Active ingredients: Sumatriptan
Sumatriptan Accord 50 mg film-coated tablets
Sumatriptan Accord 100 mg film-coated tablets
Why is Sumatriptan used - Generic Drug? What is it for?
Sumatriptan Accord belongs to a group of medicines called serotonin (5-HT1) receptor agonists.
Migraine headache is thought to be caused by dilation of blood vessels. Sumatriptan constricts these blood vessels, thereby relieving migraine headaches.
Sumatriptan Accord is used to treat migraine attacks with or without aura (aura is a warning usually associated with flashes of light, jagged images, stars or waves).
Contraindications When Sumatriptan - Generic Drug should not be used
Do not use Sumatriptan Accord if:
- you are allergic to sumatriptan or any of the other ingredients of Sumatriptan Accord (listed in section 6).
- have a heart problem, such as narrowing of the arteries (ischemic heart disease) or chest pains (angina) or have already had a heart attack.
- have had a stroke or mini-stroke (TIA or transient ischemic attack).
- have blood circulation problems in the legs which cause cramps such as pain when walking (peripheral vascular disease, PVD).
- have high blood pressure or your blood pressure remains high despite medication. - have severely reduced liver function.
- you are using, or have recently used, medicines containing ergotamine or similar medicines, such as methysergide maleate (for the treatment of migraine).
- uses, or has recently used, so-called MAO inhibitors (e.g. moclobemide for the treatment of depression or selegiline for the treatment of Parkinson's disease).
Precautions for use What you need to know before taking Sumatriptan - Generic Drug
Before prescribing Sumatriptan Accord, your doctor will determine if your headache is caused by a migraine and not by any other condition. Talk to your doctor before using Sumatriptan Accord if any of the following apply to you:
- if you have symptoms that indicate the presence of heart disease, such as chest pain or a feeling of pressure in the chest which may radiate up to the neck.
- If you are taking antidepressant medicines called selective serotonin reuptake inhibitors (SSRIs) or SNRIs (serotonin and norepinephrine reuptake inhibitors).
- If you have an "intolerance to some sugars.
- If you have reduced liver or kidney function.
- If you have a history of seizures (convulsions). Or if you have other conditions that could increase the likelihood of having a seizure, for example, head injury or alcoholism.
- If you are allergic to sulfonamide. In this case, he may also be allergic to sumatriptan. If you know you are allergic to an antibiotic but are not sure whether it is a sulphonamide, consult your doctor or pharmacist before using this medicine.
- If you are a heavy smoker or are undergoing nicotine replacement therapy and in particular:
- if you are a man over the age of 40, or
- if you are a postmenopausal woman.
In very rare cases, patients have developed severe heart disease after taking sumatriptan, even if they had no signs of heart disease before. Tell your doctor so that your heart function can be checked before you are prescribed sumatriptan.
- If you have diabetes.
If you feel chest pain or tightness after taking sumatriptan. These effects can be intense, but usually resolve quickly. If they do not go away quickly, or become severe, see a doctor immediately.
If you use sumatriptan frequently. Too frequent use of sumatriptan can make your headache worse. Your doctor may recommend that you stop using sumatriptan.
Interactions Which drugs or foods may change the effect of Sumatriptan - Generic Drug
Some medicines can affect the effects of Sumatriptan Accord and Sumatriptan Accord can influence the effects of other medicines. Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes all herbal preparations, food supplements such as vitamins, iron or calcium or medicines that you have bought without a prescription. This is especially important when using medicines that contain:
- ergotamine or its derivatives (for migraines). If you have taken a product containing ergotamine, wait at least 24 hours before taking sumatriptan. Similarly, wait at least six hours after taking sumatriptan before taking a product containing ergotamine.
- MAO inhibitors (e.g. moclobemide for depression or selegiline for the treatment of Parkinson's disease). Sumatriptan Accord should not be used if you have taken these medicines within the last 2 weeks.
- SSRIs and SNRIs used to treat depression. Using Sumatriptan Accord with these medicines can cause serotonin syndrome (a set of symptoms which may include agitation, confusion, sweating, hallucinations, increased reflexes, muscle spasms, chills, increased heart rate and tremor). doctor if it is affected.
