20 mg film-coated tablet
paroxetine (as hydrochloride hemihydrate)
What Seroxat is and what it is used for
Seroxat is used to treat adults with depression and/or anxiety. The anxiety states that Seroxat is used for are: obsessive-compulsive disorder (repeated obsessive-compulsive disorder), panic disorder (attacks of panic disorder, including those that occur with agoraphobia, ie fear of open spaces), social phobia (fear of or avoidance of social situations), post-traumatic stress disorder. stress syndrome (anxiety after a traumatic experience) and generalized anxiety (general severe anxiety or worry).
Seroxat belongs to a group of medicines called selective serotonin reuptake inhibitors ( SSRIs ). How Seroxat and other SSRIs work is not completely known but it could be because they raise the levels of serotonin in the brain. Proper treatment of your depression or anxiety is important to help you improve.
The paroxetine contained in Seroxat may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you use Seroxat
Do not use Seroxat:
| – | if you are taking medicines called monoamine oxidase inhibitors ( MAOIs, including moclobemide and methylthionine chloride (methylene blue)) or have taken them at any time during the last two weeks. Your doctor will advise you on how to start taking Seroxat after you stop taking MAOIs. |
| – | if you are taking an antipsychotic medicine that contains either thioridazine or pimozide. |
| – | if you are allergic to paroxetine or any of the other ingredients of this medicine (listed in section 6). |
| If any of the above applies to you, tell your doctor before taking Seroxat. |
Warnings and cautions
Talk to your doctor or pharmacist before using Seroxat
| – | Are you taking any other medicines (see Other medicines and Seroxat in this leaflet)? |
| – | Are you taking tamoxifen to treat breast cancer? Seroxat may reduce the effect of tamoxifen and your doctor may therefore recommend that you use other antidepressants. |
| – | Do you have kidney, liver, or heart problems? |
| – | Do you have epilepsy or have you ever had seizures or seizures? |
| – | Have you ever had manic episodes (overactive behavior or thoughts)? |
| – | Do you receive electroconvulsive therapy (ECT)? |
| – | Have you had a bleeding disorder or are taking any other medicines that may increase the risk of bleeding (blood thinners such as warfarin, antipsychotics such as perfenazine or clozapine, tricyclic antidepressants, painkillers and anti-inflammatory drugs, so-called NSAIDs (non-steroidal anti-inflammatory drugs), such as acetylsalicylic acid, ibuprofen, celecoxib, etodolac, diclofenac, meloxicam)? |
| – | Do you have diabetes? |
| – | Are you on a salt-reduced diet? |
| – | Do you have glaucoma ( glaucoma, increased pressure in the eye)? |
| – | Are you pregnant or planning to become pregnant (see Pregnancy, breast-feeding, and fertility in this leaflet)? |
| – | Are you under 18 (see Children and adolescents under 18 in this leaflet)? |
If you answer YES to any of these questions and have not previously discussed this with your doctor, consult your doctor again and ask how to apply Seroxat.
Children and adolescents under 18 years of age
Seroxat should not be used by children and adolescents under 18 years of age. The risk of side effects such as suicide attempts, suicidal ideation, and hostility (mainly aggression, defiance, and anger) is greater in patients under 18 years of age using Seroxat. If your doctor has prescribed Seroxat for you (or your child) and you want to discuss this, you should see your doctor again. You should tell your doctor if you notice any of the above symptoms or if such symptoms worsen while you (or your child) are taking Seroxat. The long-term effects on growth, maturity, and cognitive and behavioral development have not yet been established for children and adolescents under 18 years of age.
In studies with Seroxat in patients under 18 years of age, common side effects that occurred in less than 1 in 10 children/adolescents were the following: increased suicidal ideation and suicide attempts, self-harming behavior, hostile, aggressive, or unfriendly behavior, loss of appetite, tremors, abnormal sweating, hyperactivity (excess energy), agitation, emotional changes (including crying and mood swings) and unusual bruising or bleeding (eg nosebleeds). The studies showed that the same symptoms also occurred in children and adolescents who received a placebo (an inactive substance) instead of Seroxat, but less often.
