Prospect: Information for the user

Rizatriptan Aurovitas 10 mg orally disintegrating tablets EFG

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

-Keep this prospect, as you may need to read it again.

-If you have any questions, consult your doctor or pharmacist.

-This medicine has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.

-If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

1.What is Rizatriptan Aurovitas and what is it used for

2.What you need to knowbefore starting to take Rizatriptan Aurovitas

3.How to take RizatriptanAurovitas

4.Adverse effects

5.Storage of Rizatriptan Aurovitas

6.Contents of the package and additional information

Rizatriptán Aurovitas belongs to a group of medicines called selective serotonin 5-HT 1B/1D receptor agonists.

Rizatriptán is used to treat migraine headache attacks in adults.

Rizatriptán Aurovitas treatment:

Reduces the swelling of blood vessels around the brain. This swelling causes the headache of a migraine attack.

Do not takeRizatriptán Aurovitas

•if you are allergic to benzoate of rizatriptán or to any of the other components of this medication (listed in section 6).

•if you have moderately severe or uncontrolled high blood pressure.

•if you have or have had any heart problems, including myocardial infarction or chest pain (angina) or have experienced signs related to heart disease.

•if you have severe liver or kidney problems.

•if you have had a stroke or a transient ischemic attack (TIA).

•if you have peripheral vascular disease.

•if you are taking monoamine oxidase inhibitors (MAOIs) such as moclobemide, phenelzine, tranylcypromine, or pargyline (depression medications), or linezolid (an antibiotic), or if it has been less than two weeks since you stopped taking an MAOI.

•if you are currently taking an ergotamine-type medication, such as ergotamine or dihydroergotamine for your migraine, or methysergide to prevent a migraine attack.

•if you are taking any other medication of the same class, such as sumatriptan, naratriptan, or zolmitriptan for your migraine (seeOther Medications and Rizatriptán Aurovitas).

If you are unsure whether any of the above applies to you, speak with your doctor or pharmacist before taking rizatriptán.

Warnings and Precautions

Consult your doctor or pharmacist before starting to take Rizatriptán Aurovitas:

•if you have any of the following cardiovascular risk factors: high blood pressure, diabetes, smoking or using nicotine substitutes, a family history of cardiovascular disease, being a man over 40 years old or a postmenopausal woman.

•if you have kidney or liver problems.

•if you have a specific heart rhythm problem (left branch block).

•if you have or have had any allergies.

•if your headache is associated with dizziness, difficulty walking, lack of coordination, or weakness in the leg and arm.

•if you are taking herbal medicines that contain St. John's Wort.

•if you have had allergic reactions such as facial swelling, lips, tongue, and/or throat that can cause difficulty breathing or swallowing (angioedema).

•if you are taking selective serotonin reuptake inhibitors (SSRIs) such as sertraline, escitalopram oxalate, or fluoxetine, or serotonin and noradrenaline reuptake inhibitors (SNRIs) such as venlafaxine and duloxetine for depression.

•if you have had transient symptoms including chest pain and pressure.

If you take rizatriptán frequently, this may cause chronic headache. In such cases, you should contact your doctor, as you may need to stop taking rizatriptán.

Inform your doctor or pharmacist of all your symptoms. Your doctor will decide if you have migraines. You should only take rizatriptán for a migraine attack. Rizatriptán should not be used to treat other headaches that may be caused by more serious underlying diseases.

Inform your doctor that you are using, have used recently, or may need to use any other medication, including over-the-counter medications. This includes herbal medicines and those medications you take regularly for your migraine. This is because rizatriptán may affect the way some medications work. Other medications may also affect rizatriptán.

Other Medications and Rizatriptán Aurovitas

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Do not take rizatriptán:

•if you are already taking a 5-HT1B/1D agonist (sometimes called "triptans"), such as sumatriptan, naratriptan, or zolmitriptan.

•if you are taking a monoamine oxidase inhibitor (MAOI), such as moclobemide, phenelzine, tranylcypromine, linezolid, or pargyline, or if it has been less than two weeks since you stopped taking an MAOI.

•if you are taking ergotamine-type medications, such as ergotamine or dihydroergotamine for your migraine.