- Lithium (medicine used in the treatment of manic / depressive (bipolar) disorders.
- St John's Wort (Hypericum perforatum) - Taking herbal remedies containing St John's wort with Sumatriptan Accord may make side effects more likely.
Warnings It is important to know that:
Pregnancy and breastfeeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Pregnancy:
There are limited data on the safety of Sumatriptan Accord for pregnant women, although so far there is no evidence of an increased risk of birth defects. Your doctor will discuss with you whether or not it is appropriate to use Sumatriptan Accord during pregnancy.
Feeding time:
Ask your doctor or pharmacist for advice before taking any medicine. Sumatriptan is excreted in breast milk. Breastfeeding should therefore be avoided for 24 hours after taking Sumatriptan Accord.
Driving and using machines
A patient suffering from migraine may feel drowsy due to the migraine attack or treatment with Sumatriptan Accord. This should be taken into consideration when performing activities that require more concentration than usual, such as driving and using machines. .
Sumatriptan Accord contains lactose
This medicinal product contains lactose. If you have been told by your doctor that you have "intolerance to some sugars, contact your doctor before taking this medicinal product.
Dose, Method and Time of Administration How to use Sumatriptan - Generic Drug: Posology
Always take this medicine exactly as your doctor has told you. If in doubt, consult your doctor or pharmacist. It is best to take Sumatriptan Accord as soon as you feel the onset of a migraine, although it can be taken at any time during an attack. Do not use Sumatriptan Accord to try to prevent an attack - only use it after the initial symptoms of migraine appear.
Adults (aged 18 to 65 years): The recommended dose is one Sumatriptan Accord 50 mg tablet for a migraine attack. Some patients may require 100 mg. Follow your doctor's advice.
Children (under 18 years of age): The use of Sumatriptan Accord is not recommended for children.
Elderly (over 65 years of age): The use of Sumatriptan Accord is not recommended for this age group.
Method of administration:
Swallow the tablet whole with water. Preferably take it as soon as possible after the onset of a migraine attack. Do not chew or crush the tablets.
If you have the impression that the effect of Sumatriptan Accord is too strong or too weak, talk to your doctor or pharmacist.
If the first tablet has no effect
Do not take a second dose to treat the same migraine attack, even if the first dose does not relieve symptoms. Sumatriptan Accord can still be used for the next attack. If Sumatriptan Accord does not give you any relief, consult your doctor.
If the symptoms start to come back
If symptoms are reduced after the first dose but return later, the dose may be repeated once, in rare cases a maximum of twice, during the 24 hours. But it is necessary to wait at least two hours between doses. Do not exceed a daily dose of 300 mg.
Overdose What to do if you have taken too much Sumatriptan - Generic Drug
If you have taken too many Sumatriptan Accord tablets, contact your doctor or hospital immediately. The symptoms of overdose are the same as those listed in section 4 'Possible side effects'.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Side Effects What are the side effects of Sumatriptan - Generic Drug
Like all medicines, this medicine can cause side effects, although not everybody gets them. Some of the symptoms listed below may have been caused by the migraine attack itself.
Allergic reaction:
Not known (frequency cannot be estimated from the available data):
- allergic skin reaction: rash, such as red spots or hives (growths on the skin).
- Anaphylaxis (severe allergic reactions such as swelling of the eyelids, face or lips and sudden shortness of breath, throbbing, tightness in the chest or collapse).
If you experience any allergic reaction, stop taking Sumatriptan Accord. Contact your doctor immediately.
Other possible side effects:
Common (may affect up to 1 in 10 people):
- sleepiness, dizziness, sensory disturbances
- difficulty in breathing
- muscular pain
- temporary increase in blood pressure (shortly after taking), hot flashes
- feeling of weakness, tiredness
- feeling sick (nausea) or feeling sick (vomiting)
- pain, feeling of heat or cold, pressure, tightness or heaviness. These symptoms are typically transient (temporary) and can appear anywhere in the body, including the chest and throat.
