10 mg orodispersible tablets
rizatriptan
What Rizatriptan Mylan is and what it is used for
Rizatriptan Mylan belongs to a group of medicines called selective serotonin ( 5-HT 1B / 1D ) receptor agonists used to treat migraine attacks in adults.
Migraine symptoms can be caused by temporary dilation of the blood vessels in the head. It is believed that rizatriptan reduces the dilation of these blood vessels.
Rizatriptan is only used to treat migraine headaches, with or without aura (warning signs). It should not be used to prevent the onset of headaches.
Rizatriptan contained in Rizatriptan Mylan may also be approved for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you take Rizatriptan Mylan
Do not take Rizatriptan Mylan:
- if you are allergic to rizatriptan or any of the other ingredients of this medicine (listed in section 6)
- you have severe liver or kidney problems
- if you have had a stroke (stroke) or mini-stroke ( transient ischemic attack, TIA )
- if you have moderate or severe high blood pressure, or if you have slightly elevated blood pressure that is not controlled with medication
- if you have or have had heart problems, including heart attack or chest pain (angina), or if you have had symptoms of heart disease
- if you have problems with reduced blood flow to the arms and/or legs due to narrow or blocked arteries ( peripheral vascular disease)
- if you are using any other medicine from the same group, e.g. sumatriptan, naratriptan, or zolmitriptan to treat your migraine (see section Other medicines and Rizatriptan Mylan below)
- if you are taking monoamine oxidases (MAO) inhibitors such as moclobemide, phenelzine, tranylcypromine or pargyline (antidepressants), or linezolid (an antibiotic ) or if it has been less than two weeks since you stopped using MAOs
- if you are currently taking ergotamine-type medicines, such as ergotamine or dihydroergotamine, to treat your migraine or methysergide to prevent migraine attacks
If you are not sure if any of the above applies to you, talk to your doctor or pharmacist.
Warnings and cautions
Talk to your doctor or pharmacist before taking Rizatriptan Mylan
- if your headache is associated with dizziness, difficulty walking, coordination difficulties, or weakness in the legs and arms
- if you have any of the following risk factors for heart disease: high blood pressure, diabetes, you are a smoker or use nicotine replacement therapy, you are male and over 40 years old or you are a woman and have passed menopause, or if there are cases of heart disease in the family
- if you are taking any herbal medicine / traditional herbal medicine containing St. John’s wort
- you have kidney or liver problems
- you have a special type of heart rhythm problem (branch block)
- you have or have had any type of allergy, especially to any other medicine from the same group, e.g. sumatriptan, naratriptan or zolmitriptan used to treat your migraine
- you take selective serotonin reuptake inhibitors ( SSRIs ) such as sertraline, escitalopram oxalate, and fluoxetine or serotonin noradrenaline reuptake inhibitors ( SNRIs ) such as venlafaxine and duloxetine for depression
Describe your symptoms to your doctor or pharmacist. Your doctor can determine if you are suffering from migraines. You should only take Rizatriptan Mylan in case of a migraine attack. Rizatriptan Mylan should not be used to treat headaches that may be due to other more serious conditions.
During treatment
Contact a doctor immediately and do not take any more Rizatriptan Mylan tablets if the following occur during treatment:
- you have had an allergic reaction such as swelling of the face, lips, tongue, and/or throat which may cause shortness of breath and/or difficulty swallowing ( angioedema )
- you have had short-term symptoms including chest pain and pressure over the chest.
If you take rizatriptan too often, it may result in chronic headaches. In these cases, consult your doctor as you may need to stop taking Rizatriptan Mylan.
Children and young people
The use of Rizatriptan Mylan in children and adolescents under 18 years of age is not recommended.
Use in patients older than 65 years
There are no complete studies on the safety and efficacy of rizatriptan in patients older than 65 years.
Other medicines and Rizatriptan Mylan
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is because Rizatriptan Mylan may affect the way some medicines work. Other medicines can also affect Rizatriptan Mylan.
Do not take Rizatriptan Mylan:
- if you are already taking a 5 – HT 1B / 1D receptor agonist (sometimes referred to as “triptans”), such as sumatriptan, naratriptan, or zolmitriptan.
- if you are using a monoamine oxidase (MAO) inhibitor such as moclobemide, phenelzine, tranylcypromine, linezolid, or pargyline or if it has been less than two weeks since you stopped using an MAOI.
