Rizaliv

Patient Information Leaflet: Information for the User

RIZALIV 5 mg tablets, 10 mg tablets

rizatriptan
Please 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 any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including 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 taking 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 RIZALIV is and what it is used for

RIZALIV contains the active substance rizatriptan, which belongs to a class of medicines known as selective serotonin 5-HT receptor agonists, acting by stimulating these receptors.
RIZALIV is indicated in adults for the treatment of the headache phase associated with migraine attacks.
RIZALIV therapy reduces the dilation of blood vessels surrounding the brain. This dilation is responsible for the headache phase during a migraine attack.

2. What you should know before taking RIZALIV

Do not take RIZALIV if:

• you are allergic to the active substance rizatriptan benzoate or to 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 treatment
• you have or have had heart problems, including heart attack or chest pain (angina), or you have shown signs of heart disease
• you have severe liver or kidney problems
• you have had a stroke (cerebrovascular accident, CVA) or a mini-stroke (transient ischaemic attack, TIA)
• you have arterial occlusion problems (peripheral vascular disease)
• you are taking medicines for depression such as monoamine oxidase inhibitors (MAOIs), such as moclobemide, phenelzine, tranylcypromine, or pargyline, or an antibiotic containing the active substance linezolid, or if less than two weeks have passed since you stopped taking MAOIs (see "Other medicines and RIZALIV").
• you are currently taking medicines for migraine treatment such as ergotamine-like substances like ergotamine or dihydroergotamine, or medicines for the prevention of migraine attacks such as methysergide (see "Other medicines and RIZALIV").
• you are taking other migraine medicines from the same class, such 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 use nicotine replacement therapies, 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 have kidney or liver problems
• you have a specific heart rhythm problem (bundle branch block)
• your headache is associated with dizziness, difficulty walking, lack of coordination, or weakness in the arms or legs
• you are using herbal remedies containing St. John’s wort
• you have had or currently have allergic reactions such as swelling of the face, lips, tongue, and/or throat, which may cause difficulty breathing and/or swallowing (angioedema)
• you are taking medicines for depression such as selective serotonin reuptake inhibitors (SSRIs), such as sertraline, escitalopram oxalate, and fluoxetine, or serotonin-noradrenaline reuptake inhibitors (SNRIs), such as venlafaxine and duloxetine
• you have experienced brief episodes of symptoms including chest pain and chest tightness
• you are taking medicines containing buprenorphine. Taking these medicines together with RIZALIV may lead to serotonin syndrome, a condition that can be fatal (see “Other medicines and RIZALIV”).

Taking RIZALIV too frequently may cause chronic headache. In this case, contact your doctor, as it may be necessary to discontinue treatment with RIZALIV.
Inform your doctor or pharmacist about your symptoms. Your doctor will assess whether you are suffering from migraine.
You should take RIZALIV only for migraine attacks. RIZALIV must not be used to treat headaches that could be caused by more serious underlying conditions.

Children and adolescents

The use of RIZALIV tablets 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 over-the-counter medicines, herbal preparations, and medicines you usually take for migraine. This is important because RIZALIV may alter the effects of some medicines, and conversely, other medicines may affect 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 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 migraine treatment, namely ergotamine-like substances such as ergotamine or dihydroergotamine
• you are using medicines to prevent migraine attacks, such as methysergide

The above-mentioned medicines may increase the risk of adverse effects when 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 advice and information about the risks associated with taking RIZALIV if:

• you are taking medicines containing 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 duloxetina
• you are taking medicines containing buprenorphine. These medicines may interact with RIZALIV and may cause symptoms such as involuntary and rhythmic muscle contractions, including muscles controlling eye movements, agitation, hallucinations, coma, excessive sweating, tremor, exaggerated reflexes, increased muscle contraction, fever above 38°C. Contact your doctor if you experience any of these symptoms.

RIZALIV with food and drink

If RIZALIV is taken after meals, it may take longer to take effect.
Although it is preferable to take the tablet on an empty stomach, it may also be taken after eating.

Pregnancy and breastfeeding

If you are pregnant, suspect you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
It is not known whether RIZALIV can harm the unborn child when taken during pregnancy.
Avoid breastfeeding for 24 hours after taking the medicine.

Use in patients over 65 years of age

Complete studies to verify the safety and efficacy of RIZALIV in patients over 65 years of age have not been conducted.

Driving and using machines

You may experience drowsiness or dizziness when taking RIZALIV. If this occurs, do not drive or operate 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 an intolerance to certain sugars, contact them 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 an intolerance to certain sugars, contact them before taking this medicine.

