Maxalt Max 10 mg oral lyophilisate

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

MAXALT MAX 10mg orodispersible tablet

rizatriptan

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

• Keep this leaflet. 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. Do not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What MAXALT MAX is and what it is used for

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

MAXALT MAX is used to treat headache pain during migraine attacks in adults.

Treatment with MAXALT MAX:

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

2. What you need to know before taking MAXALT MAX

Do not take MAXALT MAX:

• if you are allergic to rizatriptan benzoate or to any of the other ingredients of this medicine (listed in section 6).
• you have moderately severe, severe, or uncontrolled mild high blood pressure.
• you have or have ever had heart problems, including myocardial infarction or chest pain (angina), or have experienced signs related to heart disease.
• you have severe liver or kidney problems.
• you have had a stroke or transient ischemic attack (TIA).
• you have arterial obstruction problems (peripheral vascular disease).
• you are taking monoamine oxidase inhibitors (MAO inhibitors) such as moclobemide, phenelzine, tranilcypramine, or pargyline (medicines for depression), or linezolid (an antibiotic), or if less than two weeks have passed since you stopped taking an MAO inhibitor.
• you are currently taking an ergotamine-type medicine, such as ergotamine or dihydroergotamine to treat your migraine, or methysergide to prevent migraine attacks.
• you are currently taking any other medicine of the same class, such as sumatriptan, naratriptan, or zolmitriptan, to treat your migraine (see below Taking MAXALT MAX with other medicines).

If you are unsure whether any of the above apply to you, speak with 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, you are a smoker or using nicotine replacement therapy, your family has a history of heart disease, you are a man over 40 years of age, or you are a postmenopausal woman.
• you have kidney or liver problems.
• you have a specific problem with your heart rhythm (left bundle branch block).
• you have or have had any allergies.
• your headache is associated with dizziness, difficulty walking, lack of coordination, or weakness in your arm or leg.
• you take herbal remedies containing St. John’s wort.
• you have had allergic reactions such as swelling of the face, lips, tongue, and/or throat, which may cause difficulty breathing or swallowing (angioedema).
• 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.
• you have experienced transient symptoms including chest pain or tightness.

If you take MAXALT MAX very 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 about all your symptoms. Your doctor will determine whether you have migraine. You should only take MAXALT MAX for a migraine attack. MAXALT MAX should not be used to treat other types of headache that may be caused by more serious conditions.

Inform your doctor or pharmacist if you are currently using, have recently used, or might need to use any other medicines. This includes herbal remedies and medicines you usually take for migraine. This is because MAXALT MAX may affect how some medicines work. Other medicines may also affect MAXALT MAX.

Taking MAXALT MAX with other medicines

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, tranilcypramine, 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 above-mentioned medicines, when taken with MAXALT MAX, may increase the risk of adverse effects.

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

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

Ask your doctor for instructions on how to take MAXALT MAX and information about 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-noradrenaline reuptake inhibitors (SNRIs) such as venlafaxine and duloxetina for depression.

Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicine.

Taking MAXALT MAX with food and drink

MAXALT MAX may take longer to work if taken after meals. Although it is better to take it on an empty stomach, you may still take it even if you have eaten.

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 MAXALT MAX 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.

Children and adolescents

The use of MAXALT MAX oral lyophilisate is not recommended in children under 18 years of age.

Use in patients over 65 years of age

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

Driving and using machines

When taking MAXALT MAX, you may feel drowsy or dizzy. If this occurs, do not drive or operate tools or machinery.

MAXALT MAX contains aspartame

This medicine contains 3.75 mg of aspartame in each 10 mg oral lyophilisate, equivalent to 2.1 mg of phenylalanine.

Aspartame is a source of phenylalanine, which may be harmful in individuals with phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot properly eliminate it.

3. How to take MAXALT MAX

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

Always follow the instructions for use of this medicine provided 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 should use the 5 mg dose of MAXALT. You must wait at least 2 hours between taking propranolol and taking MAXALT, and no more than 2 doses should be taken within a 24-hour period.

If migraine returns within 24 hours

In some patients, migraine symptoms may recur within 24 hours. If your migraine returns, you may take an additional dose of MAXALT MAX. Always wait at least 2 hours between doses.

If you still have migraine after 2 hours

If you do not respond to the first dose of MAXALT MAX during an attack, you should not take a second dose of MAXALT MAX to treat the same attack. However, you are still likely to respond to MAXALT MAX during the next attack.

Do not take more than 2 doses of MAXALT MAX within a 24-hour period (for example, do not take more than two 10 mg tablets or oral lyophilisates within 24 hours). 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 as a 10 mg oral lyophilisate that dissolves in the mouth.
• Open the oral lyophilisate blister pack with dry hands.
• Place the oral lyophilisate on the tongue, where it will dissolve and 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 swallowing tablets with liquid.

MAXALT is also available as tablets to be taken with liquid.

If you take more MAXALT MAX than you should

If you take more MAXALT MAX than you should, contact your doctor or pharmacist immediately or call the Toxicology Information Service at 91 5620420, stating the medication and the amount taken. It is recommended to bring the medicine packaging and leaflet to the healthcare professional.

