Package Insert: Information for the Patient

Rizatriptan Max Viatris 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 should not be given to others, even if they have the same symptoms, 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.

1.What Rizatriptan Max Viatris is and for what it is used

2.What you need to know before starting to take Rizatriptan Max Viatris

3.How to take Rizatriptan Max Viatris

4.Possible adverse effects

5.Storage of Rizatriptan Max Viatris

6.Contents of the package and additional information

Rizatriptán Max Viatris belongs to a group of medications called serotonin receptor agonists (5-HT1B/1D), used to treat migraine attacks in adults.

The symptoms of migraine may be caused by a temporary swelling of blood vessels in the head. Rizatriptán reduces the swelling of these blood vessels.

Rizatriptán is used only to treat the headaches of migraine attacks, with or without aura (warning symptoms). It should not be used as a preventive treatment for headaches.

Do not take Rizatriptán Max Viatris:

• If you are allergic to rizatriptan or any of the other ingredients of this medication (listed in section 6).
• If you have severe liver or kidney problems.
• If you have had a stroke or a transient ischemic attack (TIA).
• If you have high blood pressure, which is not controlled with medication.
• If you have or have had any heart problems, including heart attack or chest pain (angina) or have experienced symptoms related to heart disease.
• If you suffer from decreased blood flow to your arms and/or legs due to narrowing or obstruction of your arteries (Peripheral Vascular Disease).
• If you are taking any other medication of the same class as rizatriptan, such as sumatriptan, naratriptan, or zolmitriptan, to treat your migraine (see section Other Medications and Rizatriptán Max Viatris).
• If you are taking monoamine oxidase inhibitors (MAOIs) such as moclobemide, phenelzine, tranylcypromine, or pargyline (depression medications), linezolid (an antibiotic), or if it has been less than two weeks since you stopped taking an MAOI.
• If you are taking an ergotamine-type medication, such as ergotamine or dihydroergotamine, to treat your migraine or methysergide to prevent a migraine attack.

If you are unsure whether any of the above applies to you, consult your doctor or pharmacist.

Warnings and Precautions

Consult your doctor or pharmacist before starting to take Rizatriptán Max Viatris:

• If your headache is associated with dizziness, difficulty walking, lack of coordination, or weakness in your leg and arm.
• If you have any of the following risk factors for heart disease: high blood pressure, diabetes, are a smoker or taking nicotine substitutes, are a male over 40 years old, are a postmenopausal woman, or have a family history of heart disease.
• If you are taking herbal medicines that contain St. John's Wort.
• 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, especially to other medications of the same type as rizatriptan, used to treat migraine.
• If you are taking selective serotonin reuptake inhibitors (SSRIs) such as sertraline, escitalopram, citalopram, fluoxetine, paroxetine, or serotonin and norepinephrine reuptake inhibitors (SNRIs) such as venlafaxine and duloxetine, for depression.

Inform your doctor or pharmacist of all your symptoms. Your doctor will decide if you have migraines. You should only take the rizatriptan buccal tablets for migraine attacks. Rizatriptan buccal tablets should not be used to treat headaches that may be caused by other more serious diseases.

During treatment

When you take this medication, talk to your doctor immediately and do not take more rizatriptan if you experience the following:

• You experience allergic reactions such as facial swelling, lips, tongue, and/or throat, which may make it difficult to breathe and/or swallow (angioedema).
• You experience brief symptoms such as chest pain and pressure.

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

Children and adolescents

Rizatriptan is not recommended for use in children under 18 years old.

Use in patients over 65 years old

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

Other medications and Rizatriptán Max Viatris

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication. This is because rizatriptan may affect the way some medications work. Other medications may also affect rizatriptan.

Do not take rizatriptan:

• 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, 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, to treat your migraine.
• If you are taking methysergide to prevent migraine attacks.

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

Wait at least 6 hours after taking rizatriptan before taking ergotamine-type medications (e.g., ergotamine, dihydroergotamine, or methysergide).

Wait at least 24 hours after taking ergotamine-type medications before taking rizatriptan.

