Consumer Information for: AURO-ELETRIPTAN

Consumer Information

Information about the product including what the product is used for, dosage, warnings, proper use and side effects. This summary will not tell you everything about the product. Contact your healthcare professional if you have any questions about the product.


What the medication is used for

The name of your medicine is Auro-Eletriptan. This medicine is one of a group of antimigraine drugs called 5-HT1 agonists.

Auro-Eletriptan is intended to relieve your migraine headache and other associated symptoms of a migraine attack.

What it does

Migraine headache is believed to be caused by a widening of the blood vessels in the head. Auro-Eletriptan narrows the vessels and relieves the pain and other symptoms of migraine headache

When it should not be used

Auro-Eletriptan should not be used continuously to prevent or reduce the number of attacks you experience. Use Auro- Eletriptan only to treat an actual migraine headache attack. Auro-Eletriptan should not be used to relieve pain other than that associated with migraine headache.

Do not take Auro-Eletriptan if you:

  • are allergic to any of the ingredients (see What the medicinal ingredient is and What the nonmedicinal ingredients are sections)
  • have uncontrolled or severe high blood pressure
  • have heart disease or history of heart disease
  • have severe liver disease
  • have or had a stroke or problems with your blood circulation, Raynaud syndrome or transient ischemic attacks (TIAs)
  • have taken any of the following medicines in the last 72 hours:
  • ketoconazole, itraconazole, nefazodone,
  • troleandomycin, clarithromycin, ritonavir, and nelfinavir? These medicines may cause an increase in the amount of eletriptan hydrobromide in the blood, increasing the risk of serious side effects.
  • have taken the following medicines in the last 24 hours: other “triptans” like
  • almotriptan, sumatriptan, naratriptan,
  • zolmitriptan, rizatriptan or ergotamine-type medications such as ergotamine, dihydroergotamine or methysergide. These medicines are of the same class as Auro- Eletriptan, and taking them together increases the risk of serious side effects.

Do not use Auro-Eletriptan if you are pregnant, think you might be pregnant, are trying to become pregnant or are using inadequate contraception, unless you have discussed this with your physician.

What the medicinal ingredient is

Eletriptan hydrobromide

What the non-medicinal ingredients are

Each tablet also contains the following inactive ingredients: Cellulose Microcrystalline, Lactose Monohydrate, Croscarmellose Sodium, Magnesium stearate, Aquarius BT 13200 and Aquarius BT 13202 Orange contain Hypromellose, Titanium dioxide, Triacetin, Lactose monohydrate and FD&C Yellow 6 Aluminium Lake

Lactose-intolerant Patients: You should be aware that this product contains lactose.

What dosage form it comes in

Auro-Eletriptan tablets for oral administration are orange, round film-coated tablets and contain 20 or 40 mg of eletriptan base.

Warnings and precautions

The decision to use Auro-Eletriptan is one that you and your doctor should make jointly, taking into account your individual preferences and medical circumstances. If you have risk factors for heart disease (such as high blood pressure, high cholesterol, obesity, diabetes, smoking, strong family history of heart disease, or you are a postmenopausal female or a male over 40), you should tell your doctor. Your doctor should evaluate you for heart disease in order to determine if Auro-Eletriptan is appropriate for you.

Important Questions to Consider Before Taking Auro- Eletriptan: If the answer to any of the following questions is yes, or if you do not know the answer, then please speak with your doctor before you take any Auro-Eletriptan.

  • Are you pregnant? Do you think you might be pregnant? Are you trying to become pregnant? Are you using inadequate contraception? Are you breast-feeding?
  • Do you experience or have you ever experienced any pain or tightness in the chest, (which may or may not spread to your neck, jaw, or upper arm), shortness of breath, rapid heartbeats or irregular heartbeats? Do you have angina?
  • Have you ever had heart or blood vessel disease? Have you had a heart attack or stroke? Have you ever had Raynaud syndrome or transient ischemic attacks (TIAs)?
  • Do you have risk factors for heart disease, such as: high blood pressure, high cholesterol, smoking, obesity, diabetes, or strong family history of heart disease? Are you postmenopausal or a male over 40?
  • Have you ever had to stop taking this or any other medication because of an allergy or other problems?
  • Are you taking any other migraine 5-HT1 agonist medications such as almotriptan, sumatriptan succinate/sumatriptan, naratriptan as naratriptan hydrochloride, zolmitriptan,
  • rizatriptan benzoate or migraine medications containing ergotamine, dihydroergotamine, or methysergide?
  • Are you taking any medications for depression such as selective serotonin reuptake inhibitors (SSRIs) such as sertraline, escitalopram and fluoxetine, or serotonin norepinephrine reuptake inhibitors (SNRIs) such as venlafaxine, duloxetine?
  • Have you ever experienced numbness on one side of your body when you have a headache?
  • Have you ever had, or do you have epilepsy or seizures?
  • Have you ever had, or do you have liver or kidney problems?
  • Is this headache different from your usual migraine attacks?
  • Are you over 65 years of age?
  • Have you taken or will you be taking any of the following medicines within 72 hours: ketoconazole, itraconazole, nefazodone, troleandomycin, clarithromycin, ritonavir, and nelfinavir? These medicines may cause an increase in the amount of Auro-Eletriptan in the blood increasing the risk of serious side effects.

