Seroxat

Patient Information Leaflet

Warning! Keep the leaflet. Information on the immediate packaging in a foreign language.
Seroxat, 20 mg, film-coated tablets
Paroxetinum
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet to be able to read it again if necessary.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not give it to others. The medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents

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

1. What Seroxat is and what it is used for

Seroxat is used in the treatment of adults with depression and (or) anxiety disorders.
Anxiety disorders treated with Seroxat include: obsessive-compulsive disorder (recurring, obsessive thoughts with uncontrollable behaviors), panic disorder (panic attacks, including those caused by agoraphobia, which is fear of open spaces), social phobia (fear or avoidance of social situations), post-traumatic stress disorder (anxiety caused by a traumatic event), and generalized anxiety disorder (generalized feelings of worry or nervousness).
Seroxat belongs to a group of medicines called selective serotonin reuptake inhibitors (SSRIs). The exact way in which Seroxat and other SSRIs work is not fully understood, but they may increase the levels of serotonin in the brain. Proper treatment of depression and anxiety disorders is important for the patient to feel better.

2. Important information before taking Seroxat

When not to take Seroxat:

• if the patient is taking medicines known as monoamine oxidase inhibitors (MAO inhibitors, including moclobemide and methylene blue chloride (methylene blue)) or has taken them within the last two weeks. The doctor will advise the patient on how to start taking Seroxat after stopping MAO inhibitors.
• if the patient is taking antipsychotic medicines such as thioridazine or pimozide.
• if the patient is allergic to paroxetine or any of the other ingredients of this medicine (listed in section 6). If any of the above situations apply to the patient, they should contact their doctor and must not take Seroxat.

Warnings and precautions
Before starting to take Seroxat, discuss the following with your doctor or pharmacist:

• Is the patient taking any other medicines? (See: Seroxat with other medicines, later in this leaflet)?
• Is the patient taking tamoxifen for the treatment of breast cancer? Seroxat may reduce the effectiveness of tamoxifen, and therefore the treating doctor may recommend that the patient use another antidepressant.
• Does the patient have problems with the kidneys, liver, or heart?
• Does the patient have abnormal heart conduction on electrocardiogram (ECG), known as QT prolongation?
• Does the patient have a family history of QT prolongation, heart disease such as heart failure, slow heart rate, or low potassium or low magnesium levels?
• Does the patient have epilepsy or has the patient had seizures in the past?
• Has the patient ever experienced episodes of mania (excessively active behaviour or racing thoughts)?
• Is the patient receiving electroconvulsive therapy?
• Has the patient had bleeding problems in the past, or is the patient taking other medicines that may increase the risk of bleeding (including blood-thinning medicines such as warfarin, antipsychotics such as perphenazine or clozapine, tricyclic antidepressants, or pain and anti-inflammatory medicines known as non-steroidal anti-inflammatory drugs (NSAIDs), such as acetylsalicylic acid, ibuprofen, celecoxib, etodolac, diclofenac, meloxicam)?
• Does the patient have diabetes?
• Is the patient on a low-sodium diet?
• Does the patient have glaucoma (increased pressure in the eye)?
• Is the patient pregnant or planning to become pregnant? (See: Pregnancy, breastfeeding and effect on fertility, later in this leaflet)
• Is the patient under 18 years of age? (See: Children and adolescents under 18 years of age, later in this leaflet)

