RIZATRIPTAN 10 mg Orodispersible Tablet

Зміст інструкції

1. Rizatriptan Aurobindo 10 mg orodispersible tablets
   1. WHAT IS RIZATRIPTAN AUROBINDO AND WHAT IT IS USED FOR
   2. What you need to know before you take Rizatriptan Aurobindo
   3. How to take Rizatriptan Aurobindo
   4. Possible side effects
   5. HOW TO STORE RIZATRIPTAN AUROBINDO
   6. PACKAGE CONTENTS AND OTHER INFORMATION
2. Rizatriptan Aurobindo 5 mg orodispersible tablets
   1. WHAT IS RIZATRIPTAN AUROBINDO AND WHAT IT IS USED FOR
   2. What you need to know before you take Rizatriptan Aurobindo
   3. How to take Rizatriptan Aurobindo
   4. Possible side effects
   5. HOW TO STORE RIZATRIPTAN AUROBINDO
   6. PACKAGE CONTENTS AND OTHER INFORMATION

Rizatriptan Aurobindo 10 mg orodispersible tablets

Generic medicine

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

1. WHAT IS RIZATRIPTAN AUROBINDO AND WHAT IT IS USED FOR

Rizatriptan Aurobindo belongs to a class of medicines called selective serotonin (5HT) agonists.
Rizatriptan Aurobindo is used for the treatment of the headache phase of migraine attacks in
adults.
Treatment with Rizatriptan Aurobindo:
Reduces the swelling of blood vessels around the brain. This swelling causes the headache of a
migraine attack.

2. What you need to know before you take Rizatriptan Aurobindo

Do not take Rizatriptan Aurobindo if:

• you are allergic to rizatriptan benzoate or to any of the other ingredients of this medicine (listed in section 6)
• you have severely or moderately high blood pressure, or slightly elevated blood pressure that is not controlled by medicines
• you have or have had heart problems including heart attacks or chest pain (angina) or have experienced signs related to heart disease
• you have severe 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 blocked arteries (peripheral vascular disease)
• you are taking monoamine oxidase inhibitors (MAOIs) such as moclobemide, phenelzine, tranylcypromine or pargyline (medicines for depression) or linezolid (an antibiotic) or less than 2 weeks have passed since you stopped taking MAO inhibitors
• you are taking ergotamine-like medicines, such as ergotamine or dihydroergotamine to treat migraine or metisergide to prevent a migraine attack
• you are taking any other medicine belonging to the same class, such as sumatriptan, naratriptan or zolmitriptan to treat migraine (See Other medicines and Rizatriptan Aurobindo below)

If you are not sure if any of the above applies to you, ask your doctor or pharmacist before
taking Rizatriptan Aurobindo.

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

• you have any of the following risk factors for heart disease: high blood pressure, diabetes, if you smoke or if you use nicotine replacement therapy, if your family has a history of heart disease, if you are a man over 40 years old or if you are a post-menopausal woman
• if you have problems with your kidneys or liver
• if you have a particular problem with the way your heart beats (bundle branch block)
• if you have or have had allergies
• if your headache is associated with dizziness, difficulty walking, lack of coordination or weakness in your legs and arms
• if you are using herbal preparations containing St. John's Wort
• if you have had an allergic reaction such as swelling of the face, lips, tongue and/or throat that can cause difficulty breathing and/or swallowing (angioedema)
• if 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
• if you have had short-lived symptoms including chest pain and a tight chest.

If you take Rizatriptan Aurobindo too often this can cause the development of chronic headache. In
these cases you should contact your doctor as they may need to stop you taking Rizatriptan Aurobindo.
Tell your doctor or pharmacist about your symptoms. The doctor will decide if you have migraine. You should only take
Rizatriptan Aurobindo for a migraine attack. Rizatriptan Aurobindo should not be used for the
treatment of headaches that may be caused by other more serious conditions.
Tell your doctor if you are taking, have recently taken or plan to take any other
medicines, including those obtained without a prescription and those normally taken for migraine.
This is because Rizatriptan Aurobindo can affect the way some medicines work. Other medicines can also have effects on Rizatriptan Aurobindo.

