Rizatriptan 5 Mg Tablets
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Rizatriptan 5mg tablets Rizatriptan 10mg tablets
Rizatriptan
Read all ofthis 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 toothers. 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. Howtotake Rizatriptan
4. Possible side effects
5. HowtostoreRizatriptan
6. Furtherinformation
1. WHAT RIZATRIPTAN ISAND 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 phaseof yourmigraine attack. Do notuse it to preventan attack.
Treatment with Rizatriptan reduces swelling of blood vessels surrounding the brain. This swelling results in the headache pain of a migraine attack.
2. BEFOREYOU 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 moderatelysevereorsevere high blood pressure, or mild high blood pressure that is notcontrolled 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 liverorsevere kidney problems
• have had a stroke (cerebrovascular accident CVA) or mini stroke (transient ischaemic attackTIA)
• 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 asergotamineor 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, naratriptanorzolmitriptan 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.
Take special care with Rizatriptan
Beforeyou take Rizatriptan tell yourdoctoror pharmacist ifyou:
• have any of the following riskfactors for heartdisease: high blood pressure, diabetes, you smoke or you are using nicotine substitution, your family has a history of heartdisease, you are a man over40 years of age, oryou are a post-menopausal woman
• have kidneyor liver problems
• have a particular problem with the way your heart beats (bundle branch block)
• have or have had any allergies
• have headaches associated with dizziness, difficulty in walking, lackofco-ordination orweakness in the leg and arm
• use any herbal preparation containing St.John's Wort
• have had an allergic reaction like swelling ofthe 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 duloxetinefordepression
• have had shortlived symptoms including chest pain and tightness Ifyou take Rizatriptan too often this may result in you getting a chronic headache. In such cases you should contact yourdoctoras you may have to stop taking Rizatriptan.
Please tell yourdoctoror pharmacist about your symptoms. Your doctorwill decide ifyou 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 fora migraine.This is because Rizatriptan can affect the way some medicines work. Also other medicines can affect Rizatriptan.
Do not take Rizatriptan ifyou are taking:
• a 5HTib/id agonist (sometimes referred to as ‘triptans’), such as sumatriptan, naratriptanorzolmitriptan.
• a monoamine oxidase (MAO) inhibitorsuch as moclobemide, phenelzine, tranylcypromine, linezolid, or pargyline or if it has been less than two weeks since you stopped taking a MAO inhibitor.
• ergotamine-type medications such asergotamineordihydro-ergotamine to treat your migraine
• methysergide to prevent a migraine attack.
The above listed medicines when taken with Rizatriptan may increase the riskof side effects.
You should wait at least 6 hours after taking Rizatriptan beforeyou take ergotamine-type medications such asergotamineor dihydro-ergotamine or methysergide.
You should wait at least 24 hours after taking ergotamine-type medications before taking Rizatriptan.
Askyourdoctorforinstructions and the risks about taking Rizatriptan ifyou are taking:
• propranolol (seesection 3)
• SSRIs such as sertraline, escitalopram oxalate, and fluoxetine or
• SNRIssuch as venlafaxine, and duloxetinefordepression.
Taking Rizatriptan with food and drink
Rizatriptan can take longer to work if it is taken after food. Although it is betterto take iton an empty stomach, you can still take it ifyou have eaten.
Pregnancy and breast-feeding
It is not known whether Rizatriptan is harmful to an unborn baby whentaken bya pregnant woman.
Talk to your doctor before taking this medicine ifyou are pregnant, planning to get pregnant or are breast-feeding. Breast-feeding 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 ordizzy while taking Rizatriptan. Ifthis happens, do not drive or use any tools or machines.
3. HOW TO TAKE RIZATRIPTAN
Always take Rizatriptan exactly as your doctor has told you. You should checkwithyourdoctororyour pharmacist if you are notsure. The usual dose is 10mg.
Ifyou are currently taking propranolol or have kid ney or liver problems you should use the 5mg 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.
Take Rizatriptan as soon as possible after your migraine has started.
Oral use.
Rizatriptan tablets should be taken by mouth and swallowed whole with liquid. The tablets are not intended to be divided.
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 a migraine
Ifyou 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 under18 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 olderthan 65 years.
Ifyou take more Rizatriptan than you should
Ifyou 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.
Ifyou have further questions on the use of this product ask your doctoror pharmacist.
4. POSSIBLESIDEEFFECTS
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 ifyou have symptoms of allergic reactions, serotonin syndrome, heart attack or stroke (see the list below).
In addition, tell your doctor ifyou 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 heartbeat (palpitation), very fast heartbeat (tachycardia),
• flushing (redness of the face lasting a short time), hot flushes, sweating,
• throatdiscomfort, difficulty breathing (dyspnoea),
• feeling sick (nausea), dry mouth, vomiting, diarrhoea,
• feeling of heaviness in parts of the body,
• pain in abdomen orchest Uncommon (affects 1 to 10 users in 1,000)
• 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 ofthe body, stiffness, muscle weakness
Rare (affects 1 to 10 users in 10,000)
• bad taste in your mouth,
• fainting (syncope), a syndrome called ‘serotonin syndrome' that maycauseside 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 byfever(toxicepidermal necrolysis)
• heart attack, spasm of blood vessels ofthe 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 over40 years of age, post-menopausal 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 ofthe extremities including coldness and numbness ofthe hands orfeet
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell yourdoctoror pharmacist.
5. HOW TO STORE RIZATRIPTAN
Keepoutofthe reach and sight of children.
Do not use Rizatriptan aftertheexpirydate which is stated on the containerafterEXP.The expiry date refers to the lastdayofthe month. Do not store above 30°C.
Medicines should not be disposed of via wastewateror household waste. Ask your pharmacist how to dispose medicines no longer required.These measures will help to protect the environment.
6. FURTHERINFORMATION
What Rizatriptan contains
The active substance is rizatriptan.
One Rizatriptan 5mgtabletcontains 5g rizatriptan as 7.26mgof rizatriptan benzoate.
One Rizatriptan 10mg tabletcontains 10mg rizatriptan as 14.53mg of rizatriptan benzoate.
The other ingredients are: microcrystalline cellulose, maize starch, pregelatinised, starch (maize), iron oxide red (E172), magnesium stearate.
What Rizatriptan looks like and contents of pack
5mg tablets are pale pink, round biconvex tablets with dimensions 6.0±0.1mm and 3.0±0.2mm in thickness.
10mg tablets are pale pink, round biconvex tablets, with a score line in one side and dimensions 8.0±0.1mm and 3.5±0.2mm in thickness. Pack sizes: Packs with 2,3,6,12 or 18 tablets.
Notall packsizes maybe marketed.
Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder:
Aspire Pharma Ltd
Antrobus House Business Centre, 18 College Street, Petersfield,
Hampshire,GU314AD, United Kingdom
Manufacturer:
Pharmathen S.A.
6 Dervenakion str, 15351 Pallini, Attiki, Greece or
Pharmathen International S.A
Industrial ParkSapes, Rodopi Prefecture, Block No 5,
Rodopi 69300, Greece
This leaflet was last approved in
05/2011
1010072-P1.4 Pharma