•if you are taking methysergide to prevent migraine attacks.

The medications mentioned above, when taken withrizatriptán, may increase the risk of adverse effects.

After taking rizatriptán, wait at least 6 hours before taking ergotamine-type medications, such as ergotamine, dihydroergotamine, or methysergide.

After taking ergotamine-type medications, wait at least 24 hours before taking rizatriptán.

Ask your doctor for instructions on how to take rizatriptán and information on the risks

•if you are currently taking propranolol (see section 3How to take Rizatriptán Aurovitas).

•if you are currently taking selective serotonin reuptake inhibitors (SSRIs) such as sertraline, escitalopram oxalate, or fluoxetine, or serotonin and noradrenaline reuptake inhibitors (SNRIs) such as venlafaxine and duloxetine for depression.

Taking Rizatriptán Aurovitas with Food and Drinks

Rizatriptánmay take longer to take effect if taken after meals. Although it is better to take it on an empty stomach, you can still take it even if you have eaten.

Pregnancy, Breastfeeding, and Fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

The available data on the safety of rizatriptán when used during the first three months of pregnancy do not indicate an increased risk of birth defects. It is unknown whether rizatriptán is harmful to the fetus when taken by a pregnant woman after the first three months of pregnancy.

If you are breastfeeding, you can postpone breastfeeding for 12 hours after treatment to avoid exposing your baby.

Children and Adolescents

Rizatriptán is not recommended for use in children under 18 years of age.

Use in Patients Over 65 Years

There are no completed studies to evaluate the safety and efficacy of rizatriptán in patients over 65 years of age.

Driving and Operating Machines

After takingrizatriptán, you may feel drowsiness or dizziness. If this occurs, do not drive or operate tools or machines.

Rizatriptán Aurovitas Contains Aspartame

This medication contains 3,741 mg of aspartame in each buccal dispersible tablet.

Aspartame contains a source of phenylalanine that may be harmful in cases of phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body is unable to eliminate it correctly.

Rizatriptán Aurovitas Contains Sodium

This medication contains less than 1 mmol of sodium (23 mg) per buccal dispersible tablet; it is essentially "sodium-free".

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Rizatriptan is used to treat migraine crises. Take rizatriptan as soon as possible once your migraine headache begins. Do not use it to prevent a crisis.

The recommended dose is 10 mg.

If you are currently taking propranolol or have kidney or liver problems, you must use the 5 mg dose of rizatriptan. You must wait at least 2 hours between taking propranolol and rizatriptan, up to a maximum of 2 doses in a 24-hour period.

If the migraine reappears in 24 hours

In some patients, migraine symptoms may reappear within a 24-hour period. If your migraine reappears, you may take an additional dose of rizatriptan. You must always wait at least 2 hours between doses.

If after 2 hours you still have a migraine

If you do not respond to the first dose of rizatriptan during a crisis, you must not take a second dose of rizatriptan for the same crisis. However, you are still likely to respond to rizatriptan during the next crisis.

Do not take more than 2 doses of rizatriptan in a 24-hour period (for example, do not take more than two 10 mg or 5 mg tablets in a 24-hour period). Always wait at least 2 hours between doses.

If your condition worsens, seek medical attention.

How to administer Rizatriptan Aurovitas tablets

-Rizatriptan tablets dissolve in the mouth.

-Open the blister pack with dry hands.

-Place the tablet on the tongue, where it will dissolve so that it can be swallowed with saliva.

-The tablet can be used in situations where liquids are not available, or to avoid nausea and vomiting that may accompany the ingestion of tablets with liquids.

Rizatriptan is also available in tablets to be taken with liquids.

If you take more Rizatriptan Aurovitas than you should

If you take more rizatriptan than you should, consult your doctor or pharmacist immediately, or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested. Bring the packaging with you.

The signs of overdose may include dizziness, numbness, vomiting, fainting, and slow heart rate.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

The following side effects may occur with this medicine.

In adult studies, the side effects reported most frequently were dizziness, drowsiness, and fatigue.

Frequent (may affect up to 1 in 10 people)

•tingling sensation (paresthesia), headache, decreased skin sensitivity (hypoesthesia), decreased mental acuity, insomnia.

