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What is SEROXAT and what it is used for
SEROXAT is a medicine for the treatment of elderly patients with depression and / or anxiety disorders. Anxious disorders that can be treated with SEROXAT are: obsessive-compulsive disorder (recurrent intrusive thoughts with uncontrollable behavior), panic disorder (panic attacks, including those caused by agoraphobia, which is a fear of open spaces, (fear of or avoidance of social situations), post-traumatic stress disorder (anxiety after traumatic experience), and generalized anxiety disorder (constant feeling of anxiety or nervousness).
SEROXAT belongs to a group of medicines called selective serotonin reuptake inhibitors (SSRIs). Each person's brain has a substance called serotonin. People who are depressed or anxious have lower levels of serotonin than other people. It is not fully understood how SEROXAT and other serotonin reuptake inhibitors work, but they may help increase serotonin levels in the brain. Proper treatment of depression or anxiety disorders is important to help you get better.
2. What you need to know before taking SEROXAT
Do not take SEROXAT
- If you are taking medicines called monoamine oxidase inhibitors (MAOIs including moclobemide and methylthioninium chloride (methylene blue)) or have been taking them for the last two weeks. Your doctor will advise you how to start taking SEROXAT after you stop taking MAOI.
- If you are taking the antipsychotic medicines 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 apply to you, tell your doctor without taking SEROXAT.
Warnings and precautions
Talk to your doctor or pharmacist before taking SEROXAT
- Do you take any other medicines (see Other Medicines and SEROXAT in this leaflet)?
- Do you take tamoxifen for breast cancer treatment or fertility problems? SEROXAT may make tamoxifen less effective, so your doctor may recommend another antidepressant.
- Do you have kidney, liver or heart problems?
- Have you had epilepsy or have you had seizures or seizures in the past?
- Have you had any manic episodes (overactive behavior or thoughts)?
- Do you receive electroconvulsive therapy (ECT)?
- Have you had bleeding problems or are you taking medicines that may increase your risk of bleeding (this includes blood thinners such as warfarin, antipsychotic medicines such as perphenazine or clozapine, tricyclic antidepressants, medicines used to treat pain and inflammation called non-steroidal anti-inflammatory drugs or NSAIDs such as acetylsalicylic acid, ibuprofen, celecoxib, etodolac, diclofenac, meloxicam)?
- Do you have diabetes?
- Are you on a salt-free diet?
- Do you have glaucoma (increased intraocular pressure)?
- Are you pregnant or planning to become pregnant (see Pregnancy, Lactation and Fertility, in this leaflet)?
- Are you under the age of 18 (see Children and adolescents under the age of 18 in this leaflet)?
If you answer YES to any of these questions and have not yet discussed it with your doctor, ask your doctor for advice on what to do with SEROXAT.
Children and adolescents under the age of 18 years
SEROXAT should not be used in children and adolescents under 18 years of age. Also, patients under 18 years of age are at increased risk of side effects, such as suicide attempts and hostilities (mainly aggression, antagonism, and anger) when taking SEROXAT. If your doctor has prescribed SEROXAT to you (or your child) and you would like to discuss this, please return to your doctor. You should tell your doctor if any of the above symptoms occur or worsen while you (or your child) are taking SEROXAT. In addition, the long-term effects of SEROXAT on safety in terms of growth, maturation, and cognitive and behavioral development have not yet been demonstrated in this age group.
In the SEROXAT trials in children and adolescents below the age of 18 years, the common side effects affecting less than 1 in 10 patients were: increased thoughts and attempted suicide, deliberate self-harm, hostility, aggression or hostility, lack of appetite, trembling, pathological sweating, hyperactivity (too much energy), agitation, change of emotions (including crying and mood swings) and unusual onset of bruising or bleeding (such as nosebleeds). Studies have shown that the same symptoms affected children and adolescents taking sugar tablets (placebo) instead of SEROXAT, although they were less commonly observed in this case,
In some patients
If you are taking or have recently taken any of the medicines on this list and have not yet discussed them with your doctor, come back and ask him or her what to do. Your dose may need to be changed or you may be prescribed another medicine.