Some patients in studies with people under 18 years of age experienced withdrawal symptoms when they stopped taking Seroxat. These symptoms were mostly similar to those seen in adults after discontinuation of Seroxat (see section 3). In addition, it was common (in less than 1 in 10) that patients under the age of 18 experienced abdominal pain, nervousness, and emotional changes (including crying, mood swings, attempted self-harm, thoughts of suicide, and suicide attempts).
If you start to feel worse and have thoughts of harming yourself
You who are depressed and/or suffer from worry/anxiety may sometimes have thoughts of harming yourself or committing suicide. These symptoms may worsen when you start using antidepressants, as it takes time for this type of medicine to take effect, usually about 2 weeks, sometimes longer.
These thoughts may be common:
- If you have previously had thoughts of harming yourself or committing suicide.
- If you are younger than 25 years. Studies have shown that young adults (younger than 25 years) with mental illness who are treated with antidepressant drugs have an increased risk of suicidal thoughts and thoughts of harming themselves.
Contact a doctor as soon as possible or go to the nearest hospital if you have thoughts of injuring yourself or committing suicide.
It can be helpful to tell a relative or close friend that you are depressed and/or suffering from anxiety. Feel free to ask them to read this leaflet. You can also ask them to tell you if they think you are feeling worse or if they think your behavior is changing.
Important side effects that have been seen with Seroxat
Some patients who take Seroxat edevelopsomething called akathisia, which means that they feel restless and cannot sit or stand still. Others may develop something called serotonergic syndrome or malignant neuroleptic syndrome. This is meant some or all of the following symptoms: feeling very aroused or irritated, confusion, restlessness, feeling hot, sweating, shaking, chills, hallucinations (seeing or hearing strange things), muscle stiffness, sudden muscle twitching, or rapid heartbeat. The severity can increase and lead to unconsciousness. If you experience any of these symptoms, consult a doctor. For more information on these or other side effects of Seroxat, see section 4.
Drugs such as Seroxat (so-called SSRIs ) can cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms have persisted after discontinuation of treatment.
Other medicines and Seroxat
Some medicines may affect the way Seroxat works or increase the risk of side effects. Seroxat may also affect the way other medicines work. Drugs affected are:
| – | Medicines called MAOIs, including moclobemide and methylthionine chloride (methylene blue) – see Do not use Seroxat in this leaflet. |
| – | Thioridazine or pimozide, which is antipsychotic – see Do not use Seroxat in this leaflet. |
| – | Acetylsalicylic acid, ibuprofen, or other so-called NSAIDs (non-steroidal anti-inflammatory drugs) such as celecoxib, etodolac, diclofenac, and meloxicam, are used for pain and inflammation. |
| – | Tramadol, buprenorphine, and pethidine are painkillers |
| – | Buprenorphine in combination with naloxone, opioid dependence replacement therapy, |
| – | Drugs called triptans, such as sumatriptan, are used to treat migraines |
| – | Other antidepressant drugs including other SSRIs and tricyclic antidepressants such as clomipramine, nortriptyline, and desipramine |
| – | A dietary supplement called tryptophan |
| – | Mivacurium and suxamethonium (used for anesthesia) |
| – | Drugs such as lithium, risperidone, perfenazine, and clozapine (so-called antipsychotics), are used to treat certain psychiatric illnesses |
| – | A combination of fosamprenavir and ritonavir used to treat HIV infection |
| – | St. John’s wort, a natural remedy for depression |
| – | Fentanyl, used in anesthesia or the treatment of chronic pain |
| – | Phenobarbital, phenytoin, sodium valproate, or carbamazepine for the treatment of seizures or epilepsy |
| – | Atomoxetine is a drug used to treat ADHD (Attention Deficit Hyperactivity Disorder) |
| – | Procyclidine used to relieve tremors, especially in Parkinson’s disease |
| – | Warfarin or other anticoagulants, ie blood thinners |
| – | Propafenone, flecainide, and medicines used to treat irregular heartbeat |
| – | Metoprolol, a beta-blocker used to treat high blood pressure and heart problems |
| – | Pravastatin is used to treat high cholesterol |
| – | Rifampicin used to treat tuberculosis and leprosy |
| – | Linezolid which is an antibiotic |
| – | Tamoxifen used to treat breast cancer |
If you are taking or have recently taken any of the medicines listed above and have not already discussed this with your doctor, see your doctor again and ask for advice. Your dose may need to be changed or you may need another medicine.
