Quetiapine 200 Mg Film-Coated Tablets
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_ —— PACKAGE LEAFLET:
INFORMATION FOR THE USER
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Quetiapine 25 mg Film-coated Tablets Quetiapine 100 mg Film-coated Tablets Quetiapine 150 mg Film-coated Tablets Quetiapine 200 mg Film-coated Tablets Quetiapine 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 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 Tablets are and what they are used for
2. What you need to know before you take Quetiapine Tablets
3. How to take Quetiapine Tablets
4. Possible side effects
5. How to store Quetiapine Tablets
6. Contents of the pack and other information
1. WHAT QUETIAPINE TABLETS ARE AND WHAT THEY ARE USED FOR
Quetiapine Tablets contain a substance called quetiapine. This belongs to a group of medicines called anti-psychotics. Quetiapine Tablets can be used to treat several illnesses, such as:
• Bipolar depression: where you feel sad. You may find that you feel depressed, feel guilty, lack energy, lose your appetite or can't sleep.
• Mania: where you may feel very excited, elated, agitated, enthusiastic or hyperactive or have poor judgment including being aggressive or disruptive.
• 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.
Your doctor may continue to prescribe Quetiapine Tablets even when you are feeling better.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE QUETIAPINE TABLETS
Do not take Quetiapine Tablets:
• 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:
◦ some medicines for HIV
◦ azole medicines (for fungal infections)
◦ erythromycin or clarithromycin (for infections)
◦ nefazodone (for depression).
Do not take Quetiapine Tablets if the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking Quetiapine Tablets.
Warnings and precautions
Talk to your doctor or pharmacist before taking Quetiapine Tablets if:
• You, or someone in your family, have or have had any heart problems, for example heart rhythm problems, weakening of the heart muscle or inflammation of the heart 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 Tablets.
• 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 Tablets should not be taken because the group of medicines that Quetiapine Tablets belong 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.
• You have or have had a condition where you stop breathing for short periods during your normal nightly sleep (called “sleep apnoea”) and are taking medicines that slow down the normal activity of the brain (“depressants”).
• You have or have had a condition where you can't completely empty your bladder (urinary retention), have an enlarged prostate, a blockage in your intestines, or increased pressure inside your eye. These conditions are sometimes caused by medicines (called “anti-cholinergics”) that affect the way nerve cells function in order to treat certain medical conditions.
Tell your doctor immediately if you experience any of the following after taking Quetiapine Tablets:
• 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.
Tell your doctor as soon as possible if you have:
• A fever, flu-like symptoms, sore throat or any other infection, as this could be a result of a very low white blood cell count, which may require Quetiapine Tablets to be stopped and/or treatment to be given.
• Constipation along with persistent abdominal pain, or constipation which has not responded to treatment, as this may lead to a more serious blockage of the bowel.
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
Weight gain has been seen in patients taking quetiapine. You and your doctor should check your weight regularly.
Children and Adolescents
Quetiapine Tablets are not for use in children and adolescents below 18 years of age.
Other medicines and Quetiapine Tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Do not take Quetiapine Tablets, 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 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).
■ Medicines that can cause constipation.
■ Medicines (called “anti-cholinergics”) that affect the way nerve cells function in order to treat certain medical conditions.
Before you stop taking any of your medicines, please talk to your doctor or pharmacist first.
Quetiapine Tablets with food, drink and alcohol
• Quetiapine Tablets can be taken with or without food.
• Be careful how much alcohol you drink. This is because the combined effect of Quetiapine Tablets and alcohol can make you feel sleepy.
• Do not drink grapefruit juice while you are taking Quetiapine Tablets. It can affect the way the medicine works.
Pregnancy and breast-feeding
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. You should not take Quetiapine Tablets during pregnancy unless this has been discussed with your doctor. Quetiapine Tablets should not be taken if you are breastfeeding.
The following symptoms which can represent withdrawal 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.
Quetiapine Tablets contain lactose.
Quetiapine Tablets contain lactose which is a type of sugar. If you have been told by your doctor that you have an intolerance to some sugars, talk to your doctor before taking this medicine.
Effect on Urine Drug Screens
If you are having a urine drug screen, taking Quetiapine Tablets 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.
3. HOW TO TAKE Quetiapine Tablets
Always take this medicine exactly 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. 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, 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 Tablets. 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.
Use in children and adolescents
Quetiapine Tablets should not be used by children and adolescents aged under 18 years.
If you take more Quetiapine Tablets than you should
If you take more Quetiapine Tablets than prescribed by your doctor, you may feel sleepy, feel 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 a dose of Quetiapine Tablets
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 Tablets
If you suddenly stop taking Quetiapine Tablets, 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 you suffer from any of the following side effects seek immediate medical attention
• Thoughts of suicide and worsening of your depression.
• Allergic reactions that may include raised lumps (weals), swelling of the skin and swelling around the mouth.
• 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.
• 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).
• A serious blistering condition of the skin, mouth, eyes and genitals (Stevens-Johnson syndrome).
