Quetiapine 200 Mg Film-Coated Tablets
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Quetiapine 25 mg, 100 mg, 150 mg, 200 mg and 300 mg Film-Coated Tablets
(Quetiapine)
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Quetiapine is and what it is used for
2. What you need to know before you take Quetiapine
3. How to take Quetiapine
4. Possible side effects
5. How to store Quetiapine
6. Contents of the pack and other information
1. What Quetiapine is and what it is used for
Quetiapine contains a substance called quetiapine. This belongs to a group of medicines called anti-psychotics. Quetiapine 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: where you may feel sad all the time or you may find that you feel depressed, feel guilty, lack energy, lose your appetite or can't sleep.
Your doctor may continue to prescribe Quetiapine even when you are feeling better.
2. What you need to know before you take Quetiapine
Do not take Quetiapine:
- 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:
• protease inhibitors, such as nelfinavir (for HIV infection)
• azole medicines (for fungal infections)
• medicines for an infection (like erythromycin or clarithromycin)
• nefazodone (for depression).
Do not take Quetiapine if the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking Quetiapine.
Warnings and precautions
Talk to your doctor or pharmacist before taking Quetiapine:
- You, or someone in your family, have or have had any heart problems such as a very fast heart beat or prolonged QT on an ECG (heart tracing), 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 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 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.
- You are an elderly person with dementia (loss of brain function). If you are, Quetiapine should not be taken because the group of medicines that Quetiapine 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 any of the following after taking Quetiapine:
- A combination of 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.
Other medicines and Quetiapine
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
In particular, tell your doctor 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.
- Rifampicin (for tuberculosis).
- Barbiturates (for difficulty sleeping).
- Thioridazine or Lithium (other anti-psychotic medicines).
- 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.
If you have a urine drug screen, taking Quetiapine could cause positive results for methadone or drugs for depression called tricyclic antidepressants (TCAs), even though you may not be taking methadone or TCAs.
The result will need to be confirmed by a more specific test.
Quetiapine with food, drink and alcohol
- Quetiapine can be taken with or without food.
- Be careful how much alcohol you drink. This is because the combined effect of Quetiapine and alcohol can make you sleepy.
- Do not drink grapefruit juice while you are taking Quetiapine. It can affect the way the medicine works.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Quetiapine 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.
Hospital - If you go into hospital, tell the medical staff that you are taking Quetiapine.
Quetiapine contains Lactose, which is a type of sugar. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Effect on Urine Drug Screens
If you are having a urine drug screen, taking Quetiapine may cause positive results for methadone or certain drugs for depression called tricyclic antidepressants (TCAs) when some test methods are used, even though you may not be taking methadone or TCAs. If this happens, a more specific test can be performed.
If you have been on other medication for this condition, and that medication has stopped your periods, changing to Quetiapine may allow them to return.
3. How to take Quetiapine
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Your doctor will decide on your starting dose and may gradually increase it. When you are on your regular dose you will usually be taking between 150 mg and 800 mg each day. It will depend on your illness and needs.
- You will take your tablets once a day, at bedtime or twice a day, depending on your illness.
- Swallow your tablets whole with a drink of water.
- You can take your tablets with or without food.
- Do not drink grapefruit juice while you are taking Quetiapine. It can affect the way the medicine works.
- Do not stop taking your tablets even if you feel better, unless your doctor tells you.
Quetiapine tablets come in 5 different strengths and each strength is a different colour or shape.
- Even though the dose might stay the same, it might be supplied as different strength tablets. For example, one 300 mg tablet (white) or two 150 mg tablets (pale yellow).
- So don't be surprised if the colour of your tablets changes from time to time.
Liver problems
If you have liver problems your doctor may give you a lower dose.
Elderly people
If you are elderly your doctor may give you a lower dose.
Children and adolescents
Quetiapine should not be used by children and adolescents aged under 18 years.
If you take more Quetiapine than you should
If you take more Quetiapine than prescribed by your doctor, you may feel sleepy, feel faint or dizzy and experience abnormal heart beats. Contact your doctor or nearest hospital straight away. Take the Quetiapine tablets with you.
If you forget to take Quetiapine
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 dose.
If you stop taking Quetiapine
If you suddenly stop taking Quetiapine, you may be unable to sleep (insomnia), or 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 medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If any of the following happen, stop taking Quetiapine and contact a doctor or go to the nearest hospital straight away, as you may need urgent medical attention:
Uncommon (may affect up to 1 in 100 people):
- Fits or seizures.
- Allergic reactions that may include raised lumps (weals), swelling of the skin and swelling around the mouth.
- Uncontrollable movements, mainly of your face or tongue (Tardive dyskinesia).
Rare (may affect up to 1 in 1,000 people):
- A combination of high temperature (fever), sweating, stiff muscles, feeling very drowsy or faint, large increase in blood pressure or heartbeat (a disorder called “neuroleptic malignant syndrome”).
- Yellowing of the skin and eyes (jaundice).
- Inflammation of the liver (hepatits).
- A long-lasting and painful erection (priapism).
- 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.
Very rare (may affect up to 1 in 10,000 people):
- Severe allergic reaction (called anaphylaxis) that may include difficulty in breathing, dizziness, shock and collapse.
- Rapid swelling of the skin, usually around the eyes, lips and throat (angioedema).
