Auteur: Teva


Lange informatie

Waarvoor wordt dit middel gebruikt?

Quetiapine Teva contains a substance called quetiapine. This belongs to a group of medicines called anti-psychotics. Quetiapine Teva can be used to treat several illnesses, such as:

  • Schizophrenia: where you may hear or feel things that are not there, believe things that are not true or feel unusually suspicious, anxious, confused, guilty, tense or depressed.
  • Mania: where you may feel very excited, elated, agitated, enthusiastic or hyperactive or have poor judgment including being aggressive or disruptive.
  • Bipolar depression and major depressive episodes in major depressive disorder: where you feel sad. You may find that you feel depressed, feel guilty, lack energy, lose your appetite or can’t sleep.

When Quetiapine Teva is being taken to treat major depressive episodes in major depressive disorder, it will be taken in addition to another drug being used to treat this illness.

Your doctor may continue to give you Quetiapine Teva when you are feeling better.

Inhoudsopgave
Wanneer mag u dit middel niet gebruiken of moet u er extra voorzichtig mee zijn?
Hoe gebruikt u dit middel?
Mogelijke bijwerkingen?
Hoe bewaart u dit middel?
Anvullende Informatie

Wanneer mag u dit middel niet gebruiken of moet u er extra voorzichtig mee zijn?

Do not take Quetiapine Teva:

  • if you are allergic (hypersensitive) to quetiapine or any of the other ingredients of Quetiapine Teva.
  • if you are taking any of the following medicines:
    • some medicines for HIV
    • azole medicines (for fungal infections)
  • erythromycin or clarithromycin (for infections)
  • nefazodone (for depression).

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

Take special care with Quetiapine Teva

Before you take your medicine, tell your doctor if:

  • You, or someone in your family, have or have had any heart problems, for example heart rhythm problems or if you are taking any medicines that may have an impact on the way your heart beats.
  • You have low blood pressure.
  • You have had a stroke, especially if you are elderly.
  • You have problems with your liver.
  • You have ever had a fit (seizure).
  • You have diabetes or have a risk of getting diabetes. If you do, your doctor may check your blood sugar levels while you are taking Quetiapine Teva.
  • You know that you have had low levels of white blood cells in the past (which may or may not have been caused by other medicines).
  • You are an elderly person with dementia (loss of brain function). If you are, Quetiapine Teva should not be taken because the group of medicines that Quetiapine Teva belongs to may increase the risk of stroke, or in some cases the risk of death, in elderly people with dementia.
  • You or someone else in your family has a history of blood clots, as medicines like these have been associated with formation of blood clots.

Tell your doctor immediately if you experience:

  • Fever, severe muscle stiffness, sweating or a lowered level of consciousness (a disorder called “neuroleptic malignant syndrome”). Immediate medical treatment may be needed.
  • Uncontrollable movements, mainly of your face or tongue.
  • Dizziness or a severe sense of feeling sleepy. This could increase the risk of accidental injury (fall) in elderly patients.
  • Fits (seizures).
  • A long-lasting and painful erection (Priapism).

These conditions can be caused by this type of medicine.

Thoughts of suicide and worsening of your depression

If you are depressed you may sometimes have thoughts of harming or killing yourself. These may be increased when first starting treatment, since these medicines all take time to work, usually about two weeks but sometimes longer. These thoughts may also be increased if you suddenly stop taking your medication.

You may be more likely to think like this if you are a young adult. Information from clinical trials has shown an increased risk of suicidal thoughts and/or suicidal behaviour in young adults aged less than 25 years with depression.

If you have thoughts of harming or killing yourself at any time, contact your doctor or go to a hospital straight away. You may find it helpful to tell a relative or close friend that you are depressed, and ask them to read this leaflet. You might ask them to tell you if they think your depression is getting worse, or if they are worried about changes in your behaviour.

Weight gain has been seen in patients taking quetiapine. You and your doctor should check your weight regularly.

Taking other medicines

Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription and herbal medicines.

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

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

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

  • Epilepsy medicines (like phenytoin or carbamazepine).
  • High blood pressure medicines.
  • Barbiturates (for difficulty sleeping).
  • Thioridazine (another anti-psychotic medicine).
  • Medicines that have an impact on the way your heart beats, for example, drugs that can cause an imbalance in electrolytes (low levels of potassium or magnesium) such as diuretics

(water pills) or certain antibiotics (drugs to treat infections).

Before you stop taking any of your medicines, please talk to your doctor first.

Taking Quetiapine Teva with food and drink

  • Quetiapine Teva can be affected by food and you should therefore take your tablets at least one hour before a meal or prior to bedtime.
  • Be careful how much alcohol you drink. This is because the combined effect of Quetiapine Teva and alcohol can make you sleepy.
  • Do not drink grapefruit juice while you are on Quetiapine Teva treatment. It can affect the way the medicine works.

Pregnancy and breast-feeding

If you are pregnant, trying to get pregnant, or breast-feeding, talk to your doctor before taking Quetiapine Teva. You should not take Quetiapine Teva during pregnancy unless this has been discussed with your doctor. Quetiapine Teva should not be taken if you are breast-feeding.