- if you are using ergotamine-type medicines, such as ergotamine or dihydroergotamine, to treat your migraine.
- if you are using methysergide to prevent migraine attacks.
Taking Rizatriptan Mylan with the medicines listed above may increase the risk of side effects.
You must wait at least 6 hours after taking rizatriptan before taking ergotamine-type medicines (eg ergotamine, dihydroergotamine, or methysergide).
You must wait at least 24 hours after taking ergotamine-type medicines before taking rizatriptan.
Ask your doctor for advice on how to take and the risks of taking Rizatriptan Mylan
- if you are using propranolol to lower your blood pressure (see section 3)
- if you are using selective serotonin reuptake inhibitors ( SSRIs ), e.g. sertraline, escitalopram oxalate, citalopram, fluoxetine, and paroxetine or serotonin noradrenaline uptake inhibitors ( SNRIs ), e.g. venlafaxine and duloxetine for depression.
Rizatriptan Mylan with food and drink
Rizatriptan works best if taken on an empty stomach. You can still take Rizatriptan Mylan if you have eaten but it may take longer before it works.
Rizatriptan Mylan orodispersible tablets do not need to be taken with liquid.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
It is not known if rizatriptan is harmful to the fetus if taken by a pregnant woman.
Rizatriptan can be excreted in human milk. Do not breastfeed for the next 24 hours after taking Rizatriptan Mylan.
Driving and using machines
Rizatriptan or migraine can make you feel sleepy or dizzy. Do not drive or use any tools or machines if this happens.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Rizatriptan Mylan contains aspartame
This medicine contains 10 mg aspartame per 10 mg orodispersible tablet.
Aspartame is a source of phenylalanine. It can be harmful if you have phenylketonuria (PKU), a rare, inherited disease that leads to the accumulation of high levels of phenylalanine in your body.
How to take Rizatriptan Mylan
Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure. Your doctor will decide how much to take.
Rizatriptan Mylan is used to treat migraine attacks in adults. Take Rizatriptan Mylan as soon as possible after your migraine attack. Do not use it to prevent an attack.
Adults (between 18 – 65 years)
The amount of Rizatriptan Mylan you take is called dose one.
The recommended dose is 10 mg.
If you are using propranolol to lower your blood pressure or if you have a mild or moderate renal or hepatic impairment, use a lower dose (5 mg). If you are taking propranolol, at least two hours should pass between taking propranolol and Rizatriptan Mylan.
If you still have migraines after two hours
If the first dose of Rizatriptan Mylan did not help with your migraine, do not take a second dose of Rizatriptan Mylan to treat the same attack. However, Rizatriptan Mylan will likely help the next time you get a migraine.
If a migraine returns within 24 hours
In some patients, migraine symptoms may return within 24 hours. If the first dose helps but the symptoms return within 24 hours, you can take another dose of Rizatriptan Mylan.
You should always wait at least two hours between doses.
Do not take more than 2 tablets of Rizatriptan Mylan within 24 hours. You should always wait at least two hours between doses.
Seek medical attention if your condition worsens.
Use in children and adolescents (under 18 years of age) and the elderly (over 65 years of age)
Children, adolescents, and the elderly should not use Rizatriptan Mylan as there is insufficient experience with use in these age groups.
How to take Rizatriptan Mylan
Rizatriptan Mylan orodispersible tablets break easily, so you should handle the tablets carefully. Do not handle the tablets with wet hands as the tablets may break.
1. Hold the blister strip by the edges and separate a blister box from the rest of the blister pack by gently tearing along the perforations around it.
2. Carefully pull off the back.
Carefully slide out the tablet.
4. Immediately place the tablet on the tongue where it dissolves.
Rizatriptan Mylan orodispersible tablets can be used when liquid is not available, or to avoid nausea and vomiting caused by taking tablets with liquid.
If you take more Rizatriptan Mylan than you should
If you have ingested too much medicine or if e.g. If a child has ingested the medicine by mistake, contact a doctor or hospital for risk assessment and advice. Bring the medicine pack.
Symptoms of overdose may include dizziness, drowsiness, vomiting, fainting, and a slow heartbeat.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects may occur with this medicine.
In adult studies, the most commonly reported adverse reactions were dizziness, drowsiness, and fatigue.