Not known (frequency cannot be estimated from the available data):
- convulsions (seizures), involuntary movements (dystonia), tremor, nystagmus
- visual disturbances such as flickering, decreased vision, loss of vision (these can also be caused by the migraine attack itself)
- heart problems such as fast, slower heartbeat or changes in rhythm, chest pain (angina) or heart attack
- low blood pressure, Raynaud's phenomenon (a condition in which the fingers and toes turn white and lose sensation)
- inflammation of the colon (symptoms include lower left abdominal pain and bloody diarrhea)
- stiff neck
- Minor abnormalities in liver function tests have occasionally been observed
- diarrhea
- anxiety
- excessive sweating
- joint pain.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system at http://www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects you can help provide more information on the safety of this medicine.
Expiry and Retention
This medicinal product does not require any special storage conditions.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.
Do not throw any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.
Deadline "> Other information
What Sumatriptan Accord contains
50 mg film-coated tablets
Active ingredient: sumatriptan. Each tablet contains 70 mg of sumatriptan succinate equivalent to 50 mg of sumatriptan.
Other components:
- tablet core: lactose monohydrate, hypromellose, microcrystalline cellulose, croscarmellose sodium, magnesium stearate
- film coating: hypromellose, titanium dioxide (E 171), triacetin, red iron oxide (E 172)
100 mg film-coated tablets
Active ingredient: sumatriptan. Each tablet contains 140 mg of sumatriptan succinate equivalent to 100 mg of sumatriptan.
Other components:
- tablet core: lactose monohydrate, hypromellose, microcrystalline cellulose, croscarmellose sodium, magnesium stearate
- film coating: hypromellose, titanium dioxide (E 171)
Sumatriptan Accord looks like and contents of the pack
Description of the 50 mg film-coated tablet: Pink, capsule-shaped, biconvex, film-coated tablet, plain on both sides.
Description of the 100 mg film-coated tablet: White to off-white, capsule-shaped, biconvex, film-coated tablet, plain on both sides.
Sumatriptan Accord 50 mg film-coated tablets are available in blister packs of 4, 6, 12 or 18 tablets.
Sumatriptan Accord 100 mg film-coated tablets are available in blister packs of 4, 6, 12 or 18 tablets.
Not all pack sizes may be marketed.
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT -
SUMATRIPTAN ACCORD TABLETS COATED WITH FILM
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION -
Each 50 mg film-coated tablet contains 70 mg of sumatriptan succinate equivalent to 50 mg of sumatriptan.
Excipient: lactose monohydrate 72 mg.
Each 100 mg film-coated tablet contains 140 mg of sumatriptan succinate equivalent to 100 mg of sumatriptan.
Excipient: lactose monohydrate 143 mg.
For the full list of excipients, see section 6.1.
03.0 PHARMACEUTICAL FORM -
Film-coated tablet.
50 mg: pink, capsule-shaped, biconvex, film-coated tablet, plain on both sides
100 mg: white to off-white, capsule-shaped, biconvex, film-coated tablet, plain on both sides
04.0 CLINICAL INFORMATION -
04.1 Therapeutic indications -
Sumatriptan tablets are indicated for the treatment of acute migraine attacks, with or without aura. Sumatriptan should only be used in cases where there is a clear diagnosis of migraine.
04.2 Posology and method of administration -
Dosage
Sumatriptan should not be used in prophylaxis.
Sumatriptan is recommended as monotherapy for the treatment of acute migraine attack and should not be administered concomitantly with ergotamine or ergotamine derivatives (including methysergide) (see section 4.3).
It is recommended that sumatriptan be taken as soon as possible after the onset of the migraine attack.
The medicine is equally effective regardless of the stage of the attack in which it is administered.
The following recommended dosages should not be exceeded.
Adults:
The recommended dose of oral sumatriptan is a single 50 mg tablet.Some patients may require 100 mg.
If the patient does not respond to the first dose of sumatriptan, a second dose should not be taken for the same attack. In these cases the attack can be treated with paracetamol, acetylsalicylic acid or non-steroidal anti-inflammatory drugs. Sumatriptan tablets can be taken for subsequent attacks.
If the patient has responded to the first dose but symptoms recur, a second dose may be given over the next 24 hours, provided there is a minimum interval of 2 hours between the two doses. No more than 300 mg should be taken during 24 hours n.
