Rizatriptan Max Viatris 10 mg orodispersible tablets EFG

Patient Information Leaflet

Introduction

Package Leaflet: Information for the Patient

Rizatriptán Max Viatris 10 mg orodispersible tablets EFG

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, 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 effects not listed in this leaflet. See section 4.

Leaflet Contents

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

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

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

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

Rizatriptán 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 medicine (listed in section 6).
• If you have severe liver or kidney problems.
• If you have had a stroke (cerebrovascular accident, CVA) or a transient ischaemic attack (TIA).
• If you have uncontrolled high blood pressure, whether mild, moderate or severe.
• If you have or have ever had heart problems, including heart attack or chest pain (angina), or have experienced symptoms related to heart disease.
• If you suffer from reduced 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 medicine of the same class such as sumatriptan, naratriptan or zolmitriptan to treat your migraine (see section Other medicines and Rizatriptan Max Viatris).
• If you are taking monoamine oxidase inhibitors (MAOIs) such as moclobemide, phenelzine, tranylcypromine or pargyline (medicines for depression), linezolid (an antibiotic), or if less than two weeks have passed since you stopped taking an MAOI.
• If you are currently taking ergotamine-type medications, such as ergotamine or dihydroergotamine, to treat your migraine, or methysergide to prevent migraine attacks.

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 taking Rizatriptan Max Viatris:

• If your headache is associated with dizziness, difficulty walking, lack of coordination, or weakness in your arm or leg.
• If you have any of the following risk factors for heart disease: high blood pressure, diabetes, are a smoker or using nicotine replacement therapy, are a man over 40 years of age, are a postmenopausal woman, or have a family history of heart disease.
• If you are taking herbal remedies containing St. John’s wort.
• If you have kidney or liver problems.
• If you have a specific problem with your heart rhythm (left bundle branch block).
• If you have or have ever had allergies, especially to other medicines 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, escitalopram oxalate and fluoxetine, or serotonin-noradrenaline reuptake inhibitors (SNRIs) such as venlafaxine and duloxetine, for depression.

Inform your doctor or pharmacist about all your symptoms. Your doctor will determine whether you have migraines. You should only take rizatriptan orodispersible tablets for migraine attacks. Rizatriptan orodispersible tablets must not be used to treat headaches that may be caused by more serious underlying conditions.

During treatment

While taking this medicine, speak to your doctor immediately and do not take any more rizatriptan if you experience:

• Allergic reactions such as swelling of the face, lips, tongue and/or throat, which may cause difficulty breathing and/or swallowing (angioedema).
• Brief episodes of chest pain or tightness.

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

Children and adolescents

The use of rizatriptan is not recommended in children and adolescents under 18 years of age.

Use in patients over 65 years of age

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

Other medicines and Rizatriptan Max Viatris

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. This is because rizatriptan may affect how some medicines work. Other medicines 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 or pargyline, or if less than two weeks have passed since you stopped taking an MAOI.
• If you are taking ergotamine-type medicines, such as ergotamine or dihydroergotamine, to treat your migraine.
• If you are taking methysergide to prevent migraine attacks.

The medicines listed above may increase the risk of adverse effects when taken with rizatriptan.

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

After taking ergotamine-type medicines, you must 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, escitalopram oxalate, citalopram, fluoxetine, paroxetine, or serotonin-noradrenaline reuptake inhibitors (SNRIs) such as venlafaxine, duloxetine for depression.

Rizatriptan with food and drink

Rizatriptan works best on an empty stomach. However, you may take it after eating, although it may take longer to work.

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

Pregnancy and breastfeeding

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

Available data on the safety of rizatriptan during the first three months of pregnancy do not indicate an increased risk of birth defects.

It is unknown whether 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 delay breastfeeding for 12 hours after treatment to avoid exposing the baby.

Rizatriptan may be excreted in breast milk.

Driving and using machines

This medicine, like migraine itself, may cause drowsiness or dizziness. If this occurs, you must not drive or operate tools or machinery.

Rizatriptan Max Viatris contains aspartame

This medicine contains 10 mg of aspartame per tablet.

Aspartame is a source of phenylalanine. It may be harmful for 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 exactly the instructions for administering this medicine as given by your doctor or pharmacist. Consult your doctor or pharmacist if you have any doubts. Your doctor will tell you 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 the dose.

The recommended dose is 10 mg.

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

If you still have migraine after 2 hours

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

If migraine recurs within 24 hours

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

You must always wait at least 2 hours between doses.

