5 mg, 10 mg, 15 mg and 30 mg aripiprazole tablets 

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

  • Save this information, you may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not give it to others. It can harm them, even if they show signs of illness similar to yours.
  • If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet: 
1. What Aripiprazole Krka is and what it is used for 
2. What you need to know before you use Aripiprazole Krka 
3. How to use Aripiprazole Krka 
4. Possible side effects 
5. How to store Aripiprazole Krka 
6. Contents of the pack and other information 

What Aripiprazole Krka is and what it is used for

Aripiprazole Krka contains the active substance aripiprazole and belongs to a group of medicines called antipsychotic medicines. It is used to treat adults and adolescents aged 15 and up who suffer from a disease characterized by the person hearing, seeing, or experiencing things that do not exist, are suspicious, believe wrong things, speak and behave inconsistently and show a lack of emotions. People in this condition may also feel depressed, guilty, anxious, or tense.

Aripiprazole Krka is used to treat adults and adolescents aged 13 and over who suffer from a condition that manifests itself in the person feeling “high”, has excess energy, needs much less sleep than usual, speaks very quickly, and with a fast flow of ideas and sometimes is strongly annoyed. In adult patients who have been treated with Aripiprazole Krka tablets, the medicine also prevents the condition from recurring.

Aripiprazole contained in Aripiprazole Krka may also be approved for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.

What you need to know before you use Aripiprazole Krka

Do not use Aripiprazole Krka

  • if you are allergic to aripiprazole or any of the other ingredients of this medicine (listed in section 6)

Warnings and cautions

Talk to your doctor before using Aripiprazole Krka.

Suicidal ideation and suicidal ideation have been reported during treatment with aripiprazole. Tell your doctor immediately if you have thoughts or a feeling of wanting to hurt yourself.

Before receiving any treatment with Aripiprazole Krka, tell your doctor if you have any

  • high blood sugar (which can cause symptoms such as excessive thirst, increased urine output, increased appetite, and feeling weak) or diabetes in the family
  • seizures (seizures) because your doctor may want to monitor you more closely
  • involuntary, irregular muscle movements, especially of the face
  • cardiovascular diseases (diseases of the heart and circulation), coronary heart disease in the family, stroke ( stroke ) or transient, easy stroke ( TIA ), abnormal blood pressure
  • blood clots or blood clots in the family, as antipsychotic drugs have been linked to the formation of blood clots
  • former game mania

Tell your doctor if you notice that you are gaining weight, develop an abnormal movement pattern, experience fatigue that affects normal daily activities, experience difficulty swallowing, or have allergic symptoms.

If you are elderly and suffer from dementia (have memory loss or suffer from any other mental disorders), you or a relative/guardian should tell your doctor if you have ever had a stroke or transient, mild stroke.

Tell your doctor immediately if you have thoughts or a feeling of wanting to hurt yourself. Suicidal ideation and suicidal ideation have been reported during aripiprazole treatment.

Tell your doctor immediately if you suffer from muscle stiffness or immobility with high fever, sweating, altered state of mind, or very fast or irregular heartbeat.

Tell your doctor if you or your family/caregiver notices that you are developing impulses or want to behave in a way that is unusual for you and that you cannot resist the impulse, the drive, or the temptation to perform activities that may harm yourself or others. This is called disturbed impulse control. It may include behavior such as gambling addiction, excessive eating or buying behavior, abnormally high sex drive, or increased preoccupation with constant thoughts of sex or sexual feelings.

Your doctor may need to adjust your dose or stop your medication.

Aripiprazole can cause drowsiness, drops in blood pressure that occurs when you get up, dizziness, and changes in mobility, and the ability to keep your balance, which can lead to falls. Caution should be exercised, especially if you are an elderly or debilitated patient.

Children and young people

Children and adolescents under 13 years of age should not use this medicine. It is not known if it is safe and effective for these patients.

Other medicines and Aripiprazole Krka

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription.

Antihypertensive drugs: Aripiprazole Krka tablets may increase the effect of medicines used to lower blood pressure. Therefore, tell your doctor if you are taking any medicine to keep your blood pressure under control.

When Aripiprazole Krka tablets are taken with certain medicines, the doctor may need to change the dose of one of Aripiprazole Krka or the other medicines. It is especially important to mention the following medicines for your doctor:

  • drugs to correct the heart rhythm (such as quinidine, amiodarone, flecainide )
  • antidepressants or herbal medicines to treat depression or anxiety (such as fluoxetine, paroxetine, venlafaxine, St. John’s wort )
  • medicines for fungal infections (such as ketoconazole, itraconazole)
  • certain medicines used to treat HIV infection (such as efavirenz, nevirapine and protease inhibitors such as indinavir, ritonavir)
  • antispasmodics used to treat epilepsy (such as carbamazepine, phenytoin, phenobarbital)
  • certain antibiotics used to treat tuberculosis (rifabutin, rifampicin)

These medicines may increase the risk of side effects or reduce the effect of Aripiprazole Krka. If you get any unusual symptoms while taking any of these medicines with Aripiprazole Krka, you must consult a doctor.