Other medicines and Rizatriptan Aurobindo
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicine.
Do not take Rizatriptan Aurobindo:

• if you are already taking a 5HT1B/1D agonist (sometimes called “triptans”) such as sumatriptan, naratriptan or zolmitriptan
• if you are taking monoamine oxidase inhibitors (MAOIs) such as moclobemide, phenelzine, tranylcypromine, linezolid or pargyline or less than 2 weeks have passed since you stopped taking a MAO inhibitor.
• if you are using ergotamine-like medicines, such as ergotamine or dihydroergotamine to treat migraine
• if you are using metisergide to prevent a migraine attack

The medicines listed above may increase the risk of side effects when taken with
Rizatriptan Aurobindo.
You must wait at least 6 hours after taking Rizatriptan Aurobindo before taking ergotamine-like medicines such as ergotamine or dihydroergotamine or metisergide.
You must wait at least 24 hours after taking ergotamine-like medicines before taking Rizatriptan
Aurobindo.
Ask your doctor for instructions and information about the risks associated with taking Rizatriptan Aurobindo:

• if you are taking propranolol (see section 3: How to take Rizatriptan Aurobindo)
• if you are taking SSRIs such as sertraline, escitalopram oxalate and fluoxetine or SNRIs such as venlafaxine and duloxetine for depression.

Rizatriptan Aurobindo with food and drink
Rizatriptan Aurobindo may take longer to work if it is taken after a meal. It is best to
take Rizatriptan Aurobindo on an empty stomach, however you can also take it if you have eaten.

Pregnancy, breastfeeding and fertility
It is not known whether Rizatriptan Aurobindo is harmful to the fetus when taken by a pregnant woman.
Breastfeeding should be avoided for 24 hours after treatment.
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.

Children and adolescents
The use of Rizatriptan Aurobindo in children under the age of 18 years is not recommended.

Use in patients over 65 years
There are no complete studies on the safe and effective use of Rizatriptan Aurobindo in patients over 65
years of age.

Driving and using machines
While taking Rizatriptan Aurobindo you may feel drowsy or dizzy. If this happens, do not drive or
use tools or machines.

Rizatriptan Aurobindo contains Aspartame
Rizatriptan Aurobindo contains aspartame, a source of phenylalanine which may be harmful to people
with phenylketonuria.

3. How to take Rizatriptan Aurobindo

Take this medicine following the instructions of your doctor exactly. If you have any doubts, consult your
doctor or pharmacist.

Rizatriptan Aurobindo is used to treat migraine attacks. Take Rizatriptan
Aurobindo as soon as possible after the start of a migraine attack. Do not use it to prevent an
attack.
The recommended dose is 10 mg.
If you are currently taking propranolol or have kidney or liver problems, you should use the 5 mg rizatriptan
dose. You must wait at least 2 hours before taking propranolol and Rizatriptan Aurobindo, 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 your migraine returns, you can
take an additional dose of Rizatriptan Aurobindo. You must always wait at least 2 hours between doses.

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

Do not take more than 2 doses of Rizatriptan within 24 hours (for example, do not take more than 2 orodispersible tablets or tablets of 10 mg or 5 mg within 24 hours). You must always wait at least 2 hours
between doses.
If your condition worsens, seek medical advice.

How to administer Rizatriptan Aurobindo orodispersible tablets

• Rizatriptan Aurobindo orodispersible tablets dissolve in the mouth
• Open the blister pack with dry hands
• The orodispersible tablet should be placed on the tongue, where it dissolves and can be swallowed with saliva.
• The orodispersible tablet can be used in situations where liquids are not available, or to avoid nausea or vomiting that may accompany taking tablets with liquids. Rizatriptan is also available in tablets to be taken with liquids.

If you take more Rizatriptan Aurobindo than you should
If you take more Rizatriptan Aurobindo than you should, seek immediate medical attention from your doctor or pharmacist. Bring with you
the packaging of the medicine.
Signs of overdose may include dizziness, drowsiness, vomiting, fainting, and slowed heartbeat.
If you have any 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 adults, the most commonly reported side effects were dizziness, drowsiness and
fatigue.

