Ezembra Xl 400 Mg Prolonged-Release Tablets
Bluefish Pharmaceuticals
Reason of change
Revision no.
Artwork code M/QUESR/UK/P01 No. of colours 01
Pantone Shades
Strength 200/300/400 mg Packs NA
Country UK
Manufacturer Intas
Black
Dimension 170 x 550 mm
Component
Artwork made to
Braille
Blister Layout No.: NA
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Remarks Font size: Heading 15, 13 pts. Rest all 8.5 pts. Date: 29.06.2016 |
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Revision History |
R1 - Initial Mockup Artwork (AM-16-056) - 21.06.16 | |||
PACKAGE LEAFLET: INFROMATION FOR THE USER
Ezembra XL 200 mg Prolonged-release tablets Ezembra XL 300 mg Prolonged-release tablets Ezembra XL 400 mg Prolonged-release tablets
Quetiapine
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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 the side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet.
1. What Ezembra XL is and what it is use for
2. What you need to know before you take Ezembra XL
3. How to take Ezembra XL
4. Possible side effects
5. How to store Ezembra XL
6. Contents of the pack and other information
Ezembra XL contains a substance called quetiapine. This belongs to a group of medicines called anti-psychotics. Ezembra 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 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.
When Ezembra 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.
Weight gain has been seen in patients taking Ezembra XL. You and your doctor should check your weight regularly.
Other medicine and Ezembra XL:
Please tell your doctor if you are taking or have recently taken any other medicines because it may affect the way the medicines work. This includes medicines that you buy without a prescription and herbal medicines.
Do not take Ezembra XL if you are taking any of the following medicines:
- Some medicines for HIV 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 protease inhibitors like boceprevir or indinavir.
Before you stop taking any of your medicines, please talk to your doctor or pharmacist first.
Ezembra XL with food and, drink and alcohol
- Ezembra 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 Ezembra XL and alcohol can make you sleepy.
- Do not drink grapefruit juice while you are taking Ezembra XL. It can affect the way the medicine works.
Your doctor may continue to prescribe Ezembra XL even when you are feeling better.
Do not take Ezembra XL if:
- You are allergic (Hypersensitive) to Quetiapine or any of the other ingredients of Ezembra XL. (See section 6: Further Information)
- you are taking any of the following medicines:
- Some medicines for HIV
- azole medicines (for fungal infections)
- erythromycin or clarithromycin (for infection)
- nefazodone (for depression).
Do not take Ezembra XL if the above applies to you. If you are not sure than talk to your doctor or pharmacist before you take Ezembra XL.
Take special care with Ezembra XL:
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 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 Ezembra XL.
- 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 are an elderly person with dementia (loss of brain function). If you are, Ezembra XL should not be taken because the group of medicines that Ezembra XL belongs to may increase the risk of stroke, or in some cases the risk of death, in elderly people with dementia.
Tell your doctor immediately if you experience:
- 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 sever 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 medicines.
Pregnancy, breast-feeding and fertility
If you are pregnant, trying to get pregnant, or breastfeeding, talk to your doctor or pharmacist before taking Ezembra XL.
You should not take Ezembra XL during pregnancy unless this has been discussed with your doctor. Ezembra XL should not be taken if you are breastfeeding.
The following symptoms may occur in newborn babies, of mothers that have used Ezembra 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.
Important information about some of the ingredients of Ezembra XL.
Ezembra 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, contact your doctor before taking this medicinal product
Effect on Urine Drug Screens
If you are having a urine drug screen, taking Ezembra XL 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.
Always take Ezembra XL 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.
- 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 stop taking your tablets even if you feel better, unless your doctor tells you.
- Do not drink grapefruit juice while you are taking Ezembra XL. It can affect the way the medicine works
Liver problems
If you have liver problems your doctor may change your dose.
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. 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.
Elderly people
If you have liver problems your doctor may change your dose.
Children and adolescents under 18 years
Ezembra XL should not be used by children and adolescents aged under 18 years.
