Product Information for the User

Rizatriptan Vir 10 mg Bucodispersible Tablets EFG

Read this entire product information carefully before starting to take this medication, as it contains important information for you.

• Keep this product information, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed only to you, and you should not give it to others who 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 product information. See section 4.

1. What isRizatriptan Virand for what it is used

2. What you need to know before starting to takeRizatriptan Vir

3. How to takeRizatriptan Vir

4. Possible adverse effects

5. Storage ofRizatriptan Vir

6. Contents of the package and additional information

Rizatriptán Vir belongs to a group of medicines called selective serotonin 5-HT1B/1D receptor agonists

Rizatriptán Vir is used to treat headache crises of migraine in adults.

Rizatriptán Vir treatment:

Reduces the swelling of blood vessels surrounding the brain. This swelling causes the headache of a migraine crisis

Do not take Rizatriptán Vir:

- if you are allergic to rizatriptán or any of the other ingredients of this medication (listed in section 6)

- if you have moderately severe, severe, or mild high blood pressure that is not controlled with medication.

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

- if you have liver or kidney problems.

- if you have had a stroke (ACV) or a transient ischemic attack (TIA)

- if you have problems with blockages in your arteries (peripheral vascular disease)

- if you are taking monoamine oxidase inhibitors (MAOIs) such as moclobemida, fenelcina, tranilcipromina, or pargilina (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 ergotamina or dihidroergotamina to treat your migraine or metisergida to prevent a migraine attack

- if you are taking any other medication of the same class, such as sumatriptán, naratriptán, or zolmitriptán to treat your migraine (See below Rizatriptán Vir use with other medications).

If you are unsure if any of the above cases affect you, speak with your doctor or pharmacist before taking Rizatriptán Vir.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Rizatriptán Vir.

Before taking Rizatriptán Vir, inform your doctor or pharmacist if:

- you have any of the following risk factors for heart disease: high blood pressure, diabetes, are a smoker or use nicotine substitutes, your family has a history of heart disease, are a man over 40 years old or a postmenopausal woman

- you have kidney or liver problems

- you have a specific problem with the way your heart beats (left branch block)

- you have or have had any allergies

- your headache is associated with dizziness, difficulty walking, lack of coordination, or weakness in your leg and arm

- you are taking herbal medicines that contain 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).

- if you are taking selective serotonin reuptake inhibitors (SSRIs) such as sertralina, oxalato de escitalopram, and fluoxetina or serotonin and noradrenaline reuptake inhibitors (SNRIs) such as venlafaxina and duloxetina for depression.

- you have had transient symptoms including chest pain and pressure.

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

Inform your doctor or pharmacist of all your symptoms. Your doctor will decide if you have migraines. You should only take Rizatriptán Vir for a migraine attack. Rizatriptán Vir 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. This includes herbal medicines and those medications you normally take for migraines. This is because Rizatriptán may affect the way some medications work. Other medications may also affect Rizatriptán.

Rizatriptán Vir use with other medications

Do not take Rizatriptán Vir:

- if you are already taking a 5-HT1B/1D agonist (sometimes called "triptans"), such as sumatriptán, naratriptán, or zolmitriptán.

- if you are taking a monoamine oxidase inhibitor (MAOI), such as moclobemida, fenelcina, tranilcipromina, linezolid, or pargilina, or if it has been less than two weeks since you stopped taking an MAOI.

- if you are taking ergotamine-type medications, such as ergotamina or dihidroergotamina to treat your migraine.

- if you are taking metisergida to prevent a migraine attack.

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

After taking Rizatriptán Vir, wait at least 6 hours before taking ergotamine-type medications such as ergotamina, dihidroergotamina, or metisergida.

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

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

- if you are currently taking propranolol (see section 3 How to take Rizatriptán Vir)

- if you are currently taking selective serotonin reuptake inhibitors (SSRIs) such as sertralina, oxalato de escitalopram, and fluoxetina or serotonin and noradrenaline reuptake inhibitors (SNRIs) such as venlafaxina and duloxetina for depression.

Inform your doctor or pharmacist that you are using or have used recently or may need to use any other medication.

Taking Rizatriptán Vir with food and drinks

Rizatriptán may 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, think you may be pregnant, or plan to become pregnant, consult your doctor 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 if rizatriptán is harmful to the fetus when taken by a pregnant woman after the first three months of pregnancy.

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

Driving and operating machinery

When taking this medication, you may feel drowsiness or dizziness. If this occurs, do not drive or use tools or machines.

