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 levels 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 consult their doctor againand ask how to proceed with Seroxat.
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 displays 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, 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 showed that such symptoms occurred, although less frequently, in children and adolescents taking placebo (sugar pills) 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, common side effects (occurring with a frequency of less than 1 in 10) included 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 some time, usually about two weeks, for the medicines to start working, and sometimes even longer.
For the patient, such thoughts may occur more frequently:
In some patients taking Seroxat, a condition known as akathisia may develop, characterized by feeling anxious and being unable to sit or stand still. In other patients, a condition known as serotonin syndrome or neuroleptic malignant syndrome may occur, with symptoms including feeling extremely agitated or confused, feeling anxious, hot, sweaty, shaking, shivering, hallucinations (seeing or hearing things that are not there), muscle stiffness, or rapid heart rate. These symptoms can 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 function disorders (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 these medicines, and has not yet discussed this with their doctor, they should contact their doctor againand ask how to proceed. The dose of the medicine may need to be changed or a different medicine may be necessary.
, including those obtained without a prescription. The patient should also inform their doctor or pharmacist about any other medicines they are taking or plan to take, including those obtained without a prescription.
The patient should not drink alcohol while taking Seroxat. 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, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before taking this medicine. There have been reports suggesting that children whose mothers took Seroxat during the first few months of pregnancy may have an increased risk of congenital malformations, 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 takes Seroxat. The doctor will discuss with the patient whether it is better to change the medicine or gradually stop taking Seroxat during pregnancy. In some cases, the doctor may also recommend continuing to take Seroxat.
Taking Seroxat at the end of 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, when taken during pregnancy, especially in the last few months, may increase the risk of a condition in the newborn known as persistent pulmonary hypertension of the newborn (PPHN).
In PPHN, the blood pressure in the blood vessels between the heart and lungs is too high. If the patient takes Seroxat during the last 3 months of pregnancy, the newborn may also experience other symptoms, usually within the first 24 hours after birth, including:
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, together with the patient, can decide whether to breastfeed while taking Seroxat.
In animal studies, paroxetine has been shown to reduce sperm quality. This could 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 is unsure, they should consult their doctor or pharmacist.
Sometimes, taking one tablet may not provide the full recommended dose of the medicine. The following table indicates how many Seroxat tablets the patient should take for each dose.
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
Usual doses for different conditions are given below.
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 the starting dose of Seroxat.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 they should 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 their 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 the doctor 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 a missed dose.
Seroxat does not relieve symptoms immediately- all antidepressants take some 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 a follow-up visit a few weeks after 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 the patient gradually reduce the dose over a few weeks or months - this should minimize 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 on their own within two weeks. In some patients, symptoms may be more severe or may last longer.
If the patient experiences withdrawal symptomsafter stopping Seroxat, the doctor may decide that the patient should stop taking the medicine more slowly. If the symptoms are severe during the withdrawal of Seroxat, the patient should contact their doctor. The doctor may recommend restarting the tablets and stopping them more slowly.
Studies have shown that 3 in 10 patients notice one or more withdrawal symptoms when stopping Seroxat. Some of these symptoms occur more frequently than others.
In case of 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.
Side effects with unknown frequency(frequency cannot be estimated from the available data)
Side effects with unknown frequency(frequency cannot be estimated from the available data):
Some patients taking Seroxat may experience buzzing, hissing, whistling, or other persistent noises in the ears (tinnitus) during treatment.
Patient studies have shown that medicines like Seroxat (SSRIs) may increase the risk of bone fractures.
If the patient experiences any side effects, including any not listed in this leaflet, they should inform 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
By reporting side effects, more information can be collected on the safety of this 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.
The patient should not store the medicine above 30°C.
The patient should store the medicine in its 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 no longer required. 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:
Tablet core: calcium hydrogen phosphate dihydrate (E 341), magnesium stearate (E 470b), carboxymethylcellulose sodium (type A).
Coating: hypromellose (E 464), titanium dioxide (E 171), macrogol 400, polysorbate 80 (E 433).
Seroxat 20 mg, coated tablets - white, oval, biconvex, coated tablets with "SEROXAT 20" engraved on one side and a score line on the other side.
Each pack of Seroxat 20 mg coated tablets 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
Delpharm Poznań Spółka Akcyjna
ul. Grunwaldzka 189
60-322 Poznań
Poland
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Irish authorization number: PA1077/097/002
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
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 patient's doctor can provide more information.
[Information about the trademark]
Need help understanding this medicine or your symptoms? Online doctors can answer your questions and offer guidance.