Rizatriptan 10mg Tablets
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Rizatriptan 5 mg Tablets Rizatriptan 10 mg Tablets rizatriptan
Read all of this leaflet carefully before you start taking this medicinebecause it contains important information for you.
— Keep this leaflet. You may need to read it again.
— If you have any further questions, ask your doctor or pharmacist.
— This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
— If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Rizatriptan is and what it is used for
2. What you need to know before you take Rizatriptan
3. How to take Rizatriptan
4. Possible side effects
5. How to store Rizatriptan
6. Contents of the pack and other information
1. What Rizatriptan is and what it is used for
Rizatriptan are used to treat migraine attacks. Do not use them to prevent an attack.
Rizatriptan belongs to a class of medicines called selective serotonin 5-HT1B/1D receptor agonists. Rizatriptan is used to treat the headache phase of the migraine attack in adults.
Treatment with Rizatriptan:
Reduces swelling of blood vessels surrounding the brain. This swelling results in the headache pain of a migraine attack.
2. What you need to know before you take Rizatriptan
Do not take Rizatriptan:
• if you are allergic (hypersensitive) to rizatriptan benzoate or any of the other ingredients of this medicine (listed in section 6)
• if you have moderately severe or severe high blood pressure or mild high blood pressure that is not controlled by medication
• if you have or have ever had heart problems including heart attack or pain on the chest (angina) or you have experienced heart disease related signs
• if you have severe liver or severe kidney problems
• if you have had a stroke (cerebrovascular accident CVA) or mini stroke (transient ischaemic attack TIA)
• if you have reduced blood flow to your legs and arms due to blocked arteries (peripheral vascular disease)
• if you 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
• if you are taking ergotamine-type medicines, such as ergotamine or dihydro-ergotamine to treat your migraine or methysergide to prevent a migraine attack
• if you are taking any other medicines in the same class as rizatriptan, such as sumatriptan, naratriptan, or zolmitriptan to treat your migraine (see below Other medicines and Rizatriptan).
If you are not sure if any of the above apply to you talk to your doctor or pharmacist before taking Rizatriptan.
Warnings and precautions
Talk to your doctor or pharmacist before taking Rizatriptan:
• 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
• if you have kidney or liver problems
• if you have a particular problem with the way your heart beats (bundle branch block)
• if you have or have had any allergies
• your headache is associated with dizziness, difficulty in walking, lack of co-ordination or weakness in the leg or arm
• if you use herbal preparation containing St. John’s wort
• if you have had allergic reaction like swelling of face, lips, tongue and/or throat which may cause difficulty breathing and/or swallowing (angioedema)
• if you 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
• if you 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 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.
Please tell your doctor or pharmacist 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.
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.
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.
Other medicines and RizatriptanDo not take Rizatriptan if you :
• are already taking a 5HT1B/1D agonist (sometimes referred to as ‘triptans’), such as sumatriptan, naratriptan or zolmitriptan
• are taking 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
• use ergotamine-type medicines such as ergotamine or dihydro-ergotamine to treat your migraine
• use 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 medicines such as ergotamine or dihydro-ergotamine or methysergide.
You should wait at least 24 hours after taking ergotamine-type medicines before taking Rizatriptan. Ask your doctor for instructions and the risks about taking Rizatriptan if you are taking :
• propranolol (see section 3: How to take Rizatriptan)
• SSRIs such as sertraline, escitalopram oxalate, and fluoxetine or SNRIs such as venlafaxine, and duloxetine for depression.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
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, breast-feeding and fertility
It is not known whether Rizatriptan is harmful to an unborn baby when taken by a pregnant woman.
If you are pregnant or breast feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Breastfeeding should be avoided for 24 hours after treatment.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
You may feel sleepy or dizzy while taking Rizatriptan. If this happens, do not drive or use any tools or machines.
Rizatriptan contains aspartame (E951).
Aspartame contains a source of phenylalanine and this may be harmful for people with phenylketonuria.
3. How to take Rizatriptan
Rizatriptan is used to treat migraine attacks. Take Rizatriptan as soon as possible after your migraine headache has started. Do not use it to prevent an attack.
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 recommended dose is 10 mg.
Rizatriptan should be taken by mouth and swallowed whole with liquid.
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.
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G GLENMARK GENERICS LTD. |
15.01.2015 |
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Rizatriptan 5 & 10 mg Tablets (IR) (Insert-Front) NA VERSION:NA NA |
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40 gsm Bible Paper | |||
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, (for example, do not take more than two doses of 10 mg or 5 mg tablets in a 24-hour period). You should always wait at least 2 hours between doses.
If your condition worsens, seek medical attention.
Rizatriptan benzoate tablets is also available as a 5 mg and 10 mg orodispersible tablets that dissolves in the mouth. The ordispersible tablets 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 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 any 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.
Tell your doctor right away if you have symptoms of allergic reactions, serotonin syndrome, heart attack or stroke.
