Quetiapine 25mg Film-Coated Tablets
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Quetiapine 25 mg Film-coated Tablets
Read all of this leaflet carefully before you start taking this medicine.
• 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. See section 4.
In this leaflet:
1. What Quetiapine is and what it is used for
2. Before you take Quetiapine
3. How to take Quetiapine
4. Possible side effects
5. How to store Quetiapine
6. Contents of the pack and other information
Quetiapine belongs to a group of medicines called antipsychotics.
Quetiapine is used to treat:
• schizophrenia
Symptoms include:
- hallucinations, such as hearing unexplained voices
- strange and frightening thoughts
- changes in your behaviour
- feeling alone and confused
• manic episodes associated with a disease called bipolar disorder
Symptoms are:
- feeling very “high” or excited
- needing less sleep than usual
- being more talkative with racing thoughts or ideas
- feeling more irritable than usual
• depressive episodes associated with a disease called bipolar disorder
Symptoms are:
- feeling very “down” or sad
- feeling guilty
- lacking energy
- losing appetite
- can not sleep.
Your doctor may continue to give you Quetiapine when you are feeling better to prevent your symptoms from returning.
substance names ending in “azole” such as ketoconazole
- erythromycin and clarithromycin: medicines to treat bacterial infections
- nefazodone: a medicine to treat depression.
• medicines which reduce quetiapine levels in the blood and its effect, such as:
- carbamazepine and phenytoin: medicines to treat epilepsy or other illnesses. Your doctor may consider prescribing another medicine to treat epilepsy or adjust your Quetiapine dose.
- thioridazine or lithium: medicines to treat psychiatric disorders
• medicines which act on the central nervous system.
• medicines which may cause certain cardiac disorders such as:
- other antipsychotics, used to treat mental disorders
- those used to treat irregular heartbeats in class IAor III
- antibiotics, used to treat bacterial infections
- medicines to treat malaria.
• medicines which may cause electrolyte imbalance such as:
hydrochlorothiazide or similar medicines which increase your water output.
• medicines which influence hepatic enzymes such as:
- rifampicin: a medicine to treat tuberculosis or certain other infections
- barbiturates: medicines to treat sleeplessness.
• medicines that can cause constipation
Taking Quetiapine with food and drink
Quetiapine can be taken with or without food. Do not
drink alcohol during treatment with Quetiapine as the
combined effect might make you feel drowsy. Do not
drink grapefruit juice while you are taking quetiapine.
It can affect the way the medicine works.
Do not take Quetiapine
• if you are allergic (hypersensitive) to quetiapine or any of the other ingredients of this medicine as listed in chapter 6 “Further information”.
• if you take any of the following medicines:
- medicines to treat HIV infections with active substance names ending in “navir”
- medicines to treat fungal infections with active substance names ending in “azole” such as ketoconazole
- erythromycin and clarithromycin: medicines to treat bacterial infections
- nefazodone: a medicine to treat depression.
Take special care with Quetiapine
Before you take your medicine inform your doctor or pharmacist if you
• have poor circulation in the heart or brain, or other conditions inclined to cause low blood pressure.
• have or have had diseases of the heart and/or blood vessels (or a family history of heart problems), such as heart failure or irregular heart beat, especially an abnormality known as “prolonged QT-interval”.
• are taking any medicines that may have an impact on the way your heart beats.
• have had a stroke previously, especially if you are older.
• are an older person with dementia (loss of brain function). If you are, Quetiapine 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 older people with dementia.
• have had low levels of white blood cells previously which may or may not have been caused by other medicines.
• have ever suffered from convulsions.
• have diabetes mellitus, tend to have high blood sugar levels or are at risk of developing diabetes mellitus.
If you do, your doctor may check your blood sugar levels while you are taking Quetiapine.
• have high cholesterol values and so called triglyceride levels, which are certain fats, in your blood.
• have experienced considerable weight gain during an earlier treatment with a medicine belonging to the same group as Quetiapine does.
• have a liver function disorder
See chapter “3 How to take Quetiapine”.
• or someone else in your family has a history of blood clots, as medicines like these have been associated with formation of blood clots.
Pregnancy and breast-feeding
• Pregnancy
Do not take Quetiapine if you are pregnant unless your doctor has told you to. Inform your doctor immediately if you are pregnant or think you may be. The following symptoms which can represent withdrawal may occur in newborn babies, of mothers who 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.
