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Mirtazapine 30mg Tablets Last Updated on eMC 03-Oct-2013 View changes | Aurobindo Pharma - Milpharm Ltd. Contact details Name of the medicinal product Qualitative and quantitative composition Pharmaceutical form Clinical particulars - 4.1 Therapeutic indications - 4.2 Posology and method of administration - 4.3 Contraindications - 4.4 Special warnings and precautions for use - 4.5 Interaction with other medicinal products and other forms of interaction - 4.6 Pregnancy and lactation - 4.7 Effects on ability to drive and use machines - 4.8 Undesirable effects - 4.9 Overdose Pharmacological properties - 5.1 Pharmacodynamic properties - 5.2 Pharmacokinetic properties - 5.3 Preclinical safety data Pharmaceutical particulars - 6.1 List of excipients - 6.2 Incompatibilities - 6.3 Shelf life - 6.4 Special precautions for storage - 6.5 Nature and contents of container - 6.6 Special precautions for disposal and other handling Marketing authorisation holder Marketing authorisation number(s) Date of first authorisation/renewal of the authorisation Date of revision of the text ADULTSThe effective daily dose is usually between 15 and 45 mg; the starting dose is 15 or 30 mg. Mirtazapine begins to exert its effect in general after 1-2 weeks of treatment. Treatment with an adequate dose should result in a positive response within 2-4 weeks. With an insufficient response, the dose can be increased up to the maximum dose. If there is no response within a further 2-4 weeks, then treatment should be stopped. ELDERLYThe recommended dose is the same as that for adults. In elderly patients an increase in dosing should be done under close supervision to elicit a satisfactory and safe response. CHILDREN AND ADOLESCENTS UNDER THE AGE OF 18 YEARSMirtazapine should not be used in children and adolescents under the age of 18 years as efficacy was not demonstrated in two short-term clinical trials (see section 5.1) and because of safety concerns (see sections 4.4, 4.8 and 5.1) RENAL IMPAIRMENTThe clearance of mirtazapine may be decreased in patients with moderate to severe renal impairment (creatinine clearance <40 ml/min). This should be taken into account when prescribing Mirtazapine to this category of patients (see section 4.4). HEPATIC IMPAIRMENTThe clearance of mirtazapine may be decreased in patients with hepatic impairment. This should be taken into account when prescribing Mirtazapine to this category of patients, particularly with severe hepatic impairment, as patients with severe hepatic impairment have not been investigated (see section 4.4). Mirtazapine has an elimination half-life of 20-40 hours and therefore Mirtazapine is suitable for once daily administration. It should be taken preferably as a single night-time dose before going to bed. Mirtazapine may also be given in two divided doses (once in the morning and once at night-time, the higher dose should be taken at night). The tablets should be taken orally, with fluid, and swallowed without chewing. Patients with depression should be treated for a sufficient period of at least 6 months to ensure that they are free from symptoms. It is recommended to discontinue treatment with mirtazapine gradually to avoid withdrawal symptoms (see section 4.4). Use in children and adolescents under 18 years of ageMirtazapine should not be used in the treatment of children and adolescents under the age of 18 years. Suicide-related behaviours (suicide attempt and suicidal thoughts), and hostility (predominantly aggression, oppositional behaviour and anger) were more frequently observed in clinical trials among children and adolescents treated with antidepressants compared to those treated with placebo. If, based on clinical need, a decision to treat is nevertheless taken, the patient should be carefully monitored for the appearance of suicidal symptoms. In addition, long-term safety data in children and