25 mg, 100 mg, 200 mg, 300 mg film-coated tablets
quetiapine

What Quetiapine Orion is and what it is used for

Quetiapine Orion contains a substance called quetiapine. This belongs to a group

drugs called antipsychotics.

Quetiapine Orion can be used to treat several diseases, such as:

  • Bipolar depression: when you may feel down. You can feel depressed, heavy in debt, lack energy has poor r appetite,t,e or have sleep problems.
  • Mania: when you may feel very upset, elated, upset, enthusiastic, or hyperactive or have poor judgment with elements of aggressive and fragmented behavior.
  • Schizophrenia: when you may see or hear things that do not exist, believe in things that are not real, or feel unusually suspicious, anxious, confused, guilt-laden, tense, or depressed.

Your doctor may want you to continue taking Quetiapine Orion even when you do 

feel better.

Quetiapine contained in Quetiapine Orion may also be approved for the treatment of others 

diseases not mentioned in this product information. Ask your doctor, pharmacist, or, another healthcare professional if you have any further questions,d always follow their 

instruction.

What you need to know before you use Quetiapine Orion

Do not use Quetiapine Orion

Do not take Quetiapine Orion

  • If you are allergic to quetiapine or any of the other ingredients of this ingredient medicines (listed in section 6).
  • If you are taking any of the following medicines:
    • certain medicines for HIV
    • azoles (medicines for fungal infections)
    • erythromycin or clarithromycin (medicines for infections)
    • nefazodone (antidepressant).

If you are not sure, talk to your doctor or pharmacist before taking Quetiapine Orion.

Warnings and cautions

Talk to your doctor or pharmacist before taking Quetiapine Orion if:

  • you or someone in your family has or has had a heart problem, for example,, art rhythm disorders, weak heart muscle or inflammation of the heart, or if you are taking any medicines that may affect your heart rate
  • you have low blood pressure
  • you have had a stroke, especially if you are older
  • you have liver problems
  • have you ever had a seizure ( epilepsy )
  • you have diabetes or are at risk of getting diabetes. Then your doctor may need to measure your blood sugar level when you use Quetiapine Orion.
  • you know that you have previously had a low level of white blood cells (which may have been, or not been, caused by other drugs)
  • you are older and suffering from dementia (a loss of brain function). About this suit, you, do not take this medicine, as the group of Drugs to which these tablets belong may increase the risk of stroke, r in some cases the risk of death, in elderly people with dementia.
  • you are older and suffering from Parkinson’s disdisease/parkinsonism or someone in your family has had a blood clot, because similar medications have as been associated with the formation of blood clots
  • you have or have had a condition where you stop breathing for short rt per periods during normal night’s sleep (called ‘sleep apnea’) and taking medicines such as reduces the normal activity of the brain (“sedatives”)
  • you have or have had a condition where you can not empty the bladder completely ( urinary retention ), has an enlarged prostate, blockage in the intestines, or, increased pressure ins inside thee. These conditions are sometimes caused by drugs (called “anticholinergics”) that affect the way nerve cells work to treat certain diseases stastatesou have or have had problems with alcohol or drug abuse.

Talk to your doctor immediately if you experience any of the following after taking this 

medicine:

  • a combination of fever, severe muscle stiffness, sweating or, drooping level of consciousness (a condition called neuroleptic malignant syndrome). You cancan need to mediate medical attention.
  • uncontrollable movements, especially in the face or tongue
  • dizziness, or, a severe feeling of drowsiness. This can increase the risk of accidents in elderly patients.
  • seizures ( epilepsy )
  • a prolonged and painful erection (priapism).

Such conditions can be caused by this type of drug.

Tell your doctor as soon as possible if you get:

  • fever, flu-like symptoms, sore throat, or any other infection, because this could be due to a very low number of white blood cells, which can require discontinuation of Quetiapine Orion andand/treatment for infection
  • constipation along with persistent abdominal pain or constipation that hat does respond to treatment, as this can lead to a more severe blockage of the intestine.

Suicidal thoughts and worsening of your depression

If you are depressed, you may sometimes have thoughts of wanting to hurt yourself or commit 

suicide. These symptoms may worsen when you start treatment, as it takes 

time before drugs of this type take effect, usually about 2 weeks, sometimes longer 

time. Thoughts of this type can also increase if you suddenly stop taking your medicine. These 

Thoughts can be common if you are a young adult. Studies have shown that young adults, younger 

than 25 years, with depression ha, shave an increased risk of suicidal thoughts and/or suicidal behavior.