Drugs that increase serotonin levels are mainly used in diseases such as depression, generalized anxiety disorder, obsessive-compulsive disorder (OCD) and social phobia, as well as migraines and pain:

  • triptans, tramadol, and tryptophan used in diseases such as depression, generalized anxiety disorder, obsessive-compulsive disorder (OCD), and social phobia as well as migraines and pain
  • SSRIs (such as paroxetine and fluoxetine ) used in depression, OCD, panic disorder, and anxiety
  • other antidepressant drugs (such as venlafaxine and tryptophan) used in major depression
  • tricyclic antidepressants (such as clomipramine and amitriptyline) used in depression
  • St. John’s wort ( Hypericum perforatum ) used as a natural remedy for mild depression
  • painkillers (such as tramadol and pethidine) used to relieve pain
  • triptans (such as sumatriptan and zolmitriptan) used to treat migraines

These medicines may increase the risk of side effects. If you get any unusual symptoms while taking any of these medicines with Aripiprazole Krka, you must consult a doctor.

Aripiprazole Krka with food, drink, and alcohol

This medicine can be taken with or without food.

Alcohol should be avoided.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

In newborns whose mothers have taken Aripiprazole Krka during the last trimester (the last three months of pregnancy), the following symptoms may occur: tremors, stiff and/or weak muscles, drowsiness, agitation, difficulty breathing, and difficulty eating. If your child gets any of these symptoms, you may need to contact your doctor.

If you are taking Aripiprazole Krka, your doctor and you will discuss whether or not to breast-feed. You should then consider what benefit the treatment has for you compared to what benefit the child has from breastfeeding. You must not both breast-feed and take the medicine at the same time. Talk to your doctor about the best way to feed your child if you are taking this medicine.

Driving and using machines

Dizziness and vision problems may occur during treatment with this medicine (see section 4). This must be taken into account in cases where full attention is required, eg when driving or handling machines.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Aripiprazole Krka contains lactose

If you are told that you are hypersensitive to certain sugars, consult your doctor before taking this medicine.

How to use Aripiprazole Krka

Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

The recommended dose for adults is 15 mg once daily. However, your doctor may need to reduce or increase the dose one (up to a maximum of 30 mg once daily).

Use for children and adolescents

One should start with a low dose of the oral solution (in liquid form) of aripiprazole. Dose one can then be increased gradually up to the recommended dose one of 10 mg once daily for adolescents. However, your doctor may need to reduce or increase the dose to a maximum of 30 mg once a day.

If you have the impression that the effect of Aripiprazole Krka is too strong or too weak, talk to your doctor or pharmacist.

Aripiprazole Krka should be swallowed.

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

Even if you feel better, do not change or refrain from taking your daily dose of Aripiprazole Krka without first talking to your doctor.

Patients who have taken too much aripiprazole have experienced the following symptoms:

  • rapid heartbeat, anxiety/aggression, speech difficulties.
  • unusual movements (especially of the face or tongue) and decreased level of consciousness.

Other symptoms may include:

  • acute confusion, seizures ( epilepsy ), coma, a combination of fever, faster breathing, sweating.
  • muscle stiffness and drowsiness or drowsiness, slower breathing, suffocation, high or low blood pressure, abnormal heart rhythm.

Contact a doctor or hospital immediately if you experience any of the symptoms described above.

If you forget to use Aripiprazole Krka

If you miss a dose, take it as soon as you remember, but do not take a double dose on the same day.

If you stop using Aripiprazole Krka

Do not stop treatment just to make you feel better. It is important that you continue to take Aripiprazole Krka for as long as your doctor tells you.

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

4. Possible side effects

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

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

  • diabetes mellitus
  • difficulty sleeping
  • anxiety
  • the feeling of restlessness and inability to be still, difficulty sitting still
  • uncontrollable twitching, jerky or twisting movements, restlessness in the legs
  • shaking
  • headache
  • fatigue
  • somnolence
  • fainting sensation
  • shaking and blurred vision
  • decreased bowel movements or difficulty passing stools
  • indigestion
  • nausea
  • abnormally high saliva in the mouth
  • vomiting
  • feeling tired

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

  • increased levels of the hormone et prolactin in the blood
  • too much sugar in the blood
  • Depression
  • altered or increased sexual interest
  • uncontrollable movements of the mouth, tongue, arms and legs ( tardive dyskinesia )
  • muscle disease that causes twisting movements ( dystonia )
  • double vision
  • photosensitive eyes
  • high heart rate
  • drop in blood pressure that occurs when you get up, which causes dizziness, fainting, or fainting
  • hiccup

The following adverse reactions have been reported following the introduction of oral aripiprazole, but their frequency is unknown:

