Amerge - Consumer Medicine Information
|Condition:||Migraine, Migraine Headache (Migraine)|
|Ingredients:||croscarmellose sodium, hydroxypropyl methylcellulose, indigo carmine aluminium lake (FD&amp;amp;C Blue No. 2) [2.5 mg tablet only], iron oxide yellow [2.5 mg tablet only], lactose, magnesium stearate, microcrystalline cellulose, titanium dioxide, and triacetin|
naratriptan (as naratriptan hydrochloride)
About This Medication
The name of your medicine is AMERGE. It can be obtained only by prescription from your doctor. The decision to use AMERGE 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 AMERGE is appropriate for you.
What the Medication is Used For
AMERGE is intended to relieve your migraine headache and other associated symptoms of a migraine attack.
AMERGE should not be used continuously to prevent or reduce the number of attacks you experience. Use AMERGE 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. AMERGE narrows these vessels and relieves the pain and other symptoms of migraine headache.
When it Should not be Used
Do not take AMERGE 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.
AMERGE 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
croscarmellose sodium, hydroxypropyl methylcellulose, indigo carmine aluminium lake (FDandC Blue No. 2)[2.5 mg tablet only], iron oxide yellow [2.5 mg tablet only], lactose, magnesium stearate, microcrystalline cellulose, titanium dioxide and triacetin.
What Dosage Forms it Comes In
AMERGE is available as a 1 mg (white) or 2.5 mg (green) tablet.
Warnings and Precautions
AMERGE is not recommended for people over 65 years of age or for children under the age of 18.
BEFORE you use AMERGE, 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 ischaemic 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 AMERGE
Taking AMERGE too often may make your headaches worse or more frequent. If this happens to you, tell your doctor. You may have to stop taking AMERGE.
If you are not sure whether you should take AMERGE, contact your doctor or pharmacist.
Driving and Using Machines
AMERGE may make you drowsy. Do not drive or operate machinery unless you are feeling alert.
The Use of AMERGE During Pregnancy:
Do not use AMERGE 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 AMERGE and others may cause adverse effects if they’re taken with AMERGE. 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 AMERGE, 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.
For adults, the usual dose is a single 1 or 2.5 mg tablet (as recommended by your doctor) taken whole with waterThe 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 AMERGE.
If you have kidney or liver disease, take as directed by your doctor.
|In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.|
Side Effects and What to Do About Them
Like all medicines, AMERGE 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
- 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
- Difficulty sleeping
- Nose, throat and sinus infection
- Urinary tract infections
- Feeling full or bloated
- Stomach pain or discomfort
- Muscle or joint pain, muscle cramps, or
inflammation of the joints
- Feeling anxious or depressed
- Difficulty with learning, perception, memory and
- Increased sense of touch
- Skin effects such as rash, itchiness, bumpiness and
sensitivity to light
- 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
- Itchy or irritated mouth
- Muscle or joint stiffness
- Muscle twitches
- Low blood pressure
- Poor balance or coordination, slowed movement
- Lack of energy or alertfulness, confusion
- Aggression, agitation or detachmen
- Hair loss
- Red, flushed or inflamed skin
- Ear effects such as infection, difficulty hearing,
- Sudden, compelling urge to urinate
- Swelling of the glands that produce salvia
- Changes in sense of taste
Serious Side Effects, how Often They Happen and What to Do About Them
|Symptom / effect||Talk with your doctor or pharmacist||Stop taking drug and call your doctor or pharmacist|
|Only if severe||In all cases|
|Common||Unusual sensations, including numbness, tingling, feeling hot or pain in any part of the body including chest, neck, jaw, and throat||✓|
|Uncommon||Unusual fast heartbeats, or a feeling of irregular and/or forceful heartbeats; heaviness, pressure or tightness in any part of the body including chest and throat; Feeling hot or cold||✓|
|Rare||Unusually slow heartbeats;
Unexpected or prolonged bleeding, including from your ears, nose, throat and eyes or in the brain; blood in the urine; convulsions; pain or difficulty when swallowing; allergic reactions (shortness of breath, sudden wheeziness, swelling of eyelids, face of lips, lumpy skin, rash or hives)
|Very rare||Heart attack or symptoms of a heart attack (chest pain, shortness of breath); lowerabdominal pain and/or severe rectal bleeding (colonic ischemia); numbness, tingling, cold or pain in the hands or feet; pale or purple discolouration; stroke or mini-stroke (transient ischemic attack)||✓|
This is not a complete list of side effects. For any unexpected effects while taking AMERGE, contact your doctor or pharmacist
How to Store It
Do not store above 30°C. Keep away from heat and light.
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 AMERGE, do not keep any leftover medication unless your doctor tells you to.
Reporting suspected side effects
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:
- Report online at www.healthcanada.gc.ca/medeffect
- Call toll-free at 1-866-234-2345
- Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to 1-866-678-6789, or
- Mail to: Canada Vigilance Program
Postal Locator 0701E
Ottawa, ON K1A 0K9
Postage paid labels, Canada Vigilance Reporting Forms and the adverse reaction reporting guidelines are available on the MedEffect™ Canada Web site at www.healthcanada.gc.ca/medeffect.
NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.
This document plus the full product monograph, prepared for health professionals can be found at:
http://ca.gsk.com/ or by contacting the sponsor,
7333 Mississauga Road
This leaflet was prepared by GlaxoSmithKline Inc.