Seroxat
Poland
Table of Contents
Patient Information Leaflet
Warning! Keep this leaflet! Information on the immediate packaging is in a foreign language.
Seroxat, 20 mg, coated tablets
Paroxetinum
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.
- Keep this leaflet so that you can read it again if necessary.
- If you have any questions, please consult your doctor or pharmacist.
- This medicine has been prescribed for a specific individual only. Do not pass it on to others. This medicine may harm others, even if their symptoms are the same.
- If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
Table of Contents
- What Seroxat is and what it is used for
- Important information before taking Seroxat
- How to take Seroxat
- Possible side effects
- How to store Seroxat
- Contents of the pack and other information
1. What Seroxat is and what it is used for
Seroxat is used in the treatment of depression and (or) anxiety disorders in adults.
Anxiety disorders treated with Seroxat include: obsessive-compulsive disorder (recurring, obsessive thoughts with uncontrollable behaviour), panic disorder (panic attacks, including those associated with 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 anxiety or nervousness).
Seroxat belongs to a group of medicines known as selective serotonin reuptake inhibitors (SSRIs). The exact mechanism of action of Seroxat and other SSRIs is not fully understood, but they may increase the concentration of serotonin in the brain. Proper treatment of depression and anxiety disorders is important to help patients feel better.
2. Important information before using Seroxat
When not to use Seroxat:
- If the patient is taking medicines known as monoamine oxidase inhibitors (MAO inhibitors, including moclobemide and methylene blue chloride) 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 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 breast cancer treatment? Seroxat may reduce the effectiveness of tamoxifen, and therefore the treating doctor may recommend 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 interval prolongation?
- Does the patient have a family history of QT interval prolongation, heart disease such as heart failure, slow heart rate, or low potassium or 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 (ECT)?
- 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, antipsychotic medicines such as perphenazine or clozapine, tricyclic antidepressants, 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 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 see their doctor again to discuss 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 experiencing adverse effects such as suicide attempts, suicidal thoughts, and hostility (particularly aggression, defiant behaviour, and anger) while taking Seroxat. If the doctor has prescribed Seroxat to a patient under 18 years of age and there are any concerns, the patient should contact their doctor. If any of these symptoms occur or worsen during treatment with Seroxat, the doctor must be informed. Furthermore, there is currently no long-term data on the safety of Seroxat regarding growth, maturation, and cognitive and behavioural development in this age group.
In clinical trials of Seroxat in patients under 18 years of age, common adverse effects occurring in less than 1 in 10 patients included: increased frequency of suicidal thoughts and suicide attempts, self-harm, hostility, aggressive or hostile behaviour, loss of appetite, tremor, abnormal sweating, excessive activity (displaying excess energy), restlessness, emotional lability (including tearfulness and mood swings), and unusual bruising or bleeding (such as nosebleeds).
These trials also showed that the same 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 associated with 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 tearfulness, mood swings, self-harm attempts, suicidal thoughts, and suicide attempts) were also common (occurring 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 worsen 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 longer.
The patient may be more likely to experience such thoughts if:
- The patient has previously had suicidal thoughts or thoughts of self-harm.
- The patient is a young adult. Clinical studies 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 patient's depression or anxiety disorder and ask them to read this leaflet. The patient may ask them to inform them if they notice worsening depression or anxiety, or any worrying changes in their behaviour.
Important adverse effects observed during treatment with Seroxat
In some patients taking Seroxat, symptoms called akathisia may develop.
