Apo-Naratriptan: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

The name of your medicine is APO-NARATRIPTAN. It can be obtained only by prescription from your doctor. The decision to use APO-NARATRIPTAN 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 postmenopausal or a male over 40, you should tell your doctor, who should evaluate you for heart disease, in order to determine if APO-NARATRIPTAN is appropriate for you.

What the medication is used for:

APO-NARATRIPTAN is intended to relieve your migraine headache and other associated symptoms of a migraine attack. APO-NARATRIPTAN should not be used continuously to prevent or reduce the number of attacks you experience. Use APO-NARATRIPTAN only to treat an actual migraine headache attack.

What it does:

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

When it should not be used:

Do not take APO-NARATRIPTAN if you:

• are allergic to naratriptan or any of the ingredients (see What the nonmedicinal ingredients are section).
• have heart problems or a history of heart problems, such as heart failure or chest pains (angina) or have had a heart attack.
• have had a stroke or a mini-stroke (transient ischemic attack or TIA).
• have a circulation problem in your legs that cause cramp-like pains when you walk (peripheral vascular disease).
• have uncontrolled or severe high blood pressure.
• have severe liver or kidney disease.
• have taken another migraine medication such as IMITREX^® (sumatriptan), ZOMIG^® (zolmitriptan), MAXALT^® (rizatriptan), or AXERT^® (almotriptan) or ergotamine-type medications such as ergotamine, dihydroergotamine or methysergide within the last 24 hours.

APO-NARATRIPTAN should not be used to relieve pain other than from a migraine headache.

What the medicinal ingredient is:

naratriptan (as naratriptan hydrochloride)

What the nonmedicinal ingredients are:

lactose monohydrate; microcrystalline cellulose; croscarmellose sodium; magnesium stearate; hydroxypropyl methylcellulose; hydroxypropyl cellulose; polyethylene glycol 8000; indigotine aluminium lake 12 to 14%; ferric oxide yellow and titanium dioxide.(2.5 mg tablet only)

lactose monohydrate; microcrystalline cellulose; croscarmellose sodium; magnesium stearate; hydroxypropyl methylcellulose; hydroxypropyl cellulose; polyethylene glycol 8000 and titanium dioxide. (1 mg tablet only)

What dosage forms it comes in:

APO-NARATRIPTAN is available as a 1 mg (white) or 2.5 mg (green) tablet.

WARNING AND PRECAUTIONS

APO-NARATRIPTAN is not recommended for people over 65 years of age or for children under the age of 18.

BEFORE you use APO-NARATRIPTAN, talk to your doctor or pharmacist if you:

• have or have had blood vessel problems, including ischemic bowel disease

• are pregnant, think you might be pregnant, you are trying to become pregnant, you are using inadequate contraception, or you are breast-feeding

• have or had any pain or tightness in the chest (which may or may not spread to your neck, jaw, or upper arm), heart or blood vessel disease, angina, shortness of breath, or irregular heartbeats
• have had a heart attack, stroke or mini-stroke (also called a transient ischemic attack or TIA)
• 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 postmenopausal or a male over 40)
• have ever had to stop taking this or any other medication because of an allergy or other problems
• have or have had epilepsy or seizures
• suffer from peripheral vascular disease (e.g., pain in the back of the legs while walking) or are prone to cold and/or pale or purplish hands and feet
• are taking any other migraine medications such as IMITREX^® (sumatriptan), ZOMIG^® (zolmitriptan), MAXALT^® (rizatriptan), or AXERT^® (almotriptan), which may contain any triptan/5-HT₁ agonists, or ergotamine, dihydroergotamine, or methysergide
• are taking any antidepressants classed as selective serotonin reuptake inhibitors (SSRIs), serotonin noradrenaline reuptake inhibitors (SNRIs) or other medications for depression
• have ever experienced numbness or have had difficulty moving one side of your body when you have a headache
• had or have any disease of the kidney or liver
• experience a headache that is different from your usual migraine attacks

Continuous use of APO-NARATRIPTAN

Taking APO-NARATRIPTAN too often may make your headaches worse or more frequent. If this happens to you, tell your doctor. You may have to stop taking APO-NARATRIPTAN.

If you are not sure whether you should take APO-NARATRIPTAN, contact your doctor or pharmacist.

Driving and using machines

APO-NARATRIPTAN may make you drowsy. Do not drive or operate machinery unless you are feeling alert.