adolescents concerning growth, maturation and cognitive and behavioural development are lacking. Suicide/suicidal thoughts or clinical worseningDepression is associated with an increased risk of suicidal thoughts, self harm and suicide (suicide related events). This risk persists until significant remission occurs. As improvement may not occur during the first few weeks or more of treatment, patients should be closely monitored until such improvement occurs. It is general clinical experience that the risk of suicide may increase in the early stages of recovery. Patients with a history of suicide-related events or those exhibiting a significant degree of suicidal ideation prior to commencement of treatment are known to be at greater risk of suicidal thoughts or suicide attempts, and should receive careful monitoring during treatment. A meta-analysis of placebocontrolled clinical trials of antidepressants in adult patients with psychiatric disorders showed an increased risk of suicidal behaviour with antidepressants compared to placebo in patients less than 25 years old. Close supervision of patients and in particular those at high risk should accompany therapy with antidepressants especially in early treatment and following dose changes. Patients (and caregivers of patients) should be alerted about the need to monitor for any clinical worsening, suicidal behaviour or thoughts and unusual changes in behaviour and to seek medical advice immediately if these symptoms present. With regard to the chance of suicide, in particular at the beginning of treatment, only a limited number of Mirtazapine film-coated tablets should be given to the patient. Bone marrow depressionBone marrow depression, usually presenting as granulocytopenia or agranulocytosis, has been reported during treatment with Mirtazapine. Reversible agranulocytosis has been reported as a rare occurrence in clinical studies with Mirtazapine. In the postmarketing period with Mirtazapine very rare cases of agranulocytosis have been reported, mostly reversible, but in some cases fatal. Fatal cases mostly concerned patients with an age above 65. The physician should be alert for symptoms like fever, sore throat, stomatitis or other signs of infection; when such symptoms occur, treatment should be stopped and blood counts taken. JaundiceTreatment should be discontinued if jaundice occurs. Conditions which need supervisionCareful dosing as well as regular and close monitoring is necessary in patients with: epilepsy and organic brain syndrome: Although clinical experience indicates that epileptic seizures are rare during mirtazapine treatment, as with other antidepressants, Mirtazapine should be introduced cautiously in patients who have a history of seizures. Treatment should be discontinued in any patient who develops seizures, or where there is an increase in seizure frequency hepatic impairment: Following a single 15 mg oral dose of mirtazapine, the clearance of mirtazapine was approximately 35 % decreased in mild to moderate hepatically impaired patients, compared to subjects with normal hepatic function. The average plasma concentration of mirtazapine was about 55 % increased. renal impairment: Following a single 15 mg oral dose of mirtazapine, in patients with moderate (creatinine clearance 40 ml/min) and severe (creatinine clearance ≤10 ml/min) renal impairment the clearance of mirtazapine was about 30 % and 50 % decreased respectively, compared to normal subjects. The average plasma concentration of mirtazapine was about 55 % and 115 %increased respectively. No significant differences were found in patients with mild renal impairment (creatinine clearance 80 ml/min) as compared to the control group. cardiac diseases like conduction disturbances, angina pectoris and recent myocardial infarction, where normal precautions should be taken and concomitant medicines carefully administered. low blood pressure. diabetes mellitus: In patients with diabetes, antidepressants may alter glycaemic control. Insulin and/or oral hypoglycaemic dosage may need to be adjusted and close monitoring is recommended. Like with other antidepressants, the following should be taken into account: Worsening of psychotic symptoms can occur when antidepressants are administered to patients with schizophrenia or other psychotic disturbances; paranoid thoughts can be intensified. When the depressive phase of bipolar disorder is being treated, it can transform into the manic phase. Patients with a history of mania/hypomania should be closely monitored. Mirtazapine should be discontinued in any patient entering a manic phase. Although Mirtazapine is not addictive, post-marketing experience shows that abrupt termination of treatment after long term administration may sometimes result in withdrawal symptoms. The majority of withdrawal reactions are mild and self-limiting. Among the various reported withdrawal symptoms, dizziness, agitation, anxiety, headache and nausea are the most frequently reported. Even though they have been reported as withdrawal symptoms, it should be realized that these symptoms may be related to the underlying disease. As advised in section 4.2, it is recommended to discontinue treatment with mirtazapine gradually. Care should be taken in patients with micturition disturbances like prostate hypertrophy and in patients with acute narrow-angle glaucoma and increased intra-ocular pressure (although there is little chance of problems with Mirtazapine because of its very weak anticholinergic activity). Akathisia/psychomotor restlessness: The use of antidepressants have been associated with the development of akathisia, characterised by a subjectively unpleasant or distressing restlessness and need to move often accompanied by an inability to sit or stand still. This is most likely to occur within the first few weeks of treatment. In patients who develop these symptoms, increasing the dose may be detrimental. HyponatraemiaHyponatraemia, probably due to inappropriate antidiuretic hormone secretion (SIADH), has been reported very rarely with the use of mirtazapine. Caution should be exercised in patients at risk, such as elderly patients or patients concomitantly treated with medications known to cause hyponatraemia. Serotonin syndromeInteraction with serotonergic active substances: serotonin syndrome may occur when selective serotonin reuptake inhibitors (SSRIs) are used concomitantly with other serotonergic active substances (see section 4.5). Symptoms of serotonin syndrome may be hyperthermia, rigidity, myoclonus, autonomic instability with possible rapid fluctuations of vital signs, mental status changes that include confusion, irritability and extreme agitation progressing to delirium and coma. Caution should be advised and a closer clinical monitoring is required when these active substances are combined with mirtazapine. Treatment with mirtazapine should be discontinued if such events occur and supportive symptomatic treatment initiated. From post marketing experience it appears that serotonin syndrome occurs very rarely in patients treated with Mirtazapine alone (see section 4.8). Elderly patientsElderly patients are often more sensitive, especially with regard to the undesirable effects of antidepressants. During clinical research with Mirtazapine, undesirable effects have not been reported more often in elderly patients than in other age groups. LactoseThis medicinal product contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine. Pharmacodynamic interactions- Mirtazapine should not be administered concomitantly with MAO inhibitors or within two weeks after discontinuation of MAO inhibitor therapy. In the opposite way about two weeks should pass before patients treated with mirtazapine should be treated with MAO inhibitors (see section 4.3). In addition, as with SSRIs, co-administration with other