5 mg, 10 mg, 15 mg, 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 you will find information about: 
1. What Aripiprazole Accord Healthcare is and what it is used for 
2. What you need to know before taking Aripiprazole Accord Healthcare 
3. How to take Aripiprazole Accord Healthcare 
4. Possible side effects 
5. How to take Aripiprazole Accord Healthcare to be stored 
6. Contents of the packaging and other information 

What Aripiprazole Accord Healthcare is and what it is used for

Aripiprazole Accord Healthcare 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 are not there, are suspicious, believe wrong things, speak and behave inconsistently and show a deficiency in emotions. People in this condition may also feel depressed, guilty, anxious, or tense.

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

Aripiprazole contained in Aripiprazole Accord Healthcare may also be approved for the treatment of other conditions not mentioned in this product information. 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 take Aripiprazole Accord Healthcare

Do not use Aripiprazole Accord Healthcare

  • 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 Accord Healthcare.

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 you are treated with Aripiprazole Accord Healthcare, 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 disease, cardiovascular disease in the family, stroke or “mini-stroke”, abnormal blood pressure
  • blood clots, or blood clots in the family, because an association between antipsychotic drugs and the formation of blood clots has been seen
  • 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 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 sexual 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 Aripiprazole Accord Healthcare. It is not known if it is safe and effective for these patients.

Other medicines and Aripiprazole Accord Healthcare

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 Accord Healthcare may increase the effect of drugs used to lower blood pressure. Therefore, tell your doctor if you are taking any medicine to keep your blood pressure under control.

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

  • drugs to correct the heart rhythm (such as quinidine, amiodarone, flecainide )
  • antidepressants or (traditional) herbal and herbal medicines used to treat depression, anxiety or depression (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 Accord Healthcare. If you get any unusual symptoms while taking any of these medicines with Aripiprazole Accord Healthcare, 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 (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 drugs increase the risk of side effects. If you get any unusual symptoms while taking any of these medicines with Aripiprazole Accord Healthcare, you must consult a doctor.

Aripiprazole Accord Healthcare with food, drink, and alcohol

Aripiprazole Accord Healthcare 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 for advice before using this medicine.

In newborns whose mothers have taken Aripiprazole Accord Healthcare 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 Accord Healthcare, 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 should be taken into account in cases where full attention is required, e.g. 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 Accord Healthcare contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take Aripiprazole Accord Healthcare

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

You should start with a low dose of the oral solution (in liquid form) of this medicine. 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 one (up to a maximum of 30 mg once daily).

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

Try to take the Aripiprazole Accord Healthcare tablet 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 Accord Healthcare 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 take Aripiprazole Accord Healthcare

If you miss a dose, take it as soon as you remember. Do not take a double dose to make up for a forgotten tablet.

If you stop taking Aripiprazole Accord Healthcare

Do not stop treatment just to make you feel better. It is important that you continue to take Aripiprazole Accord Healthcare tablets 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.

V antigen effects (may affect up to 1 in 10): 

  • diabetes mellitus
  • difficulty sleeping
  • anxiety
  • a 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 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 pulse
  • 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:

  • 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 can 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 pulse
  • 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 you must seek medical help immediately)
  • Hypertension
  • 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
  • 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 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.

Additional 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 (occurs in more than 1 in 10 users) and abdominal pain in the upper back region, dry mouth, increased heart rate, weight gain, increased appetite, muscle twitching, uncontrolled movements, and dizziness, especially when getting up from a lying or sitting position, were common (affects more than 1 user in 100).

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. Postal address

5. How to store Aripiprazole Accord Healthcare

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 blister or can label and on the carton after EXP. The expiration date is the last day of the specified month.

Blister:

No special temperature instructions. Store in the original package. Moisture sensitive.

Can:

Do not store above 30 ° C. Close the jar tightly. Moisture sensitive.

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, 10 mg, 15 mg, or 30 mg of aripiprazole.
  • The other ingredients are lactose monohydrate, corn starch, microcrystalline cellulose, hydroxypropyl cellulose, magnesium stearate.

What the medicine looks like and the contents of the pack

Aripiprazole Accord Healthcare 5 mg tablets are round, biconvex and white, 5 mm, marked with “5” on one side and “ZL” on the other side.

Aripiprazole Accord Healthcare 10 mg tablets are capsule-shaped, biconvex and white, 8 mm x 5 mm, marked “10” on one side and “ZL” on the other side.

Aripiprazole Accord Healthcare 15 mg tablets are round, biconvex and white, 7 mm, marked “15” on one side and “ZL” on the other side.

Aripiprazole Accord Healthcare 30 mg tablets are round, biconvex and white, 9 mm, marked “30” on one side and “ZL” on the other side.

Pack sizes:

Blister packs with permeable foil: 14, 28, 30, 56, and 98 tablets respectively.

Jars with or without desiccant: 100 tablets

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Accord Healthcare BV

Winthontlaan 200

3526 VK Utrecht

Netherlands

Manufacturer

Actavis Ltd., BLB016, Bulebel Industrial Estate, Zejtun ZTN 3000, Malta.

Actavis ehf., Reykjavíkurvegur 78, 220 Hafnarfjörður, Iceland.

Balkanpharma-Dupnitsa AD, 3, Samokovsko shosse Str., 2600 Dupnitsa, Bulgaria

Manufacturing Packaging Farmacia (MPF) BV

Appelhof 13, Oudehaske, 8465RX, The Netherlands or Neptunus 12, Herenveen, 8448CN, The Netherlands

Actavis Group PTC ehf. Reykjavikurvegur 78, 220 Hafnarfjörður Iceland 

Muhammad Nadeem

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