Zykalor 15 mg. 28 tablets


ZYKALOR contains the active substance aripiprazole, which belongs to a group of medicines called antipsychotics.


Zykalor 15 mg. 28 tablets

ZYKALOR contains the active substance aripiprazole, which belongs to a group of medicines called antipsychotics.

It is used to treat adults and adolescents aged 15 and over who suffer from a condition characterized by symptoms such as hearing, seeing or feeling things that are not really there, suspicion, misconceptions, unrelated speech and behavior, and boredom. In addition, people in such a state may feel depressed, guilty, disturbing or tense.

ZYKALOR is used to treat adults and adolescents aged 13 and over who suffer from a condition characterized by symptoms such as a feeling of elevation, excess energy, need for much less sleep than usual, very fast talking with racing ideas, and sometimes severe over-irritability. In adults, it also prevents the disease from resurfacing in patients who have responded to ZICALOR treatment.

2. What you should know is harming to take ZYKALOR

Do not take ZYKALOR

if you are allergic to aripiprazole or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor before taking ZICAROR if you suffer from:

high blood sugar (characterized by symptoms such as excessive thirst, high urine output, increased appetite and feeling weak) or have a family history of diabetes
involuntary, irregular movements of the muscles, especially the face
cardiovascular disease, have a family history of cardiovascular disease, stroke or "micro" stroke, abnormal blood pressure
the presence of blood clots or a family history of blood clots as the use of antipsychotics is associated with blood clotting
a strong passion for gambling in the past
If you notice weight gain, develop unusual movements, feel drowsiness that interferes with your normal daily activities, have any difficulty in swallowing or allergic symptoms, please tell your doctor.
If you are an adult patient and suffer from dementia (loss of memory or other mental abilities), you or the caregiver should notify your doctor if you have had a stroke or a "micro" stroke.
Tell your doctor immediately if you have any thoughts or feelings of self-harm. During treatment with aripiprazole, cases of suicidal thoughts and behavior have been reported. Tell your doctor immediately if you suffer from stiffness in the muscles or from immobility with high temperature, sweating, changes in the mental state or rapid or irregular pulse.

Children and adolescents
Do not use this medicine in children and adolescents under the age of 13 years. It is not known whether it is safe and effective in these patients.

Other medicines and ZYKALOR
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Blood pressure lowering medicines: ZYKALOR may increase the blood pressure lowering effect. Make sure your doctor is informed that you are taking a medicine that controls your blood pressure.

Taking ZYKALOR with other medicines may require a change in the ZYKALORdose. It is especially important to tell your doctor about the following medicines:
anticonvulsants used to treat epilepsy
Serotonin elevators: tryptans, tramadol, tryptophan, CIPD (such as paroxetine and fluoxetine), tricyclic antidepressants (such as clomipramine, amitriptyline), pethidine, St. John's Wort, and venlafaxine These drugs increase the risk of side effects; if you get any unusual symptoms while you are taking these medicines along with ZYKALOR , talk to your doctor.

ZYKALOR with food, beverages and alcohol
ZYKALOR may be taken regardless of the diet regimen.
You should avoid taking alcohol while taking ZICALOR.

Pregnancy and breastfeeding
If you are pregnant or are breast-feeding, think you may be pregnant or plan to become pregnant, ask your doctor before taking this medicine.

The following symptoms may occur in newborns whose mothers have taken ZICALOR during the last trimester (the last three months of pregnancy): tremor, stiffness and / or weakness in the muscles, drowsiness, agitation, breathing problems and eating difficulties. If your baby develops any of these symptoms, you may need to consult your doctor.

Be sure to tell your doctor immediately if you are breast-feeding.
If you are taking ZYKALOR, you should not breast-feed.

Driving and using machines
Do not drive or use any tools or machines before you know how ZYKALOR affects you.

ZYKALOR contains lactose.

How to take ZYKALOR

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

The recommended dose for adults is 15 mg once a day. Nevertheless, your doctor may prescribe a lower or higher dose up to a maximum of 30 mg once a day.

Use in children and adolescents over 13 years of age
Aripiprazole may be initially administered in a lower dose as an oral solution (in liquid form). The dose may be increased gradually to the recommended dose in adolescents of 10 mg once daily. Nevertheless, your doctor may prescribe a lower or higher dose up to a maximum of 30 mg once a day.
A suitable form (oral solution) of ZICALOR is not available. Another medicinal product with the same active substance should be used.