They 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 confused, feeling anxious, feeling hot, sweating, trembling, chills, hallucinations (strange visions or hearing strange sounds), muscle stiffness, sudden muscle spasms, 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 about 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) – see section When not to use Seroxat
- Medicines known to increase the risk of changes in the heart's electrical activity (e.g. antipsychotic medicines thioridazine or pimozide) – see section When not to use Seroxat
- Acetylsalicylic acid, ibuprofen, or other medicines known as non-steroidal anti-inflammatory drugs (NSAIDs), such as celecoxib, etodolac, diclofenac, and meloxicam, used in the treatment of pain and inflammation
- Tramadol, buprenorphine, and pethidine, painkillers
- Buprenorphine in combination with naloxone, used in opioid substitution therapy for opioid dependence
- Medicines known as triptans, such as sumatriptan, used in the treatment of migraine
- Other antidepressants, known as SSRIs and tricyclic antidepressants, such as clomipramine, nortriptyline, and desipramine
- A dietary supplement called tryptophan
- Mivacurium and suxamethonium (used for general anaesthesia)
- Medicines such as lithium, risperidone, perphenazine, clozapine (known as antipsychotics) used in 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 in the treatment of human immunodeficiency virus (HIV) infection
- St John’s wort, used as an adjunct in depression
- Phenobarbital, phenytoin, sodium valproate, or carbamazepine, used in the treatment of seizures or epilepsy
- Atomoxetine, used in the treatment of attention deficit hyperactivity disorder (ADHD)
- Procyclidine, used to treat tremor, particularly in Parkinson’s disease
- Warfarin or other medicines (known as anticoagulants) used to thin the blood
- Propafenone, flecainide, and medicines used to treat irregular heartbeat
- Metoprolol, a beta-blocker used to treat high blood pressure and heart problems
- Pravastatin, used to treat elevated cholesterol levels
- Rifampicin, used to treat tuberculosis and acne
- Linezolid – an antibiotic
- Tamoxifen, used in the treatment of breast cancer
If the patient is currently taking or has recently taken any of these medicines, and has not yet discussed this with their doctor, they should contact their doctor again to discuss what to do. The dose of the medicine may need to be changed, or it may be necessary to take a different medicine.
Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, including medicines you plan to take, and those available without a prescription.
Seroxat with food, drink and alcohol
Do not consume alcohol while taking Seroxat. Alcohol may worsen symptoms of the illness or adverse effects. Taking Seroxat in the morning with food reduces the likelihood of nausea.
Pregnancy, breastfeeding and fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or plans to have a baby, she should consult her doctor or pharmacist before taking this medicine.
There are some reports suggesting that babies born to mothers who took Seroxat during the first few months of pregnancy may have congenital developmental abnormalities, particularly heart defects. In the general population, about 1 in 100 babies is born with a heart defect. This number increases to 2 in 100 babies if the mother took Seroxat. The doctor will decide together with the patient whether it is better to switch to another medicine or gradually discontinue Seroxat during pregnancy. In certain circumstances, the doctor may also suggest that it is better for the patient to continue taking Seroxat.
Ensure that the midwife or doctor is informed that the patient is taking Seroxat. Taking Seroxat towards the end of pregnancy may increase the risk of serious vaginal bleeding 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, the 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, the newborn may also experience, usually within the first 24 hours after birth, other symptoms, including:
- Breathing difficulties;
- Bluish skin or unstable body temperature;
- Bluish lips;
- Vomiting or difficulty feeding properly;
- Tiredness, difficulty sleeping, or increased crying;
- Stiff or floppy muscles;
- Tremors, jitteriness due to agitation, 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, contact the 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 patient may decide together that breastfeeding is acceptable while taking Seroxat.
Animal studies have shown that paroxetine reduces sperm quality. This may 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 take Seroxat
This medicine should always be taken exactly as prescribed by your doctor. If you have any doubts,
you should consult your doctor or pharmacist.
Sometimes one tablet does not correspond to the entire 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 different conditions are given below.
| Initial dose | Recommended daily dose | Maximum daily dose | |
| Depression | 20 mg | 20 mg | 50 mg |
| Obsessive-compulsive disorder | 20 mg | 40 mg | 60 mg |
| Panic disorder | 10 mg | 40 mg | 60 mg |
| Social phobia | 20 mg | 20 mg | 50 mg |
| Post-traumatic stress disorder | 20 mg | 20 mg | 50 mg |
| Generalized anxiety disorder | 20 mg | 20 mg | 50 mg |
The doctor will advise on the starting dose of Seroxat. Most
patients begin to feel better after a few weeks. If there is no improvement by this time,
you should consult your doctor. The doctor may decide to gradually increase the dose by
10 mg, up to the maximum daily dose.
