SERESTILL 10 mg /Ml Oral Drops, Solution

Содержание инструкции

1. SERESTILL 10 mg/ml oral drops solution
   1. WHAT IS SERESTILL AND WHAT IT IS USED FOR
   2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE SERESTILL
2. SERESTILL may pass in very small quantities into breast milk. If you are taking
   1. HOW TO TAKE SERESTILL
   2. POSSIBLE SIDE EFFECTS
   3. HOW TO STORE SERESTILL
   4. CONTENTS OF THE PACK AND OTHER INFORMATION

SERESTILL 10 mg/ml oral drops solution

paroxetine

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

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor.
• This medicine has been prescribed only for you. Do not give it to other people, even if their symptoms are the same as yours, as it could be dangerous.
• If any side effects occur, including those not listed in this leaflet, tell your doctor. See section 4.

Contents of this leaflet:

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

1. WHAT IS SERESTILL AND WHAT IT IS USED FOR

SERESTILL is a treatment for adults with depression and/or anxiety disorders. The anxiety disorders for which treatment with SERESTILL is indicated are the following: obsessive compulsive disorder (repetitive, obsessive thoughts with uncontrollable behavior), panic disorder (panic attacks, including those caused by agoraphobia, i.e. 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 (generally feeling very anxious or nervous).
SERESTILL belongs to the group of drugs called SSRIs (selective serotonin reuptake inhibitors).
Everyone has a substance in their brain called serotonin. People who are depressed or anxious have lower levels of serotonin than others. It is not fully understood how SERESTILL and other SSRIs work, but they may be helpful by increasing the level of serotonin in the brain.
Proper treatment of depression and anxiety disorders is important to help you feel better.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE SERESTILL

Do not take SERESTILL:

• If you are allergic to paroxetine or any of the other ingredients of this medicine (listed in section 6)
• If you are taking medicines called monoamine oxidase inhibitors (MAOIs including moclobemide and methylthioninium chloride (methylene blue)), or if you have taken them in the last two weeks. Your doctor will tell you how you should start taking SERESTILL once you have stopped taking the MAOI.
• If you are taking an antipsychotic called thioridazine or an antipsychotic called pimozide.
• If any of these applies to you, talk to your doctor before taking SERESTILL.

Warnings and precautions
Talk to your doctor or pharmacist before taking SERESTILL

• If you are taking other medicines (see “Other medicines and SERESTILL”).
• If you have kidney, liver or heart problems.
• If you have epilepsy or have had fits or convulsions.
• If you have episodes of mania (manic behaviours or thoughts).
• If you are having electroconvulsive therapy (ECT).
• If you have had bleeding in the past or are taking other medicines that can 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 or NSAIDs, such as acetylsalicylic acid, ibuprofen, celecoxib, etodolac, diclofenac, meloxicam) or if you are pregnant (see "Pregnancy, breastfeeding and fertility");.
• If you are taking tamoxifen for the treatment of breast cancer or for fertility problems, SERESTILL may make tamoxifen less effective, so your doctor may recommend you take another antidepressant.
• If you have diabetes.
• If you are on a low sodium diet.
• If you have glaucoma (increased pressure in the eye).
• If you are pregnant or planning to become pregnant (see within this leaflet Pregnancy, breastfeeding and fertility).
• If you are under 18 years old (see Children and adolescents under 18 years, within this leaflet)

In these cases, and if you have not already discussed it with your doctor, go back to your doctor and ask what to do
regarding taking SERESTILL.

Children and adolescents under 18 years
SERESTILL should not be used in children and adolescents under 18 years of
age.
Also, patients under 18 years have an increased risk of side effects such as attempts
at suicide, suicidal thoughts and hostility (mainly aggression, oppositional behaviour
and anger) when taking SERESTILL. If your doctor has prescribed SERESTILL for you (or for your
child) and you want to talk about it, go back to your doctor. You should tell your doctor if any
of the above symptoms occur or worsen when you (or your child) are taking SERESTILL.
Also, the effects on long-term growth, maturation and cognitive and
behavioural development related to SERESTILL have not yet been demonstrated in this age group.
In studies with SERESTILL in patients under 18 years, common side effects that have
affected less than 1 child/adolescent in 10 were: an increase in suicidal thoughts and
attempts, deliberately hurting themselves, hostile, aggressive or unfriendly attitude,
loss of appetite, tremors, abnormal sweating, hyperactivity (having too much energy), agitation,
change in emotions (including crying and changes in mood) and unusual bruising or bleeding
(such as nosebleeds). These studies also showed that the same symptoms
affected children and adolescents who took sugar pills (placebo) instead of
SERESTILL, although they were observed less often.
In such studies conducted in patients under 18 years, some patients experienced
discontinuation symptoms after stopping SERESTILL. These effects were mostly similar to those
observed in adults after stopping SERESTILL (see within this leaflet Paragraph
3, How to take SERESTILL). Also, patients under 18 years commonly (in less than 1 in 10 cases) experienced stomach pain, feeling nervous and
changes in emotions (including crying, changes in mood, attempts to hurt themselves,
suicidal thoughts and attempts)

