RIZATRIPTAN MAX VIATRIS 10 mg ORALLY DISINTEGRATING TABLETS

Introduction

Package Leaflet: Information for the Patient

Rizatriptan Max Viatris 10 mg Orodispersible Tablets EFG

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

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only and you should not give it to others, even if they have the same symptoms, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Rizatriptan Max Viatris and what is it used for
2. What you need to know before taking Rizatriptan Max Viatris
3. How to take Rizatriptan Max Viatris
4. Possible side effects
5. Storage of Rizatriptan Max Viatris
6. Contents of the pack and further information

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

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

Migraine symptoms can be caused by temporary swelling of blood vessels in the head. Rizatriptan reduces the swelling of these blood vessels.

Rizatriptan is used only to treat headache pain during migraine attacks, with or without aura (warning symptoms). It should not be used as a preventive treatment for headaches.

2. What you need to know before taking Rizatriptan Max Viatris

Do not take Rizatriptan 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 (CVA) or a transient ischemic attack (TIA).
• If you have high blood pressure, moderately severe, severe, or mild, that is not controlled with medication.
• If you have or have had heart problems, including heart attack or chest pain (angina pectoris) or have experienced signs related to heart disease.
• If you suffer from decreased blood flow in your arms and/or legs due to narrowing or blockage of your arteries (Peripheral Vascular Disease).
• If you are taking any other medication of the same class, such as sumatriptan, naratriptan, or zolmitriptan, to treat your migraine (see section "Other medications and Rizatriptan Max Viatris").
• If you are taking monoamine oxidase inhibitors (MAOIs) such as moclobemide, phenelzine, tranylcypromine, or pargyline (medications for depression), 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, to treat your migraine or methysergide to prevent a migraine attack.

If you are not sure if any of the above applies to you, consult your doctor or pharmacist.

Warnings and precautions

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

• If your headache is associated with dizziness, difficulty walking, lack of coordination, or weakness in the leg and arm.
• If you have any of the following risk factors for heart disease: high blood pressure, diabetes, smoking, or taking nicotine substitutes, being a man over 40 years old, being a postmenopausal woman, having a family history of heart disease.
• If you take herbal remedies containing St. John's Wort.
• If you have kidney or liver problems.
• If you have a specific problem with the way your heart beats (left bundle branch block).
• If you have or have had any allergy, especially to other medications of the same type, such as sumatriptan, naratriptan, or zolmitriptan, used to treat migraine.
• If you are taking selective serotonin reuptake inhibitors (SSRIs) such as sertraline, oxalate of escitalopram, and fluoxetine or serotonin and norepinephrine reuptake inhibitors (SNRIs) such as venlafaxine and duloxetine for depression.

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

During treatment

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

• You experience allergic reactions such as swelling of the face, lips, tongue, and/or throat, which can make breathing and/or swallowing difficult (angioedema).
• You experience brief symptoms such as chest pain and tightness.

If you take rizatriptan too frequently, it may cause you to develop 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 of age.

Use in patients over 65 years of age

There are no complete studies that evaluate the safety and efficacy of rizatriptan in patients over 65 years of age.

Other medications and Rizatriptan Max Viatris

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medication. This is because rizatriptan can affect how some medications work. Other medications can 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, when taken with rizatriptan, can increase the risk of side effects.

After taking rizatriptan, you should wait at least 6 hours before taking ergotamine-type medications (e.g., ergotamine, dihydroergotamine, or methysergide).

After taking ergotamine-type medications, you should wait at least 24 hours before taking rizatriptan.

Ask your doctor for instructions on how to take rizatriptan and information about 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, oxalate of escitalopram, citalopram, fluoxetine, paroxetine, or norepinephrine reuptake inhibitors (NRIs) such as venlafaxine, duloxetine for depression.

Rizatriptan 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 work.

It is not necessary to take rizatriptan orodispersible tablets with liquids.

Pregnancy and breastfeeding

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

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.

It is unknown if rizatriptan 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.

Rizatriptan may be excreted in breast milk.

Driving and using machines

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

Rizatriptan 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.

3. How to take Rizatriptan Max Viatris

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

Rizatriptan is used to treat migraine attacks in adults. Take rizatriptan as soon as possible once your migraine headache starts. Do not use it to prevent an attack.

Adults (between 18 and 65 years of age)

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 may recommend taking a lower dose (5 mg). If you are currently taking propranolol to reduce blood pressure, you should not use Rizatriptan Max Viatris during the first two hours after taking propranolol.

If after 2 hours you still have a migraine

If the first dose of rizatriptan did not relieve your migraine, DO NOT take a second dose for the treatment of the same attack. However, you may still respond to rizatriptan during the next attack.

If the migraine recurs within 24 hours

In some patients, migraine symptoms may recur within 24 hours. If you responded to the first dose but your migraine symptoms recur within 24 hours, you can 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 (e.g., do not take more than two 5 mg or 10 mg orodispersible tablets in a 24-hour period). You should always wait at least 2 hours between doses.