Common (may affect up to 1 in 10 people):

• tingling (paresthesia), headache, increased skin sensitivity (hypoesthesia), reduced mental acuity, insomnia.
• fast or irregular heartbeat (palpitation).
• flushing (temporary redness of the face).
• 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):

• bad taste in the mouth
• instability when walking (ataxia), dizziness (vertigo), blurred vision, tremor, fainting (syncope).
• confusion, nervousness.
• high blood pressure (hypertension), thirst, hot flushes, sweating.
• skin rash, itching and erythema with nodules (urticaria), swelling of the face, lips, tongue and/or throat which can cause difficulty breathing and/or swelling (angioedema), difficulty breathing (dyspnea).
• feeling of stiffness in some parts of the body, muscle pain
• changes in the rhythm or rate of heartbeat (arrhythmia), abnormalities in the electrocardiogram (a test that records the electrical activity of your heart), very fast heartbeat (tachycardia)
• facial pain; muscle pain

Rare (may affect up to 1 in 1000 people):

• sudden, life-threatening allergic reaction (anaphylaxis).stroke (usually occurs in patients with risk factors for heart or blood vessel disease (high blood pressure, diabetes, smoking, use of nicotine substitutes, family history of heart disease or stroke, men over 40 and postmenopausal women, particular problems with the way your heart beats [bundle branch block]))
• slowed heartbeat (bradycardia).

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

• heart attack, spasm of the heart vessels (usually occurs in patients with risk factors for heart or blood vessel disease (high blood pressure, diabetes, smoking, use of nicotine substitutes, family history of heart disease or stroke, men over 40 and postmenopausal women, particular problems with the way your heart beats [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 deterioration of the skin with or without fever (toxic epidermal necrolysis)
• convulsions
• spasm of the blood vessels of the extremities including cold and numb hands and feet
• spasm of the blood vessels of the colon (large intestine), which can cause abdominal pain

Tell your doctor immediately if you have symptoms of allergic reactions, serotonin syndrome, heart attack
or stroke.
You should also tell your doctor if you experience any symptoms that suggest an allergic reaction (such as
skin rash or itching) after taking Rizatriptan Aurobindo.

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 www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects you can
help provide more information on the safety of this medicine.

5. HOW TO STORE RIZATRIPTAN AUROBINDO

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 blister, the carton and the label of the
bottle after EXP. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of the
medicines you no longer use. This will help protect the environment.

6. PACKAGE CONTENTS AND OTHER INFORMATION

What Rizatriptan Aurobindo contains

• The active ingredient is rizatriptan. Each orodispersible tablet contains 14.530 mg of rizatriptan benzoate equivalent to 10 mg of rizatriptan.
• The other ingredients are: Microcrystalline cellulose, pregelatinized starch, mannitol, crospovidone (Type A), aspartame (see section 2), peppermint flavour (maltodextrin, natural flavours, modified corn starch), sodium stearyl fumarate

Description of the appearance of Rizatriptan Aurobindo and package contents
Orodispersible tablets

Rizatriptan Aurobindo 10 mg orodispersible tablets
Whitish, circular, biconvex, uncoated tablets imprinted with ‘F25’ on one side and smooth
on the other side with a peppermint flavour.
Rizatriptan Aurobindo orodispersible tablets are available in blister packs in
Polyamide/Aluminium/PVC – Aluminium foil containing 2, 3, 6, 10, 12 and 18 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Aurobindo Pharma (Italia) S.r.l.
Vicolo San Giovanni sul Muro, 9
20121 Milan
Italy

Manufacturer
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far, Birzebbugia, BBG 3000, Malta
Milpharm Limited
Ares, Odyssey Business Park, West End Road, South Ruislip HA46QD, United Kingdom