Suicidal thoughts and worsening of depressive or anxiety disorders
If you are depressed and/or have anxiety disorders, you may sometimes have thoughts of self-harm or suicide. 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 likely to have these thoughts:

• If you have had suicidal thoughts or self-harmed before.
• If you are a young adult. Clinical studies have shown an increased risk of suicidal behaviour in adults under 25 years with psychiatric disorders treated with an antidepressant. If at any time you have suicidal thoughts or self-harming thoughts, contact your doctor or go to hospital immediately. You may find it helpful to talk to a friend or relative about your depression or anxiety

tell them if they think your depression or anxiety is getting worse or if they are worried about
changes in your behaviour.

Important unwanted effects observed with SERESTILL
Some patients taking SERESTILL experience what is called akathisia, that is
they feel restless and as if they cannot sit or stand still. Other patients
experience what is called serotonin syndrome or neuroleptic malignant syndrome,
that is, they may have some or all of the following symptoms: feeling very agitated or irritable,
feeling confused, feeling restless, feeling hot, sweating, trembling, chills, hallucinations (seeing or hearing strange things), muscle rigidity, sudden muscle contractions or
fast heartbeat. The severity can increase, leading to loss of consciousness. If you notice any
of these symptoms, contact your doctor. For more information on these or other side
effects of SERESTILL, see section 4, Possible side effects, within this
leaflet.
Medicines like SERESTILL (so-called selective serotonin reuptake inhibitors
(SSRIs)) can cause symptoms of sexual dysfunction (see section 4). In some cases, these
symptoms have continued after stopping treatment.

Other medicines and SERESTILL
Some medicines can affect the action of SERESTILL or make unwanted effects
more likely. SERESTILL can also affect the action of other medicines. These include:

• Medicines called monoamine oxidase inhibitors (MAOIs, including moclobemide and methylthioninium chloride (methylene blue)).. See “Do not take SERESTILL” within
• Thioridazine or pimozide, antipsychotic medicines. See “Do not take SERESTILL” within
• Acetylsalicylic acid, ibuprofen and other medicines called NSAIDs (Non-Steroidal Anti-Inflammatory Drugs) such as celecoxib, etodolac, diclofenac, meloxicam and refecoxib, used for pain and inflammation.
• Tramadol, buprenorphine or pethidine, pain relievers
• 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 some psychiatric disorders.
• St John's Wort a herbal remedy for depression.
• Atomoxetine used to treat attention deficit and hyperactivity disorder (ADHD).
• Phenobarbital, phenytoin or carbamazepine used to treat convulsions 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 conditions.
• Pravastatin, used to treat high cholesterol levels.
• Rifampicin used to treat tuberculosis (TB) and leprosy.
• Linezolid an antibiotic.
• Fentanyl, used in anaesthesia or to treat chronic pain.
• A combination of fosamprenavir and ritonavir, used to treat Human Immunodeficiency Virus (HIV) infection.
• Tamoxifen, used for the treatment of breast cancer or for fertility problems.

If you are taking any medicine from this list, and you have not already discussed it with your doctor,
go back to your doctor and ask what to do. You may need to change the dose or change
medicine.

If you are taking any other medicine, even those available without a prescription, ask your
doctor or pharmacist before taking SERESTILL. They will be able to tell you if taking
SERESTILL is safe in these cases.

