PACKAGE LEAFLET: INFROMATION FOR THE USER

Atrolak XL 200 mg Atrolak XL 300 mg Atrolak XL 400 mg

Prolonged-release Tablet

Quetiapine

Read all of this leaflet carefully before you

start taking this medicine.

-    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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

-    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.

-    The name of your medicine is ‘Atrolak XL Prolonged-release Tablets' but in the rest of the leaflet it will be called 'Atrolak XL'.

In this leaflet:

1.    What Atrolak XL are and what they are used for

2.    Before you take Atrolak XL

3.    How to take Atrolak XL

4.    Possible side effects

5.    How to store Atrolak XL

6.    Further information

1. What Atrolak XL are and what they are used for

Atrolak XL contains a substance called quetiapine. This belongs to a group of medicines called anti-psychotics. Atrolak 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 ay 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 Atrolak 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.

Your doctor may continue to prescribe Atrolak XL even when you are feeling better.

2. Before you take Atrolak XL

Do not take Atrolak XL if:

-    You are allergic (Hypersensitive) to Quetiapine or any of the other ingredients of Atrolak 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 Atrolak XL if the above applies to you. If you are not sure than talk to your doctor or pharmacist before you take Atrolak XL.

Take special care with Atrolak 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 Atrolak 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, Atrolak XL should not be taken because the group of medicines that Atrolak 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:

-    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.

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 Atrolak XL. 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 because it may affect the way the medicines work. This includes medicines that you buy without a prescription and herbal medicines.

Do not take Atrolak XL 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 (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 or pharmacist first.

If you have a urine drug screen, taking Quetiapine prolonged release 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.

Taking Atrolak XL with food and drink

-    Atrolak 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 Atrolak XL and alcohol can make you sleepy.

-    Do not drink grapefruit juice while you are taking Atrolak XL. 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 or pharmacist before taking Atrolak XL.

You should not take Atrolak XL during pregnancy unless this has been discussed with your doctor. 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.

Atrolak XL should not be taken if you are breast-feeding.

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 Atrolak XL

Atrolak 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 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 Atrolak XL

Always take Atrolak 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 drink grapefruit juice while you are taking Atrolak 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.

Atrolak XL are available in 3 different strengths and each strength is a different colour.

-    Even though the dose might stay the same, it might be supplied as different strength tablets. For example one 400 mg tablet (white) or two 200 mg tablets (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 change your dose.

Elderly people

If you are elderly your doctor may give you a lower dose.

Children and adolescents under 18 years

Atrolak XL should not be used by children and adolescents aged under 18 years.

If you take more Atrolak XL than you should

If you take more Atrolak 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 Atrolak XL with you.

If you forget to take a dose of Atrolak 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 Atrolak XL

If you suddenly stop taking Atrolak 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 product, ask your doctor or pharmacist.

4. Possible Side Effect

Like all medicines, Atrolak 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 Atrolak XL) (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 (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 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

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 (Tardive dyskinesia).

-    Sexual dysfunction.

-    Alteration of the heart rhythm (called 'prolongation of QT interval', seen on ECG, electrical activity of the heart)

-    Worsening of pre-existing diabetes.

-    Deficiency in the number or quality of red blood cells (Anaemia)

Rare (affects less than 1 in 1000 patients):

-    A combination of high temperature (fever), long lasting sore throat or mouth ulcers, faster breathing, 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).

-    A long-lasting and painful erection (priapism).

-    Swelling of breasts and unexpected production of breast milk (galactorrhoea).

-    Menstrual disorder.

-    Inflammation of the liver (hepatitis).

-    Inflammation of the pancreas (pancreatitis).

-    Body temperature decreased (hypothermia).

-    Sleep walking, sleep talking and sleep related eating 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.

-    A combination of medical disorders that, when occurring together, increase the risk of developing cardiovascular disease and diabetes (Metabolic syndrome)

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 include difficulty in breathing, dizziness, collapse 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 class of medicines to which Atrolak 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, changes in the amount of thyroid hormones in the blood, increased blood creatine phosphokinase (a substance in the muscles) 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.

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 than in adults:

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.

-    Abnormal muscle movement. These include difficulty starting muscle movements, shaking, feeling restless or muscle stiffness without pain.

Common (affects less than 1 in 10 patients):

-    Feeling irritated

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any side effects not listed in this leaflet.

5. How to store Atrolak XL

-    This medicinal product does not require any special storage conditions.

-    Keep out of the reach and sight of children.

-    Do not use Atrolak 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.

6. Further information

What Atrolak XL contain

The active substance is Quetiapine (as Hemifumarate). Each Atrolak 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 (E572), Hypromellose 6 cP (E464), Titanium dioxide (E171), Macrogol (E553b). The 200mg and 300mg tablet also contain iron oxide yellow (E172).

What Atrolak XL looks like and contents of the pack

Atrolak XL 200mg is Yellow coloured, round shaped, biconvex film coated tablets, debossed with 'I2' on one side and plain on other.

Atrolak XL 300mg is Light yellow coloured, round shaped, biconvex film coated tablets, debossed with 'Q300' on one side and plain on other.

Atrolak XL 400mg is 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

Accord Healthcare Limited

Sage House, 319, Pinner Road, North Harrow,

Middlesex, HA1 4 HF, United Kingdom

Manufacturer

Accord Healthcare Limited

Sage House, 319, Pinner Road, North Harrow,

Middlesex, HA1 4 HF, United Kingdom

Or

Cemelog-BRS Ltd.,

H-2040 Budaors, Vasut u. 13,

Hungary

Or

Pharmacare Premium Ltd.,

HHF 003, Hal Far Industrial Estate, Birzebbugia, BBG 3000,

Malta.

This leaflet was last updated in 11/2012.

Frequency not known (cannot be estimated from the available data)

- toxic epidermal necrolysis (Lyell's syndrome which is a blistering and peeling of the skin) and erythema multiforme (blisters or lesions).