50 mg, 150 mg, 200 mg, 300 mg, 400 mg prolonged-release tablets are
quetiapine

What Quetiapine Krka is and what it is used for

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

  • 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.
  • 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.

When Quetiapine Krka is taken to treat depressive episodes in case of major depression, it is taken in addition to other medications used to treat this disease.

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

Quetiapine contained in Quetiapine Krka may also be approved for the treatment of other conditions not mentioned in this leaflet. 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 Krka

Do not use Quetiapine Krka

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

If you are not sure, talk to your doctor or pharmacist before taking Quetiapine Krka.

Warnings and cautions

Talk to your doctor or pharmacist before using Quetiapine Krka 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 ( epilepsy )
  • you have diabetes or are at risk of getting diabetes. If you have it, your doctor may need to measure your blood sugar level while you are using Quetiapine Krka.
  • 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 (a loss of brain function). If this is true for you, do not take Quetiapine Krka, as the group of medicines to which Quetiapine Krka 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 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.
  • 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 Quetiapine Krka:

  • 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.
  • 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 Krka and/or treatment for infection
  • constipation along with persistent pain in the abdomen 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 var
  • Erythema multiforme (EM), skin rash with itchy irregular red spots

Stop using Quetiapine Krka 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 Krka gain weight. You and your doctor should check your weight regularly.

Children and young people

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

Other medicines and Quetiapine Krka

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

Do not take Quetiapine Krka 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 function of nerve cells to treat certain disease states

Talk to your doctor before stopping any of these medicines.

Effects on drug tests in urine

If you are taking a urine sample for a drug test, the use of Quetiapine Krka 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 Krka with food, drink, and alcohol

  • Quetiapine Krka 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 Krka and alcohol can make you sleepy.
  • Do not drink grapefruit juice while taking Quetiapine Krka. 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 or pharmacist for advice before taking this medicine.

You should not take Quetiapine Krka during pregnancy unless you have discussed this with your doctor.

You should not take Quetiapine Krka 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 Krka during the last trimester (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 vigilance. 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 Krka contains lactose and sodium

Quetiapine Krka 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.

50 mg prolonged-release tablets are

This medicine contains 8.44 mg sodium (the main ingredient in table salt/table salt) per tablet. This corresponds to 0.42% of the highest recommended daily intake of sodium for adults.

150 mg prolonged-release tablets are

This medicine contains 14.53 mg sodium (the main ingredient in table salt/table salt) per tablet. This corresponds to 0.73% of the maximum recommended daily intake of sodium for adults.

200 mg prolonged-release tablets are

This medicine contains 19.38 mg sodium (the main ingredient in table salt/table salt) per tablet. This corresponds to 0.97% of the highest recommended daily intake of sodium for adults.

300 mg prolonged-release tablets are

This medicine contains 29.06 mg sodium (the main ingredient in table salt/table salt) per tablet. This corresponds to 1.45% of the maximum recommended daily sodium intake for adults.

400 mg prolonged-release tablet is

This medicine contains 23.46 mg sodium (the main ingredient in table salt/table salt) per tablet. This corresponds to 1.17% of the maximum recommended daily intake of sodium for adults.

How to use Quetiapine Krka

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

If you use more Quetiapine Krka 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 drowsy, dizzy, and feel your heart beating abnormally. Take the Quetiapine Krka tablets with you.

If you forget to use Quetiapine Krka

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 Krka

If you suddenly stop taking Quetiapine Krka, 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 (may lead to falls), headache, dry mouth
  • drowsiness (may disappear with time when you take Quetiapine Krka) (may lead to falls)
  • discontinuation symptoms (symptoms that occur when you stop taking Quetiapine Krka) 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 side effects (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 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
  • discomfort in the legs (also called restless legs syndrome)
  • 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 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)
  • 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 ) 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 perform other activities while you sleep
  • lowered 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 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
  • 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 level of creatinine 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 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
  • breakdown 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 ). 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 Quetiapine Krka 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 Krka 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 sugar in the blood, 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, 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 side effects (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 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 side effects (may affect up to 1 in 10 people):

  • weakness, fainting (may lead to falls).
  • nasal congestion
  • that you feel annoyed

How to store Quetiapine Krka

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.50 mg prolonged-release tablets: Each prolonged-release tablet contains 50 mg of quetiapine (as quetiapine hemifumarate).150 mg prolonged-release tablets: Each prolonged-release tablet contains 150 mg of quetiapine (as quetiapine hemifumarate).200 mg prolonged-release tablets: Each prolonged-release tablet contains 200 mg of quetiapine (as quetiapine hemifumarate).300 mg prolonged-release tablets: Each prolonged-release tablet contains 300 mg of quetiapine (as quetiapine hemifumarate).400 mg prolonged-release tablets: Each prolonged-release tablet contains 400 mg of quetiapine (as quetiapine hemifumarate).
  • The other ingredients in 50 mg and 400 mg prolonged-release tablets are hypromellose, lactose monohydrate, microcrystalline cellulose, sodium citrate dihydrate, and magnesium stearate in the tablet core, as well as hypromellose, titanium dioxide (E171), and macrogol 400 in the tablet coating. See section 2 “Quetiapine Krka contains lactose and sodium”.
  • The other ingredients in 150 mg prolonged-release tablets are hypromellose, lactose monohydrate, microcrystalline cellulose, disodium phosphate dihydrate, and magnesium stearate in the tablet core, as well as polyvinyl alcohol, titanium dioxide (E171), macrogol 3000, talc, red iron oxide (E172) and yellow iron (E172). See section 2 “Quetiapine Krka contains lactose and sodium”.
  • The other ingredients in 200 mg and 300 mg prolonged-release tablets are hypromellose, lactose monohydrate, microcrystalline cellulose, disodium phosphate dihydrate, and magnesium stearate in the tablet core, as well as polyvinyl alcohol, titanium dioxide (E171), macrogol 3000, talc and yellow iron oxide (E172). See section 2 “Quetiapine Krka contains lactose and sodium”.

What the medicine looks like and the contents of the pack

50 mg prolonged-release tablets are white to off-white, capsule-shaped, slightly biconvex, film-coated tablets with beveled edges, marked with 50 on one side. The tablet dimensions are a length of 16.2 mm and a thickness of 4.0 – 5.2 mm.

150 mg prolonged-release tablets are pink / orange, round, biconvex, prolonged-release tablets with beveled edges. The tablet dimensions are a diameter of 10 mm and a thickness of 4.6 – 6.0 mm.

200 mg prolonged-release tablets are amber, oval, biconvex, and prolonged-release tablets. The tablet dimensions are a length of h 16 mm and a thickness of 5.6 – 7.1 mm.

300 mg prolonged-release tablets are light yellow-brown, capsule-shaped, biconvex, prolonged-release tablets. The tablet dimensions are a length of 19.1 mm aa a d thickness of 5.9 – 7.4 mm.

400 mg prolonged-release tablets are white to off-white, capsule-shaped, biconvex, film-coated tablets, marked with 400 on one side. The tablet dimensions are a length of 18.7-19.5 mm and a thickness of 5.5 – 7.1 mm

Quetiapine Krka prolonged-release tablets are available in pack sizes of 10, 30, 50, 60, 90, and 100 prolonged-release tablets in OPA / Alu / PVC / Alu blisters.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Manufacturer

KRKA, dd, Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany

Muhammad Nadeem

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