Patient Medication Information: uses, side effects, how to take - Apo-Sumatriptan-Naproxen Sodium
Serious Warnings and Precautions
Risk of heart-related side effects Sumatriptan, a component of APO-SUMATRIPTAN-NAPROXEN SODIUM, can cause a narrowing of a coronary (heart) artery. This can cause reduced blood flow to part of the heart. Do not use APO-SUMATRIPTAN-NAPROXEN SODIUM if you have uncontrolled high blood pressure, a disease that affects the arteries of your heart, heart rhythm problems or a history of heart attacks. APO-SUMATRIPTAN-NAPROXEN SODIUM is not recommended if you have a family history of or risk factors for a disease that affects the arteries of your heart. Naproxen sodium, a component of APO-SUMATRIPTAN-NAPROXEN SODIUM, can cause an increase in heart related problems such as a stroke or heart attack. Some of these problems have led to death. You may be at greater risk if you have any heart problems or risk factors for those problems. Naproxen sodium can also cause your body to retain more salt. This can lead to an increase in blood pressure or a worsening of congestive heart failure. Risk of side effects to your digestive tract Naproxen sodium can cause an increase in side effects to the parts of your digestive tract. These include ulcers, a hole (perforation), blockage, or bleeding. These can occur at any time and without warning symptoms. You are more at risk if you are elderly or have a history of ulcers or bleeding in your digestive tract. Pregnancy: DO NOT take APO-SUMATRIPTAN-NAPROXEN SODIUM if you are pregnant and in a later stage of pregnancy (28 weeks or later). If you are pregnant and in an earlier stage of pregnancy (less than 28 weeks) ONLY take APO-SUMATRIPTAN-NAPROXEN SODIUM if you are told to do so by your doctor. Medicines like APO-SUMATRIPTAN-NAPROXEN SODIUM may cause harm to you and your baby. Your doctor will need to closely monitor your health and that of your baby (including your amniotic fluid levels) if they prescribe APO-SUMATRIPTAN-NAPROXEN SODIUM during this time. |
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What is APO-SUMATRIPTAN-NAPROXEN SODIUM used for?
- APO-SUMATRIPTAN-NAPROXEN SODIUM is used in adults for the acute treatment of migraine attacks with or without aura. It should only be used in patients who have been diagnosed with migraines.
APO-SUMATRIPTAN-NAPROXEN SODIUM is not for preventing migraines and it is not for the treatment of cluster headaches. APO-SUMATRIPTAN-NAPROXEN SODIUM is not for use in patients younger than 18 years of age.
How does APO-SUMATRIPTAN-NAPROXEN SODIUM work?
APO-SUMATRIPTAN-NAPROXEN SODIUM is a medicine prescribed by a doctor. It contains sumatriptan and naproxen sodium. Sumatriptan works to narrow blood vessels in the head and to stop the release of a chemical in the brain. These effects are thought to help with migraine pain relief.
Naproxen sodium is a nonsteroidal anti-inflammatory drug (NSAID) and can reduce the chemicals produced by your body which cause pain and swelling. It does NOT cure your illness or prevent it from getting worse. It can only relieve pain and reduce swelling as long as you continue to take it as prescribed.
What are the ingredients in APO-SUMATRIPTAN-NAPROXEN SODIUM?
Medicinal ingredients: sumatriptan (as sumatriptan succinate) and naproxen sodium
Non-medicinal ingredients: croscarmellose sodium, dibasic calcium phosphate, FD&C Blue No. 2, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, sodium bicarbonate, talc, titanium dioxide, and triacetin.
APO-SUMATRIPTAN-NAPROXEN SODIUM comes in the following dosage forms:
APO-SUMATRIPTAN-NAPROXEN SODIUM Tablets are blue film-coated tablets containing 85 mg sumatriptan (as sumatriptan succinate) and 500 mg naproxen sodium. Available in bottles of 9 tablets.
Do not use APO-SUMATRIPTAN-NAPROXEN SODIUM if:
- you are allergic to sumatriptan, naproxen sodium, or any component of APO-SUMATRIPTAN-NAPROXEN SODIUM.
- you have heart problems or a history of heart problems, including severe uncontrolled heart failure.
- you recently had or are planning to have heart bypass surgery.
- you have a history of strokes, including mini-strokes.