If you take more Ezembra XL than you should
If you take more Ezembra XL than prescribed by your doctor, you may experience sleepiness, dizziness and abnormal heart beats. Go to your doctor or nearest hospital straight away. Take the Ezembra XL with you.
If you forget to take a dose of Ezembra 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.
4. Possible Side Effects
550 mm
5. How to store Ezembra XL
6. Contents of the pack and other information
If you stop taking Ezembra XL
If you suddenly stop taking Ezembra XL, you may feel nauseous or vomit, or be unable to sleep or have jerky movements, or your original illness might come back. 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.
Not all dosing regimes are practical/possible with the present strengths of Ezembra XL and other authorised products containing quetiapine are available
Like all medicines, Ezembra XL can cause side
effects, although not everybody gets them.
If any of the following side effects get serious, or if
you notice side effects not listed in this leaflet,
please tell your doctor or pharmacist:
Very common (affects more than 1 in 10 patients):
- Dizziness (may lead to falls), headache, dry mouth
- Feeling sleepy (this may go away with time, as you keep taking Ezembra XL (may leads 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.
- Abnormal muscle movements. These include difficulty starting muscle movements, shaking, feeling restless or muscle stiffness without pain.
Common (affects less than 1 in 10 patients):
- 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 led to falls)
- Increased levels of sugar in the blood.
- Blurred vision
- 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.
Uncommon (affects less than 1 in 100 patients):
- 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.
- Uncontrolled movements, mainly of your face or tounge.
- Sexual dysfunction.
- Worsening of pre-existing diabetes.
- Change in electrical activity of the heart seen on ECG (QT prolongation).
Rare (affects less than 1 in 1000 patients):
- 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 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 (affect less than 1 in 10,000 patients):
- 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).
The following side effects are only observed in children and adolescents:
Very common (affect more than 1 in 10 patients):
Increase in blood pressure.
The following adverse events were observed more frequently in children and adolescents:
Very common (affect more than 1 in 10 patients):
- Increase in the amount of hormone call prolactin in the blood. Increasing amount of hormone call prolactin in rare cases can 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.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via 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.
- This medicinal product does not require any special storage conditions
- Keep this medicine out of the sight and reach of children.
- Do not use Ezembra XL after the expiry date which is stated on the container and blister after EXP. The expiry date refers to the last day of that month.
- 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.
What Ezembra XL contains
The active substance is Quetiapine (as Hemifumarate). Each Ezembra XL contains either 200 mg, 300 mg or 400 mg of quetiapine (as quetiapine hemifumarate).
The other ingredients are Lactose monohydrate, Hypromellose, Sodium chloride, Povidone K-30, Talc, Magnesium stearate (E470b), Hypromellose 6 cP (E464), Titanium dioxide (E171), Macrogol 400. The 200 mg and 300 mg tablet also contain iron oxide yellow (E172).
What Ezembra XL looks like and contents of the pack
Quetiapine Prolonged-release Tablets 200 mg are Yellow coloured, round shaped, biconvex film coated tablets, debossed with ‘I2’ on one side and plain on other.
Quetiapine Prolonged-release Tablets 300 mg are Light yellow coloured, round shaped, biconvex film coated tablets, debossed with ‘Q300’ on one side and plain on other.
Quetiapine Prolonged-release Tablets 400 mg are White coloured, 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 per pack are registered for all strengths. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Bluefish Pharmaceuticals AB Torsgatan 11 111 23 Stockholm Sweden
Manufacturer:
Accord Healthcare Limited Sage House, 319 Pinner Road North Harrow, Middlesex, HA1 4HF United Kingdom
Bluefish Pharmaceuticals AB Torsgatan 11 111 23 Stockholm Sweden
Pharmacare Premium Ltd HHF 003, Hal Far Industrial Estate Birzebbugia, BBG 3000, Malta
This leaflet was last updated in 10/2015.
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)
- Neutropenia
- Drug withdrawal syndrome neonatal
The class of medicines to which Ezembra 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, decreases in the number of certain types of blood cells, 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.
Therefore, your doctor may ask you to have blood tests from time to time.
Children and adolescent:
The same side effects that may occur in adults can also be present in children and adolescents.