RIZALIV 5 mg Coated Tablet

Зміст інструкції

1. RIZALIV 5 mg tablets, 10 mg tablets
   1. What is RIZALIV and what is it used for
   2. What you need to know before taking RIZALIV
   3. How to take RIZALIV
   4. Possible side effects
   5. How to store RIZALIV
   6. Contents of the pack and other information
2. RIZALIV RPD 5 mg oral lyophilisate
   1. What is RIZALIV and what is it used for
   2. What you need to know before taking RIZALIV
   3. How to take RIZALIV
   4. Possible side effects
   5. How to store RIZALIV
   6. Contents of the pack and other information

RIZALIV 5 mg tablets, 10 mg tablets

rizatriptan
Read this leaflet carefully before you start taking this medicine as 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 RIZALIV is and what it is used for
• 2. What you need to know before you take RIZALIV
• 3. How to take RIZALIV
• 4. Possible side effects
• 5. How to store RIZALIV
• 6. Contents of the pack and other information

1. What is RIZALIV and what is it used for

RIZALIV contains the active substance rizatriptan which belongs to a class of medicines
called selective serotonin 5-HT receptor agonists and which works by activating these
receptors.
Rizaliv is indicated in adults for the treatment of the headache phase that develops
during a migraine attack.
Therapy with Rizaliv reduces the dilation of blood vessels located around the
brain. This dilation causes the headache phase during a migraine attack.

2. What you need to know before taking RIZALIV

Do not take RIZALIV if:

• you are allergic to the active ingredient rizatriptan benzoate or to 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 problems with your liver or kidneys
• 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 medicines for the treatment of depression such as monoamine oxidase inhibitors (MAOIs) like moclobemide, phenelzine, tranylcypromine, or pargyline, or an antibiotic with an active ingredient called linezolid, or if less than two weeks have passed since you stopped taking MAOIs (see “ Othermedicines and RIZALIV”).
• you are taking medicines for the treatment of migraine such as ergotamine-like drugs like ergotamine or dihydroergotamine, or medicines for the prevention of migraine attacks such as methysergide (see “ Other medicines and RIZALIV”).
• if you are taking other medicines for the treatment of migraine of the same class as sumatriptan, naratriptan, or zolmitriptan (see Other medicines and RIZALIV).

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

Warnings and precautions
Talk to your doctor or pharmacist before taking RIZALIV 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 products, if there is a family history of heart disease, if you are a man over 40 years of age, or if you are a postmenopausal woman
• you suffer from problems with your kidneys or liver
• you have a particular problem with your heartbeat (bundle branch block)
• 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 or have 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 medicines for depression such as selective serotonin reuptake inhibitors (SSRIs) like sertraline, escitalopram oxalate and fluoxetine or serotonin-norepinephrine reuptake inhibitors (SNRIs), such as venlafaxine and duloxetine
• you have had short-lived symptoms including chest pain and a feeling of tightness in the chest
• you are taking medicines based on buprenorphine. The use of these medicines together with RIZALIV may lead to serotonin syndrome, a condition that can be fatal (see “Other medicines and RIZALIV”).

Taking RIZALIV too often can cause chronic headache. In this case contact your doctor because it may be necessary to stop treatment with RIZALIV.
Report your symptoms to your doctor or pharmacist. The doctor will assess whether you suffer from migraine.
You should only take RIZALIV for migraine attacks. RIZALIV should not be used for the treatment of headache that may be caused by other more serious illnesses.

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

Other medicines and RIZALIV
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those without a prescription, including herbal preparations and medicines you normally take for migraine. This is important because RIZALIV can change the way some medicines work and, at the same time, other medicines can have effects on RIZALIV.
Do not take RIZALIV if:

• you are already taking a 5-HT receptor agonist (sometimes called 'triptans') such as sumatriptan, naratriptan or zolmitriptan.
• you are taking medicines for the treatment of depression, namely monoamine oxidase inhibitors (MAOIs) such as moclobemide, phenelzine, tranylcypromine, linezolid or pargyline, or if you have stopped taking an MAOI less than two weeks ago.
• you are using medicines for the treatment of migraine, namely ergotamine-like drugs such as ergotamine or dihydroergotamine.
• you are using medicines to prevent migraine attacks such as methysergide.

The medicines listed above may increase the risk of side effects if taken with RIZALIV.
You must wait at least 6 hours after taking RIZALIV before taking ergotamine-like medicines such as ergotamine or dihydroergotamine or methysergide.
You must wait at least 24 hours after taking ergotamine-like medicines before taking RIZALIV.
Ask your doctor for instructions and risks related to taking RIZALIV if:

• you are taking medicines based on propranolol (see “ How to take RIZALIV”)
• you are taking medicines for depression such as SSRIs like sertraline, escitalopram oxalate and fluoxetine or SNRIs like venlafaxine and duloxetine
• you are taking medicines based on buprenorphine. These medicines may interact with RIZALIV and symptoms such as involuntary and rhythmic muscle contractions, including the muscles that control eye movement, agitation, hallucinations, coma, excessive sweating, tremor, increased muscle contraction, fever above 38 °C may occur. Contact your doctor if you experience such symptoms.

