Rizatriptan Aurobindo

Package Leaflet: Information for the User

Rizatriptan Aurobindo 10 mg orodispersible tablets

Equivalent medicine
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 may be harmful.
• If you experience any side effect, including those not listed in this leaflet, talk to 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 taking 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 RIZATRIPTAN AUROBINDO IS AND WHAT IT IS USED FOR

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

2. What you need to know before taking 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 mildly elevated blood pressure that is not controlled by medication
• 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 liver or kidney problems
• you have had a stroke (cerebrovascular accident, CVA) or a mini-stroke (transient ischaemic attack, TIA)
• you have arterial blockage problems (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 if less than 2 weeks have passed since you stopped taking MAO inhibitors
• you are currently taking ergotamine-like medicines, such as ergotamine or dihydroergotamine for migraine treatment, or methysergide to prevent a migraine attack
• you are currently taking any other medicine belonging to the same class, such as sumatriptan, naratriptan or zolmitriptan for migraine treatment (See Other medicines and Rizatriptan Aurobindo below)

If you are unsure whether any of the above apply to you, consult 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 use nicotine replacement products, if you have a family history of heart disease, if you are a man over 40 years of age or a post-menopausal woman
• you have kidney or liver problems
• you have a specific heart rhythm problem (bundle branch block)
• you have or have had allergies
• your headache is associated with dizziness, difficulty walking, lack of coordination, or weakness in the arms and legs
• you use herbal preparations containing St. John’s Wort (Hypericum perforatum)
• you have had an allergic reaction such as swelling of the face, lips, tongue and/or throat, which may cause difficulty breathing and/or swallowing (angioedema)
• you are taking selective serotonin reuptake inhibitors (SSRIs) such as sertraline, escitalopram oxalate and fluoxetine, or serotonin-noradrenaline reuptake inhibitors (SNRIs) such as venlafaxine and duloxetine for depression
• you have experienced short-lived symptoms including chest pain and chest tightness

If you take Rizatriptan Aurobindo too often, this may lead to chronic headache. In such cases, you should contact your doctor, as you may need to stop taking Rizatriptan Aurobindo. Inform your doctor or pharmacist about your symptoms. Your doctor will determine whether you have migraine. You should take Rizatriptan Aurobindo only for a migraine attack. Rizatriptan Aurobindo must not be used to treat headaches that may be caused by more serious conditions.

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine, including those obtained without a prescription and those commonly used for migraine. This is because Rizatriptan Aurobindo may affect how some medicines work. Other medicines may also affect 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 if less than 2 weeks have passed since you stopped taking an MAOI inhibitor
• if you are using ergotamine-like medicines such as ergotamine or dihydroergotamine for migraine treatment
• if you are using methysergide to prevent a migraine attack

The medicines listed above may increase the risk of adverse 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 methysergide.

You must wait at least 24 hours after taking ergotamine-like medicines before taking Rizatriptan Aurobindo.

Ask your doctor for advice 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 taken after a meal. It is best to take Rizatriptan Aurobindo on an empty stomach; however, you may take it even if you have eaten.

Pregnancy, breastfeeding and fertility

It is not known whether Rizatriptan Aurobindo is harmful to the foetus when taken by a pregnant woman. Breastfeeding should be avoided for 24 hours after treatment.

If you are pregnant, suspect you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist 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 experience drowsiness or dizziness. If this occurs, do not drive or operate tools or machinery.

Rizatriptan Aurobindo contains aspartame

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

3. How to take Rizatriptan Aurobindo

Take this medicine exactly as your doctor has told you. If you are unsure, consult your
doctor or pharmacist.
Rizatriptan Aurobindo is used to treat migraine attacks. Take Rizatriptan Aurobindo as soon as possible
after the onset 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 dose of rizatriptan.
You must wait at least 2 hours before taking propranolol and Rizatriptan Aurobindo, up to a maximum of 2 doses within 24 hours.
If migraine returns within 24 hours
In some patients, migraine symptoms may return within 24 hours. If your migraine returns, you may take an additional dose of Rizatriptan Aurobindo. Always 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 Rizatriptan Aurobindo during an attack, do not take a second dose of Rizatriptan Aurobindo for the treatment of the same attack. However, you are likely to respond to Rizatriptan Aurobindo during a subsequent 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). Always wait at least 2 hours between doses.
If your condition worsens, seek medical help.
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 swallowing 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, contact your doctor or pharmacist immediately. Take the medicine package with you.
Signs of overdose may include dizziness, drowsiness, vomiting, fainting, and slowed heartbeat.
If you have any further questions 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 adult studies, the most commonly reported side effects were dizziness, drowsiness and tiredness.