• Breast-feeding
You should not take Quetiapine when breast-feeding.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Only drive or operate machines if your doctor has
approved it.
This will depend upon how this therapy affects you, because Quetiapine may make you feel sleepy and dizzy and thus impair your mental alertness.
Important information about some of the ingredients of Quetiapine
Quetiapine contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking Quetiapine.
Effect on urine drug screens
If you are having a urine drug screen, taking Quetiapine 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 Quetiapine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Your doctor will tell you how many Quetiapine tablets you should take and how long you should continue to take them.
Inform your doctor or pharmacist immediately if you
• notice any involuntary movements or experience abnormal movements especially of the tongue, mouth and face while taking this medicine.
If so your doctor might reduce your dose or discontinue treatment.
• develop fever, accelerated breathing, excessive sweating, changes in consciousness or stiff muscles.
Immediate medical treatment may be needed; see chapter 4, first paragraph “neuroleptic malignant syndrome”.
• have dizziness or a severe sense of feeling sleepy.
This could increase the risk of accidential injury (fall) in older people.
• experience fits or seizures.
• have a long-lasting and painful erection.
These conditions can be caused by this type of medicine.
Medicinal products containing higher strengths of quetiapine are available for doses not practicable with this medicine. The usual dose is:
Adults
• To treat schizophrenia
Take the following total daily doses divided into two separate doses per day.
- Day 1: 50 mg quetiapine
- Day 2: 100 mg quetiapine
- Day 3: 200 mg quetiapine
- Day 4: 300 mg quetiapine
- After day 4: Your doctor will gradually increase the total daily dose from 300 mg to 450 mg quetiapine. Depending on your individual response and tolerance, the total daily dose may vary between 150 mg and 750 mg quetiapine.
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 Quetiapine 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.
• To treat manic episodes
Take the following total daily doses divided into two separate doses per day.
- Day 1: 100 mg quetiapine
- Day 2: 200 mg quetiapine
- Day 3: 300 mg quetiapine
- Day 4 and following days: 400 mg quetiapine
- From day 6: Your doctor may gradually increase the daily dose up to a maximum of 800 mg quetiapine. The daily dose increase should not exceed 200 mg quetiapine.
Depending on your individual response and tolerance, the total daily dose may vary between 200 mg and 800 mg quetiapine.
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.
• To treat depressive episodes
Take the following doses once daily every evening at bedtime.
- Day 1: 50 mg quetiapine
- Day 2: 100 mg quetiapine
- Day 3: 200 mg quetiapine
- Day 4 and following days : 300 mg quetiapine Average dose: 300 mg quetiapine per day.
Use in children and adolescents under 18 years Quetiapine should not be used by children and adolescents under 18 years of age.
Weight gain
Weight gain has been seen in patients taking Quetiapine. You and your doctor should check your weight regularly.
Older people over 65 years
Lower doses and slower dose increases may be sufficient for this age group.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
The following medicines can particularly influence or be influenced by Quetiapine:
• medicines which must not be taken together with Quetiapine - see chapter 2 “Do not take Quetiapine”:
- medicines to treat HIV infections with active substance names ending in “navir”
- medicines to treat fungal infections with active
Patients with impaired liver function
Starting dose: 25 mg quetiapine per day. This dose is increased slowly by 25 mg to 50 mg quetiapine each day until the optimal dose is reached.
Method of administration
For oral use. Swallow the tablets with a glass of water preferably at the same time each day.
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^ If you take more Quetiapine than you should
If you have accidentally taken too much Quetiapine contact your doctor or a hospital at once. Always take the tablets, leaflet and/or carton with you so the doctor will know what you took. Immediate medical care is necessary if the following signs occur: drowsiness, sedation, rapid heart beat and low blood pressure.
If you forget to take Quetiapine
If you forget a dose continue by taking your next dose at the usual time. Do not take a double dose to make up for a forgotten dose.
If you stop taking Quetiapine
Do not stop taking Quetiapine unless advised by your doctor, as this may harm the success of therapy. If you suddenly stop taking the tablets, symptoms such as nausea, headache, diarrhoea, vomiting, dizziness, irritability and sleeplessness might occur. To avoid such symptoms, it is important to reduce the dose gradually according to your doctor’s instructions.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
you notice any of these symptoms seek medical advice immediately
• hepatitis
• walking, talking, eating or other activities while you are asleep
• decrease in body temperature
• inflammation of the pancreas
• serious decrease in the number of certain white blood cells called agranulocytosis. This may occur at any time during treatment
• metabolic syndrome. This is a combination of three or more of the following metabolic risk factors: 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. It requires appropriate medical treatment.