Signs of overdose may include dizziness, numbness, vomiting, fainting, and slow heart rate.

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 experiences them. The following adverse effects may occur with this medicine.

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

Common (affect between 1 and 10 out of every 100 patients)

• tingling sensation (paraesthesia), headache, reduced skin sensitivity (hypoesthesia), decreased mental sharpness, insomnia.
• fast or irregular heartbeat (palpitations).
• flushing (temporary redness of the face).
• throat discomfort.
• malaise (nausea), dry mouth, vomiting, diarrhoea, indigestion (dyspepsia).
• heaviness in parts of the body, neck pain, numbness.
• abdominal or chest pain.

Uncommon (affect between 1 and 10 out of 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 flushes, sweating.
• skin rash, itching and rash with lumps (urticaria); swelling of the face, lips, tongue or throat which may cause difficulty breathing or swallowing (angioedema), difficulty breathing (dyspnoea).
• sensation of stiffness in parts of the body, muscle weakness.
• changes in heart rhythm or rate (arrhythmia); electrocardiogram abnormalities (a test that records the electrical activity of your heart), very fast heartbeat (tachycardia).
• facial pain; muscle pain.

Rare (affect between 1 and 10 out of every 10,000 patients)

• noisy breathing.
• allergic reaction (hypersensitivity); sudden and potentially life-threatening allergic reaction (anaphylaxis).
• stroke (this usually occurs in patients with risk factors for heart or blood vessel disease (hypertension, diabetes, smoker, use of nicotine replacement therapy, family history of heart disease or stroke, men over 40 years of age, postmenopausal women, and a specific problem with the way the heart beats (left bundle branch block)).
• slow heartbeat (bradycardia).

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

• myocardial infarction, spasms of the blood vessels of the heart (these usually occur in patients with risk factors for heart or blood vessel disease (hypertension, diabetes, smoker, use of nicotine replacement therapy, family history of heart disease or stroke, men over 40 years of age, postmenopausal women, and a specific problem with the way the heart beats (left bundle branch block)).
• a syndrome called "serotonin syndrome" which may cause adverse effects such as coma, unstable blood pressure, extremely high fever, lack of muscle coordination, agitation, and hallucinations.
• severe peeling of the skin with or without fever (toxic epidermal necrolysis).
• seizures (convulsions/spasms).
• constriction of blood vessels in the limbs, including cooling and numbness of hands and feet.
• constriction of blood vessels in the colon (large intestine), which may cause abdominal pain.

Contact 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 symptoms indicating an allergic reaction (such as rash or itching) after taking MAXALT MAX.

Reporting of adverse effects:

If you experience any kind of adverse effect, consult 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 Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of MAXALT MAX

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

Do not use this medicine after the expiry date stated on the carton/outer carton/pouch/blister after "EXP". The expiry date refers to the last day of the month indicated.

Do not store above 30°C.

Store in the original packaging to protect it from moisture.

Do not remove the oral lyophilisate blister from the outer aluminum pouch until you are ready to take the medicine contained within. Do not use the medicine if the aluminum pouch is damaged.

Always keep the aluminum pouches inside the outer carton.

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

6. Contents of the pack and other information

Composition of MAXALT MAX

• The active substance is rizatriptan. One oral lyophilisate contains 10 mg of rizatriptan, equivalent to 14.53 mg of rizatriptan benzoate.
• The other components are gelatin, mannitol (E-421), glycine, aspartame (E-951), and peppermint flavour (composed of peppermint essence, maltodextrin, and dextrin).

Appearance of the medicinal product and contents of the pack

MAXALT MAX oral lyophilisates are white or almost white, round, with a modified square on one side, and have a peppermint flavour.

Pack sizes: packs containing 2, 3, 6, 12 or 18 oral lyophilisates.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Organon Salud, S.L.
Paseo de la Castellana, 77
28046 Madrid
Spain
Tel.: 915911279

Manufacturer

Merck Sharp & Dohme B.V.
Waarderweg 39
2031 BN Haarlem
The Netherlands

N.V. Organon
Kloosterstraat 6
5349 AB Oss
The Netherlands

This medicinal product is authorised in the European Economic Area (EEA) member states under the following names:

Germany MAXALT lingua 10 mg Schmelztabletten
Austria, Finland, Sweden MAXALT RAPITAB
Belgium, Luxembourg MAXALT LYO 10 mg
Denmark MAXALT Smelt, smeltetabletter
Spain MAXALT MAX 10 mg
France MAXALT LYO
Greece MAXALT Rapid Sol. Tab.
Italy MAXALT RPD 10 mg liofilizzato orale
Iceland MAXALT SMELT 10 mg frostþurrkaðar töflur
Ireland Rizatriptan MSD 10 mg oral lyophilisates
Lithuania MAXALT 10 mg geriamieji liofilizatai
Norway Maxalt Rapitab
The Netherlands MAXALT SMELT
United Kingdom MAXALT MELT
Romania Maxalt 10 mg liofilizat oral

Date of the most recent review of this leaflet: 07/2024.

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (Agencia Española de Medicamentos y Productos Sanitarios - AEMPS) (http://www.aemps.gob.es/)