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MAXALT MELT 10 MG ORAL LYOPHILISATE

Active substance(s): RIZATRIPTAN BENZOATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Maxalt® Melt 10 mg Oral Lyophilisate /
Rizatriptan 10 mg Oral Lyophilisate
(rizatriptan benzoate)
This product is available using either of 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, because it
contains important information for you.
ƒ Keep this leaflet. You may need to read it again.
ƒ If you have further questions, ask your doctor or pharmacist.
ƒ 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.
ƒ 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

Other medicines and Maxalt Melt
Do not take Maxalt Melt:
ƒ if you are already taking a 5-HT1B/1D agonist (sometimes referred to as ‘triptans’),
such as sumatriptan, naratriptan or zolmitriptan.
ƒ 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.
ƒ if you use ergotamine-type medications such as ergotamine or dihydro-ergotamine
to treat your migraine
ƒ 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 ergotaminetype 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

1. What Maxalt Melt is and what it is used for
2. What you need to know before you take Maxalt Melt
3. How to take Maxalt Melt
4. Possible side effects
5. How to store Maxalt Melt
6. Contents of the pack and other information

ƒ if you are taking propranolol (see section 3: How to take Maxalt Melt).
ƒ 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.

1. What Maxalt Melt is and what it is used for

Maxalt Melt with food and drink

Maxalt Melt belongs to a class of medicines called selective serotonin 5-HT1B/1D
receptor agonists.

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.

Maxalt Melt is used to treat the headache phase of the migraine attack in adults.
Treatment with Maxalt Melt:

Pregnancy and breast-feeding

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 Maxalt Melt
Do not take Maxalt Melt if:
ƒ you are allergic (hypersensitive) to rizatriptan benzoate or any of the other
ingredients of this medicine (listed in section 6)
ƒ you have moderately severe or severe high blood pressure or mild high blood
pressure that is not controlled by medication
ƒ 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
ƒ you have severe liver or severe kidney problems
ƒ you have had a stroke (cerebrovascular accident CVA) or mini stroke (transient
ischaemic attack TIA)
ƒ you have blockage problems with your arteries (peripheral vascular disease)
ƒ 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
ƒ you are now taking ergotamine-type medications, such as ergotamine or dihydroergotamine to treat your migraine or methysergide to prevent a migraine attack
ƒ you are taking any other drug in the same class, such as sumatriptan, naratriptan or
zolmitriptan to treat your migraine (see Other medicines and Maxalt below).
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist
before taking Maxalt Melt.
Warnings and precautions:
Before you take Maxalt Melt, tell your doctor or pharmacist, if:

If you are pregnant or breast-feeding, think you are pregnant or planning to have a
baby ask your doctor or pharmacist for advice before taking this medicine.
It is not known whether Maxalt Melt is harmful to an unborn baby when taken by a
pregnant women. Breastfeeding should be avoided for 24 hours after treatment.
Children and adolescents
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.
Maxalt Melt contains a source of phenylalanine
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.

ƒ 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
ƒ you have kidney or liver problems
ƒ you have a particular problem with the way your heart beats (bundle branch block)
ƒ you have or have had any allergies
ƒ your headache is associated with dizziness, difficulty in walking, lack of coordination or weakness in the leg and arm
ƒ you use herbal preparation containing St. John's wort
ƒ you have had allergic reaction like swelling of face, lips, tongue and/or throat which
may cause difficulty breathing and/or swallowing (angioedema)
ƒ 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
ƒ you have had short lived symptoms including chest pain and tightness.

The usual dose is 10 mg.

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.

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.

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.

If you are currently taking propranolol or have kidney or liver problems you should use
the 5-mg dose of Maxalt Melt. 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.

If your condition worsens, seek medical attention.
How to administer Maxalt Melt oral lyophilisates
ƒ Maxalt Melt (rizatriptan benzoate) is available as a 5 or 10 mg oral lyophilisate that
dissolves in the mouth.
ƒ Open the Maxalt Melt oral lyophilisate blister pack with dry hands.
ƒ The oral lyophilisate should be placed on your tongue, where it dissolves and can
be swallowed with the saliva.
ƒ 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 Melt is also available as a tablet to be taken with liquids.

If you take more Maxalt Melt than you should:

6. Contents of the pack and other information

If you take more Maxalt Melt than you should, talk to your doctor or pharmacist straight
away. Take the medicine pack with you.