•rapid or irregular heart rate (palpitations).

•flushing (brief facial redness).

•sore throat.

•unpleasantness (nausea), dry mouth, vomiting, diarrhea, indigestion (dyspepsia).

•heaviness in parts of the body, neck pain, numbness, stomach or chest pain.

Infrequent (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 flashes, sweating.

•skin rash, itching, and rash with blisters (urticaria), swelling of the face, lips, tongue, and/or throat that may cause difficulty breathing and/or swallowing (angioedema), difficulty breathing (dyspnea).

•sensation of stiffness in parts of the body, muscle weakness.

•changes in heart rhythm or frequency (arrhythmia), electrocardiogram alterations (a test that records the heart's electrical activity), very rapid heart rate (tachycardia).

•facial pain, muscle pain.

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

•breathing sounds.

•allergic reaction (hypersensitivity): sudden and potentially life-threatening anaphylaxis.

•stroke (this usually occurs in patients with cardiovascular disease or blood vessel risk factors (hypertension, diabetes, smoking, nicotine substitute use, family history of cardiovascular disease or stroke, male over 40 years old, postmenopausal woman, and a specific heart rhythm problem (left branch block))).

•slow heart rate (bradycardia).

Unknown frequency (cannot be estimated from available data)

•myocardial infarction, coronary artery spasms (these usually occur in patients with cardiovascular disease or blood vessel risk factors (hypertension, diabetes, smoking, nicotine substitute use, family history of cardiovascular disease or stroke, male over 40 years old, postmenopausal woman, and a specific heart rhythm problem (left branch block))).

•a syndrome called "serotonin syndrome" that may cause side effects such as coma, unstable blood pressure, extremely high fever, muscle coordination problems, agitation, and hallucinations.

•severe skin peeling with or without fever (toxic epidermal necrolysis).

•seizures (convulsions/spasms).

•constriction of blood vessels in the extremities, including cooling and numbness of hands or feet.

•constriction of blood vessels in the colon (large intestine), which may cause abdominal pain.

Inform your doctor immediately if you experience symptoms of an allergic reaction, serotonin syndrome, heart attack, or stroke.

Also, inform your doctor if you experience any symptoms indicating an allergic reaction (such as rash or itching) after taking rizatriptan.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Vigilance of Medicinal Products for Human Use:www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the blister pack and on the carton after CAD. The expiration date is the last day of the month indicated.

This medication does not require special conditions for conservation.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of packaging and medications you no longer need. This will help protect the environment.

Composition of Rizatriptán Aurovitas

-The active ingredient is rizatriptan. Each buccal dispersible tablet contains 14.530 mg of rizatriptan benzoate, equivalent to 10 mg of rizatriptan.

The other components are: microcrystalline cellulose, pregelatinized cornstarch, mannitol, crospovidone (Type A), aspartame (see section 2), peppermint aroma (maltodextrin, natural flavors, modified cornstarch), stearic acid fumarate and sodium.

Appearance of the product and contents of the packaging

Buccal dispersible tablets.

Uncoated white to off-white, circular, biconvex tablets with the mark “F25” on one face and smooth on the other, with a peppermint flavor.

Rizatriptán Aurovitas buccal dispersible tablets are available in polyamide/aluminum/PVC-aluminum laminate blister packs of: 2, 3, 6, 10, 12 and 18 tablets.

Only some pack sizes may be marketed.

Marketing authorization holder

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Responsible for manufacturing

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

This medicine is authorized in the member states of the European Economic Area with the following names:

France:RIZATRIPTAN ARROW 10 mg, orodispersible tablets

Germany:Rizatriptan Aurobindo 10 mg Schmelztabletten

Spain:Rizatriptán Aurovitas 10 mg buccal dispersible tablets EFG

Netherlands:Rizatriptan Aurobindo 10 mg orodispergeerbare tablets

Italy:Rizatriptan Aurobindo 10 mg orodispersible tablets

Malta:Rizatriptan 10 mg orodispersible tablets

Last review date of this leaflet: June 2024

Further information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)(http://www.aemps.gob.es/).