Emirizia

PACKAGE LEAFLET: INFORMATION FOR THE USER

Emirizia 10 mg orodispersible tablets

Rizatriptan
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, pharmacist or nurse.
• 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 reaction, including those not listed in this leaflet, contact 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 taking 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 EMIRIZIA IS AND WHAT IT IS USED FOR

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

2. WHAT YOU SHOULD KNOW BEFORE TAKING EMIRIZIA

Do not take Emirizia if

• you are allergic to rizatriptan 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 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 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 two weeks have passed since you stopped taking MAO inhibitors
• you are being treated with ergotamine-containing medicines, such as ergotamine or dihydroergotamine, to treat your migraine, or with methysergide to prevent migraine attacks
• you are taking other medicines of the same group, such as sumatriptan, naratriptan, or zolmitriptan, to treat your

migraine (see section “Other medicines and Emirizia”).
If you are unsure 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 Emirizia 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 a post-menopausal woman
• you suffer from kidney or liver problems
• you have a specific heart rhythm problem (bundle branch block)
• you have had or have certain allergies
• your headache is associated with dizziness, difficulty walking, lack of coordination, or weakness in arms or legs
• you use herbal preparations containing St. John’s wort
• you have had 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 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 tightness in the chest.

Taking Emirizia too often may lead to chronic headache. In this case, contact your doctor, as you may
need to stop taking Emirizia.
Tell your doctor or pharmacist about your symptoms. Your doctor will determine whether you have migraine. You should
take Emirizia only for migraine attacks. Emirizia must not be used to treat headaches that could be caused by
more serious conditions.
Inform 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 Emirizia may alter the way some medicines work. Other medicines may also affect 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 medicines, such as ergotamine or dihydroergotamine, to treat migraine
• you are using methysergide to prevent migraine attacks.

The above medicines may increase the risk of adverse effects when taken with Emirizia.
You must wait at least 6 hours after taking Emirizia before taking ergotamine-containing medicines such as ergotamine
or dihydroergotamine or methysergide.
You must wait at least 24 hours after taking ergotamine-containing medicines before taking Emirizia.
Consult your doctor for instructions on use and for 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-noradrenaline reuptake inhibitors (SNRIs) such as venlafaxine and duloxetine for the treatment of depression.

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicines, including those without a prescription.
Emirizia with food and drink
The effect of Emirizia may be delayed if taken after meals. Although it is preferable to take the medicine on an
empty stomach, it may also be taken after eating.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or are breastfeeding,
please consult your doctor or pharmacist before taking this medicine.
It is not known whether Emirizia may harm an unborn child 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
Complete studies to assess the safety and efficacy of Emirizia in
patients over 65 years of age have not been conducted.
Driving and using machines
You may experience drowsiness or dizziness when taking Emirizia. If this occurs, do not drive or operate machinery.
Emirizia contains lactose monohydrate and aspartame
Emirizia contains lactose monohydrate. If your doctor has informed you that you have an intolerance to certain sugars,
please contact him or 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 to treat migraine attacks. Take Emirizia as soon as possible after the onset of migraine headache. Do not use it to prevent attacks.
Take this medicine exactly as described 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 must take Emirizia at a dose of 5 mg.
You must wait at least 2 hours between taking propranolol and Emirizia, and take no more than two doses in 24 hours.

If migraine recurs within 24 hours
In some patients, migraine symptoms may return within 24 hours. If the migraine returns, you may take an additional dose of Emirizia. You must wait at least 2 hours between doses.

If migraine recurs after 2 hours
If there is no response to the first dose of Emirizia during an attack, do not take a second dose of Emirizia to manage the same attack. However, you are still likely to respond to treatment with Emirizia during the next attack.

Do not take more than 2 doses of Emirizia in 24 hours (e.g., do not take more than 2 orodispersible tablets of 10 mg or 5 mg in 24 hours). Always wait at least 2 hours between successive doses.
If symptoms worsen, consult your doctor.

If you take more Emirizia than you should
If you take more Emirizia than recommended, inform your doctor or pharmacist immediately. Bring the medicine pack with you.
Signs of overdose 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.

Administration
Do not open the blister pack until you are ready to take the tablet. To take a single tablet, open the packaging and peel back the aluminium foil from the blister to expose the tablet. Do not push the tablet through the foil, as this may damage it.

Emirizia orodispersible tablets dissolve in the mouth and may be swallowed with liquid.
The orodispersible tablet can be used in situations where liquids are not available or to avoid nausea and vomiting that may accompany swallowing tablets with liquid. Place the orodispersible tablet on the tongue, allow it to dissolve, and then swallow it with saliva.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine may cause adverse reactions, although not everyone experiences them.
The following adverse reactions may occur.
The most common adverse reactions reported in studies were dizziness, drowsiness, and fatigue.

Common (may affect from 1 to 10 people in 100)

• Tingling (paraesthesia), headache, reduced skin sensitivity (hypoesthesia), reduced mental sharpness, insomnia
• Fast or irregular heartbeat (palpitations)
• Flushing (short-lived reddening 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 from 1 to 10 people in 1,000)

• Bad 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 the electrocardiogram (an examination that records the electrical activity of the heart), very fast heartbeat (tachycardia)
• • Facial pain, muscle pain

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

• 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 therapies, 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 therapies, family history of heart disease or stroke, men over 40 years, postmenopausal women, specific heart rhythm problems (bundle branch block))
• A condition called “serotonin syndrome” which may cause adverse reactions 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 develop any symptoms indicating an allergic reaction (such as skin rash and
itching) after taking Emirizia.

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report adverse reactions directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . By reporting adverse reactions, 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 stated on the packaging 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. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

What Emirizia contains

• The active substance is rizatriptan. Each tablet contains 10 mg of rizatriptan, equivalent to 14.53 mg of rizatriptan benzoate.
• The other components are monohydrate lactose, 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 orodispersible tablets, round, 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.