If the answer is YES to any of the above questions and the patient has not yet contacted
their doctor, they should go back to their doctor and ask how to take Seroxat.
Children and adolescents under 18 years of age
Seroxat must not be used in children and adolescents under 18 years of age. Patients under 18
years of age are at increased risk of adverse effects such as suicidal attempts, suicidal thoughts, and
hostility (particularly aggression, defiant behaviour, and symptoms of anger) while taking Seroxat. If
the doctor has prescribed Seroxat for a patient under 18 years of age and there are any doubts, the
patient should contact their doctor. If any of these symptoms occur or worsen during treatment with
Seroxat, the doctor must be informed. Furthermore, long-term data on safety with regard to growth,
maturation, and cognitive and behavioural development in this age group are currently lacking.
In clinical trials of Seroxat in patients under 18 years of age, common adverse effects occurring in
less than 1 in 10 patients were: increased frequency of suicidal thoughts and suicide attempts,
intentional self-harm, hostility, aggressive or hostile behaviour, loss of appetite, tremor, abnormal
sweating, excessive activity (displaying excess energy), restlessness, emotional lability (including
crying and mood swings), and unusual bruising or bleeding (such as nosebleeds).
These trials also showed that such symptoms occurred, although less frequently, in children and
adolescents taking placebo (sugar pills) instead of Seroxat.
In some patients under 18 years of age in these trials, symptoms related to discontinuation of Seroxat
occurred. These symptoms were very similar to those observed in adults after stopping Seroxat (see
section 3). In addition, in patients under 18 years of age, abdominal pain, feeling of agitation, and
emotional lability (including crying, mood swings, self-harm attempts, suicidal thoughts, and suicide
attempts) also occurred frequently (in less than 1 in 10 patients).
Suicidal thoughts and worsening of depression or anxiety disorder symptoms
Patients with depression and (or) anxiety disorders may sometimes experience thoughts of self-harm
or suicidal thoughts. These may increase at the beginning of treatment with antidepressants, as it may
take some time, usually about two weeks, before the medicines start to work, and sometimes even
longer.
The patient may be more likely to have such thoughts if:

• the patient previously had suicidal thoughts or thoughts of self-harm,
• the patient is a young adult. Clinical trials have shown an increased risk of suicidal behaviour in adults (under 25 years of age) with psychiatric disorders who were treated with antidepressants. If the patient ever experiences thoughts of self-harm or suicide, they must contact their doctor or the nearest hospital emergency department immediately. It may be helpful to inform a relative or friend about the depression or anxiety disorder and ask them to read this leaflet. The patient may ask them to inform the patient if they notice that the depression or anxiety disorder worsens or if there are worrying changes in their behaviour.

Important adverse effects observed during treatment with Seroxat
In some patients taking Seroxat, symptoms called akathisia may develop.
They then feel restless and unable to sit or stand still. In other patients, a condition known as
serotonin syndrome or neuroleptic malignant syndrome may develop, in which patients experience
some or all of the following symptoms: feeling highly agitated or restless, confusion, anxiety, fever,
sweating, trembling, chills, hallucinations (strange visions or hearing strange sounds), muscle
rigidity, sudden muscle contractions, or rapid heartbeat. Symptoms may worsen, leading to loss of
consciousness. If the patient notices any of these symptoms, they should contact their doctor. More
information on these or other adverse effects of Seroxat is provided in section 4.
Medicines such as Seroxat (so-called SSRIs) may cause sexual dysfunction (see section 4). In some
cases, these symptoms persisted after stopping treatment.
Seroxat with other medicines
Some medicines may affect the action of Seroxat or increase the risk of adverse effects. Seroxat may
also affect the action of other medicines. These include:

• medicines known as monoamine oxidase inhibitors (MAO inhibitors, including moclobemide and methylene blue chloride (methylene blue)) – see section: When not to take Seroxat;
• medicines known to increase the risk of changes in electrical activity of the heart (e.g. antipsychotics such as thioridazine or pimozide) – see section: When not to take Seroxat;
• acetylsalicylic acid, ibuprofen or other medicines known as non-steroidal anti-inflammatory drugs (NSAIDs), such as celecoxib, etodolac, diclofenac and meloxicam, used for the treatment of pain and inflammatory conditions;
• tramadol, buprenorphine and pethidine, painkillers;
• buprenorphine in combination with naloxone, used in opioid dependence substitution therapy;
• medicines known as triptans, such as sumatriptan, used for the treatment of migraine;
• other antidepressants, known as SSRIs and tricyclic antidepressants, such as clomipramine, nortriptyline and desipramine;
• the dietary supplement called tryptophan;
• mivacurium and suxamethonium (used for general anaesthesia);
• medicines such as lithium, risperidone, perphenazine, clozapine (known as antipsychotics) used for the treatment of certain psychiatric disorders;
• fentanyl, a medicine used during anaesthesia and for the treatment of chronic pain;
• the combination of fosamprenavir and ritonavir, used for the treatment of human immunodeficiency virus (HIV) infection;
• St John’s wort, used as an adjunct in the treatment of depression;
• phenobarbital, phenytoin, sodium valproate or carbamazepine used for the treatment of seizures or epilepsy;
• atomoxetine, used for the treatment of attention deficit hyperactivity disorder (ADHD);
• procyclidine, used for the treatment of tremor, particularly in Parkinson’s disease;
• warfarin or other medicines (known as anticoagulants) used to thin the blood;
• propafenone, flecainide and medicines used for the treatment of irregular heartbeat;
• metoprolol, a beta-blocker used for the treatment of high blood pressure and heart problems;
• pravastatin, used for the treatment of elevated cholesterol levels;
• rifampicin, used for the treatment of tuberculosis and acne;
• linezolid – an antibiotic;
• tamoxifen, used for the treatment of breast cancer.

