QUETHARTIC XL 400 MG PROLONGED-RELEASE TABLETS - patient leaflet, side effects, dosage

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CEUTICALS

Package leaflet: Information for the user

Quethartic XL 50 mg prolonged-release tablets Quethartic XL 300 mg prolonged-release tablets Quethartic 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.

• – 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

• 1. What Quethartic XL is and what it is used for

• 2. What you need to know before you take Quethartic XL

• 3. How to take Quethartic XL

• 4. Possible side effects

• 5. How to store Quethartic XL

• 6. Contents of the pack and other information

1. what quethartic xl is and what it is used for

Quethartic XL contains a substance called quetiapine. This belongs to a group of medicines called anti-psychotics. Quethartic XL can be used to treat several illnesses, such as:

• 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.
• 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.

When Quethartic XL prolonged-release tablet is being taken to treat major depressive episodes in major depressive disorder, it will be taken in addition to another medicine being used to treat this illness.

Your doctor may continue to prescribe Quethartic XL even when you are feeling better.

2. what you need to know before you take quethartic xl

Do not take Quethartic 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).

If you are not sure, talk to your doctor or pharmacist before taking this medicine.

Warnings and precautions

Talk to your doctor before taking Quethartic XL 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
• 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 Quethartic XL
• 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, you should not take Quethartic XL because the group of medicines that Quethartic XL 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 a condition where you stop breathing for short periods during your normal nightly sleep (called “sleep apnoea”) and are taking medicines that slow down the normal activity of the brain (“depressants”)
• you have or have had a condition where you can’t completely empty your bladder (urinary retention), have an enlarged prostate, a blockage in your intestines, or increased pressure inside your eye. These conditions are sometimes caused by medicines (called “anti-cholinergics”) that affect the way nerve cells function in order to treat certain medical conditions
• you have a history of alcohol or drug abuse

Tell your doctor immediately if you experience any of the following after taking Quethartic XL:

• A combination of fever, severe muscle stiffness, sweating or a lowered level of consciousness (a disorder called “neuroleptic malignant syndrome”). You may need an immediate medical treatment
• 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 you to stop taking Quethartic XL and/or receive treatment
• 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 Quethartic XL. You and your doctor should check your weight regularly.

Children and Adolescents

Quethartic XL is not for use in children and adolescents below 18 years of age.

Other medicines and Quethartic XL

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

Do not take Quethartic 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 or Lithium (other anti-psychotic medicines)
• Medicines that have an impact on the way your heart beats, for example, medicines that can cause an imbalance in electrolytes (low levels of potassium or magnesium) such as diuretics (water pills) or certain antibiotics (medicines to treat infections)
• Medicines that can cause constipation
• Medicines (called “anti-cholinergics”) that affect the way nerve cells function in order to treat certain medical conditions

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

Quethartic XL with food, drink and alcohol

• Quethartic XL prolonged-release tablet 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 Quethartic XL 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 this medicine.

Do not take Quethartic XL during pregnancy unless this has been discussed with your doctor.

Do not take Quethartic XL if you are breast-feeding.

The following symptoms which can represent withdrawal may occur in newborn babies of mothers that have used Quethartic 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 Quethartic XL tablets may make you feel sleepy. Do not drive or use any tools or machines until you know how the tablets affect you.

Quethartic XL contains lactose

Quethartic XL prolonged-release tablet 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 Quethartic XL may cause positive results for methadone or certain medicines 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 quethartic xl

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 usually between 150 mg and 800 mg.

• You will take your tablets once a day
• Do not split, chew or crush the tablets
• Swallow your tablets whole with a glass of water
• 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 Quethartic 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

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

If you take more Quethartic XL than you should

If you take more Quethartic XL 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 with you.

If you forget to take Quethartic 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 Quethartic XL

If you suddenly stop taking Quethartic 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.

4. possible side effects

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

Very common: may affect more than 1 in 10 people

• Dizziness (may lead to falls), headache, dry mouth
• Feeling sleepy, which may lead to falls (this may go away with time, as you keep taking Quethartic XL)
• Discontinuation symptoms (symptoms which occur when you stop taking Quethartic XL) 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) in the blood
• 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 hungrier
• 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:

• – Men and women to have swelling of breasts and unexpectedly produce breast milk

• – Women to have no monthly period or irregular periods

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 sensation 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
• Worsening of pre-existing diabetes
• 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 the fat around your abdomen, a decrease in “good cholesterol” (HDL-C), an increase in a type of fat in your blood called trigylcerides, 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 muscles)
• 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)
• 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 were taking Quethartic XL during their pregnancy

The class of medicines to which Quethartic XL belongs can cause heart rhythm problems, which can be serious and in severe cases 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: may affect 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:

• – boys and girls to have swelling of breasts and unexpectedly produce breast milk

• – girls to have no monthly period or irregular periods

• Increased appetite
• Vomiting
• Abnormal muscle movements. These include difficulty starting muscle movements, shaking, feeling restless or muscle stiffness without pain
• Increase in blood pressure
• 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 MHRA Yellow Card Scheme, Website:. By reporting side effects, you can help provide more information on the safety of this medicine.

5. how to store quethartic 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 container after EXP. The expiry date refers to the last day of that month.

This medicine 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 to protect the environment.

6. contents of the pack and other information

What Quethartic XL contains

• The active substance is quetiapine. Each tablet contains either 50 mg, 300 mg or 400 mg of quetiapine (as quetiapine fumarate).
• The other ingredients are:

What Quethartic XL looks like and contents of the pack

Quethartic XL 50 mg tablets are peach, bi-convex, capsule shaped, coated tablets, of dimension about 16.5 mm X 6.6 mm, debossed “AI001” on one side and plain on other side.

Quethartic XL 300 mg tablets are pale yellow, bi-convex, capsule shaped, coated tablets, of dimension about 19.1 mm X 8.1 mm, debossed “AI004” on one side and plain on other side.

Quethartic XL 400 mg tablets are white to off white, bi-convex, capsule shaped, of dimension about 20.5 mm X 9.3 mm, coated tablets, debossed “AI005” on one side and plain on other side.

PVC-Aclar/Aluminium blisters in cartons of 10, 14, 20, 28, 30, 50, 56, 60, 90, 98 and 100 tablets.

White, plastic (HDPE) bottle with a child-resistant plastic (polypropylene) screw cap containing 60 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Amneal Pharma Europe Limited

70 Sir John Rogerson’s Quay

Dublin 2

Ireland

Manufacturer:

Amneal Netherlands B.V.

Emmaplein 4Ds Hertogenbosch 5211VW

The Netherlands

Amneal Nordic ApS

Kanalholmen 14–18

2650 Hvidovre

Denmark

This leaflet was last revised in January-2017

Size : 240 × 520 mm, Colour: M Black, Key line(Not to Print)

Minimum Font Size 9 pt

Date: 03/01/17

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