- you have a rare type of migraine called hemiplegic, basilar or ophthalmoplegic because you are at a higher risk of stroke.
- you have problems with your blood circulation to your legs, arms or stomach.
- you have ischemic bowel disease, where there is less blood flow to your large intestine.
- you have uncontrolled high blood pressure.
- you have used other triptan drugs, dihydroergotamine or methysergide within the last 24 hours.
- you have taken an antidepressant medicine called monoamine oxidase (MAO) inhibitor within the last 2 weeks.
- you have had an asthma attack, hives, or other allergic reactions with acetylsalicylic acid (ASA), other NSAIDs (Nonsteroidal Anti- Inflammatory Drugs), sumatriptan, or any ingredients in APO-SUMATRIPTAN-NAPROXEN SODIUM.
- you have active or moderate to severe liver disease.
- you have active bleeding in the brain or from the stomach or gut or other bleeding disorders.
you are pregnant and in a later stage of pregnancy (28 weeks or later).
- you are currently breastfeeding (or planning to breastfeed).
- you have an active ulcer.
- you have inflammatory bowel disease (Crohn’s Disease or Ulcerative Colitis).
- you have severe or worsening kidney disease.
- you have high potassium levels in your blood.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take APO-SUMATRIPTAN-NAPROXEN SODIUM. Talk about any health conditions or problems you may have, including if you:
- have high blood pressure.
- have high cholesterol.
- have diabetes mellitus or are on a low sugar diet.
- have poor circulation to your extremities.
- are a smoker or ex-smoker.
- have kidney disease or urine problems.
- had a previous ulcer or bleeding from the stomach, gut, brain.
- have bleeding problems.
are on a strict sodium reduced diet. Each APO-SUMATRIPTAN-NAPROXEN SODIUM tablet
- contains approximately 60 mg of sodium.
- have a family history of allergy to NSAIDs, such as acetylsalicylic acid (ASA), ibuprofen.
- have a family history of asthma, nasal polyps, long-term swelling of the sinus (chronic sinusitis) or hives.
- have a family history of allergy to sulfonamide drugs.
- have narrowing of blood vessels, causing them to be blocked (atherosclerosis).
- have improper beating of the heart.
- have had a heart attack or have angina.
- have had a stroke.
- have symptoms and/or signs suggesting liver problems.
- have epilepsy or seizures.
- are pregnant, planning on becoming or become pregnant while taking APO-SUMATRIPTAN-NAPROXEN SODIUM. Before taking this medication, tell your healthcare professional if you are planning to get pregnant.
- are breastfeeding or planning to breastfeed. You and your doctor should decide if you will take APO-SUMATRIPTAN-NAPROXEN SODIUM or breastfeed. You should not do both.
Other warnings you should know about:
- Tell any other doctor, dentist, pharmacist or other healthcare professional that you see, that you are taking APO-SUMATRIPTAN-NAPROXEN SODIUM. This is important, especially if you are planning to have heart surgery.
- Do NOT drink alcoholic beverages while taking this medication. If you do, you may be more likely to develop stomach problems.
- While taking APO-SUMATRIPTAN-NAPROXEN SODIUM your fertility may be decreased. APO-SUMATRIPTAN-NAPROXEN SODIUM is not recommended in women trying to get pregnant. If you are taking APO-SUMATRIPTAN-NAPROXEN SODIUM and you are having trouble getting pregnant, talk to your doctor. You may need to stop taking APO-SUMATRIPTAN-NAPROXEN SODIUM
- Overuse of acute migraine drugs can lead to a worsening of your headaches. You can tell if this has happened to you because you may have migraine-like daily headaches. You might also have an increase in migraines.
APO-SUMATRIPTAN-NAPROXEN SODIUM can cause dizziness, weakness or drowsiness. If you have these symptoms, do not drive a car, use machinery, or do anything where you need to be alert.
- Serotonin syndrome is a rare but potentially life-threatening condition. It can cause serious changes in how your brain, muscles and digestive system work. You may develop Serotonin Syndrome if you take APO-SUMATRIPTAN-NAPROXEN SODIUM with certain antidepressants or other migraine medications.