If the patient is currently taking or has recently taken any of the medicines listed above,
and has not yet discussed this with their doctor, they should contact their doctor again and ask
what to do. The dose of the medicine may need to be changed or another medicine may need to be
taken.
Tell your doctor or pharmacist about all medicines you are currently taking or have recently
taken, as well as any medicines you plan to take, including those available without a prescription.
Seroxat with food, drink and alcohol
During treatment with Seroxat, alcohol must not be consumed. Alcohol may worsen symptoms of
the illness or adverse effects. Taking Seroxat in the morning with a meal reduces the likelihood of
nausea.
Pregnancy, breastfeeding and effect on fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a
child, she should consult her doctor or pharmacist before taking this medicine. There are some
reports indicating that children whose mothers took Seroxat during the first few months of
pregnancy had congenital developmental abnormalities, particularly heart defects. In the general
population, about 1 in 100 children are born with a heart defect. This number increases to 2 in 100
children if the mother took Seroxat. The doctor will decide together with the patient whether it is
better during pregnancy to switch to another medicine or to gradually discontinue Seroxat. In certain
circumstances, the doctor may also suggest that it is better for the patient to continue taking Seroxat.
The midwife or doctor must be informed that the patient is taking Seroxat. Taking Seroxat towards
the end of pregnancy may increase the risk of serious vaginal bleeding occurring shortly after
delivery, especially if the patient has a history of bleeding disorders. If the patient is taking Seroxat,
she should inform her doctor or midwife so they can provide appropriate advice. Medicines such as
Seroxat taken during pregnancy, especially in the later stages, may increase the risk of serious
complications in the newborn, known as persistent pulmonary hypertension of the newborn (PPHN).
In PPHN, blood pressure in the blood vessels between the baby’s heart and lungs is too high. If the
patient takes Seroxat during the last three months of pregnancy, other symptoms may also occur in
the newborn, usually within the first 24 hours after birth. These include:

• breathing difficulties;
• skin blueness or unstable body temperature;
• blueness of the lips;
• vomiting or difficulty feeding properly;
• fatigue, difficulty sleeping, or increased crying;
• stiff or floppy muscles;
• tremors, nervous jitteriness, or seizures;
• increased reflexes. If any of these symptoms occur in the baby after birth or if there are concerns about the baby’s health, the patient should contact her doctor or midwife for advice.

Seroxat may pass into breast milk in very small amounts. If the patient is taking Seroxat, she
should consult her doctor before starting breastfeeding. The doctor and the patient may decide that
the patient will breastfeed while taking Seroxat.
Animal studies have shown that paroxetine reduces semen quality. This could theoretically affect
fertility, but the effect on human fertility has not yet been established.
Driving and operating machinery
Possible adverse effects caused by Seroxat include: dizziness, disorientation, drowsiness, and visual
disturbances. If such adverse effects occur, the patient should not drive or operate machinery.
Seroxat contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is
considered "sodium-free".

