http___www.krenizdravo.com_korisno_upute_helex-tablete-alprazolam_2.xml
1.1 2.1 3.1 4.1 5.1 6.1 7.1 8.1 9.1 10.1 11.1 11.2 12.1 12.2 13.1 14.1 14.2 14.3 15.1 15.2 16.1 16.2 16.3 16.4 16.5 16.6 17.1 17.2 17.3 17.4 17.5 18.1 19.1 19.2 20.1 20.2 21.1 22.1 22.2 22.3 23.1 24.1 24.2 25.1 26.1 27.1 27.2 28.1 29.1 29.2 30.1 31.1 32.1 32.2 32.3 32.4 32.5 33.1 33.2 33.3 33.4 34.1 34.2 34.3 35.1 35.2 35.3 35.4 35.5 36.1 37.1 37.2 38.1 38.2 38.3 38.4 39.1 40.1 40.2 40.3 41.1 42.1 42.2 42.3 43.1 44.1 45.1 46.1 47.1 48.1 49.1 49.2 49.3 50.1 50.2 51.1 52.1 53.1 53.2 53.3 54.1 55.1 55.2 56.1 57.1 58.1 58.2 58.3 58.4 58.5 59.1 60.1 60.2 61.1 62.1 63.1 63.2 63.3 64.1 65.1 65.2 65.3 65.4 65.5 66.1 66.2 67.1 68.1 69.1 69.2 70.1 71.1 71.2 72.1 73.1 74.1 74.2 74.3 75.1 76.1 77.1 78.1 79.1 80.1 81.1 82.1 83.1 84.1 85.1 85.2 85.3 86.1 87.1 87.2 87.3 88.1 89.1 90.1 91.1 91.2 91.3 92.1 92.2 92.3 93.1 94.1 94.2 94.3 95.1 96.1 96.2 96.3 98.1 99.1 99.2 100.1 100.2 101.1 102.1 102.2 103.1 104.1 105.1 106.1 106.2 107.1 108.1 108.2 109.1 109.2 109.3 109.4 110.1 111.1 112.1 113.1 113.2 114.1 114.2 115.1 116.1 117.1 118.1 119.1 120.1 121.1 122.1 123.1 124.1 125.1 126.1 127.1 127.2 128.1 129.1 130.1 131.1 132.1 133.1 134.1 135.1 136.1 137.1
top top Xanax 250 microgram Tablets top Alprazolam 250 micrograms. Excipients with known effect: Each tablet also contains 96 mg lactose monohydrate. For the full list of excipients, see section 6.1 toptop White, oval, biconvex tablets containing 250 microgram (0.25 mg) alprazolam, scored on one side and marked "Upjohn 29" on the other. top Xanax is indicated for the short-term treatment of moderate or severe anxiety states and anxiety associated with depression. It is only indicated when the disorder is severe, disabling or subjecting the individual to extreme distress. Xanax should not be used to treat short-term mild anxiety, such as anxiety or tension associated with the stress of everyday life. As the efficacy of Xanax in depression and in phobic or obsessional states has yet to be established, specific treatment may have to be considered. top Treatment should be as short as possible. It is recommended that the patient be reassessed at the end of no longer than 4 weeks' treatment and the need for continued treatment established, especially in case the patient is symptom free. The overall duration of treatment should not be more than 8-12 weeks, including a tapering off process. In certain cases extension beyond the maximum treatment period may be necessary; if so, it should not take place without re-evaluation of the patient's status with special expertise. As with all benzodiazepines, physicians should be aware that long-term use might lead to dependence in certain patients. The optimum dosage of Xanax should be based upon the severity of the symptoms and individual patient response. The lowest dose which can control symptoms should be used. Dosage should be reassessed at intervals of no more than 4 weeks. The usual dosage is stated below; in the few patients who require higher doses, the dosage should be increased cautiously to avoid adverse effects. When higher dosage is required, the evening dose should be increased before the daytime doses. In general, patients who have not previously received psychotropic medications will require lower doses than those so treated, or those with a history of chronic alcoholism. Treatment should always be tapered off gradually. During discontinuation of alprazolam treatment, the dosage should be reduced slowly in keeping with good medical practice. It is suggested that the daily dosage of alprazolam be decreased by no more than 0.5 mg every three days. Some patients may require an even slower dosage reduction. (see section 4.4) There is a reduced clearance of the drug and, as with other benzodiazepines, an increased sensitivity to the drug in elderly patients. Anxiety: 250 micrograms (0.25 mg) to 500 micrograms (0.5 mg) three times daily, increasing if required to a total of 3 mg daily. The elderly or in the presence of debilitating disease: 250 micrograms (0.25 mg) two to three times daily to be gradually increased if needed and tolerated. Paediatric population: Safety and efficacy of alprazolam have not been established in children and adolescents below the age of 18 years; therefore use of alprazolam is not recommended. If side-effects occur, the dose should be lowered. It is advisable to review treatment regularly and to discontinue use as soon as possible. Should longer term treatment be necessary, then intermittent treatment may be considered to minimize the risk of dependence. top Alprazolam is contraindicated in patients with known hypersensitivity to benzodiazepines, alprazolam, or to any of the excipents listed in section 6.1. Benzodiazepines are also contraindicated in patients with myasthenia gravis, severe respiratory insufficiency, sleep apnoea syndrome, severe hepatic insufficiency. top Caution is recommended when treating patients with impaired renal function or mild to moderate hepatic insufficiency. In patients presenting with major depression or anxiety associated with depression benzodiazepines and benzodiazepine-like agents should not be prescribed alone to treat depression as they may precipitate or increase the risk of suicide. Therefore alprazolam should be used with caution and the prescription size should be limited in patients with signs and symptoms of a depressive disorder or suicidal tendencies. Safety and efficacy of alprazolam have not been established in children and adolescents below the age of 18 years; therefore use of alprazolam is not recommended. It is recommended that general principle of using the lowest effective dose to be followed in elderly and /or debilitated patients to preclude development of ataxia or over-sedation (see section 4.2). A lower dose is also recommended for patients with chronic respiratory insufficiency due to risk of respiratory depression. Benzodiazepines should be used with extreme caution in patients with a history of alcohol or drug abuse (see section 4.5). Dependence Use of benzodiazepines may lead to the development of physical and psychic dependence upon these products. The risk of dependence increases with dose and duration of treatment; it is also greater in patients with a history of alcohol and drug abuse. Pharmacodependency may occur at therapeutic doses and/or in patients with no individualised risk factor. There is an increased risk of pharmacodependency with the combined use of several benzodiazepines regardless of the anxiolytic or hypnotic indication. Cases of abuse have also been reported. Withdrawal symptoms: Once physical dependence has developed, abrupt termination of treatment will be accompanied by withdrawal symptoms. These may consist of headaches, muscle pain, extreme anxiety, tension, restlessness, confusion, irritability and insomnia. In severe cases the following symptoms may occur: derealization, depersonalisation, hyperacusis, numbness and tingling of the extremities, hypersensitivity to light, noise and physical contact, hallucinations or epileptic seizures. (see section 4.2) During discontinuation of alprazolam treatment, the dosage should be reduced slowly in keeping with good medical practice. It is suggested that the daily dosage of alprazolam be decreased by no more that 0.5 mg every three days. Some patients may require even slower dosage reduction. Rebound insomnia and anxiety: a transient syndrome whereby the symptoms that led to treatment with a benzodiazepine recur in an enhanced form may occur on withdrawal of treatment. It may be accompanied by other reactions including mood changes, anxiety or sleep disturbances and restlessness. Since the risk of withdrawal phenomena/rebound phenomena is greater after abrupt discontinuation of treatment, it is recommended that the dosage be decreased gradually by no more than 0.5 mg every three days. Some patients may require an even slower dose reduction. (see section 4.2) Duration of treatment The duration of treatment should be as short as possible (see section 4.2) depending on the indication, but should not