RIZALIV with food and drink
If RIZALIV is taken after meals, it may take longer to work.
Although it is preferable to take the tablet 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, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
It is not known whether RIZALIV can cause harm to the unborn baby when taken by a pregnant woman.
Avoid breastfeeding for 24 hours after taking the medicine.

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

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

RIZALIV contains lactose monohydrate
RIZALIV 5 mg tablets
The 5 mg tablet contains 30.25 mg of lactose monohydrate. If your doctor has diagnosed you with intolerance to certain sugars, contact him before taking this medicine.

RIZALIV 10 mg tablets
The 10 mg tablet contains 60.50 mg of lactose monohydrate. If your doctor has diagnosed you with intolerance to certain sugars, contact him before taking this medicine.

3. How to take RIZALIV

RIZALIV is used for the treatment of migraine attacks. Take RIZALIV as soon as
possible after the start of the migraine headache. Do not use it to prevent attacks.
Take this medicine following exactly the instructions of your doctor. If you have
any doubts, consult your doctor or pharmacist.
The recommended dose is 10 mg.
If you are taking propranolol or have kidney or liver problems, you should use the 5
mg dosage of RIZALIV. You must allow at least 2 hours to pass after taking propranolol before
taking RIZALIV, up to a maximum of 2 doses within 24 hours.
RIZALIV tablet must be taken orally and swallowed whole with a liquid.
RIZALIV is also available in the form of an oral lyophilisate of 5 or 10 mg which dissolves in the mouth.
The oral lyophilisate can be used in circumstances where liquids are not available to
take the tablet, or to avoid nausea and vomiting that may accompany
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 RIZALIV. 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 RIZALIV during the attack, you should not take a
second dose of RIZALIV to treat the same attack. It is still likely, however, that you
will respond to RIZALIV during the next attack.

Do not take more than 2 doses of RIZALIV within 24 hours (for example, do not take more than
two tablets or oral lyophilisates of 10 mg or 5 mg within 24 hours). You must always wait
at least 2 hours between the two doses.
Contact your doctor if your symptoms worsen during treatment with Rizaliv.

If you take more RIZALIV than you should
If you take more RIZALIV than you should, inform your doctor or pharmacist immediately. Bring the
package of the medicine with you.
Signs of overdose include dizziness, drowsiness, vomiting, fainting and slowing
of the heartbeat.

If you forget to take Rizaliv
Do not take a double dose to make up for a missed tablet.
If you have any doubts 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)
• brief flushing of the face (hot flashes)
• discomfort in the throat
• 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 100 people)

• unpleasant taste in the 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 wheals (urticaria), swelling of the face, lips, tongue and/or throat which 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 the heartbeat (arrhythmia), abnormalities in the electrocardiogram (an examination that records the electrical activity of the heart), accelerated heartbeat (tachycardia)
• facial pain, muscle pain.

Rare (may affect up to 1 in 1000 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)))
• slowed heartbeat (bradycardia).

Not known (frequency cannot be estimated on the basis of 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 years of age, postmenopausal women, specific heart rhythm problems (bundle branch block)))
• a syndrome called "serotonin syndrome" which can cause side effects such as coma, blood pressure instability, extremely high body temperature, lack of muscle coordination, agitation and hallucinations
• severe skin detachment with or without fever (toxic epidermal necrolysis)
• seizures/epileptic fits
• spasm of the blood vessels of 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 RIZALIV.

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:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the
safety of this medicine.

5. How to store RIZALIV

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 RIZALIV at a temperature above 30°C.
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. Contents of the pack and other information

What RIZALIV contains
RIZALIV 5 mg tablets
The active ingredient is rizatriptan. One tablet contains 7.265 mg of rizatriptan benzoate
equivalent to 5 mg of rizatriptan.

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

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

RIZALIV 10 mg tablets
The 10 mg tablets are pale pink, capsule-shaped and 267 inscribed on one
side.
Packs of 3, 6 or 12 tablets are available.
Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer
Marketing authorisation holder
NEOPHARMED GENTILI S.p.A.
Via San Giuseppe Cottolengo 15,
20143 Milan

Manufacturer
MERCK SHARP & DOHME B.V.
Waarderweg 39
20031 BN Haarlem
Netherlands

RIZALIV RPD 5 mg oral lyophilisate

RIZALIV RPD 10 mg oral lyophilisate
rizatriptan

Read this leaflet carefully before you start taking this medicine as 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 RIZALIV is and what it is used for
• 2. What you need to know before you take RIZALIV
• 3. How to take RIZALIV
• 4. Possible side effects
• 5. How to store RIZALIV
• 6. Contents of the pack and other information

1. What is RIZALIV and what is it used for

RIZALIV contains the active substance rizatriptan which belongs to a class of medicines
called selective serotonin 5-HT receptor agonists and which works by activating these
receptors.
Rizaliv is indicated in adults for the treatment of the headache phase that develops
during a migraine attack.
Therapy with Rizaliv reduces the dilation of blood vessels located around the
brain. This dilation causes the headache phase during a migraine attack.

