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MAXALT MELT 10MG ORAL LYOPHILISATE

Active substance(s): RIZATRIPTAN / RIZATRIPTAN BENZOATE

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T05598

Maxalt Melt 10 mg Oral Lyophilisate
®

(rizatriptan benzoate)

This medicine is available using the above name but will be referred to as Maxalt Melt throughout
the Patient Information Leaflet.
Patient Information Leaflet
Read all of this leaflet carefully before you start taking this medicine, because it contains
important information for you.
− 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 only. Do not pass it on to others. It may harm them,
even if their signs of illnessare 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 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

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.

2. What you need to know 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 this
medicine (listed in section 6)
• 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 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:
• 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 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.
Other medicines and Maxalt
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.
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.
Pregnancy and breast-feeding
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 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.
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.

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

4. Possible side effects
Like all medicines, this medicine 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, 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 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 10,000)
• 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
• Keep Maxalt Melt out of the sight and reach of children.
• Do not use Maxalt Melt after the expiry date which is stated on the container after EXP.
The expiry date refers to the last day of the month.
• Do not store Maxalt Melt oral lyophilisate above 30ºC.
• Do not remove the oral lyophilisate blister from the outer aluminium sachet until you are
ready to take the medicine inside.
• Always keep the aluminium sachets in the carrying case.
• If the medicine become discoloured or show any other signs of deterioration, you should seek
the advice of your pharmacist who will tell you what to do.
• Medicines should not be disposed of via household wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required. These measures will
help protect the environment.

6. Further information
What Maxalt Melt contains
The active substance of the Maxalt Melt is rizatriptan. Each oral lyophilisate contains 14.53 mg of
rizatriptan benzoate equivalent to 10 mg rizatriptan.
The other ingredients of Maxalt Melt oral lyophilisates are: gelatin, mannitol (E421), glycine,
aspartame (E951) and peppermint oil and maltodextrin.
What Maxalt Melt looks like and contents of pack
10 mg oral lyophilisates are white to off-white, round with a modified square on one side, with a
peppermint flavour.
Pack sizes: Packs with 3 or 6 oral lyophilisates.
Manufacturer and Product Licence Holder
Maxalt Melt is manufactured by Merck Sharp & Dohme B.V., Haarlem, The Netherlands. It is
procured from within the EU by the Product Licence Holder: Swinghope Ltd, Brandon House,
Marlowe Way, Croydon CR0 4XS UK. Repackaged by Interport Ltd, Brandon House, Marlowe
Way, Croydon CR0 4XS UK.
POM

PLPI 10380/1449

Leaflet revision date: 06/03/2015.
Maxalt® Melt is a registered trademark of Merck Sharp & Dohme Corp.
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

(Migraine Action Association and The Migraine Trust are independent organisations and are not
associated with Merck Sharp & Dohme Limited or Swinghope Ltd.)

T05598

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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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