Akelya

Package leaflet: Information for the user

Akelya 25 mg/mL oral suspension

quetiapine
Generic medicine
Please read all of this leaflet carefully before you start taking this medicine as 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, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Akelya is and what it is used for

Akelya contains a substance called quetiapine. This substance belongs to a group of
medicines known as antipsychotics. Akelya can be used to treat several conditions, such as the
following:
 bipolar depression: when feeling sad or depressed, with feelings of guilt, lack of energy,
loss of appetite, or difficulty sleeping.
 Mania: when feeling highly excited, euphoric, restless, enthusiastic, or hyperactive, or having
impaired judgment, sometimes with aggressive or destructive behaviour.
 Schizophrenia: when experiencing sensations of hearing or seeing things that are not actually
present, having fixed beliefs in things that are not true, or feeling unusually suspicious, anxious, confused, guilty, tense, or depressed.
Your doctor may continue to prescribe Akelya even if you are feeling better.

2. What you should know before taking Akelya

Do not take Akelya:

• 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:
   certain medicines for HIV.
   Azole medicines (for fungal infections).
   Erythromycin or clarithromycin (for infections).
   Nefazodone (for depression).

If you have any doubts, consult your doctor or pharmacist before taking Akelya.
Warnings and precautions
Talk to your doctor or pharmacist before taking Akelya:

• if you or someone in your family has or has previously had heart problems, such as irregular heart rhythm, weakened heart muscle, or inflammation of the heart, or if you are taking medicines that may affect your heartbeat.
• If you have low blood pressure.
• 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 Akelya.
• 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, you should not take Akelya, because the class of medicines to which Akelya 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 such medicines have been associated with blood clot formation.
• If you have or have previously had a condition (called “sleep apnea” or “obstructive sleep apnea”) 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 substance abuse.
• If you suffer from depression or other conditions treated with antidepressants. The use of these medicines together with Akelya may lead to serotonin syndrome, a potentially life-threatening condition (see “Other medicines and Akelya”).

Inform your doctor immediately if you experience any of the following symptoms after taking Akelya:

• fever associated with severe muscle stiffness, sweating, or decreased 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 intense drowsiness. This may increase the risk of accidental injuries (falls) in elderly people.
• Seizures (epileptic fits).
• Persistent and painful erection (priapism).
• Rapid or irregular heartbeat, even at rest, palpitations, breathing difficulties, chest pain, or unexplained fatigue. Your doctor should check your heart and, if necessary, refer you immediately to a cardiologist.

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 treatment with Akelya and/or specific treatment.

• Constipation together with persistent abdominal pain or constipation that has not responded to treatment, as these may lead to a more serious intestinal blockage.

• Suicidal thoughts and worsening of depression If you have depression, you may sometimes feel the urge to harm yourself or to commit 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 intensify if you suddenly stop taking the medicine. You are more likely to experience such feelings if you are a young adult. Clinical trial data have shown an increased risk of suicidal thoughts and/or behaviours in young adults with depression under the age of 25.
  If at any time you become aware of having thoughts of self-harm or suicide, contact your doctor or go to the hospital immediately. You may find it helpful to inform close family members or friends that you suffer from depression and ask them to read this leaflet. You may also ask them to alert you if they think your depression is worsening or if they are concerned about changes in your behaviour.
  Severe cutaneous adverse reactions (SCAR)
  Severe cutaneous adverse reactions (SCAR), which may be potentially life-threatening or fatal, have been very rarely reported during treatment with this medicine. These commonly include:

• Stevens-Johnson syndrome (SJS), a widespread skin 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), characterized by flu-like symptoms with rash, fever, swollen glands, and abnormal blood test results (including increased white blood cells (eosinophilia) and elevated liver enzymes).

• Acute generalized exanthematous pustulosis (AGEP), i.e., the formation of small pustules filled with pus.

• Erythema multiforme (EM), a skin rash with irregular red, itchy spots.

Stop using Akelya and contact your doctor or seek immediate medical help if you develop any of these symptoms.
Weight gain
Weight gain has been observed in patients treated with Akelya. It is important that your body weight is monitored regularly by both you and your doctor.
Children and adolescents
Akelya must not be used in children and adolescents under 18 years of age.
Other medicines and Akelya
Inform your doctor if you are taking, have recently taken, or might take any other medicine.
Do not take Akelya if you are taking any of the following medicines:

• certain medicines for HIV.
• Azole medicines (for fungal infections).
• Erythromycin or clarithromycin (for infections).
• Nefazodone (for depression).

