.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Gedeon Richter Plc. Gy mr i t 19-1103 Budapest Hungary

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Belgi /Belgique/Belgien Recordati BV T l/Tel: +32 2 461 01 Lietuva Gedeon Richter Plc. atstovyb Lietuvoje Tel: +370 5 261 01

Te .: + 359 2 8129Luxembourg/Luxemburg Recordati BV T l/Tel: + 32 2 461 01 36 (Belgique/Belgien)

esk republika Gedeon Richter Marketing R, s.r.o. Tel: +420 261 141 Magyarorsz g Richter Gedeon Nyrt. Tel.: +36 1 505 7Danmark Recordati AB Tlf: +46 8 545 80 230 (Sverige)

Malta Recordati Ireland Limited Tel: + 353 21 4379400 (Ireland)

Deutschland Recordati Pharma GMBH Tel: + 49 731 70Nederland Recordati BV Tel: + 32 2 461 01 36 (Belgi )

Eesti Richter Gedeon Eesti filiaal Tel: +372 608 5Norge Recordati AB Tlf: + 46 8 545 80 230 (Sverige)

Recordati Hellas Pharmaceuticals S.A. sterreich Recordati Austria GmbH

: + 30 210-6773Tel: + 43 676 353 0 Espa a Casen Recordati S.L. Tel: + 34 91 659 15 Polska GEDEON RICHTER POLSKA Sp. z o.o. Tel.: + 48 (22)755 96 France Bouchara-Recordati S.A.S. T l: + 33 1 45 19 10 Portugal Jaba Recordati S.A. Tel: + 351 21 432 95 Hrvatska Gedeon Richter Croatia d.o.o. Tel: + 385 1 5625 Ireland Recordati Ireland Limited Tel: + 353 21 4379Rom nia Gedeon Richter Rom nia S.A. Tel: +40-265-257 Slovenija Gedeon Richter d.o.o. Tel: + +386 8 205 68 sland Recordati AB S mi: +46 8 545 80 230 (Sv j )

Slovensk republika Gedeon Richter Slovakia, s.r.o. Tel: +421 2 5020 5Italia RECORDATI S.p.A. Tel: + 39 02 487Suomi/Finland Recordati AB Puh/Tel: +46 8 545 80 230 (Ruotsi/Sverige)

C.G. PAPALOISOU LTD. : + 357 22 490Sverige Recordati AB Tel: +46 8 545 80 Latvija Gedeon Richter Plc. p rst vniec ba Latvij
Tel: +371 67845United Kingdom (Northern Ireland) Recordati Pharmaceuticals Ltd. Tel: + 44 1491 576This leaflet was last revised in

Other sources of information Detailed and updated information on this medicine is available by scanning the QR code below and the outer carton with a smartphone. The same information is also available on the following URL: www.reagila.com

QR code to be included + www.reagila.com

Detailed information on this medicine is available on the European Medicines Agency web site: