Quetamed

Package leaflet: Information for the user

Quetamed, 25 mg film-coated tablets

Quetamed, 100 mg film-coated tablets
Quetamed, 200 mg film-coated tablets
Quetamed, 300 mg film-coated tablets
Quetamed, 25 mg/100 mg/200 mg film-coated tablets
Quetiapine
Generic medicine
Please read all of this leaflet carefully before you take this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Quetamed is and what it is used for
2. What you need to know before taking Quetamed
3. How to take Quetamed
4. Possible side effects
5. How to store Quetamed
6. Contents of the pack and other information

1. What Quetamed is and what it is used for

Quetamed contains a substance called quetiapine. This substance belongs to a group of medicines known as antipsychotics. Quetamed can be used to treat several conditions, such as the following:

• Bipolar depression: you may feel sad, depressed, guilty, without energy, without appetite, or have difficulty sleeping.
• Mania: you may feel very excited, euphoric, restless, enthusiastic or hyperactive, or have poor judgment, including aggressive or destructive behaviour.
• Schizophrenia: you may experience hearing or sensing things that are not actually present, believe things that are not true, or feel unusually suspicious, anxious, confused, guilty, tense or depressed.

Your doctor may continue to prescribe Quetamed even if you feel better.

2. What you should know before taking Quetamed

Do not take Quetamed:
if you are allergic to quetiapine or to 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 virus
azole antifungals (for fungal infections)
erythromycin or clarithromycin (for infections)
nefazodone (for depression).
If you have any doubts, consult your doctor or pharmacist before taking Quetamed.

Warnings and precautions
Talk to your doctor before taking Quetamed:

• if you or someone in your family has or has previously had heart problems, such as irregular heartbeat, weakened heart muscle, or inflammation of the heart, or if you are taking medicines that may affect heart rhythm
• if your blood pressure is low
• if you have had a stroke, especially if you are elderly
• if you have liver problems
• if you have had seizures (epileptic fits)
• if you have diabetes or are at risk of developing diabetes. In this case, your doctor may monitor your blood sugar levels while you are taking Quetamed
• if you know you have previously had low levels of white blood cells in your blood (whether caused by medicines or not)
• if you are an elderly person with dementia (loss of some brain functions). In this case, Quetamed should not be taken, as this class of medicines to which Quetamed belongs may increase the risk of stroke or, in some cases, the risk of death in elderly patients with dementia
• if you are an elderly person with Parkinson’s disease/parkinsonism
• if you or someone in your family has a history of conditions related to blood clots, as medicines of this type may increase the risk of blood clot formation
• if you have or have previously had a condition (called “sleep apnoea”) in which you stop breathing for short periods during normal sleep, and you are taking medicines that slow down normal brain activity (“depressants”)
• if you have or have previously had a condition in which you are unable to completely empty your bladder (urinary retention), have an enlarged prostate, intestinal obstruction, or increased pressure inside the eye. These conditions are sometimes caused by medicines (called “anticholinergics”) that affect how nerve cells function and are used to treat certain medical conditions
• if you have a history of alcohol or drug abuse.

Contact your doctor immediately if you experience any of the following symptoms after taking
Quetamed:

• Fever associated with severe muscle stiffness, sweating, or reduced level of consciousness (a condition called “neuroleptic malignant syndrome”). Immediate medical treatment may be required
• Uncontrollable movements, mainly of the face or tongue
• Dizziness or a strong feeling of drowsiness. This may increase the risk of accidental injuries (falls) in elderly patients
• Seizures (epileptic fits)
• Persistent and painful erection (priapism)
• Rapid or irregular heartbeat, even at rest, palpitations, breathing difficulties, chest pain, or unexplained tiredness. Your doctor should check your heart and, if necessary, refer you immediately to a cardiologist.