This medicinal product is authorised in the Member States of the European Economic Area under the following
names:
France: RIZATRIPTAN ARROW 5 mg/10 mg, orodispersible tablets
Germany Rizatriptan Aurobindo 5 mg/10 mg Schmelztabletten
Italy Rizatriptan Aurobindo
Malta Rizatriptan 5 mg/10 mg orodispersible tablets
Netherlands Rizatriptan Aurobindo 5 mg/10 mg orodispergeerbare tabletten
Spain Rizatriptán Aurobindo 10 mg comprimidos bucodispersables
United Kingdom Rizatriptan 10 mg orodispersible tablets

Rizatriptan Aurobindo 5 mg orodispersible tablets

Generic medicine

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

1. WHAT IS RIZATRIPTAN AUROBINDO AND WHAT IT IS USED FOR

Rizatriptan Aurobindo belongs to a class of medicines called selective 5HT serotonin agonists.
Rizatriptan Aurobindo is used for the treatment of the headache phase of migraine attacks in
adults.
Treatment with Rizatriptan Aurobindo:
Reduces the swelling of blood vessels around the brain. This swelling causes the headache of a
migraine attack.

2. What you need to know before you take Rizatriptan Aurobindo

Do not take Rizatriptan Aurobindo if:

• you are allergic to rizatriptan benzoate or any of the other ingredients of this medicine (listed in section 6)
• you have severely or moderately high blood pressure, or mildly elevated blood pressure that is not controlled by medicines
• you have or have had heart problems including heart attacks or chest pain (angina) or have shown signs related to heart disease
• you have severe 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 blocked arteries (peripheral vascular disease)
• you are taking monoamine oxidase inhibitors (MAOIs) such as moclobemide, phenelzine, tranylcypromine or pargyline (medicines for depression) or linezolid (an antibiotic) or less than 2 weeks have passed since you stopped taking MAO inhibitors
• you are taking ergotamine-like medicines, such as ergotamine or dihydroergotamine to treat migraine or metisergide to prevent a migraine attack
• you are taking any other medicine belonging to the same class, such as sumatriptan, naratriptan or zolmitriptan to treat migraine (See Other medicines and Rizatriptan Aurobindo below) If you are not sure whether any of the above applies to you, talk to your doctor or pharmacist before taking Rizatriptan Aurobindo.

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

• you have any of the following risk factors for heart disease: high blood pressure, diabetes, if you smoke or if you use nicotine replacement products, if your family has a history of heart disease, if you are a man over 40 years old or if you are a post-menopausal woman
• if you have problems with your kidneys or liver
• if you have a particular problem with the way your heart beats (bundle branch block)
• if you have or have had allergies
• if your headache is associated with dizziness, difficulty walking, lack of coordination or weakness in the legs and arms
• if you are using herbal preparations containing St. John's Wort
• if you have had an allergic reaction such as swelling of the face, lips, tongue and/or throat that can cause difficulty breathing and/or swallowing (angioedema)
• if 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
• if you have had symptoms of short duration including chest pain and a stiff chest.

If you take Rizatriptan Aurobindo too often this may cause the development of chronic headache. In
these cases you should contact your doctor as you may need to stop taking Rizatriptan Aurobindo.
Tell your doctor or pharmacist about your symptoms. The doctor will decide if you have migraine. You should take
Rizatriptan Aurobindo only for a migraine attack. Rizatriptan Aurobindo should not be used for the
treatment of headaches that may be caused by other more serious conditions.
Tell your doctor if you are taking, have recently taken or plan to take any other
medicines, including those obtained without a prescription and those normally taken for migraine.
This is because Rizatriptan Aurobindo can affect the way some medicines work. Other medicines can also have effects on Rizatriptan Aurobindo.

