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RIZALIV MELT 10MG

Active substance(s): RIZATRIPTAN BENZOATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
MAXALT® MELT 10mg Oral Lyophilisates/ RIZALIV MELT 10mg
(rizatriptan benzoate)
This product is available in the above names but will be referred to as
MAXALT MELT throughout this leaflet
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 MELT is and what it is used for
2. Before you take MAXALT MELT
3. How to take MAXALT MELT
4. Possible side effects
5. How to store MAXALT MELT
6. Further information
1. What MAXALT MELT is and what it is used for
MAXALT MELT belongs to a class of medicines called selective
serotonin 5‑HT1B/1D receptor agonists.
MAXALT MELT is used to treat the headache phase of the migraine
attack in adults.
Treatment with MAXALT MELT:
Reduces swelling of blood vessels surrounding the brain. This
swelling results in the headache pain of a migraine attack.

Taking with other medicines
Do not take MAXALT MELT:
 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
dihydro-ergotamine to treat your migraine
 if you use methysergide to prevent a migraine attack.
The above listed medicines when taken with MAXALT MELT may
increase the risk of side effects.
You should wait at least 6 hours after taking MAXALT MELT 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 MELT.
Ask your doctor for instructions and the risks about taking MAXALT
MELT
 if you are taking propranolol (see section 3: How to take
MAXALT MELT).
 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 MELT with food and drink:
MAXALT MELT 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.

2. Before you take MAXALT MELT
Do not take MAXALT MELT if:
 you are allergic (hypersensitive) to rizatriptan benzoate or any of
the other ingredients of MAXALT MELT
 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 MELT.
Take special care with MAXALT MELT if you:
Before you take MAXALT MELT, 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 postmenopausal 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 MELT 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 MELT.
Please tell your doctor or pharmacist about your symptoms. Your
doctor will decide if you have migraine. You should take MAXALT
MELT only for a migraine attack. MAXALT MELT 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 MELT can affect the
way some medicines work. Also, other medicines can affect MAXALT
MELT.

Pregnancy and breast-feeding
It is not known whether MAXALT MELT 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 MELT oral lyophilisates 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 MELT is amongst patients older than 65 years.
Driving or using machines
You may feel sleepy or dizzy while taking MAXALT MELT. If this
happens, do not drive or use any tools or machines.
Important information about some of the ingredients of MAXALT
MELT
Phenylketonuric patients: Contains a source of phenylalanine. May
be harmful for people with phenylketonuria. Each MAXALT MELT
oral lyophilisate contains 3.75 mg of aspartame (which contains
phenylalanine).
3. How to take MAXALT MELT
MAXALT MELT is used to treat migraine attacks. Take MAXALT
MELT as soon as possible after your migraine headache has
started. Do not use it to prevent an attack.
Always take MAXALT MELT 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
MELT up to a maximum of 2 doses in a 24-hour period.
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 MELT. 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 MELT during an
attack, you should not take a second dose of MAXALT MELT for
treatment of the same attack. It is still likely, however, that you will
respond to MAXALT MELT during the next attack.
Do not take more than 2 doses of MAXALT MELT in a 24-hour
period, (for example, do not take more than two 10 mg oral
lyophilisates or more than two 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.
How to administer MAXALT oral lyophilisates
 MAXALT (rizatriptan benzoate) is available as a 5 or 10 mg oral
lyophilisate that dissolves in the mouth.
 Open the MAXALT MELT oral lyophilisate blister pack with dry
hands.
 The oral lyophilisate should be placed on your tongue, where it
dissolves and can be swallowed with the saliva.
 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.
 MAXALT is also available as a tablet to be taken with liquids.

If you take more MAXALT MELT than you should:
If you take more MAXALT MELT 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.

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.

If you have any further questions on the use of this product ask your
doctor or pharmacist.

What MAXALT MELT contains
 Each oral lyophilisate contains 14.53mg rizatriptan benzoate
(corresponding to 10mg of rizatriptan) as the active ingredient.
 Each oral lyophilisate also contains the following inactive
ingredients: gelatin, mannitol, glycine, aspartame and peppermint
flavour.

4. Possible side effects
Like all medicines, MAXALT MELT 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,
Uncommon (affects 1 to 10 users in 1000)
 bad taste in your mouth.
 unsteadiness when walking (ataxia), dizziness (vertigo), blurred
vision.
 confusion, insomnia, nervousness.
 high blood pressure (hypertension); thirst, indigestion (dyspepsia).
 rash, itching and lumpy rash (hives),; 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.
 changes in the rhythm or rate of the heartbeat (arrhythmia);
abnormalities of the electrocardiogram (a test that records the
electrical activity of your heart).
 facial pain; muscle pain.
Rare (affects 1 to 10 users in 10,000)
 fainting (syncope).
 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 coordination, 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.
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 MELT.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side effects not listed in this leaflet. You
can also report side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard. By reporting side effects, you can help
provide more information on the safety of this medicine.
5. How to store MAXALT MELT
 Do not store above 30°C. Do not remove from original packaging
until ready to use.
 Do not use after the expiry date shown on the carton label or
blister strip.
 KEEP OUT OF THE SIGHT AND REACH OF CHILDREN
 If your doctor tells you to stop using this medicine, take any
unused medicine to your pharmacist for safe disposal. Only keep
it if told to do so by your doctor.
 If you notice signs of your medicine deteriorating, consult your
Pharmacist
Important
This medicine has been prescribed for you. Never give it to anyone
else because it may harm them even though they may seem to have
the same symptoms as you.

6. Further information

What MAXALT MELT looks like and contents of pack
 Your oral lyophilisates (wafer) are white to off white, round with a
modified square on one side with a peppermint flavour.
 They are available in packs of 3 individually sealed in a blister
within its own outer aluminium sachet.
This product is manufactured by:
Merck Sharp & Dohme B.V., Waarderweg 39, 2031, BN Haarlem,
The Netherlands.
Procured from within the EU. Product Licence holder: G Pharma Ltd,
Salford M50 2PU
POM
PL No: 16369/1019

17/07/2014

Maxalt is a registered trademark belonging to Merck & Co Inc.
How can you obtain more information about Maxalt Melt?
This leaflet gives you some of the most important information about
Maxalt Melt. If you have any questions after you have read it, ask
your doctor or pharmacist who can give you further information.
Further information about migraine is available from the following
organisations:
Migraine Action Association
27 East Street
Leicester
LE1 6NB
Tel: 0116 275 8317
Fax: 0116 254 2023
E-mail: info@migraine.org.uk
and
The Migraine Trust
55-56 Russell Square
London
WC1B 4HP
Tel: 020 7631 6970
Fax: 020 7436 2886
Email: info@migrainetrust.org
Helpline: 020 7462 6601, Monday to Friday 10am - 5pm
(Migraine Action Association and The Migraine Trust are independent
organisations and are not associated with Merck Sharp & Dohme
Limited.)

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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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