50 mg, 150 mg, 200 mg, 300 mg, 400 mg prolonged-release tablets are
quetiapine
What Seroquel Depot is and what it is used for
Seroquel Depot contains a substance called quetiapine. Quetiapine belongs to a group of medicines called antipsychotics. Seroquel Depot can be used to treat several ailments, such as:
- Bipolar depression and depressive episodes in real depression: when you may feel depressed or depressed, guilt-laden, lacking energy, have a poor appetite or have sleep problems.
- Mania: when you may feel very upset, elated, upset, enthusiastic, hyperactive, or have poor judgment with elements of aggressive and fragmented behavior.
- Schizophrenia: when you may see, hear or feel things that do not exist, believe in things that are not real, or feel unusually suspicious, anxious, confused, tense, or depressed.
When Seroquel Depot is taken to treat depressive episodes in case of major depression, it is taken in addition to other medications used to treat this disease.
Your doctor may want you to continue taking Seroquel Depot even when you feel better.
Quetiapine contained in Seroquel Depot 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 Seroquel Depot
Do not take Seroquel Depot:
- if you are allergic to quetiapine or any of the other ingredients of this medicine (listed in section 6)
- if you are taking any of the following medicines:
- certain medicines for HIV
- azoles (medicines for fungal infections)
- erythromycin and clarithromycin (medicines for infections )
- nefazodone (antidepressant).
If you are not sure, talk to your doctor or pharmacist before taking Seroquel Depot.
Warnings and cautions
Talk to your doctor or pharmacist before using Seroquel Depot:
- if you or someone in your family has or has had a heart problem, such as heart rhythm disorders, weak heart muscle, or inflammation of the heart, or if you are taking any medicines that may affect your heart rate
- if you have low blood pressure
- if you have had a stroke, especially if you are older
- if you have liver problems
- if you have ever had a seizure ( epilepsy )
- if you have diabetes or are at risk of getting diabetes. If you have it, your doctor may need to measure your blood sugar level when you use Seroquel Depot.
- if you know you have had low white blood cell counts in the past (which may or may not have been caused by other medicines)
- if you are older and suffer from dementia (a loss of brain function). If this is true for you, do not take Seroquel Depot, as the group of medicines to which Seroquel Depot belongs may increase the risk of stroke, or in some cases the risk of death, in elderly people with dementia.
- if you are older and suffering from Parkinson’s disease/parkinsonism
- if you or someone in your family has had a blood clot, as similar medicines have been linked to the formation of blood clots
- if you have or have had a condition where you stop breathing for short periods during your normal night’s sleep (called “sleep apnea”) and take medicines that reduce the normal activity of the brain (“sedatives”)
- if you have or have had a condition where you cannot empty the bladder completely ( urinary retention ), have an enlarged prostate, a blockage in the intestines, or increased pressure inside the eye. These conditions are sometimes caused by drugs (called “anticholinergics”) that affect the function of nerve cells to treat certain conditions.
- if you have or have had problems with alcohol or drug abuse.
Tell your doctor immediately if you experience any of the following after taking Seroquel Depot:
- a combination of fever, severe muscle stiffness, sweating, or decreased consciousness (a condition called malignant neuroleptic syndrome). You may need immediate medical attention.
- uncontrollable movements, especially on the face or tongue.
- dizziness or troublesome drowsiness. In older patients, this could increase the risk of accidental injuries (by falling)
- seizures
- prolonged and painful erection (priapism)
- rapid irregular heartbeat even at rest, palpitations, breathing problems, chest pain, or unexplained fatigue. The doctor needs to examine your heart and, if necessary, send (refer) you immediately to a cardiologist.
Such conditions can be caused by this type of drug.
Talk to a doctor as soon as possible if you get:
- fever, flu-like symptoms, sore throat, or any other infection, as this could be due to a very low white blood cell count, which may require discontinuation of Seroquel Depot and/or treatment for infection
- constipation along with persistent pain in the stomach or constipation that does not respond to treatment, as this can lead to a more severe blockage of the intestine.
- Suicidal thoughts and worsening depression
You who are depressed can sometimes have thoughts of wanting to hurt yourself or commit suicide. These symptoms may worsen when you start treatment, as it takes time for a drug of this type to take effect, usually about 2 weeks, but sometimes longer. 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. Clinical studies have shown that young adults (younger than 25 years) with depression have an increased risk of suicidal thoughts and/or thoughts of self-harm.
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. Feel free to ask them to read this leaflet. You can also ask them to tell you if they think the depression is getting worse or if they think your behavior is changing.
Severe skin reactions (SCAR)
Severe skin reactions (SCARs) that can be life-threatening or fatal have been reported in very rare cases during treatment with this medicine. These usually appear as:
- Stevens-Johnson syndrome (SJS), is a widespread rash with blisters and skin detachment, especially around the mouth, nose, eyes, and 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 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).
