If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses. Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.
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All rights reserved. Information is for End User's use only and may not be sold, redistributed or otherwise used for commercial purposes. Case reports and epidemiological studies case-control and cohort design have demonstrated an association between use of drugs that interfere with serotonin reuptake and the occurrence of gastrointestinal bleeding.
Patients should be cautioned about the risk of bleeding associated with the concomitant use of paroxetine and NSAIDs, aspirin, or other drugs that affect coagulation. Bone Fracture: Epidemiological studies on bone fracture risk following exposure to some antidepressants, including SSRIs, have reported an association between antidepressant treatment and fractures. There are multiple possible causes for this observation and it is unknown to what extent fracture risk is directly attributable to SSRI treatment.
The possibility of a pathological fracture, that is, a fracture produced by minimal trauma in a patient with decreased bone mineral density, should be considered in patients treated with paroxetine who present with unexplained bone pain, point tenderness, swelling, or bruising. Use in Patients With Concomitant Illness: Clinical experience with Paroxetine Tablets in patients with certain concomitant systemic illness is limited. Caution is advisable in using Paroxetine Tablets in patients with diseases or conditions that could affect metabolism or hemodynamic responses.
A few cases of acute angle closure glaucoma associated with paroxetine therapy have been reported in the literature. As mydriasis can cause acute angle closure in patients with narrow angle glaucoma, caution should be used when Paroxetine Tablets are prescribed for patients with narrow angle glaucoma.
Paroxetine Tablets have not been evaluated or used to any appreciable extent in patients with a recent history of myocardial infarction or unstable heart disease. Evaluation of electrocardiograms of patients who received Paroxetine Tablets in double-blind, placebo-controlled trials, however, did not indicate that Paroxetine Tablets are associated with the development of significant ECG abnormalities. Similarly, Paroxetine Tablets do not cause any clinically important changes in heart rate or blood pressure.
Information for Patients: Paroxetine Tablets should not be chewed or crushed, and should be swallowed whole. Patients should be cautioned about the risk of serotonin syndrome with the concomitant use of Paroxetine Tablets and triptans, tramadol, or other serotonergic agents. Patients should be advised that taking Paroxetine Tablets can cause mild pupillary dilation, which in susceptible individuals, can lead to an episode of angle closure glaucoma.
Pre-existing glaucoma is almost always open-angle glaucoma because angle closure glaucoma, when diagnosed, can be treated definitively with iridectomy. Open-angle glaucoma is not a risk factor for angle closure glaucoma. Patients may wish to be examined to determine whether they are susceptible to angle closure, and have a prophylactic procedure e. Prescribers or other health professionals should inform patients, their families, and their caregivers about the benefits and risks associated with treatment with Paroxetine Tablets and should counsel them in its appropriate use.
A patient Medication Guide is available for Paroxetine Tablets. The prescriber or health professional should instruct patients, their families, and their caregivers to read the Medication Guide and should assist them in understanding its contents. Patients should be given the opportunity to discuss the contents of the Medication Guide and to obtain answers to any questions they may have. The complete text of the Medication Guide is reprinted at the end of this document.
Patients should be advised of the following issues and asked to alert their prescriber if these occur while taking Paroxetine Tablets. Clinical Worsening and Suicide Risk: Patients, their families, and their caregivers should be encouraged to be alert to the emergence of anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia psychomotor restlessness , hypomania, mania, other unusual changes in behavior, worsening of depression, and suicidal ideation, especially early during antidepressant treatment and when the dose is adjusted up or down.
Families and caregivers of patients should be advised to look for the emergence of such symptoms on a day-to-day basis, since changes may be abrupt.
Symptoms such as these may be associated with an increased risk for suicidal thinking and behavior and indicate a need for very close monitoring and possibly changes in the medication. Drugs That Interfere With Hemostasis e. Interference With Cognitive and Motor Performance: Any psychoactive drug may impair judgment, thinking, or motor skills. Although in controlled studies Paroxetine Tablets have not been shown to impair psychomotor performance, patients should be cautioned about operating hazardous machinery, including automobiles, until they are reasonably certain that therapy with Paroxetine Tablets does not affect their ability to engage in such activities.
Completing Course of Therapy: While patients may notice improvement with treatment with Paroxetine Tablets in 1 to 4 weeks, they should be advised to continue therapy as directed.
Concomitant Medication: Patients should be advised to inform their physician if they are taking, or plan to take, any prescription or over-the-counter drugs, since there is a potential for interactions. Alcohol: Although Paroxetine Tablets have not been shown to increase the impairment of mental and motor skills caused by alcohol, patients should be advised to avoid alcohol while taking Paroxetine Tablets.
