MAXALT 5 mg Tablet

Зміст інструкції

1. MAXALT 5 mg tablets
2. MAXALT 10 mg tablets
   1. What is MAXALT and what is it used for
   2. What you need to know before you take MAXALT
   3. How to take MAXALT
   4. Possible side effects
   5. How to store MAXALT
   6. Package Contents and Other Information
3. MAXALT RPD 5 mg oral lyophilisate
4. MAXALT RPD 10 mg oral lyophilisate
   1. What is MAXALT and what it is used for
   2. What you need to know before you take MAXALT
   3. How to take MAXALT
   4. Possible side effects
   5. How to store MAXALT
   6. Package contents and other information

MAXALT 5 mg tablets

rizatriptan

MAXALT 10 mg tablets

rizatriptan
Read this leaflet carefully before you start to take this medicinebecause it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is MAXALT and what is it used for

MAXALT belongs to a class of medicines called selective serotonin receptor agonists
5-HT
MAXALT is used for the treatment of the headache phase of an adult migraine attack.
Treatment with MAXALT:
reduces the swelling of blood vessels that are around the brain. This swelling causes the pain
of the headache of a migraine attack.

2. What you need to know before you take MAXALT

Do not take MAXALT if:

• you are allergic to rizatriptan benzoate or any of the other ingredients of this medicine (listed in section 6)
• you suffer from moderately severe or severe high blood pressure or mild high blood pressure that is not controlled by therapy
• you have or have had heart problems including a heart attack or chest pain (angina) or have shown signs of heart disease
• you have serious liver or kidney problems
• you have had a stroke (cerebrovascular accident CVA) or a mini-stroke (transient ischemic attack TIA)
• you have problems with blockage of the arteries (peripheral vascular disease)
• you are taking monoamine oxidase inhibitors (MAOIs) such as moclobemide, phenelzine, tranylcypromine, or pargilina (drugs for depression), or linezolid (an antibiotic), or if less than two weeks have passed since you stopped taking MAOIs
• you are taking ergotamine-like drugs, such as ergotamine or dihydroergotamine for the treatment of migraine or metisergide for the prevention of migraine attacks
• you are taking other drugs of the same class such as sumatriptan, naratriptan or zolmitriptan for the treatment of migraine (see below: Other medicines and MAXALT).

If you have any doubts that any of the above information applies to you, contact your doctor or
pharmacist.

Warnings and precautions
Talk to your doctor or pharmacist before taking MAXALT if:

• you have any of the following risk factors for heart disease: high blood pressure, diabetes, if you smoke or if you are using nicotine replacement substances, if there is a family history of heart disease, if you are a man over 40 years old, or if you are a postmenopausal woman
• you suffer from kidney or liver problems
• you have a particular problem concerning your heartbeat (bundle branch block)
• you have or have had allergies
• your headache is associated with dizziness, difficulty walking, lack of coordination or weakness of the arms or legs
• you use herbal preparations based on St. John's wort
• you have had allergic reactions such as swelling of the face, lips, tongue and/or throat that can 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 a feeling of tightness in the chest.

Taking MAXALT too often can cause chronic headache. In this case contact your doctor
because you may need to stop taking MAXALT.
Report your symptoms to your doctor or pharmacist. The doctor will decide if you suffer from migraine. You
must only take MAXALT for migraine attacks. MAXALT should not be used for the
treatment of headache that may be caused by other more serious diseases.
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine, even those available without a prescription, including herbal preparations and
medicines that you normally take for migraine. This is important because MAXALT can
change the way some medicines work. Other medicines can also have effects
on MAXALT.

Other medicines and MAXALT
Do not take MAXALT:

• if you are already taking a 5-HT agonist (sometimes called “triptans”) such as sumatriptan, naratriptan or zolmitriptan.
• If you are taking a monoamine oxidase inhibitor (MAOI) such as moclobemide, phenelzine, tranylcypromine, linezolid or pargilina or if you have stopped taking an MAOI less than two weeks ago.
• If you are using ergotamine-like drugs, such as ergotamine or dihydroergotamine for the treatment of migraine.
• If you are using metisergide to prevent migraine attacks. The above medicines may increase the risk of side effects when taken with MAXALT.

You must wait at least 6 hours after taking MAXALT before taking ergotamine-like
medicines such as ergotamine or dihydroergotamine or metisergide.
You must wait at least 24 hours after taking ergotamine-like drugs before taking
MAXALT.
Ask your doctor for instructions and the risks of 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.

Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine, even those available without a prescription.

MAXALT with food and drink
MAXALT may take longer to work if it is taken after meals. Although it is
best to take it on an empty stomach, it can also be taken after eating.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning a pregnancy, ask your doctor or
pharmacist for advice before taking this medicine.
It is not known whether MAXALT can cause harm to the unborn baby when taken by a
pregnant woman.
Breastfeeding should be avoided for 24 hours after taking the medicine.

Children and adolescents
The use of MAXALT tablets in children under 18 years of age is not recommended.

Use in patients over 65 years of age
No studies have been conducted to fully evaluate the safety and efficacy of MAXALT in
patients over 65 years of age.

Driving and operating machinery
You may feel drowsy or dizzy when taking MAXALT. If this happens, do not drive or operate
machinery.

MAXALT containslactose monohydrate
MAXALT 5 mg tablets
The 5 mg tablet contains 30.25 mg of lactose monohydrate. If you have been diagnosed with
intolerance to some sugars, contact your doctor before taking this medicine.

MAXALT 10 mg tablets
The 10 mg tablet contains 60.50 mg of lactose monohydrate. If you have been diagnosed
with intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take MAXALT

MAXALT is used for the treatment of migraine attacks. Take MAXALT as soon as possible after the start of a migraine headache. Do not use it to prevent attacks.
Take this medicine following exactly the instructions of your doctor. If you have doubts, consult your doctor or pharmacist.
The usual dose is 10 mg.
If you are taking propranolol or have kidney or liver problems, you should use the 5 mg dosage of MAXALT. You should wait at least 2 hours after taking propranolol before taking MAXALT, up to a maximum of 2 doses within 24 hours.
MAXALT (rizatriptan benzoate) tablets should be taken by mouth and swallowed whole with a liquid.
MAXALT is also available as an orally disintegrating lyophilate of 5 or 10 mg that dissolves in the mouth. The orally disintegrating lyophilate can be used in circumstances where liquids are not available, or to avoid nausea and vomiting that may accompany the ingestion of tablets with liquids.

If the migraine returns within 24 hours
In some patients, migraine symptoms may return within 24 hours. If the migraine returns, you can take an additional dose of MAXALT. You must wait at least 2 hours between the two doses.

If you still have a migraine after 2 hours
If you do not respond to the first dose of MAXALT during the attack, you should not take a second dose of MAXALT to treat the same attack. It is still likely, however, that you will respond to MAXALT during the next attack.

Do not take more than 2 doses of MAXALT within 24 hours (for example, do not take more than two 10 mg or 5 mg tablets or orally disintegrating lyophilates within 24 hours). You should always wait at least 2 hours between the two doses.
If symptoms worsen, seek medical assistance.

If you take more MAXALT than you should
If you take more MAXALT than you should, inform your doctor or pharmacist immediately. Bring the medicine packaging with you.
Signs of overdose include dizziness, drowsiness, vomiting, fainting, and slowed heartbeat.
If you have further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
The following side effects may occur with this medicine.
In studies in adult subjects, the most commonly reported side effects were dizziness,
drowsiness and fatigue.

Common (may affect up to 1 in 10 people)

• tingling (paresthesia), headache, decreased skin sensitivity (hypoesthesia), decreased mental acuity, insomnia
• fast or irregular heartbeat (palpitations)
• hot flushes (temporary facial redness)
• throat discomfort
• feeling unwell (nausea), dry mouth, vomiting, diarrhea, indigestion (dyspepsia)
• feeling of heaviness in some parts of the body, neck pain, stiffness
• pain in the abdomen or chest.

Uncommon (may affect up to 1 in 1,000 people)

• bad taste in mouth
• loss of coordination of movements when walking (ataxia), dizziness (vertigo), blurred vision, tremor, fainting (syncope)
• confusion, nervousness
• high blood pressure (hypertension), thirst, hot flashes, sweating
• skin rash; itching and redness with welts (urticaria), swelling of the face, lips, tongue and/or throat that can cause difficulty breathing and/or swallowing (angioedema), difficulty breathing (dyspnea)
• feeling of oppression in some parts of the body, muscle weakness
• changes in the rhythm or rate of heartbeat (arrhythmia); abnormalities in the electrocardiogram (an examination that records the electrical activity of the heart), very fast heartbeat (tachycardia)
• facial pain, muscle pain. Rare (may affect up to 1 in 10,000 people)
• wheezing
• allergic reaction (hypersensitivity); sudden allergic reaction that is potentially life-threatening (anaphylaxis)
• stroke (this generally occurs in patients with risk factors for heart and blood vessel disease (high blood pressure, diabetes, smoking habit, use of nicotine substitutes, family history of heart disease or stroke, men over 40, postmenopausal women, specific heart rhythm problems (bundle branch block)))
• slow heartbeat (bradycardia).