Tablets should be taken in the morning, during a meal.
Swallow with water.
Do not chew.
Your doctor will discuss with you how long you should take 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
In patients with liver disease or severe kidney disease, the doctor may prescribe a lower dose of
Seroxat than usually 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
packaging of the tablets.
Symptoms of Seroxat overdose may include those listed in section 4:
Possible side effects, or the following symptoms: fever, involuntary muscle contractions.
Missing a dose of Seroxat
Take the medicine at the same time each day.
If you miss a dose and remember before going to bed, take it immediately.
The next day, take your usual dose as normal.
If you remember during the night or the following 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 take some time to work. 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 a few weeks of treatment,
you should consult your doctor. 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 treatment with Seroxat
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 minimize the risk of withdrawal symptoms. One way is to gradually reduce the patient's dose of Seroxat by 10 mg weekly. 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 may persist longer.
If you experience withdrawal symptoms after stopping the tablets, your doctor may
decide that you should taper the dose more slowly. If you experience severe symptoms while
discontinuing Seroxat, contact your doctor. The doctor may recommend restarting the tablets and tapering them more slowly.
Even if you experience withdrawal symptoms, it is still possible to discontinue
treatment with Seroxat.
Possible withdrawal symptoms occurring after stopping treatment
Studies show that 3 out of 10 patients notice one or more withdrawal symptoms when
stopping treatment with Seroxat. 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, 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
- Tremors
- Feeling disoriented
- Diarrhea (loose stools)
- Emotional lability or irritability
- Visual disturbances
- Palpitations or increased heart rate (pounding heart).
If you are concerned about withdrawal symptoms after stopping Seroxat,
you should contact your doctor.
If you have any further questions regarding 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 everyone will experience them.
Side effects may be more likely during the first weeks of treatment with Seroxat.
You should contact your doctor if any of the following side effects occur during treatment.
It may be necessary to contact your doctor immediately or go to the nearest hospital emergency department.
Uncommon side effects (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 side effects (occurring in up to 1 in 1000 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, or is confused, they may have low blood sodium levels. If such symptoms occur, contact the treating doctor.
Very rare side effects (occurring in up to 1 in 10,000 patients):
- Allergic reactions to Seroxat, which may be severe. If the patient develops a red, raised skin rash, 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, confusion, anxiety, fever, sweating, tremors, chills, hallucinations (strange visions or hearing unusual 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 blurred vision, they should contact the treating doctor.
Side effects with unknown frequency (frequency cannot be determined from available data):
- In some patients, during treatment with Seroxat or shortly after stopping treatment, thoughts of self-harm or suicide occurred (see Suicidal thoughts and worsening of depression or anxiety disorder in section 2).
- In some patients, aggression occurred during treatment with Seroxat.
- Severe vaginal bleeding occurring shortly after childbirth (postpartum haemorrhage), see additional information in subsection Pregnancy, breastfeeding and fertility in section 2. If any of these side effects occur, contact the treating doctor.
Other possible side effects occurring during treatment
Very common side effects (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 side effects (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 agitated
- Feeling unusually weak
- Blurred vision
- Yawning, dry mouth
- Diarrhoea or constipation
- Vomiting
- Weight gain
- Sweating
Uncommon side effects (occurring in up to 1 in 100 patients):
- Short-term increase or decrease in blood pressure, which may cause dizziness or fainting when changing suddenly to a standing position
- Faster than normal heartbeat
- Difficulty moving, stiffness, tremors, or abnormal movements of the mouth and tongue
- Pupil dilation
- Skin rash
- Itching
- Feeling confused
- Hallucinations (strange images or sounds)
- Inability to pass urine (urinary retention) or uncontrolled, involuntary passing of urine (urinary incontinence)
- In patients with diabetes, treatment with Seroxat may worsen blood sugar control. Discuss with your doctor whether insulin or diabetes medication doses need adjustment.
