Arzinka

Package leaflet: Information for the user

Arzinka 10 mg/ml oral drops solution

paroxetine
Generic medicine
Please read all of 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.
• This medicine has been prescribed for you personally. Never give it to others. This medicine may be harmful to other people, even if their symptoms are the same as yours.
• If you experience any side effect, including those not listed in this leaflet, inform your doctor. See section 4.

Contents of this leaflet:

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

1. What Arzinka is and what it is used for

Arzinka is a treatment for adults with depression and/or anxiety disorders. The anxiety disorders treated by Arzinka are: obsessive-compulsive disorder (repetitive, obsessive thoughts with uncontrollable behaviour), panic disorder (panic attacks, including those caused by agoraphobia, which is a fear of open spaces), social anxiety disorder (fear or avoidance of social situations), post-traumatic stress disorder (anxiety caused by a traumatic event), and generalized anxiety disorder (a general state of high anxiety or nervousness).
Arzinka belongs to a group of medicines called SSRIs (selective serotonin reuptake inhibitors).
Each person has a substance in the brain called serotonin. People who are depressed or anxious have lower levels of serotonin than others. It is not fully understood how Arzinka and other SSRIs work, but they may be beneficial by increasing the level of serotonin in the brain.
Proper treatment of depression and anxiety disorders is important to help you feel better.
Arzinka is used in adults for the treatment of:

• Depression (major depressive episode).
• Obsessive-compulsive disorder.
• Panic disorder with or without agoraphobia.
• Social anxiety disorder/social phobia (intense fear of any everyday social interaction situation).
• Generalized anxiety disorder.
• Post-traumatic stress disorder.

Talk to your doctor if you do not feel better or if you feel worse.

2. What you should know before taking Arzinka

Do not take Arzinka

• If you have previously had an allergic reaction to paroxetine or to any of the liquid ingredients of this medicine (listed in section 6).
• If you are taking, or have taken within the last two weeks, medicines called monoamine oxidase inhibitors (MAOIs, including moclobemide and methylene blue chloride (methylene blue)). Your doctor will advise you on how to start taking Arzinka after stopping the MAOI.
• If you are taking an antipsychotic medicine called thioridazine or an antipsychotic called pimozide. If either of these applies to you, speak with your doctor before taking Arzinka.

Warnings and precautions
Talk to your doctor or pharmacist before taking Arzinka
If you are taking other medicines (see "Other medicines and Arzinka").
If you have eye, kidney, liver, or heart problems.
If you have epilepsy or have had seizures or panic attacks.
If you have episodes of mania (manic behaviours or thoughts).
If you are undergoing electroconvulsive therapy (ECT).
If you have had bleeding disorders or are taking other medicines that may increase the risk of bleeding (these include medicines used to thin the blood, such as warfarin, antipsychotics such as perphenazine or clozapine, tricyclic antidepressants, medicines used for pain and inflammation called non-steroidal anti-inflammatory drugs – NSAIDs, such as acetylsalicylic acid, ibuprofen, celecoxib, etodolac, diclofenac, meloxicam).
If you are taking tamoxifen for the treatment of breast cancer or fertility problems, Arzinka may make tamoxifen less effective; therefore, your doctor may recommend that you take another antidepressant.
If you have diabetes.
If you are on a low-sodium diet.
If you have glaucoma (increased eye pressure).
If you are pregnant or planning a pregnancy (see Pregnancy, breastfeeding and fertility within this leaflet).
If you are under 18 years of age (see Children and adolescents within this leaflet).
Medicines like Arzinka (so-called SSRIs/SNRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms may persist after stopping treatment.
In such cases, and if you have not already discussed this with your doctor, contact your doctor and ask what to do regarding taking Arzinka.

Children and adolescents
Arzinka must not be used to treat children and adolescents under 18 years of age, as controlled clinical studies have shown that paroxetine is associated with an increased risk of suicidal behaviour and hostility (mainly aggression, oppositional behaviour and anger). Furthermore, in these studies, efficacy was not adequately demonstrated (see section "Use in children and adolescents"). If, based on medical need, a decision is nevertheless made to prescribe treatment, the patient must be closely monitored for the emergence of suicidal symptoms.

