Composition of tablets
The drug substance of SEROXAT is paroxetine (paroxetine) in the form of paroxetine hydrochloride (paroxetine hydrochloride).
Excipients include: dibasic calcium phosphate dihydrate, sodium starch glycolate, magnesium stearate, hydroxypropyl methylcellulose, titanium dioxide, polyethylene glycol 400, polysorbate 80, indigo carmine - EEC 132 (this component is present in the film coating of the tablets only by the 30 mg).
WHAT SEROXAT AND WHAT IT IS USED
Pharmaceutical form SEROXAT is in the form of:
♦ white oval tablets (with a line for dividing the tablet) coated with a film containing 20 mg paroxetine, packaged in blisters
♦ blue oval tablets (with a line for dividing the tablet) coated with a film containing 30 mg paroxetine, packaged in blisters.
Evidence
SEROXAT can be prescribed for adults with the following diseases:
♦ Depression (drug could help other antidepressants even if you have not taken effect).
♦ obsessive or compulsive behavior (obsessive thoughts and actions).
♦ Panic attacks with or without agoraphobia (fear of going to public places or open spaces).
♦ Social Anxiety Disorder / Social Phobia.
♦ Generalized Anxiety (constant feeling of causeless anxiety and nervousness).
♦ Post-traumatic stress disorder (anxiety after a traumatic experience eg. Car accident, physical violence, natural disaster such as flood or earthquake).
Not recommended for use SEROXAT in children and adolescents up to age 18
Such conditions may occur when the levels of a chemical substance in the brain, called serotonin (5-hydroxytryptamine) are lowered. During the first few weeks of treatment usually paroxetine increases the levels of serotonin in mozaka.Paroxetine belongs to the class of drugs called selective reuptake inhibitors of serotonin.
BEFORE YOU TAKE SEROXAT
Contraindications
Do not take SEROXAT:
♦ If you are hypersensitive (allergic) to paroxetine or any of the other ingredients of SEROXAT.
♦ If you are taking or have recently taken (within the last two weeks) other antidepressants called monoamine oxidase (MAO) inhibitors.
♦ If you are taking thioridazine.
Special Precautions
Before you start taking this medicine, tell your doctor if:
♦ If you are aged under 18 years (see use in children and adolescents under 18 years).
♦ Do you have health problems from kidney, liver or heart.
♦ You had manic episodes in the past (bouts of anxiety, hyperactivity or abandon).
♦ suffer or have previously suffered from epilepsy.
♦ You suffer from glaucoma (increased eye pressure).
♦ Often injured, getting easy bleeding or taking medicines that may increase bleeding (eg. Aspirin).
♦ you are pregnant, may be pregnant, plan to become pregnant or breast-feeding.
♦ taking other antidepressants.
♦ Do diagnosed with schizophrenia and taking drugs to treat this disease.
Particular attention with SEROXAT is necessary if you are over 65 or have liver problems since SEROXAT can lead to hyponatremia (reducing the amount of sodium in the blood). This can cause symptoms such as drowsiness and muscle weakness. There is more often if you have a disease called cirrhosis of the liver and / or taking other medications that cause hyponatraemia. If you experience these symptoms, please consult your doctor.
Use in children under 18 years
Not recommended for use SEROXAT in children and adolescents up to 18 years. In a study of paroxetine in patients under 18 years with major depressive disorder, obsessive-compulsive disorder or children with anxiety are identified increased adverse effects to those seen in adults, such as suicidal thoughts, hostile and unfriendly behavior and changing attitudes (see Possible side effects). Furthermore, long-term safety of treatment with paroxetine in this age group have not yet been proven.
Use in pregnancy and lactation
Pregnancy:
Before you start taking SEROXAT, consult your doctor. If you find that you are pregnant after you start treatment with SEROXAT, inform your doctor. You should talk with your doctor if you are planning to become pregnant. Some studies showed a possible increased risk of birth defects associated with the use of Seroxat in the first few months of pregnancy. If SEROXAT be used during later stages of pregnancy until birth, the neonate were observed following symptoms without causal relationship to SEROXAT:
Difficulty in sleeping, fear, constant crying, irritability, difficulty feeding, lethargy, tremors, vomiting, low blood sugar, difficulty in breathing, dark blue or turpurno coloration of the skin, fainting, feeling too relaxed muscles complications in the regulation of body temperature. These symptoms normally pass over time. However, if your baby has any of these symptoms, consult your physician as soon as possible.
