25 mg, 100 mg, 150 mg, 200 mg, 300 mg film-coated tablet
quetiapine

What Quetiapine Actavis is and what it is used for

Quetiapine Actavis contains a substance called quetiapine. It belongs to a group of medicines called antipsychotics.

Quetiapine Actavis can be used to treat several diseases, such as:

  • Bipolar depression: when you may feel depressed or depressed, heavy with guilt, lack energy, have a poor appetite or have 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.

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

Quetiapine contained in Quetiapine Actavis 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 Actavis

Do not use Quetiapine Actavis

  • if you are allergic to quetiapine or any of the other ingredients of this medicine (listed in section 6).
  • if you are taking any of the following medicines:
    • certain medicines for HIV
    • azoles (medicines for fungal infections)
    • Erythromycin or clarithromycin (medicines for infections )
    • Nefazodone (antidepressant).

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

Warnings and cautions

Talk to your doctor or pharmacist before using Quetiapine Actavis:

  • 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 when you use Quetiapine Actavis.
  • 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 Actavis as the group of medicines to which Quetiapine Actavis 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 a background in alcohol or drug abuse.

Tell your doctor immediately if you experience any of the following after using Quetiapine Actavis:

  • a combination of fever, severe muscle stiffness, sweating, or decreased consciousness (a condition called malignant neuroleptic 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
  • 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 Actavis 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 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).

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

Weight gain

Some patients taking Quetiapine Actavis have been found to gain weight. You and your doctor should check your weight regularly.

Children and young people

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

Other medicines and Quetiapine Actavis

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

Do not use Quetiapine Actavis 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 are 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 Actavis with food, drink, and alcohol

  • Quetiapine Actavis can be used with or without food.
  • You should be careful about how much alcohol you drink as the combination of Quetiapine Actavis and alcohol can make you sleepy.
  • Do not drink grapefruit juice while using Quetiapine Actavis. It may affect the way medicine works.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

  • You should not use Quetiapine Actavis during pregnancy unless you have discussed this with your doctor.
  • Do not use Quetiapine Actavis 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 Actavis 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

The 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 Actavis contains lactose and sodium

Quetiapine Actavis contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Quetiapine Actavis contains sodium

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

Effects on drug tests in urine

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

Always use this medicine exactly as your doctor 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) depends on your illness and your needs but is usually between 150 mg and 800 mg.

  • You should take the tablets once a day at night or twice a day, depending on your illness.
  • Swallow the tablets whole with a glass of water.
  • You can take the tablets with or without food.
  • Do not drink grapefruit juice while taking Quetiapine Actavis. It may affect the way medicine works.
  • Do not stop taking the 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.

Elderly

If you are older, your doctor may change your dose.

Use for children and adolescents

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

If you use more Quetiapine Actavis 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 tablets with you. If you take more Quetiapine Actavis than you were told by your doctor, you may feel drowsy, dizzy, and have an abnormal heartbeat.

If you forget to use Quetiapine Actavis

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

If you stop using Quetiapine Actavis

If you suddenly stop using Quetiapine Actavis, 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 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 experience any of the following, stop using Quetiapine Actavis and contact a doctor immediately or go to the nearest hospital, as you may need urgent medical attention:

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

  • allergic reactions that may include raised lumps or streaks, skin swelling, and swelling around the mouth
  • epilepsy or seizures
  • involuntary movements, especially of the tongue, mouth, and jaw, but also the arms, legs, fingers, and toes, grimaces, and quick blinkers. These can be symptoms of a condition called tardive dyskinesia.
  • if you get infection more easily. This may be a sign of an abnormal decrease in certain types of white blood cells in your blood ( neutropenia ).

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

  • a combination of fever, sweating, muscle stiffness, drowsiness or fainting, recurrent changes in blood pressure, and rapid heartbeat (a condition known as ‘malignant neuroleptic syndrome’) 
  • yellow skin and eyes (jaundice)
  • hepatitis _ _
  • persistent and painful erection (priapism)
  • blood clots in the veins, especially in the legs (with symptoms such as swelling, pain, and redness ) can be passed on in the blood vessels to the lungs and cause chest pain and difficulty breathing.
  • inflammation of the pancreas ( pancreatitis ). Symptoms may include severe abdominal and back pain, nausea, and vomiting.
  • a combination of fever, flu-like symptoms, sore throat, or any other infection with very low white blood cell count (a condition called agranulocytosis ).

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

  • 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 )
  • Abnormal muscle breakdown ( rhabdomyolysis ) with symptoms such as muscle pain, weakness, and swelling that can lead to kidney problems (urine may become dark).

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

  • severe, sudden allergic reaction with symptoms such as fever, blisters, and peeling of the skin ( toxic epidermal necrolysis )
  • skin rash with irregular red spots (erythema multiforme)
  • drug-induced skin rash with eosinophilia and systemic symptoms (DRESS). Widespread skin rash, high body temperature, elevated liver enzymes, blood abnormalities ( eosinophilia ), enlarged lymph nodes, and involvement of other body organs (drug-induced skin rash with eosinophilia and systemic symptoms, also known as DRESS, or drug hypersensitivity syndrome). Stop using quetiapine if you get these symptoms and contact your doctor or see a doctor immediately.
  • heart muscle disease ( cardiomyopathy )
  • myocarditis ( myocarditis )
  • stroke.