3. How to use Seroxat

This medicine should always be taken exactly as prescribed by your doctor. If in doubt, you should
consult your doctor or pharmacist.
Sometimes taking one tablet may not provide the full recommended dose of the medicine. The table
below indicates how many Seroxat tablets should be taken for each dose.
Dose Number of tablets to be taken
10 mg half a tablet
20 mg one tablet
30 mg one and a half tablets
40 mg two tablets
50 mg two and a half tablets
60 mg three tablets

The usual doses used for various conditions are given below.
Condition Recommended Maximum
starting dose daily dose daily dose
Depression 20 mg 20 mg 50 mg
Obsessive-compulsive disorder 20 mg 40 mg 60 mg
Panic disorder with agoraphobia 10 mg 40 mg 60 mg
Social phobia 20 mg 20 mg 50 mg
Post-traumatic stress disorder 20 mg 20 mg 50 mg
Generalised anxiety disorder 20 mg 20 mg 50 mg

Your doctor will advise you on which dose of Seroxat to start with. Most
patients begin to feel better after several weeks. If there is no improvement after this time,
you should consult your doctor. Your doctor may decide to gradually increase the dose
by 10 mg, up to the maximum daily dose.

Tablets should be taken in the morning, with food.
Swallow with water.
Do not chew.

Your doctor will discuss with you how long you should continue taking the tablets. Treatment may last
for several months or even longer.

Elderly patients
The maximum dose for patients over 65 years of age is 40 mg per day.

Patients with liver or kidney disease
If you have liver disease or severe kidney disease, your doctor may prescribe a lower dose of
Seroxat than normally used.

Taking more Seroxat than prescribed
Never take more tablets than your doctor has prescribed. If you (or someone else)
have taken too many Seroxat tablets, contact your doctor immediately or
go to the nearest hospital emergency department. Show them the tablet packaging.

Symptoms of Seroxat overdose may include those listed in section 4: Possible side effects,
or the following symptoms: fever, involuntary muscle contractions.

If you miss a dose of Seroxat
Take the medicine at the same time every day.
If you forget to take a dose and remember before going to bed, take it immediately.
Take your next dose at the usual time the following day.

If you remember during the night or the next day that you missed a dose, do not take the missed dose.
You may experience withdrawal symptoms, but these should quickly resolve after taking the next dose at the usual time.
Do not take a double dose to make up for a missed dose.

What to do if there is no improvement
Seroxat does not relieve symptoms of illness immediately – all antidepressant medicines
begin to work only after a certain period of time. Some patients begin to feel better after
a few weeks, while others may take longer. Some patients taking antidepressants may feel
worse before they start to feel better. If you do not feel better after several weeks of treatment,
you should consult your doctor for advice. Your doctor should schedule a follow-up visit
a few weeks after you first start taking the medicine. Inform your doctor if you have not
started to feel better.

Stopping Seroxat treatment
Do not stop taking Seroxat unless your doctor advises you to do so. When
discontinuing Seroxat, your doctor will help you gradually reduce the dose over several
weeks or months – this should help reduce the possibility of withdrawal symptoms. One
way of doing this is to gradually reduce your daily dose of Seroxat by 10 mg per week.
In most patients, withdrawal symptoms are mild and resolve on their own within two
weeks. However, in some patients, symptoms may be more severe or last longer.

If you experience withdrawal symptoms after stopping Seroxat tablets, your doctor may
decide that you should taper the medicine more slowly. If you experience severe symptoms while
discontinuing Seroxat, contact your doctor. Your doctor may recommend restarting the tablets and tapering them more slowly.

Even if you experience withdrawal symptoms, it is still possible to stop taking
Seroxat.

Possible withdrawal symptoms after stopping treatment
Studies show that 3 out of 10 patients notice one or more withdrawal symptoms when
stopping Seroxat treatment. Some of these symptoms occur more frequently than others.

Common side effects (occurring in up to 1 in 10 patients):

• dizziness, unsteadiness or difficulty maintaining balance;
• tingling sensations, burning sensations and (less commonly) electric shock-like sensations, including in the head, and ringing, buzzing, whistling, humming or other persistent noise in the ears (tinnitus);
• sleep disturbances (vivid dreams, nightmares, insomnia);
• feeling of anxiety;
• headache.