Frequency not known (the frequency cannot be estimated from the available data)

• heart attack, spasm of the heart's blood vessels (this generally occurs in patients with risk factors for heart and blood vessel disease (high blood pressure, diabetes, smoking habit, use of nicotine substitutes, family history of heart disease or stroke, men over 40, postmenopausal women, specific heart rhythm problems (bundle branch block)))
• a syndrome called “serotonin syndrome” which can cause side effects such as coma, unstable blood pressure, extremely high body temperature, lack of muscle coordination, agitation and hallucinations
• severe skin detachment with or without fever (toxic epidermal necrolysis)
• seizures/convulsions
• spasm of the blood vessels in the extremities including sensations of coldness and decreased tactile sensitivity of the hands or feet
• spasm of the blood vessels of the colon (large intestine), which can cause abdominal pain.

Immediately inform your doctor if you experience symptoms of allergic reactions, serotonin
syndrome, heart attack or stroke.
Also report to your doctor if you experience symptoms suggesting an allergic reaction (such as
skin redness or itching) after taking MAXALT.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist.
You can also report side effects directly through the national reporting system at the address:
www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa .
By reporting side effects you can help provide more information on the safety
of this medicine.

5. How to store MAXALT

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack/blister after “EXP”.
The expiry date refers to the last day of that month.

Do not store MAXALT at a temperature above 30°C.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how
to dispose of medicines you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What MAXALT contains
MAXALT 5 mg tablets
The active ingredient of MAXALT is rizatriptan. One tablet contains 5 mg of rizatriptan as
7.265 mg of rizatriptan benzoate.

MAXALT 10 mg tablets
The active ingredient of MAXALT is rizatriptan. One tablet contains 10 mg of rizatriptan as
14.53 mg of rizatriptan benzoate.
The other ingredients of MAXALT are lactose monohydrate, microcrystalline cellulose (E460a), pregelatinized
starch, iron oxide red (E172) and magnesium stearate (E572).

Description of the appearance of MAXALT and package contents
MAXALT 5 mg tablets
The 5 mg tablets are pale pink in color, capsule-shaped, with MSD inscribed on one side and
266 on the other.

MAXALT 10 mg tablets
The 10 mg tablets are pale pink in color, capsule-shaped, with MAXALT inscribed on one
side and MSD 267 on the other.
Pack sizes: packs of 2, 3, 6, 12 or 18 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Organon Italia S.r.l.
Piazza Carlo Magno, 21
00162 Rome

Manufacturer
MERCK SHARP & DOHME B.V.
Waarderweg 39
2031 BN Haarlem
Netherlands

This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations:
Maxalt 5 mg tablets
Austria, Finland, France, Greece,
Iceland, Norway, Netherlands, Poland,
Sweden, United Kingdom MAXALT
Belgium and Luxembourg MAXALT 5 mg
Czech Republic MAXALT 5 mg, tablets
Denmark MAXALT, tablets
Germany MAXALT 5 mg Tablets
Ireland Rizatriptan MSD 5 mg Tablets
Italy MAXALT 5 mg compresse
Romania MAXALT 5 mg comprimate

Maxalt 10 mg tablets
Austria, Finland, France, Greece,
Iceland, Norway, Netherlands, Poland,
Portugal, Sweden, United Kingdom MAXALT
Belgium, Luxembourg and Spain MAXALT 10 mg
Czech Republic MAXALT 10 mg, tablety
Denmark MAXALT, tablets
Germany MAXALT 10 mg Tablets
Ireland Rizatriptan MSD 10 mg Tablets
Italy MAXALT 10 mg compresse
Romania MAXALT 10 mg comprimate

MAXALT RPD 5 mg oral lyophilisate

rizatriptan

MAXALT RPD 10 mg oral lyophilisate

rizatriptan
Read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is MAXALT and what it is used for

MAXALT belongs to a class of medicines called selective serotonin receptor agonists
5-HT
MAXALT is used for the treatment of the headache phase of an adult migraine attack.
Treatment with MAXALT:
reduces the swelling of blood vessels around the brain. This swelling causes the pain
of the headache of a migraine attack.