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 continue to take Quetiapine Actavis) (may lead to falls)
  • discontinuation symptoms (symptoms that occur when you stop taking Quetiapine Actavis) that include difficulty falling asleep (insomnia), nausea, headache, diarrhea, vomiting, dizziness, and irritability. It is advisable to stop taking the medicine gradually over at least 1-2 weeks.
  • 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 )
  • weight gain.
  • decreased levels of a specific protein in the red blood cells ( hemoglobin ).

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

  • Fast heartbeat
  • feeling that the heart is pounding, rushing, or skipping a heartbeat
  • shortness of breath
  • drop in blood pressure when you get up. It may make you feel dizzy or faint (which may lead to falls)
  • constipation, upset stomach (digestive problems)
  • vomiting (mainly in the elderly)
  • strange dreams and nightmares
  • suicidal thoughts and worsening of your depression
  • increased feelings of hunger
  • speech and language disorders
  • 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 stop or become irregular.
  • dimsyn
  • feeling of irritation
  • fever
  • increased content of liver enzymes measured in blood samples
  • altered levels of thyroid hormones in the blood
  • altered levels of certain types of blood cells
  • increased levels of sugar in the blood
  • impotence
  • swelling in the arms or legs.

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

  • Feeling of discomfort in the legs (also called restless legs (RLS))
  • difficulty swallowing
  • change in the electrical activity of the heart that can be seen on the ECG ( QT prolongation)
  • diabetes
  • sexual dysfunction
  • decreased number of red blood cells ( anemia ) or platelets ( thrombocytopenia )
  • lower levels of sodium in the blood ( hyponatremia )
  • a slower-than-normal heart rate may occur at the beginning of treatment and may be associated with low blood pressure and fainting.
  • nasal congestion
  • fainting (may lead to falls)
  • difficulty urinating
  • 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
  • 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
  • that you walk, talk, eat or have other activities while you sleep
  • lowered body temperature ( hypothermia )
  • blockage of the intestine.
  • increased level of creatinine 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 which can cause low sodium levels in the blood. It can lead to symptoms such as headaches, nausea, confusion, and weakness.

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 Actavis during pregnancy.
  • inflammation of the blood vessels ( vasculitis ) often with a rash with small red or purple nodules.

Quetiapine Actavis belongs to a group of medicines 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.

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 have been seen more frequently in children and adolescents or have not been seen in adults:

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

  • The increased amount of the hormone et prolactin in the blood. Increased levels of the hormone et prolactin may 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 Actavis

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, label, and blister 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. 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 Actavis film-coated tablets contain 25 mg, 100 mg, 150 mg, 200 mg or 300 mg of quetiapine (as quetiapine fumarate).
  • Other ingredients are Tablet core: Microcrystalline cellulose, povidone K29-32, calcium hydrogen phosphate dihydrate, sodium starch glycolate (type A), lactose monohydrate, and magnesium stearate. Film coating: Hypromellose 6cP (E464), titanium dioxide (E171), lactose monohydrate, macrogol 3350, triacetin, yellow iron oxide (E172) (in 25 mg, 100 mg, and 150 mg tablets), and red iron oxide (E172) (in 25 mg tablets only).

What the medicine looks like and the contents of the pack

Quetiapine Actavis 25 mg film-coated tablet is round, 5.5 mm in diameter, biconvex, light orange and marked “Q” on one side.

Quetiapine Actavis 100 mg film-coated tablet is round, 8.5 mm in diameter, biconvex, yellow, and marked “Q” on one side.

Quetiapine Actavis 150 mg film-coated tablet is oval measuring 6.9 mm x 13.8 mm, biconvex, light yellow, and marked “Q” on one side.

Quetiapine Actavis 200 mg film-coated tablet is oval measuring 16 mm x 8.2 mm, biconvex, white, and marked “Q” on one side.

Quetiapine Actavis 300 mg film-coated tablet is oval measuring 19 mm x 7.6 mm, biconvex, white, and marked “Q” on one side and “300” on the other side.

Pack sizes

Blister packs:

25 mg film-coated tablets: 6, 10, 20, 30, 50, 60, 90 and 100 tablets.

100 mg film-coated tablets: 6, 10, 20, 30, 50, 60, 90 and 100 tablets.

150 mg film-coated tablets: 6, 10, 20, 30, 50, 60, 90 and 100 tablets.

200 mg film-coated tablets: 6, 10, 20, 30, 50, 60, 90 and 100 tablets.

300 mg film-coated tablets: 6, 10, 20, 30, 50, 60, 90 and 100 tablets.

Jars:

25 mg film-coated tablets: 100, 250 tablets

100 mg film-coated tablets: 100, 250 tablets

150 mg film-coated tablets: 100, 250 tablets

200 mg film-coated tablets: 100, 250 tablets

300 mg film-coated tablets: 60, 100, 250 tablets

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Actavis Group PTC EHF.

Reykjavikurvegur 76-78

220 Hafnafjörður, Iceland

Manufacturer

Actavis Ltd.

B16 Bulebel Industrial Estate

Zejtun ZTN 08

Malta

Actavis hf.

Reykjavikurvegur 78

IS-200 Hafnarfjörður

Iceland

Actavis Group PTC EHF.

Reykjavikurvegur 78

IS-220 Hafnarfjordur

Iceland

Balkanpharma Dupnitsa AD

3 Samokovsko Shosse Str.

Dupnitsa 2600

Bulgaria

Muhammad Nadeem

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