exceed eight to twelve weeks including tapering off process. Extension beyond these periods should not take place without re-evaluation of the situation. It may be useful to inform the patient when treatment is started that it will be of limited duration and to explain precisely how the dosage will be progressively decreased. Moreover it is important that the patient should be aware of the possibility of rebound phenomena, thereby minimising anxiety over such symptoms should they occur while the medicinal product is being discontinued. There are indications, that in the case of benzodiazepines with a short duration of action, withdrawal phenomena can become manifest within the dosage interval, especially when the dosage is high. When benzodiazepines with a long duration of action are being used it is important to warn against changing to a benzodiazepine with a short duration of action, as withdrawal symptoms may develop. Amnesia Benzodiazepines may induce anterograde amnesia. The condition occurs most often several hours after ingesting the product and therefore to reduce the risk patients should ensure that they will be able to have uninterrupted sleep of 7-8 hours. (see section 4.8) Psychiatric and paradoxical reactions Reactions like restlessness, agitation, irritability, aggressiveness, delusion, rages, nightmares, hallucinations, psychoses, inappropriate behaviour and other adverse behavioural effects are known to occur when using benzodiazepines. Should this occur, use of the medicinal product should be discontinued. They are more likely to occur in children and the elderly. Tolerance Some loss of efficacy to the hypnotic effects of benzodiazepines may develop after repeated use for a few weeks. Episodes of hypomania and mania have been reported in association with the use of alprazolam in patients with depression. Benzodiazepines are not recommended for the primary treatment of psychotic illness. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine. top Benzodiazepines produce an additive effect when co-administered with alcohol or other CNS depressants. Concomitant intake with alcohol is not recommended. Alprazolam should be used with caution when combined with CNS depressants. Enhancement of the central depressive effect may occur in cases of concomitant use with antipsychotics (neuroleptics), hypnotics, anxiolytics/sedatives, antidepressant agents, narcotic analgesics, anti-epileptic drugs, anaesthetics and sedative antihistamines. In the case of narcotic analgesics enhancement of the euphoria may also occur leading to an increase in psychic dependence. Pharmacokinetic interactions can occur when alprazolam is administered along with drugs that interfere with its metabolism. CYP3A Inhibitors Compounds that inhibit certain hepatic enzymes (particularly cytochrome P450 3A4) may increase the concentration of alprazolam and enhance its activity. Data from clinical studies with alprazolam, in-vitro studies with alprazolam and clinical studies with drugs metabolised similarly to alprazolam provide evidence for varying degrees of interaction and possible interaction with alprazolam for a number of drugs. Based on the degree of interaction and the type of data available, the following recommendations are made: • The co-administration of alprazolam with ketoconazole, itraconazole, or other azole-type antifungals is not recommended. • The co-administration of nefazodone or fluvoxamine increases the AUC of alprazolam by approximately 2-fold. Caution and consideration of dose reduction is recommended when alprazolam is co-administered with nefazodone, fluvoxamine and cimetidine. • Caution is recommended when alprazolam is co-administered with fluoxetine, propoxyphene, oral contraceptives, sertraline, diltiazem, or macrolide antibiotics such as erythromycin, clarithromycin and troleandomycin. CYP3A4 Inducers Since alprazolam is metabolized by CYP3A4, inducers of this enzyme may enhance the metabolism of alprazolam. Interactions involving HIV protease inhibitors (e.g. ritonavir) and alprazolam are complex