If you answered yes to any of the above questions, discuss them all with your physician before taking Auro-Eletriptan.

Interactions with this medication

Some medicines may increase the risk of serious side effects if taken concurrently with Auro-Eletriptan.

Do not take Auro-Eletriptan if you

  • have taken any of the following medicines in the last 72 hours: ketoconazole, itraconazole, nefazodone, troleandomycin, clarithromycin, ritonavir, and nelfinavir?
  • have taken the following medicines in the last 24 hours: other “triptans” like almotriptan, sumatriptan, naratriptan, zolmitriptan, rizatriptan or ergotamine-type medications such as ergotamine, dihydroergotamine or methysergide.

Ask your physician for instructions about taking Auro- Eletriptan if you are taking selective serotonin reuptake inhibitors (SSRIs) such as sertraline, escitalopram and fluoxetine or serotonin norepinephrine reuptake inhibitors (SNRIs) such as venlafaxine, duloxetine for depression. A life-threatening condition called serotonin syndrome can happen when medicines called triptans, such as Auro- Eletriptan, and medicines used to treat depression and mood disorders called SSRIs or SNRIs are used together. Signs and symptoms of serotonin syndrome include the following: restlessness, diarrhea, hallucinations, coma, loss of coordination, nausea, fast heartbeat, vomiting, increased body temperature, changes in blood pressure and overactive reflexes.

Proper use of this medication

Usual Dose

For adults, the dosage is 20 or 40 mg, as recommended by your physician. The dose should be taken as soon as your migraine appears, but it may be taken at any time during your migraine headache.

Auro-Eletriptan tablets should be swallowed whole with water.

If your first dose is 20 mg, a second dose of 20 mg may be taken if your headache returns. Repeat doses cannot be taken any sooner than 2 hours following the first dose. Do not take more than 40 mg in any 24-hour period.

If the first dose does not relieve the symptoms, do not take further doses for the same attack.

A reminder: This medicine has been prescribed only for you. Only a doctor knows who can use it safely. Never give this medication to anyone else. It may harm them, even if their symptoms are the same as yours.

Overdose

If you think you have taken too much Auro-Eletriptan, contact your healthcare professional, hospital emergency department or regional poison control centre immediately, even if there are no symptoms.
Side effects and what to do about them

Side Effects to Watch for: Although the vast majority of Auro-Eletriptan users have not experienced any significant problems, you should be aware of the following side effects:

  • Sensations of pain, pressure or tightness in the chest, neck, throat, jaw or arms. If this happens to you, then discuss it with your doctor before using any more Auro-Eletriptan. If the chest pain is severe (may resemble an angina attack) or does not go away, call your doctor immediately.
  • Shortness of breath; wheezing; heart throbbing; swelling of face, lips, eyelids; skin rash; skin lumps; or hives. Tell your doctor immediately. Do not continue to take Auro-Eletriptan unless advised by your doctor.
  • Feeling weak, dizziness, feeling sleepy or drowsy, tingling, difficulty swallowing, nausea and stomach pain/cramps.
  • Drowsiness in some patients. Dizziness and drowsiness have also been reported in some patients receiving Auro- Eletriptan. Therefore, do not drive or operate machinery if you are experiencing these symptoms or side effects.

If you feel unwell in any other way or have any symptoms that you do not understand, contact your doctor or pharmacist.

This is not a complete list of side effects. For any unexpected effects while taking Auro-Eletriptan, contact your doctor or pharmacist.

How to store

Keep out of reach and sight of children. Auro-Eletriptan could be harmful to children.

Store at room temperature 15°C to 30°C. Protect from moisture.

If your doctor tells you to stop taking Auro-Eletriptan or if your medicine has expired, discard it by returning it to your pharmacist.

Reporting side effects

You can report any suspected side effects associated with the use of health products to Health Canada by:

NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

More information

If you want more information about Auro-Eletriptan:

This leaflet was prepared by
Auro Pharma Inc.
3700 Steeles Avenue West, Suite # 402
Woodbridge, Ontario, L4L 8K8,
Canada.

Date of Preparation: July 26, 2018

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