Rapimig 2.5mg 6 dispersible tablets — Made in Malta — Free Delivery
(Rapimig 2.5mg )
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Description Rapimig 2.5mg 6 dispersible tablets — Made in Malta — Free Delivery
Indications
Relief of migraine attacks with and without aura.
Application
The preparation is not intended for use in the prevention of migraine attacks. Rapimig is recommended to be used as soon as possible after the onset of a migraine attack, although its effectiveness does not depend on how long after the onset of the attack the pill was taken.
The tablet does not need to be taken with liquid. The tablet is placed on the tongue, where it dissolves, and swallowed with saliva. This dosage form can be used in situations where there is no liquid on hand or to avoid nausea and vomiting that may occur when the tablet is swallowed with liquid.
This dosage form quickly dissolves in the oral cavity, however, sometimes it is still possible to delay the absorption of zolmitriptan and delay the onset of the preparations action.
The blister pack should be opened by stripping it of foil and not by punching the foil with a tablet.
The recommended dose of Rapimig to eliminate a migraine attack is 1 tablet (2.5 mg). If symptoms persist or recur within 24 hours, a second dose may be effective. If the use of a second dose is necessary, it should be taken no earlier than 2 hours after the first. If the dose of 2.5 mg is insufficiently effective, a single dose may be increased to 5 mg (the maximum single dose).
The maximum daily dose should not exceed 10 mg. Do not use more than 2 doses of zolmitriptan in a 24-hour period.
Liver failure. No dose adjustment is required in patients with mild to moderate hepatic impairment. In patients with severely impaired liver function, the daily dose should not exceed 5 mg.
Renal failure With a creatinine clearance of 15 ml / min, the dose does not need to be adjusted.
Interactions requiring dose adjustment. See INTERACTIONS.
Contraindications
Hypersensitivity to the components of the preparation. severe or moderate hypertension, as well as mild uncontrolled increase in blood pressure, coronary heart disease, including a history of myocardial infarction. angiospastic angina (prinzmetal angina). history of cerebrovascular disorders and transient ischemic attack. creatinine clearance 15 ml / min. concomitant administration of ergotamine, ergotamine derivatives, sumatriptan, naratriptan or other 5ht1b / 1d receptor agonists. peripheral vascular disease. old age (65 years).
Side effects
Usually they are not very pronounced, as a rule, passing, appear within 4 hours after taking the preparation, do not increase after its repeated use, and disappear spontaneously without additional treatment.
By the frequency of occurrence, side effects are classified as follows: very often: ≥1 / 10; often: ≥1 / 100, 1/10; sometimes: ≥1 / 1000, 1/100; rarely: ≥1 / 10,000, 1/1000:
- on the part of the cardiovascular system: often - a feeling of palpitations; sometimes - tachycardia, a slight increase in blood pressure, rarely - myocardial infarction, angina pectoris, coronary spasm;
- on the part of the central nervous system and the autonomic nervous system: often - disturbances from the sensory organs, dizziness, headache, hyperesthesia, paresthesia, drowsiness, feeling of heat;
- from the digestive system: often - abdominal pain, nausea, vomiting, dry mouth; rarely - ischemia or infarction (for example, intestinal ischemia, intestinal infarction, spleen infarction), which may manifest as bloody diarrhea or abdominal pain;
- from the genitourinary system: infrequently - polyuria, frequent urination; rarely - an imperative urge to urinate.
- from the musculoskeletal system: often - muscle weakness, muscle pain;
- general disorders: often - asthenia, feeling of heaviness, squeezing, pain or constriction in the throat, neck, limbs or chest;
- from the immune system: sometimes - hypersensitivity reactions, including urticaria, Quincke's edema and anaphylactic reactions.
- Individual symptoms may relate to the migraine itself.
special instructions
Rapimig should be used only in cases where the diagnosis of migraine is accurately established. Before starting treatment for headache in patients who have not been diagnosed with migraine before, or patients predisposed to migraine who have atypical symptoms, other neurological conditions should be excluded. Rapimig should not be prescribed for hemiplegic, basilar and ophthalmoplegic migraines. in patients taking 5ht1b / 1d agonists, stroke and other side cerebrovascular disorders are possible. individuals prone to migraine may develop certain symptoms associated with cerebrovascular insufficiency.
Rapimig is not prescribed for patients with symptomatic WPW syndrome or arrhythmias associated with other accessory pathways.
In some cases, similar to the use of other 5HT1B / 1D receptor agonists, coronary spasm, angina pectoris and myocardial infarction have been reported. In the presence of factors contributing to the development of ischemic heart disease (for example, smoking, high blood pressure, hyperlipidemia, diabetes mellitus, heredity), Rapimig is prescribed only after examining the cardiovascular system. Particular attention should be paid to postmenopausal women and men over the age of 40 with these risk factors. However, the examination does not allow identifying all patients with cardiovascular diseases, therefore, there have been isolated cases of serious cardiac events in patients without a history of cardiovascular disorders.