and time dependent. Short term, low doses of ritonavir resulted in a large impairment of alprazolam clearance, prolonged its elimination half-life and enhanced clinical effects. However, upon extended exposure to ritonavir, CYP3A induction offset this inhibition. This interaction will require a dose-adjustment or discontinuation of alprazolam. Digoxin Increased digoxin concentrations have been reported when alprazolam was given, especially in elderly (>65 years of age). Patients who receive alprazolam and digoxin should therefore be monitored for signs and symptoms related to digoxin toxicity. top Pregnancy The data concerning teratogenicity and effects on postnatal development and behavior following benzodiazepine treatment are inconsistent. A large amount of data based on cohort studies indicate that first trimester exposure to benzodiazepine is not associated with an increase in the risk of major malformation. However, some early case-control epidemiological studies have found a twofold increased risk of oral clefts. Benzodiazepine treatment at high dose, during the second and/or the third trimester of pregnancy, has revealed a decrease of fetal active movements and a variability of foetal cardiac rhythm. When treatment has to be administered for medical reasons during the last part of pregnancy, even at low doses, floppy infant syndrome such as axial hypotonia, sucking troubles leading to a poor weight gain may be observed. These signs are reversible but they may last from 1 up to 3 weeks, according to the half life of the product. At high doses, respiratory depression or apnoea and hypothermia in newborn may appear. Moreover, neonatal withdrawal symptoms with hyperexcitability, agitation and tremor may be observed a few days after birth, even if no floppy infant syndrome is observed. The apparition of withdrawal symptoms after birth depends on the half life of the substance. Alprazolam should not be used during pregnancy unless the clinical condition of the woman requires treatment with alprazolam. If alprazolam is used during pregnancy, or of the patient becomes pregnant while taking alprazolam, the patient should be apprised of the potential hazard to the foetus. If alprazolam treatment is necessary during last part of pregnancy, high doses should be avoided and withdrawal symptoms and/or floppy infant syndrome should be monitored in newborn. Breast-feeding Alprazolam is excreted in breast milk at low level. However, alprazolam is not recommended during breast-feeding. top Sedation, amnesia, impaired concentration and impaired muscle function may adversely affect the ability to drive or use machines. If insufficient sleep occurs, the likelihood of impaired alertness may be increased (see section 4.5). These effects are potentiated by alcohol (see section 4.5). Patients should be cautioned about operating motor vehicles or engaging in other dangerous activities while taking Xanax. This medicine can impair cognitive function and can affect a patient's ability to drive safely. This class of medicine is in the list of drugs included in regulations under 5a of the Road Traffic Act 1988. When prescribing this medicine, patients should be told: • The medicine is likely to affect your ability to drive • Do not drive until you know how the medicine affects you • It is an offence to drive while under the influence of this medicine • However, you would not be committing an offence (called 'statutory defence') if: o The medicine has been prescribed to treat a medical or dental problem and o You have taken it according to the instructions given by the prescriber and in the information provided with the medicine and o It was not affecting your ability to drive safely top Adverse events, if they occur, are generally observed at the beginning of therapy and usually disappear upon continued medication or decreased dosage. The following undesirable effects have been observed and reported during treatment with alprazolam with the following frequencies: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data). Withdrawal