Laboratory Tests: There are no specific laboratory tests recommended. Serotonergic Drugs: Based on the mechanism of action of SNRIs and SSRIs, including paroxetine hydrochloride, and the potential for serotonin syndrome, caution is advised when Paroxetine Tablets are coadministered with other drugs that may affect the serotonergic neurotransmitter systems, such as triptans, lithium, fentanyl, tramadol, amphetamines, or St.
Warfarin: Preliminary data suggest that there may be a pharmacodynamic interaction that causes an increased bleeding diathesis in the face of unaltered prothrombin time between paroxetine and warfarin. Triptans: There have been rare postmarketing reports of serotonin syndrome with the use of an SSRI and a triptan.
If concomitant use of Paroxetine Tablets with a triptan is clinically warranted, careful observation of the patient is advised, particularly during treatment initiation and dose increases see WARNINGS : Serotonin Syndrome.
Drugs Affecting Hepatic Metabolism: The metabolism and pharmacokinetics of paroxetine may be affected by the induction or inhibition of drug-metabolizing enzymes. Cimetidine: Cimetidine inhibits many cytochrome P oxidative enzymes. Therefore, when these drugs are administered concurrently, dosage adjustment of Paroxetine Tablets after the mg starting dose should be guided by clinical effect. Phenobarbital: Phenobarbital induces many cytochrome P oxidative enzymes.
The effect of paroxetine on phenobarbital pharmacokinetics was not studied. Since Paroxetine Tablets exhibit nonlinear pharmacokinetics, the results of this study may not address the case where the 2 drugs are both being chronically dosed.
No initial dosage adjustment of Paroxetine Tablets is considered necessary when coadministered with phenobarbital; any subsequent adjustment should be guided by clinical effect. Since both drugs exhibit nonlinear pharmacokinetics, the above studies may not address the case where the 2 drugs are both being chronically dosed. Like other agents that are metabolized by CYP2D6, paroxetine may significantly inhibit the activity of this isozyme.
Concomitant use of paroxetine with risperidone, a CYP2D6 substrate has also been evaluated. The effect of paroxetine on the pharmacokinetics of atomoxetine has been evaluated when both drugs were at steady state. In healthy volunteers who were extensive metabolizers of CYP2D6, paroxetine 20 mg daily was given in combination with 20 mg atomoxetine every 12 hours. This resulted in increases in steady state atomoxetine AUC values that were 6- to 8-fold greater and in atomoxetine C max values that were 3- to 4-fold greater than when atomoxetine was given alone.
Dosage adjustment of atomoxetine may be necessary and it is recommended that atomoxetine be initiated at a reduced dose when it is given with paroxetine. Concomitant use of Paroxetine Tablets with other drugs metabolized by cytochrome CYP2D6 has not been formally studied but may require lower doses than usually prescribed for either Paroxetine Tablets or the other drug.
Therefore, coadministration of Paroxetine Tablets with other drugs that are metabolized by this isozyme, including certain drugs effective in the treatment of major depressive disorder e. Tamoxifen is a pro-drug requiring metabolic activation by CYP2D6. Drugs Metabolized by Cytochrome CYP3A4: An in vivo interaction study involving the coadministration under steady-state conditions of paroxetine and terfenadine, a substrate for cytochrome CYP3A4, revealed no effect of paroxetine on terfenadine pharmacokinetics.
In addition, in vitro studies have shown ketoconazole, a potent inhibitor of CYP3A4 activity, to be at least times more potent than paroxetine as an inhibitor of the metabolism of several substrates for this enzyme, including terfenadine, astemizole, cisapride, triazolam, and cyclosporine. Alcohol: Although Paroxetine Tablets do not increase the impairment of mental and motor skills caused by alcohol, patients should be advised to avoid alcohol while taking Paroxetine Tablets.
Lithium: A multiple-dose study has shown that there is no pharmacokinetic interaction between Paroxetine Tablets and lithium carbonate. However, due to the potential for serotonin syndrome, caution is advised when Paroxetine Tablets are coadministered with lithium.
Digoxin: The steady-state pharmacokinetics of paroxetine was not altered when administered with digoxin at steady state. Since there is little clinical experience, the concurrent administration of paroxetine and digoxin should be undertaken with caution. Diazepam: Under steady-state conditions, diazepam does not appear to affect paroxetine kinetics. The effects of paroxetine on diazepam were not evaluated.