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

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, ask your doctor or
pharmacist for advice before taking this medicine. In newborns whose mothers had taken SERESTILL during the first months of pregnancy, there has been evidence of
an increased risk of birth defects, particularly heart defects. In the general population, about 1 baby in 100 is born with a heart defect. This event increases to 2 babies in 100
in mothers who have taken SERESTILL.
You and your doctor will decide whether it is better for you to switch to another treatment or gradually stop
taking SERESTILL during pregnancy. However, based on your clinical
condition, your doctor may suggest that it is better for you to continue taking SERESTILL.
If you take SERESTILL near the end of pregnancy, there may be an increased risk
of heavy vaginal bleeding shortly after delivery, especially if you suffer from bleeding disorders.
Inform your treating doctor or midwife/obstetrician that you are taking SERESTILL so
that they can advise you on what to do..

Make sure your midwife or doctor knows that you are taking SERESTILL.
When medicines like SERESTILL are taken during pregnancy, particularly during
the last three months of pregnancy, they can increase the risk in the baby of a serious condition,
called persistent pulmonary hypertension of the newborn (PPHN). In PPHN the blood pressure
in the blood vessels between the baby's heart and lungs is too high. If you take SERESTILL during
the last three months of pregnancy, your baby may also experience other symptoms that usually
occur during the first 24 hours after birth.
These symptoms include:

• Breathing problems.
• Bluish skin or too warm or too cold.
• Blue lips.
• Vomiting or difficulty feeding.
• Tiredness, inability to sleep or widespread crying.
• Stiff or floppy muscles.
• Tremors, nervousness or convulsions.
• Exaggerated reflexes

If your baby develops any of these symptoms at birth or you are worried about your baby's health,
contact your doctor or midwife who will be able to assist you.

SERESTILL may pass in very small quantities into breast milk. If you are taking

SERESTILL, consult your doctor and talk to them before starting breastfeeding. You and your
doctor may decide that you can breastfeed while taking SERESTILL.
Paroxetine has shown to reduce sperm quality in animal studies. Theoretically,
this could have effects on fertility, but an impact on human fertility has not been observed so far.

Driving and operating machinery
SERESTILL can cause dizziness, confusion, drowsiness and visual disturbances. If you experience
these side effects, do not drive and do not operate machinery.

SERESTILL contains

• This product contains sucrose. If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine. It may be harmful to your teeth.
• This medicine contains 26.4 mg / ml of alcohol (ethanol) in each ml which is equivalent to 3.3% v / v. Each 2 ml dose (20 mg of paroxetine) contains 52.8 mg of ethanol and each 6 ml dose (60 mg of paroxetine) contains 158.4 ml of ethanol. The amount in the 1 ml dose of this medicine is equivalent to less than 1 ml of beer or 0.3 ml of wine (6 ml are equivalent to 4 ml of beer or 1.6 ml of wine). The small amount of alcohol in this medicine will not produce significant effects.
• This medicine contains 0.001 g of benzoate salt per ml equivalent to 0.002 g/2 ml (20 mg of paroxetine) or 0.006 g/6 ml (60 mg of paroxetine). Benzoate salt may increase jaundice (yellowing of the skin and eyes) in newborns up to 4 weeks of age.
• This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially ‘sodium-free’.
• This product does not contain gluten and can be taken by people with celiac disease.

3. HOW TO TAKE SERESTILL

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

Your doctor will inform you about the daily dose and for how long you will need to take the
medicine. It may be for several months or more.

Elderly patients
The maximum dose allowed for people over 65 years of age is 4 ml per day.

Patients with liver or kidney problems
If you have severe liver or kidney problems, your doctor may decide that you may need a
lower dose than usual.

If you take more SERESTILL than you should
Do not take more medicine than recommended by your doctor.If you or someone else takes
too many drops of SERESTILL, in addition to the symptoms listed in Section 4 “POSSIBLE SIDE
EFFECTS” you may experience vomiting, dilated pupils, fever, changes in blood
pressure, headache, involuntary muscle contractions, agitation, anxiety and a faster
heartbeat than normal.
In any case, inform your doctor or go to hospital immediately, bringing the medicine bottle with you.

If you forget to take SERESTILL
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 therapy normally the next day. If you
only remember during the night or the next day, do not take the missed dose. You may experience
withdrawal effects, but these disappear after you have taken the usual dose at the usual time.
Do not take a double dose to make up for a missed dose.

What to do if you are not improving
STILIDEN will not improve your symptoms immediately, all antidepressants need
time to work. Some people start to feel better within a couple of weeks, others need
more time. If you have not started to improve after a couple of weeks, see your doctor who will
tell you what to do. Some people who take antidepressants feel worse before they improve.
Your doctor should review you a couple of weeks after you have started treatment.
Tell your doctor if you have not started to improve.