In addition, tell your doctor if you experience any symptoms that suggest an allergic reaction (such as a rash or itching) after taking Rizatriptan.
In adult studies, the most common side effects reported were dizziness, sleepiness and tiredness. Common (affects 1 to 10 users in 100)
• tingling (paraesthesia), headache, decreased sensitivity of skin (hypaesthesia), decreased mental sharpness, tremor, insomnia
• fast or irregular heart beat (palpitation),
• flushing (redness of the face lasting a short time),
• throat discomfort,
• feeling sick (nausea), dry mouth, vomiting, diarrhoea, indigestion (dyspepsia)
• feeling of heaviness in parts of the body, neck pain, stiffness
• pain in abdomen or chest
Uncommon (affects 1 to 10 users in 1000)
• bad taste in your mouth,
• unsteadiness when walking (ataxia), dizziness (vertigo), blurred vision, tremor, fainting (syncope)
• confusion, nervousness,
• high blood pressure (hypertension); thirst, hot flushes, sweating
• rash, itching and lumpy rash (hives), swelling of face, lips, tongue and/or throat which may cause difficulty breathing and/or swallowing (angioedema), difficulty in breathing (dyspnoea)
• feeling of tightness in parts of the body, muscle weakness
• changes in the rhythm or rate of the heartbeat (arrhythmia); abnormalities of the electrocardiogram (a test that records the electrical activity of your heart), very fast heartbeat (tachycardia)
• facial pain; muscle pain.
Rare (affects 1 to 10 users in 10000)
• wheezing
• allergic reaction (hypersensitivity); sudden life-threatening allergic reaction (anaphylaxis).
• stroke (this generally occurs 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, post-menopausal women, particular problem with the way your heart beats [bundle branch block]).
• Slow heartbeat (bradycardia).
Not known (frequency cannot be estimated from the available data):
• heart attack, spasm of the blood vessels of the heart (these 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)).
• 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.
• severe shedding of the skin with or without fever (toxic epidermal necrolysis).
• seizure (convulsions/fits)
• spasm of blood vessels of the extremities including coldness and numbness of the hands or feet;
• spasm of the blood vessels of the colon (large bowel), which can cause abdominal pain Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via via the Yellow Card Scheme at www. mhra.gov.co.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Rizatriptan
Keep Rizatriptan out of the sight and reach 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.
This medicinal product does not require any special storage conditions.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use.These measures will help protect the environment
6. Contents of the pack and other information
What Rizatriptan contains
The active substance of Rizatriptan is rizatriptan.
One 5 mg tablet contains 5 mg rizatriptan as 7.265 mg of rizatriptan benzoate One 10 mg tablet contains 10 mg rizatriptan as 14.53 mg of rizatriptan benzoate.
The other ingredients of Rizatriptan tablets are mannitol, microcrystalline cellulose (E460a), crospovidone, aspartame (E951), magnesium stearate (E572), Colloidal Silicon Dioxide, peppermint flavor (contains modified food starch).
What Rizatriptan looks like and contents of pack
5 mg tablets are white to off white, approximately 7 mm round, flat, beveled edged uncoated tablets, engraved with ‘467’ on one side and plain on other side.
10 mg tablets are white to off white, approximately 9mm round, flat, beveled edged uncoated tablets, engraved with ‘468’ on one side and plain on other side The tablets are packed in Aluminium/Aluminium blisters.
5 mg Pack sizes: Packs with 3, 6, or 18 tablets.
10 mg Pack sizes: Packs with 3, 6, 12 or 18 tablets.
Not all pack sizes may be marketed.
Rizatriptan is also available as an orodispersible tablet that dissolves in the mouth.
Marketing Authorisation Holder
Glenmark Pharmaceuticals Europe Limited Laxmi House, 2 B Draycott Avenue,
Kenton,
Middlesex,
HA30BU UK
Manufacturer
Glenmark Pharmaceuticals Europe Limited Building 2, Croxley Green Business Park,
Croxley Green Hertfordshire, WD18 8YA United Kingdom
Glenmark Pharmaceuticals s.r.o.
Fibfchova 143, 566 17 Vysoke Myto Czech Republic
This leaflet was last revised in 12/2014.
|
G GLENMARK GENERICS LTD. |
15.01.2015 |
Black | |
|
Rizatriptan 5 & 10 mg Tablets (IR) (Insert-Back) NA VERSION:NA NA |
PKG. DEV.: |
Item code, Version, Consistency of Design, overprint area, Pack size, Dimensions & Layout | |
|
RA |
Regulatory Text | ||
|
UK |
QA: |
Entire Text | |
|
Goa 150 x 30 mm | |||
|
PRODUCTION: |
Machine Suitability | ||
|
150 x 480 mm |
SPC comparison & QRD update variation + GAP analysis | ||
|
40 gsm Bible Paper | |||
Temple Packaging Pvt. Ltd. Font: 9pt. Times New Roman Sap code: 30100007394 File: 36988 V:04 t