If anticholinergic effects are seen, the dose of procyclidine should be reduced. Beta-Blockers: In a study where propranolol 80 mg twice daily was dosed orally for 18 days, the established steady-state plasma concentrations of propranolol were unaltered during coadministration with Paroxetine Tablets 30 mg once daily for the final 10 days.
Theophylline: Reports of elevated theophylline levels associated with treatment with Paroxetine Tablets have been reported. While this interaction has not been formally studied, it is recommended that theophylline levels be monitored when these drugs are concurrently administered. Any dose adjustment should be guided by clinical effect tolerability and efficacy. These doses are up to 2.
Because the MRHD for major depressive disorder is slightly less than that for OCD 50 mg versus 60 mg , the doses used in these carcinogenicity studies were only 2. Female rats were not affected. Although there was a dose-related increase in the number of tumors in mice, there was no drug-related increase in the number of mice with tumors. The relevance of these findings to humans is unknown. Mutagenesis: Paroxetine produced no genotoxic effects in a battery of 5 in vitro and 2 in vivo assays that included the following: Bacterial mutation assay, mouse lymphoma mutation assay, unscheduled DNA synthesis assay, and tests for cytogenetic aberrations in vivo in mouse bone marrow and in vitro in human lymphocytes and in a dominant lethal test in rats.
Irreversible lesions occurred in the reproductive tract of male rats after dosing in toxicity studies for 2 to 52 weeks. Pregnancy: Pregnancy Category D. Labor and Delivery: The effect of paroxetine on labor and delivery in humans is unknown. Nursing Mothers: Like many other drugs, paroxetine is secreted in human milk, and caution should be exercised when Paroxetine Tablets are administered to a nursing woman.
Three placebo-controlled trials in pediatric patients with MDD have been conducted with Paroxetine Tablets, and the data were not sufficient to support a claim for use in pediatric patients. Anyone considering the use of Paroxetine Tablets in a child or adolescent must balance the potential risks with the clinical need. Decreased appetite and weight loss have been observed in association with the use of SSRIs.
Consequently, regular monitoring of weight and growth should be performed in children and adolescents treated with an SSRI such as Paroxetine Tablets. Major Depressive Disorder. Social Anxiety Disorder. Generalized Anxiety Disorder. Incidence in Controlled Clinical Trials: The prescriber should be aware that the figures in the tables following cannot be used to predict the incidence of side effects in the course of usual medical practice where patient characteristics and other factors differ from those that prevailed in the clinical trials.
Similarly, the cited frequencies cannot be compared with figures obtained from other clinical investigations involving different treatments, uses, and investigators. The cited figures, however, do provide the prescribing physician with some basis for estimating the relative contribution of drug and nondrug factors to the side effect incidence rate in the populations studied. Urination Disorder. In a fixed-dose study comparing placebo and 20 mg, 40 mg, and 60 mg of Paroxetine Tablets in the treatment of OCD, there was no clear relationship between adverse events and the dose of Paroxetine Tablets to which patients were assigned.
No new adverse events were observed in the group treated with 60 mg of Paroxetine Tablets compared to any of the other treatment groups. In a fixed-dose study comparing placebo and 10 mg, 20 mg, and 40 mg of Paroxetine Tablets in the treatment of panic disorder, there was no clear relationship between adverse events and the dose of Paroxetine Tablets to which patients were assigned, except for asthenia, dry mouth, anxiety, libido decreased, tremor, and abnormal ejaculation.
In flexible-dose studies, no new adverse events were observed in patients receiving 60 mg of Paroxetine Tablets compared to any of the other treatment groups. In a fixed-dose study comparing placebo and 20 mg, 40 mg, and 60 mg of Paroxetine Tablets in the treatment of social anxiety disorder, for most of the adverse events, there was no clear relationship between adverse events and the dose of Paroxetine Tablets to which patients were assigned.
In a fixed-dose study comparing placebo and 20 mg and 40 mg of Paroxetine Tablets in the treatment of generalized anxiety disorder, for most of the adverse events, there was no clear relationship between adverse events and the dose of Paroxetine Tablets to which patients were assigned, except for the following adverse events: Asthenia, constipation, and abnormal ejaculation.
In a fixed-dose study comparing placebo and 20 and 40 mg of Paroxetine Tablets in the treatment of posttraumatic stress disorder, for most of the adverse events, there was no clear relationship between adverse events and the dose of Paroxetine Tablets to which patients were assigned, except for impotence and abnormal ejaculation.
