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

1. What Aripiprazole Teva is and what it is used for

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

What you need to know before using Aripiprazole Teva

Do not use Aripiprazole Teva

  • 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 or pharmacist before using Aripiprazole Teva.

Suicidal ideation and suicidal ideation have been reported during treatment with aripiprazole.

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 .

Before you are treated with Aripiprazole Teva, tell your doctor if you have:

  • 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
  • coronary heart disease, cardiovascular disease in the family, stroke ( stroke ) or transient, light 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 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

Aripiprazole Teva should not be used in children or adolescents under 15 years of age. Ask your doctor or pharmacist for advice before taking Aripiprazole Teva.

Other medicines and Aripiprazole Teva

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

Antihypertensive drugs: Aripiprazole Teva 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 Teva is taken with certain other medicines, your doctor may need to change the dose of Aripiprazole Teva. 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 )
  • antifungal drugs (such as ketoconazole, itraconazole)
  • certain medicines to treat HIV infection (such as efavirenz, nevirapine and protease inhibitors such as indinavir, ritonavir)
  • antiepileptic drugs (such as carbamazepine, phenytoin, phenobarbital, primidone)
  • certain antibiotics used to treat tuberculosis (rifabutin, rifampicin)

These medicines may increase the risk of side effects or reduce the effect of Aripiprazole Teva. If you get any unusual symptoms while taking any of these medicines with Aripiprazole Teva you need to see 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:

  • 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 (traditional) herbal medicine for 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 Teva you need to see a doctor.

Aripiprazole Teva with food and alcohol

Aripiprazole Teva tablets 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 Teva 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 Teva, 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

Do not drive or use any tools or machines until you know how Aripiprazole Teva affects you.

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 Teva contains lactose and sodium

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

This medicine contains less than 1 mmol sodium (23 mg), ie essentially ‘sodium-free’.

How to use Aripiprazole Teva

Always use 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 Teva is too strong or too weak, talk to your doctor or pharmacist.

Aripiprazole Teva should be swallowed.

Try to take the tablet at the same time each day. It does not matter if you take it with or without food.

For 5 mg only

Always swallow the tablet whole with water.

For 10/15/30 mg only

Always swallow the tablet with water. The tablet can be divided into two equal doses.

Even if you feel better, do not change or stop taking your daily dose of Aripiprazole Teva tablets without first talking to your doctor.

If you use more Aripiprazole Teva than you should 

If you realize that you have taken more tablets than your doctor recommended (or if someone else has taken any of your tablets), contact a doctor immediately. If you cannot reach your doctor, go to the nearest hospital and take the medicine pack with you.

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 Teva

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

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

If you stop using Aripiprazole Teva

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

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,
  • feeling of restlessness and inability to stand still, difficulty sitting still,
  • uncontrollable twitching, jerking or twisting movements, restlessness in the legs,
  • shaking,
  • headache,
  • fatigue,
  • somnolence,
  • fainting,
  • tremors and blurred vision,
  • decreased bowel movements or difficulty in bowel movements,
  • 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,
  • a drop in blood pressure that occurs when you get up, which causes dizziness, fainting or fainting,
  • hiccup.

The following side effects have been reported since the introduction of oral aripiprazole, but the frequency of these is unknown (occurs in an unknown number of users):

  • 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,
  • 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 can cause 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 bone), 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, 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,
  • the 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,
  • photosensitivity,
  • 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,
    • 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.

Additional side effects in children and adolescents

Adolescents 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 (may occur in more than 1 in 10 users), and abdominal pain in the upper region, 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 Teva

Keep this medicine out of the sight and reach of children.

Blister:

Do not use this medicine after the expiry date which is stated on the blister, jar, and carton after EXP. The expiration date is the last day of the specified month.

No special storage instructions.

HDPE cans (5/10/15/30 mg):

Do not use this medicine after the expiry date which is stated on the label or carton after EXP. The expiration date is the last day of the specified month.

Shelf life after first opening: 6 months

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.

Each tablet contains 5 mg of aripiprazole

Each tablet contains 10 mg of aripiprazole.

Each tablet contains 15 mg of aripiprazole.

Each tablet contains 30 mg of aripiprazole.

  • The other ingredients are lactose monohydrate, microcrystalline cellulose, corn starch, yellow iron oxide (E172) ( only 5 mg and 15 mg ), red iron oxide (E172) ( only 10 mg and 30 mg ), hydroxypropyl cellulose, croscarmellose sodium, magnesium stearate.

What the medicine looks like and the contents of the pack

5 mg

Light yellow, round, flat tablets with beveled edges, marked with “5” on one side and unmarked on the other side.

10 mg

Pink to light pink, oblong tablets, marked with “10” on one side and with a break notch on the other side.

The tablet can be divided into two equal doses.

15 mg

Light yellow, round, flat tablets with beveled edges, marked with “15” on one side and with a notch on the other side.

The tablet can be divided into two equal doses.

30 mg

Pink to light pink, round, biconvex tablets, marked with “30” on one side and with a notch on the other side.

The tablet can be divided into two equal doses.

5 mg

Pack sizes: 7, 7×1, 14, 14×1, 15, 28, 28×1, 30, 49, 56, 56×1, 60, 98, 98×1 and 100 tablets

10 mg

Pack sizes: 7, 7×1, 14, 14×1, 28, 28×1, 30, 49, 56, 56×1, 60, 98, 98×1 and 100 tablets

15 mg

Pack sizes: 7, 7×1, 14, 14×1, 28, 28×1, 30, 49, 56, 56×1, 60, 98, 98×1 and 100 tablets

30 mg

Pack sizes: 7, 7×1, 14, 14×1, 28, 28×1, 30, 49, 56, 56×1, 60, 98, 98×1 and 100 tablets

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Manufacturer

PLIVA Hrvatska doo (PLIVA Croatia Ltd.), Zagreb, Croatia

Merckle GmbH, Blaubeuren, Germany

Teva Pharma BV, Haarlem, The Netherlands

Teva Operations Poland Sp. zoo, Krakow, Poland

Muhammad Nadeem

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