Micrania Melts 5 mg Tablets

MICRANIA MELTS belongs to a class of medicines called triptans and is used to treat the headache phase of the migraine attack in adults.

Treatment with MICRANIA MELTS:

• Reduces widening of blood vessels surrounding the brain. This widening results in the headache pain of a migraine attack.
• Blocks the release of substances from nerve endings that cause more pain and other symptoms of migraine.
• Interrupts the sending of specific pain signals to your brain.

Do not take MICRANIA MELTS:

• if you are hypersensitive (allergic) to rizatriptan, or to any of the ingredients of MICRANIA MELTS (see section 6)
• if you are currently taking medicines called monoamine oxidase (MAO) inhibitors (e.g. moclobemide, phenelzine, tranylcypromine, linezolid or pargyline) to treat depression, or if it has been less than two weeks since you stopped taking a MAO inhibitor
• if you have high blood pressure which is not controlled by medication
• if you have heart disease or have a history of heart disease including heart attack or pain on the chest (angina)
• if you have had a stroke or mini stroke
• if you have blockage problems with your arteries, including ischaemic bowel disease (chronic inflammation of your digestive tract, where the blood flow to your bowel is blocked or cut off and your intestines don't have the oxygen needed to work correctly)
• if you are taking ergotamine-type medications, such as ergotamine or dihydro-ergotamine to treat your migraine or methysergide to prevent a migraine attack. Ask your doctor, pharmacist or other health care provider if you are not sure
• if you are pregnant or breastfeeding your baby
• Children under the age of 18 years of age.

Warnings and precautions

Take special care with MICRANIA MELTS:

• Tell your doctor or health care provider:
• if your headache is associated with dizziness, difficulty in walking, lack of coordination or weakness in the leg and arm
• if you have any of the following risk factors for heart disease: high blood pressure, diabetes (high blood sugar), you are a smoker or using nicotine substitutes, you have a family history of heart disease, you are a man over 40 years of age or you are a post-menopausal woman
• if you are taking any other medicines for migraine (e.g. sumatriptan)
• if you have short lived symptoms including chest pain and tightness
• if you are taking medicines called selective serotonin reuptake inhibitors (SSRIs) such as sertraline, escitalopram oxalate, and fluoxetine or serotonin norepinephrine reuptake inhibitors (SNRIs) such as venlafaxine, and duloxetine for depression
• if you are taking a medicine called propranolol for (used to treat heart problems, help with anxiety, prevent migraines or high blood pressure) as this may affect the way MICRANIA MELTS works
• if you use herbal preparation containing St. John's wort
• you have had allergic reaction like swelling of face, lips, tongue and/or throat which may cause difficulty breathing and/or swallowing (angioedema).

If you take MICRANIA MELTS too often this may result in you getting a chronic headache. In such cases you should contact your doctor as you may have to stop taking MICRANIA MELTS.

Tell your doctor or pharmacist about your symptoms. You should take MICRANIA MELTS only when your doctor has told you that you have migraine attacks. You should take MICRANIA MELTS only for a migraine attack. MICRANIA MELTS should not be used to treat headaches that might be caused by other, more serious conditions.

Do not share medicines prescribed for you with any other person. Always use MICRANIA MELTS exactly as your doctor, pharmacist or other health care provider has told you. You should check with your doctor, pharmacist or other health care provider if you are not sure.

Adults: The usual dose is 5 mg to 10 mg MICRANIA MELTS. Doses of MICRANIA MELTS should be taken at least 2 hours apart and not more than 30 mg MICRANIA MELTS should be taken in any 24 hour period. If your migraine returns within 24 hours, take an additional dose of MICRANIA MELTS, however always wait at least 2 hours between doses. If you do not respond to the first dose of MICRANIA MELTS during a migraine attack, you should not take a second dose of MICRANIA MELTS to treat the same attack. It is still likely, however, that you will respond to MICRANIA MELTS during the next migraine attack.

If you are currently taking propanolol you should take MICRANIA MELTS 5 mg up to a maximum of 3 x 15 mg doses (15 mg) in a 24- hour period. MICRANIA MELTS need not be taken with liquid. Do not remove the tablet from the blister until you need to take it. The tablet should be removed from the blister with dry hands and placed on the tongue, where it will dissolve and be swallowed with the saliva.

Your doctor will tell you how long your treatment with MICRANIA MELTS will last. If you have the impression that the effect of MICRANIA MELTS is too strong or too weak, tell your doctor or pharmacist.

If you take more MICRANIA MELTS than you should

In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison control centre. Symptoms of overdose may include:

• feeling dizzy and drowsy, vomiting, inability to control your bladder, high blood pressure, fainting and slow heart rate.

MICRANIA MELTS can have side effects. Not all side effects reported for MICRANIA MELTS are included in this leaflet. Should your general health worsen, or if you experience any untoward effects while using MICRANIA MELTS, please consult your health care provider for advice.

If any of the following happens, stop using MICRANIA MELTS and tell your doctor immediately or go to the casualty department at your nearest hospital:

• swelling of the hands, feet, ankles, face, lips, mouth or throat, which may cause difficulty in swallowing or breathing
• rash or itching
• fainting.

These are all very serious side effects. If you have them, you may have had a serious allergic reaction to MICRANIA MELTS. You may need urgent medical attention or hospitalisation.

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• seizures (fits)
• "serotonin syndrome" that may cause side effects like coma, unstable blood pressure, extremely high body temperature, lack of muscle coordination, agitation and hallucinations
• rapid, strong, irregular or slow heartbeat, abnormalities of the electrocardiogram (a test that records the electrical activity or your heart), heart attack
• spasm of the blood vessels of the heart (these generally occur in patients with risk factors for heart and blood vessel disease).

These are all serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following:

Frequent side effects:

• problems sleeping (insomnia)
• dizziness, sleepiness, headache, pins and needles, decreased mental sharpness, decreased sensitivity of the skin
• hot flushes or flashes
• throat discomfort
• nausea, dry mouth, vomiting, indigestion, upper abdominal discomfort, diarrhoea
• sweating, flushing
• stiffness, feeling of heaviness or tightness in parts of the body
• chest pain, abdominal pain
• lack of energy, extreme tiredness.

Less frequent side effects:

• disorientation, nervousness
• unsteadiness when walking (ataxia), vertigo (spinning sensation when standing still), distortion of taste, bad taste in the mouth, tremor
• blurred vision
• high blood pressure
• shortness of breath, wheezing
• thirst
• severe itching of the skin (pruritus), swelling of face, lips, tongue and/or throat which may cause difficulty breathing and/or swallowing (angioedema), rash
• neck pain, stiffness, muscle weakness, feeling of tightness in parts of the body, muscle pain, facial pain.

The following side effects have been reported but the frequency for them to occur is not known:

• spasm of blood vessels of the extremities including coldness and numbness of the hands or feet
• spasm of the blood vessels of the colon (large bowel), which can cause abdominal pain
• severe shedding of the skin with or without fever (toxic epidermal necrolysis).

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects

If you get 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 to SAHPRA via the “6.04 Adverse Drug Reporting Form”, found on SAHPRA’s website: www.sahpra.org.za under “online services”. By reporting side effects, you can help provide more information on the safety of MICRANIA MELTS.

Store all medicines out of reach of children.

Store at or below 25 °C

Do not to remove the tablet from the blister until just prior to dosing. Keep blister in carton until required for use. Do not use after the expiry date stated on the carton. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).