The following conditions may be caused by the type of medicine you are
taking.
Inform your doctor as soon as possible if you experience:

• Fever, flu-like symptoms, sore throat, or any other infection, as these could be signs of a very low white blood cell count, which may require stopping Quetamed and/or starting specific treatment
• Constipation together with persistent abdominal pain or constipation that has not responded to treatment, as these could lead to a more serious intestinal obstruction.

Suicidal thoughts and worsening of depression
If you are depressed, you may sometimes have thoughts of harming yourself or of suicide. These
feelings may be stronger at the beginning of treatment, as these medicines take time to work, usually about two weeks but sometimes longer.
These thoughts may also increase if you suddenly stop taking the medicine. You are more likely to have such feelings if you are a young adult.
Clinical studies have shown an increased risk of suicidal thoughts and/or suicidal behaviour in young adults with depression under the age of 25.
If at any time you experience thoughts of self-harm or suicide, contact your doctor or go to hospital immediately. You may find it helpful to tell a relative or close friend that you are depressed and ask them to read this leaflet. You may wish to ask them to inform you if they think your depression is getting worse or if they are concerned about any changes in your behaviour.

Serious cutaneous adverse reactions (SCAR)
Very rarely, serious cutaneous adverse reactions (SCAR), which may be life-threatening or fatal, have been reported with this medicine.
These reactions include:

• Stevens-Johnson syndrome (SJS), widespread rash with blisters and skin peeling, particularly around the mouth, nose, eyes, and genitals
• Toxic epidermal necrolysis (TEN), a more severe form causing extensive skin peeling
• Drug reaction with eosinophilia and systemic symptoms (DRESS), which resembles influenza and includes symptoms such as rash, fever, swollen glands, and abnormal blood test results (including increased white blood cells (eosinophilia) and liver enzymes).

Stop using Quetamed and contact your doctor or seek immediate medical attention if you develop any of these symptoms.

Weight gain
Weight gain has been reported in patients treated with Quetamed®. It is important that your body weight is monitored regularly by both you and your doctor.

Children and adolescents
Quetamed must not be used in children and adolescents under 18 years of age.

Other medicines and Quetamed
Tell your doctor if you are taking, have recently taken, or might take any other medicines.
Do not take Quetamed if you are taking any of the following medicines:

• Some medicines for HIV virus
• Azole antifungals (for fungal infections)
• Erythromycin or clarithromycin (for infections)
• Nefazodone (for depression).

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

• Medicines for epilepsy (such as phenytoin or carbamazepine)
• Medicines for high blood pressure
• Barbiturates (for sleep disorders)
• Thioridazine or lithium (other antipsychotic medicines)
• Medicines that affect heart rhythm, for example medicines that may cause electrolyte imbalance (low levels of potassium or magnesium), such as diuretics (pills that increase urine production) or certain antibiotics (medicines for treating infections)
• Medicines that may cause constipation
• Medicines (called “anticholinergics”) that affect how nerve cells function and are used to treat certain medical conditions.

Do not stop taking any medicine without first discussing it with your doctor.

Quetamed with food, drinks and alcohol

• Quetamed can be taken regardless of meals.
• Be cautious about the amount of alcohol you consume. This is important because the combined effect of Quetamed and alcohol may increase drowsiness.
• Do not drink grapefruit juice while taking Quetamed. Grapefruit juice may affect how the medicine works.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor for advice before taking this medicine. You must not take Quetamed during pregnancy without first discussing it with your doctor.
Quetamed must not be taken during breastfeeding.
The following symptoms, which may represent withdrawal, have been observed in newborns of mothers who used quetiapine during the third trimester (the last three months of pregnancy): tremor, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties, and feeding problems. If your baby shows any of these symptoms, contact your doctor.

Driving and using machines
The tablets may cause drowsiness. Do not drive or operate any tools or machinery until you know how the tablets affect you.

Quetamed contains lactose
Quetamed contains lactose, a type of sugar. If your doctor has informed you that you have an intolerance to certain sugars, consult your doctor before taking this medicine.

