25 mg film-coated tablets
quetiapine
What Quetiapine Sandoz is and what it is used for
Quetiapine Sandoz contains a substance called quetiapine. Quetiapine belongs to a group of medicines called antipsychotics.
Quetiapine Sandoz can be used to treat several diseases, such as:
- Schizophrenia: when you may hear or feel things that do not exist, believe in things that are not real, or feel unusually suspicious, anxious, confused, guilt-ridden, tense, or depressed.
- Mania: when you may feel very upset, elated, upset, enthusiastic, hyperactive, or have poor judgment with elements of aggressive and fragmented behavior.
- Bipolar depression: when you may feel depressed or depressed, heavy with guilt, lack energy, have a poor appetite, or have sleep problems.
Your doctor may want you to continue taking Quetiapine Sandoz even when you feel better.
Quetiapine contained in Quetiapine Sandoz 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 use Quetiapine Sandoz
Do not use Quetiapine Sandoz
- 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 (medicine for bacterial infections)
- nefazodone (antidepressant).
Do not take Quetiapine Sandoz if the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking Quetiapine Sandoz.
Warnings and cautions
Talk to your doctor or pharmacist before using Quetiapine Sandoz 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 medications that may affect how your heartbeats.
- you have low blood pressure.
- you have had a stroke, especially if you are older.
- you have liver problems.
- you have 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 Sandoz.
- 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).
- you are older and suffering from dementia (a loss of brain function). If this is true for you, do not take Quetiapine Sandoz, as the group of medicines to which Quetiapine Sandoz belongs may increase the risk of stroke, or in some cases the risk of death, in elderly people with dementia.
- you are older and suffering from Parkinson’s disease/parkinsonism
- you or someone in your family has had a blood clot, as similar drugs have been linked to the formation of blood clots.
- 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 drugs that reduce the normal activity of the brain (“sedative”).
- you have or have had a condition where you can not empty the bladder completely ( urinary retention ), have an enlarged prostate, 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.
- you have or have had problems with alcohol or drug abuse.
Tell your doctor immediately if you experience any of the following after taking Quetiapine Sandoz:
- 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 in 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 Quetiapine Sandoz 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 may be more 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.
Weight gain
Some patients taking Quetiapine Sandoz have been found to gain weight. You and your doctor should check your weight regularly.
Children and young people
Quetiapine Sandoz should not be used by children and adolescents under 18 years of age.
Other medicines and Quetiapine Sandoz
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Do not take Quetiapine Sandoz if you are taking any of the following medicines:
- Some medicines for HIV.
- Azoles (medicines for fungal infections).
- Erythromycin or clarithromycin (medicine for bacterial 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 insomnia).
- Thioridazine or lithium (other antipsychotic drugs).
- Medicines that affect the heartbeat, such as medicines that can cause an imbalance in the electrolytes (low levels of potassium or magnesium ) such as diuretics ( diuretics ) or certain antibiotics (medicines for bacterial infections).
- Medicines that can cause constipation.
- Drugs (called “anticholinergics”) affect the way nerve cells work to treat certain conditions.
Talk to your doctor or pharmacist before stopping any of these medicines.
Quetiapine Sandoz with food, drink, and alcohol
- Food: see section 3 under “Method of administration”.
- You should be careful about how much alcohol you drink as the combination of Quetiapine Sandoz and alcohol can make you sleepy.
- Do not drink grapefruit juice while taking Quetiapine Sandoz. 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 or pharmacist for advice before taking this medicine.
You should not take Quetiapine Sandoz during pregnancy unless you have discussed it with your doctor. 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 Quetiapine Sandoz 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.
You should not take Quetiapine Sandoz if you are breastfeeding.
Driving and using machines
Your tablets can make you drowsy and dizzy. 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.
Effects on drug tests in urine
If you are taking a urine sample for a drug test, the use of Quetiapine Sandoz 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.
Quetiapine Sandoz contains sodium and lactose
Quetiapine Sandoz contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie essentially ‘sodium-free’.
Quetiapine Sandoz 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.
How to use Quetiapine Sandoz
Always use this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
For doses that are not practical/possible to obtain with Quetiapine Sandoz film-coated tablets, other medicines contain higher doses of quetiapine.
The recommended dose is:
Adults
Your doctor will determine 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.
Older
If you are older, your doctor may change your dose.
Liver problem
If you have liver problems, your doctor may change your dose.
Use for children and adolescents
Quetiapine Sandoz should not be used by children and adolescents under 18 years of age.
Method of administration
Ingested by mouth.
- 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 Sandoz. It may affect the way medicine works.
Duration of treatment:
The doctor determines the duration of treatment. Do not stop taking your tablets even if you feel better unless your doctor tells you to.
If you take more Quetiapine Sandoz than you should
If you have ingested too much medicine or if e.g. If a child has ingested the medicine, contact a doctor or hospital for an assessment of the risk and advice.