Suicidal thoughts and worsening of depression or anxiety disorder
If you are depressed and/or have anxiety disorders, you may sometimes have self-harming or suicidal thoughts. These may increase when you first start taking antidepressants, as these medicines take time to work, usually about two weeks but sometimes longer. You may be more prone to such thoughts:
If you have previously had suicidal or self-harming thoughts.
If you are a young adult. Clinical studies have shown an increased risk of suicidal behaviour in adults under 25 years of age with psychiatric disorders treated with an antidepressant.
If at any time you experience suicidal or self-harming thoughts, contact your doctor or go immediately to hospital.
You may find it helpful to talk to a friend or relative about your depression or anxiety disorder, and you may ask them to read this leaflet. You could ask them to tell you if they think your depression or anxiety is getting worse or if they are concerned about changes in your behaviour.

Important side effects observed with Arzinka
Some patients taking Arzinka develop a condition called akathisia, in which they feel restless and unable to sit still. Other patients develop a condition called serotonin syndrome, which may include some or all of the following symptoms: confusion, restlessness, sweating, tremors, chills, hallucinations (strange visions or sounds), muscle stiffness, sudden muscle jerks, or rapid heartbeat. If you experience any of these symptoms, contact your doctor. For more information on these or other side effects of Arzinka, see section 4, Possible side effects, within this leaflet.
Medicines like Arzinka (so-called SSRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms may persist after stopping treatment.

Other medicines and Arzinka
Some medicines may affect the action of Arzinka or increase the risk of side effects. Arzinka may also affect the action of other medicines. These include:
Medicines called monoamine oxidase inhibitors (MAOIs, including moclobemide and methylene blue chloride). See "Do not take Arzinka" within this leaflet.
Thioridazine or pimozide, antipsychotic medicines. See "Do not take Arzinka" within this leaflet.
Acetylsalicylic acid, ibuprofen, and other medicines called NSAIDs (Non-Steroidal Anti-Inflammatory Drugs) such as celecoxib, etodolac, diclofenac, meloxicam, and rofecoxib, used for pain and inflammation.
The painkillers tramadol and pethidine.
Medicines called triptans such as sumatriptan, used to treat migraine.
Other antidepressants, including other SSRIs, and tricyclic antidepressants such as clomipramine, nortriptyline, and desipramine.
A dietary supplement called tryptophan.
Mivacurium and succinylcholine (used in anaesthesia).
Medicines such as lithium, risperidone, perphenazine, clozapine (called antipsychotics or neuroleptics) used to treat certain psychiatric disorders.
St. John’s wort, a herbal remedy for depression.
Atomoxetine, used to treat attention deficit hyperactivity disorder (ADHD).
Phenobarbital, phenytoin, or carbamazepine, used to treat seizures or epilepsy.
Procyclidine, used to relieve tremor, especially in Parkinson’s disease.
Warfarin or other medicines (called anticoagulants) used to thin the blood.
Propafenone, flecainide, and medicines used for arrhythmias (irregular heartbeat).
Metoprolol, a beta-blocker used to treat high blood pressure and heart disorders.
Pravastatin, used to treat high cholesterol levels.
Rifampicin, used to treat tuberculosis (TB) and leprosy.
Linezolid, an antibiotic.
Fentanyl, used in anaesthesia or for treating chronic pain.
A combination of fosamprenavir and ritonavir, used to treat human immunodeficiency virus (HIV) infection.
Tamoxifen, used to treat breast cancer or fertility problems.

If you are taking, or have recently taken, any medicine from this list, and have not yet discussed it with your doctor, contact your doctor and ask what to do. Your dose may need to be adjusted or you may need to switch to another medicine.
If you are taking any other medicine, including those without a prescription, ask your doctor or pharmacist before taking Arzinka. They will be able to advise you whether taking Arzinka is safe in your case.

Taking Arzinka with alcohol
Do not drink alcohol while taking Arzinka. Alcohol may worsen your symptoms or side effects.

Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, or if you suspect or are planning a pregnancy, consult your doctor or pharmacist before taking this medicine.
In newborns whose mothers took Arzinka during the first months of pregnancy, there is evidence of an increased risk of birth defects, particularly heart defects. In the general population, about 1 in 100 babies is born with a heart defect.
You and your doctor will decide whether it is best for you to gradually discontinue Arzinka during pregnancy. However, depending on your clinical condition, your doctor may advise you to continue taking Arzinka.
If you take Arzinka towards the end of pregnancy, there may be an increased risk of severe vaginal bleeding shortly after delivery, especially if you have a history of bleeding disorders. Your doctor or midwife should be aware that you are taking Arzinka so they can advise you.
Make sure your midwife or doctor knows that you are taking Arzinka. When medicines like Arzinka are taken during pregnancy, particularly during the last three months, they may increase the risk of a serious condition in the baby called persistent pulmonary hypertension of the newborn (PPHN). In PPHN, the blood pressure in the blood vessels between the newborn’s heart and lungs is too high. If you take Arzinka during the last three months of pregnancy, your baby may also experience other symptoms, which usually appear within the first 24 hours after birth.
These symptoms include:
breathing difficulties
bluish, too hot, or too cold skin
blue lips
vomiting or feeding difficulties
lethargy, inability to sleep, or excessive crying
stiff or floppy muscles
tremors, restlessness, or seizures
exaggerated reflexes.
If your baby shows any of these symptoms at birth or if you are concerned about your baby’s health, contact your doctor or midwife, who will be able to assist you.