If your condition worsens, seek medical attention.

Use in children and adolescents (under 18 years of age) and elderly patients (over 65 years of age)

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

Method and route of administration

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

1. Hold the blister strip by the edges and separate one cell from the rest of the strip by cutting gently along the perforated lines surrounding it.
2. Carefully peel off the backing.
3. Then, carefully push the tablet out.
4. Place the tablet directly on your tongue, where it will dissolve.

Rizatriptan 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.

If you take more Rizatriptan Max Viatris than you should

Inform your doctor or the nearest hospital immediately. It is recommended to bring the package. Symptoms of overdose may include dizziness, drowsiness, vomiting, fainting, and decreased heart rate.

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

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone gets them. The following side effects may occur with this medication.

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

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

Uncommon(may affect up to 1 in 100 people)

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

• Itching.
• Swelling of the face, lips, tongue, or throat, which can cause difficulty breathing or swallowing (angioedema).
• Anaphylactic reaction (wheezing caused by congestion of the airways, swelling of the lips, tongue, and throat, or body, rash, fainting, or difficulty swallowing).

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

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

Frequency not known(cannot be estimated from available data)

• Seizures (convulsions/attacks).
• Widespread rash with blisters and peeling of the skin over a large area of the body, may be accompanied by fever (toxic epidermal necrolysis).
• Serotonin syndrome, which can cause side effects such as coma, unstable blood pressure, extremely high body temperature, lack of muscle coordination, agitation, and hallucinations.
• Myocardial infarction, spasms of the heart's blood vessels. These usually occurred in patients with risk factors for heart or blood vessel disease (hypertension, diabetes, smoking, use of nicotine substitutes, family history of heart disease or stroke, being a man over 40 years old, being a postmenopausal woman, a specific problem with the way the heart beats [left bundle branch block]).

Other side effects you may experience:

Common(may affect up to 1 in 10 people)

• Numbness or tingling of hands and feet (paresthesia), headache, reduced skin sensitivity (hypoesthesia).
• Decreased mental sharpness, difficulty sleeping (insomnia).
• Dizziness, drowsiness.
• Fast or irregular heartbeat (palpitations).
• Short-term flushing of the face (flushing).
• Sore throat.
• Indigestion (dyspepsia), nausea, or vomiting, dry mouth, diarrhea.
• Feeling of fatigue or heaviness in parts of the body, neck pain, stiffness.
• Pain in the stomach or chest.

Uncommon(may affect up to 1 in 100 people)

• Lack of muscle coordination (ataxia), tremors.
• Vertigo or feeling that the floor is tilted (vertigo), fainting.
• Altered taste, bad taste in the mouth.
• Changes in heart rhythm or frequency (arrhythmia).
• Alterations in the electrocardiogram (a test that records the electrical activity of your heart), very fast heartbeat (tachycardia).
• High blood pressure (hypertension).
• Difficulty breathing (dyspnea).
• Hot flashes, sweating.
• Thirst.
• Itching, red, raised, itchy bumps (urticaria).
• Muscle weakness, feeling of heaviness in some parts of the body.
• Confusion, nervousness.
• Blurred vision.
• Rash.
• Muscle pain (myalgia).
• Facial pain.

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

• Slow heartbeat (bradycardia).
• Noises when breathing.

Frequency not known(cannot be estimated from available data)

• Spasm or blockage of blood vessels in the limbs, including cooling and numbness of hands or feet.
• Spasm of the blood vessels in the colon (large intestine), which can cause abdominal pain or inflammation of the colon.

Reporting of side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Rizatriptan Max Viatris

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date stated on the carton or 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 from moisture.

Medications should not be disposed of through wastewater or household waste. Place the packaging and any unused medication in the SIGRE collection point at your usual pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package Contents and Additional Information

Rizatriptan Max Viatris Composition

• The active ingredient is rizatriptan. Each tablet contains 10 mg of rizatriptan (as rizatriptan benzoate).
• The other ingredients 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 flavor (containing natural flavor, corn maltodextrin, modified corn starch).

Product Appearance and Package Contents

White or almost white, round tablets with beveled edges, engraved with "M" on one side and "RN2" on the other side.

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

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

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

For further information on this medicinal product, please contact the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.

C/ General Aranaz, 86

28027 - Madrid

Spain

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

DenmarkRizatriptan Viatris 10 mg

SpainRizatriptán Max Viatris 10 mg orodispersible tablets EFG

FranceRizatriptan Viatris 10 mg Orodispersible Tablet

ItalyRizatriptan Mylan Generics

NetherlandsRizatriptan SmeltTab Viatris 10 mg, orodispergeerbare tabletten

Slovak RepublicRizatriptan Viatris 10 mg

SwedenRizatriptan Viatris 10 mg

Date of the Last Revision of this Leaflet:June 2024

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (https://www.aemps.gob.es/)