Inform 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 an electrolyte imbalance (low potassium or magnesium levels), such as diuretics (medicines 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.

• Antidepressants. These medicines may interact with Akelya and may cause symptoms such as involuntary and rhythmic muscle contractions, including those controlling eye movement, agitation, hallucinations, coma, excessive sweating, tremor, exaggerated reflexes, increased muscle tension, and body temperature above 38°C (serotonin syndrome). Consult your doctor if you experience these symptoms.

Do not stop taking any medicine without first discussing it with your doctor.
Akelya with food, drinks, and alcohol

• Akelya should be taken with a glass of water.
• Akelya may be taken with or without food.
• Be cautious about the amount of alcohol you consume. This is important because the combined effect of Akelya and alcohol may increase drowsiness.
• Do not drink grapefruit juice while taking Akelya, as it may affect the medicine’s action.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor before taking this medicine. You should not take Akelya during pregnancy unless you have discussed it with your doctor. Akelya must not be taken during breastfeeding.
The following symptoms, which may indicate withdrawal, have been observed in newborns whose mothers took Akelya during the third trimester (the last three months of pregnancy): tremor, muscle stiffness and/or weakness, drowsiness, restlessness, breathing difficulties, and feeding problems.
If your baby shows any of these symptoms, contact your doctor.
Driving and using machines
Akelya may cause drowsiness. Do not drive or operate any tools or machinery until you know how this medicine affects you.
Akelya contains sodium benzoate
This medicine contains 1.0 mg of sodium benzoate per mL.
Akelya contains sorbitol
This medicine contains 384.2 mg of sorbitol (E 420) per mL.
Sorbitol is a source of fructose. If your doctor has told you that you have an intolerance to certain sugars, or if you have been diagnosed with hereditary fructose intolerance, a rare genetic disorder in which patients cannot metabolize fructose, talk to your doctor before taking this medicine. Sorbitol may cause gastrointestinal problems and has a mild laxative effect.
Akelya contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per mL, i.e., essentially ‘sodium-free’.
Akelya contains glycerol
This medicine contains 29.25 mg of glycerol per mL.
It may cause headache, gastric disturbances, and diarrhoea.
Effect on urine screening tests
If you need to undergo a urine screening test, taking Akelya may lead to false-positive results for methadone or certain antidepressant medicines called tricyclic antidepressants (TCA), when certain testing methods are used, even if you are not taking methadone or TCAs. In such cases, more specific tests should be performed.

3. How to take Akelya

Take this medicine exactly as prescribed 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.

• This medicine contains 25 mg of quetiapine in each mL of suspension. You must take the medicine once daily at bedtime, or twice daily, depending on the condition being treated.
• Take this medicine by mouth.
• Always shake the bottle before use.
• Use only the syringe and dosing cup provided with the package.
• This medicine can be taken with or without food and with a glass of water.
• Do not drink grapefruit juice while taking Akelya, as it may affect the medicine's mechanism of action.
• Do not stop taking the medicine even if you feel better, unless your doctor tells you otherwise.

Dose Measurement
Instructions for using the syringe (for doses less than 5 mL)

1. To open the bottle, press the cap downward and rotate it counterclockwise (Figure 1).
2. Take the syringe and insert it into the adapter opening (Figure 2).
3. Invert the bottle (Figure 2).
4. Fill the syringe with a small amount of suspension by pulling the plunger downward (Figure 3A). Then push the plunger upward to remove any air bubbles (Figure 3B). Finally, pull the plunger to the mark corresponding to the dose prescribed by your doctor. The dose is expressed in mL (Figure 3C).
5. Return the bottle to an upright position.
6. Remove the syringe from the adapter. Place the tip of the syringe into your mouth and slowly push the plunger in to administer the medicine.
7. Wash the syringe with water and allow it to dry before reusing.
8. Close the bottle with the plastic screw cap.
9. Store the syringe in its original box. The syringe must be used exclusively for this product.