Contact a doctor as soon as possible or go to the nearest hospital if you have thoughts of injuring yourself or committing suicide. It can be helpful to tell a relative or 

close friend that you are depressed. Also as,k them to read this leaflet. You can 

Also, ask them to tell you if they think your depression is getting worse or if 

they are worried that your behavior will change.

Severe skin reactions (SCAR)

Severe skin reactions (SCARs) that can be life-threatening or fatal have been reported extensively

rain e cases during treatment with this medicine. These usually appear as:

  • Stevens-Johnson syndrome (SJS), a wise widespread skin rash with blisters and skin detachment, especially around the mouth, nose, eyes an,d genitals
  • Toxic epidermal necrolysis (TEN), a more serious form that causes extensive skin detachment
  • Drug-induced skin rash with eosinophilia and systemic symptoms (DRESS) consisting of influenza-like symptoms with rash, fever, swollen glands an,d abnormal results of blood tests (including incan rease in white blood cells ( eosinophilia ) and liver enzymes)
  • Acute generalized exanthematous pustulosis (AGEP), small blisters filled with var
  • Erythema multiforme (EM), skin rash with itchy irregular red spots.

Stop using Quetiapine Orion if you get these symptoms and contact your doctor or see a doctor immediately.

Weight gain

Some patients taking Quetiapine Orion have been shown to gain weight. You and your doctor should check your weight regularly.

Children and young people

Quetiapine Orion should not be used in children and adolescents under 18 years of age.

Other medicines and Quetiapine Orion

Tell your doctor or pharmacist if you are taking, have recently taken, or, might need to take 

take other medicines.

Do not take Quetiapine Orion if you are taking any of the following medicines:

  • certain medicines for HIV
  • azoles (medicines for fungal infections)
  • erythromycin or clarithromycin (medicines for infections)
  • nefazodone (antidepressant).

Tell your doctor if you are taking any of the following medicines:

  • epilepsy drugs (such as phenytoin or carbamazepine)
  • medicines for high blood pressure
  • barbiturates (medicines for sleep disorders)
  • thioridazine or lithium (other antipsychotics)
  • drugs that affect the heartbeat, such as drugs that can cause electrolyte imbalances (low levels of potassium or magnesium ) such as diuretics (diuretics) or certain antibiotics (drugs for infections)
  • drugs that can cause constipation
  • drugs (called “anticholinergics”) that affect the function of nerve cells to treat certain disease states.

Talk to your doctor before stopping any of these medications.

Quetiapine Orion with food, drink an,d alcohol

  • The tablets can be taken with or without food.
  • You should be careful about how much alcohol you drink because of it The combined effects of this medication and alcohol can make you sleepy.
  • Do not drink grapefruit juice while taking this medicine. It may affect the way theanine works.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or, are planning to have a baby, 

consult a doctor before using Quetiapine Orion. You should not take this medicine 

during pregnancy, you have not discussed this with your doctor. You should not take quetiapine tablets if you are breast-feeding.

The following symptoms, which correspond to disthe comfort that may occur when you stop 

the drug, may occur in newborns of mothers who have used quetiapine during the last trimester (the last three months of pregnancy): tremors, muscle stiffness, and/or weakness, drowsiness, irritability, breathing problems, and 

problems eating. If your child has any of these symptoms, you may need to 

consult a doctor.

Driving and using machines

Your tablets can make you sleepy. Do not drive or use tools or 

machines until you know how the tablets affect 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 because of their 

effects and/orde effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss 

with your doctor or pharmacist if you are not sure.

Quetiapine Orion contains excipients

Quetiapine Orion contains lactose

Quetiapine Orion tablets contain lactose which is This medicine contains 4.9 mg (in 25 mg tablets), 19.7 mg (in 100 mg tablets), 39.3 mg (in 200 mg tablets) and 59 mg (in 300 mg tablets) ) lactose (as monohydrate). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine 

this medicine.

Other excipients

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

How to use Quetiapine Orion

Always take this medicine exactly as your doctor has told you. Consult a doctor or 

pharmacy staff if you are unsure. Your doctor will determine your starting dose. 

The maintenance dose (the daily dose) depends on your illness and your needs but is usually between 150 mg and 800 mg.

  • You should take the tablets once a day, at night, or twice a day, depending on your illness
  • Swallow the tablets whole with a glass of water
  • You can take the tablets with or without food
  • Do not drink grapefruit juice while taking quetiapine tablets. It may affect the way medicine works.
  • Do not stop taking your tablets even if you feel better unless your doctor tells you to.

Liver problem

If you have liver problems, your doctor may change the dose.

Older

If you are older, your doctor may change your dose.