Breastfeeding
Arzinka may pass into breast milk in very small amounts. If you are taking Arzinka, talk to your doctor before starting breastfeeding. You and your doctor may decide that you can breastfeed while taking Arzinka.

Effect on male fertility
Medicines like Arzinka may reduce sperm quality. Although the impact on fertility is not known, fertility may be impaired in some men while taking Arzinka.

Driving and using machines
Arzinka may cause dizziness, confusion, drowsiness, and visual disturbances. If you experience these side effects, do not drive and do not operate machinery.

Arzinka contains benzoic acid
Benzoic acid may increase jaundice (yellowing of the skin and eyes) in newborns (up to 4 weeks of age).

3. How to take Arzinka

Take Arzinka drops, diluted in water, in the morning with breakfast.
It is important to take the medicine exactly as prescribed by your doctor, who will advise you on the dose
to take when you first start using Arzinka.
Most people begin to feel better after a couple of weeks. If you do not start to feel better after this time,
inform your doctor, who may decide to gradually increase the dose, up to the maximum allowed daily dose.
The usual doses for the different indications are shown in the table below:

Your doctor will inform you about the daily dose and how long you should take the
medicinal product. This may be for several months or longer.
Use in children and adolescents
Arzinka must not be used in children and adolescents under 18 years of age because its efficacy has not been
demonstrated in these age groups. In addition, patients under 18 years of age who take Arzinka have an increased
risk of adverse effects such as suicidal thoughts and self-harming behaviour. If your doctor has prescribed Arzinka
for you (or your child) and you wish to discuss this, please consult your doctor again. In clinical studies with
Arzinka, fewer than 1 in 10 patients under 18 years of age developed increased suicidal thoughts and suicide
attempts, self-harm, hostility, aggression, or irritability, loss of appetite, tremor, abnormal sweating,
hyperactivity (excessive energy), restlessness, emotional changes (including crying and mood changes), and
unexpected bruising or bleeding (e.g. nosebleeds). These studies also showed that the same symptoms occurred in
children and adolescents taking sugar tablets (placebo) instead of Arzinka, although less frequently. In these
studies, some patients under 18 years of age experienced withdrawal effects similar to those seen in adults after
stopping treatment with Arzinka. In addition, fewer than 1 in 10 patients under 18 years of age experienced
stomach ache, nervousness, and emotional changes (including crying, mood changes, self-harm, suicidal thoughts,
and suicide attempts).
Elderly patients
The maximum recommended dose for people aged 65 years and over is 4 ml per day.
Patients with hepatic or renal impairment
If you have severe liver or kidney problems, your doctor may decide that you may need a lower than normal dose.
If you take more Arzinka than you should
If you or someone else takes too many drops of Arzinka, in addition to the symptoms listed in section 4 “Possible
undesirable effects”, you may experience vomiting, dilated pupils, fever, changes in blood pressure, headache,
involuntary muscle contractions, restlessness, anxiety, and a faster than normal heartbeat.
In any case, inform your doctor immediately or go to hospital straight away, taking the medicinal product bottle
with you.
If you forget to take Arzinka
Take the medicine at the same time each day. If you forget to take a dose and remember before going to bed, take
it immediately and continue your treatment as normal the next day. If you only remember during the night or the
following day, do not take the missed dose. You may experience withdrawal effects, but these will disappear once
you have taken your usual dose at the regular time. Do not take a double dose to make up for a forgotten dose.
If you stop taking Arzinka
Do not stop taking Arzinka unless your doctor advises you to do so.
When you stop treatment, your doctor will help you gradually reduce the dose over several weeks or months to
minimise the risk of withdrawal effects. One way to do this is to gradually reduce your Arzinka dose by 10 mg per
week.
