Package leaflet: Information for the user

Atrolak XL 50 mg Atrolak XL 200 mg Atrolak XL 300 mg Atrolak XL 400 mg

Prolonged-release 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 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 of the side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet.

What is in this leaflet:

1.    What Atrolak XL is and what it is used for

2.    What you need to know before you take Atrolak XL

3.    How to take Atrolak XL

4.    Possible side effects

5.    How to store Atrolak XL

6.    Contents of the pack and other information

1. What Atrolak XL is and what it is 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 feel sad. 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.

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 Atrolak XL

Do not take Atrolak 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

-    azole medicines (for fungal infections)

-    erythromycin or clarithromycin (for infections)

-    nefazodone (for depression).

Do not take Atrolak XL if the above applies to you. If you are not sure.Talk to your doctor or pharmacist before taking Atrolak XL.

Warnings and precautions

Talk to your doctor or pharmacist or nurse before taking Atrolak XL

-    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 any of the following after taking Atrolak 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.

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.

Other medicines and Atrolak XL

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other 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.

-    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.

Atrolak XL with food, drink and alcohol

-    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, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, askyour doctor or pharmacist advice before taking this medicine.You should not take Atrolak XL during pregnancy unless this has been discussed with your doctor. Atrolak XL should not be taken if you are breast-feeding.

The following symptoms may occur in newborn babies of mothers that have used Atrolak 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.

Atrolak XL contains Lactose

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, 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 Atrolak 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 recommended 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.

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

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

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.

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. Contact your doctor or nearest hospital straight away. Keep the Atrolak XL with you.

If you forget to take 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 medicine, ask your doctor or pharmacist or nurse.

4. Possible side effect

Like all medicines, this medicine 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: 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 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: 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 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 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 100 people

-    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).

-    Slow heartbeat

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 (pancreatitis).

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 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, 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.

Additional 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:

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.

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

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

You can also report any 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 Atrolak 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, carton and blister after EXPe. 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 throw away medicines you no longer use. These measures will help to protect the environment.

-    Atrolak XL does not require any special storage conditions.

6. Contents of the pack and other information

What Atrolak XL contains

-    The active substance is quetiapine. Each Atrolak XL contains either 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. The 50 mg tablet also contains silicified microcrystalline cellulose (Siliciumdioxide & Microcrystalline Cellulose).

Tablet coating: Titanium dioxide (E171), Macrogol (E 1521). The 50 mg tablet also contains Poly (Vinyl alcohol) (E1203), Talc (E553b) and Iron oxide red (E172). The 50mg, 200mg and 300mg tablet also contain iron oxide yellow(E172). The 200 mg, 300 mg and 400 mg also contains Hypromellose 6 cP (E464)

What Atrolak XL looks like and contents of the pack

Atrolak XL 50 mg is Peach colored, round shaped, biconvex film coated tablets, debossed with 'Q50' on one side and plain on the other Atrolak XL 200 mg is Yellow coloured, round shaped, biconvex film coated tablets, debossed with 'I2' on one side and plain on other Atrolak XL 300 mg is Light yellow coloured, round shaped, biconvex film coated tablets, debossed with 'Q300' on one side and plain on other. Atrolak XL 400 mg is White coloured, round shaped, biconvex, film coated tablets debossed with 'I4' on one side and plain on other.

PVC/PVDC-Alu blister pack. Pack sizes of 10,

30, 50, 60 and 100 tablets per pack are registered for Atrolak XL 200 mg, 300 mg and 400 mg.

PVC/PVDC-Alu blister pack or OPA/Alu/PVC -Alu blister pack. Pack size of 6, 10, 20, 28, 30,

50, 60, 90 and 100 tablets per pack are registered for Atrolak XL 50mg.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Accord Healthcare 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

Or

Cemelog-BRS Ltd.,

Akron utea 1. (Camel Park),

Budaors, 2040 Hungary

Or

Pharmacare Premium Ltd.,

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

Malta.

This leaflet was last revised in 06/2013.