Package Insert: Information for the User

MAXALT 10mg Tablets

rizatriptan

Read this package insert carefully before you start taking this medicine, because it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others who have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section4.

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

MAXALT is used to treat the headaches of migraine attacks in adults.

Treatment with MAXALT:

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

Do not take MAXALT:

• if you are allergic to rizatriptan benzoate or any of the other ingredients 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 have experienced symptoms related to heart disease.
• if you have severe liver or kidney problems.
• if you have had a stroke or a transient ischemic attack (TIA).
• 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 (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 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 for your migraine (see below Taking MAXALT with other medications).

If you are unsure whether any of the above applies to you, talk to your doctor or pharmacist before taking MAXALT.

Warnings and precautions

Consult your doctor or pharmacist before starting to take MAXALT, if:

• you have any of the following risk factors for heart disease: high blood pressure, diabetes, smoking, or using nicotine substitutes, a family history of heart disease, being 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 or swallowing (angioedema).
• you are taking selective serotonin reuptake inhibitors (SSRIs) such as sertraline, escitalopram oxalate, and fluoxetine or serotonin and noradrenaline reuptake inhibitors (SNRIs) such as venlafaxine and duloxetine for depression.
• you have had transient symptoms including chest pain and pressure.

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

Inform your doctor or pharmacist of all your symptoms. Your doctor will decide if you have a migraine. You should only take MAXALT for a migraine attack. MAXALT should not be used to treat other headaches that may be caused by more serious underlying diseases.

Inform your doctor or pharmacist if 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 your migraine. This is because MAXALT may affect the way some medications work. Other medications may also affect MAXALT.

Taking MAXALT with other medications

Do not take MAXALT:

• 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 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 for 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 MAXALT.

After taking MAXALT, 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 MAXALT.

Ask your doctor for instructions on how to take MAXALT and information on the risks.

• if you are currently taking propranolol (see section How to take MAXALT).
• if you are currently taking selective serotonin reuptake inhibitors (SSRIs) such as sertraline, escitalopram oxalate, and fluoxetine or serotonin and noradrenaline reuptake inhibitors (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.

Taking MAXALT with food and drinks

MAXALT 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 and breastfeeding

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

The available data on the safety of rizatriptan when used during the first 3 months of pregnancy do not indicate an increased risk of birth defects.The safety of MAXALT for the fetus when taken by a pregnant woman after the first 3 months of pregnancy is unknown.

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

Children and adolescents

MAXALT tablets are not recommended for children under 18 years old.

Use in patients over 65 years old

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

Driving and operating machinery

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

MAXALT contains lactose monohydrate

This medication contains lactose. The 10 mg tablet contains 60.50 mg of lactose monohydrate. If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medication.

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

Follow exactly the administration instructions for this medication indicated by your doctor or pharmacist. If in 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 the 5 mg dose of MAXALT. You must wait at least 2 hours between taking propranolol and MAXALT, up to a maximum of 2 doses in a 24-hour period.

MAXALT tablets should be taken orally and swallowed whole with a liquid.

MAXALT is also available in a 10 mg oral lyophilisate that dissolves in the mouth. The oral lyophilisate 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 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 MAXALT. 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 MAXALT during an attack, do not take a second dose of MAXALT for the same attack. However, you are still likely to respond to MAXALT during the next attack.

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

If your condition worsens, seek medical attention.

If you take more MAXALT than you should

If you take more MAXALT than you should, consult your doctor or pharmacist immediately, 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 questions 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.

Frequent (affects between 1 and 10 in 100 patients)

• tingling sensation (paresthesia), headache, decreased skin sensitivity (hypoesthesia), decreased mental acuity, insomnia.
• rapid or irregular heart rate (palpitation).
• flushing (temporary redness of the face).
• throat discomfort.
• unpleasantness (nausea), dry mouth, vomiting, diarrhea, indigestion (dyspepsia).
• heaviness in parts of the body, neck pain, numbness.
• abdominal or chest pain.

Infrequent (affects between 1 and 10 in 1,000 patients)

• bad taste in the mouth.
• unsteadiness when walking (ataxia), dizziness (vertigo), blurred vision, tremor, fainting (syncope).
• confusion, nervousness.
• high blood pressure (hypertension); thirst, hot flashes, sweating.
• skin rash, itching, and hives (urticaria); swelling of the face, lips, tongue, or throat 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); alterations in the electrocardiogram (a test that records the heart's electrical activity), rapid heart rate (tachycardia).
• facial pain; muscle pain.

Rare (affects between 1 and 10 in 10,000 patients)

• breathing sounds.
• allergic reaction (hypersensitivity); sudden and potentially fatal 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, man 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 (the frequency cannot be estimated from available data)

• myocardial infarction, 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, man 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 may 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 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 symptom that indicates an allergic reaction (such as rash or itching) after taking MAXALT.

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 box/pouch after "CAD". The expiration date is the last day of the month indicated.

Do not store above 86°F.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medications. By doing so, you will help protect the environment.

Composition of MAXALT

• The active ingredient is rizatriptan. A tablet contains 10mg of rizatriptan equivalent to 14.53mg of rizatriptan benzoate.
• The other components are lactose monohydrate, microcrystalline cellulose (E‑460a), pregelatinized cornstarch, iron oxide red (E‑172) and magnesium stearate (E‑572).

Appearance of the product and contents of the package

The 10mg tablets are pale pink, capsule-shaped, with the code “MAXALT” on one side and “MSD 267” on the other.

Package sizes: packages with 2, 3, 6, 12 or 18tablets.

Packages may only be marketed in some sizes.

Marketing authorization holder and manufacturer

Marketing authorization holder

Organon Salud, S.L.

Paseo de la Castellana, 77

28046 Madrid

Spain

Phone: 915911279

Manufacturer

Merck Sharp & Dohme B.V.

Waarderweg 39

2031 BN Haarlem

Netherlands

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

Austria, Finland, France, Greece, Iceland, Norway,

Netherlands, Portugal, Sweden and United KingdomMAXALT

Belgium, Luxembourg and SpainMAXALT 10mg

GermanyMAXALT 10mg Tabletten

DenmarkMAXALT, tabletter

ItalyMAXALT 10mg compresse

IrelandRizatriptan MSD 10mg Tablets

Czech RepublicMAXALT 10mg, tablety

RomaniaMAXALT 10mg comprimate

Last review date of this leaflet:07/2024.

For detailed and updated information on this medicine, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)