Paroxetine
Anxiety disorders for which Seroxat is used include: obsessive-compulsive disorder (recurring, obsessive thoughts with uncontrolled behavior), panic disorder (panic attacks, including those caused by agoraphobia, which is a 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 feeling of anxiety or nervousness).
Seroxat belongs to a group of medicines called selective serotonin reuptake inhibitors (SSRIs). It is not fully understood how Seroxat and other SSRIs work, but they may increase the level of serotonin in the brain. Proper treatment of depression and anxiety disorders is important for the patient to feel better.
If the answer is YES to any of the above questionsand the patient has not yet consulted their doctor, they should do so againand ask how to proceed. The dose of the medicine may need to be changed or a different medicine may be prescribed.
Seroxat should not be used in children and adolescents under 18 years old.Patients under 18 years old are at increased risk of side effects, such as suicidal attempts, suicidal thoughts, and hostility (especially aggression, rebellious behavior, and signs of anger) when taking Seroxat. If the doctor has prescribed Seroxat to a patient under 18 years old and there are concerns, the patient should consult their doctor. If these symptoms occur or worsen while taking Seroxat, the patient should inform their doctor. Additionally, there is currently no data on the long-term safety of Seroxat regarding growth, maturation, and cognitive and behavioral development in this age group.
In studies of Seroxat in patients under 18 years old, common side effects that occurred with a frequency of less than 1 in 10 were: increased suicidal thoughts and attempts, intentional self-harm, hostility, aggressive behavior, or unfriendly behavior, loss of appetite, tremors, abnormal sweating, excessive activity (excess energy), restlessness, emotional instability (including tearfulness and mood changes), and unusual bruising or bleeding (such as nosebleeds).
These studies also found that such symptoms occurred, although less frequently, in children and adolescents taking placebo tablets instead of Seroxat.
Some patients under 18 years old in these studies experienced withdrawal symptoms when stopping Seroxat. These symptoms were very similar to those observed in adults after stopping Seroxat (see section 3). Additionally, in patients under 18 years old, the following symptoms also occurred frequently (with a frequency of less than 1 in 10): abdominal pain, feeling nervous, and emotional instability (including tearfulness, mood changes, self-harm, suicidal thoughts, and suicidal attempts).
In patients with depression and/or anxiety disorders, suicidal thoughts or self-harm may sometimes occur. They may be more frequent at the start of antidepressant treatment, as it may take a few weeks, usually about two weeks, for the medicine to start working, and sometimes even longer.
For the patient, such thoughts may occur more frequently:
In some patients taking Seroxat, a condition called akathisia may develop.
They may feel anxious and unable to sit or stand still. In other patients, a condition called serotonin syndrome or malignant neuroleptic syndrome may develop, in which patients have some or all of the following symptoms: feeling highly agitated or irritated, feeling confused (disoriented), feeling anxious, fever, sweating, shaking, chills, hallucinations (seeing or hearing strange things), muscle stiffness, 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 about these or other side effects of Seroxat can be found in section 4.
Medicines like Seroxat (SSRIs) may cause sexual dysfunction (see section 4). In some cases, these symptoms have persisted after stopping treatment.
Some medicines may affect the action of Seroxat or increase the risk of side effects. Seroxat may also affect the action of other medicines. These medicines include:
If the patient is currently taking or has recently taken any of the above medicines, and has not yet discussed this with their doctor, they should do so againand ask how to proceed. The dose of the medicine may need to be changed or a different medicine may be prescribed.
, including those obtained without a prescription. The patient should tell their doctor or pharmacist about all medicines they are taking or plan to take, including those obtained without a prescription.
While taking Seroxat, the patient should not drink alcohol. Alcohol may increase the symptoms of the disease or side effects. Taking Seroxat in the morning, with food, reduces the likelihood of nausea.
If the patient is pregnant or breastfeeding, or thinks they may be pregnant or plans to have a baby, they should consult their doctor or pharmacist before taking this medicine. There are reports that children whose mothers took Seroxat during the first few months of pregnancy had congenital malformations, particularly heart defects. In the general population, about 1 in 100 children is born with a heart defect. This number increases to 2 in 100 children if the mother takes Seroxat. The doctor will decide with the patient whether to change the medicine during pregnancy or to gradually stop taking Seroxat. In some cases, the doctor may also suggest that it is better for the patient to continue taking Seroxat.
Taking Seroxat late in pregnancy may increase the risk of serious bleeding from the vagina, occurring shortly after delivery, especially if the patient has a history of bleeding disorders. If the patient is taking Seroxat, they should inform their doctor or midwife so that they can provide appropriate advice. Medicines like Seroxat taken during pregnancy, especially in the last few months, may increase the risk of a condition called persistent pulmonary hypertension in the newborn (PPHN).
In PPHN, the blood pressure in the blood vessels between the heart and lungs is too high. If the patient is taking Seroxat during the last 3 months of pregnancy, the newborn may also experience other symptoms, usually within the first 24 hours after birth. These include:
Seroxat may pass into breast milk in very small amounts. If the patient is taking Seroxat, they should consult their doctor before breastfeeding. The doctor and patient can decide together whether to breastfeed while taking Seroxat. In animal studies, paroxetine has been shown to reduce sperm quality. This may theoretically affect fertility, but the impact on human fertility has not been determined.