Please 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 consume alcohol while taking SEROXAT. Alcohol can aggravate your symptoms or side effects. Taking SEROXAT in the morning with food will reduce the likelihood of nausea.
Pregnancy, breastfeeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before using this medicine. Some studies have shown an increased risk of birth defects, especially those affecting the heart, in babies whose mothers have taken SEROXAT during the first few months of pregnancy. In the general population, approximately 1 in 100 babies is born with a heart defect. This ratio rises to 2 in 100 babies in mothers who have taken SEROXAT. You and your doctor may decide that it is better to switch to another treatment or to gradually stop taking SEROXAT while you are pregnant. However, depending on your circumstances, your doctor may decide that it is better for you to continue taking SEROXAT.
Tell your midwife or doctor if you are taking SEROXAT. Medicines such as SEROXAT taken during pregnancy, especially in recent months, may increase the risk of a serious condition in babies called persistent pulmonary hypertension of the newborn. In this condition, the blood pressure in the blood vessels between the heart and the baby's lungs is too high. If you are taking SEROXAT during the last 3 months of pregnancy, your newborn baby may also have other conditions that usually start within the first 24 hours after birth.
- breathing problems
- bluish skin tone or skin is too warm or cold
- vomiting or malnutrition
- major fatigue, inability to sleep, or prolonged crying
- tight or relaxed muscles
- tremors, tremors or convulsions
- Enhanced reflexes.
If your baby has any of these symptoms when he is born or is worried about his health, contact your doctor or midwife for advice on what to do.
Seroxate may be excreted in very small amounts in breast milk. If you are taking SEROXAT, you should return to your doctor and talk to your doctor before you start breast-feeding. You and your doctor may decide that you may breast-feed while you are taking SEROXAT.
In animal studies, paroxetine has been shown to reduce sperm quality. This could theoretically affect fertility, but so far no effect on human fertility has been observed.
Driving and using machines
Possible side effects of SEROXAT include dizziness, confusion, drowsiness or blurred vision. Do not drive or operate machinery if you experience these side effects.
3. How to take SEROXAT
Always take this medicine exactly as your doctor or pharmacist has told you.
If you are not sure, ask your doctor or pharmacist.
Sometimes you may need to take more than one tablet or half a tablet. The table below shows how many tablets you should take and the appropriate doses for different conditions.
Initial dose Recommended daily dose Maximum daily dose
Depression 20 mg (1 tablet) 20 mg (1 tablet) 50 mg (2 tablets and a half)
Obsessive Compulsive Disorder 20 mg (1 tablet) 40 mg (2 tablets) 60 mg (3 tablets)
Panic Disorder 10 mg (half tablet) 40 mg (2 tablets) 60 mg (3 tablets)
Social Anxiety Disorder 20 mg (1 tablet) 20 mg (1 tablet) 50 mg (2 tablets and a half)
Post-traumatic stress disorder 20 mg (1 tablet) 20 mg (1 tablet) 50 mg (2 tablets and a half)
Generalized Anxiety Disorder 20 mg (1 tablet) 20 mg (1 tablet) 50 mg (2 tablets and a half)
Your doctor will advise you on the dose you need when you first start taking SEROXAT for the first time. Most people start to feel better after a few weeks. If you do not feel better after this period, talk to your doctor and he or she will advise you on what to do. Your doctor may decide to gradually increase your dose by 10 mg, until the maximum daily dose is reached.
Take the tablets in the morning with food.
Swallow them with water.
Do not chew them.
Your doctor will tell you how long it will take to take the pills. This period can be many months or even longer.
The maximum dose for people over 65 is 40 mg daily.
Patients with liver or kidney disease
If there is
If you remember at night or the next day, leave out the missed dose. You may get withdrawal symptoms, but they should go away when you take your next dose at the usual time.
Do not take a double dose to make up for a forgotten dose.
What to do if you don't feel better
SEROXAT will not relieve your symptoms immediately - all antidepressants take time to act. Some people start to feel better after a few weeks, but for others it may be longer. Some people who take antidepressants initially get worse and then improve. If you do not feel well after a few weeks, return to your doctor and he or she will advise you what to do. Your doctor should schedule a repeat visit a few weeks after the initial start of treatment. Tell your doctor if you have not started to feel better.
