This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: This medicine does not require any special storage conditions. The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the enviroment.
Each tablet contains either What Paroxetine tablets look like and contents of the pack Paroxetine 20mg tablets are white and Paroxetine 30mg tablets are blue, circular film-coated tablets. Pack sizes are 30 tablets. Manufacturer 3 Samokovsko Shosse Str. Remember to always consult your physician or health care provider before starting, stopping, or altering a treatment or health care regimen.
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Neither Everyday Health nor its licensors endorse drugs, diagnose patients or recommend therapy. Decreased appetite and weight loss have been observed in association with the use of SSRIs.
These include overdoses with paroxetine alone and in combination with other substances. Of these, 48 cases were fatal and of the fatalities, 17 appeared to involve paroxetine alone. Eight fatal cases that documented the amount of paroxetine ingested were generally confounded by the ingestion of other drugs or alcohol or the presence of significant comorbid conditions.
Of non-fatal cases with known outcome, most recovered without sequelae. The largest known ingestion involved 2, mg of paroxetine 33 times the maximum recommended daily dose in a patient who recovered. Commonly reported adverse events associated with paroxetine overdosage include somnolence , coma, nausea, tremor , tachycardia , confusion, vomiting, and dizziness. Other notable signs and symptoms observed with overdoses involving paroxetine alone or with other substances include mydriasis , convulsions including status epilepticus , ventricular dysrhythmias including torsade de pointes , hypertension , aggressive reactions, syncope , hypotension , stupor, bradycardia , dystonia , rhabdomyolysis , symptoms of hepatic dysfunction including hepatic failure, hepatic necrosis , jaundice , hepatitis , and hepatic steatosis , serotonin syndrome, manic reactions, myoclonus , acute renal failure, and urinary retention.
Overdosage Management No specific antidotes for paroxetine are known. Treatment should consist of those general measures employed in the management of overdosage with any drugs effective in the treatment of major depressive disorder.
Ensure an adequate airway, oxygenation , and ventilation. Monitor cardiac rhythm and vital signs. General supportive and symptomatic measures are also recommended.
Induction of emesis is not recommended. Due to the large volume of distribution of this drug, forced diuresis , dialysis , hemoperfusion, or exchange transfusion are unlikely to be of benefit. A specific caution involves patients who are taking or have recently taken paroxetine who might ingest excessive quantities of a tricyclic antidepressant. In managing overdosage, consider the possibility of multiple drug involvement.
The physician should consider contacting a poison control center for additional information on the treatment of any overdose. Studies at clinically relevant doses in humans have demonstrated that paroxetine blocks the uptake of serotonin into human platelets. In vitro studies in animals also suggest that paroxetine is a potent and highly selective inhibitor of neuronal serotonin reuptake and has only very weak effects on norepinephrine and dopamine neuronal reuptake.
In vitro radioligand binding studies indicate that paroxetine has little affinity for muscarinic, alpha1-, alpha2-, beta-adrenergic-, dopamine D2 -, 5-HT1-, 5-HT2-, and histamine H1 -receptors; antagonism of muscarinic, histaminergic, and alpha1-adrenergic receptors has been associated with various anticholinergic , sedative , and cardiovascular effects for other psychotropic drugs.
Pharmacokinetics Paroxetine hydrochloride is completely absorbed after oral dosing of a solution of the hydrochloride salt. Paroxetine is extensively metabolized and the metabolites are considered to be inactive. Nonlinearity in pharmacokinetics is observed with increasing doses. Paroxetine metabolism is mediated in part by CYP2D6, and the metabolites are primarily excreted in the urine and to some extent in the feces.
Pharmacokinetic behavior of paroxetine has not been evaluated in subjects who are deficient in CYP2D6 poor metabolizers. Absorption And Distribution Paroxetine is equally bioavailable from the oral suspension and tablet.
Paroxetine hydrochloride is completely absorbed after oral dosing of a solution of the hydrochloride salt. The steady-state Cmax and Cmin values were about 6 and 14 times what would be predicted from single-dose studies.
Steady-state drug exposure based on AUC was about 8 times greater than would have been predicted from single-dose data in these subjects.
The excess accumulation is a consequence of the fact that 1 of the enzymes that metabolizes paroxetine is readily saturable. The effects of food on the bioavailability of paroxetine were studied in subjects administered a single dose with and without food. This may result in abnormal blood flow to the lungs and heart and the baby cannot get enough oxygen into their bloodstream. These symptoms usually begin during the first 24 hours after birth and include not being able to sleep or feed properly, breathing faster, a blue-ish skin or being too hot or cold, being sick, crying a lot, stiff or floppy muscles, lethargy, tremors, jitters or fits.
If your baby has any of these symptoms when it is born and you are concerned, contact your doctor or midwife who will be able to advise you. Paroxetine has been shown to reduce the quality of sperm in animal studies. Theoretically, this could affect fertility, but impact on human fertility has not been observed as yet.
Driving and using machines Paroxetine may cause dizziness, confusion or changes in eyesight. If you are affected by these side effects, do not drive or use machinery. Paroxetine tablets contain soya lecithin If you are allergic to peanut or soya, do not use this medicine. How to take Paroxetine tablets Always take paroxetine exactly as your doctor has told you.
If you are not sure, check with your doctor or pharmacist. Take your tablets in the morning with food. Swallow them with a drink of water. For people with seizures: Caution should be used when taking this drug if you have a history of seizures.
If seizures occur while you take this drug, you should stop taking it and contact your doctor. For people with kidney disease: If you have kidney disease, your kidneys may not be able to get rid of this drug as well as they should.
This may cause levels of the drug to build up in your body and cause more side effects. For people with liver disease: If you have liver disease, your body may not be able to process this drug as well as it should.
This may increase the levels of this drug to build up in your body and cause more side effects. Warnings for other groups For pregnant women: Paroxetine oral tablet is a category D pregnancy drug. That means two things: Women of childbearing age should use reliable birth control while taking this drug.
Paroxetine except for the brand-named drug Brisdelle is a category D pregnancy drug. Research in humans has shown adverse effects to the fetus when the mother takes the drug. This drug should only be used during pregnancy in serious cases where it's needed to treat a dangerous condition in the mother.
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