Most people find that withdrawal symptoms are mild and disappear spontaneously within two weeks. For some
people, these symptoms may be more severe or last longer. If you experience withdrawal effects when stopping the
drops, your doctor may decide to discontinue the medicine more slowly. If you experience severe withdrawal
effects when stopping Arzinka, contact your doctor. Your doctor may ask you to restart taking the drops and then
discontinue treatment more gradually. Despite withdrawal effects, you will still be able to stop taking Arzinka.
Possible withdrawal effects when stopping treatment
Studies show that 3 out of 10 patients report one or more symptoms when stopping treatment with Arzinka. Some
withdrawal symptoms occur more frequently than others.
Symptoms that may occur in 1 out of 10 people:
Feeling dizzy, unsteady, or off balance.
Tingling sensation, burning sensation, and (less commonly) electric shock-like sensations, even in the head, and
ringing, buzzing, hissing, or other persistent noises in the ear (tinnitus).
Sleep disturbances (disturbing dreams, nightmares, difficulty falling asleep).
Anxiety.
Headache.
Symptoms that may occur in 1 out of 100 people:
Feeling unwell (nausea).
Sweating (including night sweats).
Restlessness or agitation.
Tremor (shaking).
Confusion or disorientation.
Diarrhoea (loose stools).
Increased emotional sensitivity or irritability.
Visual disturbances.
Changes in heart rate (palpitations).
Inform your doctor if you are concerned about these withdrawal effects when stopping
treatment with Arzinka.
If you have any further questions about the use of this medicinal product, ask your doctor or pharmacist.
What to do if you are not improving
Arzinka will not improve your symptoms immediately; all antidepressants require time to take effect. Some people
start to feel better within a couple of weeks, while others need more time. If you have not started to improve after
a couple of weeks, see your doctor, who will advise you on what to do. Some people taking antidepressants feel
worse before they start to improve. Your doctor should review you a couple of weeks after you start treatment.
Inform your doctor if you have not started to improve.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them. Side effects are more likely to occur during the first few weeks of taking Arzinka.
If you experience any of the following side effects during treatment, contact your doctor or go
immediately to hospital.
Uncommon (occurring in 1 out of 100 patients)
Contact your doctor or go to hospital immediately:
If you have bruises without a specific cause or bleeding, including blood in vomit or stools;
If you experience difficulty urinating.
Rare (occurring in 1 out of 1,000 patients)
If you have seizures, contact your doctor or go immediately to hospital.
If you feel restless or unable to sit still, you may have a condition called akathisia. Increasing your dose of Arzinka could worsen these symptoms.
If you feel tired, weak, or confused and have muscle pain, stiffness, or incoordination, this could be due to a rare effect of Arzinka that may lead to low sodium levels in your blood.
Very rare (occurring in 1 out of 10,000 patients)
Allergic reactions to Arzinka, which can be severe. If you develop redness and skin rashes, swelling of the eyelids, face, lips, mouth, or tongue, itching, or difficulty breathing (shortness of breath) or swallowing, and if you feel weak or dizzy leading to collapse or loss of consciousness, contact your doctor or go immediately to the nearest hospital.
If you develop serotonin syndrome. Symptoms include: confusion, restlessness, sweating, shaking, tremors, hallucinations (strange visions or sounds), sudden muscle contractions, or rapid heartbeat. If you have these symptoms, contact your doctor.
Acute glaucoma. If your eyes become painful and you experience blurred vision, contact your doctor.
Not known (frequency cannot be estimated from available data)
Some people have had thoughts of harming themselves or of suicide while taking Arzinka or immediately after stopping treatment (see section 2, What you should know before taking Arzinka).
Severe vaginal bleeding immediately after childbirth (postpartum haemorrhage); see “Pregnancy, breastfeeding and fertility” in section 2 for further information.
If these side effects occur, contact your doctor.

