Zomig 2.5mg. 5mg Tablets

ZOMIG is indicated for the acute treatment of migraine with or without aura in adults.

The recommended dose of ZOMIG to treat a migraine attack is 2,5 mg. If a patient does not achieve satisfactory relief with 2,5 mg doses, subsequent attacks can be treated with 5 mg doses of ZOMIG. ZOMIG is effective whenever the tablets are taken during a migraine attack; although it is advisable that the ZOMIG tablets are taken as early as possible after the onset of migraine headache.

The ZOMIG conventional tablet should be swallowed whole with water. ZOMIG Rapimelt orodispersible tablets can be taken when water is not available or by patients who suffer from nausea and are unable to drink during a migraine attack. The blister pack should be peeled open as shown on the foil (tablets should not be pushed through the foil). The ZOMIG Rapimelt tablet should be placed on the tongue, where it will dissolve and be swallowed with the saliva. If symptoms persist or return within 24 hours, a second dose has been shown to be effective. If a second dose is required, it should not be taken within 2 hours of the initial dose. In those patients who respond, statistically significant efficacy is apparent within 1 hour of dosing. In the event of recurrent attacks, it is recommended that the total intake of ZOMIG in a 24 hour period should not exceed 10 mg. ZOMIG is not indicated for prophylaxis of migraine.

Use in patient subgroups: Use in adolescents and children (under 18 years): Safety and efficacy have not been established. Use of ZOMIG in adolescents and children is therefore not recommended. The efficacy and safety of ZOMIG in paediatric patients below 12 years have not been evaluated.

ZOMIG is contraindicated in patients with known hypersensitivity to any component of the product. ZOMIG must not be given to patients with severe hypertension. Ischaemic heart disease. Coronary vasospasm/Prinzmetalu2019s angina. Moderate to severe hepatic impairment.

ZOMIG should not be given to patients with symptomatic Wolff-Parkinson-White syndrome or dysrhythmias associated with other cardiac accessory conduction pathways. ZOMIG has been associated with coronary vasospasm, angina pectoris and myocardial infarction. In patients with risk factors for ischaemic heart disease, cardiovascular evaluation prior to commencement of treatment with ZOMIG, is recommended (see u201cContraindicationsu201d). These evaluations, however, may not identify every patient who has cardiac disease and serious cardiac events have occurred in patients without underlying cardiovascular disease. Patients with phenylketonuria should be informed that ZOMIG Rapimelt orodispersible tablets contain phenylalanine (a component of aspartame). Each 2,5 mg orodispersible tablet contains 2,81 mg of phenylalanine. The serotonin syndrome has been reported with combined use of triptans such as ZOMIG, and selective serotonin reuptake inhibitors (SSRIs) and serotonin norepinephrine reuptake inhibitors (SNRIs). Serotonin syndrome is a potentially life-threatening condition, and it may include signs and symptoms such as mental status changes (e.g. agitation, hallucinations, coma), autonomic instability (e.g. tachycardia, labile blood-pressure, hyperthermia), neuromuscular aberrations (e.g. hyperreflexia, in-coordination), and/or gastrointestinal symptoms (e.g. nausea, vomiting, diarrhoea). Careful observation of the patient is advised, if concomitant treatment with ZOMIG and SSRI or SNRI, particularly during treatment initiation and dosage increases (see u201cInteractionsu201d). Use in patients aged over 65 years: Safety and efficacy of ZOMIG in individuals aged over 65 years have not been systematically evaluated. Patients with hepatic impairment: Although zolmitriptan metabolism is reduced in patients with hepatic impairment, no dosage adjustment is required for patients with mild hepatic impairment. A maximum dose of 5 mg of ZOMIG in 24 hours is recommended. Patients with renal impairment: No dosage adjustment required (see u201cPharmacokinetic propertiesu201d).