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription.
Seroxat with food, drink, and alcohol
Do not use alcohol while taking Seroxat. Alcohol can worsen your symptoms or side effects. Taking Seroxat in the morning with food may reduce the risk of nausea.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. There are reports of an increased risk of malformations, especially heart malformations in children whose mothers took Seroxat during the first months of pregnancy. In the general population, about 1 in 100 children is born with heart defects. The risk is higher in children whose mothers have taken Seroxat, where the risk is 2 out of 100 children. You and your doctor can decide together if you should switch to another treatment or if you should gradually reduce Seroxat while you are pregnant. Depending on the circumstances, your doctor may decide that continued treatment with Seroxat is better for you.
Tell your midwife or doctor that you are using Seroxat.
Taking Seroxat at the end of your pregnancy may increase the risk of heavy vaginal bleeding shortly after delivery, especially if you have a history of bleeding disorders. Your doctor or midwife should be informed that you are taking Seroxat so that they can advise you on this.
When drugs such as Seroxat are used during pregnancy, especially late in pregnancy, they may increase the risk of a serious condition called persistent pulmonary hypertension in the newborn (PPHN). In PPHN, the blood pressure in the blood vessels between the baby’s heart and lungs is too high. If you are taking Seroxat during the last 3 months of pregnancy, your newborn baby may also have other symptoms that usually start within the first 24 hours after birth and include:
- difficulty breathing
- bluish skin or that the child is too hot or cold
- blue lips
- vomiting or the child not eating properly
- that the child is very tired, has difficulty sleeping, or cries persistently
- tense or slack muscles
- tremors, twitches, or cramps
- excessive reflexes.
If your baby gets any of these symptoms after birth, or if you are worried about your baby’s health, contact your doctor or midwife for advice.
Seroxat can be excreted in breast milk in very small amounts. Consult your doctor before breastfeeding. You and your doctor can decide together if you can breastfeed while taking Seroxat.
In animal studies, it has been shown that paroxetine reduces the quality of semen. In theory, this could affect fertility, but no such reducing effect of paroxetine on fertility has yet been demonstrated in humans.
Driving and using machines
Possible side effects of Seroxat include dizziness, confusion, drowsiness, or blurred vision. If you get these side effects, do not drive or use machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Seroxat contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie it is essentially ‘sodium-free’.
How to use Seroxat
Always use this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
| Sometimes you may need to take more than one tablet or just half a tablet. This table shows you the number of tablets to take. | Dose | The number of tablets to be taken |
| 10 mg | Half a tablet | |
| 20 mg | A pill | |
| 30 mg | One and a half tablets | |
| 40 mg | Two tablets | |
| 50 mg | Two and a half tablets | |
| 60 mg | Three tablets |
The normal dosage for different conditions is given in the table below.
| Starting dose | Recommended daily dose | Maximum daily dose | |
| Depression | 20 mg | 20 mg | 50 mg |
| Obsessive-compulsive disorder | 20 mg | 40 mg | 60 mg |
| Panic syndrome | 10 mg | 40 mg | 60 mg |
| Social Phobia | 20 mg | 20 mg | 50 mg |
| Posttraumatic stressyndrome | 20 mg | 20 mg | 50 mg |
| Generalized anxiety disorder | 20 mg | 20 mg | 50 mg |
Your doctor will advise you on which dose of Seroxat to start with. Most people start to feel better after a few weeks. If you do not notice any improvement after this time, consult your doctor for advice. Your doctor may decide to increase your dose gradually, by 10 mg at a time, up to the highest daily dose.
