Quetiapine Sandoz SR 400 mg, tabletten met verlengde afgifte

Quetiapine Sandoz SR contains the active substance called quetiapine. This belongs to a group of medicines called anti-psychotics. Quetiapine Sandoz SR 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 all the time or you may find that you feel depressed, feel guilty, lack energy, lose your appetite or can’t sleep.

When Quetiapine Sandoz SR 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 Quetiapine Sandoz SR even when you feel better.

Do not take Quetiapine Sandoz SR if

• you are allergic to quetiapine or any of the other ingredients of this medicine (listed in section 6)
• you are taking any of the following medicines:
  • some medicines used to treat HIV infections
  • azole medicines (medicines used to treat fungal infections)
  • erythromycin or clarithromycin (medicines used to treat bacterial infections)
  • nefazodone (medicine used to treat depression).

Do not take Quetiapine Sandoz SR if the above applies to you. If you are not sure, talk to your doctor or pharmacist before you take Quetiapine Sandoz SR.

Warnings and precautions

Talk to your doctor before taking Quetiapine Sandoz SR 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 Quetiapine Sandoz SR.
• 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, Quetiapine Sandoz SR should not be taken because the group of medicines that Quetiapine Sandoz SR 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 Quetiapine Sandoz SR:

• 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 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

Weight gain has been seen in patients taking Quetiapine Sandoz SR. You and your doctor should check your weight regularly.

Children and adolescents under 18 years

Do not give this medicine to children and adolescents below 18 years of age, due to a lack of data to support use in this age group.

Other medicines and Quetiapine Sandoz SR

Tell your doctor if you are taking, have recently taken or might take any other medicines because it may affect the way the medicines work.

Do not take Quetiapine Sandoz SR if you are taking any of the following medicines

• Some medicines used to treat HIV infections.
• Azole medicines (medicines used to treat fungal infections).
• Erythromycin or clarithromycin (medicines used to treat bacterial infections).
• Nefazodone (medicine used to treat depression).

Tell your doctor if you are taking any of the following medicines:

• Epilepsy medicines (like phenytoin or carbamazepine).
• High blood pressure medicines.
• Barbiturates (medicines used to treat 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 (medicines used to treat bacterial infections).

Before you stop taking any of your medicines, please talk to your doctor first.

Quetiapine Sandoz SR with food, drink and alcohol

• Food: see section 3 under „Method of administration“
• Be careful how much alcohol you drink. This is because the combined effect of Quetiapine Sandoz SR and alcohol can make you sleepy.
• Do not drink grapefruit juice while you are taking Quetiapine Sandoz SR. 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 Quetiapine Sandoz SR during pregnancy unless this has been discussed with your doctor. The following symptoms may occur in newborn babies, of mothers who have used Quetiapine Sandoz SR 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.

Quetiapine Sandoz SR should not be taken if you are breast-feeding.

Driving and using machines

Your tablets may make you feel sleepy and dizzy. Do not drive or use any tools or machines until you know how the tablets affect you.

Quetiapine Sandoz SR contains lactose

Quetiapine Sandoz SR 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 Sandoz SR 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.

Quetiapine Sandoz SR is 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).

The recommended dose is:

Adults

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.

Elderly patients

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

Patients with liver problems

If you have liver problems your doctor may change your dose.

Children and adolescents under 18 years

Quetiapine Sandoz SR should not be used by children and adolescents aged under 18 years.

Method of administration:

Oral use.

• 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.
• Quetiapine Sandoz SR can be affected by food and you should therefore 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 Quetiapine Sandoz SR. It can affect the way the medicine works.

Duration of use:

This will be decided by your doctor. Do not stop taking your tablets even if you feel better, unless your doctor tells you.

If you take more Quetiapine Sandoz SR than you should

If you take more Quetiapine Sandoz SR 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 tablets with you.

If you forget to take Quetiapine Sandoz SR

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 Quetiapine Sandoz SR

If you suddenly stop taking Quetiapine Sandoz SR, 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.

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

STOP taking Quetiapine Sandoz SR and contact your doctor immediately or go to the nearest hospital if you experience any of the following serious side effects:

Uncommon side effects, may affect up to 1 in 100 people:

• Fits or seizures
• Uncontrollable movements, mainly of your face or tongue.

Rare side effects, may affect up to 1 in 1,000 people:

• A combination of high temperature (fever), long lasting sore throat or mouth ulcers, faster breathing, sweating, stiff muscles, feeling very drowsy or faint (a disorder called “neuroleptic malignant syndrome”).
• 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.