Rizatriptán Vir contains aspartamo

Each Rizatriptán Vir 10 mg buccal dispersible tablet contains 2.90 mg of aspartamo (which contains phenylalanine).

This medication contains 2.90 mg of aspartamo in each tablet. Aspartamo is a source of phenylalanine. It may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot eliminate it properly.

Rizatriptan Vir is used to treat migraine attacks. Take Rizatriptan Vir as soon as possible once your migraine headache has started. Do not use it to prevent a migraine attack.

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

The recommended dose is 10 mg.

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

Rizatriptan Vir is available in orally disintegrating tablets of 10 mg that dissolve in the mouth.

• Open the Rizatriptan Vir blister with dry hands.

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

• The orally disintegrating tablet can be used in situations where there are no liquids available, or to avoid nausea and vomiting that may accompany the ingestion of tablets with liquids.

If the migraine reappears in 24 hours

In some patients, migraine symptoms may reappear within a 24-hour period. If your migraine reappears, you can take an additional dose of Rizatriptan Vir.

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, do not take a second dose of rizatriptan for the treatment of 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 2 tablets of 10 mg in a 24-hour period). Always wait at least 2 hours between doses.

If your condition worsens, seek medical attention.

If you take more Rizatriptan Vir than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20 indicating the medication and the amount ingested. Bring the medication 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 product, ask your doctor or pharmacist.

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 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.

- discomfort (nausea), dry mouth, vomiting, diarrhea, indigestion (dyspepsia).

- heaviness in parts of the body, neck pain, numbness.

- abdominal 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, sweating
• skin rash, itching, and hives (urticaria), facial, lip, tongue, or throat swelling that may cause difficulty breathing or swallowing (angioedema), difficulty breathing (dyspnea)
• sensation of stiffness in parts of the body, muscle weakness
• changes in heart rhythm or frequency (arrhythmia), electrocardiogram (ECG) abnormalities (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 allergic reaction (anaphylaxis)
• stroke (this usually occurs in patients with risk factors for heart disease or blood vessel disease (hypertension, diabetes, smoking, nicotine substitute use, family history of heart disease or stroke, male over 40 years old, postmenopausal woman, and a specific problem with the way the heart beats (left branch block)).
• slow heart rate (bradycardia)

Unknown frequency (cannot be estimated from available data)

• heart attack, spasms of the heart's blood vessels (these usually occur in patients with risk factors for heart disease or blood vessel disease (hypertension, diabetes, smoking, nicotine substitute use, family history of heart disease or stroke, male over 40 years old, postmenopausal woman, and a specific problem with the way the heart beats (left branch block)).
• a syndrome called "serotonin syndrome" that can 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)
• contraction of blood vessels in the extremities, including cooling and numbness of hands and feet.
• contraction of blood vessels in the colon (large intestine), which can 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 that suggest 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,pharmacist, or nurse, evensisesideeffectssthat do not appearenthisprospect.You cancomunicarlosdirectamentea travésdel SistemaEspañoldeFarmacovigilancia de Medicamentos deUsoHumano:www.notificaram.es.Mediantelacomunicación deefectos adversosusted puedecontribuiraproporcionar másinformaciónsobrela seguridad de estemedicamento.

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

Do not use this medication after the expiration date that appears on the packaging after “CAD”. The expiration date is the last day of the month indicated.

Do not store at a temperature above 30°C.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

- The active ingredient is rizatriptan.Cada comprimido contains 10 mg of rizatriptan as 14.53 mg of rizatriptan benzoate.

- The other components are: microcrystalline cellulose (E460a), cornstarch, anhydrous colloidal silica, aspartame (E951), peppermint powder (menthol, menthone, menthyl acetate, menthofuran)and magnesium stearate (E572).

Appearance of the product and contents of the packaging

Rizatriptan Vir 10 mg orally disintegrating tablets are white, round, biconvex, scored on one side, and have a peppermint flavor.The score is not for dividing the tablet.

Rizatriptan 10 mg orally disintegrating tablets are available in aluminum/aluminum blister packs containing 2, 3, or 6 tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder

INDUSTRIA QUIMICA Y FARMACEUTICA VIR, S.A.
Laguna, 66-68-70. Poligono Industrial Urtinsa II
28923- Alcorcón (Madrid)
Spain

Responsible for manufacturing

Pharmathen S.A

6th Dervenakion Str

15351, Pallini Athens

Greece

or

INDUSTRIA QUIMICA Y FARMACEUTICA VIR, S.A.
Laguna, 66-68-70. Poligono Industrial Urtinsa II
28923- Alcorcón (Madrid)
Spain

This leaflet was approved in June 2024

“The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.es/”