Quetta contains a substance called quetiapine. This belongs to a group of medicines called anti- psychotics.

Quetta 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 Quetta even when you are feeling better.

Do not take Quetta :

- if you are allergic (hypersensitive) 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 Quetta if the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking Quetta .

Warnings and precautions

Talk to your doctor or pharmacist before taking Quetta .

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 have diabetes or have a risk of getting diabetes. If you do, your doctor may check your blood sugar levels while you are taking Quetta .

- 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, Quetta should not be taken because the group of medicines that Quetta belongs 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.

While taking this medicine, tell your doctor immediately if you experience:

- A high temperature (fever), stiff muscles, feeling of being confused and changes in consciousness. These might be signs of a so-called ‘neuroleptic malignant syndrome’.

- Involuntary and abnormal movements, especially of the tongue, mouth and jaw, facial

grimacing, rapid eye blinking and uncontrollable movements of arms, legs, fingers and toes. These might be symptoms of ‘tardive dyskinesia’.

- Tremor, twisting and repetitive movements or abnormal body posture, slurred speech,

restlessness and stiff muscles. These might be symptoms of ‘extrapyramidal symptoms’.

- Dizziness or a feeling of severe sleepiness. This could increase the risk of accidental injury (fall), especially in elderly patients.

- Trouble swallowing.

- Weight gain. Your doctor might need to monitor your treatment more closely.

- Fits (seizures).

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

These conditions can be caused by this type of medicine and your doctor might need to reduce your dose or discontinue treatment.

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.

Children and adolescents

Quetta should not be used in children and adolescent below 18 years of age due to higher risk of side effects.

Other medicines and Quetta

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

Do not take Quetta 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

- Medicines which act on the central nervous system

- Thioridazine (a medicine to treat psychiatric disorders)

- 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).

If you are not sure about what type of medicines you are taking, talk to your doctor or pharmacist before taking Quetta .

Quetta with food, drink and alcohol

Quetta can be taken with or without food.

You should be careful how much alcohol you drink. The combined effect of Quetta and alcohol might make you feel drowsy.

Do not drink grapefruit juice while you are taking Quetta. 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 Quetta during pregnancy unless this has been discussed with your doctor.

- Quetta should not be taken if you are breast-feeding.

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.

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.

Quetta contains lactose

Quetta 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 Quetta 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 this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Dosage

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.

Method of administration

- 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 Quetta . 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

Quetta should not be used in children and adolescents below 18 years of age.

If you take more Quetta than you should

If you take more Quetta 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 tablets, leaflet and/or carton with you so the doctor will know what you took.

If you forget to take Quetta

If you miss a dose, take that dose 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 Quetta

Do not stop taking your tablets even if you are feeling better, unless your doctor tells you. If you suddenly stop taking Quetta you may be unable to sleep (insomnia), or you may feel sick (nausea), or you may experience headache, diarrhea, 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.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If any of the following occurs, stop taking Quetta and contact a doctor or go to the nearest hospital straight away, as you may need urgent medical attention:

Uncommon (may affect up to 1 in 100 people):

- Allergic reactions that may include raised lumps (wheals), swelling of the skin and swelling around the mouth

- Fits or seizures

- Uncontrollable movements, mainly of your tongue, mouth and jaw, but also of arms, legs, fingers and toes, facial grimacing and rapid eye blinking. These might be symptoms of a condition called ‘tardive dyskinesia’.

Rare (may affect up to 1 in 1,000 people):

- A combination of high temperature (fever), sweating, stiff muscles, feeling very drowsy or faint, large increase in blood pressure and fast heartbeat (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)

- 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

- Inflammation of the pancreas (pancreatitis). Symptoms can include severe pain in the abdomen and back, nausea and vomiting.

Very rare (may affect up to 1 in 10,000 people):

- 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)

- Severe rash, blisters, or red patches on the skin (Stevens-Johnson syndrome)

- Abnormal muscle breakdown (rhabdomyolysis) with symptoms such as muscle pain, weakness and swelling which can lead to kidney problems (urine can become dark).