- A serious blistering condition of the skin, mouth, eyes and genitals (Stevens-Johnson syndrome).
Other possible side effects:
Very common (may affect more than 1 in 10 people):
- Dizziness (may lead to falls), headache, dry mouth.
- Feeling sleepy (this may go away with time, as you keep taking Quetiapine) (may lead to falls).
- Discontinuation symptoms (symptoms which occur when you stop taking Quetiapine) 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 (may affect up to 1 in 10 people):
- Rapid heartbeat.
- Feeling like your heart is pounding, racing or has skipped beats.
- Upset stomach (indigestion) or constipation.
- Swelling of arms or legs.
- Increased levels of sugar in the blood.
- Low blood pressure when standing. This may make you feel dizzy or faint (may lead to falls).
- Blurred vision.
- Abnormal muscle movements. These include difficulty starting muscle movements, shaking, feeling restless or muscle stiffness without pain.
- Abnormal dreams and nightmares.
- Feeling more hungry.
- Feeling irritated.
- Disturbance in speech or language.
- Thoughts of suicide and worsening of your depression.
- Shortness of breath.
- Vomiting (mainly in the elderly).
- Fever.
- Feeling weak, fainting (may lead to falls).
- Stuffy nose.
Uncommon (may affect up to 1 in 100 people):
- Unpleasant sensations in the legs (also called restless leg syndrome).
- Difficulty swallowing.
- Sexual dysfunction.
- Diabetes.
- Change in electrical activity of the heart seen on ECG (QT prolongation).
- A slower than normal heart rate which may occur when starting treatment and which may be associated with low blood pressure and fainting.
Rare (may affect up to 1 in 1,000 people):
- Swelling of breasts and unexpected production of breast milk (galactorrhoea).
- Menstrual disorder.
- Walking, talking, eating or other activities while you are asleep.
- Body temperature decreased (hypothermia).
- Inflammation of the pancreas, which causes severe pain in the abdomen and back.
- A condition (called “metabolic syndrome”) where you may have a combination of 3 or more of the following: an increase in fat around your abdomen, a decrease in “good cholesterol” (HDL-C), an increase in a type of fat in your blood called triglycerides, high blood pressure and an increase in your blood sugar.
Very rare (may affect up to 1 in 10,000 people):
- Severe rash, blisters, or red patches on the skin.
- Worsening of pre-existing diabetes.
- Inappropriate secretion of a hormone that controls urine volume.
- Breakdown of muscle fibres and pain in muscles (rhabdomyolysis).
Not known (frequency 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 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), decreases 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 the 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.
Additional side effects in children and adolescents:
Very Common (may affect more than 1 in 10 people):
• Increase in blood pressure.
The following side effects have been seen more often in children and adolescents:
Very Common (may affect more than 1 in 10 people):
• 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.
• Vomiting
Common (may affect up to 1 in 10 people):
• Feeling weak, fainting (may lead to falls).
• Stuffy nose.
• Feeling irritated.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme, website: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Quetiapine
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 label and carton after EXP. The expiry date refers to the last day of that month.
Do not store above 30°C. Store in the original package.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Quetiapine contains
- The active substance is quetiapine. Each film-coated tablet contains 25 mg, 100 mg, 150 mg,
- 200 mg or 300 mg of quetiapine (as quetiapine fumarate).
- The other ingredients are lactose monohydrate, cellulose microcrystalline, calcium hydrogen phosphate dihydrate, sodium starch glycolate (type A), povidone k-90, silica, magnesium stearate. The coating contains hypromellose, titanium dioxide (E171), macrogol 400. The 25, 100 & 150 mg tablets also contain yellow iron oxide (E172) and the 25 mg tablets also contain red iron oxide (E172).
What Quetiapine looks like and contents of the pack
Quetiapine 25 mg tablets are round, peach, biconvex film-coated tablets, imprinted ‘QTP' on one side and ‘25' on the other side.
Quetiapine 100 mg tablets are round, yellow, biconvex film-coated tablets, imprinted ‘QTP' on one side and ‘100' on the other side.
Quetiapine 150 mg tablets are round, pale yellow, biconvex film-coated tablets, imprinted ‘QTP' on one side and ‘150' on the other side.
Quetiapine 200 mg tablets are round, white, biconvex film-coated tablets, imprinted ‘QTP' on one side and ‘200' on the other side.
Quetiapine 300 mg tablets are white, capsule shaped, biconvex film-coated tablets, imprinted ‘QTP' on one side and ‘300' on the other.
Pack sizes: 20, 50, 60, 100 film-coated tablets. Additionally for -25 mg: 6, 30 film-coated tablets. Additionally for -150 mg/-200 mg/-300 mg: 10 film-coated tablets.
Not all pack sizes may be available.
Marketing Authorisation Holder and Manufacturer
[To be completed nationally]
This medicinal product is authorised in the Member States of the eEa under the following names:
Germany: Quetiapine beta 25, 100, 150, 200, 300 mg Filmtabletten
Italy: Quetiapina Dr. Reddy's 25, 100, 200, 300 mg compresse rivestite con film Romania: Kinpride 25, 100, 150, 200, 300 mg comprimate filmate
United Kingdom: Quetiapine 25, 100,150, 200, 300 mg film-coated Tablets
This leaflet was last revised in May 2014.