Serotonin Syndrome symptoms include:
- fever, sweating, shivering, diarrhea, nausea, vomiting;
- muscle shakes, jerks, twitches or stiffness, overactive reflexes, loss of coordination; • fast heartbeat, changes in blood pressure;
- confusion, agitation, restlessness, hallucinations, mood changes, unconsciousness and coma.
Serious Skin Reactions: In rare cases, serious or life-threatening skin reactions listed below have been reported with some NSAIDs, such as APO-SUMATRIPTAN-NAPROXEN SODIUM.
- Drug reaction with eosinophilia and systemic symptoms (DRESS)
- Stevens-Johnson syndrome (SJS),
- toxic epidermal necrolysis (TEN),
- exfoliative dermatitis and
- erythema multiforme
You may be at a greater risk of experiencing a serious skin reaction usually during the first month of treatment. See the Serious side effects and what to do about them table, below, for more information on these and other serious side effects.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with APO-SUMATRIPTAN-NAPROXEN SODIUM:
- Acetylsalicylic Acid (ASA) or other NSAIDs
- Antacids
- Antidepressants, including Monoamine Oxidase- A Inhibitors, Selective Serotonin Reuptake Inhibitors (SSRIs), and Serotonin Norepinephrine Reuptake Inhibitors (SNRIs)
- Drugs to treat anxiety and schizophrenia
- Blood pressure medications, including propranolol and other beta-blockers
- Blood thinners
- Corticosteroids (including glucocorticoids), used to treat many conditions
- Cyclosporin, used to prevent organ transplant rejection
- Digoxin, used to treat heart problems
- Diuretics, also known as water pills, used to treat high blood pressure
- Hydantoins, drugs used to treat epilepsy or seizures
- Lithium, used to treat bipolar disorder
- Methotrexate or pemetrexed, used to treat cancer
- Oral contraceptives (birth control)
- Other drugs to treat migraines, such as dihydroergotamine or methysergide
- Sulfonylureas, drugs used to treat diabetes
Your healthcare professional may prescribe low dose ASA (acetylsalicylic acid) as a blood thinner to reduce your risk of having a heart attack or stroke while you are taking APO-SUMATRIPTAN-NAPROXEN SODIUM. Take only the amount of ASA prescribed by your healthcare professional. You are more likely to upset or damage your stomach if you take both APO-SUMATRIPTAN-NAPROXEN SODIUM and ASA than if you take APO-SUMATRIPTAN-NAPROXEN SODIUM alone.
The naproxen sodium part of APO-SUMATRIPTAN-NAPROXEN SODIUM may affect the results of any urine tests you may need to have.
How to take APO-SUMATRIPTAN-NAPROXEN SODIUM:
- Ask your healthcare professional if you should take your first dose of APO-SUMATRIPTAN-NAPROXEN SODIUM in a medical setting. Certain people should take their first dose this way.
- Take APO-SUMATRIPTAN-NAPROXEN SODIUM exactly as your healthcare professional tells you to. Do not change your dose or stop APO-SUMATRIPTAN-NAPROXEN SODIUM without talking to your doctor.
- Take APO-SUMATRIPTAN-NAPROXEN SODIUM tablets whole with water or other liquids.
APO-SUMATRIPTAN-NAPROXEN SODIUM can be taken with or without food.
- You should write down when you have headaches and when you take APO-SUMATRIPTAN-NAPROXEN SODIUM. This way, you can talk with your healthcare professional about how APO-SUMATRIPTAN-NAPROXEN SODIUM is working for you.
Usual dose:
The recommended dose for adults is to take 1 tablet as soon as you can after getting a migraine.
- If you do not get any relief after your first dose, do not take a second dose. Talk with your healthcare professional first.
If your headache comes back or you only get some relief from your headache:
- You can take a second dose 2 hours after the first dose. Do not take more than 2 doses of APO-SUMATRIPTAN-NAPROXEN SODIUM in a 24-hour period.
If you have mild liver or kidney problems and you have to take APO-SUMATRIPTAN-NAPROXEN SODIUM, you should only take one tablet of APO-SUMATRIPTAN-NAPROXEN SODIUM per day.
Overdose:
| If you think you have taken too much APO-SUMATRIPTAN-NAPROXEN SODIUM, contact your healthcare professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms. |
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Missed Dose:
APO-SUMATRIPTAN-NAPROXEN SODIUM is only taken when needed to treat your migraine.
