AKELYA 25 mg /Ml Оральная Суспензия

Содержание инструкции

1. Akelya 25 mg/mL oral suspension
   1. What is Akelya and what is it 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

Akelya 25 mg/mL oral suspension

quetiapine
Generic medicine

Read this leaflet carefully before you start taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it may be harmful.
• If you get any side effects, even 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 you take 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 is Akelya and what is it used for

Akelya contains a substance called quetiapine. This substance belongs to a group of
medicines called antipsychotics. Akelya can be used to treat various conditions, such as the
following:
 Bipolar depression: when you feel sad or depressed, with feelings of guilt, lacking
energy, loss of appetite, or difficulty falling asleep.
 Mania: when you feel very excited, euphoric, agitated, enthusiastic, or hyperactive, or have poor
judgment, including states of aggression or destructiveness.
 Schizophrenia: when you have the sensation of hearing or feeling things that are not actually
present, become convinced of things that are not true, or feel unusually
suspicious, anxious, confused, with feelings of guilt, tense, or depressed.
Your doctor may continue to prescribe Akelya even if you feel better.

2. What you need to know before taking Akelya

Do not take Akelya:

• if you are allergic to quetiapine or any of the other ingredients of this medicine (listed in section 6);
• if you are taking any of the following medicines:  some medicines for HIV  azole medicines (for infections caused by fungi)  erythromycin or clarithromycin (for infections)  nefazodone (for depression).

If you have any doubts, ask 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 a history of heart problems, such as irregular heartbeat, weakening of the heart muscle or inflammation of the heart, or if you are taking medicines that can affect your heartbeat;
• 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 suffered from convulsions (seizures);
• if you have diabetes or are at risk of developing diabetes. In this case, your doctor may check your blood sugar levels while you are taking Akelya;
• if you know that you have had low levels of white blood cells in your blood in the past (whether or not caused by other medicines);
• 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 people with dementia;
• if you are an elderly person with Parkinson’s disease/parkinsonism;
• if you or someone in your family has a history of blood clot-related disorders, as this type of medicine has been associated with the formation of blood clots;
• if you have or have had a condition (“sleep apnea”) where you stop breathing for short periods during normal sleep and are taking medicines that slow down normal brain activity (“depressants”);
• if you have or have had a condition where you are unable to completely empty your bladder (urinary retention), have an enlarged prostate, a blockage of the intestine, or increased pressure inside your eye. These conditions are sometimes caused by medicines (“anticholinergics”) that affect how nerve cells work 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 can lead to serotonin syndrome, a condition that could potentially be life-threatening (see “Other medicines and Akelya”).

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

• fever accompanied by severe muscle stiffness, sweating or decreased level of consciousness (a condition called “neuroleptic malignant syndrome”). You may need immediate medical attention;
• uncontrollable movements, mainly of the face or tongue;
• dizziness or an intense feeling of drowsiness. This may increase the risk of accidental injuries (falls) in elderly people;
• convulsions (seizures);
• persistent and painful erection (priapism);
• fast and irregular heartbeat, even at rest, palpitations, difficulty breathing, chest pain or unexplained fatigue. Your doctor will need to check your heart and, if necessary, refer you immediately to a cardiologist.

These conditions may be caused by this type of medicine.
Tell your doctor as soon as possible if you experience:

• fever, flu-like symptoms, sore throat or any other infection, as these may be a consequence of a very low white blood cell count that may require discontinuation of therapy with Akelya and/or administration of treatment;
• constipation together with persistent abdominal pain or constipation that has not responded to treatment, as this may lead to a more serious intestinal blockage;
• thoughts of suicide and worsening of depressionIf you have depression, you may sometimes feel the need to harm yourself or kill yourself. These feelings may be more intense at the beginning of treatment, as these medicines have

a need for time to act, usually about two weeks but sometimes even longer. These thoughts
may also intensify if you suddenly stop taking the medicine. You are more
likely to have these feelings if you are a young adult. Information
from clinical studies has in fact highlighted an increased risk of thoughts and/or
suicidal behaviors in young adults with depression under the age of 25.
If at any time you realize you are having thoughts of self-harm or suicide, contact your
doctor or go to the hospital immediately. You may find it helpful to tell relatives or friends
to ask them to warn you if they think your depressive state is worsening or if they are
concerned about changes in your behavior.

Severe skin reactions (SCAR)
Severe skin reactions (SCAR) that can be potentially life-threatening or
fatal have been very rarely reported during treatment with this medicine. These are
commonly represented by:

• Stevens-Johnson syndrome (SJS), a widespread rash with blisters and peeling of the skin, especially around the mouth, nose, eyes and genitals;
• toxic epidermal necrolysis (TEN), a more severe form that causes extensive peeling of the skin;
• drug reaction with eosinophilia and systemic symptoms (DRESS), which consists of flu-like symptoms with rash, fever, swollen glands and abnormal blood test results (including increased white blood cells (eosinophilia) and increased liver enzymes);
• acute generalized exanthematous pustulosis (AGEP), i.e. formation of small blisters filled with pus;
• erythema multiforme (EM), a rash with irregular red and itchy spots.

Stop using Akelya if you develop these symptoms and contact your doctor or seek immediate
medical assistance.

Weight gain
Weight gain has been observed in patients treated with Akelya. Your body
weight should be checked regularly by you and your doctor.

Children and adolescents
Akellya should not be used in children and adolescents under the age of 18.

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

• some medicines for HIV;
• azole medicines (for infections caused by fungi);
• 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 drugs);
• medicines that affect your heartbeat, such as medicines that can cause an electrolyte imbalance (low levels of potassium or magnesium) such as diuretics (medicines that increase urine production) or some antibiotics (medicines for the treatment of infections);
• medicines that can cause constipation;
• medicines (“anticholinergics”), that affect how nerve cells

function and are used to treat certain medical conditions;

• antidepressants. These medicines can interact with Akelya and may manifest as involuntary and rhythmic muscle contractions, including muscles that control eye movement, agitation, hallucinations, coma, excessive sweating, tremor, exaggerated reflexes, increased muscle tension, a temperature above 38 °C (serotonin syndrome). See your doctor if you experience these symptoms.

Before stopping taking any medicine, talk to your doctor.

Akellya with food, drink and alcohol

• Akellya should be taken with a glass of water.
• Akellya can be taken with or without food.
• Pay attention to the amount of alcohol you consume. This is important because the combined effect of Akelya and alcohol may promote drowsiness.
• Do not drink grapefruit juice while taking Akelya, as it may affect the action of the medicine.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning a pregnancy, ask your doctor for advice before taking this medicine. You should not take Akelya
during pregnancy without first talking to your doctor. Akelya should not be taken during
breastfeeding.
The following symptoms, which may be a sign of withdrawal, have been observed in newborns of mothers who
have taken Akelya during the last trimester (the last three months of pregnancy): tremor, stiffness and/or
muscle weakness, drowsiness, agitation, breathing problems and difficulty feeding.
If the baby shows any of these symptoms, contact your doctor.

Driving and using machines
Akellya can cause drowsiness. Do not drive or use any tools or machinery until you
know what effect this medicine has on you.

Akellya contains sodium benzoate
This medicine contains 1.0 mg of sodium benzoate in each mL.

Akellya contains sorbitol
This medicine contains 384.2 mg of sorbitol (E420) in each mL.
Sorbitol is a source of fructose. If your doctor has told you that you are intolerant to some sugars, or
if you have a diagnosis of hereditary fructose intolerance, a rare genetic disease in which patients
cannot transform fructose, talk to your doctor before taking this medicine. Sorbitol may cause
gastrointestinal problems and have a mild laxative effect.

Akellya contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per mL, i.e. essentially ‘sodium-free’.

Akellya containsglycerol
This medicine contains 29.25 mg of glycerol in each mL.
It may cause headache, stomach upset and diarrhea.

Effect on screening tests performed on urine
If you need to undergo a screening test on your urine, taking Akelya may lead to false
positives in the results for methadone or some medicines for depression called tricyclic antidepressants (TCAs)
when certain testing methods are used, even if you are not taking
methadone or TCAs. If this happens, more specific tests must be performed.

3. How to take Akelya

Take this medicine following the doctor's instructions exactly. If you have any doubts, consult your
doctor or pharmacist.
The doctor will decide what the most appropriate initial dose is 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 a day at bedtime, or twice a day, depending on the illness.
• Take this medicine by mouth.
• Always shake the bottle before use.
• Use only the syringe 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 mechanism of action of the medicine.
• Do not stop taking the medicine even if you feel better, unless your doctor tells you that you can.

Measuring the dose
Instructions for using the syringe

• 1. To open the bottle, press the cap down and rotate it counterclockwise (figure 1).
• 2. Take the syringe and insert it into the opening of the adapter (figure 2).
• 3. Turn the bottle upside down (figure 2).
• 4. Fill the syringe with a small amount of suspension by pulling the plunger down (figure 3A). Then push the plunger up to eliminate any air bubbles (figure 3B). Finally, pull the plunger up to the mark corresponding to the dose prescribed by the doctor. The dose is expressed in mL (figure 3C).
• 5. Put the bottle upright.
• 6. Remove the syringe from the adapter. Put the end of the syringe in your mouth and slowly push the plunger inward to take the medicine.
• 7. Wash the syringe with water and let it dry before reusing it.
• 8. Close the bottle with the plastic screw cap.
• 9. Store the syringe in its original box. The syringe must be usedexclusively for this product.

How much to take
The doctor will decide what the most appropriate initial dose is for you and may tell 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 illness, you will need to take the medicine:  once a day, at bedtime;  twice a day, the doctor will tell you when to take the doses.

The following table provides the equivalence between doses in mg and doses in mL and indicates the syringe to be used
for administering each dose. Each mL contains 25 mg of quetiapine.

Liver problems
If you have liver problems, your doctor may adjust the dose.

Elderly people
If you are an elderly person, your doctor may adjust the dose.

Use in children and adolescents
Akelya should 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 sleepy, dizzy
and perceive an irregular heartbeat. Contact your doctor or the nearest hospital immediately
and bring the Akelya package 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 to take

the next dose, wait until the scheduled time. Do not take a double dose to make up for the
missed dose.

If you stop taking Akelya
If you suddenly stop taking Akelya you may have difficulty sleeping
(insomnia), feel unwell (nausea), or experience headache, diarrhea, feeling unwell (vomiting), dizziness or irritability. The doctor may suggest that you gradually reduce the dose
before stopping treatment.
If you have any doubts about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Very common: may affect more than 1 in 10 people

• dizziness (which may lead to falls), headache, dry mouth;
• feeling sleepy (which may disappear over time, continuing treatment with Akelya) (which can lead to falls);
• withdrawal symptoms (symptoms that appear when you stop taking Akelya), which include inability to fall asleep (insomnia), feeling unwell (nausea), headache, diarrhea, feeling sick (vomiting), dizziness and irritability. Gradual discontinuation of the medicine is recommended, over a period of at least 1 or 2 weeks;
• weight gain;
• abnormal muscle movements, including difficulty starting a muscle movement, tremor, feeling restless or muscle stiffness without pain;
• changes in the levels of certain fats (triglycerides and total cholesterol).

Common: may affect up to 1 in 10 people

• fast heartbeat;
• feeling that the heart is racing, pounding or skipping beats;
• constipation, stomach discomfort (indigestion);
• feeling weak;
• swelling of the arms or legs
• low blood pressure when getting up, which can cause dizziness or fainting (with potential 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 the levels of thyroid hormones in the blood;
• decreases in the number of certain types of blood cells;
• increases in the amount of liver enzymes in the blood;
• increases in the amount of the hormone prolactin in the blood. Increases in the hormone prolactin which may, in rare cases, lead to the following: o breast enlargement and unexpected production of milk in both men and women; o absence or irregularity of the menstrual cycle in women.

Uncommon: may affect up to 1 in 100 people

• convulsions or seizures;
• allergic reactions that may include the appearance of swelling (hives), skin swelling and swelling around the mouth;
• unpleasant sensation in the legs (also called restless legs syndrome);
• difficulty swallowing;
• uncontrollable movements, mainly of the face or tongue;
• sexual dysfunction;
• diabetes;
• alteration of the electrical activity of the heart detected on an ECG (prolongation of the QT interval);
• slowing of the normal heartbeat, which can occur at the beginning of treatment and may be associated with low blood pressure and fainting;
• difficulty urinating;
• fainting (may cause falls);
• blocked nose;
• reduction in the number of red blood cells in the blood;
• reduction in the amount of sodium in the blood;
• worsening of any pre-existing diabetes;
• confusion.

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

• high body temperature (fever) associated with sweating, muscle stiffness, heightened sense of stiffness 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 production of milk (galactorrhea);
• menstrual disorders;
• blood clots in the veins, especially in the legs (symptoms include swelling, pain and redness of the legs), which can move through the blood vessels to the lungs, causing chest pain and difficulty breathing. 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”) that can cause a combination of three or more of the following symptoms: increased fat around the abdomen, decreased “good” cholesterol (HDL-C), increased 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 called agranulocytosis;
• intestinal obstruction;
• increased levels of creatine phosphokinase (a substance present in muscles) in the blood.

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) that can cause difficulty breathing or shock;
• rapid swelling of the skin, usually in the area around the eyes, lips and throat (angioedema);
• severe condition characterized by blistering of the skin, in the mouth, eyes and genitals (Stevens-Johnson syndrome);
• inappropriate secretion of the hormone that controls urine volume;
• damage to muscle fibers and muscle pain (rhabdomyolysis).

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

• skin rash associated with the appearance of irregular red patches (erythema multiforme). See section 2;
• rapid onset of areas of skin reddened studded with small pustules (small blisters filled with white/yellow liquid called acute generalized exanthematous pustulosis (AGEP)). See section 2;
• severe sudden 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 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 have taken quetiapine during pregnancy;
• stroke;
• heart muscle disorder (cardiomyopathy);
• inflammation of the heart muscle (myocarditis);
• Inflammation of blood vessels (vasculitis), often with a rash with small red or purple bumps.

The class of medicines to which Akelya belongs can cause problems with the heart rhythm,
which can also be serious and, in some cases, fatal.
Some side effects are only visible after a blood test. These include changes in the levels of
certain fats (triglycerides and total cholesterol) or sugars present in the blood, changes in the
levels of thyroid hormones in the blood, increased liver enzymes, decreased number of certain
types of blood cells, decreased amount of red blood cells, increased serum creatine
phosphokinase (a substance present in muscles), decreased amount of sodium in the blood, and
increases in the amount of the hormone prolactin present in the blood. Increases in the hormone
prolactin which may, in rare cases, lead to the following:

• breast enlargement and unexpected production of milk in both men and women;
• absence or irregularity of the menstrual cycle in women.

The doctor may then prescribe you blood tests from time to time.

Additional side effects in children and adolescents
The same side effects observed in adults can also occur in children and adolescents.
The following side effects have been reported more frequently in children and adolescents or have not
been reported in adults:

Very common: may affect more than 1 in 10 people

• increased levels in the blood of a hormone called prolactin. Increases in the hormone prolactin which may, in rare cases, lead to the following: o breast enlargement and unexpected production of milk in both men and women; o absence or irregularity of the menstrual cycle in girls;
• increased appetite;
• vomiting;
• abnormal muscle movements, including difficulty starting a muscle movement, tremor, feeling restless or muscle stiffness without pain;
• Increased blood pressure.

Common: may affect up to 1 in 10 people

• weakness, fainting (may cause falls);
• blocked nose;
• irritability.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can
also report side effects directly through the system 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 which is stated on the pack 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 in waste water 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 Akelya contains

• The active ingredient is quetiapine. Each mL of suspension contains 25 mg of quetiapine (as quetiapine fumarate).
• The other ingredients are: sodium benzoate (E211), glycerol, sorbitol (E420), polysorbate 20, strawberry flavour (containing propylene glycol (E1520) and acetic acid), tragacanth gum (E413) and purified water.

Description of the appearance of Akelya and contents of the pack
Akellya oral suspension is an oral suspension of white colour and homogeneous when
mixed.
Pack: a transparent bottle containing 50 mL of suspension.
Measuring devices:
 5 mL syringe with 0.2 mL graduations;
 20 mL syringe with 1 mL graduations.

Marketing Authorisation Holder
Italfarmaco S.p.A.
Viale Fulvio Testi 330,
20126 Milano,
Italy

Manufacturer
Italfarmaco S.A.
Calle San Rafael, 3
Polígono Industrial Alcobendas
28108 Alcobendas
Madrid, Spain

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
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