Sumatriptan Accord is available in strengths of 50 and 100 mg.
Pediatric population
The efficacy and safety of sumatriptan tablets in children aged less than 10 years have not been established. No clinical data are available in this age group.
The efficacy and safety of sumatriptan tablets in children aged 10-17 years have not been demonstrated in clinical trials conducted in this age group. Therefore, the use of sumatriptan tablets in children aged 10-17 years old has not been demonstrated. 17 years is not recommended (see section 5.1).
Elderly population (over 65 years of age)
There is limited experience with the use of sumatriptan in patients over 65 years of age. The pharmacokinetics do not differ significantly from that of the younger population, but until further clinical data become available, the use of sumatriptan in patients over 65 years of age is not recommended.
Hepatic impairment
Patients with mild to moderate hepatic impairment: Administration of low doses of 25-50 mg should be considered for these patients.
Kidney damage
Sumatriptan should be used with caution in patients with renal impairment.
Method of administration
The tablets should be swallowed whole with water.
04.3 Contraindications -
- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
- Sumatriptan must not be used in patients who have had myocardial infarction or who have ischemic heart disease, coronary vasospasm (Prinzmetal's angina), peripheral vascular disease or with symptoms or signs attributable to ischemic heart disease.
- Sumatriptan must not be given to patients with a history of cerebrovascular accident (CVA) or transient ischemic attack (TIA).
- Sumatriptan must not be given to patients with severe hepatic impairment.
- The use of sumatriptan is contraindicated in patients with moderate and severe hypertension and mild uncontrolled hypertension.
- Concomitant administration of ergotamine or ergotamine derivatives (including methysergide) or any triptan / 5-hydroxytryptamine1 (5-HT1) receptor agonist is contraindicated (see section 4.5).
- Concomitant administration of reversible (e.g. moclobemide) or irreversible (e.g. selegiline) monoamine oxidase (MAOI) and sumatriptan inhibitors is contraindicated.
Sumatriptan should not be used within 2 weeks of stopping monoamine oxidase inhibitor therapy.
04.4 Special warnings and appropriate precautions for use -
Sumatriptan should only be used after a clear diagnosis of migraine has been made.
The use of sumatriptan is not indicated in the treatment of hemiplegic, basilar or ophthalmoplegic migraine.
As with other therapies for the treatment of acute migraine attack, care should be taken to exclude headache treatment in previously diagnosed migraine patients, and in migraine patients presenting with atypical symptoms, prior to initiating headache treatment. the presence of other potentially serious neurological diseases.
It should be noted that migraine patients may be at increased risk for some cerebrovascular events (eg CVA, TIA).
Administration of sumatriptan may be accompanied by transient symptoms including chest pain and tightness which may be intense and affect the throat (see section 4.8). If these symptoms are believed to be indicative of ischemic heart disease, no further doses of sumatriptan should be given and appropriate evaluation made.
Sumatriptan should be administered with caution in patients with mild controlled hypertension, as transient increases in blood pressure and peripheral vascular resistance have been observed in a small percentage of patients (see section 4.3).
Sumatriptan should not be given to patients with risk factors for ischemic heart disease, including diabetic patients and patients who are heavy smokers or using nicotine replacement therapies, without first conducting a cardiovascular evaluation (see section 4.3). Particular consideration must be given to postmenopausal women and men over 40 years of age in whom these risk factors are present. However, these assessments may not identify every patient who has cardiac disease and, in very rare cases, serious cardiac events have occurred in patients without underlying cardiovascular disease.
There have been rare post-marketing reports of patients with serotonin syndrome (which included altered mental status, autonomic instability and neuromuscular abnormalities) following the use of a selective serotonin reuptake inhibitor (SSRI) and sumatriptan. The serotonin syndrome is It has been reported following concomitant treatment with triptans and serotonin norepinephrine reuptake inhibitors (SNRIs).
In cases where concomitant treatment of sumatriptan with an SSRI or SNRI is clinically justified, adequate patient monitoring is recommended (see section 4.5).