The following symptoms may occur in newborn babies, of mothers that have used quetiapine in the last trimester (last three months of their pregnancy): shaking, muscle stiffness and/or weakness, sleepiness, agitation, breathing problems, and difficulty in feeding. If your baby develops any of these symptoms you may need to contact your doctor.

Driving and using machines

Your tablets may make you feel sleepy. Do not drive or use any tools or machines until you know how the tablets affect you.

Effect on Urine Drug Screens

If you are taking quetiapine and have a urine drug screen, some test methods may cause positive results for methadone or TCAs (drugs for depression called tricyclic antidepressants), even though you may not be taking methadone or TCAs. If this happens, a more specific test can be performed.

Hoe gebruikt u dit middel?

Always take Quetiapine Teva exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. Your doctor will decide on your starting dose. The maintenance dose (daily dose) will depend on your illness and needs but will usually be between 150 mg and 800 mg.

  • You will take your tablets once a day.
  • Do not split, chew or crush the tablets.
  • Swallow your tablets whole with a drink of water.
  • Take your tablets without food (at least one hour before a meal or at bedtime, your doctor will tell you when).
  • Do not drink grapefruit juice while you are taking Quetiapine Teva treatment. It can affect the way the medicine works.
  • Do not stop taking your tablets even if you feel better, unless your doctor tells you.

Liver problems

If you have liver problems your doctor may change your dose.

Elderly people

If you are elderly your doctor may change your dose.

Children and adolescents under 18 years

Quetiapine Teva should not be used by children and adolescents aged under 18 years.

If you take more Quetiapine Teva than you should

If you take more Quetiapine Teva than prescribed by your doctor, you may experience sleepiness, dizziness and abnormal heart beats. Contact your doctor or nearest hospital straight away.

Keep the Quetiapine Teva tablets with you.

If you forget to take a dose of Quetiapine Teva

If you forget to take a dose, take it as soon as you remember. If it is almost time to take the 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 be unable to sleep (insomnia), you may feel sick (nausea), or you may experience headache, diarrhoea, being sick (vomiting), dizziness or irritability. Your doctor may suggest 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.

Mogelijke bijwerkingen?

Like all medicines, Quetiapine Teva can cause side effects, although not everybody gets them. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Very common (affects more than 1 patient in 10):

  • Dizziness (may lead to falls), headache, dry mouth.
  • Feeling sleepy (this may go away with time, as you keep taking Quetiapine Teva) (may lead to falls).
  • Discontinuation symptoms (symptoms which occur when you stop taking Quetiapine Teva) include not being able to sleep (insomnia), feeling sick (nausea), headache, diarrhoea, being sick (vomiting), dizziness, and irritability. Gradual withdrawal over a period of at least 1 to 2 weeks is advisable.
  • Putting on weight.

Common (affects 1 to 10 patients in 100):

  • Rapid heartbeat.
  • Feeling like your heart is pounding, racing or has skipped beats.
  • Stuffy nose.
  • Constipation, upset stomach (indigestion).
  • Feeling weak, fainting (may lead to falls).
  • Swelling of arms or legs.
  • Low blood pressure when standing up. This may make you feel dizzy or faint (may lead to falls).
  • Increased levels of sugar in the blood.
  • Blurred vision.
  • Abnormal muscle movements. These include difficulty starting muscle movements, shaking, feeling restless or muscle stiffness without pain.
  • Abnormal dreams and nightmares.
  • Increased appetite.
  • Feeling irritated.
  • Disturbance in speech and language.
  • Thoughts of suicide and worsening of your depression
  • Shortness of breath
  • Vomiting (mainly in the elderly)
  • Fever

Uncommon (affects 1 to 10 patients in 1,000):

  • Fits or seizures.
  • Allergic reactions that may include raised lumps (weals), swelling of the skin and swelling around the mouth.
  • Unpleasant sensations in the legs (also called restless legs syndrome).
  • Difficulty swallowing.
  • Uncontrollable movements, mainly of your face or tongue.
  • Sexual dysfunction.
  • Worsening of pre-existing diabetes.
  • Change in electrical activity of the heart seen on ECG (QT prolongation).

Rare (affects 1 to 10 patients in 10,000):

  • A combination of high temperature (fever), sweating, stiff muscles, feeling very drowsy or

faint (a disorder called “neuroleptic malignant syndrome’’).

  • Yellowing of the skin and eyes (jaundice).
  • Inflammation of the liver (hepatitis).
  • A long-lasting and painful erection (priapism).
  • Swelling of breasts and unexpected production of breast milk (galactorrhoea).
  • Menstrual disorder.
  • Blood clots in the veins especially in the legs (symptoms include swelling, pain and redness in the leg), which may travel through blood vessels to the lungs causing chest pain and difficulty in breathing. If you notice any of these symptoms seek medical advice immediately.
  • Walking, talking , eating or other activities while you are asleep.
  • Body temperature decreased (hypothermia).
  • Inflammation of the pancreas

Very rare (affects less than 1 patient in 10,000):

  • Severe rash, blisters, or red patches on the skin.
  • A severe allergic reaction (called anaphylaxis) which may cause difficulty in breathing or shock.
  • Rapid swelling of the skin, usually around the eyes, lips and throat (angioedema).
  • Inappropriate secretion of a hormone that controls urine volume.
  • Breakdown of muscle fibers and pain in muscles (rhabdomyolysis).