Uncommon side effects (occurring in up to 1 in 100 patients):

• nausea;
• sweating (including night sweats);
• feeling restless or agitated;
• tremor;
• feeling disoriented;
• diarrhoea (loose stools);
• emotional lability or irritability;
• visual disturbances;
• palpitations or increased heart rate (pounding heartbeat).

If you are concerned about withdrawal symptoms after stopping Seroxat,
you should contact your doctor.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Adverse reactions may be more likely during the first few weeks of taking Seroxat.
You should contact your doctor if any of the following adverse reactions occur during treatment.
It may be necessary to contact your doctor immediately or go to the nearest hospital emergency department.

Uncommon adverse reactions (occurring in up to 1 in 100 patients):

• If the patient experiences unusual bruising or bleeding, including vomiting blood or blood in the stool, they should contact a doctor immediately or go to hospital.
• If the patient experiences difficulty passing urine, they should contact a doctor immediately or go to hospital.

Rare adverse reactions (occurring in up to 1 in 1,000 patients):

• If the patient has a seizure (fit), they should contact a doctor immediately or go to hospital.
• If the patient feels restless or unable to sit or stand still, they may be experiencing a condition called akathisia. Increasing the dose of Seroxat may worsen these feelings. If such symptoms occur, contact the doctor.
• If the patient experiences fatigue, weakness, pain, stiffness, or lack of muscle coordination, and is disoriented, they may have low blood sodium levels. If such symptoms occur, contact the treating doctor.

Very rare adverse reactions (occurring in up to 1 in 10,000 patients):

• allergic reactions to Seroxat, which may be severe. If the patient develops a red, blotchy rash on the skin, swelling of the eyelids, face, lips, mouth or tongue, itching, difficulty breathing (shortness of breath) or swallowing, or feels weak or dizzy leading to collapse or loss of consciousness, they should contact a doctor immediately or go to hospital;
• If the patient has some or all of the symptoms listed below, they may be experiencing a condition known as serotonin syndrome or neuroleptic malignant syndrome. These symptoms include: a feeling of intense agitation or irritability, disorientation, anxiety, fever, sweating, tremors, chills, hallucinations (strange visions or hearing strange sounds), muscle stiffness, sudden muscle contractions, or rapid heartbeat. Symptoms may worsen and lead to loss of consciousness. If such symptoms occur, contact the doctor;
• acute glaucoma. If the patient experiences eye pain and develops blurred vision, they should contact the treating doctor.

Adverse reactions with unknown frequency (frequency cannot be determined from available data)

• In some patients, thoughts of self-harm or suicide occurred during treatment with Seroxat or shortly after stopping treatment (see Suicidal thoughts and worsening of depression or anxiety symptoms in section 2).
• In some patients, aggression occurred during treatment with Seroxat.
• Severe vaginal bleeding shortly after childbirth (postpartum haemorrhage), see additional information in subsection Pregnancy, breastfeeding and fertility in section 2. If any of these adverse reactions occur, contact the treating doctor.

Other possible adverse reactions occurring during treatment
Very common adverse reactions (occurring in more than 1 in 10 patients):

• nausea. Taking Seroxat in the morning with food reduces the likelihood of nausea.
• changes in sexual desire or sexual function. For example, lack of orgasm, or in men, disturbances of erection and ejaculation.

Common adverse reactions (occurring in up to 1 in 10 patients):

• increased blood cholesterol levels;
• loss of appetite;
• sleep disturbances (insomnia) or drowsiness;
• unusual dreams (nightmares);
• dizziness or tremors;
• headache;
• difficulty concentrating;
• feeling of restlessness;
• feeling of excessive tiredness;
• blurred vision;
• yawning, dry mouth;
• diarrhoea or constipation;
• vomiting;
• weight gain;
• sweating.

