5 mg and 10 mg orodispersible tablets
rizatriptan
What Rizasmelt is and what it is used for
Rizasmelt belongs to a class of medicines called selective 5-HT 1B / 1D serotonin receptor agonists.
You have been prescribed Rizasmelt by a doctor to treat the headache phase of your migraine attacks. Riza melt should not be used for preventive purposes.
Treatment with Rizasmelt reduces the swelling of the blood vessels that surround the brain. This swelling causes headaches during a migraine attack.
Rizatriptan contained in Rizasmelt may also be approved for the treatment of other conditions not mentioned in this product information. 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 using Rizasmelt
Do not use Rizasmelt
- if you are allergic to rizatriptan benzoate, menthol, or any of the other ingredients of this medicine (listed in section 6)
- if you have moderate or severe high blood pressure or if you have slightly elevated blood pressure that is not treated with medication
- if you have or have ever had heart problems including heart attack or chest pain (angina) or if you have experienced symptoms that may indicate heart disease
- if you have severe liver or kidney disease
- if you have had a stroke (stroke) or mini-stroke ( transient ischemic attack, TIA )
- if you have problems with blood clots in your blood vessels ( peripheral vascular disease)
- if you are taking monoamine oxidase inhibitors ( MAOIs ) such as moclobemide, phenelzine, tranylcypromine or pargyline (antidepressants) or linezolid (an antibiotic ) or if it has been less than two weeks since you stopped taking MAOIs
- 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 taking another medicine of the same type as sumatriptan, naratriptan, or zolmitriptan to treat your migraine (see Other medicines and Rizasmelt below).
If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking Rizasmelt.
Warnings and cautions
Talk to your doctor or pharmacist before taking Rizasmelt 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, there are cases of heart disease in the family, you are a man and over 40 years or you are a woman and have passed menopause
- 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
- your headache is associated with dizziness, difficulty walking, coordination difficulties, or weakness in the arms and legs
- you are using any herbal remedy that contains St. John’s wort
- you have had an allergic reaction such as swelling of the face, lips, tongue, and/or throat which may cause shortness of breath and difficulty swallowing ( angioedema )
- 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
- you have had short-term symptoms including chest pain and pressure over the chest.
If you take Rizasmelt too often, it can lead to chronic headaches. If this happens, you should contact your doctor as you may need to stop taking Rizasmelt.
Describe your symptoms to a doctor or pharmacist. Your doctor can determine if you have a migraine. You should only take Rizasmelt in case of a migraine attack. Rizasmelt should not be used to treat headaches that may be due to other, more serious conditions.
Children and young people
The use of Rizasmelt in children under 18 years of age is not recommended.
Other medicines and Rizasmelt
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is because Rizasmelt may affect the effectiveness of certain other medicines. Other medicines may also affect Rizasmelt.
Do not take Rizasmelt
- if you are already taking a 5HT 1B / D receptor agonist (sometimes referred to as ‘triptans’) such as sumatriptan, naratriptan, or zolmitriptan
- if you are taking an MAOI 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 taking ergotamine-type medicines such as ergotamine or dihydroergotamine to treat your migraine
- if you are using methysergide to prevent migraine attacks.
If you take the medicines listed above with Rizasmelt, the risk of side effects may increase.
You should wait at least 6 hours after taking Rizasmelt before taking ergotamine-type medicines such as ergotamine, dihydroergotamine, or methysergide.
You should wait at least 24 hours after taking ergotamine-type medicines before taking Rizasmelt.
Consult a physician for instructions and risk assessment regarding the intake of Rizasmelt
- if you are taking propranolol (see section 3: How to take Rizasmelt)
- if you are taking SSRIs such as sertraline, escitalopram oxalate, and fluoxetine or SNRIs such as venlafaxine and duloxetine for depression.
Older
There are no complete studies on the safety and efficacy of rizatriptan in patients older than 65 years.
Rice melt with food, drink, and alcohol
It may take longer for Rizasmelt to start working if taken after a meal. Although it is better to take it on an empty stomach, it is possible to take it after a meal.
Pregnancy, breastfeeding, and fertility
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 Rizasmelt is harmful to the fetus if taken by a pregnant woman.
Breast-feeding should be avoided for 24 hours after treatment.
Driving and using machines
You may feel drowsy or dizzy while taking Rizasmelt. If this happens, do not drive or use machines.
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.
Riza melt contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per orodispersible tablet, ie. is next to “sodium-free”.
How to use Rizasmelt
Riza melt is used to treat migraine attacks. Take Rizasmelt as soon as possible after your migraine attack. Do not use it to prevent an attack.
Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
The recommended dose is 10 mg.
If you are currently taking propranolol or have kidney or liver problems, you should use 5 mg doses of Rizasmelt. There should be at least two hours between taking propranolol and rizatriptan and you should take a maximum of two doses over 24 hours.
If a migraine returns within 24 hours
In some patients, migraine symptoms may return within 24 hours. If a migraine recurs, you can take another dose of Rizasmelt. You should always allow at least two hours between doses.
If you still have migraines after 2 hours
If the first dose of Rizasmelt does not work, you should not take a second dose for the same migraine attack. It is still likely that Rizasmelt will work in the next attack.