3. How to take RIZALIV

RIZALIV is used to treat migraine attacks. Take RIZALIV as early as possible once the migraine headache starts. Do not use it to prevent attacks.
Take this medicine exactly as your doctor has told you. If you are not sure, consult your doctor or pharmacist.
The recommended dose is 10 mg.
If you are taking propranolol or have kidney or liver problems, you must use the 5 mg dose of RIZALIV. You must wait at least 2 hours after taking propranolol before taking RIZALIV, and take no more than 2 doses within 24 hours.
RIZALIV tablets should be taken by mouth and swallowed whole with a liquid.
RIZALIV is also available as an oral lyophilisate of 5 or 10 mg, which dissolves in the mouth.
The oral lyophilisate may be used in circumstances where liquids are not available to swallow a tablet, or to avoid nausea and vomiting that may accompany the ingestion of tablets with liquids.
If migraine returns within 24 hours
In some patients, migraine symptoms may return within 24 hours. If the migraine returns, you may take an additional dose of RIZALIV. You must wait at least 2 hours between doses.
If you still have migraine after 2 hours
If you do not respond to the first dose of RIZALIV during an attack, do not take a second dose of RIZALIV to treat the same attack. However, you may still 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 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. Take the medicine pack with you.
Signs of overdose include dizziness, drowsiness, vomiting, fainting, and slowed heart rate.
If you forget to take RIZALIV
Do not take a double dose to make up for the forgotten tablet.
If you have any doubts about how to use 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 sensations (paraesthesia), headache, reduced skin sensitivity (hypoesthesia), reduced mental sharpness, insomnia
• fast or irregular heartbeat (palpitations)
• short-lived facial redness (flushing)
• sore throat
• feeling unwell (nausea), dry mouth, vomiting, diarrhoea, indigestion (dyspepsia)
• sensation of heaviness in parts of the body, neck pain, stiffness
• abdominal or chest pain.

Uncommon (may affect up to 1 in 100 people)

• unpleasant taste in the mouth
• loss of coordination 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 may cause difficulty breathing and/or swallowing (angioedema), difficulty breathing (dyspnoea)
• sensation of pressure in parts of the body, muscle weakness
• changes in heart rate or rhythm (arrhythmia), abnormalities in electrocardiogram (an examination that records the electrical activity of the heart), increased heart rate (tachycardia)
• facial pain, muscle pain.

Rare (may affect up to 1 in 1,000 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 diseases (high blood pressure, diabetes, smoking, use of nicotine replacement therapy, family history of heart disease or stroke, men over 40 years of age, postmenopausal women, specific heart rhythm problems (bundle branch block)))
• slow heartbeat (bradycardia).

Not known (frequency cannot be estimated from the available data)

• heart attack, spasm of blood vessels in the heart (this generally occurs in patients with risk factors for heart and blood vessel diseases (high blood pressure, diabetes, smoking, use of nicotine replacement therapy, family history of heart disease or stroke, men over 40 years of age, postmenopausal women, specific heart rhythm problems (bundle branch block)))
• a condition called "serotonin syndrome" which may cause side effects such as coma, unstable blood pressure, extremely high body temperature, lack of muscle coordination, agitation, and hallucinations
• severe peeling of the skin with or without fever (toxic epidermal necrolysis)
• seizures/epileptic fits
• spasm of blood vessels in the extremities including cold sensations and reduced tactile sensitivity in the hands or feet
• spasm of blood vessels in the colon (large intestine), which may cause abdominal pain.

Contact your doctor immediately if you experience symptoms of allergic reactions,
serotonin syndrome, heart attack, or stroke.
Also inform 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, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via 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 stated on the carton/blister after "EXP". The expiry date refers to the last day of that month.
Do not store RIZALIV above 30°C.
Do not dispose of medicines via 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 RIZALIV contains
RIZALIV 5 mg tablets
The active substance is rizatriptan. One tablet contains 7.265 mg of rizatriptan benzoate,
equivalent to 5 mg of rizatriptan.
RIZALIV 10 mg tablets
The active substance is rizatriptan. One tablet contains 14.53 mg of rizatriptan benzoate,
equivalent to 10 mg of rizatriptan.
The other components are: monohydrate lactose, microcrystalline cellulose (E460a), pregelatinized starch, red iron oxide (E172) and magnesium stearate (E572).

