50 mg, 150 mg, 200 mg, 300 mg, 400 mg prolonged-release tablet is
quetiapine

What Quetiapine Teva is and what it is used for

Quetiapine Teva contains a substance called quetiapine. Quetiapine belongs to a group of medicines called antipsychotics. Quetiapine Teva can be used to treat a number of diseases, such as:

  • Bipolar depression and depressive episodes in actual depression: when you may feel depressed or depressed, guilt-laden, lacking in energy, have poor appetite or 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 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.

When Quetiapine Teva is taken to treat depressive episodes in major depression, it is taken in addition to other medicines used to treat this disease.

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

Quetiapine contained in Quetiapine Teva may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist or other healthcare professional if you have any further questions and always follow their instructions.

What you need to know before you take Quetiapine Teva

Do not take Quetiapine Teva:

  • 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 and clarithromycin (medicines for infections )
    • nefazodone (antidepressant).

Do not take Quetiapine Teva if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Quetiapine Teva.

Warnings and cautions

Talk to your doctor or pharmacist before taking Quetiapine Teva if:

  • you or someone in your family has or has had a heart problem, such as heart rhythm disturbances, weak heart muscle or inflammation of the heart, or if you are taking any medicines that may affect your heartbeat
  • you have low blood pressure
  • you have had a stroke , especially if you are older
  • you have liver problems
  • have you ever had a seizure (epileptic seizure)
  • 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 it
  • you know you have had low white blood cell levels in the past (which may or may not have been caused by other medicines)
  • you are older and suffering from dementia (loss of brain function). If this is true for you, do not take Quetiapine Teva, as the group of medicines to which Quetiapine Teva belongs may increase the risk of stroke , or in some cases the risk of death, in elderly people with dementia.
  • you or someone in your family has had a blood clot, as similar medicines 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.

Tell your doctor immediately if you experience any of the following after taking Quetiapine Teva:

  • a combination of fever, severe muscle stiffness, sweating or decreased consciousness (a condition called neuroleptic malignant syndrome). You may need immediate medical attention.
  • 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.
  • 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 (epileptic seizures)
  • prolonged and painful erection (priapism).

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 Teva 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 have been shown to gain weight. You and your doctor should check your weight regularly.

Children and young people

Quetiapine Teva should not be used in children and adolescents under 18 years of age.

Other medicines and Quetiapine Teva

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

Do not take Quetiapine Teva 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.

Quetiapine Teva with food, drink and alcohol

  • Quetiapine Teva 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 Quetiapine Teva and alcohol can make you sleepy.
  • Do not drink grapefruit juice while taking Quetiapine Teva. It may affect the way the medicine works.

Pregnancy and breastfeeding

If you are pregnant or breast-feeding, 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 Quetiapine Teva during pregnancy unless you have discussed this with your doctor. You should not take Quetiapine Teva if you are breast-feeding.

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 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.

Effects on drug tests in urine

If you are taking a urine sample for a drug test, using Quetiapine Teva 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 Teva contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per tablet, ie essentially ‘sodium-free’.

How to take Quetiapine Teva

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. 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 along 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 Quetiapine Teva. It may affect the way the 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 Teva should not be used in children and adolescents under 18 years of age.

If you take more Quetiapine Teva than you should

If you have ingested too much medicine or if e.g. If a child has ingested the medicine by mistake, contact a doctor or hospital for risk assessment and advice. If you have taken more Quetiapine Teva than your doctor prescribes, you may feel dizzy, dizzy and feel your heart beating abnormally. Take the Quetiapine Teva tablets with you.

If you forget to take Quetiapine Teva

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

If you stop taking Quetiapine Teva

If you suddenly stop taking Quetiapine Teva, 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.

If you get any of the following serious side effects , stop taking Quetiapine Teva immediately and see a doctor or nearest hospital immediately:

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

  • suicidal thoughts and worsening of your depression

Uncommon (may affect up to 1 in 100 people):

  • sudden fever, especially in combination with sore throat and other flu-like symptoms . This may be a sign of an abnormal, low white blood cell count
  • signs of skin reactions such as skin rash, hives , raised lumps or streaks, redness , itching , possibly with swelling of the face , eyelids and lips. This could also lead to difficulty breathing, dizziness and shock .
  • seizures or epileptic seizures
  • involuntary movements, especially of the face or tongue ( tardive dyskinesia )
  • feeling that the heart is  pounding or rushing in connection with dizziness or fainting . This can be a sign of serious heart rhythm problems and can be fatal in severe cases.