Use for children and adolescents

Quetiapine tablets should not be used by children and adolescents under 18 years of age.

If you use more Quetiapine Orion than you should  

If you have ingested too much medicine or if e.g. a child ingested the drug 

risk assessment and advice. Take the Quetiapine Orion tablets with you.

If you take more doses than your doctor prescribes, you may feel drowsy, dizzy, and dizzy 

feel the heart beating abnormally.

If you forget to use Quetiapine Orion

If you forget to take a dose, take it as soon as you remember. If it is soon 

time for the next dose, wait until then. Do not take you to be dose to make up for fora gotten 

tablet.

If you stop using Quetiapine Orion

If you suddenly stop taking Quetiapine Orion, you may have difficulty falling asleep 

(insomnia), feefeeluseous or, or experiencing headaches, diarrhea, vomiting, dizziness

order efeelingritable. Your doctor may suggest that you gradually reduce the dose before you 

end your treatment.

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

Possible side effects

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

do not need to get them.

Very common (may affect more than 1 user in 10):

  • dizziness (may lead to falls), headache, dry mouth
  • drowsiness (may disappear with time when you take Quetiapine Orion) (may lead to falls)
  • discontinuation symptoms (symptoms that occur when you stop taking Quetiapine Orion) that include difficulty falling asleep (insomnia), malaise (nausea), headache, diarrhea, vomiting, dizziness, and irritability. It is advisable to stop taking the medicine gradually over at least 1-2 weeks.
  • weight gain
  • abnormal muscle movements, e.g. difficult to start movements, shaking, a feeling of restlessness, or muscle stiffness without pain
  • altered levels of certain fats ( triglycerides and total cholesterol).

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

  • fast heartbeat
  • feeling that the heart is pounding, rushing, or skipping a heartbeat
  • constipation, upset stomach (digestive problems)
  • impotence
  • swelling in arms or legs
  • drop in blood pressure when you get up. This may make you feel dizzy or faint (which may lead to falls).
  • increased blood sugar content
  • dimsyn
  • abnormal dreams and nightmares
  • increased feelings of hunger
  • feeling of irritation
  • speech and language disorders
  • suicidal thoughts and worsening of your depression
  • shortness of breath
  • vomiting (mainly in the elderly)
  • fever
  • altered levels of thyroid hormones in the blood
  • decreased levels of certain types of blood cells
  • increased content of liver enzymes measured in blood samples
  • increased level of the hormone prolactin in the blood. An increase in the hormone prolactin can in rare cases lead to the following:
    • men and women can get a swelling of the breasts and unexpected production of breast milk
    • in women, menstruation may cease or become irregular.

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

  • epilepsy or seizures
  • allergic reactions which may include raised lumps or streaks, skin swelling, and swelling around the mouth
  • the feeling of discomfort in the legs (also called restless legs (RLS))
  • difficulty swallowing
  • involuntary movements, especially of the face and tongue
  • sexual dysfunction
  • diabetes
  • change in the electrical activity of the heart that can be seen on the ECG ( QT prolongation)
  • a slower-than-normal heart rate may occur at the beginning of treatment and may be associated with low blood pressure and fainting
  • difficulty urinating
  • fainting (may lead to falls)
  • nasal congestion
  • reduced level of red blood cells
  • lowered sodium levels in the blood
  • worsening diabetes
  • confusion.

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

  • a combination of fever, sweating, muscle stiffness, severe drowsiness, or fainting (a condition called ‘malignant neuroleptic syndrome’)
  • yellow skin and eyes (jaundice)
  • hepatitis _ _
  • persistent and painful erection (priapism)
  • swelling of the breasts and unexpected production of breast milk ( galactorrhea )
  • menstrual disorder
  • blood clots in the veins, especially in the legs (with symptoms such as swelling, pain, and redness ) can be passed on in the blood vessels to the lungs and cause chest pain and difficulty breathing. If you get symptoms similar to these, see a doctor immediately.
  • that you walk, talk, eat or have other activities while you sleep
  • lowered body temperature ( hypothermia )
  • pancreatitis
  • a condition (so-called “metabolic syndrome”) in which you may have a combination of at least 3 of the following signs: an increase in abdominal fat, a decrease in “the good cholesterol ”( HDL-C ), an increase in a type of fat in the blood called triglycerides, high blood pressure and an increase in blood sugar
  • a combination of fever, flu-like symptoms, sore throat, or any other infection with a very low number of white blood cells (a condition called agranulocytosis )
  • blockage of the intestine
  • increased level of creatine phosphokinase in the blood (a substance that comes from the muscles).