Take Seroxat in the morning with food.
Swallow the tablets whole with a glass of water. Do not chew them.
Your doctor will discuss with you how long you need to continue taking Seroxat. It can be many 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 problems or severe kidney disease, your doctor may decide that your dose of Seroxat should be lower than what is normally recommended.
If you take more Seroxat than you were told to
Never take more Seroxat than your doctor advised.
If you have ingested too much medicine or if e.g. If a child has ingested the medicine by mistake, contact a doctor or hospital for risk assessment and advice. Show the medicine package.
A person who has overdosed on Seroxat may experience side effects listed in section 4. Possible side effects or the following symptoms: fever, uncontrollable muscle contraction.
If you forget to take Seroxat
Take Seroxat at the same time each day.
If you forget to take a dose and think about it before going to bed at night, take a dose immediately. Continue as usual the next day.
If you forget to take a dose and only remember to do so overnight or the next day, do not take any extra dose. You may experience some withdrawal symptoms, but these should go away after you take your next dose at the usual time.
Do not take a double dose to make up for a forgotten dose.
If you do not feel any improvement
Seroxat will not relieve your symptoms immediately. All antidepressant drugs require time to work. Some patients improve after a couple of weeks while for others it may take longer. Some people who take antidepressants experience a worsening before they start to feel better. If you have not started to get better after a few weeks, contact your doctor for advice. Your doctor should suggest a return visit a few weeks after you start treatment. Tell your doctor if you do not notice any improvement.
If you stop taking Seroxat
Do not stop taking Seroxat until your doctor tells you to.
When stopping Seroxat, your doctor will help you slowly reduce your dose over several weeks or months to reduce the risk of withdrawal symptoms. One way to do this is to gradually reduce your dose of Seroxat by 10 mg per week. Most people experience that the withdrawal symptoms are mild and disappear on their own within 2 weeks. For some patients, the symptoms may be more severe or more prolonged.
If you experience withdrawal symptoms when you stop your treatment, your doctor may recommend that you discontinue Seroxat more slowly. Contact your doctor if you experience severe withdrawal symptoms. Your doctor may ask you to start taking Seroxat again, then discontinue the medicine more slowly.
Even if you experience withdrawal symptoms, it will be possible for you to stop taking Seroxat.
Withdrawal symptoms that may occur when treatment is stopped
According to studies, 3 out of 10 patients experience one or more withdrawal symptoms when stopping treatment with Seroxat. Some symptoms occur more often than others.
Common withdrawal symptoms
These can occur in up to 1 in 10 users
| – | Dizziness (feeling of instability, balance difficulties) |
| – | Emotional disorders such as ant crawling, burning sensation and less common, feeling of electric shock even in the head, as well as buzzing, whistling, ringing, or other persistent sounds in the ears ( tinnitus ) |
| – | Sleep disorders (vivid dreams, nightmares, difficulty falling asleep) |
| – | Anxiety |
| – | Headache. |
Uncommon withdrawal symptoms
These can occur in up to 1 in 100 users
| – | Nausea |
| – | Sweating (including night sweats) |
| – | Restlessness or agitation |
| – | Tremor (shaking) |
| – | Confusion or disorientation |
| – | Diarrhea |
| – | Emotional instability or irritability |
| – | Visual disturbances |
| – | Fluttering and throbbing heartbeat (palpitations). |
If you are concerned about withdrawal symptoms when stopping treatment with Seroxat, talk to your doctor.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Adverse reactions occur more frequently during the first weeks of treatment with Seroxat.
