25 mg, 100 mg, 200 mg, 300 mg film-coated tablets
quetiapine
What Quetiapine Stada is and what it is used for
Quetiapine Stada contains a substance called quetiapine. Quetiapine belongs to a group of medicines called antipsychotics. Quetiapine Stada can be used to treat several diseases, such as:
- Bipolar depression: when you feel down. You may feel depressed, overweight, low 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 can see, hear or feel things that do not exist, believe in things that are not real or feel unusually suspicious, anxious, confused, have feelings of guilt, feel tense or depressed.
Your doctor may want you to continue taking Quetiapine Stada even when you feel better.
Quetiapine contained in Quetiapine Stada 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 Stada
Do not use Quetiapine Stada
- 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 anti- HIV drugs
- 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 Stada.
Warnings and cautions
Talk to your doctor or pharmacist before taking Quetiapine Stada:
- 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 while you are taking Quetiapine Stada
- 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 Quetiapine Stada, as the group of medicines to which Quetiapine Stada 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 suffer from Parkinson’s disease/parkinsonism
- if you or someone in your family has had a blood clot, as similar medicines have been linked to 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 (“sedative”)
- if you have or have had a condition where you can not 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.
Talk to your doctor immediately if you experience any of the following after taking Quetiapine Stada:
- 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 Stada 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 of your 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, 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 young. Studies have shown that young adults (younger than 25 years) with depression have an increased risk of suicidal thoughts and 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. Feel free to ask them to read this leaflet. You can also ask them to tell you if they think you are feeling worse or if they think your behavior is changing.
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 Stada if you get these symptoms and contact your doctor or see a doctor immediately.
Weight gain
Some patients taking Quetiapine Stada have been shown to gain weight. You and your doctor should check your weight regularly.
Children and young people
Quetiapine Stada should not be used by children and adolescents under 18 years of age.
Other medicines and Quetiapine Stada
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Do not take Quetiapine Stada if you are taking any of the following medicines:
- certain anti- HIV drugs
- 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)
- medicines that affect the heartbeat, such as medicines that can cause an imbalance in certain substances in the blood (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.
Quetiapine Stada with food, drink, and alcohol
Quetiapine Stada can be taken with or without food.
You should be careful about how much alcohol you drink as the combination of Quetiapine Stada and alcohol can make you sleepy.
Do not drink grapefruit juice while taking Quetiapine Stada. It may affect the way medicine works.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine. You should not take Quetiapine Stada during pregnancy unless you have discussed this with your doctor. You should not take Quetiapine Stada 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 Quetiapine Stada during the last three months of pregnancy: shaking, muscle stiffness and/or weakness, drowsiness, anxiety, breathing problems or difficulty eating. If your child has any of these symptoms, you may need to contact your 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.
Quetiapine Stada contains lactose and sodium
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 contains less than 1 mmol (23 mg) sodium per tablet, ie essentially ‘sodium-free’. essentially “sodium-free”.
Effect on drug tests in urine
If you are taking a urine sample for a drug test, using Quetiapine Stada 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 use Quetiapine Stada
Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
Your doctor will determine your starting dose. and how many Quetiapine Stada tablets you should take per day. 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 bedtime or twice a day depending on your illness.
- Swallow the tablets whole along with a glass of water.
- You can take the tablets with or without food.
- Do not drink grapefruit juice while taking Quetiapine Stada. 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
Quetiapine Stada should not be used by children and adolescents under 18 years of age.
If you use more Quetiapine Stada 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 dizzy, dizzy and have abnormal heartbeats. Bring your Quetiapine Stada tablets.
If you forget to use Quetiapine Stada
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 using Quetiapine Stada
If you suddenly stop taking Quetiapine Stada, 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 Quetiapine Stada) (may lead to falls)
- withdrawal symptoms (symptoms that occur when you stop taking Quetiapine Stada) which 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 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 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):
- 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 ) which 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 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 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 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 )
- 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):
- skin rash with irregular red spots (erythema multiforme)
- severe, sudden allergic reaction with symptoms such as fever, blistering, and peeling of the skin ( toxic epidermal necrosis )
- Problems with discontinuation of the drug may occur in newborns of mothers who have used Quetiapine Stada 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.
Quetiapine Stada 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 blood tests are taken. These include altered levels of certain fats ( triglycerides and cholesterol ) or increased blood sugar levels, altered levels of thyroid hormones in your blood, elevated levels of liver enzymes, decreased levels of certain blood cells, decreased levels of red blood cells, increased levels of creatinine phosphokinase (a substance in muscles) in the blood, decreased amount of sodium in the blood and increase of hormone et prolactin in the blood.