Very rare (may affect up to 1 in 10,000 people):

  • severe rash, blisters, or red spots on the skin
  • severe allergic reaction ( anaphylactic reaction ) which may cause difficulty breathing or shock
  • rapid swelling of the skin, usually around the eyes, lips, and neck ( angioedema )
  • a serious disease with blistering of the skin, mouth, eyes, and genitals (Stevens-Johnson syndrome). See section 2.
  • disturbed secretion of a hormone that regulates urine volume
  • degradation of muscle fibers and muscle pain ( rhabdomyolysis ).

No known frequency (can not be calculated from the available data):

  • skin rash with irregular red spots (erythema multiforme). See section 2.
  • rapidly emerging areas of red skin with small blisters filled with white / yellow fluid called acute generalized exanthematous pustulosis (AGEP). See section 2
  • severe, sudden allergic reaction with symptoms such as fever, blisters, and peeling of the skin (toxic epidermal necrolysis), See section 2.
  • drug reaction with eosinophilia and systemic symptoms (DRESS) consisting of flu-like symptoms with rash, fever, swollen glands, and abnormal results of blood tests (including an increase in white blood cells ( eosinophilia ) and liver enzymes). See section 2.
  • Disorders associated with discontinuation of the drug may occur in newborns to mothers who have used Quetiapine Orion during pregnancy.
  • stroke.

Quetiapine Orion belongs to a type of medicine that can cause heart rhythm disorders. Such disorders can be serious and, in severe cases, fatal.

Some side effects are only visible if you take a blood sample. This includes changed 

levels of certain fats ( triglycerides and total cholesterol ) or sugar in the blood, altered levels of thyroid hormones in the blood, elevated levels of liver enzymes, 

decrease in the number of certain types of blood cells, decreased level of red blood cells, increased 

amount of creatine phosphokinase in the blood (a substance in the muscles), decreased amount of sodium 

in the blood and increase in od levels of a hormone called prolactin. An increase 

of the hormone pr,olactin may in rare cases lead to:

  • men and women can get a swelling of the breasts and unexpected production of breast milk
  • Women can lose their menstrual period or get irregular menstruation. 

Your doctor may sometimes ask you to take a blood sample.

Additional side effects in children and adolescents

The same side effects that can occur in adults can also occur in children and 

young people. The following side effect has been seen more often in children and adolescents or has not

seen in adults:

Very common (may affect more than 1 user in 10):

  • the increased amount of the hormone prolactin in the blood. Increased amounts of the hormone prolactin may in rare cases lead to the following:
    • the breasts can swell in both boys and girls and unexpectedly form breast milk
    • menstruation may cease or become irregular in girls
  • increased appetite
  • vomiting
  • abnormal muscle movements. This includes difficulty in initiating muscle movements, tremors, a feeling of restlessness, or muscle stiffness without pain.
  • increased blood pressure.

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

  • weakness, fainting (may lead to falls)
  • nasal congestion
  • that you feel annoyed.

How to store Quetiapine Orion

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 blister. 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 pharmacy staff how to dispose of medicines no longer required. These measures are for 

to protect the environment.

6. Contents of the pack and other information

Content declaration

  • The active substance is quetiapine. A film-coated tablet contains 25, 100, 200 or 300 mg of quetiapine (as quetiapine fumarate).
  • The other ingredients are microcrystalline cellulose, calcium hydrogen phosphate dihydrate, lactose monohydrate, sodium starch glycolate, povidone, magnesium stearate, and silica, colloidal, anhydrous.
  • Ingredients in the tablet coating are hypromellose, titanium dioxide, macrogol (E1521), and iron oxide.

What the medicine looks like and conthe tents of the pack

25 mg: Peach-colored, round, film-coated tablet, diameter 6 mm, marked ‘F71’ on one side and smooth on the other side.

100 mg: Yellow, round, film-coated tablet, diameter 9 mm, marked ‘F73’ on one side and smooth on the other side.

200 mg: White, round, film-coated tablet, diameter 11 mm, marked ‘F75’ on one side and smooth on the other side.

300 mg: White, capsule-shaped, film-coated tablet, length 19 mm, marked ‘F76’ on one side and smooth on the other side.

The tablets are packaged in blister packs of 10, 30, 60, 90, or 100 tablets. Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Orion Corporation 

Orionintie 1

FI-02200 Espoo

Finland

Manufacturer

Orion Corporation

Orionintie 1

FI-02200 Espoo

Finland

Orion Corporation

Joensuunkatu 7

FI-24100 Salo

Finland

For further information on this medicine, please contact your local representative:

Orion Pharma AB, Danderyd

medinfo@orionpharma.com

Muhammad Nadeem

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