50 mg, 200 mg, 300 mg, and 400 mg The prolonged-release tablet is
quetiapine

What Quetiapine Accord is and what it is used for

Quetiapine Accord contains a substance called quetiapine. It belongs to a group of medicines called antipsychotics. Quetiapine Accord can be used to treat a variety of ailments, such as:

  • 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.
  • Mania: when you may feel very upset, elated, upset, enthusiastic, hyperactive, or have poor judgment and are aggressive or disruptive.
  • Bipolar depression and depressive episodes in actual depression: when you may feel depressed or depressed, guilt-laden, lacking in energy, have a poor appetite or have sleep problems.

When Quetiapine Accord is taken to treat actual depressive episodes in actual depression, it is taken in addition to other medication used to treat this disease.

Your doctor may want you to continue taking Quetiapine Accord even when you feel better.

Quetiapine contained in Quetiapine Accord 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 using Quetiapine Accord

Do not take Quetiapine Accord if:

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

Do not take Quetiapine Accord if the above applies to you. Talk to your doctor, pharmacist, or nurse before taking Quetiapine Accord prolonged-release tablets.

Warnings and cautions

Talk to your doctor, pharmacist, or nurse before taking Quetiapine Accord

  • you or someone in your family has or has had heart problems, e.g. abnormal heart rhythm, weak heart muscle, or inflammation of the heart, or if you are taking any medicines that may affect the way your heart beats
  • 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 developing diabetes. If so, your doctor may check your blood sugar levels while you are taking Quetiapine Accord prolonged-release tablets.
  • you know you have had low white blood cell counts in the past (possibly due to other medicines)
  • you are older and suffering from dementia (a loss of brain function). If this is true for you, do not take Quetiapine Accord, as the group of medicines to which Quetiapine Accord 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
  • you or someone else in your family has had a blood clot in the past because a connection has been seen between similar drugs and the occurrence 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 (“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 Accord

  • a combination of fever, severe muscle stiffness, sweating, or decreased consciousness (a condition called malignant neuroleptic syndrome). You may need immediate medical attention
  • uncontrolled movements, especially in the face and 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.

These symptoms can be caused by this type of medicine.

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 Accord prolonged-release tablets and/or treatment for infection.
  • Constipation along with persistent pain in the abdomen or constipation does not respond to treatment, as can lead to a more severe blockage of the intestine.

Suicidal ideation or worsening of depression

If you are depressed, you can sometimes have thoughts of harming yourself or taking your own life. These thoughts may get worse when you first start taking the medicine, as it always takes a while for medicines of this type to take effect, usually about 2 weeks but sometimes longer. Such thoughts may also increase if you suddenly stop taking the medicine. It may be more common to have such thoughts if you are a young adult. Information from clinical trials has shown that the risk of suicidal ideation and/or suicidal behavior is higher in young adults under 25 suffering from depression.

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.

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).

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

Weight gain

It has been shown that some patients taking Quetiapine Accord gain weight. You and your doctor should check your weight regularly.

Children and young people

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

Other medicines and Quetiapine Accord

Tell your doctor if you are taking, have recently taken, or might take any other medicines.

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

  • Some HIV medicines
  • Azole drugs (against fungal infections)
  • Erythromycin or clarithromycin (for infections )
  • Nefazodone (for depression).

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

  • medicines to treat epilepsy (eg phenytoin or carbamazepine)
  • medicines for high blood pressure
  • barbiturates (for difficulty sleeping)
  • thioridazine or lithium (other antipsychotics)
  • medicines that affect the heart’s beat, for example, medicines 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 function of nerve cells to treat certain disease states

Talk to your doctor before stopping taking any of your medicines.

Quetiapine Accord with food, drink, and alcohol

  • Quetiapine Accord can be affected by food and you should therefore take your tablets at least 1 hour before a meal or at night.
  • Be careful about how much alcohol you drink, as the combination of Quetiapine Accord and alcohol can make you sleepy.
  • Do not drink grapefruit juice while taking Quetiapine Accord. It may affect the effectiveness of the medicine.

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 Accord during pregnancy without first discussing it with your doctor.

You should not take Quetiapine Accord 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 Quetiapine Accord prolonged-release tablets during the last trimester (last three months of pregnancy): tremors, muscle stiffness, and/or 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

Quetiapine Accord can make you sleepy. Do not drive or use 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 Accord contains lactose

Quetiapine Accord 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 Quetiapine Accord.