Description of the appearance of RIZALIV and the contents of the pack
RIZALIV 5 mg tablets
The 5 mg tablets are pale pink, capsule-shaped, with "MSD" engraved on one side and "266" on the other.
RIZALIV 10 mg tablets
The 10 mg tablets are pale pink, capsule-shaped, with "267" engraved on one side.
Packs containing 3, 6 or 12 tablets are available.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
NEOPHARMED GENTILI S.p.A.
Via San Giuseppe Cottolengo 15,
20143 Milan, Italy

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

Package leaflet: Information for the user

RIZALIV RPD 5 mg lyophilisate for oral use, RPD 10 mg lyophilisate for oral use

rizatriptan
Please read this entire leaflet carefully before 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 give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, consult 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 taking 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 RIZALIV is and what it is used for

RIZALIV contains the active substance rizatriptan, which belongs to a class of medicines known as selective serotonin 5-HT receptor agonists, and works by activating these receptors.
RIZALIV is indicated in adults for the treatment of the headache phase of migraine attacks.
RIZALIV therapy reduces the dilation of blood vessels 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 substance rizatriptan benzoate or to 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 treatment
• you have or have had heart problems including heart attack or chest pain (angina), or you 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 arterial blockage problems (peripheral vascular disease)
• you are taking medicines for depression called monoamine oxidase inhibitors (MAOIs), such as moclobemide, phenelzine, tranilcypramine, or selegiline, or an antibiotic containing the active substance linezolid, or if less than two weeks have passed since you stopped taking MAOIs (see “Other medicines and RIZALIV”)
• you are taking medicines for migraine such as ergotamine-like drugs, such as ergotamine or dihydroergotamine, or medicines to prevent migraine attacks such as methysergide (see “Other medicines and RIZALIV”)
• you are taking other migraine medicines of the same class, such as sumatriptan, naratriptan or zolmitriptan (see “Other medicines and RIZALIV”).

If you are unsure whether any of the above apply 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 use 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 have kidney or liver problems
• you have a specific heart rhythm problem (bundle branch block)
• your headache is associated with dizziness, difficulty walking, lack of coordination, or weakness in the arms or legs
• you are using herbal preparations containing St. John’s wort
• you have had or have allergic reactions such as swelling of the face, lips, tongue and/or throat, which may cause difficulty breathing and/or swallowing (angioedema)
• you are taking medicines for depression such as selective serotonin reuptake inhibitors (SSRIs), such as sertraline, escitalopram oxalate and fluoxetine, or serotonin-norepinephrine reuptake inhibitors (SNRIs), such as venlafaxine and duloxetine
• you have experienced brief symptoms including chest pain or chest tightness
• you are taking medicines containing buprenorphine. Using 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 may cause chronic headache. In this case, contact your doctor, as it may be necessary to stop treatment with RIZALIV.
Inform your doctor or pharmacist about your symptoms. Your doctor will assess whether you are suffering from migraine.
You should take RIZALIV only for migraine attacks. RIZALIV must not be used to treat headaches that could be caused by other, more serious conditions.

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, herbal preparations, and medicines you usually take for migraine. This is important because RIZALIV may alter the way some medicines work, and at the same time, other medicines may affect 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 depression, namely monoamine oxidase inhibitors (MAOIs), such as moclobemide, phenelzine, tranilcypramine, linezolid or selegiline, or if you have stopped taking an MAOI less than two weeks ago
• you are taking medicines for migraine treatment, namely ergotamine-like drugs such as ergotamine or dihydroergotamine
• you are taking medicines to prevent migraine attacks such as methysergide.

The above medicines may increase the risk of adverse effects when 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 advice and information about risks associated with taking RIZALIV if:

• you are taking medicines containing 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 containing buprenorphine. These medicines may interact with RIZALIV and may cause symptoms such as involuntary rhythmic muscle contractions, including muscles controlling eye movement, agitation, hallucinations, coma, excessive sweating, tremor, hyperreflexia, increased muscle tone, fever above 38°C. Contact your doctor if you experience such symptoms.

RIZALIV with food and drink

If RIZALIV is taken after meals, it may take longer to take effect.
Although it is preferable to take the tablet on an empty stomach, it may also be taken after eating.

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
It is not known whether RIZALIV may harm the unborn child when taken by a pregnant woman.
Avoid breastfeeding for 24 hours after taking the medicine.

Use in patients over 65 years of age

No complete studies have been conducted to 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 occurs, do not drive or operate machinery.

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 accumulate because the body cannot eliminate it properly.

3. How to take RIZALIV

RIZALIV is used to treat migraine attacks. Take RIZALIV as early as possible after the
onset of migraine headache. Do not use it to prevent attacks.
Take this medicine exactly as prescribed by 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 must use the 5 mg dose of
RIZALIV. You must wait at least 2 hours after taking propranolol before taking RIZALIV, and
no more than 2 doses should be taken within 24 hours.
How to take oral lyophilisate RIZALIV

• RIZALIV is available as an oral lyophilisate in doses of 5 or 10 mg, which dissolves in the mouth.
• Open the blister with dry hands to remove the RIZALIV oral lyophilisate.
• Place the oral lyophilisate on the tongue, where it will dissolve and can be swallowed with saliva.

