Rizatriptan 10mg Orodispersible Tablets
Out of date information, search anotherPACKAGE LEAFLET: INFORMATION FOR THE USER [Rizatriptan] 5 mg Oridispersible tablets [Rizatriptan] 10mg Orodispersible tablets
Rizatriptan
Read all of this leaflet carefully before you start taking this medicine,
- Keep this leaflet. You may need to read it again.
- If you have further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
- If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What [Rizatriptan] is and what it is used for
2. Before you take [Rizatriptan]
3. How to take [Rizatriptan]
4. Possible side effects
5. How to store [Rizatriptan]
6. Further information
1. WHAT [RIZATRIPTAN] IS AND WHAT IT IS USED FOR
[Rizatriptan] belongs to a class of medicines called selective serotonin 5-HTIB/ID receptor agonists.
Your doctor has prescribed [Rizatriptan] to treat the headache phase of your migraine attack. Do not use it to prevent an attack.
Treatment with [Rizatriptan] reduces swelling of blood vessels surrounding the brain. This swelling results in the headache pain of a migraine attack.
2. BEFORE YOU TAKE [RIZATRIPTAN]
Do not take [Rizatriptan] if you:
• are allergic (hypersensitive) to rizatriptan benzoate or any of the other ingredients of
• [Rizatriptan] (see section 6)
• have moderately severe or severe high blood pressure, or mild high blood pressure that is not controlled by medication
• have or have ever had heart problems including heart attack or pain on the chest
• (angina) or you have experienced heart disease related signs
• have severe liver or severe kidney problems
• have had a stroke (cerebrovascular accident CVA) or mini stroke (transient ischaemic attack TIA)
• have blockage problems with your arteries (peripheral vascular disease)
• are taking monoamine oxidase (MAO) inhibitors such as moclobemide, phenelzine, tranylcypromine, or pargyline (medicines against depression), or linezolid (an antibiotic), or if it has been less than two weeks since you stopped taking MAO inhibitors
• are now taking ergotamine-type medicines, such as ergotamine or dihydro-ergotamine to treat your migraine or methysergide to prevent a migraine attack
• are taking any other medicine in the same class, such as sumatriptan, naratriptan or zolmitriptan to treat your migraine. (See Taking with other medicines below)
If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking
[Rizatriptan].
Before you take [Rizatriptan] tell your doctor or pharmacist if you:
• have any of the following risk factors for heart disease: high blood pressure, diabetes, you smoke or you are using nicotine substitution, your family has a history of heart disease, you are a man over 40 years of age, or you are a post-menopausal woman
• have kidney or liver problems
• have a particular problem with the way your heart beats (bundle branch block)
• have or have had any allergies.
• headache is associated with dizziness, difficulty in walking, lack of co-ordination or weakness in the leg and arm
• use any herbal preparation containing St. John’s Wort
• have had an allergic reaction like swelling of the face, lips, tongue and/or throat which may cause difficulty breathing and/or swallowing (angioedema).
• are taking 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.
• have had short lived symptoms including chest pain and tightness.
If you take [Rizatriptan] 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 [Rizatriptan].
Please tell your doctor or pharmacist about your symptoms. Your doctor will decide if you have a migraine. You should take [Rizatriptan] only for a migraine attack. [Rizatriptan] should not be used to treat headaches that might be caused by other, more serious conditions.
Taking other medicines
Please tell your doctor if you are taking or have recently taken or plan to take, any other medicines including medicines obtained without a prescription. This includes herbal medicines and those you normally take for a migraine. This is because [Rizatriptan] can affect the way some medicines work.
Also other medicines can affect [Rizatriptan].
Do not take [Rizatriptan] if you are taking:
• a 5HTib/id agonist (sometimes referred to as ‘triptans’), such as sumatriptan, naratriptan or zolmitriptan.
• 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 taking an MAO inhibitor.
• ergotamine-type medications such as ergotamine or dihydro-ergotamine to treat your migraine
• methysergide to prevent a migraine attack.