What are possible side effects from using APO-SUMATRIPTAN-NAPROXEN SODIUM?
These are not all the possible side effects you may feel when taking APO-SUMATRIPTAN-NAPROXEN SODIUM. If you experience any side effects not listed here, contact your healthcare professional.
APO-SUMATRIPTAN-NAPROXEN SODIUM may cause you to become more sensitive to sunlight. Any exposure to sunlight or sunlamps may cause sunburn, skin blisters, skin rash, redness, itching or discolouration, or vision changes. If you have a reaction from the sun, check with your healthcare professional.
Common side effects of APO-SUMATRIPTAN-NAPROXEN SODIUM:
- Dizziness, light-headedness
- Feeling weak, drowsy, or tired
- Nausea
- Heartburn or indigestion
- Dry mouth
- Muscle tightness
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | ||
|---|---|---|---|---|
| Only if severe | In all cases | |||
| COMMON | ||||
| Pain, discomfort, or stiffness in your neck, throat, jaw, abdomen or chest | √ | |||
| Tingling or numbness in your fingers or toes | √ | |||
| Heartbeat problems (fast or irregular) | √ | |||
| RARE | ||||
| Nausea that seems out of proportion to your migraine | √ | |||
| Sudden/severe pain in your belly | √ | |||
| Vomiting blood | √ | |||
| √ | ||||
| Serious side effects and what to do about them | ||||
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | ||
| Only if severe | In all cases | |||
| Blood in your bowel movement or it is black and sticky like tar | √ | |||
| Yellow discolouration of the skin or eyes, with or without itchy skin | √ | |||
| Unusual weight gain | √ | |||
| Malaise, fatigue, loss of appetite | √ | |||
| Serious Skin Reactions: fever, severe rash, swollen lymph glands, flu-like feeling, blisters and peeling skin that may start in and around the mouth, nose, eyes and genitals and spread to other areas of the body, swelling of face and/or legs, yellow skin or eyes, shortness of breath, dry cough, chest pain or discomfort, feeling thirsty, urinating less often, less urine or dark urine | √ | |||
| Flu-like symptoms | √ | |||
| Vomiting or persistent indigestion, nausea, stomach pain or diarrhea | √ | |||
Swelling of the arms, legs, hands, and feet Tenderness in your upper right side | √ | |||
| Serotonin Syndrome: mental changes such as agitation, hallucinations, confusion or other changes in mental status; coordination problems, uncontrolled muscle spasms, or muscle twitching (overactive reflexes); restlessness, shaking, shivering, racing or fast heartbeat, high or low blood | √ | |||
| Mental confusion, depression | √ | |||
| Hearing problems | √ | |||
| Worsening of headache | √ | |||
| Serious side effects and what to do about them | ||||
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | ||
| Only if severe | In all cases | |||
| pressure, sweating or fever, nausea, vomiting, or diarrhea, muscle rigidity (stiff muscles), tremor, loss of muscle control) | ||||
| Raynaud’s Syndrome: cold feeling in fingers and toes (and sometimes nose, lips and ears), prickly or stinging feeling, change in skin colour to white then blue | √ | |||
| Allergic reaction: difficulty swallowing or breathing, wheezing; drop in blood pressure; feeling sick to your stomach and throwing up; hives or rash; swelling of the face, lips, tongue or throat. | √ | |||
| Seizures: loss of consciousness with uncontrollable shaking | √ | |||
| Blurred vision, or any visual disturbance | √ | |||
| Symptoms of a heart attack pressure or squeezing pain between the shoulder blades, in the chest, jaw, left arm or upper abdomen, shortness of breath, dizziness, fatigue, light-headedness, clammy skin, sweating, indigestion, anxiety, feeling faint and possible irregular heartbeat. | √ | |||
| Any change in the amount or colour of your urine (red or brown) | √ | |||
| Any pain or difficulty experienced while urinating | √ | |||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
NOTE: Contact your healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice. |
Storage:
- Store APO-SUMATRIPTAN-NAPROXEN SODIUM at 15° to 30°C.
- Keep out of reach and sight of children.
If you want more information about APO-SUMATRIPTAN-NAPROXEN SODIUM:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website (http://www.apotex.ca/products), or by calling 1-800-667-4708.