In some patients, after taking zolmitriptan, a feeling of heaviness in the region of the heart was noted. If you experience chest pain or symptoms characteristic of coronary artery disease, Rapimig should be discontinued prior to an appropriate medical examination.
In patients with both a history of elevated blood pressure and normal blood pressure, a transient increase in blood pressure is possible. Very rarely, such an increase in blood pressure is associated with serious clinical manifestations. Rapimig should be used in a dose that does not exceed the recommended dose.
With the simultaneous use of triptans and collections of medicinal plants containing St. John's wort, the frequency of adverse reactions may increase.
Long-term use of any pain reliever for headaches can make the pain worse. In such a situation, it is necessary to stop treatment and consult a doctor. Over-treatment headache should be suspected in patients with frequent or daily occurrence of such pain that is not relieved by regular use of the medication.
Rapimig contains aspartame (a source of phenylalanine), which may cause side effects in patients with phenylketonuria. Each 2.5 mg tablet contains 4 mg of aspartame, each 5 mg tablet contains 8 mg of aspartame.
Use during pregnancy and lactation. During pregnancy, Rapimig is used only if the potential therapeutic effect for the mother outweighs the potential risk to the fetus. There is no data on the penetration of zolmitriptan into breast milk. Therefore, during breastfeeding, Rapimig must be used with caution. The effect on the infant must be minimized, therefore, breastfeeding is resumed no earlier than 24 hours after taking the preparation.
Children. The preparation is not used in children under the age of 18.
Influence on the ability to drive vehicles and work with complex mechanisms. When the preparation was taken by a small group of healthy volunteers at a dosage of up to 20 mg, there was no significant effect on the results of psychomotor tests.
But drivers of vehicles and persons whose work is associated with increased concentration of attention should be warned that in the event of a migraine attack, drowsiness and other symptoms may develop.
Interactions
It is permissible to use the preparation with caffeine, paracetamol, metoclopramide, pizotifen, fluoxetine, rifampicin and propranolol.
Based on the data obtained with the participation of healthy volunteers, there was no pharmacokinetic or other interaction of clinical significance between zolmitriptan and ergotamine. Since the risk of coronary spasm may theoretically increase, Rapimig is recommended to be taken at least 24 hours after taking the preparation containing ergotamine. Conversely, a preparation containing ergotamine is recommended to be taken at least 6 hours after Rapimig is used.
After the use of moclobemide, a specific inhibitor of MAO-A, a slight increase (26%) in AUC for zolmitriptan and a three-fold increase in AUC for the active metabolite was revealed. Therefore, patients who are using an MAO-A inhibitor are advised to take zolmitriptan at a dose of no more than 5 mg / day. The preparations should not be administered concurrently when taking moclobemide at a dose of 150 mg 2 times a day.
After taking cimetidine, a common inhibitor of P450, the T1 / 2 of zolmitriptan increased by 44% and the AUC by 48%. In addition, cimetidine doubled the T½ and AUC of the active, N-dimethylated metabolite (183C91). For patients using cimetidine, it is recommended to take zolmitriptan in a dose of no more than 5 mg / day. Based on the general profile of interaction, the possibility of interaction with specific inhibitors of CYP 1A2 cannot be ruled out. Therefore, when using preparations such as fluvoxamine and ciprofloxacin, it is also recommended to reduce the dose.
From a pharmacokinetic point of view, selegiline (an MAO-B inhibitor) and fluoxetine (a selective serotonin reuptake inhibitor) do not interact with zolmitriptan.
After the simultaneous use of triptans and selective serotonin reuptake inhibitors or serotonin and norepinephrine reuptake inhibitors, serotonin syndrome has been reported (including changes in mental state, autonomic lability, neuromuscular abnormalities). These reactions can be severe. If the simultaneous use of zolmitriptan, a selective serotonin and norepinephrine reuptake inhibitor, is clinically feasible, it is recommended to conduct an appropriate examination of the patient, especially at the beginning of treatment, with an increase in the dose or the use of another serotonergic agent.
Like other 5HT1B / 1D receptor agonists, zolmitriptan can slow the absorption of other preparations.
Overdose
Symptoms: The volunteers who took zolmitriptan at a dose of 50 mg once had a sedative effect. monitoring the condition of patients in case of overdose should last at least 15 hours or until symptoms disappear.
Treatment: gastric lavage, intake of activated charcoal, symptomatic therapy, including ensuring airway patency, monitoring and maintaining the function of the cardiovascular system. There is no specific antidote.
It is not known how hemodialysis and peritoneal dialysis affect the plasma concentration of zolmitriptan.
Storage conditions
Store in original packaging. does not require special storage conditions.
Tags: Rapimig
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