Increases in the hormone et prolactin may 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 for a blood test at any time.
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 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 boys and girls and unexpectedly form breast milk
- menstruation may cease 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):
- weakness, fainting (may lead to falls)
- nasal congestion
- that you feel annoyed.
How to store Quetiapine Stada
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 and 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 will help to protect the environment.
Contents of the pack and other information
Content declaration
Quetiapine Stada 25 mg film-coated tablets
- The active substance is quetiapine. 1 film-coated tablet contains 25 mg quetiapine (as quetiapine fumarate).
- Other ingredients are:
- Tablet core: Calcium hydrogen phosphate, lactose monohydrate, microcrystalline cellulose, sodium starch glycollate (Type A), povidone K27-32, magnesium stearate
- Coating: Hypromellose, titanium dioxide (E171), macrogol 400, yellow iron oxide (E172), red iron oxide (E172)
Quetiapine Stada 100 mg film-coated tablets
- The active substance is quetiapine. 1 film-coated tablet contains 100 mg quetiapine (as quetiapine fumarate).
- Other ingredients are:
- Tablet core: Calcium hydrogen phosphate, lactose monohydrate, microcrystalline cellulose, sodium starch glycollate (Type A), povidone K27-32, magnesium stearate
- Coating: Hypromellose, titanium dioxide (E171), macrogol 400, yellow iron oxide (E172)
Quetiapine Stada 200 mg film-coated tablets
- The active substance is quetiapine. 1 film-coated tablet contains 200 mg quetiapine (as quetiapine fumarate).
- Other ingredients are:
- Tablet core: Calcium hydrogen phosphate, lactose monohydrate, microcrystalline cellulose, sodium starch glycollate (Type A), povidone K27-32, magnesium stearate
- Coating: Hypromellose, titanium dioxide (E171), macrogol 400
Quetiapine Stada 300 mg film-coated tablets
- The active substance is quetiapine. 1 film-coated tablet contains 300 mg quetiapine (as quetiapine fumarate).
- Other ingredients are:
- Tablet core: Calcium hydrogen phosphate, lactose monohydrate, microcrystalline cellulose, sodium starch glycollate (Type A), povidone K27-32, magnesium stearate
- Coating: Hypromellose, titanium dioxide (E171), macrogol 400
What the medicine looks like and the contents of the pack
Quetiapine Stada 25 mg film-coated tablets:
Peach-colored, round, biconvex, film-coated tablets.
Quetiapine Stada 100 mg film-coated tablets:
Yellow, round, biconvex, film-coated tablets with a notch on one side. *
Quetiapine Stada 200 mg film-coated tablets:
White, round, biconvex, film-coated tablets.
Quetiapine Stada 300 mg film-coated tablets:
White, capsule-shaped, film-coated tablets with a scoreline on one side. *
* The tablet can be divided into two equal parts.
Quetiapine Stada 25 mg film-coated tablets
PVC / PE / PVdC / Aluminum blister:
Blister packs: 6, 10, 20, 30, 50, 60 and 100 tablets
Hospital packaging: 50 tablets
Quetiapine Stada 100 mg film-coated tablets
PVC / PE / PVdC / Aluminum blister:
Blister packs: 10, 20, 30, 50, 60, 90, 100, 120, 150 and 180 tablets
Hospital packaging: 50 tablets
Quetiapine Stada 200 mg film-coated tablets
PVC / PE / PVdC / Aluminum blister:
Blister packs: 10, 20, 30, 50, 60, 90, 100, 120, 150 and 180 tablets
Hospital packaging: 50 tablets
Quetiapine Stada 300 mg film-coated tablets
PVC / PE / PVdC / Aluminum blister:
Blister packs: 10, 20, 30, 50, 60, 90, 100, 120, 150 and 180 tablets
Hospital packaging: 50 tablets
Marketing Authorization Holder and Manufacturer
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany
Other manufacturers
HBM Pharma sro
Sklabinská 30
036 80 Martin
Slovenia
Sanico NV
Veedijk 59, Industrial Zone IV
2300 Turnhout
Belgium
Bluepharma – Indústria Pharmacêutica, SA,
S. Martinho do Bispo,
Coimbra, 3045-016
Portugal
LAMP San Prospero SpA
Via Della Pace, 25 / A
41030 – S. Prospero S / S, Italy Modena
Local representative
STADA Nordic ApS
Marielundvej 46 A
2730 Herlev
Denmark