RIZATRIPTAN 10 MG TABLETS

Active substance: RIZATRIPTAN BENZOATE

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Maxalt® 10 mg Tablets
Rizatriptan 10 mg Tablets

2475
08.05.13[2]

(rizatriptan benzoate)
PATIENT INFORMATION LEAFLET
Your medicine is known as one of the above names but will be referred to
as Maxalt throughout the leaflet.
Maxalt Tablets are also available in 5 mg strength.
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 Maxalt is and what it is used for
2. Before you take Maxalt
3. How to take Maxalt
4. Possible side effects
5. How to store Maxalt
6. Further information
1. WHAT MAXALT IS AND WHAT IT IS USED FOR
Maxalt belongs to a class of medicines called selective serotonin 5-HT1B/1D
receptor agonists.
Maxalt is used to treat the headache phase of the migraine attack in adults.
Treatment with Maxalt:
Reduces swelling of blood vessels surrounding the brain. This swelling
results in the headache pain of a migraine attack.
2. BEFORE YOU TAKE MAXALT
Do not take Maxalt if:
- you are allergic (hypersensitive) to rizatriptan benzoate or any of the
other ingredients of Maxalt
- you have moderately severe or severe high blood pressure or mild high
blood pressure that is not controlled by medication
- 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
- you have severe liver or severe kidney problems
- you have had a stroke (cerebrovascular accident CVA) or mini stroke
(transient ischaemic attack TIA)
- you have blockage problems with your arteries (peripheral vascular
disease)
- you are taking monoamine oxidase (MAO) inhibitors such as
moclobemide, phenelzine, tranylcypromine, or pargyline, (drugs against
depression), or linezolid (an antibiotic), or if it has been less than two
weeks since you stopped taking MAO inhibitors
- you are now taking ergotamine-type medications, such as ergotamine or
dihydro-ergotamine to treat your migraine or methysergide to prevent a
migraine attack
- you are taking any other drug 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 apply to you talk to your doctor or
pharmacist before taking Maxalt.
Take special care with Maxalt if you:
Before you take Maxalt, 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
- you have kidney or liver problems
- you have a particular problem with the way your heart beats (bundle
branch block)
- 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 and arm
- you use herbal preparation containing St. John's wort
- you have had allergic reaction like swelling of face, lips, tongue and/or
throat which may cause difficulty breathing and/or swallowing
(angioedema).
- 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
- you have had short lived symptoms including chest pain and tightness

If you take Maxalt 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 Maxalt.
Please tell your doctor or pharmacist about your symptoms. Your doctor will
decide if you have migraine. You should take Maxalt only for a migraine
attack. Maxalt should not be used to treat headaches that might be caused
by other, more serious conditions.
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 Maxalt can affect the way some medicines
work. Also, other medicines can affect Maxalt.
Taking with other medicines
Do not take Maxalt
- if you are already taking a 5-HT1B/1D agonist (sometimes referred to as
‘triptans’), such as sumatriptan, naratriptan or zolmitriptan.
- if you 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.
- if you use ergotamine-type medications such as ergotamine or dihydroergotamine to treat your migraine.
- if you use methysergide to prevent a migraine attack.
The above listed medicines when taken with Maxalt may increase the risk
of side-effects.
You should wait at least 6 hours after taking Maxalt 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 Maxalt.
Ask your doctor for instructions and the risks about taking Maxalt
- if you are taking propranolol (see section 3: How to take Maxalt)
- if you are taking 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.
Taking Maxalt with food and drink:
Maxalt 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 Maxalt 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.
Use in children
The use of Maxalt in children under 18 years of age is not recommended.
Use in patients older than 65 years
There have been no full studies to look at how safe and effective Maxalt is
amongst patients older than 65 years.
Driving or using machines
You may feel sleepy or dizzy while taking Maxalt. If this happens, do not
drive or use any tools or machines.
Important information about some of the ingredients of Maxalt
The 5 mg tablet contains 30.25 mg of lactose monohydrate and the 10 mg
tablet contains 60.50 mg of lactose monohydrate. If you have been told by
your doctor that you have an intolerance to some sugars, contact your
doctor before taking this medicinal product.
3. HOW TO TAKE MAXALT
Maxalt is used to treat migraine attacks. Take Maxalt as soon as
possible after your migraine headache has started. Do not use it to
prevent an attack.
Always take Maxalt 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 Maxalt. You should leave at least 2 hours
between taking propranolol and Maxalt up to a maximum of 2 doses in a
24-hour period.
Maxalt (rizatriptan benzoate) tablets should be taken by mouth and
swallowed whole with liquid.
Maxalt is also available as a 10-mg oral lyophilisate that dissolves in the
mouth. The oral lyophilisate 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 Maxalt. You
should always wait at least 2 hours between doses.
If after 2 hours you still have a migraine
If you do not respond to the first dose of Maxalt during an attack, you
should not take a second dose of Maxalt for treatment of the same attack. It
is still likely, however, that you will respond to Maxalt during the next attack.

