Quetiapine ahcl

PACKAGE LEAFLET: INFORMATION FOR THE USER

QUETIAPINE AHCL 25 mg film-coated tablets, 100 mg film-coated tablets, 200 mg film-coated tablets, 300 mg film-coated tablets

Generic medicine
Read this leaflet carefully before taking 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 other people, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

1. What Quetiapina AHCL is and what it is used for

Quetiapina AHCL contains a substance called quetiapine, which belongs to a group of
medicines called antipsychotics. These medicines are useful for the treatment of clinical
conditions that cause symptoms such as:
Schizophrenia: you may have the sensation of hearing or seeing things that do not exist,
believing in things that are not real, or feeling unusually suspicious, anxious, confused,
guilty, tense, or depressed.
Mania: you may feel highly excited, euphoric, agitated, enthusiastic, or hyperactive, or have
poor judgment, including states of aggression, disturbance, or aggressive behaviour.
Bipolar depression: you may feel sad. You may feel depressed, guilty, without energy, may
lose your appetite and/or be unable to sleep.
Your doctor may continue to prescribe quetiapine tablets even if you feel better.

2. What you should know before taking Quetiapine AHCL

Do not take Quetiapine AHCL:
if you are allergic to quetiapine or to any of the excipients of this medicine
(listed in Section 6).
if you are currently taking any of the following medicines:

• certain medicines used to treat HIV
• azole antifungals (for fungal infections)
• erythromycin or clarithromycin (for infections)
• nefazodone (for depression).

If you have any doubts, speak with your doctor or pharmacist before taking Quetiapine
AHCL.
Warnings and precautions
Talk to your doctor or pharmacist before taking Quetiapine AHCL if:
you or someone in your family has or has had heart problems, such as irregular heart rhythm, weakened heart muscle, or inflammation of the heart, or if you are taking any medicine that may affect how your heart beats.
you have low blood pressure.
you have had a stroke, especially if you are elderly.
you have liver problems.
you have ever had seizures (epileptic fits).
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 Quetiapine AHCL.
you know you have previously had low levels of white blood cells in your blood (whether or not caused by other medicines).
you are an elderly person with dementia (loss of some brain functions). In this case, you should not take Quetiapine AHCL, because this class of medicines, to which Quetiapine AHCL belongs, may increase the risk of stroke, or in some cases the risk of death in elderly patients with dementia.
you or someone in your family has previously had blood clots, because these types of medicines are associated with blood clot formation.

• you have or have had a condition (called “sleep apnoea”) where you stop breathing for short periods during normal night sleep, and you are taking medicines that slow down normal brain activity (“depressants”).
• you have or have had a condition where 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.
• you have a history of drug or alcohol abuse. Inform your doctor immediately if you experience any of the following symptoms after taking Quetiapine AHCL: A combination of fever, 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 severe drowsiness. This may increase the risk of accidental injury (falls) in elderly patients. Seizures (fits). Prolonged and painful erection (priapism).

These conditions may be caused by this type of medicine.
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 Quetiapine AHCL and/or receiving treatment.
• Constipation together with persistent abdominal pain or constipation that has not responded to treatment, as these could lead to a more serious intestinal blockage.

Suicidal thoughts and worsening of depression
If you are depressed, you may sometimes think about harming yourself or committing suicide. These thoughts may be stronger at the beginning of treatment, as all these medicines take time to work, usually about two weeks or sometimes longer. These thoughts may also increase if you suddenly stop taking the medicine. You are more likely to have such thoughts if you are a young adult. Clinical trial data have shown an increased risk of suicidal thoughts and/or suicidal behaviour in young adults under 25 years of age with depression.
If you think about harming yourself or committing 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 ask them to inform you if they think your depression is getting worse or if they are concerned about changes in your behaviour.
Weight gain
Weight gain has been observed in patients taking quetiapine. You and your doctor should monitor your weight regularly.
Children and adolescents
Quetiapine AHCL must not be used in children and adolescents under 18 years of age.
Other medicines and Quetiapine AHCL:
Tell your doctor if you are taking, have recently taken, or might take any other medicines.
Do not take Quetiapine AHCL if you are taking any of the following medicines:
Certain medicines for HIV.
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 difficulties).
Thioridazine or lithium (another antipsychotic medicine).
Medicines that affect how your heart beats, for example, medicines that may cause an electrolyte imbalance (low levels of potassium or magnesium) such as diuretics (“water pills”) or certain antibiotics (medicines to treat infections).
Before stopping any of the medicines you are taking, inform your doctor.
Quetiapine AHCL with food, drinks and alcohol
Quetiapine AHCL can be taken with or without food.
Be cautious about the amount of alcohol you drink, as taking Quetiapine AHCL with alcohol may cause drowsiness.
Do not drink grapefruit juice when taking Quetiapine AHCL, as it may affect the medicine’s effectiveness.
Pregnancy and breastfeeding:
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor before taking this medicine. You must not take Quetiapine AHCL during pregnancy unless discussed with your doctor. You must not take Quetiapine AHCL while breastfeeding.
The following symptoms, which may represent withdrawal, may occur in newborns whose mothers have taken Quetiapine AHCL 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, you must contact your doctor.
Driving and using machines
Your tablets may cause drowsiness. Do not drive or operate machinery until you know how this medicine affects you.
Quetiapine AHCL contains lactose
Quetiapine AHCL contains lactose, which is a type of sugar. If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.
Effect on urine drug screening tests
If you undergo urine drug screening tests, taking Quetiapine AHCL may cause positive results for methadone or certain antidepressants called tricyclic antidepressants (TCA) when certain testing methods are used, even if you are not taking tricyclic antidepressants or methadone. In such cases, a more specific test can be performed.