Quetamed 25 mg contains sunset yellow (E110), which may cause allergic reactions.

Effect on urine screening tests
If you need to undergo a urine screening test, taking Quetamed may lead to false positive results for methadone or certain antidepressants called tricyclic antidepressants (TCA), when certain testing methods are used, even if you are not taking methadone or TCAs. If this occurs, more specific tests should be performed.

3. How to take Quetamed

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist. Your doctor will decide the most appropriate starting dose for you. The maintenance dose (daily dose) will depend on the type of illness and individual needs, but is usually between 150 mg and 800 mg.

• You will take the tablets once daily, in the evening before going to bed, or twice daily, depending on the condition being treated.
• Swallow the tablets whole with a glass of water.
• You may take the tablets regardless of meals.
• Do not drink grapefruit juice while taking Quetamed, as it may affect the medicine's action.
• Do not stop taking the tablets even if you feel better, unless your doctor tells you otherwise.

Liver problems
If you have liver problems, your doctor may adjust your dose.
Elderly
If you are elderly, your doctor may adjust your dose.
Use in children and adolescents
Quetamed must not be used in children and adolescents under 18 years of age.
If you take more Quetamed than you should
If you take more Quetamed than prescribed by your doctor, you may feel drowsy, experience dizziness, or notice an abnormal heartbeat. Contact your doctor or the nearest hospital immediately, and bring the Quetamed packaging with you.
If you forget to take Quetamed
If you forget to take a dose, take it as soon as you remember. If it is almost time for your next dose, wait and take the next dose at the scheduled time. Do not take a double dose to make up for the missed tablet.
If you stop taking Quetamed
If you stop treatment with Quetamed suddenly, you may have difficulty sleeping (insomnia), feel unwell (nausea), or experience headache, diarrhoea, malaise (vomiting), dizziness, or irritability. Your doctor may advise you to gradually reduce the dose before stopping treatment.
If you have any questions about the use of this medicine, consult 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 (which may lead to falls), headache, dry mouth.
• Drowsiness (which diminishes over time with continued treatment with Quetamed) (which may lead to falls).
• Withdrawal symptoms (symptoms that occur when you stop taking Quetamed), including inability to sleep (insomnia), nausea, headache, diarrhoea, vomiting, dizziness, and irritability. Gradual discontinuation of the medicine over a period of at least 1 or 2 weeks is recommended.
• Increase in body weight.
• Abnormal muscle movements, including difficulty initiating muscle movement, tremor, restlessness, or muscle stiffness without pain.
• Changes in levels of certain blood fats (triglycerides and total cholesterol).

Common: may affect up to 1 in 10 people

• Fast heartbeat
• Awareness of heart beating rapidly, pounding, or irregularly (palpitations)
• Constipation, stomach discomfort (indigestion)
• Feeling weak
• Swelling of arms or legs
• Low blood pressure when standing up. This may cause dizziness or fainting (which may lead to falls)
• Increased blood sugar levels
• Blurred vision
• Abnormal dreams and nightmares
• Increased feeling of hunger
• Irritability
• Problems with speech and language
• Suicidal thoughts and worsening of depression
• Shortness of breath
• Vomiting (especially in elderly patients)
• Fever
• Changes in levels of thyroid hormones in the blood
• Decreased number of certain types of blood cells
• Increased levels of liver enzymes in the blood
• Increased levels of the hormone prolactin in the blood. Elevated prolactin levels may rarely lead to the following:
  • Men and women may experience breast enlargement and unexpected production of breast milk
  • Women may experience absence of menstrual periods or irregular menstrual cycles.