Sumatriptan should be administered with caution to patients with conditions that can significantly alter the absorption, metabolism or excretion of the drug, eg. hepatic impairment or reduced kidney function.
Sumatriptan should be used with caution in patients with a history of seizures or other risk factors that lower the seizure threshold level, as seizures have been reported in association with sumatriptan (see section 4.8).
Patients with known hypersensitivity to sulfonamides may experience an allergic reaction after administration of sumatriptan. Reactions can range from cutaneous hypersensitivity to “anaphylaxis.” Evidence of cross-reactivity is limited, however, caution should be exercised before using sumatriptan in these patients.
Undesirable effects may occur more commonly during concomitant use of triptans and St. John's Wort preparations (Hypericum perforatum).
Prolonged use of any type of pain reliever for headache can make it worse. If this occurs or is suspected, a doctor should be consulted and treatment discontinued. Drug abuse headache (MOH) should be suspected in patients who have frequent or daily headaches despite regular use (or use) of headache medicines.
The recommended doses of Sumatriptan Accord should not be exceeded.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption should not take this medicine as it contains lactose.
04.5 Interactions with other medicinal products and other forms of interaction -
There is no evidence of interactions with propranolol, flunarizine, pizotifen or alcohol.
Data on interactions with ergotamine-containing preparations or other triptans / 5-HT1 receptor agonists are limited. There is a theoretical possibility of an increased risk of coronary vasospasm, therefore concomitant administration is contraindicated (see section 4.3).
The time interval between the use of sumatriptan and preparations containing ergotamine or other triptans / 5-HT1 receptor agonists is not known. This will also depend on the doses and types of products used. Effects can be additive. It is recommended to wait at least 24 hours after using ergotamine-containing preparations or other triptan / 5-HT1 receptor agonists before administering sumatriptan. Conversely, it is recommended to wait at least 6 hours after using sumatriptan before administering an ergotamine-containing product and at least 24 hours before administering other triptans / 5-HT1 receptor agonists (see section 4.3).
An interaction between sumatriptan and MAOIs may occur and concomitant administration is contraindicated (see section 4.3).
There have been rare post-marketing reports of patients with serotonin syndrome (which included altered mental status, autonomic instability and neuromuscular abnormalities) following the use of SSRIs and sumatriptan. Serotonin syndrome has also been reported following concomitant treatment with triptans. and SNRIs (see section 4.4).
There may be a risk of serotonin syndrome even when sumatriptan is used concomitantly with lithium.
04.6 Pregnancy and breastfeeding -
Pregnancy
There are post-marketing data on the use of sumatriptan during the first trimester of pregnancy in over 1,000 women. Although these data do not contain sufficient information to draw firm conclusions, they did not reveal an increase in the risk of congenital defects. the use of sumatriptan in the second and third trimesters is limited.
Evaluation of experimental animal studies does not indicate direct teratogenic effects or harmful effects in peri- or postnatal development. However, embryonic and fetal death may occur in rabbits (see section 5.3).
Administration of sumatriptan should only be considered if the benefit to the mother is greater than the possible risk to the fetus.
Feeding time
It has been shown that following subcutaneous administration, sumatriptan is excreted in human milk. The exposure of infants to the drug can be minimized by avoiding breastfeeding during the 12 hours following treatment, during this period the amount of breast milk must be eliminated.
04.7 Effects on ability to drive and use machines -
No studies on the effect on the ability to drive and use machines have been performed. Migraine or its treatment with sumatriptan may lead to somnolence. This may affect the ability to drive or use machines.
04.8 Undesirable effects -
Undesirable effects are listed below by system organ class and frequency.
Frequencies are defined as: very common (≥ 1/10), common (≥ 1/100,
Some of the symptoms reported as side effects may be symptoms associated with migraine.
Disorders of the immune system
Not known: hypersensitivity reactions which can range from cutaneous hypersensitivity (such as hives) to anaphylaxis.
Psychiatric disorders
Not known: anxiety.
Nervous system disorders
Common: dizziness, somnolence, sensory disturbances including paraesthesia and hypoesthesia.
Not known: seizures, although some of these cases have occurred in patients with a history of seizures or concomitant conditions predisposing to seizures. There are also reports in patients for whom such predisposing factors are not evident.