If you stop taking SEROXAT
Do not stop taking SEROXAT until your doctor tells you to.
When you stop taking SEROXAT, your doctor will help you reduce the dose slowly over a few weeks or months, which should reduce the likelihood of taking withdrawal effects. The only way to do this is to gradually reduce the dose you are taking by 10 mg per week. In most people, the symptoms of stopping SEROXAT are mild and disappear spontaneously within two weeks. In some people, these symptoms may be more severe or last longer.
If you experience withdrawal symptoms when you reduce your tablet intake, your doctor may decide that you should reduce them slowly. Please consult your doctor if you experience severe withdrawal effects when you stop taking SEROXAT. Your doctor may tell you to start taking the medicine again and reduce the dose more slowly.
If you get withdrawal symptoms, you may still stop taking SEROXAT.
Possible withdrawal symptoms when you stop treatment
Studies show that 3 in 10 patients notice the onset of one or more symptoms when stopping SEROXAT. Some withdrawal symptoms are more common than others.
Common side effects that usually affect up to 1 in every 10 patients:
- Feeling dizzy, unstable or lacking balance
- Tingling, burning sensation and (less commonly) sensation of electric current, including the head, as well as hum, hiss, whistling, ringing or other intrusive tinnitus (tinnitus)
- Sleep disorders (vivid dreams, nightmares, inability to sleep)
Uncommon side effects that usually affect up to 1 in every 100 patients:
- Sweating (including at night)
- Nervousness or anxiety Tremor (shaking)
- Confusion or disorientation
- Diarrhea (disorder)
- Hypersensitivity or irritability
- Visual impairment
- Irregular or rapid heart rate (palpitations).
Please consult your doctor if you are concerned about the effects of stopping the medicine when you stop taking SEROXAT.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. There is a greater likelihood of side effects occurring within the first few weeks of taking SEROXAT.
See your doctor if you experience any of the following side effects during treatment.
You may need to contact your doctor or go directly to a hospital.
Uncommon side effects that usually affect up to 1 in every 100 patients:
- Contact your doctor or go directly to a hospital if you experience unusual bruising or bleeding, including vomiting of blood or blood in your stool.
- Contact your doctor or go directly to the hospital if you find that you cannot urinate.
Rare side effects that usually affect up to 1 in every 1,000 patients:
- Contact your doctor or go directly to the hospital if you have seizures
- If you have a feeling that you cannot find a place, sit or stand straight, you may have a condition called akathisia. Increasing the dose can aggravate these feelings. Contact your doctor if you feel as described.
- If you feel tired, weak or confused and your muscles ache, are stiff or unable to coordinate, the cause may be low levels of sodium in your blood. Contact your doctor if you have these symptoms.
Very rare side effects, which usually affect up to 1 in every 10,000 patients:
- Allergic reactions to SEROXAT which can be severe.
Contact your doctor or go directly to the hospital if you get a red and lump-like skin rash, swelling of the eyelids, face, lips, mouth
How to store SEROXAT
Keep out of the reach and sight of children.
Do not use this medicine after the expiry date which is stated on the blister and the carton. The expiry date refers to the last day of that month.
Do not store above 30 ° C.
Store in the original package in order to protect from light.
If you use half a tablet, carefully store it in a safe place in the pack.
Do not dispose of medicines in sewage or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment.
6. Contents of the pack and other information
What SEROXAT film-coated tablets contain
The active substance is paroxetine (20 mg) as hydrochloride hemihydrate.
The other ingredients are;
- at the core of the tablet: dibasic calcium phosphate dihydrate (E341), magnesium stearate (E470b) and sodium starch glycolate (Type A).
- in film coating: hypromellose (E464), titanium dioxide (E171), macrogol 400 and polysorbate 80 (E433).
What SEROXAT looks like and contents of the pack
SEROXAT 20 mg film-coated tablets are white, oval, biconvex tablets engraved with “SEROXAT 20” or “20” on one side and a dividing line on the other. The tablets are packaged in child-resistant blisters. Each pack contains 30 tablets.
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