Other medicines and Rizatriptan AurobindoTell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.
Do not take Rizatriptan Aurobindo:

• if you are already taking a 5HT1B/1D agonist (sometimes called “triptans”) such as sumatriptan, naratriptan or zolmitriptan
• if you are taking monoamine oxidase inhibitors (MAOIs) such as moclobemide, phenelzine, tranylcypromine, linezolid or pargyline or less than 2 weeks have passed since you stopped taking a MAO inhibitor.
• if you are using ergotamine-like medicines, such as ergotamine or dihydroergotamine to treat migraine
• if you are using metisergide to prevent a migraine attack

The medicines listed above may increase the risk of side effects when taken with
Rizatriptan Aurobindo.
You must wait at least 6 hours after taking Rizatriptan Aurobindo before taking ergotamine-like medicines such as ergotamine or dihydroergotamine or metisergide.
You must wait at least 24 hours after taking ergotamine-like medicines before taking Rizatriptan
Aurobindo.
Ask your doctor for instructions and information about the risks of taking Rizatriptan Aurobindo:

• if you are taking propranolol (see section 3: How to take Rizatriptan Aurobindo)
• if you are taking SSRIs such as sertraline, escitalopram oxalate and fluoxetine or SNRIs such as venlafaxine and duloxetine for depression.

Rizatriptan Aurobindo with food and drink
Rizatriptan Aurobindo may take longer to work if it is taken after a meal. It is best to
take Rizatriptan Aurobindo on an empty stomach, however you can also take it if you have eaten.

Pregnancy, breastfeeding and fertility
It is not known whether Rizatriptan Aurobindo is harmful to the fetus when taken by a pregnant woman.
Breastfeeding should be avoided for 24 hours after treatment.
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.

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

Use in patients over 65 years of age
There are no complete studies on the safe and effective use of Rizatriptan Aurobindo in patients over 65
years of age.

Driving and using machines
While taking Rizatriptan Aurobindo you may feel drowsy or dizzy. If this happens, do not drive or
use tools or machines.

Rizatriptan Aurobindo contains aspartame
Rizatriptan Aurobindo contains aspartame, a source of phenylalanine, which may be harmful to people
with phenylketonuria.

3. How to take Rizatriptan Aurobindo

Take this medicine following the instructions of your doctor exactly. If you have any doubts, consult your
doctor or pharmacist.

Rizatriptan Aurobindo is used to treat migraine attacks. Take Rizatriptan
Aurobindo as soon as possible after the start of a migraine attack. Do not use it to prevent an
attack.
The recommended dose is 10 mg.
If you are currently taking propranolol or have kidney or liver problems, you should use the 5 mg rizatriptan
dose. You must wait at least 2 hours before taking propranolol and Rizatriptan Aurobindo, 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 your migraine returns, you can
take an additional dose of Rizatriptan Aurobindo. You must always wait at least 2 hours between doses.

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

Do not take more than 2 doses of Rizatriptan within 24 hours (for example, do not take more than 2 orodispersible tablets
or tablets of 10 mg or 5 mg within 24 hours). You must always wait at least 2 hours
between doses.
If your condition worsens, seek medical advice.

How to administer Rizatriptan Aurobindo orodispersible tablets

• Rizatriptan Aurobindo orodispersible tablets dissolve in the mouth
• Open the blister pack with dry hands
• The orodispersible tablet should be placed on the tongue, where it dissolves and can be swallowed with saliva.
• The orodispersible tablet can be used in situations where liquids are not available, or to avoid nausea or vomiting that may accompany taking tablets with liquids. Rizatriptan is also available in tablets to be taken with liquids.

If you take more Rizatriptan Aurobindo than you should
If you take more Rizatriptan Aurobindo than you should, seek immediate medical or pharmacist advice. Bring with you
the packaging of the medicine.
Signs of overdose may include dizziness, drowsiness, vomiting, fainting, and slowed heartbeat.
If you have any 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 on adults, the most commonly reported side effects were dizziness, drowsiness and
fatigue.

