Document: Quetiapin Orion film-coated tablet ENG PL change

• Quetiapin Orion film-coated tablet PL
• Quetiapin Orion film-coated tablet ENG PL

---

Package leaflet: Information for the user

Quetiapin Orion 25 mg film-coated tablets

Quetiapin Orion 100 mg film-coated tablets

Quetiapin Orion 200 mg film-coated tablets

Quetiapin Orion 300 mg film-coated 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.

• 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 side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

Quetiapin Orion contains a substance called quetiapine. This belongs to a group of medicines called antipsychotics.

Quetiapin Orion 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 Quetiapin Orion even when you are feeling better.

Do not take Quetiapin Orion:

• 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 Quetiapin Orion if the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking Quetiapin Orion.

Warnings and precautions

Talk to your doctor or pharmacist before taking Quetiapin Orion if:

• you, or someone in your family have or have had any heart problems, for example heart rhythm problems, weakening of the heart muscle or inflammation of the heart 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 Quetiapin Orion.

• 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, this medicine should not be taken because the group of medicines that these tablets 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

• you have or have had problems with alcohol or drug abuse.

Tell your doctor immediately if you experience any of the following after taking this medicine:

• 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.

Tell your doctor as soon as possible if you have:

• a fever, flu-like symptoms, sore throat, or any other infection, as this could be a result of a very low white blood cell count, which may require Quetiapin Orion to be stopped and/or treatment to be given

• constipation along with persistent abdominal pain, or constipation which has not responded to treatment, as this may lead to a more serious blockage of the bowel.

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 Quetiapin Orion. You and your doctor should check your weight regularly.

Children and adolescents

Quetiapin Orion is not for use in children and adolescents below 18 years of age.

Other medicines and Quetiapin Orion

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

Do not take Quetiapin Orion 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 carbamazapine)

• high blood pressure medicines

• barbiturates (for difficulty sleeping)

• thioridazine or lithium (other antipsychotic medicines)

• 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)

• medicines that can cause constipation.

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

Quetiapin Orion with food, drink and alcohol

• The tablets can be taken with or without food.

• Be careful how much alcohol you drink. This is because the combined effect of this medicine and alcohol can make you sleepy.

• Do not drink grapefruit juice while you are taking this medicine. 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 for advice before taking Quetiapin Orion. You should not take this medicine during pregnancy unless this has been discussed with your doctor. Quetiapine tablets should not be taken if you are breast-feeding.

The following symptoms which can represent withdrawal 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.

Quetiapin Orion contains lactose

Quetiapin Orion 100 mg, 200 mg and 300 mg tablets contain 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 this medicine 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 Quetiapin Orion

Always take this medicine exactly as your doctor has told you. 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, at bedtime or twice a day, depending on your illness

• 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 quetiapine tablets. 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

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

If you take more Quetiapin Orionthan you should

If you take more tablets than prescribed by your doctor, you may feel sleepy, feel dizzy and experience abnormal heart beats. Contact your doctor or nearest hospital straight away. Keep the Quetiapin Orion tablets with you.

If you forget to take Quetiapin Orion

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 Quetiapin Orion

If you suddenly stop taking this medicine, 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.

4. Possible side effects

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

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 Quetiapin Orion) (may lead to falls)

• Discontinuation symptoms (symptoms which occur when you stop taking Quetiapin Orion) 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.

• Changes in the amount of certain fats (triglycerides and total cholesterol).

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

• Rapid heartbeat

• Feeling like your heart is pounding, racing or has skipped beats

• Constipation, upset stomach (indigestion)

• Feeling weak

• 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 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

• Changes in the amount of thyroid hormones in your blood

• Decreases in the number of certain types of blood cells

• Increases in the amount of liver enzymes measured in the blood

• Increases in the amount of the hormone prolactin in the blood. Increases in the hormone prolactin could in rare cases lead to the following:

Uncommon side effects (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

• Diabetes

• Change in electrical activity of the heart seen on ECG (QT prolongation)

• A slower than normal heart rate which may occur when starting treatment and which may be associated with low blood pressure and fainting

• Difficulty in passing urine

• Fainting (may lead to falls)

• Stuffy nose

• Decrease in the amount of red blood cells

• Decrease in the amount of sodium in the blood.

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

• 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 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

• A condition (called “metabolic syndrome”) where you may have a combination of 3 or more of the following: an increase in fat around your abdomen, a decrease in “good cholesterol” (HDL-C), an increase in a type of fat in your blood called triglycerides, high blood pressure and an increase in your blood sugar.

• Combination of fever, flu-like symptoms, sore throat, or any other infection with very low white blood cell count, a condition called agranulocytosis

• Bowel obstruction

• Increased blood creatine phosphokinase (a substance from the muscles).

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)

• A serious blistering condition of the skin, mouth, eyes and genitals (Stevens-Johnson syndrome)

• Inappropriate secretion of a hormone that controls urine volume

• Breakdown of muscle fibers and pain in muscles (rhabdomyolysis)

• Worsening of pre-existing diabetes.

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)

• Symptoms of withdrawal may occur in newborn babies of mothers that have used Quetiapin Orion during their pregnancy.

The class of medicines to which Quetiapin Orion 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 or have not been seen in adults:

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

• Increased appetite

• Vomiting

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

• Increase in blood pressure.

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

• Feeling weak, fainting (may lead to falls)

• Stuffy nose

• Feeling irritated.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Quetiapin Orion

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 pack. The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions.

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 protect the environment.

6. Contents of the pack and other information

What Quetiapin Orioncontains

The active substance is quetiapine.

• One film-coated tablet contains 25, 100, 200 or 300 mg quetiapine (as quetiapine fumarate).

• The other ingredients in the 25 mg tablet core are microcrystalline cellulose, croscarmellose sodium, povidone (K30) and magnesium stearate.

• The other ingredients in the 100, 200 and 300 mg tablet core are microcrystalline cellulose, calcium hydrogen phosphate dihydrate, lactose monohydrate, sodium starch glycolate (Type A), povidone (K30) and magnesium stearate.

What Quetiapin Orionlooks like and contents of the pack

25 mg tablet: brown/dark pink, round, convex, film-coated tablet, diameter 6 mm, debossed ‘OR41’ on one side and plain on the other side.

100 mg tablet: light yellow, round, convex, film-coated tablet, diameter 8 mm, debossed ‘OR411’ on one side and plain on the other side.

200 mg tablet: white, round, convex, film-coated tablet, diameter 11 mm, debossed ‘OR412’ on one side and plain on the other side.

300 mg tablet: white, capsule-shaped, film-coated tablet, length 19 mm, debossed ‘OR413’ on one side and plain on the other side.

The tablets are available in blister strips and in HDPE jars.

Blisters:

25 mg: 6, 10, 30, 60 and 100 tablets.

100 mg: 10, 30, 60, 90 and 100 tablets

200 mg and 300 mg: 30, 60, 90 and 100 tablets.

Plastic jars:

25 mg, 100 mg, 200 mg and 300 mg: 100 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

To be completed nationally

Manufacturer

Orion Corporation Orion Pharma

Orionintie 1

FI-02200 Espoo

Finland

This leaflet was last revised in

2016-09-12