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

• If you are currently taking propranolol to reduce blood pressure (see section 3).
• If you are taking selective serotonin reuptake inhibitors (SSRIs) such as sertraline, escitalopram, citalopram, fluoxetine, paroxetine, or serotonin and norepinephrine reuptake inhibitors (SNRIs) such as venlafaxine and duloxetine for depression.

Rizatriptán with food and drinks

Rizatriptan works best on an empty stomach. However, you can take it if you have eaten, but it may take longer to take effect.

You do not need to take rizatriptan with liquids.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or 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 for the fetus when taken by a pregnant woman after the first three months of pregnancy is unknown.

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

Rizatriptan may be excreted in breast milk.

Driving and operating machinery

This medication, like migraine, may cause drowsiness or dizziness, in which case you should not drive or use tools or machines.

Rizatriptán Max Viatris contains aspartame

This medication contains 10 mg of aspartame in each tablet.

Aspartame is a source of phenylalanine. It may be harmful to patients with phenylketonuria, a rare genetic disorder in which phenylalanine accumulates because the body cannot eliminate it properly.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. Consult your doctor or pharmacist if you have doubts. Your doctor will indicate the dose you should take.

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

Adults (between 18 and 65 years)

The amount of rizatriptan you take is called a dose.

The recommended dose is 10 mg.

If you have kidney or liver problems, your doctor will recommend taking a lower dose (5 mg). If you are currently taking propanolol to reduce your blood pressure, do not use Rizatriptan Max Viatris during the first 2 hours after taking propanolol.

If after 2 hours you still have a migraine

If the first dose of rizatriptan did not alleviate your migraine, DO NOT TAKEa second dose for the treatment of the same crisis. However, it is still likely that you will respond to rizatriptan during the next crisis.

If the migraine reappears in 24 hours

In some patients, migraine symptoms may reappear within a 24-hour period. If you respond to the first dose, but your migraine symptoms reappear within 24 hours, you may take an additional dose of rizatriptan.

You should always wait at least 2 hours between doses.

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

If your condition worsens, seek medical attention.

Use in children and adolescents (under 18 years) and elderly people (over 65 years)

There is no experience with the use of Rizatriptan Max Viatris in children, adolescents, or elderly patients, therefore, it is not recommended for use in these patients.

Method and route of administration

Rizatriptan tablets are easily broken, so they should be handled with care. The tablets should be handled with dry hands, otherwise they may dissolve.

1. You should hold the blister strip by the edges and separate one cell from the rest of the strip, cutting gently along the perforated lines that surround it.
2. Carefully remove the back.
3. Next, and with care, push the tablet out.
4. Place the tablet directly on your tongue so that it can dissolve.

Rizatriptan 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 you take more Rizatriptan Max Viatris than you should

Inform your doctor or the nearest hospital immediately. It is recommended to bring the packaging. The symptoms of overdose may be dizziness, drowsiness, vomiting, fainting, and decreased heart rate.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service (phone 91 562 04 20) indicating the medication and the amount ingested.

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.

If you experience any of the following symptoms, consult your doctor or seek immediate emergency help:

Infrequent(may affect up to 1 in 100 people):

• If you have an allergic reaction. Such reactions may appear in the form of anaphylaxis (a severe allergic reaction) with symptoms such as:

• Itching.
• Swelling of the face, lips, tongue, or throat, which may cause difficulty breathing or swallowing (angioedema).
• Anaphylactic reaction (high-pitched sound produced by respiratory tract congestion, swelling of the lips, tongue, and throat, or body, skin rash, fainting, or difficulty swallowing).

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

• Stroke. These occurred, generally, in patients with risk factors for heart disease or blood vessels (hypertension, diabetes, smoker, use of nicotine substitutes, family history of heart disease or stroke, man over 40 years, postmenopausal woman, a specific problem with the way their heart beats [left branch block]).

Unknown frequency(cannot be estimated from available data):

• Seizures (convulsions/attacks).
• Generalized rash with blisters and skin peeling on most of the body's surface, which may be accompanied by fever (toxic epidermal necrolysis).
• Syndrome called "serotonin syndrome," which may cause adverse effects such as coma, unstable blood pressure, extremely high body temperature, muscle coordination disorder, agitation, and hallucinations.
• Myocardial infarction, spasms of the heart's blood vessels. These occurred, generally, in patients with risk factors for heart disease or blood vessels (hypertension, diabetes, smoker, use of nicotine substitutes, family history of heart disease or stroke, man over 40 years, postmenopausal woman, a specific problem with the way their heart beats [left branch block]).