2. What you need to know before taking RIZALIV

Do not take RIZALIV if:

• you are allergic to the active ingredient rizatriptan benzoate or to 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 problems with the liver or kidneys
• 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 medicines for the treatment of depression such as monoamine oxidase inhibitors (MAOIs) like moclobemide, phenelzine, tranylcypromine, or pargyline, or an antibiotic with an active ingredient called linezolid, or if less than two weeks have passed since you stopped taking MAOIs (see “Other medicines and Rizaliv”)
• you are taking medicines for the treatment of migraine such as ergotamine-like medicines, like ergotamine or dihydroergotamine or medicines for the prevention of migraine attacks such as methysergide (see “Other medicines and Rizaliv”)
• you are taking other medicines for the treatment of migraine of the same class as sumatriptan, naratriptan or zolmitriptan (see “Other medicines and RIZALIV”).

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

Warnings and precautions
Talk to your doctor or pharmacist before taking RIZALIV 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 products, if there are cases of heart disease in your family, if you are a man over 40 years of age, or if you are a postmenopausal woman
• you suffer from problems with the kidneys or liver
• you have a particular problem concerning your heartbeat (bundle branch block)
• 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 or have 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 medicines for depression such as selective serotonin reuptake inhibitors (SSRIs) like sertraline, escitalopram oxalate and fluoxetine or serotonin-norepinephrine reuptake inhibitors (SNRIs), such as venlafaxine and duloxetine
• you have had symptoms of short duration including chest pain and a feeling of tightness in the chest
• you are taking medicines based on buprenorphine. The use of these medicines together with RIZALIV may lead to serotonin syndrome, a condition that can be life-threatening (see “Other medicines and RIZALIV”).

Taking RIZALIV too often can cause chronic headache. In this case contact your doctor because it may be necessary to stop treatment with RIZALIV.
Report your symptoms to your doctor or pharmacist. The doctor will assess whether you suffer from migraine.
You should only take RIZALIV for migraine attacks. RIZALIV should not be used for the treatment of headache that may be caused by other more serious illnesses.

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

Other medicines and RIZALIV
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those without a prescription, including herbal preparations and medicines that you normally take for migraine. This is important because RIZALIV can change the way some medicines work and, at the same time, other medicines can have effects on RIZALIV.
Do not take RIZALIV if:

• you are already taking a 5-HT receptor agonist (sometimes called “triptans”) such as sumatriptan, naratriptan or zolmitriptan
• you are taking medicines for the treatment of depression i.e. monoamine oxidase inhibitors (MAOIs) such as moclobemide, phenelzine, tranylcypromine, linezolid or pargyline, or if you have stopped taking an MAOI less than two weeks ago
• you are using medicines for the treatment of migraine i.e. ergotamine-like medicines such as ergotamine or dihydroergotamine
• you are using medicines to prevent migraine attacks such as methysergide.

The medicines listed above may increase the risk of side effects if taken with RIZALIV.
You must wait at least 6 hours after taking RIZALIV before taking ergotamine-like medicines such as ergotamine or dihydroergotamine or methysergide.
You must wait at least 24 hours after taking ergotamine-like medicines before taking RIZALIV.
Ask your doctor for instructions and risks related to taking RIZALIV if:

• you are taking medicines based on propranolol (see “How to take RIZALIV”)
• you are taking medicines for depression such as SSRIs like sertraline, escitalopram oxalate and fluoxetine or SNRIs like venlafaxine and duloxetine
• you are taking medicines based on buprenorphine. These medicines may interact with RIZALIV and symptoms such as involuntary and rhythmic muscle contractions, including the muscles that control eye movement, agitation, hallucinations, coma, excessive sweating, tremor, increased muscle contraction, fever above 38 °C may occur. Contact your doctor if you experience such symptoms.

RIZALIV with food and drink
If RIZALIV is taken after meals, it may take longer to work.
Although it is preferable to take the tablet on an empty stomach, it can also be taken after eating.

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

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

Driving and using machines
You may feel drowsy or dizzy when taking RIZALIV. If this happens, do not drive vehicles or use machines.