Instructions for using the dosing cup (for doses greater than 5 mL)

1. To open the bottle, press the cap downward and rotate it counterclockwise (Figure 1).
2. For doses from 6 mL to 16 mL, pour the medicine into the dosing cup up to the mark corresponding to the desired dose (Figure 2).
3. Wash the cup with water and allow it to dry before reusing.
4. Close the bottle with the plastic screw cap.
5. Store the cup in its original box. The dosing cup must be used exclusively for this product.

What amount to take
Your doctor will decide the most appropriate starting dose for you and may instruct you to increase it
gradually.

• A typical dose is usually between 150 and 800 mg per day. The dose to be used will depend on your illness and individual needs.
• Depending on the condition, you will need to take the medicine:
   once daily, at bedtime;
   twice daily; your doctor will tell you when to take the doses.

The table below provides the equivalence between doses in mg and doses in mL, and indicates whether the syringe or dosing cup should be used for administration of each dose. Each mL contains 25 mg of quetiapine.

Liver problems
If you have liver problems, your doctor may adjust the dose.
Elderly patients
If you are elderly, your doctor may adjust the dose.
Use in children and adolescents
Akelya must not be used in children and adolescents under 18 years of age.
If you take more Akelya than you should
If you take more Akelya 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 take the Akelya packaging with you.
If you forget to take Akelya
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 forgotten dose.
If you stop taking Akelya
If you suddenly stop treatment with Akelya, you may experience difficulty sleeping (insomnia), feel unwell (nausea), or develop 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 may decrease over time while continuing treatment with Akelya) (which may lead to falls).
• Withdrawal symptoms (symptoms that occur when you stop taking Akelya), including inability to sleep (insomnia), feeling unwell (nausea), headache, diarrhoea, feeling unwell (vomiting), dizziness, and irritability. Gradual discontinuation of the medicine is recommended over a period of at least 1 or 2 weeks.
• Increase in body weight.
• Abnormal muscle movements, including difficulty initiating muscle movement, tremor, feeling of restlessness, or painless muscle rigidity.
• Changes in levels of certain blood fats (triglycerides and total cholesterol).

Common: may affect up to 1 in 10 people

• Fast heartbeat.
• Sensation of rapid or forceful heartbeat, or of missed beats.
• Constipation, stomach discomfort (indigestion).
• Feeling of weakness.
• Swelling of arms or legs.
• Low blood pressure when standing up. This may cause dizziness or fainting (with potential for falls).
• Increased blood sugar levels.
• Blurred vision.
• Abnormal dreams and nightmares.
• Increased feeling of hunger.
• Irritability.
• Speech and language disorders.
• Suicidal thoughts and worsening of depression.
• Shortness of breath.
• Vomiting (especially in elderly people).
• Fever.
• Changes in levels of thyroid hormones in the blood.
• Reduction in the 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 which, in rare cases, may lead to the following:
  o Breast enlargement and unexpected milk production in both men and women;
  o Absence or irregularity of menstrual cycle in women.

Uncommon: may affect up to 1 in 100 people

• Seizures or epileptic fits.
• Allergic reactions which may include appearance of swellings (wheals), skin swelling, and swelling around the mouth.
• Unpleasant sensation 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 QT interval).
• Slowing of the normal heart rate, which may occur at the beginning of treatment and may be associated with low blood pressure and fainting.
• Difficulty urinating.
• Fainting (may cause falls).
• Nasal congestion.
• Reduction in the number of red blood cells in the blood.
• Reduction in the amount of sodium in the blood.
• Worsening of pre-existing diabetes.
• Confusion.

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

• High body temperature (fever) associated with sweating, muscle stiffness, marked feeling of numbness or fainting (a condition called "neuroleptic malignant syndrome").
• Yellowing of the skin and eyes (jaundice).
• Inflammation of the liver (hepatitis).
• Persistent and painful erection (priapism).
• Breast enlargement and unexpected milk production (galactorrhea).
• 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.
• Walking, talking, eating, or performing other activities while asleep.
• Decrease in body temperature (hypothermia).
• Inflammation of the pancreas.
• A condition (called "metabolic syndrome") which may cause a combination of three or more of the following symptoms: increased abdominal fat, decreased "good cholesterol" (HDL-C), increased levels of a type of fat in the blood 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 found in 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 characterised by blister formation on the skin, in the mouth, eyes, and genitals (Stevens-Johnson syndrome).
• Inappropriate secretion of the hormone controlling urine volume (syndrome of inappropriate antidiuretic hormone secretion, SIADH).
• Muscle fibre damage and muscle pain (rhabdomyolysis).