Other possible side effects of lesser severity that may occur during treatment
Very common (occurring in more than 1 out of 10 patients)
Feeling unwell (nausea). Taking the medicine in the morning with breakfast will reduce the likelihood of these symptoms occurring.
Changes in sexual habits or sexual function. For example, absence of orgasm and, in men, abnormal erection and ejaculation.
Common (occurring in 1 out of 10 patients)
Increased level of cholesterol in the blood.
Loss of appetite.
Sleep disturbances (insomnia) or drowsiness.
Abnormal dreams (including nightmares).
Dizziness or shaking (tremors).
Difficulty concentrating.
Headache.
Feeling agitated.
Blurred vision.
Yawning, dry mouth.
Diarrhoea or constipation.
Vomiting.
Weight gain.
Feeling weak.
Sweating.
Uncommon (occurring in 1 out of 100 patients)
Transient increases or decreases in blood pressure, faster than normal heartbeat.
Inability to move, stiffness, shaking, or abnormal movements of the mouth and tongue.
Dilated pupils.
Skin rashes.
Confusion.
Hallucinations (strange visions and sounds).
Drop in blood pressure upon changing from a lying or sitting position to a standing position, with dizziness, feeling faint, and possible visual disturbances.
Inability to urinate (urinary retention) or involuntary and uncontrollable loss of urine (urinary incontinence).
If you are a diabetic patient, you may notice changes in your blood glucose levels during treatment with Arzinka. In such cases, consult your doctor, who will explain how to adjust the dosage of insulin or other medications you are using for diabetes treatment.
Rare (occurring in 1 out of 1,000 patients)
Abnormal production of milk in the mammary glands of men and women.
Slowed heartbeat.
Liver changes detected by specific blood tests for liver function.
Panic attacks.
Manic behaviour or thoughts.
Feeling detached from your body (depersonalisation).
Anxiety.
Irresistible urge to move the legs (Restless Legs Syndrome).
Joint or muscle pain.
Very rare (occurring in 1 out of 10,000 patients)
Liver problems causing yellowing of the skin or whites of the eyes.
Syndrome of inappropriate antidiuretic hormone secretion (SIADH), a condition in which the body retains excess water and sodium concentration (salt) decreases, due to improper chemical signals. Patients with SIADH may become seriously ill or may have no symptoms at all.
Water and fluid retention that may cause swelling of the arms or legs.
Sensitivity to sunlight.
Skin rash, which may present with blisters and appear as small targets (dark central spots surrounded by a lighter area, with a dark ring around the edge), known as erythema multiforme.
A widespread skin rash with blisters and peeling of the skin, particularly around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome).
A widespread skin rash with blisters and peeling of the skin over a large part of the body surface (toxic epidermal necrolysis).
Prolonged and painful erection of the penis.
Unexpected bleeding, for example bleeding gums, blood in urine or vomit, or unexpected bruising or blood vessel rupture (rupture of veins).
Some patients have reported ringing, buzzing, hissing, or other persistent noises in the ear (tinnitus) while taking Arzinka.
An increased risk of bone fractures has been observed in patients taking this type of medicine.
Frequency not known (frequency cannot be estimated from available data)
Aggression. Suicidal ideation, suicidal behaviour.
Teeth grinding.
Inflammation of the colon (causing diarrhoea).

Additional side effects in children and adolescents:
Common (may affect up to 1 in 10 people)

• Increased suicidal thoughts and suicide attempts.
• Deliberate self-harm.
• Hostile, aggressive, or withdrawn behaviour.
• Loss of appetite.
• Tremor.
• Abnormal sweating.
• Hyperactivity (excessive energy).
• Agitation.
• Changes in emotions (including crying and mood changes).
• Unusual bruising or bleeding (such as nosebleeds).
  Effects due to discontinuation similar to those observed in adults after stopping treatment with Arzinka.
  Stomach ache.
  Feeling nervous and changes in emotions (including crying and mood changes, self-harm attempts, suicidal thoughts and suicide attempts).

If you have any concerns while taking Arzinka, talk to your doctor and/or pharmacist, who will be able to advise you.

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 Arzinka

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the bottle and carton after
Exp. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Store in the original packaging.
Period of validity after first opening of the bottle: 2 months.
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 Arzinka contains

• The active substance is paroxetine (10 mg/ml) as hemihydrochloride. Each ml of liquid (1 ml corresponds to 14 drops) contains 10 mg of paroxetine.
• The other components are: povidone K30, benzoic acid (E210), sucralose, curcumin 8% (E100), natural orange/lemon flavour, purified water.

Description of the appearance of Arzinka and contents of the pack
Arzinka 10 mg/ml is a clear yellow liquid.
It is available in a 60 ml amber glass bottle with a tamper-evident screw cap, child-resistant closure and dropper.
Marketing Authorization Holder
Laboratorio Farmaceutico CT S.r.l.
Via Dante Alighieri, 71
18038 Sanremo (IM)
Italy
Manufacturer
Doppel Farmaceutici S.r.l.
Via Volturno, 48
20089 Quinto de’ Stampi – Rozzano (MI)
Italy
Vamfarma S.r.l.
Via Kennedy, 5
26833 Comazzo (LO)
Italy
Doppel Farmaceutici S.r.l.
Via Martiri delle Foibe, 1
29016 Cortemaggiore (PC)
Italy