• bowel obstruction
Like all medicines, Quetiapine can cause side effects, although not everybody gets them.
Stop taking Quetiapine immediately and contact your doctor at once or go to the nearest hospital if any of the following events happen to you:
• a combination of fever, persistent sore throat or mouth ulcers, faster breathing, sweating, muscle stiffness and reduced consciousness - all of these are symptoms of a severe disorder called “neuroleptic malignant syndrome”
• a severe allergic reaction, which involves difficulty breathing, low blood pressure, swelling in the mouth or throat, skin rash and itching
• symptoms of “angioedema” such as swollen face, tongue or pharynx, difficulties to swallow and to breath and hives
• fits or seizures
• long-lasting and painful erection
• 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
• serious, sudden allergic reaction with symptoms such as fever and blisters on the skin and peeling of the skin (toxic epidermal necrolysis).
Reported side effects listed according to the frequencies are:
Very common, affects more than 1 user in 10:
• dizziness (may lead to falls)
• feeling sleepy (may lead to falls)
• headache
• dry mouth
These symptoms usually occur when beginning therapy and gradually disappear as treatment continues
• increased values for fats called triglycerides and total cholesterol (predominantly LDL cholesterol) in the blood
• decreased values for fats called HDL cholesterol in the blood
• discontinuation symptoms such as nausea, headache, diarrhoea, vomiting, dizziness, irritability and sleeplessness.
These occur when you suddenly stop taking Quetiapine. Gradual withdrawal over a period of at least 1 to 2 weeks is advisable
• weight gain
• decrease of a certain protein called haemoglobin in your blood
• abnormal muscle movements which include difficulty starting muscle movements, shaking, feeling restless or muscle stiffness without pain
Common, affects 1 to 10 users in 100:
• particularly at the beginning of treatment:
- rapid heart beat
- fall in blood pressure especially when sitting or standing up after lying down
This can cause dizziness (may lead to falls) and increased heart beat
• feeling like your heart is pounding, racing or has skipped beats
• decrease in the total number of white blood cells and of a specific subgroup called neutrophils
This leads to an increased susceptibility to infections and may occur after therapy has ended. It is temporary and not severe
• increase in the number of certain blood cells called eosinophilic granulocytes
This indicates that your body’s immune system is highly activated
• indigestion, constipation
• feeling weak
• swelling of arms or legs due to accumulation of fluid in the tissues
• blurred vision
• temporary increase of a liver enzyme called ALT in the blood
• temporary increase of the liver enzyme called gamma-GT in the blood
• increase in the amount of sugar in the blood
• increase in the amount of a hormone called prolactin in the blood
This can 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
• decrease in the amount of thyroid gland hormones in the blood
• increase in the amount of a hormone which stimulates the hormone production by the thyroid gland abnormal dreams and nightmares
• increased appetite
• feeling irritated
• disturbance in speech and language
• thoughts of suicide and worsening of your depression
• shortness of breath
• vomiting, mainly in older people
• fever.
Uncommon, affects 1 to 10 users in 1,000:
• decrease in the number of certain blood cells called thrombocytes and platelets.
This can lead to an increased tendency to bruise and to bleed
• deficiency in red blood cells
• allergic reactions that may include raised lumps (weals), swelling of the skin and swelling around the mouth
• seizure
• heart rhythm disorder known as “QT-prolongation” and seen on ECG
• a slower than normal heartrate which may occur when starting treatment which may be associated with low blood pressure and fainting
• unpleasant sensations in the legs, so called “restless legs syndrome”
• difficulty swallowing
• sexual dysfunction
• decrease in the amount of sodium in the blood
• during or after a prolonged course of treatment: movement disorders including uncontrollable tongue, mouth and facial movements known as tardive dyskinesia
• diabetes mellitus or worsening of pre-existing diabetes mellitus
• decrease in the amount of a specific hormone produced by the thyroid gland, called triiodothyroxine, in the blood
• deficiency in thyroid gland function
• stuffy nose
• fainting (may lead to falls), particularly at the beginning of treatment
• temporary increase of a liver enzyme called AST in the blood
• difficulty passing urine
Rare, affects 1 to 10 users in 10,000:
• jaundice
• long lasting and painful erection
• so called “neuroleptic malignant syndrome”, see also first paragraph in this chapter
• increase of an enzyme called creatine phosphokinase in the blood
• swelling of breasts and unexpected production of breast milk
• 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
Very rare, affects less than 1 user in 10,000:
• so called “angioedema”, see also first paragraph in this chapter
• a serious blistering condition of the skin, mouth, eyes and genitals (Stevens-Johnson syndrome)
• severe allergic reaction, see also first paragraph in this chapter
• inappropriate secretion of a hormone that controls urine volume
• breakdown of muscle fibers and pain in muscles.