- Decreased white blood cell count
Rare side effects (occurring in up to 1 in 1000 patients):
- Abnormal milk production in the breast glands in men and women
- Slow heartbeat
- Liver effects shown in blood tests of liver function
- Panic attacks
- Excessive activity or racing thoughts (mania)
- Feeling of unreality about oneself (depersonalisation)
- Feelings 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 periods)
Very rare side effects (occurring in up to 1 in 10,000 patients):
- 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 at the edge)
- Widespread skin rash with blisters and peeling of the skin, particularly around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome)
- Widespread skin rash with blisters and peeling of large areas of skin (toxic epidermal necrolysis)
- Liver function disorders causing yellowing of the skin or whites of the eyes (jaundice)
- Syndrome of inappropriate antidiuretic hormone secretion (SIADH), where due to abnormal chemical signals in the body, excess water is retained and sodium levels are reduced. Patients with SIADH may show symptoms of serious illness or may have no symptoms at all
- Fluid retention or water retention (which may lead to swelling of the hands or feet)
- Light sensitivity
- Painful, persistent erection (priapism)
- Decreased platelet count
Side effects 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 side effects
If any side effects occur, including any not listed in this leaflet, tell your doctor or pharmacist. Side effects can 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, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Reporting side effects helps provide more information on the safety of this medicine.
5. How to store Seroxat
Keep this 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 a pharmacist how to dispose of medicines no longer in use. This will help protect the environment.
6. Contents of the package and other information
What Seroxat contains
The active substance is paroxetine (20 mg) in the form of paroxetine hydrochloride hemihydrate.
Other components of the medicine are:
Tablet core: calcium hydrogen phosphate dihydrate, magnesium stearate, sodium carboxymethyl starch (type A).
Tablet coating: hypromellose, titanium dioxide (E 171), macrogol 400, polysorbate 80.
What Seroxat looks like and contents of the pack
Seroxat 20 mg, film-coated tablets – white, oval, biconvex film-coated tablets, with the inscription “SEROXAT 20” or “20” imprinted on one side and a dividing groove on the other side allowing the tablet to be broken.
Each pack of Seroxat 20 mg, film-coated tablets contains 28 tablets in child-resistant blister packs.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing Authorisation Holder in Spain, the country of export:
GlaxoSmithKline, S.A.
P.T.M. C/ Severo Ochoa, 2
28760 Tres Cantos (Madrid), Spain
Manufacturer:
Delpharm Poznań Spółka Akcyjna
ul. Grunwaldzka 189
60-322 Poznań, Poland
Parallel Importer:
InPharm Sp. z o.o., ul. Strumykowa 28/11, 03-138 Warsaw
Repackaged by:
InPharm Sp. z o.o. Services sp. k., ul. Chełmżyńska 249, 04-458 Warsaw
Marketing Authorisation Numbers in Spain, the country of export: 757195.7
760314.6
866905.9
Parallel Import Marketing Authorisation Number: 261/24
This medicinal product is authorised in the Member States of the European Economic Area under the following names:
| Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, Greece, Spain, Netherlands, Iceland, Ireland, Lithuania, Luxembourg, Latvia, Malta, Germany, Norway, Poland, Portugal, Slovakia, Slovenia, Sweden, Italy | Seroxat |
| France | Deroxat |
It may be helpful for the patient to contact a support group or patient organization,
where they can learn more about their condition. Detailed information can be provided by the attending physician.
Translation of the day-of-the-week symbols found next to each tablet on the immediate packaging:
Lu – Monday
Ma – Tuesday
Mi – Wednesday
Ju – Thursday
Vi – Friday
Sa – Saturday
Do – Sunday