The above listed medicines when taken with [Rizatriptan] may increase the risk of side effects.
You should wait at least 6 hours after taking [Rizatriptan] before you take ergotamine- type medications such as ergotamine or dihydro-ergotamine or methysergide.
You should wait at least 24 hours after taking ergotamine-type medications before taking [Rizatriptan].
Ask your doctor for instructions and the risks about taking [Rizatriptan] if you are taking:
• propranolol (see section 3)
• SSRIs such as sertraline, escitalopram oxalate, and fluoxetine or
• SNRIs such as venlafaxine, and duloxetine for depression.
Taking [Rizatriptan] with food and drink:
[Rizatriptan] can take longer to work if it is taken after food. Although it is better to take it on an empty stomach, you can still take it if you have eaten.
Pregnancy and breast-feeding
It is not known whether [Rizatriptan] is harmful to an unborn baby when taken by a pregnant woman.
Talk to your doctor before taking this medicine if you are pregnant, planning to get pregnant or are breastfeeding. Breastfeeding should be avoided for 24 hours after treatment.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving or using machines
You may feel sleepy or dizzy while taking [Rizatriptan]. If this happens, do not drive or use any tools or machines.
Important information about some of the ingredients of [Rizatriptan]
[Rizatriptan] orodispersable tablets contain aspartame, a source of phenylalanine. May be harmful for people with phenylketonuria.
3. HOW TO TAKE [RIZATRIPTAN]
Always take [Rizatriptan] exactly as your doctor has told you. You should check with your doctor or your pharmacist if you are not sure.
The usual dose is 10 mg.
If you are currently taking propranolol or have kidney or liver problems you should use the 5-mg dose of [Rizatriptan]. You should leave at least 2 hours between taking propranolol and [Rizatriptan] up to a maximum of 2 doses in a 24-hour period.
Method of administration
• Oral use
• Open the blister with dry hands.
• The orodispersible tablets are not intended to be divided.
• The orodispersible tablet should be placed on your tongue, where it dissolves and can be swallowed with the saliva.
• The [Rizatriptan] Orodispersible tablet can be used in situations in which liquids are not available, or to avoid the nausea and vomiting that may accompany the ingestion of tablets with liquids.
If migraine returns within 24 hours
In some patients, migraine symptoms can return within a 24-hour period. If your migraine does return you can take an additional dose of [Rizatriptan]. You should always wait at least 2 hours between doses.
If after 2 hours you still have migraine
If you do not respond to the first dose of [Rizatriptan] during an attack, you should not take a second dose of [Rizatriptan] for treatment of the same attack. It is still likely, however, that you will respond to [Rizatriptan] during the next attack.
Do not take more than 2 doses of [Rizatriptan] in a 24-hour period. You should always wait at least 2 hours between doses.
If your condition worsens, seek medical attention.
Use in children and adolescents
There is no experience with the use of [Rizatriptan] in children and adolescents under 18 years of age, therefore children and adolescents should not be given [Rizatriptan].
Use in patients older than 65 years
There have been no full studies to look at how safe and effective [Rizatriptan] is amongst patients older than 65 years.
If you take more [Rizatriptan] than you should:
If you take more [Rizatriptan] than you should, talk to your doctor or pharmacist straight away. Take the medicine pack with you.
Signs of overdose can include dizziness, drowsiness, vomiting, fainting and slow heart rate.
If you have further questions on the use of this product ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, [Rizatriptan] can cause side effects, although not everybody gets them. The following side effects may happen with this medicine.
In studies, the most common side effects reported were dizziness, sleepiness and tiredness.
Tell your doctor right away if you have symptoms of allergic reactions, serotonin syndrome, heart attack or stroke (see the list below).
In addition, tell your doctor if you experience any symptoms that suggest an allergic reaction (such as a rash or itching) after taking [Rizatriptan].