Possible side effects of Seroxat include dizziness, disorientation, drowsiness, and vision disturbances. If the patient experiences any of these side effects, they should not drive or operate machinery.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially 'sodium-free'.
This medicine should always be taken as directed by the doctor. If the patient has any doubts, they should consult their doctor or pharmacist.
Sometimes taking one tablet does not ensure the entire recommended dose of the medicine. The following table indicates how many Seroxat tablets should be taken for a given dose.
Usual doses for different conditions are listed below.
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
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 anxiety disorder
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 the patient on which dose of Seroxat to start with. Most patients start to feel better after a few weeks. If there is no improvement after this time, the patient should consult their doctor. The doctor may decide to gradually increase the dose by 10 mg until the maximum daily dose is reached.
The doctor will discuss with the patient how long to take the tablets. Treatment may last for several months or even longer.
The maximum dose for patients over 65 years old is 40 mg per day.
The doctor may recommend a lower dose of Seroxat for patients with liver or severe kidney disease.
The patient should never take more tablets than prescribed by the doctor. If the patient (or someone else) has taken too many Seroxat tablets, they should immediately inform their doctor or contact the nearest emergency department. They should show them the packaging of the tablets.
As a result of overdosing on Seroxat, the patient may experience side effects described in section 4: Possible side effects, or the following symptoms: fever, involuntary muscle contractions.
The medicine should be taken at the same time every day.
If a dose is missed and the patient remembers before going to bed, they should take it immediately. The next day, they should take the dose as usual.
If the patient remembers in the night or the next day that they missed a dose, they should not take the missed dose. The patient may experience withdrawal symptoms, but they should resolve quickly after taking the next dose at the usual time.
The patient should not take a double dose to make up for the missed dose.
Seroxat does not relieve symptoms immediately; all antidepressant medicines take time to start working. Some patients start to feel better after a few weeks, and others later. Some patients taking antidepressants feel worse before they start to feel better. If the patient does not feel better after a few weeks of treatment, they should consult their doctor for advice. The doctor should recommend that the patient have a follow-up visit after a few weeks of starting Seroxat for the first time. The patient should inform their doctor if they have not started to feel better.
When stopping Seroxat, the doctor will help gradually reduce the dose over a few weeks or months to limit the risk of withdrawal symptoms. One way to do this is to gradually reduce the dose of Seroxat by 10 mg per week. In most patients, withdrawal symptoms are mild and resolve within two weeks. In some patients, symptoms may be more severe or may last longer.
If the patient experiences withdrawal symptoms after stopping Seroxat, the doctor may decide that the patient should stop taking the medicine more slowly. If the symptoms are severe during Seroxat withdrawal, the patient should contact their doctor. The doctor may recommend restarting the tablets and stopping them more slowly.
Studies have shown 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.
In case of any further doubts about taking this medicine, the patient should consult their doctor or pharmacist.
Like all medicines, Seroxat can cause side effects, although not everybody gets them.
Side effects are more common during the first few weeks of taking Seroxat.
It may be necessary to contact the doctor or the nearest emergency department immediately.
(frequency cannot be estimated from the available data)
(frequency cannot be estimated from the available data)
In some patients taking Seroxat, ringing, buzzing, whistling, or other persistent noises in the ears (tinnitus) have occurred during treatment.
Patients taking medicines like Seroxat have been found to have an increased risk of bone fractures.
If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych (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 side effects helps to gather more information on the safety of the medicine.
The medicine should be stored out of sight and reach of children.
The patient should not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated.
The patient should not store the medicine above 30°C. The patient should store it in the original packaging to protect it from light.
If the patient is taking half-tablets, they should be careful to store them in the medicine packaging.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.
The active substance of Seroxat is paroxetine (20 mg) in the form of paroxetine hydrochloride hemihydrate.
Other ingredients of the medicine are:
Core: calcium hydrogen phosphate, magnesium stearate, sodium carboxymethylcellulose (type A).
Coating: Opadry White YS-1R-7003: hypromellose, titanium dioxide (E 171), macrogol 400, polysorbate 80.
White, coated, oval, biconvex tablets with the inscription "20" on one side and a score line on the other side. If necessary, the 20 mg coated tablet can be divided into equal doses.
Each pack contains 30 coated tablets in blisters.
For more detailed information, the patient should contact the marketing authorization holder or the parallel importer.
GlaxoSmithKline (Ireland) Limited
12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland
GlaxoSmithKline Pharmaceuticals S.A.
Grunwaldzka 189, 60-322 Poznań
S.C. Europharm S.A.
Str. Panselelor nr.2, Braşov, 500419, Romania
Delfarma Sp. z o.o.
Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Delfarma Sp. z o.o.
Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Marketing authorization number in Romania, the country of export: 601/2008/02
Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, United Kingdom (Northern Ireland)
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. The doctor can provide more detailed information.
Date of leaflet approval: 07.07.2022
[Information about the trademark]
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