2. What you need to know before you take MAXALT

Do not take MAXALT if:

• you are allergic to rizatriptan benzoate or any of the other ingredients of this medicine (listed in section 6)
• you suffer from moderately severe or severe high blood pressure or mild high blood pressure that is not controlled by therapy
• you have or have had heart problems including heart attack or chest pain (angina) or have shown signs of heart disease
• you have serious liver or kidney problems
• you have had a stroke (cerebrovascular accident CVA) or a mini-stroke (transient ischemic attack TIA)
• you have problems with blockage of the arteries (peripheral vascular disease)
• you are taking monoamine oxidase inhibitors (MAOIs) such as moclobemide, phenelzine, tranylcypromine, or pargilina (drugs for depression), or linezolid (an antibiotic), or if less than two weeks have passed since you stopped taking MAOIs
• you are taking ergotamine-like drugs, such as ergotamine or dihydroergotamine for the treatment of migraine or metisergide for the prevention of migraine attacks
• you are taking other drugs of the same class such as sumatriptan, naratriptan or zolmitriptan for the treatment of migraine (see below: Other medicines and MAXALT).

If you have any doubts that any of the above information applies to you, contact your doctor or
pharmacist.

Warnings and precautions
Talk to your doctor or pharmacist before taking MAXALT if:

• you have any of the following risk factors for heart disease: high blood pressure, diabetes, if you smoke or if you are using nicotine replacement substances, if there are cases of heart disease in your family, if you are a man over 40 years old, or if you are a postmenopausal woman
• you suffer from kidney or liver problems
• you have a particular problem concerning your heartbeat (bundle branch block)
• you have or have had allergies
• your headache is associated with dizziness, difficulty walking, lack of coordination or weakness of the arms or legs
• you use herbal preparations based on St. John's wort
• you have had allergic reactions such as swelling of the face, lips, tongue and/or throat that can cause difficulty breathing and/or swallowing (angioedema)
• you are taking selective serotonin reuptake inhibitors (SSRIs) such as sertraline, escitalopram oxalate and fluoxetine or serotonin-noradrenaline reuptake inhibitors (SNRIs), such as venlafaxine and duloxetine for depression
• you have had short-lived symptoms including chest pain and a feeling of tightness in the chest. Taking MAXALT too often can cause chronic headache. In this case contact your doctor because you may need to stop taking MAXALT. Report your symptoms to your doctor or pharmacist. The doctor will decide if you suffer from migraine. You should only take MAXALT for migraine attacks. MAXALT should not be used for the treatment of headache that may be caused by other more serious illnesses.

Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine, even those available without a prescription, including herbal preparations and
medicines you normally take for migraine. This is important because MAXALT can
change the way some medicines work. Other medicines can also have effects
on MAXALT.

Other medicines and MAXALT
Do not take MAXALT:

• if you are already taking a 5-HT agonist (sometimes called “triptans”) such as sumatriptan, naratriptan or zolmitriptan.
• If you are taking a monoamine oxidase inhibitor (MAOI) such as moclobemide, phenelzine, tranylcypromine, linezolid or pargilina or if you have stopped taking an MAOI less than two weeks ago.
• If you are using ergotamine-like drugs such as ergotamine or dihydroergotamine for the treatment of migraine.
• If you are using metisergide to prevent migraine attacks.

The medicines listed above may increase the risk of side effects if taken with MAXALT.
You must wait at least 6 hours after taking MAXALT before taking ergotamine-like
medicines such as ergotamine or dihydroergotamine or metisergide.
You must wait at least 24 hours after taking ergotamine-like drugs before taking
MAXALT.
Ask your doctor for instructions and risks of 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. Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicine, even those available without a prescription.

MAXALT with food and drink
MAXALT may take longer to work if it is taken after meals. Although it is
best to take it on an empty stomach, it can also be taken after eating.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.
It is not known whether MAXALT can cause harm to the unborn baby when taken by a
pregnant woman.
Breastfeeding should be avoided for 24 hours after taking the medicine.

Children and adolescents
The use of MAXALT oral lyophilisate in children under 18 years of age is not recommended.

Use in patients over 65 years of age
No complete studies have been conducted to verify the safety and efficacy of MAXALT in
patients over 65 years of age.

Driving and using machines
You may feel drowsy or dizzy when taking MAXALT. If this happens, do not drive or operate
machinery.