If you think that the effect of ZYKALOR is too strong or too weak, talk to your doctor or pharmacist.

Try to take ZYKALOR at the same time each day. It does not matter if you take it with or without food. Always take the tablet with water and swallow it whole.

Even if you feel better, do not change the dose and stop taking ZYKALOR daily before first consulting your doctor.

If you take more ZYKALOR than you should
If you find that you have taken more ZYKALOR tablets than your doctor has prescribed (or if someone else has taken ZYKALOR tablets), contact your doctor immediately. If you can not contact your doctor, visit the nearest hospital and take the pack with you.

If you forget to take ZYKALOR
If you miss a dose, take the missed dose as soon as you remember, but do not take two doses in a day. If you have any other questions about the use of this medicine, ask your doctor or pharmacist.

If you stop using ZYKALOR
Do not stop your treatment just because you feel better. It is important that you continue to take ZICALOR tablets for as long as your doctor has told you.

4. Possible side effects

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

Common side effects (may affect up to 1 in 10 people) diabetes mellitus, sleep problems, anxiety, feeling unwell and unable to sit together, difficulty in sitting, uncontrolled twitching, convulsions or convulsions, restless legs syndrome, trembling, headache, fatigue, drowsiness, dizziness, shaking and blurred vision, reduced number of stools or difficulty walking, indigestion, nausea, more saliva in the mouth than usual, vomiting feeling tired.

Uncommon side effects (may affect up to 1 in 100 people): increased levels of the blood prolactin hormone, increased blood sugar, depression, altered or increased sexual interest, uncontrolled movements of the mouth, tongue and limbs (tardive dyskinesia), muscle disorder, (dystonia), double vision, rapid heart beat, drop in blood pressure when straightening, causing dizziness, dizziness or fainting, hiccups.
The following undesirable effects have been reported following the marketing of oral aripiprazole, but the frequency with which they occur is not known (frequency can not be estimated from the available data): low levels of white blood cells, low platelet counts, allergic reaction (eg swelling of the mouth, tongue, face or throat, pruritus, urticaria), the onset or worsening of diabetes, ketoacidosis (ketones in the blood and urine) or coma, high blood glucose levels, insufficient sodium in the blood, of appetite (anorexia), weight loss, weight gain, suicidal thoughts, suicide attempts, suicide attempt, strong gambling, aggression, agitation, nervousness, high temperature combination, muscle stiffness, rapid breathing, sweating, blurred consciousness and a sudden change in blood pressure and heart rate, fainting (malignant neuroleptic syndrome), seizure, serotonin syndrome (a reaction that can cause a feeling of excessive happiness, drowsiness, clumsiness, restlessness, intoxication, sweating or rigors in the muscles), speech disorders, sudden unexplained death, life-threatening irregular heartbeat, heart attack (heart attack), slow heart rate, blood clots in the veins, especially the legs (symptoms include swelling of the limb, redness) that can get through the blood vessels to the lungs and cause chest pain and difficulty breathing (in the presence of these symptoms, seek immediate medical attention), high blood pressure, fainting, ing of food with risk of pneumonia (lung infection), tightening of the muscles arounD
How to store ZYKALOR

Keep out of the reach and sight of children.

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

This medicinal product does not require any special storage conditions.

Do not dispose of medicines in the sewer or in the household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment.

6. Contents of the package in additional information

What ZYKALOR contains
The active substance is aripiprazole.

Each 10 mg tablet contains 10 mg of aripiprazole.
Each Zicalar 15 mg tablet contains 15 mg of aripiprazole.
The other ingredients are: For all concentrations: lactose monohydrate, cellulose, microcrystalline, corn starch, croscarmellose sodium, hydroxypropyl cellulose, magnesium stearate.

10 mg: red iron oxide (E172)
15 mg: yellow iron oxide (E172)
What ZYKALOR looks like on the packaging
Zicalo 10 mg tablets: Pink, rectangular tablets of approximately 8.5 x 4.0 mm and scored on one side. The tablet can be divided into two equal doses.

ZYKALOR 15 mg tablets: Light yellow round tablets of approximately 7.0 mm diameter.

Boxes of 14, 28, 30, 56, 60, 84 and 90 tablets in OPA / Al / PVC-Al blisters.

Not all pack sizes may be marketed.



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