Package Insert: Information for the User

Rizatriptan Viso Pharmaceutical 10 mg Bucodispersable Tablets EFG

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

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication 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 package insert. See section 4.

Rizatriptan Viso Farmacéutica is used to treat migraine attacks. Do not use it to prevent an attack.

Rizatriptan Viso Farmacéutica belongs to a type of medications called selective 5-HT 1B/1D receptor agonists.

Rizatriptan Viso Farmacéutica is used to treat the headache phase of migraine attacks in adults.

Treatment with Rizatriptan Viso Farmacéutica:

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

Do not take Rizatriptan Viso Farmacéutica:

• • if you are allergic to the active ingredient (rizatriptan, benzoate) or any of the other components of this medication (listed in section 6).
• if you have moderately severe, severe, or mild hypertension that is not controlled with medication.
• • if you have or have had any heart problems, including myocardial infarction or chest pain (angina), or if you have experienced symptoms related to heart disease.
  • if you have had severe liver or kidney problems.
  • if you have had a stroke (ACV) or a transient ischemic attack (AIT).
  • if you have peripheral vascular disease (obstruction in your arteries).
  • if you are taking monoamine oxidase inhibitors (MAOIs) such as moclobemide, phenelzine, tranylcypromine, or pargyline (depression medications), or linezolid (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 (seeUse of Rizatriptan Viso Farmacéutica with other medications).

If you are unsure if any of the above cases affect you, talk to your doctor or pharmacist before taking Rizatriptan Viso Farmacéutica.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Rizatriptan Viso Farmacéutica:

• if you have any of the following risk factors for heart disease: high blood pressure, diabetes, smoking, or taking nicotine substitutes, a family history of heart disease, being a man over 40 years old or a postmenopausal woman.
• if you have kidney or liver problems.
• if you have a specific problem with the way your heart beats (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 legs and arms.
• if you are taking herbal medicines that contain St. John's Wort.
• if you have had allergic reactions such as swelling of the face, 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, and fluoxetine or serotonin and norepinephrine reuptake inhibitors (SNRIs) such as venlafaxine and duloxetine for depression.
• if you have had transient symptoms including chest pain and pressure.

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

Inform your doctor or pharmacist of your symptoms. Your doctor will decide if you have migraines. You should only take Rizatriptan Viso Farmacéutica for a migraine attack. Rizatriptan Viso Farmacéutica 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 those purchased without a prescription. This includes herbal medicines and those medications you normally take for migraines. This is because Rizatriptan Viso Farmacéutica may affect the way some medications work. Other medications may also affect Rizatriptan Viso Farmacéutica.

Children and adolescents

There is no experience with the use of Rizatriptan Viso Farmacéutica in children and adolescents under 18 years of age, therefore, the use of Rizatriptan Viso Farmacéutica is not recommended in children and adolescents.

Patients over 65 years old

There are no complete studies that evaluate the safety and efficacy of Rizatriptan Viso Farmacéutica in patients over 65 years old.

Use of Rizatriptan Viso Farmacéutica with other medications

Do not take Rizatriptan Viso Farmacéutica if:

• you are already taking a 5-HT1B/1D agonist (sometimes called "triptans"), such as sumatriptan, naratriptan, or zolmitriptan.
• you are taking monoamine oxidase inhibitors (MAOIs) such as moclobemide, phenelzine, tranylcypromine, linezolid, or pargyline, or if it has been less than two weeks since you stopped taking an MAOI.
• you are taking ergotamine-type medications, such as ergotamine or dihydroergotamine for your migraine.
• you are taking methysergide to prevent a migraine attack.

When taking the above-mentioned medications with Rizatriptan Viso Farmacéutica, the risk of adverse effects may increase.

After taking Rizatriptan Viso Farmacéutica, 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 Rizatriptan Viso Farmacéutica.

Ask your doctor for instructions on how to take Rizatriptan Viso Farmacéutica and information on the risks if:

• you are currently taking propranolol (see section3:How to take Rizatriptan Viso Farmacéutica
• you are currently taking SSRIs such as sertraline, escitalopram oxalate, and fluoxetine or SNRIs such as venlafaxine and duloxetine for depression.

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

Use of Rizatriptan Viso Farmacéutica with food and drinks

Rizatriptan Viso Farmacéutica may take longer to take effect if taken after meals. Although it is better to take it on an empty stomach, you can 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 rizatriptan when used during the first three months of pregnancy do not indicate an increased risk of birth defects.The safety of Rizatriptan Viso Farmacéutica for the fetus when taken by a pregnant woman after the first three months of pregnancy is unknown.

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

Driving and operating machinery

After taking Rizatriptan Viso Farmacéutica, you may feel drowsiness or dizziness. If this occurs, do not drive or use tools or machinery.

Rizatriptan Viso Farmacéutica contains aspartame (E951)

Aspartame contains a source of phenylalanine that may be harmful to individuals with phenylketonuria.