What MAXALT MELT contains

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

The active substance of the Maxalt Melt is rizatriptan.
Each oral lyophilisate contains 14.53 mg rizatriptan benzoate equivalent to 10 mg
rizatriptan.
The other ingredients of Maxalt Melt oral lyophilisates are: gelatin, mannitol (E421),
glycine, aspartame (E951) and peppermint flavour (composed of peppermint oil,
maltodextrin and dextrin).

4. Possible side effects

What MAXALT MELT looks like and contents of pack

Like all medicines, this medicine can cause side effects, although not everybody gets
them. The following side effects may happen with this medicine.

Maxalt Melt is white to off-white, round with a modified square with rounded corners on
one side and plain on the other side, with a peppermint flavour.
Pack sizes:
ƒ 3 oral lyophilisates: packed in one plastic carrying case containing three aluminium
sachets.
ƒ 6 oral lyophilisates: packed in two plastic carrying cases containing three aluminium
sachets each.

Signs of overdosage can include dizziness, drowsiness, vomiting, fainting and slow
heart rate.

In adult studies, the most common side effects reported were dizziness, sleepiness
and tiredness.
Common (affects 1 to 10 users in 100)
ƒ tingling (paraesthesia), headache, decreased sensitivity of skin (hypoaesthesia),
decreased mental sharpness, insomnia
ƒ fast or irregular heart beat (palpitation),
ƒ flushing (redness of the face lasting a short time)
ƒ throat discomfort
ƒ feeling sick (nausea), dry mouth, vomiting, diarrhoea, indigestion (dyspepsia)
ƒ feeling of heaviness in parts of the body, neck pain, stiffness
ƒ pain in abdomen or chest
Uncommon (affects 1 to 10 users in 1000)
ƒ bad taste in your mouth.
ƒ unsteadiness when walking (ataxia), dizziness (vertigo), blurred vision, tremor,
fainting (syncope)
ƒ confusion, nervousness.
ƒ high blood pressure (hypertension); thirst, hot flushes, sweating
ƒ rash, itching and lumpy rash (hives); swelling of face, lips, tongue and/or throat
which may cause difficulty breathing and/or swallowing (angioedema), difficulty
breathing (dyspnoea)
ƒ feeling of tightness in parts of the body, muscle weakness.
ƒ 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)
ƒ facial pain; muscle pain.
Rare (affects 1 to 10 users in 10,000)
ƒ wheezing.
ƒ allergic reaction (hypersensitivity); sudden life-threatening allergic reaction
(anaphylaxis).
ƒ 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, postmenopausal
women, particular problem with the way your heart beats [bundle branch block]).
ƒ Slow heartbeat (bradycardia).
Not known (frequency cannot be estimated from the available data):
ƒ 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)).
ƒ 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.
ƒ severe shedding of the skin with or without fever (toxic epidermal necrolysis),
ƒ seizure (convulsions/fits).
ƒ spasm of blood vessels of the extremities including coldness and numbness of the
hands or feet.
ƒ 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, tell your doctor or pharmacist. This includes any possible
side effects not listed in this leaflet. You can also report side effects directly via Yellow
Card Scheme Website: www.mhra.gov.uk/yellowcard. By reporting side affects you
can help provide more information on the safety of this medicine.
5. How to store Maxalt Melt
ƒ Keep of the sight and reach of children.
ƒ Do not use this medicine after the expiry date which is stated on the carton/carry
case/sachet/blister after “EXP”. The expiry date refers to the last day of the month.
ƒ Do not store above 30°C. Store in the original packaging in order to protect from
moisture.
ƒ Do not remove the oral lyophilisate blister from the outer aluminium sachet until you
are ready to take the medicine inside. Do not use the medicine if the aluminium
sachet is damaged.
ƒ Always keep the aluminium sachets in the carrying case.
ƒ 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.
ƒ If your medicine become discoloured or show signs of any deterioration, consult
your doctor or pharmacist who will tell you what to do.

POM

PL 15814/1147

Manufactured by Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem,
The Netherlands.
Procured from within the EU and repackaged by the Product Licence holder: O.P.D.
Laboratories Ltd., Unit 6 Colonial Way, Watford, Herts WD24 4PR.
Leaflet revision and issue date (Ref.): 22.06.2015.
Maxalt is a registered trademark of Merck Sharp & Dohme Corp., USA.
To request a copy of this leaflet in Braille, large print or audio please call 01923 332
796.
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
4th Floor, 27 East Street
Leicester
LE1 6NB
Tel: 0116 275 8317
Fax: 0116 254 2023
and
The Migraine Trust
52-53 Russell Square
London
WC1B 4HP
Tel: 020 7631 6970
Fax: 020 7436 2886
Email: info@migrainetrust.org

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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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