- Acute generalized exanthematous pustulosis (AGEP), small blisters filled with var
- Erythema multiforme (EM), skin rash with itchy irregular red spots
Stop using Seroquel Depot if you get these symptoms and contact your doctor or see a doctor immediately.
Weight gain
Some patients taking Seroquel Depot have been shown to gain weight. You and your doctor should check your weight regularly.
Children and young people
Seroquel Depot should not be used by children and adolescents under 18 years of age.
Other medicines and Seroquel Depot
Tell your doctor if you are taking, have recently taken, or might take any other medicines.
Do not take Seroquel Depot 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 an imbalance in the electrolytes (low levels of potassium or magnesium ) such as diuretics ( diuretics ) or certain antibiotics (medicines for infections )
- drugs that can cause constipation
- drugs (called “anticholinergics”) that affect the way nerve cells work to treat certain conditions.
Talk to your doctor before stopping any of these medicines.
Seroquel Depot with food, drink, and alcohol
- Seroquel Depot can be affected by food and you should therefore take your tablets at least 1 hour before a meal or before bedtime.
- You should be careful about how much alcohol you drink as the combination of Seroquel Depot and alcohol can make you sleepy.
- Do not drink grapefruit juice while taking Seroquel Depot. It may affect the way medicine works.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before using this medicine. You should not take Seroquel Depot during pregnancy unless you have discussed it with your doctor.
You should not take Seroquel Depot if you are breastfeeding.
The following symptoms, which are similar to those that may occur when you stop taking the medicine, may occur in newborns of mothers who have used Seroquel Depot during the last trimester (last three months of pregnancy): tremors, muscle stiffness, and/or muscle weakness, drowsiness, anxiety, breathing problems and difficulty 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 any 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 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.
Seroquel Depot contains lactose
Seroquel Depot contains lactose (a sugar). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Seroquel Depot contains sodium
Seroquel Depot 50 mg prolonged-release tablets, Seroquel Depot 150 mg prolonged-release tablets, and Seroquel Depot 200 mg prolonged-release tablets contain less than 1 mmol (23 mg) sodium per tablet, ie are essential ‘sodium-free’.
Seroquel Depot 300 mg prolonged-release tablets and Seroquel Depot 400 mg prolonged-release tablets contain 27 mg of sodium (the main ingredient in table salt/table salt) per tablet. This corresponds to 1.35% of the maximum recommended daily sodium intake for adults.
Effects on drug tests in urine
If you are taking a urine sample for a drug test, using Seroquel may make you test positive for methadone or certain antidepressants called tricyclic antidepressants (TCAs). This can happen when certain test methods are used, even though you may not be taking methadone or TCA, in which case a more specific test may be performed.
How to take Seroquel Depot
Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
Your doctor will decide on your starting dose. The maintenance dose (the daily dose one) depends on your illness and your needs but is normally between 150 mg and 800 mg.
- You should take the tablets once a day.
- Do not divide, chew or crush the tablets.
- Swallow the tablets whole with a glass of water.
- Take the tablets without food (at least 1 hour before a meal or at night – your doctor will tell you which time is best).
- Do not drink grapefruit juice while taking Seroquel Depot. 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 your dose.
Older
If you are older, your doctor may change your dose.
Use for children and adolescents
Seroquel Depot should not be used by children and adolescents under 18 years of age.
If you take more Seroquel Depot than you should
If you have ingested too much medicine or if, for example, a child has accidentally ingested the medicine, contact a doctor or hospital for risk assessment and advice. If you take more doses than your doctor prescribes, you may feel drowsy, dizzy, and feel your heart beating abnormally. Bring the Seroquel Depot tablets.
If you forget to take Seroquel Depot
If you forget to take a tablet, take it as soon as you remember. If it’s soon time for the next tablet, wait until then. Do not take a double dose to make up for a forgotten tablet.
If you stop taking Seroquel Depot
If you suddenly stop taking Seroquel Depot, you may have difficulty sleeping, feel nauseous or experience headaches, diarrhea, vomiting, dizziness, or feel irritable. Your doctor may suggest that you reduce the dose gradually before stopping 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.
Very common: may affect more than 1 user in 10
- dizziness (may lead to falls), headache, dry mouth
- drowsiness (may disappear with time when taking Seroquel Depot ) (may lead to falls)
- discontinuation symptoms (symptoms that occur when you stop taking Seroquel Depot ) 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, tremors, 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 users
- 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. It may make you feel dizzy or faint (which may lead to falls)
- increased blood sugar content
- dimsyn
- strange 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 levels of the hormone et prolactin in the blood. An increase in the hormone et prolactin may 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 that may include raised lumps or streaks, skin swelling, and swelling around the mouth
- the feeling of discomfort in the legs (also called restless legs syndrome)
- difficulty swallowing
- involuntary movements, especially of the face and tongue
- sexual dysfunction
- diabetes
- change in heart electrical activity that can be seen on 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 levels of red blood cells
- lowered sodium levels in the blood
- worsening diabetes
- confusion.