Lactation
Tell your doctor if you are breastfeeding. You should not take SEROXAT, while breast-feeding, unless your doctor tells you otherwise.
Interactions with other drugs
Taking other medicines:
Please tell the doctor if you are taking or have recently taken any other medicines, including those you buy without a prescription. SEROXAT can influence the effect of other drugs and other drugs may interfere with the effect of SEROXAT.Lekarstva that can interact with SEROXAT are:
♦ Other antidepressants.
♦ Other drugs that affect serotonin such as lithium, linezolid, tramadol, tryptophan, medicines containing St. John's wort, medicines for the treatment of migraine.
♦ Medicines to treat arrhythmias.
♦ Medicines to treat schizophrenia.
♦ procyclidine, which is used for treatment of Parkinson's disease or other movement disorders.
♦ Metoprolol, which is used to treat high blood pressure, arrhythmia, and angina (angina pectoris).
♦ Medicines affecting coagulation and increasing bleeding, such as oral anticoagulants (eg. Warfarin), aspirin and other nonsteroidal anti-inflammatory drugs (eg. Ibuprofen).
♦ Medicines to treat epilepsy.
As with many other medications are not recommended for use alcohol while taking SEROXAT.
Effects on ability to drive or operate machinery
SEROXAT can cause drowsiness. Before you drive or operate machines to make sure that when taking SEROXAT not feel tired or sleepy. If you feel tired or sleepy, these activities should be avoided.
HOW TO TAKE SEROXAT
Follow the doctor's advice about how and when to take medicine. Your doctor will decide how many tablets a day should be taken.
Usage
It is recommended to swallow the tablets whole with water, preferably during meals. Do not chew tabletkite.Priemayte medicine in the morning, preferably with breakfast.
Dosage
Typically, the recommended daily dose of SEROXAT for treating depression, anxiety and stress disorder pasttravmatichno is 30 mg.
For the treatment of panic attacks or obsessions recommended daily dose of 40 mg SEROXAT. The doctor may start you on a lower dose of the above gradually increase it to reach them. In general, most patients received doses between 20 mg and 50 mg SEROXAT a day depending on their individual response.
For the treatment of panic attacks or obsessions doctor may advise you to take 60 mg SEROXAT day. If you are aged over 65, the maximum recommended dose is 40 mg per day.
Duration of treatment
You need to keep taking the medicine even if you feel more dobrevednaga as it can take several weeks until SEROXAT podeystva.Konsultirayte your doctor if you feel that the effect of SEROXAT is too strong or too weak, or if you have other issues that you think; that could be related to taking SEROXAT. Keep taking your medicine unless your doctor tells you to stop. The doctor may advise you to keep taking SEROXAT for several months, even if you feel better, as this will prevent the re-occurrence of symptoms. Follow the doctor's prescription.
Once you have started treatment with SEROXAT
Like other drugs of this class, SEROXAT will not relieve your symptoms immediately. Patients usually start to feel better after about a couple of weeks. Sometimes symptoms of depression or other psychiatric conditions may include thoughts of harming or killing themselves. These symptoms may continue or intensify occur until the antidepressant effect of the drug. This is more likely if you are under the age of 30 years or you've never taken antidipresivna therapy. Tell your doctor immediately if you have thoughts or attempted suicide or self-harm, as well as worsening of depression or other symptoms during lechenieto.Vazmozhno small number of patients have anxiety or agitation, accompanied by an inability to sit or stand, especially during the first few weeks of treatment. If you experience these symptoms, tell your doctor as soon as possible after barzo.Dori feel better to prevent recurrence of symptoms, it is important to keep taking the medicine for as long as your doctor advises. Depression, this period may be several months, and in panic disorder and obsessive-compulsive disorder and more.
What to do if you take more than prescribed
If you take more than you need SEROXAT or if someone else has taken your medicine by mistake, seek medical advice immediately.
What should you do if you miss one or more doses
If you forget to take SEROXAT, wait and take your next dose as usual the next morning. If you forget to take your medicine during the day, do not take a double dose the next day.
