Paxil/Seroxat 40 mg. 30 tablets
Paxil is a medicine for the treatment of elderly patients with depression and / or anxiety disorders. Anxious disorders that can be treated with Paxil 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).
Paxil 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 Paxiland 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 Paxil
Do not take Paxil
- 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 Paxil 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 Paxil
Warnings and precautions
Talk to your doctor or pharmacist before taking Paxil
- Do you take any other medicines (see Other Medicines and Paxil in this leaflet)?
- Do you take tamoxifen for breast cancer treatment or fertility problems? Paxil 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 Paxil
Children and adolescents under the age of 18 years
Paxil 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 Paxil . If your doctor has prescribed Paxil 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 Paxil. In addition, the long-term effects of Paxil on safety in terms of growth, maturation, and cognitive and behavioral development have not yet been demonstrated in this age group.
In the Paxil 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 Paxil , although they were less commonly observed in this case,
In some patients
Other antidepressants, including other serotonin reuptake inhibitors and tricyclic antidepressants, such as clomipramine, nortriptyline and desipramine.
- A dietary supplement called tryptophan.
- Mivacurium and suxamethonium (used in anesthesia)
Medicines such as lithium, risperidone, perphenazine, clozapine (called antipsychotic medicines), which are used to treat certain psychiatric conditions.
- Fentanyl used in anesthesia or for the treatment of chronic pain.
- A combination of fosamprenavir and ritonavir, which is used to treat HIV infection.
- St. John's wort, an herb used for depression.
- Phenobarbital, phenytoin, sodium valproate or carbamazepine used to treat seizures or epilepsy.
- Atomoxetine, used to treat attention-deficit hyperactive disorder.
- Procycididine, which is used to relieve tremor, mainly in Parkinson's disease.
- Warfarin or other medicines (called anticoagulants) that are used to thin the blood.
- Propafenone, flecainide and medicines used to treat irregular heart rhythm.
- Metoprolol, a beta-blocker for the treatment of high blood pressure and heart problems.
- Pravastatin used to treat high cholesterol
- Rifampicin used to treat tuberculosis and leprosy.
- Linezolid, an antibiotic.
- Tamoxifen, used to treat breast cancer or fertility problems.
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.
Paxil with food, drink and alcohol
Do not consume alcohol while taking Paxil . Alcohol can aggravate your symptoms or side effects. Taking Paxil 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 Paxil 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 Paxil . You and your doctor may decide that it is better to switch to another treatment or to gradually stop taking Paxilwhile you are pregnant. However, depending on your circumstances, your doctor may decide that it is better for you to continue taking Paxil
Tell your midwife or doctor if you are taking Paxil . Medications such as Paxil taken during pregnancy, especially in recent months, may increase the risk of a serious condition in babies called persistent pulmonary hypertension in 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 Paxil 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 Paxil , 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 Paxil
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 Paxil include dizziness, confusion, drowsiness or blurred vision. Do not drive or operate machinery if you experience these side effects.
3. How to take Paxil
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
If you take more Paxil than you should
Never take more tablets than your doctor advised. If you take too many tablets of Paxil (or someone else takes more tablets), tell your doctor immediately or call a hospital. Show them the pack of tablets.
If you take an overdose of Paxil, you may experience some of the symptoms listed in section 4, Possible side effects, or the following symptoms: fever, uncontrolled muscle tightening.
If you forget to take Paxil
Take your medicine at the same time each day.
If you forget to take the medicine and remember before going to bed, take it straight. Continue the next day as usual.
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
Paxil 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 Paxil
Do not stop taking Paxil until your doctor tells you to.
When you stop taking Paxil, 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 Paxil 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 Paxil . 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 Paxil .
Possible withdrawal symptoms when you stop treatment
Studies show that 3 in 10 patients notice the onset of one or more symptoms when stopping Paxil . 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 Paxil
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 Paxil
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
Very rare side effects, which usually affect up to 1 in every 10,000 patients:
- A skin rash that can form blisters and looks like small targets (a central dark spot surrounded by a paler area with a dark circle around the edge) called a multiform erythema
- Extensive rash with blisters and exfoliation, especially around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome)
- Extensive rash with blisters and skin exfoliation on most of the body surface (toxic epidermal necrolysis)
- Liver problems that make the skin or white of the eyes yellow
- Syndrome of improper secretion of anti-diuretic hormone, which is a condition in which water is retained in the body and the concentration of sodium (salt) is reduced as a result of incorrect chemical signals. Patients with syndrome of improper secretion of antidiuretic hormone may be severely ill or have no symptoms.
- Fluid or water retention (leading to swelling of the hands or feet) - Sensitivity to sunlight
- Painful erection of the penis that does not pass
- Low platelet count in the blood.
Some patients develop buzzing, hissing, whistling, ringing, or other intrusive tinnitus (tinnitus) when taking Paxil
Patients taking this type of medication have an increased risk of bone fractures
How to store Paxil
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 Paxil 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 Paxil looks like and contents of the pack
Paxil 20 mg film-coated tablets are white, oval, biconvex tablets engraved with “Paxil 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.