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.
- spasm of the blood vessels of the colon (large bowel), which can cause
abdominal pain
- muscle pain
- changes in the rhythm or rate of the heartbeat (arrhythmia), slow
heartbeat (bradycardia), abnormalities of the electrocardiogram (a test
that records the electrical activity of your heart).
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 Maxalt.
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.
5. HOW TO STORE MAXALT
Keep Maxalt out of the sight and reach of children.

Do not take more than 2 doses of Maxalt in a 24-hour period, (for
example, do not take more than two 10-mg or 5 mg tablets or oral
lyophilisate in a 24-hour period). You should always wait at least 2
hours between doses.

Do not use Maxalt after the expiry date which is stated on the container
after EXP. The expiry date refers to the last day of the month.

If your condition worsens, seek medical attention.

If the medicines become discoloured or show any other signs of
deterioration, consult your pharmacist who will tell you what to do.

If you take more Maxalt than you should:
If you take more Maxalt than you should, talk to your doctor or pharmacist
straight away. Take the medicine pack with you.
Signs of overdosage 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, Maxalt can cause side effects, although not everybody
gets them. The following side effects may happen with this medicine.
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
(hypoaesthesia), 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,
- rash
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), allergic reaction (hypersensitivity);
swelling of face, lips, tongue and/or throat which may cause difficulty
breathing and/or swallowing (angioedema)
- neck pain, feeling of tightness in parts of the 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 may
cause side effects like coma, unstable blood pressure, extremely high
body temperature, lack of muscle co-ordination, agitation and
hallucinations
- facial pain, wheezing
- sudden life-threatening allergic reaction (anaphylaxis) severe shedding
of the skin with or without 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]).

o

Do not store Maxalt above 30 C.

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 Maxalt contains
The active substance of Maxalt is rizatriptan.
Each tablet contains 14.53 mg rizatriptan benzoate equivalent to 10 mg
rizatriptan.
The other ingredients of Maxalt tablets are lactose monohydrate,
microcrystalline cellulose (E460a), pregelatinised maize starch, red iron
oxide (E172) and magnesium stearate (E572).
What Maxalt looks like and contents of pack
Tablets are pale pink, capsule-shaped, coded 'MAXALT' on one side and
'MSD 267' on the other.
Available in blister packs of 6 and 18 Tablets.
MANUFACTURER AND PRODUCT LICENCE HOLDER
Manufactured by Merck Sharp & Dohme BV., Waarderweg 39, NL-2031
BN, Haarlem, The Netherlands and procured from within the EU by Product
Licence holder: Star Pharmaceuticals Ltd., 5 Sandridge Close, Harrow,
Middlesex HA1 1XD. Repackaged by Servipharm Ltd.
POM

PL 20636/2475

Leaflet issue and revision date (Ref): 08.05.13[2]
Maxalt is trademark of Merck Sharp & Dohme Corp.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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