RIZALIV contains aspartame
Rizaliv 5 mg oral lyophilisate
This medicine contains 1.88 mg of aspartame per 5 mg of oral lyophilisate
equivalent to 1.1 mg of phenylalanine.
Rizaliv 10 mg oral lyophilisate
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 if you have phenylketonuria, a rare genetic disorder that causes phenylalanine to build up because the body cannot break it down properly.

3. How to take RIZALIV

RIZALIV is used for the treatment of migraine attacks. Take RIZALIV as soon as
possible after the start of the 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 recommended dose is 10 mg.
If you are taking propranolol or have kidney or liver problems, you should use the 5
mg dosage of RIZALIV. You must allow at least 2 hours to pass after taking propranolol before
taking RIZALIV, up to a maximum of 2 doses within 24 hours.

How to take RIZALIV oral lyophilisate

• RIZALIV is available in the form of an oral lyophilisate of 5 or 10 mg that dissolves in the mouth.
• Open the blister pack with the RIZALIV oral lyophilisate with dry hands.
• The oral lyophilisate should be placed on the tongue, where it dissolves and can be swallowed with saliva.

Rizaliv is also available in tablets, to be taken with liquids.
The oral lyophilisate can be used in circumstances where liquids are not available to
take the tablet, or to avoid nausea and vomiting that may accompany
ingestion of tablets with liquids.

If the migraine returns within 24 hours
In some patients, the symptoms of migraine may return within 24 hours. If the migraine
returns, you can take an additional dose of RIZALIV. 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 RIZALIV during the attack, you should not take a
second dose of RIZALIV to treat the same attack. It is still likely, however, that you
will respond to RIZALIV during the next attack.

Do not take more than 2 doses of RIZALIV within 24 hours (for example, do not take more than
two 10 mg or 5 mg tablets or oral lyophilisates within 24 hours). You must always wait
at least 2 hours between the two doses.
Contact your doctor if your symptoms worsen during treatment with Rizaliv.

• If you take more RIZALIV than you shouldIf you take more RIZALIV than you should, inform your doctor or pharmacist immediately. Bring the packaging of the medicine with you.

Signs of overdose include dizziness, drowsiness, vomiting, fainting and slowing
of the heartbeat.

If you forget to take Rizaliv
Do not take a double dose to make up for a missed dose.
If you have any doubts about the use of this medicine, consult 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)
• brief flushing of the face (hot flushes)
• discomfort in the throat
• 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 100 people)

• unpleasant taste in the mouth
• loss of coordination of movements when walking (ataxia), dizziness (vertigo), blurred vision, tremor, fainting (syncope)
• confusion, nervousness
• high blood pressure (hypertension), thirst, hot flushes, sweating
• skin rash, itching and redness with wheals (urticaria), swelling of the face, lips, tongue and/or throat which 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 frequency of the heartbeat (arrhythmia), abnormalities in the electrocardiogram (a test that records the electrical activity of the heart), accelerated heartbeat (tachycardia)
• facial pain, muscle pain.

Rare (may affect up to 1 in 1,000 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)))
• slowed heartbeat (bradycardia).

Not known (frequency cannot be estimated on the basis of 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, blood pressure instability, extremely high body temperature, lack of muscle coordination, agitation and hallucinations
• severe skin detachment with or without fever (toxic epidermal necrolysis)
• seizures/fits
• spasm of the blood vessels of the extremities including sensations of cold 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 that suggest an allergic reaction
such as skin redness or itching after taking RIZALIV.

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:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the
safety of this medicine.

5. How to store RIZALIV

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 package/container/sachet/blister after “EXP”. The expiry date refers to
the last day of that month.

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

6. Contents of the pack and other information

What RIZALIV contains
RIZALIV 5 mg oral lyophilisate
The active ingredient is rizatriptan. One oral lyophilisate contains 7.265 mg of rizatriptan
benzoate equivalent to 5 mg of rizatriptan.

RIZALIV 10 mg oral lyophilisate
The active ingredient is rizatriptan. One oral lyophilisate contains 14.53 mg of rizatriptan
benzoate equivalent to 10 mg of rizatriptan.
The other ingredients are: gelatin, mannitol (E421), glycine, aspartame (E951), peppermint
flavor (compound of peppermint oil, maltodextrin and dextrose).

Description of the appearance of RIZALIV and contents of the pack
RIZALIV 5 mg oral lyophilisate
The 5 mg oral lyophilisates are white to off-white in color, round in shape, with a
modified triangle on one side, and peppermint flavored.

RIZALIV 10 mg oral lyophilisate
The 10 mg oral lyophilisates are white to off-white in color, round in shape, with a
modified square on one side, and peppermint flavored.
Packs of 3, 6 or 12 oral lyophilisates are available.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
NEOPHARMED GENTILI S.p.A.
Via San Giuseppe Cottolengo, 15
20143 Milano

Manufacturer
NEOPHARMED GENTILI S.p.A.
Via San Giuseppe Cottolengo, 15
20143 Milano