Uncommon adverse reactions (occurring in up to 1 in 100 patients):

• brief increases or decreases in blood pressure, which may cause dizziness or fainting when standing up suddenly;
• faster than normal heartbeat;
• difficulty moving, stiffness, tremors, or abnormal movements of the mouth and tongue;
• dilated pupils;
• rash;
• itching;
• feeling of disorientation;
• hallucinations (strange images or sounds);
• inability to pass urine (urinary retention) or uncontrolled, involuntary urination (urinary incontinence);
• in patients with diabetes, treatment with Seroxat may lead to worsening of blood sugar control. Discuss with your doctor about adjusting the dose of insulin or diabetes medication;
• decreased white blood cell count.

Rare adverse reactions (occurring in up to 1 in 1,000 patients):

• abnormal milk production in the breast glands in men and women;
• slow heartbeat;
• liver effects shown in blood tests assessing liver function;
• panic attacks;
• excessive activity or racing thoughts (mania);
• feeling of detachment from oneself (depersonalization);
• feeling of anxiety;
• irresistible urge to move the legs (restless legs syndrome);
• joint or muscle pain;
• increased levels of a hormone called prolactin in the blood;
• menstrual disorders (including heavy or irregular bleeding, intermenstrual bleeding, or absence or delay of menstruation).

Very rare adverse reactions (occurring in up to 1 in 10,000 patients):

• a skin rash called erythema multiforme, which may include blisters and appear as target-like lesions (a dark spot in the centre surrounded by a lighter ring and a dark ring around the edge);
• widespread blistering skin rash with peeling skin, particularly around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome);
• widespread blistering rash with peeling of large areas of skin (toxic epidermal necrolysis);
• liver function disturbances causing yellowing of the skin or whites of the eyes;
• syndrome of inappropriate antidiuretic hormone secretion (SIADH), where, due to incorrect chemical signals in the body, excessive water retention and low sodium (salt) levels occur. Patients with SIADH may show symptoms of serious illness or may have no symptoms at all;
• fluid retention (which may lead to swelling of the hands or feet);
• light sensitivity;
• painful, persistent penile erection;
• decreased platelet count.

Adverse reactions with unknown frequency (frequency cannot be determined from available data):

• inflammation of the large intestine (causing diarrhoea);
• teeth grinding.

Some patients may experience ringing, buzzing, whistling, or other persistent noise in the ears (tinnitus) while taking Seroxat.
In patients taking this type of medicine, an increased risk of bone fractures has been observed.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can also be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 (22) 49 21 301
Fax: +48 (22) 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Seroxat

Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Do not store above 30°C.
Store in the original packaging to protect from light.
If the patient is using half tablets, care should be taken to store them in the medicine's packaging.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Seroxat contains
The active substance is paroxetine (20 mg) in the form of paroxetine hydrochloride hemihydrate.
Other ingredients of the medicine are:
Tablet core: calcium hydrogen phosphate dihydrate (E 341), magnesium stearate (E 470b),
sodium carboxymethyl starch (type A).
Tablet coating: hypromellose (E 464), titanium dioxide (E 171), macrogol 400, polysorbate 80 (E 433).
What Seroxat looks like and contents of the pack
Seroxat 20 mg, coated tablets – white, oval, biconvex coated tablets, with the imprint “SEROXAT 20” on one side and a score line on the other side.
Each Seroxat 20 mg pack contains 30 coated tablets in blisters.
For further information, please contact the Marketing Authorisation Holder or Parallel Importer.
Marketing Authorisation Holder in Ireland, country of export:
GlaxoSmithKline (Ireland) Limited
12 Riverwalk
Citywest Business Campus
Dublin 24
Ireland
Manufacturer:
Delpharm Poznań Spółka Akcyjna
ul. Grunwaldzka 189
60-322 Poznań
Poland
Parallel Importer:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Relabelled and/or repackaged by:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Marketing Authorisation number in Ireland, country of export: PA1077/097/002
Parallel Import Licence number: 37/20
This medicinal product is authorised in the following names in the European Economic Area:
Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Seroxat
Finland, Greece, Spain, Netherlands, Iceland,
Ireland, Lithuania, Luxembourg, Latvia, Malta,
Germany, Norway, Poland, Portugal, Slovakia,
Slovenia, Sweden, Italy
France Deroxat
Patients may find it helpful to contact a support group or patient organisation where they can obtain further information about their condition. Further details are available from the treating physician.