Tremor, dystonia, nystagmus, scotoma.
Eye disorders
Not known: vision flickering, diplopia, impaired vision. Loss of vision, including cases of permanent defects. However, visual disturbances can also occur during the migraine attack itself.
Cardiac pathologies
Not known: bradycardia, tachycardia, palpitations, cardiac arrhythmias, transient ischemic-type ECG changes, coronary artery vasospasm, angina, myocardial infarction (see sections 4.3 and 4.4).
Vascular pathologies
Common: transient increase in blood pressure occurring soon after administration. Redness.
Not known: hypotension, Raynaud's syndrome.
Respiratory, thoracic and mediastinal disorders
Common: dyspnoea
Gastrointestinal disorders
Common: Nausea and vomiting have occurred in some patients, but it is unclear whether this is related to sumatriptan or pre-existing conditions.
Not known: ischemic colitis, diarrhea.
Skin and subcutaneous tissue disorders
Not known: hyperhidrosis.
Musculoskeletal and connective tissue disorders
Common: feeling of heaviness (usually transient, can be intense and can affect any part of the body, including the chest and throat). Myalgia.
Not known: neck stiffness, arthralgia.
General disorders and administration site conditions
Common: pain, sensation of heat or cold, pressure or tightness (these events are usually transient and can be intense and can affect any part of the body, including the chest and throat). Feeling of weakness, fatigue (both events are mostly mild to moderate in intensity and transient).
Diagnostic tests
Very rare: Mild changes in liver function tests have occasionally been observed.
Reporting of suspected adverse reactions
Reporting of suspected adverse reactions occurring after authorization of the medicinal product is important as it allows continuous monitoring of the benefit / risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system www .agenziafarmaco.gov.it / it / responsible.
04.9 Overdose -
A few cases of overdose with sumatriptan tablets have been reported.
Symptoms
Doses above 400 mg orally and 16 mg subcutaneously were not associated with side effects other than those mentioned. There were no significant side effects in patients who received single subcutaneous injections of up to 12 mg.
Treatment
In the event of an overdose, the patient should be monitored for at least 10 hours and appropriate standard supportive care instituted if necessary. The effects of hemodialysis or peritoneal dialysis on plasma concentrations of sumatriptan are unknown.
05.0 PHARMACOLOGICAL PROPERTIES -
05.1 "Pharmacodynamic properties -
Pharmacotherapeutic group: anti-migraine drugs, selective serotonin (5-HT1) receptor agonists.
ATC code: N02CC01.
Mechanism of action
Sumatriptan is a specific and selective 5-hydroxytryptamine 1D1 (5HT1D) receptor agonist without interference with other 5HT (5HT2-5HT7) receptor subtypes.
The vascular 5HT1D receptor is mainly present in the cerebral vessels and mediates vasoconstriction. In animals, sumatriptan works by selectively constricting the circulation of the carotid arteries without affecting cerebral blood flow. The circulation of the blood in the carotid arteries irrigates the extracranial and intracranial tissues such as the meninges and it is believed that the dilation of these vessels and / or the formation of edema is the basis of the pathogenetic mechanism of migraine in humans.
Furthermore, evidence from animal studies suggests that sumatriptan may inhibit trigeminal nerve activity. Both of these actions (cranial vasoconstriction and inhibition of trigeminal nerve activity) may contribute to the anti-migraine action of sumatriptan in humans.
Sumatriptan remains effective in the treatment of menstrual migraine, which is migraine without aura that occurs between 3 days before and up to 5 days after the start of menstruation. Sumatriptan should be taken as soon as possible in an attack.
Clinical response begins approximately 30 minutes after an oral dose of 100 mg.
Although the recommended oral dose of sumatriptan is 50 mg, the severity of migraine attacks varies both in the same patients and from patient to patient. Doses of 25 mg - 100 mg have been shown to be more effective than placebo in clinical trials. but the 25 mg dose is statistically significantly less effective than 50 mg and 100 mg.