serotonergic active substances (Ltryptophan, triptans, tramadol, linezolid, SSRIs, venlafaxine, lithium and St. John's Wort Hypericum perforatum preparations) may lead to an incidence of serotonin associated effects (serotonin syndrome: see section 4.4). Caution should be advised and a closer clinical monitoring is required when these active substances are combined with mirtazapine. - Mirtazapine may increase the sedating properties of benzodiazepines and other sedatives (notably most antipsychotics, antihistamine H1 antagonists, opioids). Caution should be exercised when these medicinal products are prescribed together with mirtazapine. - Mirtazapine may increase the CNS depressant effect of alcohol. Patients should therefore be advised to avoid alcoholic beverages while taking mirtazapine.- Mirtazapine dosed at 30 mg once daily caused a small but statistically significant increase in the international normalized ratio (INR) in subjects treated with warfarin. As at a higher dose of mirtazapine a more pronounced effect can not be excluded, it is advisable to monitor the INR in case of concomitant treatment of warfarin with mirtazapine. Pharmacokinetic interactions- Carbamazepine and phenytoin, CYP3A4 inducers, increased mirtazapine clearance about twofold, resulting in a decrease in average plasma mirtazapine concentration of 60 % and 45 %, respectively. When carbamazepine or any other inducer of hepatic metabolism (such as rifampicin) is added to mirtazapine therapy, the mirtazapine dose may have to be increased. If treatment with such medicinal product is discontinued, it may be necessary to reduce the mirtazapine dose.- Co-administration of the potent CYP3A4 inhibitor ketoconazole increased the peak plasma levels and the AUC of mirtazapine by approximately 40 % and 50 % respectively.- When cimetidine (weak inhibitor of CYP1A2, CYP2D6 and CYP3A4) is administered with mirtazapine, the mean plasma concentration of mirtazapine may increase more than 50 %. Caution should be exercised and the dose may have to be decreased when co-administering mirtazapine with potent CYP3A4 inhibitors, HIV protease inhibitors, azole antifungals, erythromycin, cimetidine or nefazodone.- Interaction studies did not indicate any relevant pharmacokinetic effects on concurrent treatment of mirtazapine with paroxetine, amitriptyline, risperidone or lithium. Paediatric population:Two randomised, double-blind, placebo-controlled trials in children aged between 7 and 18 years with major depressive disorder (n=259) using a flexible dose for the first 4 weeks (15-45mg mirtazapine) followed by a fixed dose (15, 30 or 45 mg mirtazapine) for another 4 weeks failed to demonstrate significant differences between mirtazapine and placebo on the primary and all secondary endpoints. Significant weight gain (≥7%) was observed in 48.8% of the mirtazapine treated subjects compared to 5.7% in the placebo arm. Urticaria (11.8% vs 6.8%) and hypertriglyceridaemia (2.9% vs 0%) were also commonly observed. Core:Lactose monohydrate, Maize starch, Low substituted Hydroxypropyl Cellulose, Magnesium Stearate (E470b) and Silica Colloidal anhydrous Film Coating:Hypromellose (E464), Titanium dioxide (E 171) Yellow Iron oxide (E172), Red Iron oxide (E172) and Black Iron oxide (E172). Aurobindo Pharma - Milpharm Ltd. Odyssey Business Park, Ares Block, West End Road, South Ruislip, Middlesex, HA4 6QD Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why? Active ingredients Legal categories This site uses cookies. By continuing to browse the site you are agreeing to our policy on the use of cookies. Find out more here.