Not known (frequency cannot be estimated from the available data):

- Severe skin conditions called ‘toxic epidermal necrolysis’ (severe rash involving reddening, peeling and swelling of the skin that resembles severe burns) and ‘erythema multiforme’ (irregular red patches on the skin of the hands and arms).

Other possible side effects:

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 your tablets) (may lead to falls)

- Discontinuation symptoms (symptoms which occur when you stop taking Quetta ) include not being able to sleep (insomnia), feeling sick (nausea), headache, diarrhoea, being sick (vomiting), dizziness, and irritability

- Changes in the amount of certain fats (triglycerides and cholesterol) in the blood

- Putting on weight

- Decreased levels of a certain protein in red blood cells (haemoglobin).

Common (may affect up to 1 in 10 people):

- Decrease in number of certain white blood cells (leukopenia)

- Fainting (may lead to falls)

- Rapid heartbeat

- Awareness of unusual heartbeats (palpitations)

- Shortness of breath (dyspnoea)

- Low blood pressure when standing up, which may result in dizziness or feeling faint (may lead to falls)

- Stuffy nose

- Constipation, indigestion, vomiting

- Extrapyramidal side effects with symptoms such as abnormal and repetitive muscle movements. These include difficulty starting muscle movements, shaking, feeling restless or muscle stiffness without pain

- Abnormal dreams and nightmares

- Thoughts of suicide and worsening of your depression

- Increased appetite

- Disturbance in speech and language

- Increases in the amount of the hormone prolactin in the blood. In rare cases it could lead to swelling of breasts and unexpected breast milk production in both men and women. Also, it could cause absence of monthly period or irregular periods in women

- Blurred vision

- Feeling irritated

- Fever

- Changes as seen in blood tests, such as increased levels of liver enzymes, decrease or increase in white blood cells (neutrophils or eosinophils, respectively), changes in the amount of thyroid hormones (total T4, free T4, total T3, TSH) and increase in blood sugar (glucose)

- Feeling weak

- Swelling of arms or legs.

Uncommon (may affect up to 1 in 100 people):

- Restless legs syndrome (unpleasant sensation in the legs)

- Difficulty swallowing

- Heart condition called ‘QT-prolongation’ which can affect your heart beat rhythm (measured with an electrocardiogram)

- Diabetes or worsening of pre-existing diabetes

- Sexual dysfunction

- Changes as seen in blood tests, such as increase in certain enzymes (gamma-GT), decreased number of red blood cells (anaemia) or platelets in the blood (thrombocytopenia), lower levels of sodium in the blood (hyponatraemia) or changes of the amount of thyroid hormones (free T3) and thyroid problems (hypothyroidism).

- Slow heartbeat

Rare (may affect up to 1 in 1,000 people):

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

- Menstrual disorder

- Metabolic syndrome (changes in your weight, blood glucose and certain fats in your blood that can increase the risk of heart problems and diabetes)

- Sleepwalking, sleep talking and sleep related eating disorder

- Lowering of body temperature

- Increased levels of the enzyme creatine phosphokinase, decrease in certain types of white blood cells (agranulocytosis) as seen in blood tests.

Very rare (may affect up to 1 in 10,000 people):

- A condition called ‘Syndrome of inappropriate antidiuretic hormone secretion’ (SIADH) which causes low sodium levels in your blood. That can lead to symptoms such as headache, nausea, confusion and weakness.

Not known (frequency cannot be estimated from the available data):

- Decreased number of white blood cells in the blood (neutropenia).

The class of medicines to which Quetta belongs can cause heart rhythm problems, which can be serious and in severe cases may be fatal.

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 than in adults or have only been seen in children and adolescents:

Very common (may affect more than 1 in 10 people):

- Increase in blood pressure

- 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

- Extrapyramidal side effects with symptoms such as abnormal and repetitive muscle movements. These include difficulty starting muscle movements, shaking, feeling restless or muscle stiffness without pain.

Common (may affect up to 1 in 10 people):

- Feeling irritated.

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

Keep out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton, label and blister after ‘EXP’. The expiry date refers to the last day of that month.

Do not store above 30° C.

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 to protect the environment.