If you get any of the following side effects during treatment, contact your doctor immediately or consult a hospital.
Uncommon side effects are
These can occur in up to 1 in 100 users
| – | If you get unusual bruising or bleeding, bloody vomiting, or blood in the stool, contact a doctor or see a hospital immediately. |
| – | If you have difficulty urinating (throwing water), consult a doctor or see a hospital immediately. |
Rare side effects
These can occur in up to 1 in 1,000 users
| – | If you have a seizure, consult a doctor or see a hospital immediately. |
| – | If you feel restless and have difficulty sitting or standing still, it may be something called akathisia. Increasing the Seroxat dose may worsen the symptoms. Contact a doctor if you experience these symptoms. |
| – | If you feel tired, weak, or confused and have sore, stiff, or uncoordinated muscles, this may be due to too low a level of sodium in the blood. Contact a doctor if you get these symptoms. |
Very rare side effects
These can occur in up to 1 in 10,000 user
| – | Allergic reaction, which may be severe, to Seroxat. If you develop red and lumpy skin rash, swelling of eyelids, face, lips, mouth or tongue, itching or difficulty breathing (shortness of breath), or swallowing and feeling weak or dizzy resulting in fainting or unconsciousness, consult a doctor or see a hospital. immediately. |
| – | If you have one or all of the following symptoms, it could be a so-called serotonergic syndrome or malignant neuroleptic syndrome. The symptoms consist of feeling very aroused or irritated, confusion, restlessness, feeling hot, sweating, shaking, shivering, hallucinations (hearing and seeing strange things), muscle stiffness, sudden muscle twitching, or palpitations. The severity can increase and lead to unconsciousness. Contact a doctor if you experience this. |
| – | Acute glaucoma. |
| – | If it suddenly hurts in your eyes and you get blurred vision, consult a doctor. |
Has been reported
Occurs in an unknown number of users
| – | Some people have had thoughts of harming themselves or taking their own lives while taking Seroxat or shortly after stopping treatment (see If you start to feel worse and have thoughts of harming yourself in section 2). |
| – | Some people have experienced aggression while taking Seroxat. |
| – | Severe vaginal bleeding shortly after delivery ( postpartum hemorrhage), see Pregnancy, breastfeeding, and fertility in section 2 for more information. |
| If you experience these side effects, consult your doctor. |
Other possible side effects are during the treatment
Very common side effects are
These can occur in more than 1 in 10 user
| – | Nausea. Taking Seroxat with food in the morning reduces the risk of this. |
| – | Changes in sexual drive or function, such as missed orgasm, and in men, erectile dysfunction and ejaculation. |
Common side effects are
These can occur in up to 1 in 10 users
| – | Elevated blood cholesterol levels |
| – | Loss of appetite |
| – | Poor sleep (difficulty falling asleep) or drowsiness |
| – | Abnormal dreams (including nightmares) |
| – | Dizziness or tremors ( tremor ) |
| – | Headache |
| – | Concentration difficulties |
| – | Indignation |
| – | Unusual weakness |
| – | Dimsyn |
| – | Yawning, dry mouth |
| – | Diarrhea or constipation |
| – | Vomiting |
| – | Weight gain |
| – | Sweating. |
Uncommon side effects are
These can occur in up to 1 in 100 users
| – | A short-term increase in blood pressure, or a short-term decrease that may make you feel dizzy or faint when you get up quickly |
| – | Faster heart rate than normal |
| – | Impairment of movement, stiffness, shaking, or abnormal movements of the mouth or tongue |
| – | Dilated pupil is |
| – | Rash |
| – | Itching |
| – | Confusion |
| – | Hallucinations (seeing and hearing strange things) |
| – | Inability to urinate ( urinary retention ) or uncontrollable, involuntary urination (urinary incontinence) |
| – | If you are a diabetic patient, you may experience a loss of control of your blood sugar levels while taking Seroxat. Talk to your doctor about adjusting the dose of your insulin or diabetes medicine. |