Common (affects 1 to 10 users in 100)
• tingling (paraesthesia), headache, decreased sensitivity of skin (hypaesthesia), decreased mental sharpness, tremor,
• fast or irregular heart beat (palpitation), very fast heartbeat (tachycardia),
• flushing (redness of the face lasting a short time), hot flushes, sweating,
• throat discomfort, difficulty breathing (dyspnoea),
• feeling sick (nausea), dry mouth, vomiting, diarrhoea,
• feeling of heaviness in parts of the body,
• pain in abdomen or chest
Uncommon (affects 1 to 10 users in 1000)
• unsteadiness when walking (ataxia), dizziness (vertigo), blurred vision,
• confusion, insomnia, nervousness,
• high blood pressure (hypertension); thirst, indigestion (dyspepsia),
• itching and lumpy rash (hives),
• neck pain, feeling of tightness in parts of the body, stiffness, muscle weakness
Rare (affects 1 to 10 users in 10000)
• bad taste in your mouth,
• fainting (syncope), a syndrome called “serotonin syndrome“ that may cause side effects like coma, unstable blood pressure, extremely high body temperature, lack of muscle co-ordination, agitation, and hallucinations
• facial pain, wheezing
• allergic reaction like swelling of the face, lips, tongue and/or throat which may cause difficulty breathing and/or swallowing (angioedema); rash, severe shedding of the skin including accompanied by fever (toxic epidermal necrolysis)
• heart attack, spasm of blood vessels of the heart, stroke. They generally occur in patients with risk factors for heart and blood vessel disease (high blood pressure, diabetes, smoking, use of nicotine substitution, family history of heart disease or stroke, man over 40 years of age, postmenopausal women, particular problem with the way your heart beats [bundle branch block]).
Not known (frequency cannot be estimated from the available data) :
• seizure (convulsions/fits)
• spasm of blood vessels of the extremities including coldness and numbness of the hands or feet
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell
your doctor or pharmacist.
Keep out of the reach and sight of children.
Do not use [Rizatriptan] after the expiry date which is stated on the container after EXP. The expiry date refers to the last day of the month.
Do not store above 30oC.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose medicines no longer required. These measures will help to protect the environment.
6. FURTHER INFORMATION What [Rizatriptan] Orodispersible contains
The active substance is rizatriptan.
One orodispersable tablet contains 5mg rizatriptan as 7,26 mg of rizatriptan benzoate.
One orodispersible tablet contains 10mg rizatriptan as 14,53 mg of rizatriptan benzoate.
The other ingredients are: microcrystalline cellulose, maize starch, silica colloidal anhydrous, aspartame (E951), mint powder (consisting of mint oil, terpeneless mint oil, eucalyptol, menthone, isomenthone, methyl acetate, menthole) and magnesium stearate.
What [Rizatriptan] looks like and contents of pack
5mg and 10 mg orodispersible tablets are white, round biconvex tablets.
Pack sizes: Packs with 2, 3, 6, 12 or 18 orodispersible tablets.
Not all pack sizes may be marketed
Marketing Authorization Holder
Aspire Pharma Ltd. Antrobus House Business Centre,
18 College Street,Petersfield,
Hampshire,
GU31 4AD,
United Kingdom
Manufacturer
PharmathenS.A.6Dervenakionstr,15351Pallini,Attiki,Greece
or
PharmathenInternationalS.A.IndustrialParkSapes,RodopiPrefecture,BlockNo5,Rodopi69300,Greece
This medicinal product is authorized in the Member States of the EEA under the following names: Germany Rizatriptan Pharmathen 5mg & 10mg Schmelztabletten
United Kingdom Rizatriptan 5mg & 10mg Orodispersible tablets
Italy Rizatriptan Doc
Spain Rizatriptan 10mg Pharmathen ODT tablets
Cyprus Rizamigran 5mg & 10mg lingual tablets
Hellas Rizatriptan / Pharmathen 5mg & 10mg ODT tablets
Iceland Rizatriptan Portfarma 10mg ODT tablets