Uncommon: may affect up to 1 in 100 people

• Seizures or epileptic fits
• Allergic reactions including swellings (hives), skin swelling, and swelling around the mouth
• Unpleasant sensations in the legs (also known as restless legs syndrome)
• Difficulty swallowing
• Uncontrollable movements, mainly of the face or tongue
• Sexual dysfunction
• Diabetes
• Changes in the heart's electrical activity seen on ECG (prolongation of the QT interval)
• Slowing of the normal heart rate may occur when starting treatment and may be associated with low blood pressure and fainting
• Difficulty urinating
• Fainting (may lead to falls)
• Stuffy nose
• Decreased number of red blood cells in the blood
• Decreased sodium levels in the blood
• Worsening of pre-existing diabetes.

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

• High body temperature (fever) associated with sweating, muscle stiffness, pronounced drowsiness or fainting (a condition called "neuroleptic malignant syndrome")
• Yellowing of the skin and eyes (jaundice)
• Inflammation of the liver (hepatitis)
• Prolonged and painful erection (priapism)
• Breast enlargement and unexpected production of milk from the mammary gland (galactorrhoea)
• Menstrual disorders
• Blood clots in the veins, especially in the legs (symptoms include swelling, pain, and redness in the legs), which may travel through blood vessels to the lungs, causing chest pain and breathing difficulties. If you notice any of these symptoms, contact your doctor immediately
• Sleepwalking and other related events (such as talking, walking, or eating during sleep)
• Decreased body temperature (hypothermia)
• Inflammation of the pancreas
• A condition (called "metabolic syndrome") in which you may have a combination of 3 or more of the following symptoms: increased abdominal fat, decreased "good cholesterol" (HDL-C), increased levels of a blood fat called triglycerides, high blood pressure, and increased blood sugar levels
• Combination of fever, flu-like symptoms, sore throat, or any other infection with a very low white blood cell count, a condition known as agranulocytosis
• Intestinal obstruction
• Increased blood levels of creatine phosphokinase (a substance from muscles).

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

• Severe skin rash, blisters, or red patches on the skin
• Severe allergic reaction (called anaphylaxis), which may cause breathing difficulties or shock
• Rapid swelling of the skin, usually around the eyes, lips, and throat (angioedema)
• Severe condition characterized by blistering of the skin, mouth, eyes, and genitals (Stevens-Johnson syndrome)
• Inappropriate secretion of the hormone that controls urine volume (syndrome of inappropriate antidiuretic hormone secretion, SIADH)
• Damage to muscle fibres and muscle pain (rhabdomyolysis).

Not known: frequency cannot be estimated from the available data

• Skin rash associated with appearance of irregular red patches (erythema multiforme)
• Sudden, severe allergic reaction with symptoms such as fever, blistering of the skin, and skin peeling (toxic epidermal necrolysis)
• Drug reaction with eosinophilia (increase in certain blood cells) and systemic symptoms (DRESS), resembling influenza, with symptoms such as: skin rash, fever, swollen glands, and abnormal blood test results (including increased white blood cells (eosinophilia) and liver enzymes)
• Withdrawal symptoms may occur in newborns of mothers who used Quetamed during pregnancy
• Stroke
• Heart muscle disorder (cardiomyopathy)
• Inflammation of the heart muscle (myocarditis)
• Inflammation of blood vessels (vasculitis), often with a skin rash showing small red or purple raised spots. The class of medicines to which Quetamed belongs can cause problems with heart rhythm, which may in some cases be serious and even fatal.

Some side effects are only detectable through blood tests. These include changes in levels of certain blood fats (triglycerides and total cholesterol) or blood sugar, changes in blood levels of thyroid hormones, increased liver enzymes, decreased number of certain types of blood cells, decreased number of red blood cells, increased levels of a substance from muscles (serum creatine phosphokinase), decreased sodium levels in the blood, and increased levels of the hormone prolactin in the blood. Increased levels of prolactin may, in rare cases, lead to the following consequences:

• Breast enlargement and unexpected production of milk from the mammary gland in both men and women
• Absence or irregularity of menstrual cycles in women.

Your doctor will therefore occasionally prescribe blood tests for you.

Additional side effects in children and adolescents:

The same side effects observed in adults may also occur in children and adolescents.