Quetiapine Accord contains sodium

Quetiapine Accord prolonged-release tablets contain less than 1 mmol (23 mg) sodium per tablet, ie are essential ‘sodium-free’.

Effects on drug tests in urine

If you are taking a urine sample for a drug test, using Quetiapine Accord 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 Quetiapine Accord

Always take this medicine exactly as your doctor or pharmacist 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 split, chew or crush the tablets.
  • Swallow the tablets whole with a glass of water.
  • Take the tablets without food (at least one hour before a meal or at night – your doctor will tell you which time is best).
  • Do not drink grapefruit juice while taking Quetiapine Accord. It may affect the way medicine works.
  • Continue to take the tablets even if you feel better, as long as your doctor has not told you otherwise.

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 Accord should not be used by children or adolescents under 18 years of age.

If you use more Quetiapine Accord 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. Take the Quetiapine Accord pack with you. If you take more doses than your doctor prescribes, you may feel drowsy, dizzy, and feel your heart beating abnormally.

If you forget to use Quetiapine Accord

If you forget to take a dose, take it as soon as you remember. If it is almost time for your next dose, wait until then. Do not take a double dose to make up for a forgotten dose.

If you stop using Quetiapine Accord

If you suddenly stop taking Quetiapine Accord, 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 side effects (may affect more than 1 user in 10):

  • Dizziness (which may lead to falls), headache, dry mouth
  • Drowsiness (this symptom may disappear overtime during your treatment with Quetiapine Accord) (may lead to falls)
  • Symptoms you may experience when you stop taking Quetiapine Accord include difficulty sleeping, 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, such as difficulty starting movements, tremors, feelings of restlessness, or muscle stiffness without pain
  • Altered levels of certain fats ( triglycerides and total cholesterol ).

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

  • Fast heartbeat
  • Feeling that the heart is beating, rushing, or skipping a heartbeat
  • Constipation, upset stomach (digestive problems)
  • Impotence,
  • Swelling in arms or legs
  • Drop-in blood pressure when you get up which can make you feel dizzy or faint (may lead to falls)
  • Increased blood sugar content
  • Dimsyn
  • Abnormal dreams and nightmares
  • Increased feelings of hunger
  • Feeling irritated
  • Speech and language disorders
  • Suicidal ideation or worsening of depression.
  • Respiratory distress
  • 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 tests
  • Increased levels of the hormone et prolactin in the blood. An increase in the hormone et prolactin can in rare cases lead to the following:
    -Men and women may have swelling of the breasts and unexpected production of breast milk
    – In women, menstruation may stop or become irregular

Uncommon side effects (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
  • Feelings of discomfort in the legs (also called restless legs or RLS)
  • Difficult to swallow
  • Involuntary movements, especially in the face and tongue
  • Sexual dysfunction.
  • Diabetes.
  • Changes in the electrical activity of the heart can be seen in ECG measurement ( QT prolongation).
  • 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 (which can lead to falls)
  • Nasal congestion
  • Reduced level of red blood cells
  • Reduced sodium levels in the blood
  • Impaired diabetes

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”)
  • Yellow skin and eyes (jaundice)
  • Hepatitis _ _
  • Persistent and painful erection (priapism)
  • Swollen breasts or 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
  • Walk, talk, eat in your sleep
  • Decreased body temperature ( hypothermia )
  • Inflammation of the pancreas
  • A condition (called “metabolic syndrome”) in which you may have a combination of at least three of the following symptoms: an increase in abdominal fat, a decrease in “good cholesterol” ( HDL ), 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 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 side effects (may affect up to 1 in 10,000 people):

  • Severe rash, blisters, or red areas on the skin
  • Severe allergic reaction ( anaphylactic reaction ) with, for example, difficulty breathing or shock
  • Rapid swelling of the skin, usually around the eyes, lips, and neck ( angioedema )
  • A serious condition 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 pain in the muscles ( 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 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.
  • Withdrawal problems may occur in newborns of mothers who have used Quetiapine Accord during pregnancy
  • Stroke
  • Cardiomyopathy Cardiomyopathy _
  • Myocarditis ( myocarditis )
  • Inflammation of the blood vessels ( vasculitis ) often with a rash with small red or purple nodules.