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

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

The recommended dose is 10 mg.

Rizatriptan Viso Farmacéutica is a buccal disintegrating tablet that dissolves in the mouth.

• Remove the buccal disintegrating tablet from the blister with dry hands and place it on the tongue, where it will dissolve and can be swallowed with saliva.
• The buccal disintegrating tablet can be taken in situations where there are no liquids available or to avoid nausea and vomiting that may accompany the ingestion of tablets with liquids.

If you are currently taking propanolol or have kidney or liver problems, you must take the dose of 5 mg of Rizatriptan Viso Farmacéutica. You must wait at least 2 hours between the intake of propanolol and Rizatriptan Viso Farmacéutica 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 can take an additional dose of Rizatriptan Viso Farmacéutica. 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 Viso Farmacéutica during an attack, do not take a second dose of Rizatriptan Viso Farmacéutica for the same attack. However, it is still likely that you will respond to Rizatriptan Viso Farmacéutica during the next attack.

Do not take more than 2 doses of Rizatriptan in a 24-hour period(for example, do not take more than 2 buccal disintegrating tablets of 10 mg or 5 mg in a 24-hour period). You must always wait at least 2 hours between doses.

If your condition worsens, seek medical attention.

If you take more Rizatriptan Viso Farmacéutica than you should

If you take more Rizatriptan Viso Farmacéutica than you should, consult immediately with your doctor or pharmacist, or call the Toxicological Information Service, phone 91 5620420, indicating the medication and the amount taken. It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

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 can cause side effects, although not everyone will experience them. This medicine can cause the following side effects.

In adult studies, the most frequently reported side effects 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 heartbeat (palpitations)
• flushing (brief facial redness)
• sore throat
• unpleasantness (nausea), dry mouth, vomiting, diarrhea, indigestion (dyspepsia)
• discomfort or 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,shaking, fainting (syncope)
• confusion, nervousness
• high blood pressure (hypertension), thirst,angina, sweating
• eruption, itching, and blistering (urticaria), facial swelling, lips, tongue, and/or throat swelling, which 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 (test that records the heart's electrical activity), very rapid heartbeat (tachycardia)
• facial pain, muscle pain

Rare (may affect up to 1 in 1000 people)

• breathing sounds
• allergic reaction (hypersensitivity); sudden allergic reaction with risk of death (anaphylaxis)
• stroke (usually 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, men over 40, postmenopausal women, and a special problem related to the way the heart beats (left branch block)).
• slow heart rate (bradycardia)

Unknown frequency

• heart attack, spasms of the heart's blood vessels, (usually 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, men over 40, postmenopausal women, and a special problem related to the way the heart beats (left branch block)).
• serotonin syndrome that can cause side effects such as coma, unstable blood pressure, extremely high fever, muscle coordination disorder, agitation, and hallucinations
• severe skin peeling with or without fever (toxic epidermal necrolysis)

• seizures (convulsions/spasms)
• contraction of the blood vessels in the extremities, including cooling and numbness of hands and feet
• contraction of the 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 that suggest an allergic reaction (such as rash or urticaria) after taking Rizatriptan Viso Farmacéutica.

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 Pharmacovigilance of Medicines for Human Use: https://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 packaging after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Do not dispose of medications through drains or trash. Dispose of packaging and medications you no longer need at the SIGRE drop-off 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 Rizatriptan Viso Pharmaceutical

• The active ingredient is rizatriptan.

A 10 mg buccodispersible tablet contains 10 mg of rizatriptan as 14.53 mg of rizatriptan benzoate.

• The other components are mannitol (E421),microcrystalline cellulose (E460a), crospovidone type A, aspartame (E951), magnesium stearate (E572), colloidal silicon dioxide, and peppermint aroma (contains modified food starch E1450).

Appearance of the product and contents of the package

The 10 mg buccodispersible tablets are white or off-white, round, flat, beveled-edged, and uncoated, with "468" engraved on one side and nothing on the other.

The buccodispersible tablets are presented in aluminum blisters.

Package sizes for 10 mg: blisters of 2, 3, 6, 12, or 18 buccodispersible tablets.

Only some package sizes may be marketed.

Rizatriptan benzoate is also available as a tablet that can be taken with liquids.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Glenmark Arzneimittel GmbH

Industriestr. 31

82194 Gröbenzell

Germany

Responsible for manufacturing

Glenmark Pharmaceuticals Europe Limited

Building 2, Croxley Green Business Park,

Croxley Green

Hertfordshire, WD18 8YA

United Kingdom

or

Glenmark Pharmaceuticals s.r.o.

Fibíchova 143

566 17 Vysoké Mýto

Czech Republic

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Viso Farmacéutica, S.L.U.

c/ Retama 7, 7ª Planta

28045 Madrid

Spain

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

Last review date of this prospectus:July 2024.

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