symptoms have occurred following rapid decrease or abrupt discontinuance of benzodiazepines including alprazolam. These can range from mild dysphoria and insomnia to a major syndrome, which may include abdominal and muscle cramps, vomiting, sweating, tremor and convulsions. In addition, withdrawal seizures have occurred upon rapid decrease or abrupt discontinuation of therapy with alprazolam. Amnesia Anterograde amnesia may occur at therapeutic dosages, the risk increasing at higher dosages. Amnesic effects may be associated with inappropriate behaviour. (see section 4.4). Depression Pre-existing depression may be unmasked during benzodiazepine use. Psychiatric and paradoxical reactions Reactions like restlessness, agitation, irritability, aggressiveness, delusion, rages, nightmares, hallucinations, psychoses, inappropriate behaviour and other adverse behavioural effects are known to occur when using benzodiazepines or benzodiazepine-like agents. They may be quite severe with this product. They are more likely to occur in children and the elderly. In many of the spontaneous case reports of adverse behavioural effects, patients were receiving other CNS drugs concomitantly and/or were described as having underlying psychiatric conditions. Patients who have borderline personality disorder, a prior history of violent or aggressive behaviour, or alcohol or substance abuse may be at risk of such events. Instances of irritability, hostility and intrusive thoughts have been reported during discontinuance of alprazolam in patients with post-traumatic stress disorder. Dependence Use (even at therapeutic doses) may lead to the development of physical dependence: discontinuation of the therapy may result in withdrawal or rebound phenomena (see section 4.4). Psychic dependence may occur. Abuse of benzodiazepines has been reported. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard toptop As with other benzodiazepines, overdose should not present a threat to life unless combined with other CNS depressants (including alcohol). In the management of overdose with any medicinal product, it should be borne in mind that multiple agents have been taken. Following overdose with oral benzodiazepines, vomiting may be induced (within 1 hour) if the patient is conscious or gastric lavage undertaken with the airway protected if the patient is unconscious. If there is no advantage in emptying the stomach, activated charcoal should be given to reduce absorption. Special attention should be paid to respiratory and cardiovascular functions in intensive care. Overdose of benzodiazepines is usually manifested by degrees of central nervous system depression ranging from drowsiness to coma. In mild cases, symptoms include drowsiness, mental confusion and lethargy, in more serious cases, symptoms may include ataxia, hypotonia, hypotension, respiratory depression, rarely coma and very rarely death. Flumazenil may be useful as an antidote. top Pharmacotherapeutic group: Benzodiazepine derivatives, ATC code: N05BA12 Alprazolam, like other benzodiazepines, has a high affinity for the benzodiazepine binding site in the brain. It facilitates the inhibitory neurotransmitter action of gamma-aminobutyric acid, which mediates both pre- and post synaptic inhibition in the central nervous system (CNS). top Alprazolam is readily absorbed. Following oral administration peak concentration in the plasma occurs after 1 - 2 hours. The mean half-life is 12 - 15 hours. Repeated dosage may lead to accumulation and this should be borne in mind in elderly patients and those with impaired renal or hepatic function. Alprazolam and its metabolites are excreted primarily in the urine. In vitro alprazolam is bound (80%) to human serum protein. toptop Non-clinical data reveal no special hazard for humans based on conventional studies of genotoxicity and carcinogenic potential. When rats were treated orally with alprazolam for 2 years, a tendency for a dose related increase in the number of cataracts (females) and corneal vascularization (males) was