Rare: may affect up to 1 in 1,000 users
- a combination of fever, sweating, muscle stiffness, 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, you should see a doctor immediately.
- that you walk, talk, eat or have other activities while you sleep
- decreased body temperature ( hypothermia )
- pancreatitis
- a condition (so-called “metabolic syndrome”) where you may have a combination of at least 3 of the following signs: an increase in belly fat, a decrease in “good cholesterol” ( HDL-C ), an increase in a type of fat in 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 very low white blood cell count, a condition called agranulocytosis
- blockage of the intestine
- increased levels 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, blistering, and peeling of the skin ( toxic epidermal necrolysis ). See section 2.
- drug-induced skin rash 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.
- Problems with discontinuation of the drug may occur in newborns of mothers who have used Seroquel Depot during pregnancy.
- stroke.
- heart muscle disease ( cardiomyopathy ).
- Myocarditis ( myocarditis ).
- Inflammation of the blood vessels ( vasculitis ) often with a rash with small red or purple nodules.
Seroquel Depot is a type of medicine that can cause heart rhythm disturbances. Such disorders can be serious and, in severe cases, fatal.
Some side effects are only visible if you take a blood sample. These include altered 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, decreased number of certain types of blood cells, decreased levels of red blood cells, increased levels of creatine phosphokinase (a substance in the muscles) in the blood, lowered sodium levels in the blood and elevated levels in the blood of the hormone et prolactin. An increase in the hormone et prolactin can in rare cases lead to:
- Men and women can get a swelling of the breasts and unexpected production of breast milk.
- in women, menstruation may cease or become irregular.
Your doctor may ask you to have blood tests regularly.
Additional side effects are in children and adolescents
The same side effects that can occur in adults can also occur in children and adolescents.
The following side effects may be more common in children and adolescents or may not occur at all in adults:
Very common: may affect more than 1 user in 10
- The increased amount of the hormone et prolactin in the blood. Increased amounts of the hormone et prolactin may in rare cases lead to the following:
- Breasts can swell in both boys and girls and unexpectedly form breast milk
- Menstruation can stop or become irregular in girls
- Increased appetite
- Vomiting
- Abnormal muscle movements. These include difficulty starting muscle movements, tremors, restlessness, or muscle stiffness without pain
- Increased blood pressure.
Common: may affect up to 1 in 10 users
- Weakness, fainting (may lead to falls)
- nasal congestion
- That you feel annoyed.
How to store Seroquel Depot
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 are to
Contents of the packaging and other information
Content declaration
- The active substance is quetiapine. Seroquel Depot tablets contain 50 mg, 150 mg, 200 mg, 300 mg or 400 mg of quetiapine (as quetiapine fumarate).
- Other ingredients are Tablet core: microcrystalline cellulose, sodium citrate, lactose monohydrate, magnesium stearate, and hypromellose.Tablet cover: hypromellose, macrogol, titanium dioxide (E171). The 50 mg, 200 mg, and 300 mg tablets also contain yellow iron oxide (E172) and the 50 mg tablets contain red iron oxide (E172).
What the medicine looks like and the contents of the pack
All prolonged-release tablets are capsule-shaped and imprinted with XR and strength. The 50 mg tablets are peach-colored, the 150 mg tablets are white, the 200 mg tablets are yellow, the 300 mg tablets are light yellow and the 400 mg tablets are white.
Pack sizes of 10, 30, 50, 60, and 100 tablets are registered for all strengths.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing authorization holder: AstraZeneca AB, 151 85 Södertälje.
Manufacturer: AstraZeneca GmbH, Tinsdaler Weg 183, 22880 Wedel, Germany.
AstraZeneca AB, Gärtunavägen, 151 85 Södertälje.
This medicinal product is authorized under the European Economic Area under the names:
Seroquel XR: Belgium, Cyprus, Estonia, Greece, Ireland, Croatia, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Slovakia, Hungary, and Austria.
Seroquel Prolong: Denmark, Finland, Iceland, Spain, Czech Republic and Germany (Seroquel Prolong® 50 mg Retard Tablet, Seroquel Prolong® 150 mg Retard Tablet, Seroquel Prolong® 200 mg Retard Tablet, Seroquel Prolong® 300 mg Retard Tablet, Seroquel Prolong® 400 mg .
Seroquel Depot: Norway and Sweden.
Seroquel SR: Portugal and Slovenia.
Xeroquel LP: France.
Seroquel XL: Great Britain.
Seroquel compresses to prolonged release: Italien.
Quetiapine XR AstraZeneca: The Netherlands.