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RIZATRIPTAN 10MG ORAL LYOPHILISATES

Active substance(s): RIZATRIPTAN / RIZATRIPTAN BENZOATE

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Maxalt® Melt 10mg Oral Lyophilisates
Rizatriptan 10mg Oral Lyophilisates
(rizatriptan benzoate)
Your medicine is known by either of the above names, but will be referred
to as Maxalt Melt throughout this 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. 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.
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 5HT
receptor agonists.
1B/1D

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 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.
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.
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.

5) How to store Maxalt Melt
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.




Keep out of the sight and reach of children.
Do not use this medicine after the expiry date which is printed on the
carton/carry case/sachet/blister after “Exp”. The expiry date refers to
the last day of the month.
Do not store above 30°C. Store in the original packaging in order to
protect from moisture. 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.
Always keep the aluminium sachets in the carrying case.
If the wafers become discoloured or show any other signs of
deterioration, you should seek the advice of your pharmacist who will
tell you what to do.
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.




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, postmenopausal 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, 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.



6) Further information
What Maxalt Melt contains:
The active substance of the Maxalt Melt is rizatriptan. One oral lyophilisate
contains 10 mg rizatriptan as 14.53mg rizatriptan benzoate.
The other ingredients of Maxalt Melt oral lyophilisates are: gelatin, mannitol
(E421), glycine, aspartame (E-951) and peppermint flavour (composed of
peppermint oil, maltodextrin and dextrin).
What Maxalt Melt looks like and contents of the pack
Each off-white round wafer (technically known as oral lyophilisate), marked
with a rounded square on one side with a peppermint flavour contains
10mg of the active ingredient rizatriptan (as benzoate).
Maxalt Melt is available as blister packs of 2 or 6 oral lyophilisates.
PL 10383/1207

POM

Who makes and repackages your medicine?
Your medicine is manufactured by Merck Sharp & Dohme B.V.
Waarderweg 39 20031 BN Haarlem Paises Bajos, The Netherlands.
Procured from within the EU and repackaged by Product Licence Holder:
Primecrown Ltd., 4/5 Northolt Trading Estate, Belvue Road, Northolt,
Middlesex, UB5 5QS.

Leaflet date: 11.02.2015
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
E-mail: info@migrainetrust.org
(Migraine Action and The Migraine Trust are independent organisations
and are not associated with Merck Sharp & Dohme Limited or Primecrown
Ltd.)
Maxalt Melt is a trademark of Merck & Co., Inc., Whitehouse Station, NJ,
U.S.A.

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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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