Do not take more than 2 rizatriptan tablets within a 24-hour period (for example, do not take more than two orodispersible tablets of 5 mg or 10 mg within 24 hours). You must 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 patient groups.

Method and route of administration

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

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

Rizatriptan may be used in situations where liquids are not available, or to avoid nausea and vomiting that may accompany swallowing tablets with liquid.

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. Symptoms of overdose may include dizziness, drowsiness, vomiting, fainting, and decreased heart rate.

In case of overdose or accidental ingestion, contact 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 medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them. The following adverse effects may occur with this medicine.

In adult studies, the most frequently reported adverse effects were dizziness, somnolence, and fatigue.

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

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

• If you have an allergic reaction. Such reactions may manifest as 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 (wheezing due to airway congestion, swelling of the lips, tongue, or throat or body, skin rash, fainting, or difficulty swallowing).

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

• Stroke. These generally occurred in patients with risk factors for heart or blood vessel disease (hypertension, diabetes, smoking, use of nicotine replacement therapy, family history of heart disease or stroke, men over 40 years of age, postmenopausal women, a specific problem with the way the heart beats [left bundle branch block]).

Frequency not known (cannot be estimated from available data):

• Seizures (fits/seizures).
• Widespread rash with blisters and extensive peeling of the skin, possibly accompanied by fever (toxic epidermal necrolysis).
• A syndrome called "serotonin syndrome," which may cause adverse effects such as coma, unstable blood pressure, extremely high body temperature, lack of muscle coordination, agitation, and hallucinations.
• Myocardial infarction, spasms of the blood vessels of the heart. These generally occurred in patients with risk factors for heart or blood vessel disease (hypertension, diabetes, smoking, use of nicotine replacement therapy, family history of heart disease or stroke, men over 40 years of age, postmenopausal women, a specific problem with the way the heart beats [left bundle branch block]).

Other adverse effects you may experience:

Common (may affect up to 1 in 10 people)

• Tingling or numbness in hands and feet (paraesthesia), headache, reduced skin sensitivity (hypoesthesia).
• Reduced mental sharpness, difficulty sleeping (insomnia).
• Dizziness, drowsiness.
• Fast or irregular heartbeat (palpitations).
• Brief reddening of the face (flushing).
• Throat discomfort.
• Indigestion (dyspepsia), discomfort (nausea), or vomiting, dry mouth, diarrhea.
• Feeling of tiredness or heaviness in parts of the body, neck pain, stiffness.
• Stomach or chest pain.

Uncommon (may affect up to 1 in 100 people)

• Lack of muscle coordination (ataxia), tremor.
• Dizziness or sensation that the ground is tilted (vertigo), fainting.
• Taste disturbance, unpleasant taste in the mouth.
• Changes in the rhythm or rate of heartbeat (arrhythmia).
• Electrocardiogram abnormalities (a test that records the electrical activity of your heart), very fast heartbeat (tachycardia).
• High blood pressure (hypertension).
• Difficulty breathing (dyspnea).
• Hot flushes, sweating.
• Thirst.
• Itching, red raised itchy bumps (urticaria).
• Muscle weakness, sensation of heaviness in certain 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).
• Noisy 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 blood vessels in the colon (large intestine), which may cause abdominal pain or inflammation of the colon.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Rizatriptan Max Viatris

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

Do not use this medicine after the expiry date stated on the carton or blister after CAD or EXP. The expiry date refers to the last day of the month indicated.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your usual pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Rizatriptan Max Viatris

• The active substance 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”), mint flavour (containing natural flavour, corn maltodextrin, modified corn starch).

Appearance of the product and contents of the pack

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

Orodispersible tablets of Rizatriptan Max Viatris are packed in single-dose perforated blisters made of OPA/Al/PVC, containing 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

Mylan Hungary Kft.

H-2900 Komárom

Mylan utca 1.

Hungary

Further information on this medicinal product is available upon request by contacting 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 European Economic Area (EEA) member states under the following names:

Denmark Rizatriptan Viatris 10 mg

Spain Rizatriptán Max Viatris 10 mg orodispersible tablets EFG

France Rizatriptan Viatris 10 mg Comprimé orodispersible

Italy Rizatriptan Mylan Generics

Netherlands Rizatriptan SmeltTab Viatris 10 mg, orodispergeerbare tabletten

Slovak Republic Rizatriptan Viatris 10 mg

Sweden Rizatriptan Viatris 10 mg

Date of the most recent review of this leaflet: June 2024

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