If you get any of the following side effects, contact your doctor immediately or seek medical advice immediately :
Uncommon (may affect up to 1 in 100 people):
- If you get an allergic reaction. Such reactions can occur in the form of anaphylaxis (a severe form of allergic reaction ) with symptoms such as:
- rash,
- swelling of the face, lips, mouth, tongue, or throat which may cause difficulty in swallowing or breathing (angioedema),
- anaphylactic reaction (sudden wheezing, swelling of the lips, tongue and throat or body, rash, fainting, or difficulty swallowing).
Rare (may affect up to 1 in 1,000 people):
- Stroke. This most often occurs in patients with risk factors for cardiovascular disease (high blood pressure, diabetes, smoking, use of nicotine replacement therapy, stroke in the family, men over 40 years of age, postmenopausal women, special heart rhythm disorders (branch block)).
Has been reported (occurs in an unknown number of users):
- seizures (seizures),
- a widespread rash with blisters and flaky skin on large parts of the body surface may be accompanied by fever ( toxic epidermal necrolysis ),
- a syndrome called “serotonergic syndrome” which can cause side effects such as coma, unstable blood pressure, extremely high body temperature, disturbance in the coordination of muscle movements, anxiety, hallucinations,
- heart attack, and spasm in the blood vessels of the heart. These are most common in patients with risk factors for cardiovascular disease (high blood pressure, diabetes, smoking, use of nicotine replacement therapy, family heart disease, men over 40 years, postmenopausal women, special heart rhythm disorders (branch block)).
Other side effects that may occur:
Common (may affect up to 1 in 10 people):
- tingling or numbness in the hands and feet ( paresthesias ), headache, decreased sensation or sensitivity of the skin ( hypesthesia )
- impaired mental acuity, insomnia
- dizziness, drowsiness
- fast or irregular heartbeat ( palpitation )
- short-term redness of the face
- difficulty swallowing
- indigestion ( dyspepsia ), nausea, vomiting, dry mouth, diarrhea
- fatigue or heaviness in parts of the body, neck pain, stiffness
- abdominal or chest pain.
Uncommon (may affect up to 1 in 100 people):
- difficulty coordinating muscle movements ( ataxia ), tremors
- the feeling of dizziness or that the floor is sloping ( vertigo ), fainting
- taste changes, bad taste in the mouth
- changes in heart rate or rate ( arrhythmia )
- ECG abnormalities ( examination measuring the heart’s electrical activity), very fast heart rhythm ( tachycardia )
- high blood pressure ( hypertension )
- shortness of breath ( dyspnoea )
- hot flashes, sweating
- thirst
- itching, raised red itchy rash ( hives ), muscle weakness, feeling of tightness in parts of the body
- confusion, nervousness
- dimsyn
- rash
- muscle pain (myalgia)
- facial pain.
Rare (may affect up to 1 in 1,000 people):
- slow heartbeat ( bradycardia )
- wheezing.
Has been reported (occurs in an unknown number of users):
- spasm or blockage of blood vessels in the arms and legs including feeling cold and numbness of the hands and feet
- spasm in the blood vessels of the colon which can cause abdominal pain or inflammation of the colon.
How to store Rizatriptan Mylan
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton or blister after EXP. The expiration date is the last day of the specified month.
Do not store above 25 ° C. Store in the original package. Moisture sensitive.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
Content declaration
The active substance is rizatriptan.
An orodispersible tablet contains 10 mg of rizatriptan (as rizatriptan benzoate).
The other ingredients are anhydrous colloidal silica, crospovidone (Type B), crospovidone (Type A), mannitol, microcrystalline cellulose, guar galactomannan, magnesium stearate, aspartame (E951) (see section “Rizatriptan Mylan contains aspartame”) and peppermint aroma ( corn maltodextrin and modified corn starch).
What the medicine looks like and the contents of the pack
White to off-white, round, flat tablets with beveled edges, debossed with ‘M’ on one side ‘And RN2’ on the other side.
Rizatriptan Mylan orodispersible tablets are available as OPA / Al / PVC perforated unit dose blisters of 2 x 1, 3 x 1, 6 x 1, 12 x 1, 18 x 1 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Mylan AB Box 23033 104 35 Stockholm
Manufacturer
McDermott Laboratories to Gerard Laboratories Ltd, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland.
Mylan Hungary Kft., H-2900, Komárom, Mylan utca 1, Hungary