Do not take more than 2 doses of Rizasmelt over 24 hours (for example, do not take more than two 10 mg or 5 mg orodispersible tablets during 24 hours). You should always allow at least two hours between doses.
Seek care if your condition worsens.
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.
Administration
Rizasmelt orodispersible tablets dissolve in the mouth and can be swallowed with liquid.
The orodispersible tablet can be used in situations where the liquid is not available, or to avoid nausea or vomiting that may occur after taking tablets with liquid. Place the orodispersible tablet on the tongue, allow it to dissolve, and swallow with saliva.
If you use more Rizasmelt 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 and show it to the staff if you need to go to the hospital.
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
This medicine can cause side effects like all medicines, although not everybody gets them.
Contact a doctor immediately if you experience symptoms of an allergic reaction, serotonergic syndrome, heart attack, or stroke.
You should also tell your doctor if you get symptoms that may indicate an allergic reaction (such as a rash and itching ) after taking Rizasmelt.
The following side effects may occur with this medicine.
In adult studies, the most commonly reported side effects were dizziness, drowsiness, and fatigue.
Common (may affect up to 1 in 10 people)
- ant crawling ( paresthesias ), headache, decreased sensitivity to touching the skin ( hypesthesia ), decreased mental acuity, tremors
- fast or irregular heartbeat ( palpitation ), very fast heartbeat ( tachycardia )
- redness (short-lived in the face), feeling hot, sweating
- throat discomfort, difficulty breathing ( dyspnoea )
- nausea, dry mouth, vomiting, diarrhea
- the feeling of heaviness in parts of the body
- abdominal or chest pain
Uncommon (may affect up to 1 in 100 people)
- bad taste in the mouth
- unsteady gait ( ataxia ), dizziness, dizziness (a feeling of spinning), blurred vision
- confusion, insomnia, nervousness
- high blood pressure ( hypertension ), thirst, heartburn / acid reflux ( dyspepsia )
- skin rash, itching, and hives ( urticaria ), swelling of the face, lips, tongue, and / or throat which may cause shortness of breath and/or difficulty swallowing ( angioedema )
- neck pain, feeling of tightness in parts of the body, stiffness, and muscle weakness.
- changes in heart rate or arrhythmia ( arrhythmia ), ECG abnormalities (examination measuring the heart’s electrical activity)
- facial pain, muscle pain
Rare (may affect up to 1 in 1,000 people)
- fainting ( syncope )
- wheezing
- allergic reactions (hypersensitivity); a sudden life-threatening allergic reaction ( anaphylaxis )
- stroke (this most often occurs in patients with risk factors for cardiovascular disease (high blood pressure, diabetes, smoking, use of nicotine replacement therapy, heart disease or stroke in the family, men over 40 years, men who have passed menopause, special heart rhythm disorders (branch block))
- slow heartbeat ( bradycardia )
Has been reported (occurs in an unknown number of users)
- myocardial infarction, cardiovascular spasm (these are most common in patients with risk factors for cardiovascular disease (high blood pressure, diabetes, smoking, use of nicotine replacement therapy, heart disease or stroke in the family, men over 40 years, menopausal women, special heart rhythm disorders) (branch block))
- a so-called serotonergic syndrome that can cause side effects such as coma, unstable blood pressure, extremely high body temperature, disturbance in the coordination of muscle movements, anxiety, and hallucinations
- severe skin rash with or without fever ( toxic epidermal necrolysis )
- seizures (seizures)
- cramping of blood vessels in the arms and legs including feeling cold and numbness of the hands and feet
- spasm of the blood vessels in the colon which can cause abdominal pain.
How to store Rizasmelt
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 blister pack and carton after EXP. The expiration date is the last day of the specified month.
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.
One Riza Melt 5 mg orodispersible tablet contains 5 mg rizatriptan as 7.265 mg rizatriptan benzoate.
One Riza Melt 10 mg orodispersible tablet contains 10 mg rizatriptan as 14.53 mg rizatriptan benzoate.
The other ingredients are mannitol, maltodextrin, microcrystalline cellulose, crospovidone type A, saccharin sodium, colloidal anhydrous silica, magnesium stearate, and menthol flavor (maltodextrin, natural menthol, modified corn starch).
What the medicine looks like and the contents of the pack
Riza melt 5 mg orodispersible tablets
Riza melts 5 mg orodispersible tablets are round, flat, white to off-white tablets, 8 mm in diameter with beveled edges.
Riza melt 10 mg orodispersible tablets
Riza melts 10 mg orodispersible tablets are round, flat, white to off-white tablets with a diameter of 10 mm with beveled edges.
Rizasmelt 5 mg orodispersible tablets are packaged in Aluminum / Aluminum Blisters containing 2, 3, 6, or 18 orodispersible tablets.
Rizasmelt 10 mg orodispersible tablets are packaged in Aluminum / Aluminum Blisters containing 1, 2, 3, 6, 12, or 18 orodispersible tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Stada Arzneimittel AG
Stadastr. 2-18
61118 Bad Vilbel
Germany
Local representative
STADA Nordic ApS
Marielundvej 46 A
2730 Herlev
Denmark