The use of APO-NARATRIPTAN During Pregnancy:

Do not use APO-NARATRIPTAN if you are pregnant, think you might be pregnant, are trying to become pregnant, or are not using adequate contraception, unless you have discussed this with your doctor.

INTERACTIONS WITH THIS MEDICATION

Tell your doctor or pharmacist if you’re taking any other medicines, if you have taken any recently, or if you start taking new ones. This includes medicines you’ve bought without a prescription.

Some medicines must not be taken with APO-NARATRIPTAN and others may cause adverse effects if they’re taken with APO-NARATRIPTAN. These include:

• SSRIs (Selective Serotonin Reuptake Inhibitors) or SNRIs (serotonin-noradrenaline reuptake inhibitors) used to treat depression. A life-threatening condition called serotonin syndrome can happen when medicines called triptans, such as APO-NARATRIPTAN, and medicines used to treat depression and mood disorders called SSRIs and 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.
• Other 5-HT₁ receptor agonists, such as sumatriptan used to treat migraine.
• Ergotamine also used to treat migraine, or similar medicines such as methysergide.

Tell your doctor or pharmacist if you are taking any of these.

PROPER USE OF THIS MEDICATION

REMEMBER: this medicine was prescribed only for YOU. Only a physician knows who can use it safely. Never give it to someone else. It may harm them, even if their symptoms are the same as yours.

Usual dose:

For adults, the usual dose is a single 1 or 2.5 mg tablet (as recommended by your doctor) taken whole with water. The tablet should be taken as soon as your migraine appears, but may be taken anytime after the headache starts. A second tablet may be taken if your headache returns or if you need more relief, but not sooner than 4 hours following the first tablet.

For an individual attack, if you have no response to the first tablet, do not take a second tablet without first talking to your doctor. Do not take more than a total of 5 mg in any 24-hour period.

If you are taking any other migraine medicines, check with your doctor first before taking APO-NARATRIPTAN.

If you have kidney or liver disease, take as directed by your doctor.

Overdose:

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Like all medicines, APO-NARATRIPTAN can cause some side effects. You may not experience any of them. For most patients these side effects are likely to be minor and temporary. However, some may be serious. Consult your doctor if you experience these or other side effects.

Common side effects – these may affect up to 1 in 10 people:

• Ear, nose and throat infections
• Nausea, vomiting
• Drowsiness
• Dizziness
• Headache
• Dry mouth
• Feeling tired or unwell

Uncommon side effects – these may affect up to 1 in 100 people:

• Rise in blood pressure
• Fainting, light-headedness

• Tremor

  • Difficulty sleeping
  • Nose, throat and sinus infection
  • Urinary tract infections
  • Feeling full or bloated
  • Stomach pain or discomfort
  • Diarrhea
  • Constipation
  • Muscle or joint pain, muscle cramps, or inflammation of the joints
  • Feeling anxious or depressed
  • Difficulty with learning, perception, memory and problem solving
  • Increased sense of touch
  • Skin effects such as rash, itchiness, bumpiness and sensitivity to light
  • Sweating
  • Feeling thirsty
  • Sensitivity to sound

Rare side effects – these may affect up to 1 in 1000 people:

• Nasal congestion (allergic rhinitis)
• Eye problems such as dry eyes, blurred vision and sensitivity to light
• Acid reflux
• Hemorrhoids
• Itchy or irritated mouth
• Ulcers
• Muscle or joint stiffness
• Muscle twitches
• Low blood pressure
• Poor balance or coordination, slowed movement
• Lack of energy or alertfulness, confusion
• Aggression, agitation or detachment
• Hair loss
• Red, flushed or inflamed skin
• Ear effects such as infection, difficulty hearing, ringing sensation
• Sudden, compelling urge to urinate
• Swelling of the glands that produce saliva
• Changes in sense of taste

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

HOW TO STORE IT

Store at controlled room temperature 15°C to 30°C.

Keep out of the reach and sight of children.

If your medication has expired, do not use it. Throw it away.

If your doctor decides to stop treatment with APO-NARATRIPTAN, do not keep any leftover medication unless your doctor tells you to.

REPORTING SIDE EFFECTS

MORE INFORMATION

If you want more information about APO-NARATRIPTAN:

• Talk to your healthcare professional

Find the full product monograph that is prepared for healthcare professionals and includes this Consumer Information by visiting the Health Canada website ( https://health-products.canada.ca/dpd-bdpp/index-eng.jsp). Find the Consumer Information on the manufacturer’s website http://www.apotex.ca/products, or by calling:

1-800-667-4708

Last revised: January 16, 2020