Label: information for the user

MAXALT MAX 10mg lyophilized oral

rizatriptan

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

• Keep this label, as you may need to read 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 who 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 label. See section4.

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

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

Treatment with MAXALT MAX:

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

Do not take MAXALT MAX:

• 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 uncontrolled high blood pressure.
• if you have or have had any heart problems, including myocardial infarction or chest pain (angina) or have experienced signs 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 MAX with other medications).

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take MAXALT MAX, 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, are 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 may 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 MAX frequently, this may lead to chronic headache. In such cases, you should contact your doctor, as you may need to stop taking MAXALT MAX.

Inform your doctor or pharmacist of all your symptoms. Your doctor will decide if you have a migraine. You should only take MAXALT MAX for a migraine attack. MAXALT MAX 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 take regularly for your migraine. This is because MAXALT MAX may affect the way some medications work. Other medications may also affect MAXALT MAX.

Taking MAXALT MAX with other medications

Do not take MAXALT MAX:

• 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 listed above may increase the risk of adverse effects when taken with MAXALT MAX.

After taking MAXALT MAX, you should wait at least 6 hours before taking ergotamine-type medications, such as ergotamine, dihydroergotamine, or methysergide.

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

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

• if you are currently taking propranolol (see section 3 How to take MAXALT MAX).
• 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 MAX with food and drinks

MAXALT MAX may take longer to work if you take it after meals. Although it is best 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 MAX for the fetus when taken by a pregnant woman after the first 3 months of pregnancy is unknown.

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

Children and adolescents

MAXALT MAX lyophilized oral powder 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 MAXALT MAX in patients over 65 years old.

Driving and operating machinery

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

MAXALT MAX contains aspartame

This medication contains 3.75 mg of aspartame in each 10 mg lyophilized oral powder, equivalent to 2.1 mg of phenylalanine.

Aspartame contains a source of phenylalanine that may be harmful in the case of phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body is unable to eliminate it correctly.

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

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of 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 the intake of propranolol and MAXALT, 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 MAXALT MAX. 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 MAX during an attack, do not take a second dose of MAXALT MAX for the treatment of the same attack. However, it is still likely that you will respond to MAXALT MAX during the next attack.

Do not take more than 2 doses of MAXALT MAX 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.

How to administer MAXALT MAX oral lyophilisate

• MAXALT MAX (rizatriptan benzoate) is available in oral lyophilisate form of 10 mg that dissolves in the mouth.
• Open the blister pack of the oral lyophilisate of MAXALT MAX with dry hands.
• Deposit the oral lyophilisate on the tongue, where it will dissolve so that it can be swallowed with saliva.
• 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.

MAXALT is also available in tablets to be taken with liquids.

If you take more MAXALT MAX than you should

If you take more MAXALT MAX 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 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.

Frequent (affects between 1 and 10 in every 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.
• uncomfortable feeling (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 every 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 rash with bumps (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 rate (arrhythmia); alterations in the electrocardiogram (a test that records the electrical activity of the heart), rapid heart rate (tachycardia).
• facial pain; muscle pain.

Rare (affects between 1 and 10 in every 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, smoker, use of nicotine substitutes, 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).

Frequency unknown (the frequency cannot be estimated from the available data)

• heart attack, spasms of the heart's blood vessels (these usually occur in patients with risk factors for heart disease or blood vessel disease (hypertension, diabetes, smoker, use of nicotine substitutes, 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 can 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 of the extremities including cooling and numbness of hands and feet.
• contraction of the blood vessels of 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 MAX.

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 of 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/container/packet after "CAD".The expiration date is the last day of the month indicated.

Do not store at a temperature above 30°C.

Store in the original packaging to protect it from moisture.

Do not remove the blister pack from the aluminum outer envelope until you are about to take the medication it contains.Do not use the medication if the aluminum envelope is damaged.

Always keep the aluminum envelopes inside the container.

Medications should not be disposed of through the drains or trash.Deposit the containers and medications you no longer need at the SIGRE point of the pharmacy.Ask your pharmacist how to dispose of the containers and medications you no longer need if you are unsure. By doing so, you will help protect the environment.

Composition of MAXALT MAX

• The active ingredient is rizatriptan. An oral lyophilisate contains 10mg of rizatriptan equivalent to 14.53mg of rizatriptan benzoate.
• The other components are gelatine, mannitol (E‑421), glycine, aspartame (E‑951) and peppermint aroma (composed of peppermint essence, maltodextrin and dextrin).

Appearance of the product and contents of the package

MAXALT MAX oral lyophilisates are white or off-white, round, with a modified square on one face, with a peppermint flavor.

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

Only some package sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Organon Health, S.L.

Paseo de la Castellana, 77

28046 Madrid

Spain

Phone: 915911279

Responsible for manufacturing

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:

GermanyMAXALT lingua 10mg Schmelztabletten

Austria, Finland, SwedenMAXALT RAPITAB

Belgium, LuxembourgMAXALT LYO 10mg

DenmarkMAXALT Smelt, smeltetabletter

SpainMAXALT MAX 10mg

FranceMAXALT LYO

GreeceMAXALT Rapid Sol. Tab.

ItalyMAXALT RPD 10mg lyophilized oral

IcelandMAXALT SMELT 10mg frostþurrkaðar töflur

IrelandRizatriptan MSD 10mg oral lyophilisates

LithuaniaMAXALT 10mg geriamieji liofilizatai

NorwayMaxalt Rapitab

NetherlandsMAXALT SMELT

United KingdomMAXALT MELT

RomaniaMaxalt 10mg lyophilized oral

Last review date of this leaflet:07/2024.

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)