There is no evidence that concomitant use of migraine prophylactic medications has any effect on the efficacy or unwanted effects of ZOMIG (for example beta blockers, oral dihydroergotamine, pizotifen). The pharmacokinetics and tolerability of ZOMIG were unaffected by acute symptomatic treatments such as paracetamol, metoclopramide and ergotamine. Concomitant administration of other 5HT 1B/1D agonists within 12 hours of ZOMIG treatment should be avoided. Ergot-containing medicines have been reported to cause prolonged vasospastic reactions. Because there is a theoretical basis that these effects may be additive, 24 hours should elapse between the use of ergotamine containing or ergot-type medications (like dihydroergotamine or methysergide) and ZOMIG. Conversely, it is advised to wait at least 6 hours following the use of ZOMIG before administering an ergotamine containing preparation. In a small group of healthy individuals there was no pharmacokinetic interaction with ergotamine. Concomitant administration of ZOMIG with ergotamine/caffeine did not result in any increase in adverse events or blood pressure changes as compared with ZOMIG alone. Selegiline, an MAO-B inhibitor, and fluoxetine (a selective serotonin reuptake inhibitor; SSRI) had no effect on the pharmacokinetic parameters of zolmitriptan. Following administration of moclobemide, a specific MAO-A inhibitor, there was a small increase (26 %) in AUC for zolmitriptan and a 3-fold increase in AUC of the active metabolite. Therefore, a maximum intake of 5 mg ZOMIG in 24 hours is recommended in patients taking an MAO-A inhibitor. Following the administration of cimetidine, a general P450 inhibitor, the half-lives of zolmitriptan and the active metabolite were significantly increased. A maximum dose of 5 mg ZOMIG in 24 hours is recommended in patients taking cimetidine. Based on the overall interaction profile, an interaction with inhibitors of the cytochrome P450 isoenzyme CYP1A2 cannot be excluded. Therefore, the same dosage reduction is recommended with compounds of this type, such as fluvoxamine and the quinolone antibiotics (e.g. ciprofloxacin). Following the administration of rifampicin, no clinically relevant differences in the pharmacokinetics of zolmitriptan or its active metabolite were observed. Cases of life threatening serotonin syndrome have been reported during combined use of triptans, and selective serotonin reuptake inhibitors (SSRIs) (e.g. fluoxetine, paroxetine, sertraline) and serotonin norepinephrine reuptake inhibitors (SNRIs) (e.g. venlafaxine, duloxetine) (see u201cWarningsu201d).

Pregnancy: Safety in pregnancy and lactation has not been established. Lactation: ZOMIG is not recommended for women who are breastfeeding.

There was no statistically significant impairment of performance of psychomotor tests with doses up to 20 mg ZOMIG. However, it should be taken into account that somnolence may occur.

Possible adverse reactions tend to occur within 4 hours of dosing and are no more frequent following repeated dosing.

Frequency System Organ Class Event
Common ( u2265 1 % - < 10 %) Nervous system disorders Abnormalities or disturbances of sensation, Dizziness, Paraesthesia, Somnolence, Warm sensation, Headache
Cardiac disorders Palpitations
Gastrointestinal disorders Dry mouth, Nausea, Vomiting, Dysphagia, Dyspepsia, Abdominal pain
Musculoskeletal and connective tissue disorders Muscle weakness, Myalgia
General disorders Asthenia, Heaviness, Tightness, Pain or pressure in throat, neck, limbs or chest
Uncommon ( u2265 0,1 % - < 1 %) Cardiac disorders Tachycardia
Vascular disorders Transient increases in systemic blood pressure
Renal urinary disorders Polyuria, Increased urinary frequency
Rare ( u2265 0,01 % - < 0,1 %) Immune system disorders Anaphylaxis/Anaphylactoid reactions, Hypersensitivity reactions
Skin and subcutaneous tissue disorders Angioedema, Urticaria
Very rare (< 0, 01 %) Cardiac disorders Angina pectoris, Coronary vasospasm, Myocardial infarction
Gastrointestinal disorders Bloody diarrhoea, Gastrointestinal infarction or necrosis, Gastrointestinal ischaemic events, Ischaemic colitis, Splenic infarction
Renal and urinary disorders Urinary urgency

Volunteers receiving single oral doses of 50 mg commonly experienced sedation. The elimination half-life of zolmitriptan administration is approximately 3 hours and therefore monitoring of patients after overdose with ZOMIG tablets should continue for at least 15 hours or while symptoms or signs persist. There is no specific antidote to zolmitriptan. In cases of severe intoxication, intensive care procedures are recommended, including establishing and maintaining a patent airway, ensuring adequate oxygenation and ventilation, and monitoring and support of the cardiovascular system. It is unknown what effect haemodialysis or peritoneal dialysis has on the serum concentrations of zolmitriptan.