Common (may affect up to 1 in 10 people):

• tingling (paresthesia), headache, increased skin sensitivity (hypoesthesia), reduced mental acuity, insomnia.
• fast or irregular heartbeat (palpitation),
• flushing (temporary redness of the face),
• 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):

• bad taste in the mouth
• instability when walking (ataxia), dizziness (vertigo), blurred vision, tremor, fainting (syncope).
• confusion, nervousness.
• high blood pressure (hypertension), thirst, hot flushes, sweating.
• skin rash, itching and erythema with nodules (urticaria), swelling of the face, lips, tongue and/or throat which can cause difficulty breathing and/or swelling (angioedema), difficulty breathing (dyspnea).
• feeling of stiffness in some parts of the body, muscle pain
• changes in the rhythm or rate of heartbeat (arrhythmia), abnormalities in the electrocardiogram (a test that records the electrical activity of your heart), very fast heartbeat (tachycardia)
• facial pain; muscle pain

1 in 1000 people):

• wheezing
• ; a sudden, life-threatening allergic reaction (anaphylaxis) stroke (usually occurs in patients with risk factors for heart or blood vessel disease (high blood pressure, diabetes, smoking, use of nicotine substitutes, family history of heart disease or stroke, men over 40 and postmenopausal women, particular problems with the way your heart beats [bundle branch block]))
• slowed heartbeat (bradycardia).

Not known (frequency cannot be estimated from available data)

• heart attack, spasm of the heart's blood vessels (Usually occurs in patients with risk factors for heart or blood vessel disease (high blood pressure, diabetes, smoking, use of nicotine substitutes, family history of heart disease or stroke, men over 40 and postmenopausal women, particular problems with the way your heart beats [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 deterioration with or without fever (toxic epidermal necrolysis)
• seizures
• spasm of the blood vessels of the extremities including cold and numb hands and feet
• spasm of the blood vessels of the colon (large intestine), which can cause abdominal pain

Immediately inform your doctor if you have symptoms of allergic reactions, serotonin syndrome, heart attack
or stroke.
You should also inform your doctor if you experience any symptom that suggests an allergic reaction (such as
skin rash or itching) after taking Rizatriptan Aurobindo.

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 www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects you can help provide more information on the safety of this medicine.

5. HOW TO STORE RIZATRIPTAN AUROBINDO

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 blister, the carton and the label of the
bottle after EXP. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to dispose of the
medicines you no longer use. This will help protect the environment.

6. PACKAGE CONTENTS AND OTHER INFORMATION

What Rizatriptan Aurobindo contains

• The active ingredient is rizatriptan. Each orodispersible tablet contains 7.265 mg of rizatriptan benzoate equivalent to 5 mg of rizatriptan.

The other ingredients are: microcrystalline cellulose, pregelatinized starch, mannitol, crospovidone (type
A), aspartame (see section 2), peppermint flavour (maltodextrin, natural flavours, modified corn
starch), sodium stearyl fumarate

Description of the appearance of Rizatriptan Aurobindo and package contents
Orodispersible tablets

Rizatriptan Aurobindo 5 mg orodispersible tablets:
Whitish, circular, biconvex, uncoated tablets imprinted with ‘F24’ on one side and smooth
on the other side with a peppermint flavour.
Rizatriptan Aurobindo orodispersible tablets are available in blister packs made of
polyamide/aluminium/PVC – aluminium foil containing 2, 3, 6, 10, 12 and 18 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Aurobindo Pharma (Italia) S.r.l.
Vicolo San Giovanni sul Muro, 9 - 20121 Milano
Italy

Manufacturer
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate,
Hal Far, Birzebbugia,
BBG 3000 Malta
Milpharm Limited
Ares, Odyssey Business Park, West End Road, South Ruislip HA46QD, United Kingdom

This medicinal product is authorised in the Member States of the European Economic Area with the following
names:
France: RIZATRIPTAN ARROW 5 mg/10 mg, orodispersible tablets
Germany: Rizatriptan Aurobindo 5 mg/10 mg Schmelztabletten
Italy: Rizatriptan Aurobindo 5 mg/10 mg compresse orodispersibili
Malta: Rizatriptan 5 mg/10 mg orodispersible tablets
Netherlands: Rizatriptan Aurobindo 5 mg/10 mg orodispergeerbare tabletten
Spain: Rizatriptán Aurobindo 10 mg comprimidos bucodispersables
United Kingdom: Rizatriptan 10 mg orodispersible tablets
<[Complete with national data]>