  • low levels of white blood cells
  • low levels of platelets
  • allergic reactions (eg swelling of the mouth, tongue, face, and throat, itching, rash)
  • onset or worsening of diabetes, ketoacidosis (ketones in the blood and urine), or coma
  • high blood sugar
  • insufficient level of sodium in the blood
  • loss of appetite ( anorexia )
  • weight loss
  • weight gain
  • suicidal thoughts, suicide attempts, and suicide
  • aggressiveness
  • agitation
  • concern
  • a combination of fever, muscle stiffness, faster breathing, sweating, decreased consciousness and sudden changes in blood pressure and heart rate, fainting (malignant neuroleptic syndrome)
  • seizures
  • serotonergic syndrome (a reaction that may cause feelings of happiness, drowsiness, clumsiness, restlessness, intoxication, fever, sweating, or stiff muscles)
  • speech changes
  • that the eyeballs are fixed in one position
  • sudden unexplained death
  • life-threatening irregular heartbeat
  • heart attack
  • slower heart rate, blood clots in the veins, especially in the legs (symptoms include swelling, pain, and redness of the leg), which can be transported through the blood vessels to the lungs and cause chest pain and difficulty breathing (if you notice any of these symptoms you must seek medical help immediately )
  • high blood pressure
  • fainting
  • unintentional inhalation of food with the risk of pneumonia
  • spasm in the muscles around the larynx
  • inflammation of the pancreas
  • difficulty swallowing
  • diarrhea
  • a feeling of discomfort in the abdomen
  • stomach upset
  • liver failure
  • inflammation of the liver
  • yellowing of the skin and whites of the eyes
  • reports of abnormal liver values
  • rash
  • photosensitive skin
  • hair loss
  • heavy sweating
  • abnormal muscle breakdown which can lead to kidney problems
  • muscle pain
  • stiffness
  • involuntary urination ( incontinence )
  • difficulty urinating
  • withdrawal symptoms in newborns after exposure during pregnancy
  • persistent and/or painful erection
  • disorders of body temperature regulation (eg fever)
  • chest pain
  • swelling of hands, ankles, or feet
  • in blood tests: rising and falling blood sugar, increase in glycosylated hemoglobin
  • inability to resist the impulse, drive, or desire to perform an act that may be harmful to yourself and others, which may include:
    • a strong impulse to play excessively much despite serious personal or family consequences,
    • altered or increased sexual interest and behavior, of significant inconvenience to you or others, such as increased sexual drive,
    • uncontrollable excessive buying behavior or wasting money,
    • binge eating (eating large amounts of food for a short time) or compulsive eating (eating larger amounts of food than normal and more than is needed to satisfy hunger),
    • a tendency to wander away

Tell your doctor if you experience any of the above behaviors. He or she will discuss how to manage or reduce the symptoms.

In elderly patients with dementia, more deaths have been reported among those using aripiprazole. Furthermore, strokes or transient, mild strokes have been reported.

Y t t Religare side effects in children and adolescents

Adolescents 13 years of age and older experienced side effects similar to those of adults in frequency and type with the exception that drowsiness, uncontrollable twitching or jerky movements, restlessness, and fatigue were very common side effects (occurring in more than 1 in 10 users), and Upper abdominal pain, dry mouth, increased heart rate, weight gain, increased appetite, muscle twitching, uncontrolled movement, and dizziness, especially when getting up from a lying or sitting position, were common side effects (may affect up to 1 in 10 people).

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. 

5. How to store Aripiprazole Krka

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 after EXP. The expiration date is the last day of the specified month.

No special storage 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.

6. Contents of the packaging and other information

Content declaration

The active substance is aripiprazole.

Aripiprazole Krka 5 mg tablets:

Each tablet contains 5 mg of aripiprazole.

Aripiprazole Krka 10 mg tablets:

Each tablet contains 10 mg of aripiprazole.

Aripiprazole Krka 15 mg tablets:

Each tablet contains 15 mg of aripiprazole.

Aripiprazole Krka 30 mg tablets:

Each tablet contains 30 mg of aripiprazole.

The other ingredients are lactose monohydrate, microcrystalline cellulose, corn starch, hydroxypropyl cellulose, red iron oxide (E172) – only in 10 mg and 30 mg tablets, yellow iron oxide (E172) – only in 15 mg tablets, indigo carmine aluminum lacquer (E132) – only in 5 mg tablets, and magnesium stearate. See section 2 “Aripiprazole contains lactose”.

What the medicine looks like and the contents of the pack

5 mg tablets: Blue, round tablets with beveled edges and possibly darker and lighter spots (diameter: 5 mm, thickness: 1.4 – 2.4 mm).

10 mg tablets: Light pink, rectangular tablets, possibly with darker and lighter spots, marked with A10 on one side (length: 8 mm, width: 4.5 mm, thickness: 2.1 – 3.1 mm).

15 mg tablets: Light yellow to brownish yellow, round, slightly biconvex tablets with beveled edges and possibly darker and lighter spots, marked with A15 on one side (diameter: 7.5 mm, thickness: 2.5 – 3.7 mm).

30 mg tablets: Light pink, round, biconvex tablets with beveled edges and possibly darker and lighter spots, marked with A30 on one side (diameter: 9 mm, thickness: 3.9 – 5.3 mm).

Aripiprazole Krka is available in cartons of 14, 28, 30, 50, 56, 60, 84, 90, 98, or 100 tablets in blisters.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

KRKA Sverige AB, Göta Ark 175, 118 72 Stockholm,

Manufacturer

Krka, dd, Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany

Muhammad Nadeem

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