Rare side effects
These can occur in up to 1 in 1,000 users
| – | Abnormal production of breast milk in men and women |
| – | Slow pulse |
| – | Liver effects in the form of elevated liver function values in blood |
| – | Panic attacks |
| – | Overactive behavior or thoughts (mania) |
| – | The feeling of being outside your own body (depersonalization) |
| – | Anxiety |
| – | The uncontrollable need to move the legs (Restless Legs syndrome) |
| – | Pain in joints and muscles. |
| – | Increase of hormone and prolactin in the blood. |
| – | Menstrual disorders (including heavy or irregular menstrual bleeding, bleeding between periods, and absence or delayed menstruation). |
Very rare side effects
These can occur in up to 1 in 10,000 users
| – | Skin rashes that can cause blisters and look like small “targets” (a central dark spot surrounded by a paler area, with a dark ring around the edge) are called erythema multiforme |
| – | Extensive rash with blisters and flaky skin, especially around mouth, nose, eyes, and genitals ( Stevens-Johnson syndrome) |
| – | Extensive skin rash with blisters and scales that occupy a large part of the body surface ( toxic epidermal necrolysis ) |
| – | Liver problems that cause the skin and whites of the eyes to turn yellow |
| – | Syndrome with insufficient production of antidiuretic hormone (SIADH), a condition that causes excess water and decreased sodium (salt) concentration in the body, this due to incorrect chemical signals. Patients with SIADH may become seriously ill or may be completely asymptomatic. |
| – | Accumulation of fluid or water (which may cause swelling of the arms and legs) |
| – | Sensitivity to sunlight |
| – | Painful and persistent erection of the penis |
| – | Decreased number of platelets in the blood. |
Has been reported
Occurs in an unknown number of users
- Inflammation of the colon (causing diarrhea)
- Tooth grinding.
Some patients have experienced buzzing, whistling, ringing, or another persistent ringing in the ears ( tinnitus ) when using Seroxat.
An increased risk of bone fractures has been seen in patients taking this type of drug.
How to store Seroxat
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 carton or can and on the carton after EXP. The expiration date is the last day of the specified month.
Do not store above 30 ° C.
Store in the original package. Sensitive to light.
If you use half tablets, be sure to store them safely in the package.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the packaging and other information
Content declaration
| – | The active substance is paroxetine (20 mg), in the form of hydrochloride hemihydrate. | |
| – | The other ingredients are | |
| ο | in the tablet core: calcium hydrogen phosphate dihydrate (E341), magnesium stearate (E470b), and sodium starch glycolate (type A) | |
| ο | in the film coating: hypromellose (E464), titanium dioxide (dye E171), macrogol 400, and polysorbate 80 (E433). |
What the medicine looks like and the contents of the pack
Seroxat 20 mg film-coated tablet is white, oval, and debossed with “20” on one side and a score line on the other side. Seroxat 20 mg tablets are available in child-resistant pressure packs or 50 x 50, 1, 4, 10, 14, 20, 28, 30, 50, 56, 60, 98, 100, 250 or 500 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
GlaxoSmithKline AB, Box 516, 169 29 Solna
Tel .: 08-638 93 00
E-mail: info.produkt@gsk.com
Manufacturer
GlaxoSmithKline Pharmaceuticals SA
ul. Grunwaldzka 189
60-322 Poznan
Poland
This medicine is authorized in the European Economic Area
and in the United Kingdom (Northern Ireland) under the names:
20 mg film-coated tablet
| Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, Germany, Greece, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, United Kingdom (Northern Ireland) | Seroxat |
| France | Deroxate |
It may also be helpful for you to contact a self-help or patient organization support group to find out more about your illness. Your doctor can give you the detailed information.