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Deprozel tablete – Uputa o lijeku Proizvođač: Pliva Samo na recept? DA Primjena: antidepresiv Opis Sastav 1 tableta sadržava 20 mg ili 30 mg paroksetina u obliku paroksetin mesilata. Pomoćne tvari: kalcij hidrogenfosfat bezvodni, natrij škrob glikolat, magnezij stearat, hipromeloza, hidroksipropil celuloza, titan dioksid (E171), željezo oksid žuti (E172), željezo oksid crveni (E172). Farmaceutski oblik i veličina pakovanja Film-tablete; 30 tableta Farmakoterapijska skupina i djelovanje Paroksetin je jaki i selektivni antidepresiv, inhibitor ponovne pohrane serotonina, a smatra se da je njegovo antidepresivno djelovanje i djelotvornost u liječenju opsesivno-kompulzivnih poremećaja i paničnih stanja povezano sa specifičnom inhibicijom ponovne pohrane 5-hidroksitriptamina (5-HT, serotonin) u moždanim neuronima. Paroksetin nije kemijski povezan s tricikličnim, tetracikličnim ili ostalim raspoloživim antidepresivima. Način i mjesto izdavanja Na recept Rok valjanosti Označen je na pakovanju. Lijek se ne smije rabiti nakon isteka roka valjanosti. LIJEK VALJA ČUVATI IZVAN DOSEGA DJECE! Primjena Terapijske indikacije Liječenje simptoma svih vrsta depresije uključujući depresiju praćenu tjeskobom. Nakon početnog zadovoljavajućeg odgovora, nastavak liječenja paroksetinom djelotvoran je u prevenciji recidiva. Liječenje simptoma i prevencija recidiva opsesivno-kompulzivnog poremećaja. Liječenje simptoma i prevencija recidiva paničnih stanja sa ili bez agorafobije. Liječenje simptoma socijalne anksioznosti/socijalne fobije. Paroksetin je djelotvoran u liječenju posttraumatskog stresa. Liječenje simptoma i prevencija recidiva generaliziranog anksioznog poremećaja. Doziranje i način uporabe Deprozel tablete se uzimaju jednom dnevno, ujutro uz obrok. Tablete je bolje progutati cijele nego žvakati. ODRASLI Depresija Preporučena doza je 20 mg dnevno. U nekih je bolesnika potrebno povećati dozu. Dozu valja povećavati postupno za 10 mg do postizanja najviše doze od 50 mg/dnevno u skladu s odgovorom bolesnika. Opsesivno-kompulzivni poremećaj Preporučena doza je 40 mg dnevno. Početna doza je 20 mg i može se povećavati tjedno za 10 mg. U nekih je bolesnika potrebno povećati dozu do najviše 60 mg/dnevno. Panična stanja Preporučena doza je 40 mg dnevno. Početna doza je 10 mg dnevno i tjedno se povećava za 10 mg u skladu s odgovorom bolesnika. Doza se u nekih bolesnika mora povećati do najviše 50 mg/dnevno. Kao što je opće poznato, simptomi paničnih stanja mogu se pogoršati tijekom početka liječenja te se stoga preporučuje niža početna doza. Socijalna anksioznost/socijalna fobija Preporučena doza je 20 mg dnevno. Početna doza je 20 mg dnevno, a ako se nakon najmanje dva tjedna ne zabilježi nikakvo poboljšanje, doza se može povećati do najviše 50 mg/dnevno. Dozu valja povećavati za 10 mg, u intervalima od najmanje jednog tjedna, a u skladu s odgovorom bolesnika. Posttraumatski stres Preporučena početna doza i doza održavanja u većine bolesnika je 20 mg dnevno. Međutim, u bolesnika koji ne odgovaraju na dozu od 20 mg dnevno, ona se može povećavati za 10 mg u skladu s potrebama, do najviše 50 mg dnevno u skladu s odgovorom bolesnika. Generalizirani anksiozni poremećaj Početna i preporučena doza je 20 mg dnevno. Stariji bolesnici Kod starijih bolesnika javljaju se povećane koncentracije paroksetina u plazmi. Početna doza može biti kao i u odraslih bolesnika, a zatim se može povećavati za 10 mg tjedno do najviše 40 mg dnevno u skladu s odgovorom bolesnika. DJECA Ne preporučuje se uporaba paroksetina u djece jer u toj populaciji još nije utvrđena njegova djelotvornost i neškodljivost. Kao i kod svih ostalih antidepresiva, doza paroksetina se mora kontrolirati i prilagoditi ako je potrebno u roku od dva do tri tjedna od početka terapije, a nakon toga kad se smatra da je klinički prikladno. Liječenje treba trajati dovoljno dugo kako bi se osiguralo povlačenje simptoma. Liječenje treba trajati najmanje četiri do šest mjeseci nakon oporavka od depresije, ili čak i duže u slučaju opsesivno-kompulzivnih poremećaja i paničnih stanja. Kao i kod ostalih psihoaktivnih lijekova, mora se izbjegavati nagli prekid terapije. Predoziranje Iskustvo u predoziranju paroksetinom je pokazalo