Very rare side effects, 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).

Not known, frequency of these side effects cannot be estimated from the available data:

• 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 Quetiapine Sandoz SR belongs can cause heart rhythm problems, which can be serious and in severe cases may be fatal.

You may experience any of the following side effects listed below. If the side effect is severe or persistent, you should contact your doctor.

Very common side effects, 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 Quetiapine Sandoz SR (may lead to falls).
• Discontinuation symptoms (symptoms which occur when you stop taking [invented name]) 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 side effects, 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 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 and language.
• Thoughts of suicide and worsening of your depression
• Shortness of breath
• Vomiting (mainly in the elderly)
• Fever

Uncommon side effects, may affect up to 1 in 100 people:

• 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.
• Sexual dysfunction.
• Worsening of pre-existing diabetes.
• Change in electrical activity of the heart seen on ECG (QT prolongation).
• Slow heartbeat.

Rare side effects, may affect up to 1 in 1,000 people:

• Yellowing of the skin and eyes (jaundice).
• Inflammation of the liver (hepatitis)
• Swelling of breasts and unexpected production of breast milk (galactorrhoea).
• Menstrual disorder.
• Walking, talking, eating or other activities while you are asleep.
• Body temperature decreased (hypothermia).
• Inflammation of the pancreas.

Very rare side effects, may affect up to 1 in 10,000 people:

• Inappropriate secretion of a hormone that controls urine volume.
• Breakdown of muscle fibers and pain in muscles (rhabdomyolysis).

Not known, frequency of these side effects cannot be estimated from the available data:

• Skin rash with irregular red spots (erythema multiforme).

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 and increase 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.

Therefore, 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 effect has been observed only in children and adolescents:

Very common side effects, may affect more than 1 in 10 people:

Increase in blood pressure.

The following side effects have been observed more often in children and adolescents:

Very common side effects, may affect more than 1 in 10 people:

• Increase in the amount of a hormone called prolactin in the blood. This can 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 movements. 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. This includes any possible side effects not listed in this leaflet.

• • This medicinal product does not require any special storage conditions
  • Keep out of the sight and reach of children.
  • Do not use Quetiapine Sandoz SR 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.
  • 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.

What Quetiapine Sandoz SR contains

The active substance is quetiapine (as quetiapine hemifumarate).

Each Quetiapine Sandoz SR prolonged release tablet 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 (E464), titanium dioxide (E171), macrogol 6000. Quetiapine Sandoz SR 200 mg and Quetiapine Sandoz SR 300 mg] also contain iron oxide yellow(E172).

What Quetiapine Sandoz SR looks like and contents of the pack

Quetiapine Sandoz SR 200 mg are yellow coloured, round shaped, biconvex film coated tablets, debossed with ‘I2’ on one side and plain on other

Quetiapine Sandoz SR 300 mg are light yellow coloured, round shaped, biconvex film coated tablets, debossed with ‘Q300’ on one side and plain on other.

Quetiapine Sandoz SR 400 mg are White coloured, round shaped, biconvex, film coated tablets debossed with ‘I4’ on one side and plain on other.

Pack sizes of 6, 10, 20, 28, 30, 50, 60, 90, 100 and 120 tablets per pack are registered for all strengths. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Sandoz B.V., Veluwezoom 22, Almere, Nederland

Correspondentie: Postbus 10332, 1301 AH Almere

Manufacturers

LEK S.A.

ul. Domaniewska 50 C 02-672 Warszawa Polen

Lek Pharmaceuticals d.d. Verovškova 57

1526 Ljubljana Slovenië

Lek Pharmaceuticals d.d. Trimlini 2D

9220 Lendava Slovenië

Salutas Pharma GmbH

Otto-von-Guericke-Allee 1,

39179 Barleben

Duitsland

S.C. Sandoz, S.R.L.

Str. Livezeni nr. 7A

RO-540472 Targu-Mures

Roemenië

Pharmacare Premium Ltd

HHF 003, Hal Far Industrial Estate,

Birzebbugia, BBG 3000

Malta

MA-numbers:

RVG 110302

RVG 110304

RVG 110307

This medicinal product is authorised in the Member States of the EEA under the following names:

uvoľňovaním

Quetiapin Sandoz 300 mg filmom obalené tablety s predĺženým uvoľňovaním

The United Kingdom Quesery XL 200 mg Prolonged Release Tablets – Quesery XL 300 mg Prolonged Release Tablets – Quesery XL 400 mg Prolonged Release Tablets –

Deze bijsluiter is voor het laatst goedgekeurd in juni 2013.