5 mg and 10 mg orodispersible tablets
rizatriptan
What Rizatriptan Glenmark is and what it is used for
Rizatriptan Glenmark is used to treat migraine attacks. Do not use it to prevent an attack.
Rizatriptan Glenmark belongs to the group of selective serotonin 5 HT 1B / 1D receptor agonists.
Rizatriptan Glenmark is used to treat the headache phase of the adult migraine attack.
Treatment with Rizatriptan Glenmark:
Reduces the swelling of the blood vessels that surround the brain. This swelling causes headaches during a migraine attack.
Rizatriptan contained in Rizatriptan Glenmark 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 you take Rizatriptan Glenmark
Do not take Rizatriptan Glenmark:
- if you are allergic to rizatriptan benzoate 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 had symptoms of heart disease
- if you have severe liver or kidney problems
- if you have had a stroke (stroke) or mini-stroke ( transient ischemic attack, TIA )
- if you have reduced blood flow to your arms and legs due to blocked arteries ( peripheral vascular disease)
- 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 taking ergotamine-type medicines, such as ergotamine or dihydroergotamine to treat your migraine or methysergide to prevent migraine attacks
- if you are using another medicine from the same group as rizatriptan, such as sumatriptan, naratriptan, or zolmitriptan to treat your migraine (see also Other medicines and Rizatriptan Glenmark below)
If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking Rizatriptan Glenmark.
Warnings and cautions
Talk to your doctor or pharmacist before taking Rizatriptan Glenmark 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 male and over 40 years old 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/or 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 tightness
If you take Rizatriptan Glenmark too often, it may result in chronic headaches. In these cases, consult a doctor as you may need to stop taking Rizatriptan Glenmark.
Describe your symptoms to your doctor or pharmacist. Your doctor can determine if you are suffering from migraines. You should only take Rizatriptan Glenmark in case of a migraine attack. Rizatriptan Glenmark can not be used to treat headaches that may be due to other more serious conditions.
Children and young people
There is no experience with the use of Rizatriptan Glenmark in children and adolescents under 18 years of age and Rizatriptan Glenmark should therefore not be given to children and adolescents.
Patients older than 65 years
There are no complete studies on the safety and effectiveness of Rizatriptan Glenmark in patients older than 65 years.
Other medicines and Rizatriptan Glenmark
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription. This also applies to (traditional) herbal medicines and the medicines you normally take for your migraine. This is because Rizatriptan Glenmark may affect the way other medicines work. Other medicines may also affect the way Rizatriptan Glenmark works.
Do not take Rizatriptan Glenmark
- if you are already taking a 5 HT 1B / 1D agonist ( sometimes called ‘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 taking 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 Glenmark with the medicines listed above may increase the risk of side effects.
You should wait at least 6 hours after taking Rizatriptan Glenmark 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 Rizatriptan Glenmark.
Ask your doctor for advice on how to take and the risks of taking Rizatriptan Glenmark
- if you are taking propranolol (see section 3: How to take Rizatriptan Glenmark)
- if you are taking SSRIs such as sertraline, escitalopram oxalate, and fluoxetine or SNRIs such as venlafaxine and duloxetine for depression.
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Rizatriptan Glenmark with food and drink
It may take longer for Rizatriptan Glenmark to work if taken after eating. Even if it is better to take it on an empty stomach, you can still take it if you have eaten.
Pregnancy, breastfeeding, and fertility
It is not known if Rizatriptan Glenmark is harmful to the fetus if taken by a pregnant woman.
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. Breast-feeding should be avoided 24 hours after treatment.
Driving and using machines
You may feel drowsy or dizzy when you use Rizatriptan Glenmark. 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 Glenmark contains aspartame (E951)
Aspartame contains phenylalanine and this may be harmful to people with phenylketonuria.
How to take Rizatriptan Glenmark
Rizatriptan Glenmark is used to treat migraine attacks. Take Rizatriptan Glenmark as soon as possible after your migraine attack. Do not use it to prevent an attack.
Always take Rizatriptan Glenmark exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
The recommended dose is 10 mg.
Rizatriptan Glenmark ( rizatriptan benzoate) is an orodispersible tablet that dissolves in the mouth.
- Take the orodispersible tablet from the blister pack with dry hands, and place the tablet on the tongue, where it dissolves and can be swallowed with saliva.
- The orodispersible tablet can be used in situations when a drink is not available, or to avoid nausea and vomiting that may occur when taking orodispersible tablets with liquid.
If you are currently using propranolol or have kidney or liver problems, you should use a 5 mg dose of one of Rizatriptan Glenmark. It should take at least two hours between taking propranolol and Rizatriptan Glenmark up to a maximum of 2 doses over 24 hours.
If a migraine returns within 24 hours
In some patients, migraine symptoms may return within 24 hours. If your migraine returns, you can take another dose of Rizatriptan Glenmark. There should be at least two hours between doses.
If you still have migraines after two hours
If you do not respond to the first dose of Rizatriptan Glenmark during an attack, do not take a second dose of Rizatriptan Glenmark to treat the same attack. However, you will likely respond to Rizatriptan Glenmark during the next attack.
Do not take Rizatriptan Glenmark for the same 24-hour period (eg do not take more than two doses of 5 mg or 10 mg orodispersible tablets during the same 24-hour period).