Not known (cannot be estimated from the available data)

  • Skin rash with irregular red spots (erythema multiforme)
  • Serious, sudden allergic reaction with symptoms such as fever and blisters on the skin and peeling of the skin (toxic epidermal necrolysis)

The class of medicines to which Quetiapine Teva belongs can cause heart rhythm problems, which can be serious and in severe cases may be fatal.

Some side effects are only seen when a blood test is taken. These include changes in the amount of certain fats (triglycerides and total cholesterol) or sugar in the blood, changes in the amount of thyroid hormones in your blood, increased liver enzymes, decreases in the number of certain types of blood cells, decrease in the amount of red blood cells, increased blood creatine phosphokinase (a substance in the muscles), decrease in the amount of sodium in the blood and increases in the amount of the hormone prolactin in the blood.

Increases in the hormone prolactin could in rare cases lead to the following:

  • Men and women to have swelling of breasts and unexpectedly produce breast milk.
  • Women to have no monthly period or irregular periods.

Your doctor may ask you to have blood tests from time to time.

Children and adolescents

The same side effects that may occur in adults may also occur in children and adolescents. The following side effect has been seen only in children and adolescents:

Very Common (affects more than 1 patient in 10):

  • Increase in blood pressure.

The following side effects have been seen more often in children and adolescents:

Very Common (affects more than 1 patient in 10):

  • Increase in the amount of a hormone called prolactin, in the blood. Increases in the hormone prolactin could in rare cases lead to the following:
    • Boys and girls to have swelling of breasts and unexpectedly produce breast milk.
    • Girls to have no monthly period or irregular periods.
  • Increased appetite.
  • Abnormal muscle movements. These include difficulty starting muscle movements, shaking, feeling restless or muscle stiffness without pain.

Hoe bewaart u dit middel?

Keep out of the reach and sight of children.

Do not use Quetiapine Teva after the expiry date which is stated on the container after EXP. The expiry date refers to the last day of that month.

Quetiapine Teva does not require any special storage conditions.

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.

Anvullende Informatie

What Quetiapine Teva contains

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

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

Tablet coating: titanium dioxide (E171), hypromellose, macrogol/PEG 400, polysorbate 80. The 50 mg, 200 mg and 300 mg tablets contain Iron Oxide Yellow (E172) and Iron Oxide Red (E172). The 50 mg and 300 mg tablets also contain Iron Oxide Black (E172).

What Quetiapine Teva looks like and contents of the pack

All strengths of Quetiapine Teva prolonged-release tablets are capsule shaped, film-coated tablets. 50 mg tablets are brown coloured, debossed “Q 50” on one side, plain on the other; 150 mg tablets are white coloured, debossed “Q 150” on one side, plain on the other; 200 mg tablets are yellow coloured, debossed “Q 200” on one side, plain on the other; 300 mg tablets are light yellow coloured, debossed “Q 300” on one side, plain on the other and 400 mg tablets are white coloured, debossed “Q 400” on one side, plain on the other.

Packs of 10, 20, 30, 50, 50x1 (hospital pack), 56 (calendar pack), 60, 90 and100 tablets are registered for all strengths. Not all pack sizes may be available.

In het register ingeschreven onder nummer

RVG 111319

Marketing Authorisation Holder and Manufacturer

Vergunninghouder

Teva Nederland B.V.

Swensweg 5

2031 GA Haarlem

Nederland

Fabrikanten

TEVA Pharmaceutical Works Private Limited Company Pallagi út 13

4042 Debrecen Hongarije

TEVA UK Ltd

Brampton Road, Hampden Park

Eastbourne, East Sussex,

BN22 9AG

Verenigd Koninkrijk

Pharmachemie B.V.

Swensweg 5

2031 GA Haarlem

Nederland

Teva Czech Industries s.r.o. Ostravska 29, c.p. 305 74770 Opava-Komarov Tsjechië

Teva Operations Sp. z.o.o. ul. Mogilska 80

31-546, Krakow Polen

TEVA PHARMA S.L.U.

C/C, n. 4, Poligono Industrial Malpica 50016 Zaragoza

Spanje

Merckle GmbH

Ludwig-Merckle-Straße 3

89143 Blaubeuren

Duitsland

CT Arzneimittel GmbH Graf-Arco-Straße 3 89079UIm

Duitsland

This medicinal product is authorised in the Member States of the EEA under the following names:

{Name of the Member State} {Name of the medicinal product} {Name of the Member State} {Name of the medicinal product}

This leaflet was last approved in november 2012

[To be completed nationally]

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