EMIRIZIA 10 mg Tabletka Orodispersyjna

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1. Emirizia 10 mg orodispersible tablets
   1. WHAT IS EMIRIZIA AND WHAT IS IT USED FOR
   2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE EMIRIZIA
   3. HOW TO TAKE EMIRIZIA
   4. POSSIBLE SIDE EFFECTS
   5. HOW TO STORE EMIRIZIA
   6. CONTENTS OF THE PACK AND OTHER INFORMATION

Emirizia 10 mg orodispersible tablets

Rizatriptan
Generic medicine

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, pharmacist or nurse.
• 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, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

1. WHAT IS EMIRIZIA AND WHAT IS IT USED FOR

Emirizia belongs to a class of medicines known as selective serotonin receptor agonists 5-
HT .
Emirizia is used for the treatment of the headache phase of migraine attacks in adults.
Treatment with Emirizia reduces the swelling of blood vessels around the brain. This swelling causes the
headache pain of a migraine attack.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE EMIRIZIA

Do not take Emirizia if

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

your migraine (see section “Other medicines and Emirizia”).
If you have any doubts that any of the above information applies to you, contact your doctor or pharmacist.

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

• you have any of the following risk factors for heart disease: high blood pressure, diabetes, if you smoke or if you are using nicotine replacement products, if there is a family history of heart disease, if you are a man over 40 years old or a post-menopausal woman
• you suffer from kidney or liver problems
• you have a particular problem concerning your heartbeat (bundle branch block)
• you have had or have some allergies
• your headache is associated with dizziness, difficulty walking, lack of coordination or weakness of the arms or legs
• you use herbal preparations based on St. John's wort
• you have had allergic reactions such as swelling of the face, lips, tongue and/or throat that can cause difficulty breathing and/or swallowing (angioedema)
• you are taking selective serotonin reuptake inhibitors (SSRIs) such as sertraline, escitalopram oxalate and fluoxetine or serotonin-norepinephrine reuptake inhibitors (SNRIs) such as venlafaxine and duloxetine for depression
• you have had short-lived symptoms including chest pain and a feeling of tightness in the chest.

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

Other medicines and Emirizia
Do not take Emirizia if:

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

The medicines listed above may increase the risk of side effects when taken with Emirizia.
You must wait at least 6 hours after taking Emirizia before taking ergotamine medications such as ergotamine
or dihydroergotamine or metisergide.
You must wait at least 24 hours after taking ergotamine medications before taking Emirizia.
Consult your doctor for instructions on the use and possible risks associated with taking Emirizia

• if you are taking propranolol (see section 3 “How to take Emirizia”)
• 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 the treatment of depression.

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

Emirizia with food and drink
The effect of Emirizia may be delayed if taken after meals. Although it is best to take the medicine on an
empty stomach, it can also be taken after eating.

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

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

Use in patients over 65 years of age
Studies have not been conducted to fully assess the safety and efficacy of Emirizia in
patients over 65 years of age.

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

Emirizia contains lactose monohydrate and aspartame
Emirizia contains lactose monohydrate. If your doctor has told you that you have an intolerance to some sugars, contact
him/her before taking this medicine.
Emirizia contains aspartame, a source of phenylalanine which may be harmful to people with
phenylketonuria.

3. HOW TO TAKE EMIRIZIA

Emirizia is used for the treatment of migraine attacks. Take Emirizia as soon as possible from the beginning of the migraine headache. Do not use it to prevent attacks.
Take this medicine following exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The usual dose is 10 mg.
If you are taking propranolol or have kidney or liver problems, you should use Emirizia at a dose of 5 mg.
You must wait at least 2 hours between taking propranolol and Emirizia before taking a maximum of two doses in 24 hours.
If the migraine returns within 24 hours
In some patients, migraine symptoms may return within 24 hours. If the migraine returns, you can take an additional dose of Emirizia. You must wait at least 2 hours between the two doses.
If the migraine returns after 2 hours
If you do not respond to the first dose of Emirizia during an attack, do not take a second dose of Emirizia to manage the same attack. It is still likely, however, that you will respond to treatment with Emirizia during the next attack.

Do not take more than 2 doses of Emirizia in 24 hours (for example, do not take more than 2 orally disintegrating tablets of 10 mg or 5 mg in 24 hours). You must always wait at least 2 hours between taking successive doses.
If symptoms worsen, consult your doctor.

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

Administration
Do not open the blister until you are ready to administer. To take the single tablet, open the package and remove the aluminum from the blister to reveal the tablet. Do not push the tablet through the aluminum as this could damage it.
The orally disintegrating tablets of Emirizia dissolve in the mouth and can be swallowed with liquid.
The orally disintegrating tablet can be used in situations where liquids are not available or to avoid nausea and vomiting that may accompany ingestion of tablets with liquid. Place the orally disintegrating tablet on the tongue, let it dissolve and swallow it with saliva.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may occur.
The most common side effects reported in studies were dizziness, drowsiness and fatigue.

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

• Tingling (paresthesia), headache, decreased skin sensitivity (hypoesthesia), decreased mental acuity, insomnia
• Fast or irregular heartbeat (palpitations),
• Hot flushes (temporary facial redness),
• Throat discomfort,
• Feeling unwell (nausea), dry mouth, vomiting, diarrhea, indigestion (dyspepsia)
• Feeling of heaviness in some parts of the body, neck pain, stiffness
• Pain in the abdomen or chest

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

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

Rare, (may affect up to 1 in 10,000 people)

• wheezing
• allergic reaction (hypersensitivity); sudden, potentially life-threatening allergic reaction (anaphylaxis)
• stroke (this generally occurs in patients with risk factors for heart and blood vessel disease (high blood pressure, diabetes, smoking habit, use of nicotine substitutes, family history of heart disease or stroke, men over 40, postmenopausal women, specific heart rhythm problems (bundle branch block))
• slow heartbeat (bradycardia).

Not known (frequency cannot be estimated from available data)

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

Immediately inform your doctor if you experience symptoms of allergic reactions, serotonin
syndrome, heart attack or stroke.
Also inform your doctor of the appearance of any symptoms indicative of an allergic reaction (such as
skin rash and itching) after taking Emirizia.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . By reporting side effects you can help provide more information on the safety of this medicine.

5. HOW TO STORE EMIRIZIA

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack after “Exp.”. The expiry date refers to the last day of that month.
The 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 medicines you no longer use. This will help protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Emirizia contains

• The active ingredient is rizatriptan. Each tablet contains 10 mg of rizatriptan equivalent to 14.53 mg of rizatriptan benzoate.
• The other ingredients are lactose monohydrate, microcrystalline cellulose, calcium silicate, crospovidone, aspartame, peppermint flavour, anhydrous colloidal silica and magnesium stearate.

Description of the appearance of Emirizia and contents of the pack
Emirizia 10 mg tablets are round, orodispersible tablets, from white to off-white in colour, flat and
bevelled.
Emirizia is available in packs containing Al/Al blisters of 3 and 6 tablets.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Neuraxpharm Italy S.p.A.
Via Piceno Aprutina, 47
63100 Ascoli Piceno
Italy

Manufacturer responsible for batch release:
Laboratorios Lesvi S.L.
Avda. Barcelona, 69
08970 Sant Joan Despí (Barcelona), Spain

This leaflet was last updated on.