Quetiapine Accord 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 cholesterol ) or blood sugar levels, altered levels of thyroid hormones in the blood, increased number of liver enzymes, decrease in certain types of blood cells, decreased number of red blood cells, increased levels of creatine phosphokinase (a substance in the muscles) in blood, decreased amount of sodium in the blood and increase in blood levels of a hormone called prolactin. Increased prolactin levels can in rare cases lead to the following:

  • Breasts in men and women can swell up and unexpectedly produce breast milk.
  • Menstruation may cease in women or become irregular.

Your doctor may therefore ask you to take a blood sample from time to time.

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 in 10 people):

  • Elevated levels of the hormone et prolactin in the blood. Elevated prolactin levels can in rare cases lead to the following:
    – The breasts of boys and girls can swell up and unexpectedly produce breast milk.
    – Menstruation can stop in girls or become irregular.
  • Appetite increase.
  • Vomiting
  • Abnormal muscle movements. These include difficulty starting muscle movements, shaking, restlessness, or muscle friction without pain
  • Increased blood pressure

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

  • Weakness, fainting (may lead to falls)
  • Nasal congestion
  • Feeling irritated.

How to store Quetiapine Accord

  • 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”. and on the blister after “EXP”. The expiration date is the last day of the specified month.
  • 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.
  • No special storage instructions.

Contents of the pack and other information

Content declaration

The active substance is quetiapine. Each prolonged-release tablet contains 50 mg, 200 mg, 300 mg or 400 mg of quetiapine (as quetiapine fumarate).

Other ingredients are:

Tablet core: lactose monohydrate, hypromellose, sodium chloride, povidone K-30, talc, and magnesium stearate. The 50 mg prolonged-release tablets also contain silicified microcrystalline cellulose (silica and microcrystalline cellulose). 

Tablet coating: titanium dioxide (E171), macrogol 400 (E1521). The 50 mg prolonged-release tablets also contain polyvinyl alcohol ( E1203 ), talc (E553b), and red iron oxide (E172). The prolonged-release tablets of 50 mg, 200 mg, and 300 mg also contain yellow iron oxide (E172). The prolonged-release tablets of 50 mg, 200 mg, 300 mg, and 400 mg also contain hypromellose 6cP (E464).

What the medicine looks like and the contents of the pack

Quetiapine Accord 50 mg are peach-colored, round, biconvex, film-coated tablets, smooth on one side and imprinted with “Q50” on the other side.

Quetiapine Accord 200 mg are yellow, round, biconvex, film-coated tablets, smooth on one side and debossed with “I2” on the other side. The 200 mg tablet has a diameter of about 9.6 mm.

Quetiapine Accord 300 mg are light yellow, round, biconvex, film-coated tablets, smooth on one side and debossed with “Q300” on the other side. The 300 mg tablet has a diameter of about 11.2 mm.

Quetiapine Accord 400 mg are white, round, biconvex, film-coated tablets, smooth on one side and debossed with “I4” on the other side. The 400 mg tablet has a diameter of about 12.8 mm.

Blister pack in PVC / PVdC aluminum

Packs of 10, 30, 50, 60, and 100 tablets are registered for Quetiapine Accord 200 mg, 300 mg, and 400 mg prolonged-release tablets.

Blister pack in PVC / PVdC-aluminum or OPA / PVC / aluminum Packs of 6, 10, 20, 28, 30, 50, 60, 90 and 100 tablets are registered for Quetiapine Accord 50 mg prolonged-release tablets .

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder:

Accord Healthcare BV

Winthontlaan 200

3526 VK Utrecht

Netherlands

Manufacturer

Accord Healthcare Limited

Sage House, 319, Pinner Road, North Harrow

Middlesex, HA1 4 HF, UK

or

GAP SA,

46, Agissilaou str.

Agios Dimitrios, Athens

Post Code: 17341

Greece

or

Accord Healthcare Polska Sp.z oo,

ul. Lutomierska 50,95-200 Pabianice, Poland

or

ACCORD-UK LTD

WHIDDON VALLEY, BARNSTAPLE, DEVON, EX32 8NS,

UK

or

Accord Healthcare BV

Winthontlaan 200

3526 VK Utrecht

Netherlands

Quetiapine Accord 50 mg prolonged-release tablets:

ARROW GENERIQUES- LYON,

26 avenue Tony Garnier, LYON, 69007,

France

Muhammad Nadeem

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