Frequency not known: frequency cannot be estimated from the available data

• Skin rash associated with appearance of irregular red patches (erythema multiforme). See section 2.
• Rapid appearance of red, blotchy skin areas with small pustules (small blisters filled with white/yellow fluid called acute generalised exanthematous pustulosis (AGEP)). See section 2.
• Sudden, severe allergic reaction with symptoms such as fever, blistering of the skin, and skin peeling (toxic epidermal necrolysis). See section 2.
• Drug reaction with eosinophilia and systemic symptoms (DRESS), consisting of flu-like symptoms with skin rash, fever, swollen glands, and abnormal blood test results (including increased white blood cells (eosinophilia) and increased liver enzymes). See section 2.
• Withdrawal symptoms, which may occur in newborns of mothers who took quetiapine 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 bumps.

The class of medicines to which Akelya belongs can cause problems with heart rhythm, which may be serious and, in some cases, fatal.

Some side effects can only be detected by blood tests. These include changes in levels of certain blood fats (triglycerides and total cholesterol) or blood sugar, changes in levels of thyroid hormones in the blood, increased liver enzymes, reduced number of certain types of blood cells, reduced number of red blood cells, increased serum creatine phosphokinase (a substance found in muscles), reduced sodium levels in the blood, and increased levels of the hormone prolactin in the blood. Elevated prolactin levels which, in rare cases, may lead to the following:

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

Your doctor may 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. Elevated prolactin levels which, in rare cases, may lead to the following:
  o Breast enlargement and unexpected milk production in both men and women.
  o Absence or irregularity of menstrual cycle in girls.
• Increased appetite.
• Vomiting.
• Abnormal muscle movements, including difficulty initiating muscle movement, tremor, feeling of restlessness, or painless muscle rigidity.
• Increased blood pressure.

Common: may affect up to 1 in 10 people

• Weakness, fainting (may cause falls).
• Nasal congestion.
• 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 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 Akelya

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the container after "Exp.".
The expiry date refers to the last day of that month.
Do not use the medicine after 50 days from first opening.
This medicine does not require any special storage conditions.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Akelya contains

• The active substance is quetiapine. Each mL of suspension contains 25 mg of quetiapine (as quetiapine fumarate).
• The other components are: sodium benzoate (E 211), glycerol, sorbitol (E 420), polysorbate 20, strawberry flavour (containing propylene glycol (E 1520) and acetic acid), tragacanth gum (E 413) and purified water.

Description of the appearance of Akelya and contents of the pack
Akelya oral suspension is a white, homogeneous oral suspension when mixed.
Pack sizes:

• 1 bottle or 2 bottles of 50 mL of suspension.

Not all pack sizes may be marketed.
Dosage devices:
 5 mL syringe with 0.2 mL graduations;
 20 mL dosing cup with markings at 6 mL, 8 mL, 10 mL, 12 mL and 16 mL.
Marketing Authorisation Holder
Italfarmaco S.p.A.
Viale Fulvio Testi 330,
20126 Milan,
Italy
Manufacturer
Italfarmaco S.A.
Calle San Rafael, 3
Polígono Industrial Alcobendas
28108 Alcobendas
Madrid, Spain
This medicinal product is authorised in the European Economic Area countries under the
following names:
Belgium KETYALIX 25 mg/ml Suspension zum Einnehmen
Cyprus AQUETIA 25 mg/ml πόσιμο εναιώρημα
France QUETIAPINE ITALFARMACO 25 mg/mL, suspension buvable
Germany AQUETIA 25 mg/ml Suspension zum Einnehmen
Greece AQUETIA 25 mg/ml πόσιμο εναιώρημα
Italy AKELYA
Luxembourg AQUETIA 25 mg/ml Suspension zum Einnehmen
Netherlands AQUETIA 25 mg/ml suspensie voor oraal gebruik
Portugal AQUETIA 25 mg/ml Suspensão oral
Spain KETYALIX 25 mg/ml suspensión oral