Reliable estimates of the incidence and severity of untoward experiences involving sexual desire, performance, and satisfaction are difficult to obtain, however, in part because patients and physicians may be reluctant to discuss them. Accordingly, estimates of the incidence of untoward sexual experience and performance cited in product labeling, are likely to underestimate their actual incidence. In placebo-controlled clinical trials involving more than 3, patients, the ranges for the reported incidence of sexual side effects in males and females with major depressive disorder, OCD, panic disorder, social anxiety disorder and GAD, and PTSD are displayed in Table 6.
There are no adequate and well-controlled studies examining sexual dysfunction with paroxetine treatment. Paroxetine treatment has been associated with several cases of priapism. In those cases with a known outcome, patients recovered without sequelae. While it is difficult to know the precise risk of sexual dysfunction associated with the use of SSRIs, physicians should routinely inquire about such possible side effects. The frequencies presented, therefore, represent the proportion of the 9, patients exposed to multiple doses of Paroxetine Tablets who experienced an event of the type cited on at least 1 occasion while receiving Paroxetine Tablets.
All reported events are included except those already listed in Tables 2 to 5, those reported in terms so general as to be uninformative and those events where a drug cause was remote. It is important to emphasize that although the events reported occurred during treatment with paroxetine, they were not necessarily caused by it.
Body as a Whole: Infrequent: Allergic reaction, chills, face edema, malaise, neck pain; rare: Adrenergic syndrome, cellulitis, moniliasis, neck rigidity, pelvic pain, peritonitis, sepsis, ulcer. Cardiovascular System: Frequent: Hypertension, tachycardia; infrequent: Bradycardia, hematoma, hypotension, migraine, postural hypotension, syncope; rare: Angina pectoris, arrhythmia nodal, atrial fibrillation, bundle branch block, cerebral ischemia, cerebrovascular accident, congestive heart failure, heart block, low cardiac output, myocardial infarct, myocardial ischemia, pallor, phlebitis, pulmonary embolus, supraventricular extrasystoles, thrombophlebitis, thrombosis, varicose vein, vascular headache, ventricular extrasystoles.
Digestive System: Infrequent: Bruxism, colitis, dysphagia, eructation, gastritis, gastroenteritis, gingivitis, glossitis, increased salivation, liver function tests abnormal, rectal hemorrhage, ulcerative stomatitis; rare: Aphthous stomatitis, bloody diarrhea, bulimia, cardiospasm, cholelithiasis, duodenitis, enteritis, esophagitis, fecal impactions, fecal incontinence, gum hemorrhage, hematemesis, hepatitis, ileitis, ileus, intestinal obstruction, jaundice, melena, mouth ulceration, peptic ulcer, salivary gland enlargement, sialadenitis, stomach ulcer, stomatitis, tongue discoloration, tongue edema, tooth caries.
Endocrine System: Rare: Diabetes mellitus, goiter, hyperthyroidism, hypothyroidism, thyroiditis. Hemic and Lymphatic Systems: Infrequent: Anemia, leukopenia, lymphadenopathy, purpura; rare: Abnormal erythrocytes, basophilia, bleeding time increased, eosinophilia, hypochromic anemia, iron deficiency anemia, leukocytosis, lymphedema, abnormal lymphocytes, lymphocytosis, microcytic anemia, monocytosis, normocytic anemia, thrombocythemia, thrombocytopenia.
Metabolic and Nutritional: Frequent: Weight gain; infrequent: Edema, peripheral edema, SGOT increased, SGPT increased, thirst, weight loss; rare: Alkaline phosphatase increased, bilirubinemia, BUN increased, creatinine phosphokinase increased, dehydration, gamma globulins increased, gout, hypercalcemia, hypercholesteremia, hyperglycemia, hyperkalemia, hyperphosphatemia, hypocalcemia, hypoglycemia, hypokalemia, hyponatremia, ketosis, lactic dehydrogenase increased, non-protein nitrogen NPN increased.
Musculoskeletal System: Frequent: Arthralgia; infrequent: Arthritis, arthrosis; rare: Bursitis, myositis, osteoporosis, generalized spasm, tenosynovitis, tetany.