Not known, frequency cannot be estimated from the available data
• decrease in the number of certain blood cells called neutrophilic granulocytes
These belong to the white blood cells, see above under “Common”.
This occurs particularly after treatment has ended, is temporary and not severe
• symptoms of withdrawal may occur in newborn babies of mothers who have used Quetiapine during their pregnancy
• 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).
Also reported are:
• heart arrest
• specific heart rhythm disorders
• sudden unexplained death.
These occurred with the entire group of medicines called antipsychotics and not with quetiapine in particular.
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, changes in the number of certain types of blood cells, increased blood creatine phosphokinase (a substance in the muscle), decrease in the amount of sodium in the blood and increases in the amount of a hormone called prolactin in the blood. Thus your doctor may ask you to have blood tests from time to time.
Children and adolescents (10 to 17 years)
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 user in 10:
• increase in blood pressure.
The following side effects have been seen more often in children and adolescents:
Very common, affects more than 1 user in 10:
• 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
• vomiting
• abnormal muscle movements which include difficulty starting muscle movements, shaking, feeling restless or muscle stiffness without pain.
Common, may affect up to 1 in 10 people:
• feeling weak
• fainting (may lead to falls)
• stuffy nose
• feeling irritated
Reporting of side effects
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. You can also report side effects directly via the Yellow Card Scheme (www.mhra.gov.uk/yellowcard). By reporting side effects you can help provide more information on the safety of this medicine.
Keep out of the reach and sight of children.
Do not use Quetiapine after the expiry date which is stated on the carton and on the blister/bottle label. The expiry date refers to the last day of that month.
Plastic bottles: Do not use after 6 months have elapsed from first opening.
This medicinal product does not require any special storage conditions.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
What Quetiapine contains
The active substance is quetiapine. Each film-coated tablet contains 25 mg quetiapine (as quetiapine fumarate).
The other ingredients are:
• Tablet core: calcium hydrogen phosphate dihydrate, microcrystalline cellulose, lactose monohydrate, magnesium stearate, povidone (K29/32), silica colloidal hydrated, sodium starch glycolate (type A)
• Tablet coating: hypromellose, lactose monohydrate, macrogol 4000, titanium dioxide (E171), iron oxide red (E172), iron oxide yellow (E172)
What Quetiapine looks like and contents of the pack
Quetiapine 25 mg film-coated tablets are salmon-pink coloured and round (6.0 mm diameter).
Quetiapine 25 mg film-coated tablets are available in
• blister packs with 6, 10, 14, 20, 30, 50, 60, 90, 100 or 120 film-coated tablets
• perforated unit dose blister packs with 100 x 1 film-coated tablets
• plastic bottles with screw caps with 50, 60, 100, 250 or 500 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder UK:
Sandoz Ltd, Frimley Business Park, Frimley,
Camberley, Surrey, GU16 7SR, UK.
Malta:
Sandoz d.d., Verovskova 57, 1000 Ljubljana, Slovenia. Manufacturer
Salutas Pharma GmbH Otto-von-Guericke-Allee 1, 39179 Barleben or Salutas Pharma GmbH Dieselstrasse 5, 70839 Gerlingen or Lek Pharmaceuticals d.d.,Verovskova 57, 1526 Ljubljana, Slovenia or Lek Pharmaceuticals d.d., Trimlini 2D, 9220 Lendava, Slovenia or LEK S.A., Ul. Podlipie 16 C, 95 010Strykow, Poland or LEKS.A.,Ul. Domaniewska 50 C, 02-672 Warszawa, Poland or S.C. Sandoz S.R.L., 7A Livezeni Street, 540472 Targu Mures, Jud. Mures, Romania
This leaflet was last revised in 09/2014.
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