The following side effects have been reported more frequently in children and adolescents, or were not reported in adults:

Very common: may affect more than 1 in 10 people

• Increased blood levels of a hormone called prolactin. In rare cases, these increases in prolactin levels may cause the following conditions:
  • Breast enlargement and unexpected production of milk from the mammary gland in boys and girls
  • Absence or irregularity of menstrual cycles in girls
• Increased appetite
• Vomiting
• Abnormal muscle movements, including difficulty initiating muscle movement, tremor, restlessness, or muscle stiffness without pain
• Increased blood pressure.

Common: may affect up to 1 in 10 people

• Weakness, fainting (may lead to falls)
• Stuffy nose
• Irritability.

Reporting of side effects

If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system:

Website:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse

By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Quetamed

• This medicine does not require any special storage conditions. Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the packaging following the abbreviation EXP. The expiry date refers to the last day of the month.
• Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Quetamed contains

• The active substance is quetiapine. Each 25 mg film-coated tablet contains 25 mg of quetiapine (as quetiapine fumarate). Each 100 mg film-coated tablet contains 100 mg of quetiapine (as quetiapine fumarate). Each 200 mg film-coated tablet contains 200 mg of quetiapine (as quetiapine fumarate). Each 300 mg film-coated tablet contains 300 mg of quetiapine (as quetiapine fumarate). The pack “25 mg/100 mg/200 mg film-coated tablets” contains 6 tablets of 25 mg, 3 tablets of 100 mg and 1 tablet of 200 mg of quetiapine (as quetiapine fumarate).

The other components are:
Tablet core:
Hypromellose (E464)
Calcium hydrogen phosphate dihydrate
Lactose monohydrate
Maize starch
Sodium starch glycolate type A
Magnesium stearate (E572)
Microcrystalline cellulose pH 102 (E460)
Talc (E552b)
Colloidal anhydrous silica
Tablet film coating:
25 mg:
Red and yellow iron oxide (E172)
Hypromellose 2910 (E464)
Titanium dioxide (E171)
Macrogol 400
Yellow sunset FCF aluminium lake (E110)
100 mg:
Yellow iron oxide (E172)
Hypromellose 2910 (E464)
Titanium dioxide (E171)
Macrogol 400
200 and 300 mg:
Hydroxypropylcellulose (E463)
Hypromellose 2910 (E464)
Talc (E552b)
Titanium dioxide (E171)

Description of the appearance of Quetamed and contents of the pack
25 mg:
Peach-coloured, biconvex, round film-coated tablets with a diameter of approximately 5.7 mm.
100 mg:
Yellow, biconvex, round film-coated tablets with a score line on one side and a diameter of approximately 9.1 mm.
200 mg:
White, biconvex, round film-coated tablets with a score line on one side and a diameter of approximately 12.1 mm.
300 mg:
White, biconvex, oblong film-coated tablets with a score line on one side. The tablet dimensions are approximately 7 mm thick, 19 mm long and 9 mm wide.
The 100 mg, 200 mg and 300 mg tablets can be divided into equal parts.
The pack “25 mg/100 mg/200 mg film-coated tablets” contains 6 tablets of 25 mg, 3 tablets of 100 mg and 1 tablet of 200 mg of quetiapine (as quetiapine fumarate).

Pack sizes:
25 mg:
6, 30 tablets (in blisters of 6, 10)
100 mg:
60 tablets (in blisters of 10)
200 mg:
60 tablets (in blisters of 10)
300 mg:
60 tablets (in blisters of 10)
25 mg/100 mg/200 mg:
6 tablets of 25 mg, 3 tablets of 100 mg and 1 tablet of 200 mg

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Fairmed Healthcare GmbH
Dorotheenstraße 48, 22301 Hamburg
Germany

Manufacturer
Genepharm S.A.
18 Km. Marathon Ave., 153 51 Pallini
Greece

This medicinal product is authorized in the European Economic Area Member States
under the following names: