Yadina

Patient Information Leaflet

Yadina 25 mg/mL oral suspension

quetiapine
Please read all of 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 pass it on to other people, even if they have the same symptoms as you, because it may 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 Yadina is and what it is used for
2. What you need to know before taking Yadina
3. How to take Yadina
4. Possible side effects
5. How to store Yadina
6. Contents of the pack and other information

1. What Yadina is and what it is used for

Yadina contains a substance called quetiapine. This substance belongs to a group of medicines
called antipsychotics. Yadina can be used to treat several conditions, for example:

• Bipolar depression: when you feel sad. You may feel depressed, guilty, lack energy, have no appetite or be unable to sleep.
• Mania: when you may feel very excited, euphoric, agitated, enthusiastic or hyperactive, or have poor judgment, possibly becoming aggressive or destructive.
• Schizophrenia: when you hear or feel things that do not exist, believe things that are not true, or feel unusually suspicious, anxious, confused, guilty, tense or depressed.

Your doctor may continue to prescribe Yadina even after you start feeling better.

2. What you need to know before taking Yadina

Do not take Yadina:

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

If in doubt, consult your doctor or pharmacist before taking Yadina.
Warnings and precautions
Talk to your doctor or pharmacist before taking Yadina:

• If you suffer from depression or other conditions treated with antidepressants. The use of these medicines together with Yadina may cause serotonin syndrome, a potentially life-threatening condition (see "Other medicines and Yadina").
• if you, or someone in your family, have or have ever had heart problems, such as arrhythmia, weakened heart muscle or inflammation of the heart, or if you are taking medicines that could affect your heart rhythm.
• 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 ever had a seizure (epileptic fit).
• 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 Yadina.
• if you know you have previously had low levels of white blood cells (whether or not caused by other medicines).
• if you are an elderly person with dementia (loss of brain function). In this case, Yadina must not be taken because the group of medicines to which Yadina 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 blood clots, as medicines like this have been associated with blood clot formation.
• if you have or have had a condition in which you stop breathing for short periods during normal nighttime sleep (called "sleep apnea") and are taking medicines that slow down normal brain activity ("depressants").
• if you have or have had a condition that prevents you from completely emptying your bladder (urinary retention), have an enlarged prostate, intestinal obstruction, or increased intraocular pressure. These conditions are sometimes caused by medicines (called "anticholinergics") that affect nerve cell function to treat certain medical conditions.
• if you have a history of alcohol or drug abuse.

Inform your doctor immediately if you experience the following symptoms after taking Yadina:

• A combination of fever, severe muscle stiffness, sweating, or decreased level of consciousness (a disorder 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).
• You have a fast or irregular heartbeat, even at rest, palpitations, breathing problems, 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 result from a very low white blood cell count, which may require discontinuation of treatment with Yadina and/or administration of treatment.
• Constipation accompanied by persistent abdominal pain or constipation that has not responded to treatment, as this could lead to a more severe intestinal obstruction.
• Suicidal thoughts and worsening of your depression If you are depressed, you may sometimes have thoughts of harming yourself or of suicide. These thoughts may increase at the beginning of treatment, as all these medicines take time to work, usually about two weeks, but sometimes longer. These thoughts may also increase if you suddenly stop taking your medicine. You may be more likely to have such thoughts if you are a young adult. Data from clinical trials have shown an increased risk of suicidal thoughts and/or suicidal behaviour in young adults with depression under 25 years of age. If at any time you have thoughts of harming yourself or of suicide, contact your doctor or go to hospital immediately. You may find it helpful to inform a relative or close friend that you suffer from depression and ask them to read this leaflet. You may wish to ask them to alert you if they think your depression is worsening or if they are concerned about changes in your behaviour.

Serious cutaneous adverse reactions (SCARs)
Serious cutaneous adverse reactions (SCARs), which may be potentially life-threatening or fatal, have been reported very rarely during treatment with this medicine. These commonly present as:

• Stevens-Johnson syndrome (SJS), a widespread rash with blisters and peeling of the skin, 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), consisting of flu-like symptoms with rash, fever, swollen glands, and abnormal blood test results (including increased white blood cells (eosinophilia) and liver enzymes)
• Acute Generalized Exanthematous Pustulosis (AGEP), small pustules filled with pus
• Erythema multiforme (EM), skin rash with irregular red, itchy spots

Stop using Yadina if you develop these symptoms and contact your doctor immediately or seek medical assistance.
Weight gain
Weight gain has been observed in patients taking Yadina. You and your doctor should regularly monitor your weight.
Children and adolescents
Yadina is not indicated for use in children and adolescents under 18 years of age.
Other medicines and Yadina
Inform your doctor if you are taking, have recently taken, or might take any other medicines.
Do not take Yadina if you are taking any of the following medicines:

• Some 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:

• Antidepressants. These medicines can interact with Yadina and you may experience symptoms such as involuntary and rhythmic muscle contractions, including muscles controlling eye movement, agitation, hallucinations, coma, excessive sweating, tremor, exaggerated reflexes, increased muscle tone, and body temperature above 38 °C (serotonin syndrome). If such symptoms occur, contact your doctor.

• 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 your heart rhythm, for example, medicines that may cause an electrolyte imbalance (low levels of potassium or magnesium), such as diuretics (medicines that increase urine production) or certain antibiotics (medicines to treat infections).

• Medicines that may cause constipation.

• Medicines (called “anticholinergics”) that affect how nerve cells function in order to treat certain medical conditions.

Do not stop taking any of your medicines before consulting your doctor.
Yadina with food, drinks and alcohol

• Yadina can be taken with or without food.
• Be cautious about the amount of alcohol you consume. This is because the combined effect of Yadina and alcohol may cause drowsiness.
• Do not drink grapefruit juice while taking Yadina. 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, ask your doctor for advice before taking this medicine. You must not take Yadina during pregnancy unless you have discussed it with your doctor. Yadina must not be taken during breastfeeding.
The following symptoms, which may represent withdrawal, may occur in newborns of mothers who have taken Yadina during the third trimester (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 may need to contact your doctor.
Driving and using machines
Quetiapine may cause drowsiness. Do not drive or operate tools or machinery until you know how this medicine affects you.
Yadina contains Sodium Benzoate
This medicine contains 0.3 mg of sodium benzoate per mL.
Yadina contains Sorbitol (E420)
This medicine contains 30 mg of sorbitol per mL.
Sorbitol is a source of fructose. If your doctor has told you that you are intolerant to certain sugars, or if you have been diagnosed with hereditary fructose intolerance, a rare genetic condition in which patients cannot metabolize fructose, talk to your doctor before taking this medicine.
Yadina contains Propylene Glycol (E1520)
This medicine contains 22.5 mg of propylene glycol per mL.
Yadina contains Sodium
This medicine contains less than 1 mmol (23 mg) of sodium per mL, i.e. essentially "sodium-free".
Yadina contains Methyl 4-hydroxybenzoate (E218)
May cause allergic reactions (including delayed reactions).
Effect on urine drug screening tests
If you are undergoing a urine drug test, taking Yadina may cause positive results for methadone or for 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, a more specific test can be performed.

3. How to take Yadina

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
The recommended dose is indicated in section 'How much to take'.

Taking this medicine

• This medicine contains 25 mg of quetiapine in each mL of suspension.
• Take this medicine by mouth. Always shake the bottle for 15 seconds before use.
• Always use the oral syringe or dosing cup provided in the package. Use the syringe for doses equal to or less than 5 mL and the dosing cup for doses greater than 5 mL.
• You may take Yadina with or without food.
• Do not drink grapefruit juice while taking Yadina. It may affect the action of the medicine.
• Do not stop taking the medicine, even if you feel better, unless your doctor tells you to.

Measuring the dose

Instructions for using the syringe (for doses equal to or less than 5 mL):

1. To open the bottle, press the cap down and turn it counterclockwise (Figure 1).
2. Insert the syringe adapter into the neck of the

bottle (Figure 2).

3. Take the syringe and insert it into the opening of the adapter (Figure 2).
4. Turn the bottle upside down (Figure 3).
5. Completely fill the syringe by pulling the plunger down (Figure 4A). Then push the plunger all the way up (all the medicine returns into the bottle). This removes any air bubbles (Figure 4B). Finally, pull the plunger down to the mark corresponding to the dose prescribed by your doctor. The dose is indicated in mL (Figure 4C).
6. Turn the bottle right side up.
7. Remove the syringe from the adapter. Place the tip of the syringe in your mouth and slowly push the plunger in to take the medicine.
8. Wash the syringe with water and let it dry before using it again.
9. Close the bottle with the plastic screw cap, leaving the adapter in the neck of the bottle.
10. The syringe must be used only with the medicine supplied.

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

1. To open the bottle, press the cap down and turn it counterclockwise.
2. Pour the medicine into the dosing cup up to the desired dose mark. For certain doses, you may need to use the dosing cup twice.
3. Wash the dosing cup with water and let it dry before using it again.
4. Close the bottle with the plastic screw cap.

How much to take

• Your doctor will decide your starting dose. The maintenance dose (daily dose) will depend on your condition and individual needs, but will usually be between 150 mg (6 mL) and 800 mg (32 mL).
• Depending on your condition, you will take the medicine once daily, before bedtime, or twice daily.

The table below will help you measure the exact dose prescribed by your doctor:
Dosage equivalence for the syringe:

Note that the total volume of the syringe is 5 mL.
Dose equivalence for the dosing spoon:

Note that the total volume of the dosing spoon is 20 mL.
Liver problems
If you have liver problems, your doctor may adjust the dose.
Elderly
If you are elderly, your doctor may adjust the dose.
Use in children and adolescents
Yadina must not be used in children and adolescents under 18 years of age.
If you take more Yadina than you should
If you take more Yadina than prescribed by your doctor, you may feel drowsy, experience dizziness, or notice an irregular heartbeat. Contact your doctor or the nearest hospital immediately. Take the medicine with you.
If you forget to take Yadina
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 dose.
If you stop taking Yadina
If you suddenly stop taking Yadina, you may have difficulty sleeping (insomnia), feel unwell (nausea), or experience headache, diarrhoea, feel sick (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 disappear over time as treatment with Yadina continues) (may lead to falls).
• Withdrawal symptoms (symptoms that occur when you stop taking Yadina), including inability to sleep (insomnia), feeling unwell (nausea), headache, diarrhoea, feeling sick (vomiting), dizziness, and irritability. A gradual discontinuation over a period of at least 1 or 2 weeks is recommended.
• Weight gain.
• Abnormal muscle movements. These include difficulty initiating a muscular movement, tremor, feeling of restlessness, or muscle rigidity without pain.
• Changes in levels of certain fats (triglycerides and total cholesterol).

Common: may affect up to 1 in 10 people

• Fast heartbeat.
• Sensation of strong, rapid, or irregular heartbeat.
• Constipation, stomach discomfort (indigestion).
• Feeling of weakness.
• 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.
• Speech and language disturbances.
• Suicidal thoughts and worsening of depression.
• Shortness of breath.
• Vomiting (especially in elderly patients).
• Fever.
• Changes in thyroid hormone levels in the blood.
• Reduction in the 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:
  • Men and women may experience breast enlargement and unexpected milk production.
  • Women may experience absent 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 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 the QT interval).
• A 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.
• 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

• A combination of high temperature (fever), sweating, muscle rigidity, 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).
• Breast enlargement and unexpected milk production (galactorrhoea).
• Menstrual disorders.
• Blood clots in 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 experience any of these symptoms, contact a doctor immediately.
• Walking, talking, eating, or other activities while asleep.
• 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 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 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).
• A serious condition with blisters on the skin, mouth, eyes, and genitals (Stevens-Johnson syndrome). See section 2.
• Inappropriate secretion of the hormone that controls urine volume (syndrome of inappropriate antidiuretic hormone secretion, SIADH).
• Muscle fibre damage and muscle pain (rhabdomyolysis).

Not known: frequency cannot be estimated from the available data

• Skin rash with irregular red patches (erythema multiforme). See section 2.
• Rapid appearance of red skin areas with small pustules (small blisters filled with white/yellow fluid called Acute Generalized 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 rash, fever, swollen glands, and abnormal blood test results (including increased white blood cells (eosinophilia) and liver enzymes). See section 2.
• Withdrawal symptoms may occur in newborns of mothers who used Yadina during pregnancy.
• Stroke.
• Heart muscle disorder (cardiomyopathy).
• Inflammation of the heart muscle (myocarditis).
• Inflammation of blood vessels (vasculitis), often with a rash showing small red or purple bumps.

The class of medicines to which Yadina belongs can cause problems with heart rhythm, which can be serious and, in the most severe cases, may be fatal.

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

• Men and women may experience breast enlargement and unexpected milk production.
• Women may experience absent or irregular menstruation.

Your doctor may ask you to have blood tests from time to time.

Additional side effects in 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 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 increased prolactin levels may cause the following conditions:
  • Breast enlargement and unexpected milk production in boys and girls.
  • Absence or irregularity of menstrual cycles in girls.
• Increased appetite.
• Vomiting.
• Abnormal muscle movements. These include difficulty initiating a muscular movement, tremor, feeling of restlessness, or muscle rigidity without pain.
• Increased blood pressure.

Common: may affect up to 1 in 10 people

• Feeling of 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 at 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 Yadina

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after EXP. The expiry date refers to the last day of that month.
Yadina can be used for up to 4 months after first opening the bottle. After 4 months, any unused solution must be discarded. To help remember the 4-month deadline, write down the date of opening in the designated space on the packaging.
Do not store above 30 °C.
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 Yadina contains

• The active substance is quetiapine. Each mL contains 25 mg of quetiapine (as fumarate).
• The other components are: Sodium benzoate (E211), Methyl parahydroxybenzoate (E218), Sodium saccharin (E954), Disodium phosphate (E339), Sorbitol solution 70% (E420), Propylene glycol (E1520), Glycerol (E422), Silicified microcrystalline cellulose, Sodium carmellose (E466), Xanthan gum (E415), Poloxamer 188, Macrogol 400 (E1521), Sucralose (E955), Cherry flavour, Water.

Description of the appearance of Yadina and package contents
Yadina is an off-white oral suspension supplied in glass and PET bottles with a child-resistant plastic cap.
Dosage device: a 5 mL syringe with 0.5 mL graduations and a dosing cup with a capacity of 20 mL (graduated at 2.0 mL, 2.5 mL, 3.0 mL, 4.0 mL, 5.0 mL, 6.0 mL, 7.0 mL, 7.5 mL, 8.0 mL, 9.0 mL, 10.0 mL, 11.0 mL, 12.0 mL, 12.5 mL, 15.0 mL and 20.0 mL).
A plastic bottle adapter.
Pack sizes: 60 mL and 120 mL. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Exeltis Italia S.r.l.
Via Lombardia, 2/A
20068 Peschiera Borromeo (MI)
Italy

Manufacturer
Laboratorios Liconsa S.A.
Avenida De Miralcampo 7
Poligono Industrial Miralcampo
19200 Azuqueca De Henares, Guadalajara
Spain

This medicinal product is authorised in the European Economic Area countries under the
following names:
Sweden: Zenaxel
Austria: Zenaxel
Belgium: Quexima 25 mg/mL suspensie voor oraal gebruik
Quexima 25 mg/mL suspension buvable
Quexima 25 mg/mL Suspension zum Einnehmen
Poland: Kwexyma
Germany: Zenaxel 25 mg/mL Suspension zum Einnehmen
France: Queliva 25 mg/mL, suspension buvable
Italy: Yadina
Finland: Zenaxel
Spain: Zenaxel
Czech Republic: Equilion
Slovakia: Zenaxel
Portugal: Zenaxel
Norway: Zenaxel
Luxembourg: Zenaxel 25 mg/mL suspension buvable
Zenaxel 25 mg/mL Suspension zum Einnehmen