da se osim simptoma navedenih u poglavlju Nuspojave javljaju i povraćanje, proširene zjenice, vrućica, promjene krvnog tlaka, glavobolja, nevoljne mišićne kontrakcije, nemir, tjeskoba i tahikardije. Bolesnici su se uglavnom oporavili bez ozbiljnih posljedica, čak i nakon doze od 2000 mg. Povremeno se javljala koma ili EKG promjene, jako rijetko s fatalnim posljedicama, ali obično kad je paroksetin uziman u kombinaciji s ostalim psihotropnim lijekovima, sa ili bez alkohola. U liječenju se trebaju primjenjivati općenite mjere koje se primjenjuju u slučaju predoziranja ostalim antidepresivima. Ne postoji specifični antidot. Ranom primjenom aktivnog ugljena može se odgoditi apsorpcija paroksetina. Mjere opreza Budući da tijekom prvih nekoliko ili više tjedana liječenja paroksetinom ne mora doći do poboljšanja, bolesnici se moraju pratiti tijekom tog perioda. Postoji inherentna mogućnost pokušaja suicida u depresivnih bolesnika i to stanje može potrajati dok se ne postigne značajni terapijski učinak. Opće je kliničko iskustvo sa svim antidepresivnim lijekovima da se rizik od suicida može povećati u ranim fazama oporavka. Ne postoji veliko iskustvo u istovremenoj primjeni paroksetina i elektrokonvulzivne terapije te se stoga preporučuje oprez. Kontraindikacije Poznata preosjetljivost na paroksetin. Paroksetin se ne smije koristiti u kombinaciji s inhibitorima monoamino oksidaze (MAO). Terapija paroksetinom može započeti 14 dana nakon prestanka uzimanja ireverzibilnih inhibitora monoamino oksidaze i najmanje jedan dan nakon prestanka uzimanja reverzibilnog inhibitora monoamino oksidaze – moklobemida. Interval između prestanka primjene paroksetina i početka primjene reverzibilnih inhibitora monoamino oksidaze treba biti najmanje 14 dana. Posebna upozorenja Kao i ostali selektivni inhibitori ponovne pohrane serotonina, paroksetin se mora primjenjivati s oprezom u bolesnika koji već uzimaju neuroleptike, budući da su u slučaju njihove kombinacije zabilježeni simptomi koji ukazuju na neuroleptični maligni sindrom. Povećane koncentracije paroksetina primjećene su u plazmi bolesnika s teškim bubrežnim oštećenjem (klirens kreatinina Paroksetin se mora izbjegavati u bolesnika s nestabilnom epilepsijom, a bolesnici s kontroliranom epilepsijom moraju se pažljivo pratiti. Terapija se mora prekinuti u slučaju da napadaji postanu učestaliji. Paroksetin se treba koristiti s oprezom u bolesnika koji u anamnezi imaju maniju/hipomaniju. Terapija paroksetinom se mora prekinuti u bilo kojeg bolesnika koji uđe u maničnu fazu. Krvarenje iz kože i sluznice, npr. ekhimoza i purpura, zabilježeno je nakon liječenja paroksetinom. Paroksetin se stoga mora koristiti s oprezom u bolesnika koji istovremeno uzimaju lijekove kod kojih postoji povećani rizik od krvarenja, npr. atipične antipsihotike i fenotijazine, većinu tricikličnih antidepresiva, aspirin i nesteroidne protuupalne lijekove, oralne antikoagulanse, kao i u bolesnika s poznatom sklonošću za krvarenje i u onih s predispozicijom za i/ili poremećajima krvarenja u anamnezi. Kao i ostali selektivni inhibitori ponovne pohrane serotonina, paroksetin ponekad uzrokuje midrijazu i mora se koristiti s oprezom u bolesnika s glaukomom zatvorenog kuta. Utjecaj na sposobnost upravljanja vozilima i strojevima Kliničko iskustvo pokazuje da terapija paroksetinom nije povezana s oštećenjem kognitivnih ili psihomotornih funkcija. Međutim, kao i prilikom terapije ostalim psihoaktivnim lijekovima, bolesnike treba upozoriti na smanjenu sposobnost upravljanja vozilima i strojevima. Trudnoća i dojenje Budući da neškodljivost paroksetina tijekom trudnoće nije dokazana, paroksetin se smije koristiti u trudnoći samo ako je očekivana korist terapije za majku veća od mogućeg rizika za fetus. Paroksetin se izlučuje u mlijeko dojilje. Nisu poznati njegovi učinci na dojenče. Ako se liječenje paroksetinom smatra neophodnim, mora se razmotriti prestanak dojenja. Nuspojave Nuspojave