25 mg, 100 mg, 150 mg, 200 mg, 300 mg film-coated tablets
quetiapine
What Seroquel is and what it is used for
Seroquel contains a substance called quetiapine. Quetiapine belongs to a group of medicines called antipsychotics. Seroquel can be used to treat several diseases, such as:
- Bipolar depression: when you may feel depressed or depressed, heavy with guilt, lack 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.
Your doctor may want you to continue taking Seroquel even when you feel better.
The quetiapine contained in Seroquel 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
Do not take Seroquel:
- 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 or clarithromycin (medicines for infections )
- nefazodone (antidepressant).
If you are not sure, talk to your doctor or pharmacist before taking Seroquel.
Warnings and cautions
Talk to your doctor or pharmacist before using Seroquel:
- 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. Then your doctor may need to measure your blood sugar level when you use Seroquel.
- if you know that you have previously had a low level of white blood cells (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, as the group of medicines to which Seroquel 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 way nerve cells work 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:
- 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 therapy 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 where
- Erythema multiforme (EM), skin rash with itchy irregular red spots
Stop using Seroquel if you get these symptoms and contact your doctor or see a doctor immediately.
Weight gain
Some patients taking Seroquel have been shown to gain weight. You and your doctor should check your weight regularly.
Children and young people
Seroquel should not be used by children and adolescents under 18 years of age.
Other medicines and Seroquel
Tell your doctor if you are taking, have recently taken, or might take any other medicines.
Do not take Seroquel 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 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 with food, drink, and alcohol
- Seroquel can be taken with or without food.
- You should be careful about how much alcohol you drink as the combination of Seroquel and alcohol can make you sleepy.
- Do not drink grapefruit juice while taking Seroquel. 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 during pregnancy unless you have discussed it with your doctor. You should not take Seroquel if you are breastfeeding.
The following symptoms, which correspond to problems that may occur when you stop taking the medicine, may occur in newborns of mothers who have used this medicine during the last trimester (the 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 contains lactose
Seroquel 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 contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie it is essentially ‘sodium-free’.
Effects on drug tests in urine
If you are taking a urine sample for a drug test, the use of 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
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 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 Seroquel. 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 should not be used by children and adolescents under 18 years of age.
If you take more Seroquel 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. Bring the Seroquel tablets. If you take more doses than your doctor prescribes, you may feel drowsy, dizzy, and feel your heart beating abnormally.
If you forget to take Seroquel
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
If you suddenly stop taking Seroquel, 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) (may lead to falls)
- discontinuation symptoms (symptoms that occur when you stop taking Seroquel) 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, 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 (RLS))
- 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 known as ‘neuroleptic malignant syndrome)
- yellow skin and eyes (jaundice)
- hepatitis _ _
- persistent and painful erection (priapism)
- swelling of the breasts and unexpected production of breast milk ( galactorrhea )
- menstrual disorders
- 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 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 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. These include altered levels of certain fats ( triglycerides and total cholesterol ) or blood sugar, 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 have been seen more frequently in children and adolescents or have not been seen 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 can 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
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.
Do not store above 30 ° C.
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.
Contents of the packaging and other information
Content declaration
- The active substance is quetiapine. Seroquel tablets contain 25 mg, 100 mg, 150 mg, 200 mg or 300 mg of quetiapine (as quetiapine fumarate).
- The other ingredients are:
Tablet core: povidone, calcium hydrogen phosphate dihydrate, microcrystalline cellulose, sodium starch glycolate type A, lactose monohydrate, magnesium stearate.
Tablet cover: hypromellose, macrogol, titanium dioxide (E171). The 25 mg, 100 mg, and 150 mg tablets also contain yellow iron oxide (E172) and the 25 mg tablets contain red iron oxide (E172).
What the medicine looks like and the contents of the pack
Seroquel 25 mg film-coated tablets are peach-colored, round, biconvex, and marked “SEROQUEL 25” on one side.
Seroquel 100 mg film-coated tablets are yellow, round, biconvex, and marked “SEROQUEL 100” on one side.
Seroquel 150 mg film-coated tablets are light yellow, round, biconvex, and marked “SEROQUEL 150” on one side.
Seroquel 200 mg film-coated tablets are white, round, biconvex, and marked “SEROQUEL 200” on one side.
Seroquel 300 mg film-coated tablets are white, capsule-shaped, and marked “SEROQUEL” on one side and “300” on the other side.
Pack sizes of 20, 30, 50, 60, and 100 tablets are registered for all strengths. For 25 mg tablets, the pack size of 6 tablets is also registered. For 100 mg, 150 mg, 200 mg, and 300 mg tablets, pack sizes of 10 and 90 tablets are registered. For 150 mg and 300 mg tablets, pack sizes of 120, 180, and 240 tablets are registered. 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: Belgium, Cyprus, Denmark, Estonia, Finland, Greece, Ireland, Iceland, Italy, Croatia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Portugal, Slovenia, Spain, UK, Sweden, Germany (Seroquel® 25 mg film tablets, Seroquel® 100 mg Film Tablet, Seroquel® 200 mg Film Tablet, Seroquel® 300 mg Film Tablet) and Austria.