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

• tingling sensations (paraesthesia), headache, increased skin sensitivity (hypoesthesia), reduced mental sharpness, insomnia.
• fast or irregular heartbeat (palpitations).
• flushing (short-lived redness of the face).
• throat discomfort.
• 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):

• bad taste in the mouth.
• unsteadiness when walking (ataxia), dizziness (vertigo), blurred vision, tremor, fainting (syncope).
• confusion, nervousness.
• high blood pressure (hypertension), thirst, hot flushes, sweating.
• skin rash, itching and erythematous rash with wheals (urticaria), swelling of the face, lips, tongue and/or throat which may cause breathing difficulties and/or swelling (angioedema), difficulty breathing (dyspnoea).
• sensation of stiffness in certain parts of the body, muscle pain.
• changes in the rhythm or rate of heartbeat (arrhythmia), abnormalities in the electrocardiogram (an examination that records the electrical activity of your heart), very fast heartbeat (tachycardia).
• facial pain; muscle pain.

Rare (may affect up to 1 in 1,000 people):

• sudden allergic reaction, life-threatening (anaphylaxis).
• stroke (usually occurs in patients with risk factors for heart or blood vessel diseases (high blood pressure, diabetes, smoking, use of nicotine replacement products, family history of heart disease or stroke, men over 40 years of age and postmenopausal women, specific problems with heart rhythm [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 (usually occurs in patients with risk factors for heart or blood vessel diseases (high blood pressure, diabetes, smoking, use of nicotine replacement products, family history of heart disease or stroke, men over 40 years of age and postmenopausal women, specific problems with heart rhythm [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 skin deterioration with or without fever (toxic epidermal necrolysis).
• seizures.
• spasm of blood vessels in the extremities including cold and numb hands and feet.
• spasm of blood vessels in the colon (large intestine), which may cause abdominal pain.

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

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 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 stated on the blister, carton and label of the bottle after EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
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. PACK CONTENTS AND OTHER INFORMATION

What Rizatriptan Aurobindo contains

• The active substance is rizatriptan. Each orodispersible tablet contains 14,530 mg of rizatriptan benzoate, equivalent to 10 mg of rizatriptan.
• The other components are: microcrystalline cellulose, pregelatinized starch, mannitol, crospovidone (Type A), aspartame (see section 2), peppermint flavour (maltodextrin, natural flavours, modified maize starch), sodium stearyl fumarate.

Description of the appearance of Rizatriptan Aurobindo and pack contents
Orodispersible tablets
Rizatriptan Aurobindo 10 mg orodispersible tablets
White to off-white, circular, biconvex, uncoated tablets, embossed with 'F25' on one side and smooth on the other, with a peppermint flavour.
Rizatriptan Aurobindo orodispersible tablets are available in blister packs made of polyamide/aluminum/PVC – aluminum 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 European Economic Area member states 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

Patient Information Leaflet

Rizatriptan Aurobindo 5 mg orodispersible tablets

Generic medicine
Please read this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not 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, contact 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 taking 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 RIZATRIPTAN AUROBINDO IS 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 swelling of the blood vessels around the brain. This swelling causes the headache of a migraine attack.

2. What you need to know before taking 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 mildly high blood pressure that is not controlled by medication
• 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 liver or kidney problems
• you have had a stroke (cerebrovascular accident, CVA) or a mini-stroke (transient ischaemic attack, TIA)
• you have arterial blockage problems (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 if less than 2 weeks have passed since you stopped taking MAO inhibitors
• you are currently taking ergotamine-like medicines, such as ergotamine or dihydroergotamine for migraine, or methysergide to prevent migraine attacks
• you are currently taking any other medicine belonging to the same class, such as sumatriptan, naratriptan or zolmitriptan, for migraine treatment (See Other medicines and Rizatriptan Aurobindo below).
  If you are unsure whether any of the above apply to you, consult 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 use nicotine replacement products, if you have a family history of heart disease, if you are a man over 40 years of age, or if you are a post-menopausal woman
• you have kidney or liver problems
• you have a specific condition affecting your heart rhythm (bundle branch block)
• you have or have had allergies
• your headache is accompanied by dizziness, difficulty walking, lack of coordination, or weakness in the arms and legs
• you are using herbal preparations containing St. John’s Wort (Hypericum perforatum)
• you have had an allergic reaction such as swelling of the face, lips, tongue and/or throat, which may cause difficulty breathing and/or swallowing (angioedema)
• you are taking selective serotonin reuptake inhibitors (SSRIs) such as sertraline, escitalopram oxalate and fluoxetine, or serotonin-noradrenaline reuptake inhibitors (SNRIs) such as venlafaxine and duloxetine for depression
• you have experienced brief episodes of symptoms such as chest pain and chest tightness.

Taking Rizatriptan Aurobindo too frequently may lead to chronic headache development. In such cases, you should contact your doctor, as you may need to stop taking Rizatriptan Aurobindo. Inform your doctor or pharmacist about your symptoms. Your doctor will determine whether you have migraine. You should take Rizatriptan Aurobindo only for a migraine attack. Rizatriptan Aurobindo must not be used to treat headaches that may be caused by more serious underlying conditions.
Inform your doctor if you are currently taking, have recently taken, or plan to take any other medicine, including those obtained without a prescription and those commonly used for migraine. This is because Rizatriptan Aurobindo may affect how some medicines work. Other medicines may also affect Rizatriptan Aurobindo.