paroksetina su obično blage i ne utječu na kvalitetu života bolesnika. Produljenim liječenjem može se smanjiti jakost i učestalost nuspojava te one obično ne uzrokuju prekid liječenja paroksetinom. Najčešće zabilježene nuspojave povezane s primjenom paroksetina u kliničkim studijama bile su: - mučnina, - pospanost, - znojenje, - tremor, - astenija, - suhoća usta, - nesanica, - seksualna disfunkcija, - vrtoglavica, - opstipacija, - proljev, - smanjeni tek. Rijetko su zabilježene slijedeće nuspojave: - osip, - akutni glaukom, - retencija mokraće, - periferni i facijalni edem, - sinus tahikardija, - trombocitopenija, - serotoninski sindrom (simptomi uključuju agitaciju, zbunjenost, dijaforezu, halucinacije, hiperrefleksiju, mioklonus, drhtavicu, tahikardiju i tremor), - simptomi koji ukazuju na hiperprolaktinemiju/galaktoreju i hiponatrijemija (uglavnom u starijih bolesnika) koja se može povezati sa sindromom nepravilnog izlučivanja antidiuretičkog hormona (SIADH). Zabilježene su povišene vrijednosti jetrenih enzima. Rijetko su zabilježeni teški poremećaji funkcije jetre. Treba razmotriti prekid terapije paroksetinom u slučaju dugotrajnije povišenih vrijednosti jetrenih enzima. Rijetko su se tijekom liječenja paroksetinom javljala abnormalna krvarenja (uglavnom ekhimoza i purpura). Manične reakcije zabilježene su vrlo rijetko. Može se javiti zamućenje vida. Zabilježene su povremene ekstrapiramidalne reakcije, uključujući orofacijalnu distoniju u bolesnika s prethodnim poremećajima kretanja ili onih koji su uzimali neuroleptike. Kao i kod mnogih psihoaktivnih lijekova, nagli prekid liječenja može izazvati simptome poput vrtoglavice, osjetilnih smetnji, poremećaja spavanja, uznemirenosti ili tjeskobe, mučnine i znojenja. Kao i kod drugih inhibitora ponovne pohrane serotonina, nakon liječenja paroksetinom zabilježena su prolazna povišenja ili sniženja krvnog tlaka, obično u bolesnika s otprije postojećom hipertenzijom ili anksioznošću. Kao i kod drugih inhibitora ponovne pohrane serotonina, rijetko su zabilježeni: zbunjenost, konvulzije i fotosenzitivne reakcije. O svakoj nuspojavi valja obavijestiti svog liječnika ili ljekarnika. Interakcije Hrana ili antacidi ne utječu na apsorpciju i farmakokinetiku paroksetina. Ne preporučuje se istovremeno uzimanje paroksetina s alkoholom. Istovremena primjena serotoninskih lijekova (npr. tramadola, sumatriptana) može povećati učinke povezane s 5-HT. Postoje izvješća o pojačanom učinku prilikom istovremene primjene selektivnih inhibitora ponovnog povrata serotonina i litija i triptofana te se stoga preporučuje oprez pri takvom kombiniranom liječenju. Na metabolizam i farmakokinetiku paroksetina mogu djelovati lijekovi koji induciraju ili inhibiraju jetrene enzime. Kad se paroksetin primjenjuje istovremeno s poznatim inhibitorom metabolizma, moraju se koristiti doze u donjim granicama preporučenog raspona. Paroksetin ne povećava sedaciju i pospanost ako se koristi u kombinaciji s haloperidolom, amilobarbitonom ili oksazepamom. Kao i u slučaju ostalih inhibitora ponovne pohrane 5-HT, ispitivanja na životinjama su pokazala da može doći do interakcije između paroksetina i inhibitora monoamino oksidaze (MAO). Istovremena primjena paroksetina i fenitoina povezuje se sa smanjenom koncentracijom paroksetina u plazmi i s pojačanim neželjenim učincima. Istovremena primjena paroksetina s ostalim antikonvulzivima također može dovesti do veće učestalosti neželjenih učinaka. Preliminarni podaci pokazuju da postoji mogućnosti farmakodinamske interakcije između paroksetina i varfarina koja može dovesti do pojačanog krvarenja u slučaju nepromijenjenog protrombinskog vremena. Stoga paroksetin valja s velikim oprezom davati bolesnicima koji uzimaju oralne antikoagulanse. Svakodnevna primjena paroksetina znatno povećava koncentraciju prociklidina u plazmi. Amantilla Relax Značajno ublažava stres i tjeskobu. Tensilen Prirodno rješenje za stres, umor i iscrpljenost.