3. How to take Quetiapine AHCL

Always take Quetiapine AHCL exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist. Your doctor will determine the initial dose. The maintenance dose (daily dose) will depend on your condition and individual needs, but will generally range between 150 mg and 800 mg.

Take the tablets once daily, in the evening before going to bed, or twice daily, depending on your condition.

Swallow the tablets whole with a glass of water.

You may take the tablets with or without food.

Do not drink grapefruit juice while taking Quetiapine AHCL, as it may affect the medicine's effectiveness.

Do not stop taking the tablets, even if you feel better, unless your doctor tells you it is safe to do so.

Liver problems
Your doctor may adjust your dose if you have liver problems.

Elderly patients
Your doctor may adjust the dose if you are elderly.

Use in children and adolescents
Quetiapine AHCL must not be used in children and adolescents under 18 years of age.

If you take more Quetiapine AHCL than you should
If you take more Quetiapine AHCL than prescribed, you may experience drowsiness, dizziness, or abnormal heartbeats. Contact your doctor or the nearest hospital immediately. Take the medicine pack with you.

If you forget to take a dose of Quetiapine AHCL
If you forget to take a dose, take it as soon as you remember. If it is almost time for your next dose, wait until the scheduled time. Do not take a double dose to make up for a missed dose.

If you stop taking Quetiapine AHCL
If you suddenly stop taking Quetiapine AHCL, you may have difficulty sleeping (insomnia), feel nauseous, or develop headache, diarrhoea, 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, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Quetiapine AHCL can cause side effects, although not everyone gets them.

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

• Dizziness (may lead to falls), headache, dry mouth, anaemia.
• Drowsiness (this may disappear over time with continued treatment with Quetiapine AHCL) (may lead to falls).
• Withdrawal symptoms (symptoms that occur when you stop taking quetiapine), including difficulty falling asleep (insomnia), nausea, headache, diarrhoea, vomiting, dizziness, and irritability. Gradual discontinuation over a period of at least 1–2 weeks is recommended.
• Weight gain.
• Abnormal muscle movements, including difficulty initiating muscle movement, tremor, restlessness, or painless muscle stiffness.
• Changes in levels of certain blood lipids (triglycerides and total cholesterol).

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

• Fast heartbeat.
• Sensation of rapid and irregular heartbeat.
• Constipation, stomach discomfort (indigestion).
• Feeling weak.
• Swelling of arms and legs.
• Low blood pressure upon standing. This may cause dizziness or fainting (which may lead to falls).
• High blood sugar levels.
• Blurred vision.
• Abnormal dreams and nightmares.
• Increased appetite.
• Feeling irritable.
• Speech or language disorders.
• 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 blood tests.
• Increased levels of prolactin hormone in the blood. Elevated prolactin levels may rarely lead to the following:
  o Breast enlargement and unexpected production of breast milk in both men and women.
  o Women may experience absent or irregular menstrual cycles.
• Fainting (syncope).

Uncommon (may affect 1 in 100 people):

• Seizures or epileptic fits.
• Allergic reactions including swellings (wheals), skin swelling, and swelling around the mouth.
• Fainting (may lead to falls).
• Unpleasant sensations in the legs and/or restless 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 (QT prolongation).
• Slower than normal heart rate, which may occur at the beginning of treatment and may be associated with low blood pressure and fainting.
• Difficulty urinating.
• Reduced number of red blood cells (anaemia).
• Reduced sodium levels in the blood.
• Worsening of pre-existing diabetes.