There should be at least two hours between doses.
Seek medical attention if your condition worsens.
If you take more Rizatriptan Glenmark 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.
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, Rizatriptan Glenmark 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.
Common (may affect up to 1 in 10 people)
- ant crawling ( paresthesias ), headache, decreased sensitivity to skin touch ( hypesthesia ), decreased mental acuity, and insomnia.
- fast or irregular heartbeat ( palpitation ).
- redness (short-lived in the face).
- difficulty swallowing.
- nausea, dry mouth, vomiting, diarrhea, stomach upset ( dyspepsia ).
- the feeling of heaviness in parts of the body, neck pain, stiffness.
- abdominal or chest pain
Uncommon (may affect up to 1 in 100 people)
- bad taste in the mouth
- unsteady gait ( ataxia ), dizziness (dizziness), blurred vision, tremors, fainting ( syncope )
- confusion, nervousness
- high blood pressure ( hypertension ), thirst, feeling hot and sweating.
- rash, itching and raised rash (hives), swelling of the face, lips, tongue, and/or throat, which may cause shortness of breath or difficulty swallowing ( angioedema ), shortness of breath ( dyspnoea )
- the feeling of tightness in parts of the body, muscle weakness
- changes in the rhythm or speed of the heartbeat ( arrhythmia ), abnormalities on the ECG (examination in which the heart’s electrical activity is measured), and very fast heart rhythm ( tachycardia ).
- facial pain, muscle aches
Rare (may affect up to 1 in 1,000 people)
- wheezing
- allergic reactions (hypersensitivity), 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 of age, women who have passed menopause, special heart rhythm disorders [branch block)).
- slow heart rate ( bradycardia )
Has been reported (occurs in an unknown number of users)
- 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, heart disease or stroke in the family, men over 40 years of age, women who have passed menopause, 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 )
- cramp (seizure)
- spasm 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
Contact a doctor immediately if you experience symptoms of an allergic reaction, serotonergic syndrome, heart attack, or stroke.
Also, contact your doctor if you notice any symptoms that may indicate an allergic reaction (such as a rash or itching ) after taking Rizatriptan Glenmark orodispersible tablets.
How to store Rizatriptan Glenmark
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 after EXP. day. The expiration date is the last day of the specified month.
No special storage instructions.
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 5 mg orodispersible tablet contains 5 mg of rizatriptan equivalent to 7.265 mg of rizatriptan benzoate.
One 10 mg orodispersible tablet contains 10 mg of rizatriptan equivalent to 14.53 mg of rizatriptan benzoate.
The other ingredients are mannitol, microcrystalline cellulose (E460a), crospovidone type A, aspartame (E951), and magnesium stearate (E572), colloidal silica, peppermint flavor (contains natural flavors and modified food E1450).
What the medicine looks like and the contents of the pack
The 5 mg orodispersible tablets are white to off-white, round, flat with beveled edges, marked with “467” on one side and unmarked on the other side.
The 10 mg orodispersible tablets are white to off-white, round, flat with beveled edges, marked with “468” on one side and unmarked on the other side.
The orodispersible tablets are packaged in aluminum/aluminum blisters.
5 mg pack sizes: Packs of 3, 6, or 18 orodispersible tablets.
10 mg pack sizes: Packs of 2, 3, 6, 12, or 18 orodispersible tablets.
Not all pack sizes may be marketed.
Rizatriptan benzoate is also available as a tablet to be taken with liquid.
Marketing Authorization Holder and Manufacturer
Holder of marketing authorization and manufacturer
Glenmark Arzneimittel GmbH
Industriestr. 31, 82194 Gröbenzell,
Germany
Manufacturer
Glenmark Pharmaceuticals Europe Limited
Building 2, Croxley Green Business Park,
Croxley Green
Hertfordshire, WD18 8YA
UK
Glenmark Pharmaceuticals sro
Fibíchova 143, 566 17 Vysoké Mýto
Czech Republic
This medicinal product is authorized under the European Economic Area under the names:
| Germany | Rizatriptan Glenmark 5mg orodispersible tabletsRizatriptan Glenmark 10mg orodispersible tablets |
| Denmark | Rizatriptan Glenmark Orodispersible TabletsRizatriptan Glenmark Orodispersible Tablets |
| Finland | Rizatriptan Glenmark 5mg tablets, suussa hajoavaRizatriptan Glenmark 10mg tablets, suussa hajoava |
| Italy | RIZATRIPTANO GLENMARK 5mg orodispersible compressRIZATRIPTANO GLENMARK 10mg orodispersible compress |
| Netherlands | Rizatriptan Glenmark 5mg Orodispersible TabletsRizatriptan Glenmark 10mg Orodispersible Tablets |
| Norway | Rizatriptan Glenmark Orodispersible tabletRizatriptan Glenmark Orodispersible tablet |
| Spain | Rizatriptan Viso Pharmacéutica 5mg compresses bucodispersables EFGRizatriptan Viso Pharmacéutica 10mg compresses bucodispersables EFG |
| Sweden | Rizatriptan Glenmark orodispersible tabletRizatriptan Glenmark orodispersible tablet |
| UK | Rizatriptan 5mg Orodispersible TabletsRizatriptan 10mg Orodispersible Tablets |