If you take more doses than your doctor prescribes, you may feel dizzy, dizzy, and feel your heart beating abnormally. Contact your doctor or nearest hospital immediately. Take the Quetiapine Sandoz tablets.
If you forget to take Quetiapine Sandoz
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 Quetiapine Sandoz
If you suddenly stop taking Quetiapine Sandoz, 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.
Stop using Quetiapine Sandoz immediately and contact a doctor immediately or go to the nearest hospital if you get any of the following serious side effects:
Uncommon side effects (may affect up to 1 in 100 people):
- epilepsy or seizures
- involuntary movements, especially of the face and tongue
Rare side effects (may affect up to 1 in 1,000 people):
- a combination of fever, sweating, muscle stiffness, drowsiness, or fainting (a condition called “malignant neuroleptic syndrome”)
- persistent and painful erection (priapism)
- 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
- a combination of fever, flu-like symptoms, sore throat, or any other infection with very low white blood cell count (a condition called agranulocytosis )
Very rare side effects (may affect up to 1 in 10,000 people):
- a serious disease with blistering of the skin, mouth, eyes, and genitals ( Stevens-Johnson syndrome )
- 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 )
Has been reported (occurs in an unknown number of users):
- severe, sudden allergic reaction with symptoms such as fever, blisters, and peeling of the skin ( toxic epidermal necrolysis )
- skin rash with irregular red spots (erythema multiforme)
- drug-induced skin rash with eosinophilia and systemic symptoms (DRESS). Widespread skin rash, high body temperature, elevated liver enzymes, blood abnormalities ( eosinophilia ), enlarged lymph nodes, and involvement of other body organs (drug-induced skin rash with eosinophilia and systemic symptoms, also known as DRESS, or drug hypersensitivity syndrome). Stop using Quetiapine Sandoz if you get these symptoms and contact your doctor or see a doctor immediately.
Quetiapine Sandoz belongs to a type of medicine that can cause heart rhythm disorders. Such disorders can be serious and, in severe cases, fatal.
You can get any of the other reported side effects listed below divided as follows:
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 Sandoz) (may lead to falls)
- discontinuation symptoms (symptoms that occur when you stop taking Quetiapine Sandoz) 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. 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 may experience swelling of the breasts and unexpected production of breast milk.- in women, menstruation may stop or become irregular
Uncommon (may affect up to 1 in 100 people):
- 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
- 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.
Rare (may affect up to 1 in 1,000 people):
- yellow skin and eyes (jaundice)
- hepatitis _ _
- swelling of the breasts and unexpected production of breast milk ( galactorrhea )
- menstrual disorder
- 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 “good cholesterol” ( HDL-C ), an increase in a type of fat in blood called triglycerides, high blood pressure and an increase in blood sugar
- 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
- disturbed secretion of a hormone that regulates urine volume
- degradation of muscle fibers and muscle pain ( rhabdomyolysis ).
Has been reported (occurs in an unknown number of users):
- Problems with discontinuation of the drug may occur in newborns of mothers who have used Quetiapine Sandoz 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.
Some side effects are only visible if you take a blood sample. This includes 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, decrease in the number of certain types of blood cells, decreased levels of red blood cells, elevated 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 stop or become irregular.
Your doctor may ask you to have blood tests regularly.
Additional side effects 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:- The 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 people):
- impotence
- fainting (may lead to falling)
- nasal congestion
- that you feel annoyed
How to store Quetiapine Sandoz
Keep this medicine out of the sight and reach of children.
No special storage instructions.
Do not use this medicine after the expiry date which is stated on the carton and the blister/jar after “EXP”. or “EXP”. The expiration date is the last day of the specified month.
Shelf life after first opening the plastic jar: Used no later than 6 months after opening.
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 pack and other information
Content declaration
- The active substance is quetiapine (as fumarate). One film-coated tablet contains 25 mg quetiapine (as fumarate).
- The other ingredients are: tablet core: calcium hydrogen phosphate dihydrate, microcrystalline cellulose, lactose monohydrate, magnesium stearate, povidone (K 29/32), hydrated colloidal silica, sodium starch glycolate (type A); tablet coating: hypromellose, lactose monohydrate, macrogol 4000, titanium dioxide (E171), red iron oxide (E172), yellow iron oxide (E172)
What the medicine looks like and the contents of the pack
Quetiapine Sandoz 25 mg film-coated tablets are salmon pink and round (approximately 6.0 mm in diameter).
The film-coated tablets are packaged in PVC / PVDC / Al or PVC / PE / PVDC / Al blisters and inserted in a carton or HDPE cans with PP screw caps containing desiccant.
Pack sizes:
Blisters: 6, 10, 14, 20, 30, 50, 60, 90, 100, 100×1 (perforated unit dose blisters) or 120 film-coated tablets.
Jar: 50, 60, 100, 250 or 500 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder:
Sandoz A / S, Edvard Thomsens Vej 14, 2300 Copenhagen S, Denmark
Manufacturer:
Lek Pharmaceuticals dd, Trimline 2D, 9220, Lendava, Slovenia