observed. These lesions did not appear until after 11 months of treatment. In reproductive toxicity studies administration of alprazolam in rats and rabbits is associated at very high doses with developmental delay and an increased incidence of fetal death and skeletal malformations. In fertility studies, treatment of male rats at high doses prior to mating resulted in a decrease in the percentage of dams conceiving. toptoptop Lactose monohydrate Microcrystalline cellulose Colloidal anhydrous silica Maize starch Magnesium stearate Docusate sodium with sodium benzoate. top Do not store above 25°C. Blister pack: Keep container in the outer carton. Bottle pack only: Store in the original container. toptop Clear PVC/aluminium foil blister strips of 10 tablets, packed 6 strips to a box. Glass bottle with metal screw cap or HDPE bottle with LDPE tamper evident cap containing 100 or 1000 tablets. Not all pack sizes may be marketed. toptop Pfizer Limited Ramsgate Road Sandwich Kent CT13 9NJ United Kingdom top 27 August 1982/23 January 2003
1.1 2.1 3.1 4.1 5.1 6.1 7.1 8.1 9.1 10.1 11.1 12.1 13.1 14.1 15.1 16.1 17.1 17.2 18.1 18.2 19.1 20.1 21.1 22.1 23.1 24.1 25.1 26.1 27.1 28.1 29.1 30.1 31.1 32.1 33.1 33.2 33.3 34.1 35.1 36.1 36.2 37.1 38.1 39.1 39.2 39.3 40.1 41.1 42.1 43.1 44.1 44.2 44.3 44.4 45.1 46.1 47.1 48.1 49.1 49.2 49.3 49.4 50.1 50.2 51.1 52.1 53.1 54.1 54.2 55.1 55.2 56.1 57.1 57.2 58.1 58.2
Uputa o lijeku sadržava sljedeće podatke: Djelatna tvar je alprazolam Pomoćne tvari su: HELEX tablete 0,25 mg: laktoza hidrat; kukuruzni škrob, povidon, krospovidon, polisorbat 80, magnezijev stearat. HELEX tablete 0,5 mg: laktoza, kukuruzni škrob, povidon,boja roza (E127), krospovidon, polisorbat 80, magnezijev stearat. HELEX tablete 1 mg: laktoza, kukuruzni škrob, povidon, plava boja (E131+ E151), krospovidon, polisorbat 80, magnezijev stearat. Farmaceutski oblik i veličina pakovanja Tablete. HELEX tablete od 0,25 mg, 0,5 mg i 1 mg dostupne su u blister pakovanju od 30 tableta (2×15 tableta) ili 90 tableta (6×15 tableta), u kutiji. Farmakoterapijska skupina Derivati benzodiazepina. Nositelj odobrenja za stavljanje lijeka u promet KRKA – FARMA d.o.o., Radnička cesta 48, 10000 Zagreb, Hrvatska Način i mjesto izdavanja Lijek se izdaje na recept, u ljekarni. ŠTO JE HELEX I ZA ŠTO SE KORISTI? Alprazolam je anksiolitik iz skupine derivata benzodiazepina. Helex djeluje smirujuće na središnji živčani sustav. Helex se može primijeniti u liječenju poremećaja uzrokovanih napadima paničnog straha, sa ili bez agorafobije, kod anksioznih stanja različite težine, također onih povezanih s depresijom. Osim toga, može se primijeniti u liječenju uznemirenosti, nemira i napetosti, sa ili bez psihosomatskih reakcija, te kao dodatak inicijalnom liječenju depresije kad je prisutna i anksioznost. ŠTO MORATE ZNATI PRIJE POČETKA UZIMANJA HELEXA? Ne uzimajte HELEX: - ako ste alergični na alprazolam ili na bilo koji od gore navedenih sastojaka, ili ste u prošlosti imali alergijsku reakciju na drugi benzodiazepin; - ako bolujete od miastenije gravis (teške mišićne slabosti); - ako imate tešku bolest pluća, npr. bronhitis, emfizem; - ako imate “apneju u snu”, stanje kod kojeg dolazi do privremenog prestanka disanja za vrijeme spavanja; - ako imate tešku bolest jetre. Budite posebno oprezni pri uzimanju HELEXA: - ako bolujete od epilepsije ili ste u prošlosti imali napadaje; - ako imate bilo kakvih poteškoća s disanjem; - ako ste ikada bolovali od bilo koje mentalne bolesti koja je zahtijevala liječenje u bolnici; - ako Vam je ponekad teško prestati s uzimanjem lijekova, konzumiranjem alkohola, s uzimanjem sredstava za koje vjerujete da Vam pomažu u rješavanju svakodnevnih poteškoća – liječnik će Vam pružiti dodatnu pomoć prilikom prestanka uzimanja takvih tableta; - ako imate bolest bubrega; - ako ste mlađi od 18 godina, ili stariji od 60 godina; - ako ste se ikada osjećali toliko beskorisno ili bezvrijedno da ste razmišljali o oduzimanju vlastitog života. Vrlo je važno da o tome obavijestite svog liječnika, kako bi Vam mogla biti pružena pomoć. S