Other side effects you may experience:

Frequent(may affect up to 1 in 10 people)

• Tickling or numbness of hands and feet (paresthesia), headache, decreased skin sensitivity (hypoesthesia).
• Decreased mental acuity, difficulty sleeping (insomnia).
• Dizziness, drowsiness.
• Fast or irregular heartbeat (palpitations).
• Transient facial redness (flushing).
• Throat discomfort.
• Indigestion (dyspepsia), nausea, or vomiting, dry mouth, diarrhea.
• Sensation of fatigue or heaviness in parts of the body, neck pain, stiffness.
• Abdominal or chest pain.

Infrequent(may affect up to 1 in 100 people)

• Lack of muscle coordination (ataxia), tremor.
• Dizziness or sensation that the floor is tilted (vertigo), fainting.
• Alteration of taste, bad taste in the mouth.
• Changes in heart rhythm or frequency (arrhythmia).
• Alterations in the electrocardiogram (a test that records the heart's electrical activity), fast heartbeat (tachycardia).
• High blood pressure (hypertension).
• Difficulty breathing (dyspnea).
• Sweating, hot flashes.
• Thirst.
• Itching, raised red bumps that itch (urticaria).
• Muscle weakness, sensation of heaviness in some parts of the body.
• Confusion, nervousness.
• Blurred vision.
• Skin rash.
• Muscle pain (myalgia).
• Facial pain.

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

• Slow heartbeat (bradycardia).
• Respiratory sounds.

Unknown frequency(cannot be estimated from available data)

• Spasm or blockage of blood vessels in the extremities, including hand or foot cooling and numbness.
• Spasm of the colon's blood vessels (large intestine), which may cause abdominal pain or colon inflammation.

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 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 medicationafter the expiration date that appears on the box or on the blister after CAD or EXP. The expiration date is the last day of the month indicated.

Do not store above 25°C. Store in the original packaging to protect it from moisture.

Medicines should not be disposed of through drains or in the trash. Dispose of the containers and medicines you no longer need at your local SIGRE collection pointat your usual pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Rizatriptan Max Viatris

• The active ingredient is rizatriptan. Each tablet contains 10 mg of rizatriptan (as rizatriptan benzoate).
• The other components are anhydrous colloidal silica, crospovidone (Type B), crospovidone (Type A), mannitol (E-421), microcrystalline cellulose, guar galactomannan, magnesium stearate (E-470B), aspartame (E-951) (see section 2 “Rizatriptan Max Viatris contains aspartame”), peppermint aroma (containing natural aroma, corn maltodextrin, modified corn starch).

Appearance of the product and contents of the package

White or almost white, round tablets with beveled edges, trocheed, marked with “M” on one side and “RN2” on the other side.

The buccal dispersible tablets of Rizatriptan Max Viatris are packaged in perforated single-dose OPA/Al/PVC blisters of 2, 3, 6, 12, and 18 tablets.

Only some package sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Responsible manufacturer

McDermott Laboratories t/a Gerard Laboratories Ltd.

35/36 Baldoyle Industrial Estate

Grange Road, Dublin 13

Ireland

Or

Mylan Hungary Kft.

H-2900 Komárom

Mylan utca 1.

Hungary

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

Viatris Pharmaceuticals, S.L.

C/ General Aranaz, 86

28027 - Madrid

Spain

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

DenmarkRizatriptan Viatris 10 mg

SpainRizatriptán Max Viatris 10 mg buccal dispersible tablets EFG

FranceRizatriptan Viatris 10 mg Comprimé orodispersible

ItalyRizatriptan Mylan Generics

NetherlandsRizatriptan SmeltTab Viatris 10 mg, orodispergeerbare tabletten

Slovak RepublicRizatriptan Viatris 10 mg

SwedenRizatriptan Viatris 10 mg

Last review date of this leaflet:June 2024

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