Quetiapine Neuraxpharm 50 mg, filmomhulde tabletten

Quetiapine Neuraxpharm contains a substance called quetiapine. This belongs to a group of medicines called antipsychotics. Quetiapine Neuraxpharm 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 Quetiapine Neuraxpharm even when you are feeling better.

2. What you need to know before you take Quetiapine Neuraxpharm

Do not take Quetiapine Neuraxpharm 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:

o some medicines for HIV

o azole medicines (for fungal infections)

o erythromycin or clarithromycin (for infections) o nefazodone (for depression).

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

Warnings and precautions

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 problems with your liver.
• You have ever had a fit (seizure).
• You have had a stroke, especially if you are elderly.
• 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 Neuraxpharm.
• 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, Quetiapine Neuraxpharm should not be taken because the group of medicines that quetiapine 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.

Tell your doctor immediately if you experience any of the following after taking Quetiapine Neuraxpharm:

• 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.

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 behavior 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 quetiapine. You and your doctor should check your weight regularly.

Children and adolescents

Quetiapine is not recommended for use in children and adolescents below 18 years of age, due to a lack of data. Clinical trials of quetiapine have shown a higher frequency in children and adolescents compared to adults of symptoms such as: increased appetite, increase in blood pressure, increased feeling of a need to move often and changes in how your thyroid works.

Furthermore, it is not known how quetiapine impacts on growth and development.

Other medicines and Quetiapine Neuraxpharm

Please tell your doctor if you are taking or have recently taken any other medicines because it may affect the way the medicine works. This includes medicines that you buy without a prescription and herbal medicines.

Do not take Quetiapine Neuraxpharm 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 first.

Quetiapine Neuraxpharm with food, drink and alcohol

• Quetiapine Neuraxpharm can be taken with or without food.
• Be careful how much alcohol you drink. This is because the combined effect of Quetiapine Neuraxpharm and alcohol can make you sleepy.
• Do not drink grapefruit juice while you are taking Quetiapine Neuraxpharm. It can affect the way the medicine works.

Pregnancy and breastfeeding

If you are pregnant, trying to get pregnant, or breast-feeding, talk to your doctor before taking Quetiapine Neuraxpharm. You should not take Quetiapine Neuraxpharm during pregnancy unless this has been discussed with your doctor. Quetiapine Neuraxpharm should not be taken if you are breast-feeding.

The following symptoms may occur in newborn babies, of mothers that have used Quetiapine Neuraxpharm 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.

Important information about some of the ingredients of Quetiapine Neuraxpharm

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

If you take more Quetiapine Neuraxpharm than you should

If you take more Quetiapine Neuraxpharm 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 Quetiapine Neuraxpharm tablets with you.

If you forget to take Quetiapine Neuraxpharm

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 Neuraxpharm

If you suddenly stop taking Quetiapine Neuraxpharm, 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.

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 (affects 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 Neuraxpharm) (may lead to falls).
• Discontinuation symptoms (symptoms which occur when you stop taking Quetiapine Neuraxpharm) 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 more than 1 in 100 and less than 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 (affects more than 1 in 1000 and less than 1 in100 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 leg 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)

Rare (affects more than 1 in 10.000 and less than 1 in1,000 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 the 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

Very rare (affects less than 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 (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 peelingof the skin (toxic epidermal necrolysis)

The class of medicines to which Quetiapine Neuraxpharm 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 effect has been seen only in children and adolescents:

Very Common (affects more than 1 in 10 people):

• Increase in blood pressure

The following side effect has been seen more often in children and adolescents:

Very Common (affects more than 1 in 10 people):

• • 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:
    • o Boys and girls to have swelling of breasts and unexpectedly produce breast milk o 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

• • • 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 carton after EXP. 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.

What Quetiapine Neuraxpharm contains

Each 50 mg tablet contains 50 mg quetiapine (as quetiapine fumarate)

The other ingredients are:

Tablet core:

Hypromellose 2910 (E464)

Calcium hydrogen phosphate dihydrate

Lactose monohydrate

Maize starch

Sodium starch glycolate Type A

Magnesium stearate

Microcrystalline Cellulose pH 102

Talc

Silica colloidal anhydrous

Film coating: 50 mg:

Hydroxypropyl cellulose (E463) HPMC 2910/Hypromellose 6 cP (E464) Titanium dioxide (E171)

Talc

What Quetiapine Neuraxpharm looks like and contents of the pack

White, round, biconvex film coated tablets with a score line on one side.

The tablets can be divided into equal halves.

Pack sizes:

10, 20, 50, 60 and 100 tablets contained in a carton. Not all pack sizes may be marketed.

Marketing authorisation holder and Manufactuer neuraxpharm Arzneimittel GmbH Elisabeth-Selbert-Str. 23, D-40764 Langenfeld Germany

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

Germany: Quetiapin-neuraxpharm 50 mg, Filmtabletten

The Netherland: Quetiapine Neuraxpharm 50 mg, filmomhulde tabletten Poland: Kwetiapina NEURAXPHARM

This leaflet was last revised in May 2013.