obzirom da Helex nije prikladan za liječenje tog oblika depresije, propisat će Vam se drugi lijek. Uzimanje drugih lijekova Obavijestite svojeg liječnika ili ljekarnika ako uzimate ili ste nedavno uzimali bilo koji lijek, čak i ako ste ga nabavili bez recepta. Istovremeno uzimanje s alkoholom nije preporučljivo. Kada se lijek uzima u kombinaciji s alkoholom sedativni učinci mogu biti pojačani, a to utječe na sposobnost upravljanja vozilima ili strojevima. Kombinacija s depresorima SŽS-a U slučajevima istovremenog uzimanja antipsihotika (neuroleptika), hipnotika, anksiolitika/sedativa, antidepresivnih sredstava, opijatnih analgetika, antiepileptičnih lijekova, anestetika i sedativnih antihistaminika može doći do pojačanja središnjeg depresivnog učinka. Kada se alprazolam primjenjuje zajedno s lijekovima koji interferiraju s njegovim metabolizmom može doći do farmakokinetskih interakcija. Sredstva koja inhibiraju određene enzime jetre (osobito citokrom P450 3A4) mogu povećati koncentraciju alprazolama i pojačati njegovo djelovanje. Podaci iz kliničkih ispitivanja s alprazolamom, in-vitro ispitivanja s alprazolamom i kliničkih ispitivanja s lijekovima koji se metaboliziraju na sličan način kao alprazolam, pružaju dokaze za različite stupnjeve interakcije i moguće interakcije alprazolama s brojnim lijekovima. Prema stupnju interakcije i vrsti dostupnih podataka, donesene su sljedeće preporuke: - Istovremena primjena alprazolama s ketokonazolom, itrakonazolom, ili drugim antimikoticima azolne vrste se ne preporučuje. - Preporučuje se oprez i razmatranje mogućnosti smanjivanja doze kada se alprazolam istovremeno primjenjuje s nefazodonom, fluvoksaminom i cimetidinom. - Preporučuje se oprez kada se alprazolam istovremeno primjenjuje s fluoksetinom, propoksifenom, oralnim kontraceptivima, sertralinom, diltiazemom, ili makrolidnim antibioticima kao što su eritromicin i troleandomicin. - Interakcije koje uključuju inhibitore HIV proteaze (npr. ritonavir) i alprazolam su složene i ovisne o vremenu. Male doze ritonavira dovele su do velikog poremećaja klirensa alprazolama, produžile su njegovo poluvrijeme eliminacije i pojačale kliničke učinke. Međutim, nakon produžene izloženosti ritonaviru, indukcija CYP3A djeluje kao protuteža toj inhibiciji. Zbog navedene interakcije biti će potrebno prilagoditi dozu ili prekinuti primjenu alprazolama. Uzimanje HELEXA zajedno s hranom i pićem Istovremeno uzimanje alkoholnih pića i Helexa nije prikladno, jer može doći do izrazitog pojačanja supresivnog učinka lijeka na središnji živčani sustav. Posebna upozorenja Posavjetujte se s liječnikom ili ljekarnikom prije nego uzmete bilo koji lijek. Helex Vam u pravilu neće biti propisan ako ste trudni. Ukoliko zatrudnite za vrijeme uzimanja ovog lijeka, obavezno se posavjetujte sa svojim liječnikom o prestanku liječenja. Ponekad, zbog opravdanih medicinskih razloga, liječnik će Vam savjetovati nastavak liječenja tijekom trudnoće ili tijekom poroda. Kada se rodi, Vaše dijete mora biti brižljivo pregledano, jer zbog lijeka kojeg ste uzimali može imati sniženu tjelesnu temperaturu, mlohavost mišića, te mu disanje može biti otežano. Pored toga, postoji mogućnost da je Vaše dijete postalo ovisno o lijeku, stoga bi moglo razviti simptome ustezanja u vremenu nakon poroda. Dojenje Alprazolam se izlučuje u mlijeko, zbog toga ne smijete dojiti za vrijeme liječenja. Utjecaj na sposobnost upravljanja vozilima i strojevima Helex može snažno utjecati na Vaše psihofizičke sposobnosti. Na početku liječenja ne smijete upravljati vozilima ni strojevima sve dok Vaš liječnik ne potvrdi da se kod Vas ne pojavljuju vrtoglavica ili pospanost. Liječnik će procijeniti Vašu sposobnost upravljanja vozilima uzimajući u obzir osnovnu bolest i učinke liječenja. Važni podaci o nekim sastojcima HELEXA Helex tablete sadržavaju vrlo male količine azo bojila E 151. Azo bojilo E 151 može izazvati alergijske reakcije. Napomena: Ove upute o proizvodima samo su ilustrativnog karaktera. Ukoliko trebate savjet u vezi korištenja lijeka obratite se liječniku ili ljekarniku.