MAXALT containsaspartame
This medicine contains 1.88 mg of aspartame per 5 mg of oral lyophilisate equivalent to
1.1 mg of phenylalanine. This medicine contains 3.75 mg of aspartame per 10 mg of
oral lyophilisate equivalent to 2.1 mg of phenylalanine.
Aspartame is a source of phenylalanine. It may be harmful to you if you have phenylketonuria, a rare
genetic disease that causes a build-up of phenylalanine because the body cannot eliminate it
correctly.

3. How to take MAXALT

MAXALT is used for the treatment of migraine attacks. Take MAXALT as soon as possible after the start of a migraine headache. Do not use it to prevent attacks.
Take this medicine following exactly the instructions of your doctor. If you have doubts, consult your doctor or pharmacist.
The usual dose is 10 mg.
If you are taking propranolol or have kidney or liver problems, you should use the 5 mg dosage of MAXALT. You must wait at least 2 hours after taking propranolol before taking MAXALT, up to a maximum of 2 doses within 24 hours.

If the migraine returns within 24 hours
In some patients, migraine symptoms may return within 24 hours. If the migraine returns, you can take an additional dose of MAXALT. You must wait at least 2 hours between the two doses.

If you still have a migraine after 2 hours
If you do not respond to the first dose of MAXALT during the attack, you should not take a second dose of MAXALT to treat the same attack. However, it is still likely that you will respond to MAXALT during the next attack.

Do not take more than 2 doses of MAXALT within 24 hours (for example, do not take more than two 10 mg or 5 mg oral lyophilisates within 24 hours). You must always wait at least 2 hours between the two doses.
If symptoms worsen, seek medical assistance.

How to administer MAXALT oral lyophilisate

• MAXALT (rizatriptan benzoate) is available in the form of an oral lyophilisate of 5 or 10 mg that dissolves in the mouth.
• Open the blister pack containing the MAXALT oral lyophilisate with dry hands.
• The oral lyophilisate should be placed on the tongue, where it dissolves and can be swallowed with saliva.
• The oral lyophilisate can be used in circumstances where liquids are not available, or to avoid nausea and vomiting that may accompany the ingestion of tablets with liquids.

MAXALT is also available in tablets to be taken with liquids.

If you take more MAXALT than you should:
If you take more MAXALT than you should, inform your doctor or pharmacist immediately. Bring the medicine package with you.
Signs of overdose include dizziness, drowsiness, vomiting, fainting, and slowed heart rate.
If you have further questions about the use of this medicine, 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 occur with this medicine.
In studies in adult subjects, the most commonly reported side effects were dizziness,
drowsiness and fatigue.

Common (may affect up to 1 in 10 people)

• tingling (paresthesia), headache, decreased skin sensitivity (hypoesthesia), decreased mental acuity, insomnia
• fast or irregular heartbeat (palpitations)
• hot flushes (temporary facial redness)
• throat discomfort
• feeling unwell (nausea), dry mouth, vomiting, diarrhea, indigestion (dyspepsia)
• feeling of heaviness in some parts of the body, neck pain, stiffness
• pain in the abdomen or chest.

Uncommon (may affect up to 1 in 1,000 people)

• bad taste in mouth
• loss of coordination of movements when walking (ataxia), dizziness (vertigo), blurred vision, tremor, fainting (syncope)
• confusion, nervousness
• high blood pressure (hypertension), thirst, hot flashes, sweating
• skin rash; itching and redness with welts (urticaria), swelling of the face, lips, tongue and/or throat that can cause difficulty breathing and/or swallowing (angioedema), difficulty breathing (dyspnea)
• feeling of tightness in some parts of the body, muscle weakness
• changes in the rhythm or rate of the heartbeat (arrhythmia); abnormalities in the electrocardiogram (a test that records the electrical activity of the heart), very fast heartbeat (tachycardia)
• facial pain, muscle pain. Rare (may affect up to 1 in 10,000 people)
• wheezing
• allergic reaction (hypersensitivity); sudden, potentially 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 habit, use of nicotine substitutes, family history of heart disease or stroke, men over 40, postmenopausal women, specific heart rhythm problems (bundle branch block))
• slow heartbeat (bradycardia).