Rare (may affect up to 1 in 1,000 people):

  • severe pain and / or swelling and redness in one of your legs ; sudden severe pain in the chest , which may radiate to the left arm or sudden shortness of breath . This may be a sign of blood clots in the veins.
  • severe pain in the upper abdomen that often radiates backwards towards the back, sometimes together with nausea and vomiting . This may be a sign of inflammation of the pancreas.
  • constipation along with persistent abdominal pain or constipation that has not responded to treatment, as this can lead to a more severe blockage of the bowel.
  • yellow skin and eyes (jaundice), dark urine, especially with unusual tiredness or fever (signs of hepatitis )
  • persistent and painful erection
  • a combination of fever, sweating, muscle stiffness, drowsiness or fainting (a condition called “neuroleptic malignant syndrome”)

Very rare (may affect up to 1 in 10,000 people):

  • severe skin reactions with rash or blisters, irregular red spots and or scaling of the skin, possibly around the mouth, eyes and genitals and often together with fever or flu-like symptoms. These reactions can develop rapidly.
  • unexplained muscle pain, tenderness or weakness. These can be early signs of potentially severe muscle breakdown.

Has been reported (occurs in an unknown number of users):

  • heart muscle disease ( cardiomyopathy )
  • myocarditis ( myocarditis ).

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 Teva if you get these symptoms and contact your doctor or see a doctor immediately.

Other possible side effects are

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 Teva) (may lead to falls)
  • discontinuation symptoms (symptoms that occur when you stop taking Quetiapine Teva) include difficulty falling asleep (insomnia), nausea, headache, diarrhea, vomiting, dizziness and irritability. It is advisable to stop taking the medicine gradually over a period of 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
  • decreased levels of hemoglobin ( protein in red blood cells that carry oxygen)
  • 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 (may lead to falls)
  • increased blood sugar content
  • dimsyn
  • strange dreams and nightmares
  • increased feelings of hunger
  • feeling of irritation
  • speech and language disorders
  • shortness of breath
  • vomiting (mainly in the elderly)
  • fever
  • altered levels of thyroid hormones in the blood
  • altered 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):

  • discomfort in the legs (also called restless legs syndrome)
  • difficulty swallowing
  • sexual dysfunction
  • diabetes
  • 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
  • lowered sodium levels in the blood
  • worsening diabetes .

Rare (may affect up to 1 in 1,000 people)

  • swelling of the breasts and unexpected production of breast milk ( galactorrhea )
  • menstrual disorder
  • that you walk, talk, eat or perform other activities while you sleep
  • lowered body temperature ( hypothermia )
  • a condition (so-called “metabolic syndrome”) where 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
  • 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):

  • disturbed secretion of a hormone that regulates urine volume

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 Teva during pregnancy.
  • inflammation of the blood vessels ( vasculitis ) often with 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 cease 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 may occur more frequently in children and adolescents or may not occur at all in adults:

Very common (may affect more than 1 user in 10):

  • 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 people):

  • Weakness, fainting (may lead to falls).
  • Nasal congestion.
  • That you feel annoyed.

How to store Quetiapine Teva

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.

Store in the original package. Moisture sensitive.

No special temperature 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

  • The active substance is quetiapine. Quetiapine Teva prolonged-release tablets contain 50 mg, 150 mg, 200 mg, 300 mg or 400 mg of quetiapine (as quetiapine fumarate).
  • Other ingredients are:

Tablet core: hypromellose, microcrystalline cellulose, anhydrous sodium citrate, magnesium stearate.

Coating: titanium dioxide (E171), hypromellose, macrogol / PEG 400, polysorbate 80. The 50 mg, 200 mg and 300 mg tablets contain yellow iron oxide (E172) and red iron oxide (E172). The 50 mg and 300 mg tablets also contain black iron oxide (E172).

What the medicine looks like and contents of the pack

Quetiapine Teva 50 mg prolonged-release tablet is

Brown, biconvex, rectangular, film-coated tablets, debossed with “Q50” on one side.

Quetiapine Teva 150 mg prolonged-release tablet is

White, biconvex, rectangular, film-coated tablets, debossed with “Q150” on one side.

Quetiapine Teva 200 mg prolonged-release tablet is

Yellow, biconvex, rectangular, film-coated tablets, debossed with “Q200” on one side.

Quetiapine Teva 300 mg prolonged-release tablet is

Light yellow, biconvex, rectangular, film-coated tablets, debossed with “Q300” on one side.

Quetiapine Teva 400 mg prolonged-release tablet is

White, biconvex, rectangular, film-coated tablets, debossed with “Q400” on one side.

Pack sizes 10, 20, 30, 50, 50×1 (perforated unit dose blisters) (hospital pack), 56 ( calendar pack ), 60, 90 and 100 tablets are registered for all strengths.

Not all pack sizes may be marketed.

Muhammad Nadeem

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