• “Muscle weakness, tenderness or pain and particularly, if at the same time, you feel unwell, have a high temperature or have dark urine. They may be caused by an abnormal muscle breakdown which can be life threatening and lead to kidney problems (a condition called rhabdomyolysis).”
• 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).
Very common side effects (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 Tablets) (may lead to falls)
• Discontinuation symptoms (symptoms which occur when you stop taking Quetiapine Tablets) 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.
• Abnormal muscle movements. These include difficulty starting muscle movements, shaking, feeling restless or muscle stiffness without pain.
• Changes in the amount of certain fats (triglycerides and total cholesterol).
Common side effects (may affect up to 1 in 10 people):
• Rapid heartbeat.
• Feeling like your heart is pounding, racing or has skipped beats.
• Constipation, upset stomach (indigestion).
• Feeling weak.
• 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 dreams and nightmares.
• Feeling more hungry.
• Feeling irritated.
• Disturbance in speech and language.
• Shortness of breath.
• Vomiting (mainly in the elderly).
• Fever.
• Changes in the amount of thyroid hormones in your blood.
• Decreases in the number of certain types of blood cells.
• Increases in the amount of liver enzymes measured in the blood.
• 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.
Uncommon side effects (may affect up to 1 in 100 people):
• Fits or seizures.
• Unpleasant sensations in the legs (also called restless legs syndrome).
• Difficulty swallowing.
• Uncontrollable movements, mainly of your face or tongue.
• 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.
• Difficulty in passing urine.
• Fainting (may lead to falls).
• Stuffy nose.
• Decrease in the amount of red blood cells.
• Decrease in the amount of sodium in the blood.
• Worsening of pre-existing diabetes.
Rare side effects (may affect up to 1 in 1,000 people):
• A combination of high temperature (fever), sweating, stiff muscles, feeling very drowsy or faint (a disease 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.
• Walking, talking, eating or other activities while you are asleep.
• Body temperature decreased (hypothermia).
• Inflammation of the pancreas.
• 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.
• Combination of fever, flu-like symptoms, sore throat or any other infection with very low white blood cell count, a condition called agranulocytosis.
• Bowel obstruction.
• Increased blood creatine phosphokinase (a substance from the muscles).
Very rare side effects (may affect up to 1 in 10,000 people):
• Inappropriate secretion of a hormone that controls urine volume.
Not known (frequency cannot be estimated from the available data):
• Symptoms of withdrawal may occur in newborn babies of mothers that have used Quetiapine Tablets during their pregnancy.
The class of medicines to which Quetiapine Tablets 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 a hormone called 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.
Side effects in children and adolescents
The same side effects that may occur in adults may also occur in children and adolescents.
The following side effects have been seen more often in children and adolescents or have not been seen in adults:
Very Common side effects (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
• Abnormal muscle movements. These include difficulty starting muscle movements, shaking, feeling restless or muscle stiffness without pain.
• Increase in blood pressure.
Common side effects (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 Yellow Card Scheme at: 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 TABLETS
• Keep this medicine out of the sight and reach of children.
• Keep this medicine in the original pack.
• Do not use this medicine after the expiry date which is stated on the carton and blister. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not throw away any medicines via wastewater. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. FURTHER INFORMATION What Quetiapine Tablets contain:
• The active substance is quetiapine (as quetiapine fumarate). Quetiapine Tablets contain 25 milligrams (mg), 100 mg, 150 mg, 200 mg or 300 mg of quetiapine (as quetiapine fumarate).
• The other ingredients are dibasic calcium phosphate, hypromellose (E464), lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, sodium starch glycolate and titanium dioxide (E171).
• The 25 mg tablets contain iron oxide yellow (E172) and iron oxide red (E172).
• The 100 mg and 150 mg tablets contain iron oxide yellow (E172).
What Quetiapine Tablets look like and contents of the pack:
Quetiapine Tablets are available in clear transparent PVC/aluminium Blister:
For 25 mg (coloured peach): pack sizes of 6, 20, 30, 50, 60, 100 film-coated tablets;
For 100 mg (coloured yellow): pack sizes of 20, 30, 50 (10 strip x 5 blisters), 50 (5 strip x 10 blisters), 60, 90, 100 film-coated tablets;
For 150 mg (coloured off white to light yellow): pack sizes of 20, 30, 50 (10 strip x 5 blisters), 50 (5 strip x 10 blisters), 60, 90, 100 film-coated tablets;
For 200 mg (coloured white): pack sizes of 10, 20, 30, 50 (10 strip x 5 blisters), 50 (5 strip x 10 blisters), 60, 90, 100 film-coated tablets;
For 300 mg (coloured white): pack sizes of 10, 20, 30, 50 (10 strip x 5 blisters), 50 (5 strip x 10 blisters), 60, 90, 100 film-coated tablets.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder ALKEM PHARMAGmbH
Gutenbergstralie 13 24941 Flensburg Germany
Manufacturer Wave Pharma Limited
4th Floor, Cavendish House 369 Burnt Oak Broadway, Edgware,
Middlesex HA8 SAW,
United Kingdom
The leaflet was last revised in 08/2016.
PT 2439-01