Effects after discontinuation of SEROXAT
Do not stop treatment with Seroxat until your doctor tells you. The doctor will usually recommend a gradual reduction of the dose over a period of several weeks. When stopping treatment with SEROXAT, especially if it is abruptly, you may experience side effects (See "Possible side effects").
Possible side effects
Many patients do not have problems in the treatment with Seroxat. However, like all drugs, SEROXAT can cause side effects. Most of the side effects become more pronounced after the first few days of treatment.
Side effects that may occur during therapy:
Some people may be hypersensitive (allergic) to medicines, although this is very rare. If you have any of these symptoms after taking SEROXAT, seek immediate medical attention:
♦ swelling of the eyelids, face, lips, mouth or tongue
♦ skin rash
♦ itching
♦ difficulty breathing or swallowing
If you notice any side effects other than those listed below, which may or may not be associated with SEROXAT, you should tell your doctor.
The most common side effects when taking SEROXAT are:
♦ nausea (taking the medicine in the morning with food will reduce the possibility of this sesluchi)
♦ breach in normal sexual function, for example. impotence, premature ejaculation
♦ decreased appetite
♦ sleepiness
♦ insomnia
dizziness
♦ tremors (uncontrollable shaking)
♦ blurred vision
♦ yawning
♦ constipation
♦ diarrhea
♦ dry mouth
♦ sweating or feeling faint
♦ weight gain
Less frequent adverse effects which may be observed in the treatment with SEROXAT, include:
♦ easy bruising or unusual bleeding, especially of the skin and mucous membranes
♦ confusion
♦ hallucinations
♦ uncontrolled movements of the body, including the face
♦ rapid pulse
♦ temporary increase or decrease in blood pressure (usually seen in patients with anxiety or high blood pressure)
♦ skin rashes
♦ inability to pass urine
Some side effects are rare and occur in a small number of patients:
♦ seizures
♦ anxiety and agitation, which may be accompanied by an inability to sit or stand in one place
♦ manic reactions (attacks of uncontrollable behavior, excitement and over-reactivity)
♦ reduced levels of sodium in the blood (especially the elderly)
♦ increased intraocular pressure (acute glaucoma)
♦ disturbed levels of liver enzymes or symptoms of liver damage, which can be expressed in nausea, vomiting, lack of appetite, malaise, fever, itching, yellowing of the skin and eyes, dark urine
♦ secretion of milk outside periods of lactation
♦ swelling of hands / feet
♦ gastrointestinal bleeding
♦ reduced number of platelets in the blood
♦ skin sensitivity to sunlight
♦ "serotonin syndrome" (symptoms, including anxiety, confusion, sweating, hallucinations, increased reflexes, muscle spasms, tremors, rapid heartbeat and trembling)
♦ Surplus antidiuretic hormone that causes fluid retention and water
Side effects that may occur PRI discontinuation:
Studies show that 3 in 10 patients reported having symptoms associated with stopping treatment with SEROXAT. For comparison, these symptoms were reported from 2 to 10 people, when they stop taking tablets containing only sugar. However, these symptoms are not the same as the substances of addiction or dependency (e. Heroin).
Symptoms include:
♦ dizziness
♦ sensory disturbances such as tingling, burning sensation and a feeling of electricity
♦ sleep disorders, including restless dreams
♦ agitation or anxiety nausea
♦ tremor
♦ confusion
♦ sweating
♦ headache
♦ diarrhea
These symptoms occur within the first few days of treatment discontinuation or in very rare cases, if a dose is missed. However, the more likely they are to occur in too abruptly stopping treatment with Seroxat. Therefore always consult your doctor before stopping the drug. In most patients, symptoms disappear after a few weeks. However, if you feel that the side effects are severe, consult your doctor who will advise you how to gradually stop lechenieto.Ako side effects become particularly troublesome, tell your doctor si.Ako observe any side effect that It is not mentioned in this leaflet, molyainformirayte doctor.
HOW TO STORE SEROXAT
Keep out of reach of children.
Tablets should be stored in a cool, dry place below 30 ° C, in the original opakovka.Ne take the medicine after the expiry date stated on the packaging.