RIZALIV is also available as tablets, to be taken with liquid.
The oral lyophilisate may be used in circumstances where liquids are not available to take
the tablet, or to avoid nausea and vomiting that may accompany swallowing tablets with
liquid.
If migraine returns within 24 hours
In some patients, migraine symptoms may return within 24 hours. If migraine returns, you may
take an additional dose of RIZALIV. You must wait at least 2 hours between doses.
If migraine persists after 2 hours
If there is no response to the first dose of RIZALIV during an attack, do not take a second
dose of RIZALIV to treat the same attack. However, you are still likely to respond to RIZALIV
during a subsequent 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). Always wait at least 2 hours
between 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. Take the medicine package with you.

Signs of overdose include dizziness, drowsiness, vomiting, fainting, and slowed heart rate.
If you forget to take RIZALIV
Do not take a double dose to make up for a forgotten dose.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

Common (may affect up to 1 in 10 people)

• tingling (paraesthesia), headache, decreased skin sensitivity (hypoesthesia), reduced mental sharpness, insomnia
• fast or irregular heartbeat (palpitations)
• short-lived facial flushing (hot flushes)
• throat irritation
• feeling unwell (nausea), dry mouth, vomiting, diarrhoea, indigestion (dyspepsia)
• sensation of heaviness in certain parts of the body, neck pain, stiffness
• abdominal or chest pain.

Uncommon (may affect up to 1 in 100 people)

• unpleasant taste in the mouth
• loss of coordination 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 may cause difficulty breathing and/or swallowing (angioedema), difficulty breathing (dyspnoea)
• sensation of pressure in certain parts of the body, muscle weakness
• changes in heart rate or rhythm (arrhythmia), abnormalities in electrocardiogram (an examination that records the electrical activity of the heart), increased heart rate (tachycardia)
• facial pain, muscle pain.

Rare (may affect up to 1 in 1,000 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 diseases (high blood pressure, diabetes, smoking, use of nicotine replacement therapy, family history of heart disease or stroke, men over 40 years, postmenopausal women, specific heart rhythm problems (bundle branch block)))
• slow heartbeat (bradycardia).

Not known (frequency cannot be estimated from the available data)

• heart attack, spasm of blood vessels in the heart (this generally occurs in patients with risk factors for heart and blood vessel diseases (high blood pressure, diabetes, smoking, use of nicotine replacement therapy, family history of heart disease or stroke, men over 40 years, postmenopausal women, specific heart rhythm problems (bundle branch block)))
• a condition known as “serotonin syndrome” which may 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/epileptic fits
• spasm of blood vessels in the extremities, including cold sensations and reduced tactile sensitivity in the hands or feet
• spasm of blood vessels in the colon (large intestine), which may cause abdominal pain.

Contact your doctor immediately if you experience symptoms of allergic reactions,
serotonin syndrome, heart attack, or stroke.
Also inform your doctor if you experience symptoms suggestive of an allergic reaction such as skin redness or itching after taking RIZALIV.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via 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 stated on the carton/container/pouch/blister after "EXP". The expiry date refers to the last day of that month.
Do not store RIZALIV above 30°C.
Store in the original packaging to protect the medicine from moisture.
Do not remove the oral lyophilisate blister from the outer aluminium pouch until you are ready to take the medicine inside. Do not use the medicine if you notice that the aluminium pouch is damaged.
Always keep the aluminium pouches in the container.
Do not dispose of any medicine via 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 RIZALIV contains
RIZALIV 5 mg oral lyophilisate
The active substance 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 substance is rizatriptan. One oral lyophilisate contains 14.53 mg of rizatriptan
benzoate, equivalent to 10 mg of rizatriptan.
The other components are: gelatin, mannitol (E421), glycine, aspartame (E951), peppermint
flavour (composed of peppermint oil, maltodextrin and dextrin).

Description of the appearance of RIZALIV and pack contents
RIZALIV 5 mg oral lyophilisate
The 5 mg oral lyophilisates are white to off-white, round in shape, with a modified triangle on one side, and have a peppermint flavour.
RIZALIV 10 mg oral lyophilisate
The 10 mg oral lyophilisates are white to off-white, round in shape, with a modified square on one side, and have a peppermint flavour.
Packs containing 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