If you stop taking SERESTILL
Do not stop taking SERESTILL until your doctor advises you to
When you stop treatment, your doctor will help you to reduce the dose slowly over
several weeks or months to reduce the risk of withdrawal effects. One way to do this is
to gradually reduce the dose of SERESTILL you take 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 you stop taking the drops, your doctor may
decide to stop the drug more slowly. If you experience severe withdrawal effects when
you stop taking SERESTILL, see your doctor. Your doctor may ask you to
restart taking the drops and stop treatment more slowly. Despite withdrawal effects, you will still be able to stop SERESTILL.

Possible withdrawal effects when stopping treatment
Studies show that 3 out of 10 patients report one or more symptoms when stopping treatment with
SERESTILL. Some withdrawal symptoms occur more frequently than others.

Common side effects that may affect up to 1 in 10 people:

• Feeling of dizziness, instability or loss of balance.
• Sensation of tingling, burning sensation and (less commonly) electric shock sensation, also in the head and ringing, buzzing, whistling, tinkling or other persistent noises in the ears (tinnitus).
• Sleep disturbances (disturbed dreams, nightmares, difficulty falling asleep).
• Anxiety.
• Headache. Uncommon side effects that may affect 1 in 100 people:
• Feeling unwell (nausea).
• Sweating (including night sweats).
• Restlessness or agitation.
• Tremors (shaking).
• Confusion or disorientation.
• Diarrhea (loose stools).
• Increased emotionality or irritability.
• Visual disturbances.
• Changes in heartbeat (palpitations).

Tell your doctor if you are worried about these withdrawal effects when you stop
treatment with SERESTILL.
If you have any questions about the use of this medicine, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects are more likely to occur during the first few weeks of
treatment with SERESTILL.

If you experience any of the following side effects during treatment, contact your doctor or go
to hospital immediately.
Uncommon, may affect up to 1 in 100 people

• If you develop bruises for no specific reason or bleeding, including blood in your vomit or stools. Contact your doctor or go immediately to the nearest hospital
• If you have difficulty urinating. Contact your doctor or go immediately to the nearest hospital Rare, may affect up to 1 in 1,000
• If you have convulsions. Contact your doctor or go immediately to the nearest hospital
• If you feel restless or are unable to sit or stay still, you may have what is called akathisia. Increasing your dose of SERESTILL may worsen these symptoms. Contact your doctor.
• If you feel tired, weak or confused and have muscle pain, stiffness or incoordination, this may be due to a rare effect of SERESTILL that can lead to a deficiency of sodium in your blood. Contact your doctor.

Very rare, may affect up to 1 in 10,000

• Allergic reactions to SERESTILL, 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 with resulting collapse or loss of consciousness, contact your doctor or go immediately to the nearest hospital.
• If you have some or all of the following symptoms, you may have what is called serotonin syndrome or neuroleptic malignant syndrome. The symptoms include: feeling of great agitation or irritability, feeling confused, feeling restless, feeling hot, sweating, tremors, chills, hallucinations (strange visions or sounds), muscle stiffness, sudden muscle contractions or a racing heartbeat. The severity can increase, leading to loss of consciousness. If you have these symptoms, contact your doctor.
• Acute glaucoma If your eyes become painful and you have blurred vision, contact your doctor.

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

• Some people have had thoughts of harming themselves or committing suicide while taking SERESTILL or shortly after stopping treatment (see section 2, What you need to know before you take SERESTILL).
• Some people have shown aggression during treatment with Serestill
• Heavy vaginal bleeding shortly after childbirth (postpartum hemorrhage), see section 2 "Pregnancy, breastfeeding and fertility" for more information. If these side effects occur, contact your doctor.

If these side effects occur, contact your doctor.

Other possible side effects of minor severity that may occur during treatment
Very common, may affect more than 1 in 10

• Feeling unwell (nausea). Taking the medicine in the morning with breakfast will reduce the possibility of these symptoms occurring.
• Changes in sexual drive or sexual function. For example, lack of orgasm and, in men, abnormal erection and ejaculation.

Common,may affect up to 1 in 10

• Increased cholesterol levels in the blood.
• Loss of appetite.
• Sleep disturbances (insomnia) or drowsiness.
• Strange dreams (including nightmares).
• Dizziness or shaking (tremors).
• Difficulty concentrating.
• Headache.
• Feeling agitated.
• Blurred vision.
• Yawning, dry mouth.
• Diarrhea or constipation.
• Vomiting.
• Weight gain.
• Feeling unusually weak.
• Sweating.