Pediatric population
A number of placebo-controlled clinical trials have evaluated the safety and efficacy of oral sumatriptan in approximately 800 children and adolescents with migraine, aged 10 to 17. These studies have demonstrated no relevant differences in headache relief. 2 hours between placebo and any dose of sumatriptan The undesirable effect profile of oral sumatriptan in adolescents aged 10 to 17 years was similar to that reported from studies in the adult population.
05.2 "Pharmacokinetic properties -
The pharmacokinetics of oral sumatriptan are not significantly affected by migraine attacks.
Absorption
After oral administration, sumatriptan is rapidly absorbed; 70% of the maximum concentration is reached in 45 minutes. After the 100 mg dose, the maximum plasma concentration is 54 ng / ml and is reached in 2 hours. The mean absolute oral bioavailability is 14%, partly due to presystemic metabolism and partly due to incomplete absorption.
Distribution
Plasma protein binding is low (14-21%) and the mean volume of distribution is 170 liters.
Biotransformation
The main metabolite, the derivative indole acetic acid analogue of sumatriptan, is excreted mainly in the urine, in which it is present in both free acid and conjugated glucuronide form. It has no known 5HT1 or 5HT2 activity.No minor metabolites were identified.
Elimination
The elimination half-life is approximately 2 hours. The mean total plasma clearance is approximately 1160 ml / min and the mean renal plasma clearance is approximately 260 ml / min. Non-renal clearance is approximately 80% of the clearance. total, which suggests that sumatriptan is primarily eliminated via monoamine oxidase A mediated oxidative metabolism.
Elderly population
In a pilot study, there were no significant differences in pharmacokinetic parameters between elderly and young healthy volunteers.
05.3 Preclinical safety data -
Sumatriptan was found to be devoid of genotoxic and carcinogenic activity in in vitro and animal studies.
In the study of fertility in rats, a reduction in the success of inseminations was observed at doses significantly higher than the maximum doses used in humans.
In rabbits, embryonic lethality without marked teratogenic effects was observed. The relevance of these findings to humans is unknown.
06.0 PHARMACEUTICAL INFORMATION -
06.1 Excipients -
50 mg coated tablet
Core of the tablet:
Lactose monohydrate
Hypromellose
Microcrystalline cellulose
Croscarmellose sodium
Magnesium stearate
Coating film:
Hypromellose
Titanium dioxide (E 171)
Red iron oxide (E 172)
Triacetin
100 mg coated tablet
Core of the tablet :
Lactose monohydrate
Hypromellose
Microcrystalline cellulose
Croscarmellose sodium
Magnesium stearate
Coating film:
Hypromellose
Titanium dioxide (E 171)
06.2 Incompatibility "-
Not relevant.
06.3 Period of validity "-
2 years.
06.4 Special precautions for storage -
This medicinal product does not require any special storage conditions.
06.5 Nature of the immediate packaging and contents of the package -
The individual tablets are packed in blisters (Al / Al).
Pack sizes:
For 50 mg: 4, 6, 12 and 18 tablets
For 100 mg: 4, 6, 12 and 18 tablets.
Not all pack sizes may be marketed.
06.6 Instructions for use and handling -
Unused medicine and waste derived from this medicine must be disposed of in accordance with local regulations.
No special instructions.
07.0 HOLDER OF THE "MARKETING AUTHORIZATION" -
Accord Healthcare Limited
Sage House, 319 Pinner Road,
North Harrow, Middlesex, HA1 4HF,
UK
08.0 MARKETING AUTHORIZATION NUMBER -
042571012 "50 mg film-coated tablets" 6 tablets in AL / AL blister
042571024 "50 mg film-coated tablets" 12 tablets in AL / AL blister
042571036 "100 mg film-coated tablets" 6 tablets in AL / AL blister
042571048 "100 mg film-coated tablets" 12 tablets in AL / AL blister
042571063 "50 mg film-coated tablets" 4 tablets in AL / AL blister
042571075 "50 mg film-coated tablets" 18 tablets in AL / AL blister
042571087 "100 mg film-coated tablets" 4 tablets in AL / AL blister
042571099 "100 mg film-coated tablets" 18 tablets in AL / AL blister
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION -
13 February 2015
10.0 DATE OF REVISION OF THE TEXT -
October 2015