Nervous System: Frequent: Emotional lability, vertigo; infrequent: Abnormal thinking, alcohol abuse, ataxia, dystonia, dyskinesia, euphoria, hallucinations, hostility, hypertonia, hypesthesia, hypokinesia, incoordination, lack of emotion, libido increased, manic reaction, neurosis, paralysis, paranoid reaction; rare: Abnormal gait, akinesia, antisocial reaction, aphasia, choreoathetosis, circumoral paresthesias, convulsion, delirium, delusions, diplopia, drug dependence, dysarthria, extrapyramidal syndrome, fasciculations, grand mal convulsion, hyperalgesia, hysteria, manic-depressive reaction, meningitis, myelitis, neuralgia, neuropathy, nystagmus, peripheral neuritis, psychotic depression, psychosis, reflexes decreased, reflexes increased, stupor, torticollis, trismus, withdrawal syndrome.
Respiratory System: Infrequent: Asthma, bronchitis, dyspnea, epistaxis, hyperventilation, pneumonia, respiratory flu; rare: Emphysema, hemoptysis, hiccups, lung fibrosis, pulmonary edema, sputum increased, stridor, voice alteration. Skin and Appendages: Frequent: Pruritus; infrequent: Acne, alopecia, contact dermatitis, dry skin, ecchymosis, eczema, herpes simplex, photosensitivity, urticaria; rare: Angioedema, erythema nodosum, erythema multiforme, exfoliative dermatitis, fungal dermatitis, furunculosis; herpes zoster, hirsutism, maculopapular rash, seborrhea, skin discoloration, skin hypertrophy, skin ulcer, sweating decreased, vesiculobullous rash.
Special Senses: Frequent: Tinnitus; infrequent: Abnormality of accommodation, conjunctivitis, ear pain, eye pain, keratoconjunctivitis, mydriasis, otitis media; rare: Amblyopia, anisocoria, blepharitis, cataract, conjunctival edema, corneal ulcer, deafness, exophthalmos, eye hemorrhage, glaucoma, hyperacusis, night blindness, otitis externa, parosmia, photophobia, ptosis, retinal hemorrhage, taste loss, visual field defect. Urogenital System: Infrequent: Amenorrhea, breast pain, cystitis, dysuria, hematuria, menorrhagia, nocturia, polyuria, pyuria, urinary incontinence, urinary retention, urinary urgency, vaginitis; rare: Abortion, breast atrophy, breast enlargement, endometrial disorder, epididymitis, female lactation, fibrocystic breast, kidney calculus, kidney pain, leukorrhea, mastitis, metrorrhagia, nephritis, oliguria, salpingitis, urethritis, urinary casts, uterine spasm, urolith, vaginal hemorrhage, vaginal moniliasis.
There has been a case report of an elevated phenytoin level after 4 weeks of Paroxetine Tablets and phenytoin coadministration. There has been a case report of severe hypotension when Paroxetine Tablets were added to chronic metoprolol treatment. Controlled Substance Class: Paroxetine hydrochloride is not a controlled substance.
Physical and Psychologic Dependence: Paroxetine Tablets have not been systematically studied in animals or humans for its potential for abuse, tolerance or physical dependence. Consequently, patients should be evaluated carefully for history of drug abuse, and such patients should be observed closely for signs of misuse or abuse of Paroxetine Tablets e.
Human Experience: Since the introduction of Paroxetine Tablets in the United States, spontaneous cases of deliberate or accidental overdosage during paroxetine treatment have been reported worldwide circa 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.
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.
Systematic evaluation of the efficacy of Paroxetine Tablets has shown that efficacy is maintained for periods of up to 1 year with doses that averaged about 30 mg. Obsessive Compulsive Disorder: Usual Initial Dosage: Paroxetine Tablets should be administered as a single daily dose with or without food, usually in the morning.
Dose changes should occur at intervals of at least 1 week. Panic Disorder: Usual Initial Dosage: Paroxetine Tablets should be administered as a single daily dose with or without food, usually in the morning. Social Anxiety Disorder: Usual Initial Dosage: Paroxetine Tablets should be administered as a single daily dose with or without food, usually in the morning. Generalized Anxiety Disorder: Usual Initial Dosage: Paroxetine Tablets should be administered as a single daily dose with or without food, usually in the morning.
Nevertheless, patients should be periodically reassessed to determine the need for maintenance treatment. Posttraumatic Stress Disorder: Usual Initial Dosage : Paroxetine Tablets should be administered as a single daily dose with or without food, usually in the morning.
Maintenance Therapy : There is no body of evidence available to answer the question of how long the patient treated with Paroxetine Tablets should remain on it. If you split it, you could get an overdose. These materials were made possible by a grant from the state Attorney General Consumer and Prescriber Education Grant Program, which is funded by a multistate settlement of consumer fraud claims regarding the marketing of the prescription drug Neurontin gabapentin.
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