Uncommon, may affect up to 1 in 100

• Temporary increase in blood pressure or temporary decrease in blood pressure after moving from a lying or sitting position to an upright position, with dizziness, lightheadedness and possible visual disturbances.
• Faster heartbeat than normal.
• Inability to move, stiffness, shaking or abnormal movements of the mouth and tongue.
• Pupil dilation.
• Skin rashes.
• Itching
• Confusion.
• Hallucinations (strange visions and sounds).
• Inability to urinate (urinary retention) or involuntary loss of urine (urinary incontinence).
• If you are a diabetic patient, you may notice a change in your blood glucose levels during the administration of SERESTILL. In these cases, consult your doctor, who will explain how to adjust the dosage of insulin or other medications you are using to treat diabetes.

Rare, may affect up to 1 in 1,000

• Abnormal production of milk in the mammary glands of men and women.
• Slowed heartbeat.
• Changes in liver function as evidenced by specific liver blood tests.
• Panic attacks.
• Manic behavior or thoughts.
• Feeling detached from one's body (depersonalization).
• Anxiety.
• Irresistible urge to move the legs (Restless Legs Syndrome).
• Joint or muscle pain.
• Increase in the blood of a hormone called prolactin.
• Menstrual cycle disorders (including heavy or irregular periods, bleeding between periods, and absence or delay of periods).

Very rare, may affect up to 1 in 10,000

• Liver problems that cause yellowing of your skin or the whites of your eyes.
• Syndrome of inappropriate antidiuretic hormone secretion (SIADH) which is a condition in which the body develops an excess of water and a decrease in the concentration of sodium (salt), following improper chemical signals. Patients with SIADH may become seriously ill or have no symptoms.
• Fluid and liquid retention that can cause swelling of the arms or legs.
• Sensitivity to sunlight.
• Skin rash, which may appear with blisters and resemble small targets (dark central spots surrounded by a lighter area, with a dark ring around the edge) called erythema multiforme
• A widespread skin rash with blisters and peeling skin, especially around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome)
• A widespread skin rash with blisters and peeling skin on a large area of the body surface (toxic epidermal necrolysis)
• Continuous and painful erection of the penis.
• Unexpected bleeding for example bleeding gums, blood in the urine or vomit or the appearance of unexpected bruises or rupture of blood vessels (rupture of veins).
• Some patients have complained of ringing, whistling, hissing, tingling or other persistent noises in the ear (tinnitus) when taking SERESTILL.
• An increased risk of bone fractures has been observed in patients taking this type of medication.

Frequency not known (frequency cannot be estimated from the available data)
Teeth grinding
Inflammation of the colon (causing diarrhea)
If you have any concerns while taking SERESTILL, talk to your doctor and/or pharmacist
who will be able to advise you.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, please tell your
doctor. You can also report side effects directly through 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 SERESTILL

• 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 package after EXP. The expiry date refers to the last day of the month.
• After the first opening of the bottle, the oral solution is valid for 30 days for the 30 ml bottle and 60 days for the 60 ml bottle.
• Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What SERESTILL contains

• The active ingredient is paroxetine as hydrochloride.
• The other excipients are: hydroxypropyl betadex, sucrose, anise flavour (anethole, water, ethanol), sodium benzoate E211, purified water, 1N hydrochloric acid. Description of the appearance of SERESTILL and contents of the packEach carton contains a bottle of 30 ml or 60 ml and a graduated pipette. Each ml of liquid (20 drops) contains 10 mg of paroxetine. Marketing Authorisation Holder and ManufacturerChemi S.p.A - Via dei Lavoratori 54 - 20092 Cinisello Balsamo (MI) Tel: +39.02.64431 Fax: +39.02.6128960 e-mail: [email protected]

Distributor for sales
Farmaceutici CABER S.r.l.
Via del Mare n. 36
00071 Pomezia (RM)

Manufacturer and final control
Italfarmaco S. A.
28108 Alcobendas (Madrid) (E), San Rafael, 3 – Polig. Industrial de Alcobendas
Tel: +39.02.64431
Fax: +39.02.644346
This medicinal product is authorised in the Member States of the European Community with the following
names:
Italy Serestill