Glavetrim Xl 200 Mg Prolonged-Release Tablet
Package leaflet: Information for the user
Glavetrim XL 50 mg prolonged-release Tablet Glavetrim XL 200 mg prolonged-release Tablet Glavetrim XL 300 mg prolonged-release Tablet Glavetrim XL 400 mg prolonged-release Tablet
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 or nurse.
- 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 or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Glavetrim XL is and what it is used for
2. What you need to know before you take Glavetrim XL
3. How to take Glavetrim XL
4. Possible side effects
5. How to store Glavetrim XL
6. Contents of the pack and other information_
1. What Glavetrim XL is and what it is used for
Glavetrim XL contains a substance called quetiapine. This belongs to a group of medicines called anti-psychotics.
Glavetrim XL 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 Glavetrim XL 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.
You must talk to a doctor if you do not feel better or if you feel worse.
2. What you need to know before you take Glavetrim XL_
Do not take Glavetrim XL:
• 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 or HCV
- azole medicines (for fungal infections)
- erythromycin or clarithromycin (for infections)
- nefazodone (for depression)
Do not take Glavetrim XL if the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking
Glavetrim XL.
Warnings and precautions:
Talk to your doctor or pharmacist or nurse before taking Glavetrim XL:
• 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.
• If you have low blood pressure.
• If you have had a stroke, especially if you are elderly.
• If you have problems with your liver.
• If you have ever had a fit (seizure).
• If 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).
• If 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 Glavetrim XL.
• If 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.
• If you are an elderly person with dementia (loss of brain function), Glavetrim XL should not be taken because the group of medicines that Glavetrim XL belongs to may increase the risk of stroke, or in some cases the risk of death, in elderly people with dementia.
Tell vour doctor immediately if you experience any of the following after taking Glavetrim XL:
• 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 Glavetrim XL. You and your doctor should check your weight regularly.
Other medicines and Glavetrim XL
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Do not take Glavetrim XL if you are taking any of the following medicines:
• Some medicines for HIV or HCV which are strong inhibitors of cytochrome P450 (CYP) 3A4.
• 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).
• HIV and HCV protease inhibitors (like boceprevir or indinavir).
Before you stop taking any of your medicines, please talk to your doctor or pharmacist first.
Glavetrim XL with food, drink and alcohol
• Glavetrim XL 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 <Invented Name> and alcohol can make you sleepy.
• Do not drink grapefruit juice while you are taking Glavetrim XL. 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.
The following symptoms may occur in newborn babies, of mothers that have used Glavetrim XL 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.
Glavetrim XL contains lactose
Glavetrim XL contains 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 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 Glavetrim XL
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.
• Swallow your tablets whole with a drink of water.
• Do not split, chew or crush the tablets.
• 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 Glavetrim XL. 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 under 18 years
Glavetrim XL should not be used by children and adolescents aged under 18 years.
If you take more Glavetrim XL than you should
If you take more Glavetrim XL than prescribed by your doctor, you may feel sleepy, feel dizzy and experience abnormal heart beats. Contact your doctor or nearest hospital straight away. Keep the Glavetrim XL with you.
If you forget to take Glavetrim XL
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 Glavetrim XL
If you suddenly stop taking Glavetrim XL, 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 or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
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 Glavetrim XL (may lead to falls).
• Discontinuation symptoms (symptoms which occur when you stop taking Glavetrim XL) 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 stuffness without pain.
Common (may affect up to 1 in 10 people):
• 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 dreams and nightmares
• Feeling more hungry
• 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 (may affect up to 1 in 100people):
• 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).
• 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):
• A combination of high temperature (fever), long 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 (may affect up to 1 in 10,000 people):
• 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 (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 Glavetrim XL 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 (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. Increase 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
If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the 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 Glavetrim XL
• 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 after EXP. The expiry date refers to the last day of that month.
• Do not use this medicine if you notice {description of the visible signs of deterioration}.
• 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.
• Glavetrim XL does not require any special storage conditions.
6. Contents of the pack and other information
What Glavetrim XL contains
• The active substance is quetiapine. <Invented Name> contain 50 mg, 200 mg, 300 mg or 400 mg of quetiapine (as quetiapine fumarate).
• The other ingredients are:
Tablet core: Lactose monohydrate, Hypromellose, Sodium chloride, Povidone K-30, Talc and Magnesium stearate (E470b). The 50 mg tablet also contains silicified microcrystalline cellulose (cellulose microcrystalline and silica colloidal anhydrous).
Tablet coating: Titanium dioxide (E171), Macrogol (E1521). The 50 mg tablet also contains Poly (Vinyl alcohol) (E1203), Talc (E553b) and Iron oxide red (E172). The 50 mg, 200 mg and 300 mg also contain iron oxide yellow (E172). The 200 mg, 300 mg and 400 mg also contains Hypromellose (E464).
What Glavetrim XL looks like and contents of the pack
Glavetrim XL 50 mg are Peach colored, round shaped, biconvex film coated tablets, debossed with 'Q50' on one side and plain on the other.
Glavetrim XL 200mg are Yellow colored, round shaped, biconvex film coated tablets, debossed with 'I2' on one side and plain on other
Glavetrim XL 300mg are Light yellow colored, round shaped, biconvex film coated tablets, debossed with 'Q300' on one side and plain on other.
Glavetrim XL 400mg are White colored, round shaped, biconvex, film coated tablets debossed with 'I4' on one side and plain on other.
Pack sizes of 10, 30, 50, 60 and 100 tablets blister pack are available for all strengths. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Intas Pharmaceuticals Limited Sage House,
319 Pinner Road, North Harrow,
Middlesex, HA1 4HF United Kingdom
Manufacturer
Accord Healthcare Limited,
Sage House,
319 Pinner Road, North Harrow,
Middlesex, HA1 4HF United Kingdom