Other medicines and Rizatriptan Aurobindo
Inform 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 if less than 2 weeks have passed since you stopped taking an MAOI inhibitor
• if you are using ergotamine-like medicines such as ergotamine or dihydroergotamine to treat migraine
• if you are using methysergide to prevent a migraine attack

The above-mentioned medicines may increase the risk of adverse effects when taken together 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 methysergide.
You must wait at least 24 hours after taking ergotamine-like medicines before taking Rizatriptan Aurobindo.
Ask your doctor for advice 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 taken after a meal. It is best to take Rizatriptan Aurobindo on an empty stomach; however, you may also take it after eating.

Pregnancy, breast-feeding and fertility
It is not known whether Rizatriptan Aurobindo is harmful to the foetus when taken by a pregnant woman.
Breast-feeding should be avoided for 24 hours after treatment.
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or are breast-feeding, consult your doctor or pharmacist 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
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 experience drowsiness or dizziness. If this occurs, do not drive or operate tools or machinery.

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

3. How to take Rizatriptan Aurobindo

Take this medicine exactly as directed by your doctor. 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 onset 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 between taking propranolol and Rizatriptan Aurobindo, and no more than 2 doses should be taken within 24 hours.
If migraine returns within 24 hours
In some patients, migraine symptoms may return within 24 hours. If your migraine returns, you may take an additional dose of Rizatriptan Aurobindo. Always wait at least 2 hours between doses.
If migraine persists after 2 hours
If there is no response to the first dose of Rizatriptan Aurobindo during an attack, do not take a second dose of Rizatriptan Aurobindo for the same attack. However, you are likely to respond to Rizatriptan Aurobindo during a subsequent attack.
Do not take more than 2 doses of Rizatriptan within 24 hours (e.g., do not take more than 2 orodispersible tablets or tablets of 10 mg or 5 mg within 24 hours). Always wait at least 2 hours between doses.
If your condition worsens, seek medical attention.
How to administer Rizatriptan Aurobindo orodispersible tablets

• Rizatriptan Aurobindo orodispersible tablets dissolve in the mouth
• Open the blister pack with dry hands
• Place the orodispersible tablet on the tongue, where it will dissolve 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 swallowing tablets with liquid. Rizatriptan is also available in tablets to be taken with liquid.

If you take more Rizatriptan Aurobindo than you should
If you take more Rizatriptan Aurobindo than you should, contact your doctor or pharmacist immediately. Take the medicine package with you.
Signs of overdose may include dizziness, drowsiness, vomiting, fainting, and slowed heart rate.
If you have further questions 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 everyone experiences 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 (paraesthesia), headache, increased sensitivity of the skin (hypoesthesia), reduced mental sharpness, insomnia.
• fast or irregular heartbeat (palpitations),
• flushing (short-lived redness of the face),
• throat discomfort.
• 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
• unsteadiness when walking (ataxia), dizziness (vertigo), blurred vision, tremor, fainting (syncope).
• confusion, nervousness.
• high blood pressure (hypertension), thirst, hot flushes, sweating.
• skin rash, itching and red, raised patches (urticaria), swelling of the face, lips, tongue and/or throat which may cause difficulty breathing and/or swelling (angioedema), difficulty breathing (dyspnoea).
• sensation of stiffness in certain parts of the body, muscle pain
• changes in the rhythm or rate of heartbeat (arrhythmia), abnormalities in the electrocardiogram (an examination that records the electrical activity of your heart), very fast heartbeat (tachycardia)
• facial pain; muscle pain

Rare (may affect up to 1 in 1,000 people):

• wheezing
• 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 replacement therapy, family history of heart disease or stroke, men over 40 years of age and postmenopausal women, specific problems with heart rhythm [bundle branch block]))
• slow heartbeat (bradycardia).

Not known (frequency cannot be estimated from available data)

• heart attack, spasm of blood vessels in the heart (usually occurs in patients with risk factors for heart or blood vessel disease (high blood pressure, diabetes, smoking, use of nicotine replacement therapy, family history of heart disease or stroke, men over 40 years of age and postmenopausal women, specific problems with heart rhythm [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 skin deterioration with or without fever (toxic epidermal necrolysis)
• seizures
• spasm of blood vessels in the extremities including cold and numb hands and feet
• spasm of blood vessels in the colon (large intestine), which may cause abdominal pain

Contact your doctor immediately if you experience symptoms of an allergic reaction, serotonin syndrome, heart attack, or stroke.
You should also inform your doctor if you experience any symptoms suggesting an allergic reaction (such as skin rash or itching) after taking Rizatriptan Aurobindo.

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 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 stated on the blister, carton, and label of the bottle after EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
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. PACKAGING CONTENTS AND OTHER INFORMATION

What Rizatriptan Aurobindo contains

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

The other components 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 packaging contents

Orodispersible tablets

Rizatriptan Aurobindo 5 mg orodispersible tablets:
White to off-white, circular, biconvex, uncoated tablets with 'F24' engraved on one side and smooth on the other side, with a peppermint flavour.

Rizatriptan Aurobindo orodispersible tablets are available in PVC/aluminum/aluminum blister packs 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 European Economic Area Member States under the following names:

France: RIZATRIPTAN ARROW 5 mg/10 mg, comprimés orodispersibles
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
<[To be completed with national details]>