Not known (frequency cannot be estimated from available data)

• heart attack, spasm of the heart's blood vessels (this generally occurs in patients with risk factors for heart and blood vessel disease (high blood pressure, diabetes, smoking habit, use of nicotine substitutes, family history of heart disease or stroke, men over 40, postmenopausal women, specific heart rhythm problems (bundle branch block))
• a syndrome called “serotonin syndrome” which can cause side effects such as coma, unstable blood pressure, extremely high body temperature, lack of muscle coordination, agitation and hallucinations
• severe skin detachment with or without fever (toxic epidermal necrolysis)
• seizures/convulsions
• spasm of the blood vessels in the extremities including sensations of coldness and decreased tactile sensitivity of the hands or feet
• spasm of the blood vessels of the colon (large intestine), which can cause abdominal pain.

Immediately inform your doctor if you experience symptoms of allergic reactions, serotonin
syndrome, heart attack or stroke.
Also report to your doctor if you experience symptoms suggesting an allergic reaction (such as
skin redness or itching) after taking MAXALT.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through
the national reporting system at the address: www.agenziafarmaco.gov.it/content/come-segnalare-
una-sospetta-reazione-avversa .
By reporting side effects you can help provide more information on the safety
of this medicine.

5. How to store MAXALT

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated
on the carton/container/sachet/blister after “EXP”. The expiry date refers to the last
day of that month.

Do not store MAXALT lyophilized oral at a temperature above 30°C.
Store in the original packaging to protect the medicine from moisture.
Do not remove the blister with the oral lyophilisate from the outer aluminum sachet until you are
ready to take the medicine contained inside. Do not use the medicine if you notice that the aluminum
sachet is damaged.
Always store the aluminum sachets in the container.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What MAXALT contains
MAXALT 5 mg oral lyophilisate
The active ingredient of MAXALT is rizatriptan. One oral lyophilisate contains 5 mg of rizatriptan as
7.265 mg of rizatriptan benzoate.

MAXALT 10 mg oral lyophilisate
The active ingredient of MAXALT is rizatriptan. One oral lyophilisate contains 10 mg of rizatriptan as
14.53 mg of rizatriptan benzoate.
The other ingredients of MAXALT oral lyophilisate are: gelatin, mannitol (E421), glycine,
aspartame (E951), peppermint flavour (mixture of peppermint oil, maltodextrin and
dextrin).

Description of the appearance of MAXALT and package contents
MAXALT 5 mg oral lyophilisate
The 5 mg oral lyophilisates are white to off-white in colour, round in shape, with a modified triangle
on one side, and peppermint flavoured.

MAXALT 10 mg oral lyophilisate
The 10 mg oral lyophilisates are white to off-white in colour, round in shape, with a modified square
on one side, and peppermint flavoured.
Pack sizes: packs of 2, 3, 6, 12 or 18 oral lyophilisates.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Organon Italia S.r.l.
Piazza Carlo Magno, 21
00162 Rome

Manufacturer
MERCK SHARP & DOHME B.V.
Waarderweg 39
2031 BN Haarlem
Netherlands

This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations:
Maxalt 5 mg Oral Lyophilisate
Austria, Finland, Sweden MAXALT RAPITAB
Belgium, Luxembourg MAXALT LYO 5 mg
Denmark MAXALT Smelt, smeltetabletter
Germany MAXALT lingua 5 mg Schmelztabletten
Greece MAXALT Rapid Sol. Tab.
Ireland Rizatriptan MSD 5 mg oral lyophilisates
Iceland MAXALT SMELT 5 mg frostþurrkaðar töflur
Italy MAXALT RPD 5 mg liofilizzato orale
Norway Maxalt Rapitab
Netherlands MAXALT SMELT
Poland MAXALT RPD
Romania Maxalt 5 mg liofilizat oral

Maxalt 10 mg Oral Lyophilisate
Austria, Finland, Sweden MAXALT RAPITAB
Belgium, Luxembourg MAXALT LYO 10 mg
Denmark MAXALT Smelt, smeltetabletter
France MAXALTLYO
Germany MAXALT lingua 10 mg Schmelztabletten
Greece MAXALT Rapid Sol. Tab.
Ireland Rizatriptan MSD 10 mg oral lyophilisates
Iceland MAXALT SMELT 10 mg frostþurrkaðar töflur
Italy MAXALT RPD 10 mg liofilizzato orale
Lithuania MAXALT 10 mg geriamieji liofilizatai
Norway Maxalt Rapitab
Netherlands MAXALT SMELT
Poland MAXALT RPD
United Kingdom MAXALT MELT
Romania Maxalt 10 mg liofilizat oral
Spain MAXALT MAX 10 mg