Rare (may affect less than 1 in 1,000 people):

• High body temperature (fever) associated with sweating, muscle stiffness, marked 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).
• Menstrual disorders.
• Walking, talking, eating, or performing other activities while asleep.
• Decreased body temperature (hypothermia).
• Breast enlargement and unexpected production of milk (galactorrhoea).
• Inflammation of the pancreas.
• A condition (called "metabolic syndrome") involving a combination of 3 or more of the following: increased abdominal fat, reduced "good cholesterol" (HDL-C), increased blood triglycerides, high blood pressure, and elevated blood sugar.
• Combination of fever, flu-like symptoms, sore throat, or other infections with very low white blood cell count, known as agranulocytosis.
• Bowel obstruction.
• Increased blood levels of creatine phosphokinase (a substance from muscles).
• Venous thromboembolism.

Very rare (may affect less than 1 in 10,000 people):

• Severe skin rash, blisters, or red patches on the skin.
• Severe allergic reaction (called anaphylaxis), which may cause difficulty breathing or shock.
• Rapid swelling of the skin, usually around the eyes, lips, and throat (angioedema).
• Severe condition characterised by blistering of the skin, mouth, eyes, and genitals (Stevens-Johnson syndrome).
• Inappropriate secretion of an antidiuretic hormone (syndrome of inappropriate antidiuretic hormone secretion, SIADH).
• Muscle fibre breakdown and muscle pain (rhabdomyolysis).

Not known (frequency cannot be estimated from available data):

• Skin rash with irregular red spots (erythema multiforme).
• Severe sudden allergic reaction with symptoms such as fever, skin blisters, and skin peeling (toxic epidermal necrolysis).
• Withdrawal symptoms may occur in newborns of mothers who used Quetiapine AHCL during pregnancy.

The class of medicines to which Quetiapine AHCL belongs can cause problems with heart rhythm, which in severe cases may be fatal.

Some side effects are only detectable through blood tests. These include changes in levels of certain blood lipids (triglycerides and total cholesterol) or blood glucose, changes in thyroid hormone levels, increased liver enzymes, decreased numbers of certain blood cells, increased blood creatine phosphokinase (a muscle-derived substance), decreased blood sodium levels, and increased blood prolactin levels. Elevated prolactin levels may, in rare cases, lead to the following:

• Breast enlargement and unexpected production of breast milk in both men and women.
• Absence or irregularity of menstrual cycles in women.

Your doctor may ask you to have regular blood tests.

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 observed more frequently in children and adolescents, or were not reported in adults:

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

• Increased levels of a hormone called prolactin in the blood. In rare cases, increased levels of the hormone called prolactin may cause the following:
  o Breast enlargement and unexpected production of breast milk in both boys and girls.
  o Absence or irregularity of menstrual cycles in girls.
• Increased appetite.
• Vomiting.
• Abnormal muscle movements, which may include difficulty performing movements, tremors, restlessness, or painless muscle stiffness.
• Increased blood pressure.

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

• Feeling tired, fainting (which may lead to falls).
• Stuffy nose.
• Feeling irritable.

Reporting of side effects

If you experience any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse.

You can also report side effects directly via the national reporting system at 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 Quetiapina AHCL

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

6. Contents of the pack and other information

What Quetiapina AHCL contains:
The active substance is quetiapine.
Each film-coated tablet contains 25 mg / 100 mg / 200 mg / 300 mg of quetiapine
(as quetiapine hemifumarate).

The excipients are:

Tablet core:
Lactose monohydrate, microcrystalline cellulose, povidone K30,
magnesium stearate (E 470b), sodium starch glycolate (Type A), dicalcium phosphate dihydrate.

Film coating contains:
25 mg: Opadry pink (03B84929)
Hypromellose 6cP
Titanium dioxide
Polyethylene glycol 400
Iron oxide yellow
Iron oxide red

100 mg: Opadry yellow (03B52117)
Hypromellose 6cP
Titanium dioxide
Polyethylene glycol 400
Iron oxide yellow

200 mg:
Hypromellose E-5
Polyethylene glycol 400
Titanium dioxide

300 mg:

Description of the appearance of Quetiapine AHCL and contents of the pack
The 25 mg tablets are pink, round, biconvex, film-coated tablets, smooth on both sides.

PVC/aluminum foil blisters in packs of 6, 7, 10, 14, 20, 28, 30, 50, 56, 60, 84, 90, 98,
and 100 tablets per carton.
Not all pack sizes may be marketed.
Marketing Authorization Holder:
Accord Healthcare S.L.U.
World Trade Center,
Moll de Barcelona,
s/n, Edifici Est 6ª planta,
08039 Barcelona,
Spain
Manufacturer:
Accord Healthcare Limited, Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1
4HF, United Kingdom
Laboratori FUNDACIO DAU,
C/ De la letra C, 12-14,
Poligono Industrial de la Zona Franca,
08040 Barcelona,
Spain
This medicinal product is authorized in the European Economic Area Member States
under the following names: